Florida Senate - 2008 CS for CS for SB 2756
By the Committees on Judiciary; Health Regulation; and Senator Peaden
590-08217-08 20082756c2
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A bill to be entitled
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An act relating to drugs, devices, and cosmetics; amending
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and reorganizing provisions in part I of ch. 499, F.S.;
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amending s. 499.002, F.S.; expanding the provisions of the
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section to include administration and enforcement of,
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exemptions from, and purpose of the part; amending and
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499.081, F.S., as provisions in that section relating to
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such functions to conform; amending s. 499.003, F.S.;
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revising and providing definitions; amending and
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499.0661, F.S., relating to definitions, as provisions of
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that section; amending s. 499.005, F.S.; conforming
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provisions to changes made by the act, including the
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substitution of the term "prescription drug" for the term
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"legend drug"; amending s. 499.0051, F.S.; substituting
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the term "prescription drug" for the term "legend drug"
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with regard to criminal acts; consolidating criminal act
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provisions of part I of ch. 499, F.S.; amending and
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and 499.0691, F.S., as criminal offense provisions in that
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section; providing penalties; conforming provisions to
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changes made by the act; amending s. 499.0054, F.S.,
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relating to advertising and labeling of drugs, devices,
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and cosmetics to include certain exemptions; amending and
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provisions relating to those functions in that section;
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amending s. 499.006, F.S.; conforming provisions to
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changes made by the act; amending s. 499.007, F.S.;
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conforming provisions to changes made by the act;
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providing that a drug or device is misbranded if it is an
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active pharmaceutical ingredient in bulk form and does not
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bear a label containing certain information; amending ss.
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changes made by the act; amending s. 499.01, F.S.;
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providing that the section relates only to permits;
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requiring a permit to operate as a third party logistics
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provider and a health care clinic establishment; providing
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requirements for obtaining a permit to operate in certain
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capacities; deleting certain permit requirements;
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providing an exemption for a nonresident prescription drug
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manufacturer permit; providing requirements for such
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exemption; providing requirements for a third party
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logistics provider permit and a health care clinic
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establishment permit; amending and redesignating
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such functions as provisions of that section; conforming
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provisions and cross-references to changes made by the
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act; amending s. 499.012, F.S.; providing that the section
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relates to permit application requirements; providing that
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a separate establishment permit is not required when a
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permitted prescription drug wholesale distributor operates
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temporary transit storage facilities for the sole purpose
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of storage; amending the provisions to conform; amending
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and redesignating provisions of s. 499.01, F.S., relating
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to such functions as provisions of that section;
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conforming provisions and cross-references to changes made
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by the act; amending s. 499.01201, F.S.; conforming
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provisions to changes made by the act; amending s.
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499.0121, F.S., relating to storage and handling of
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prescription drugs and recordkeeping; directing the
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department to adopt rules requiring a wholesale
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distributor to maintain pedigree papers separate and
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distinct from other required records; deleting a
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requirement that a person who is engaged in the wholesale
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distribution of a prescription drug and who is not the
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manufacturer of that drug provide a pedigree paper to the
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person who receives the drug; deleting the department's
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requirement to adopt rules with regard to recordkeeping by
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affiliated groups; conforming provisions and cross-
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references to changes made by the act; amending and
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redesignating a provision of s. 499.013, F.S., relating to
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such functions as a provision of that section; amending s.
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499.01211, F.S.; conforming provisions and cross-
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references to changes made by the act; creating s.
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499.01212, F.S.; requiring a person who is engaged in the
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wholesale distribution of a prescription drug to provide a
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pedigree paper to the person who receives the drug;
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requiring certain information in a pedigree paper;
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requiring a wholesale distributor to maintain and make
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available to the department certain information; providing
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exceptions to the requirement of a pedigree paper;
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repealing s. 499.0122, F.S., relating to medical oxygen
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and veterinary legend drug retail establishments;
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repealing s. 499.013, F.S., relating to manufacturers and
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repackagers of drugs, devices, and cosmetics; amending ss.
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conforming provisions and cross-references to changes made
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conforming terminology to changes made by the act;
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amending s. 499.039, F.S.; conforming a provision and
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cross-reference; amending ss. 499.04, F.S.; conforming
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provisions to changes made by the act; amending s.
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499.041, F.S.; conforming provisions to changes made by
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the act; requiring the department to assess an annual fee
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for a third part logistic provider permit and a health
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care clinic establishment permit; amending s. 499.05,
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F.S.; conforming provisions to changes made by the act;
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requiring the department to adopt rules with regard to
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procedures and forms relating to pedigree paper
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requirements, alternatives to compliance with the
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requirement of certain pedigree papers, and the return of
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prescription drugs purchased before a specified date;
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amending and redesignating provisions of ss. 499.013 and
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499.0122, F.S., as provisions relating to rulemaking
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changes made by the act; amending s. 499.062, F.S.;
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providing that the section relates to seizure and
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condemnation of drugs, devices, or cosmetics; conforming a
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provision to changes made by the act; amending and
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relating to such functions in that section; amending ss.
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provisions and cross-references to changes made by the
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changes made by the act; conforming cross-references to
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changes made by the act; providing an effective date.
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Be It Enacted by the Legislature of the State of Florida:
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Section 1. Section 499.002, Florida Statutes, is amended;
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section 499.004, Florida Statutes, is redesignated as subsection
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(2) of that section and amended; section 499.0053, Florida
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Statutes, is redesignated as subsection (3) of that section and
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amended; section 499.07, Florida Statutes, is redesignated as
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subsection (4) of that section and amended; section 499.071,
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Florida Statutes, is redesignated as subsection (5) of that
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section and amended; and section 499.081, Florida Statutes, is
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redesignated as subsection (6) of that section and amended, to
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read:
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499.002 Purpose, administration, and enforcement of and
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(a)(1) Safeguard the public health and promote the public
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welfare by protecting the public from injury by product use and
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by merchandising deceit involving drugs, devices, and cosmetics.
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(b)(2) Provide uniform legislation to be administered so
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far as practicable in conformity with the provisions of, and
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regulations issued under the authority of, the Federal Food,
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Drug, and Cosmetic Act and that portion of the Federal Trade
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Commission Act which expressly prohibits the false advertisement
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of drugs, devices, and cosmetics.
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(c)(3) Promote thereby uniformity of such state and federal
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laws, and their administration and enforcement, throughout the
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United States.
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(2) 499.004 Administration and enforcement by
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department.--The department of Health shall administer and
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adulteration, misbranding, or false advertising in the
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preparation, manufacture, repackaging, or distribution of drugs,
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devices, and cosmetics.
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(3) 499.0053 Power to administer oaths, take depositions,
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and issue and serve subpoenas.--For the purpose of any
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investigation or proceeding conducted by the department under
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oaths, take depositions, issue and serve subpoenas, and compel
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the attendance of witnesses and the production of books, papers,
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documents, or other evidence. The department shall exercise this
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power on its own initiative. Challenges to, and enforcement of,
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the subpoenas and orders shall be handled as provided in s.
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(4) 499.07 Duty of prosecuting officer.--Each state
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attorney, county attorney, or municipal attorney to whom the
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department or its designated agent reports any violation of this
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be instituted in the proper courts without delay and to be
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prosecuted in the manner required by law.
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(5) 499.071 Issuance of warnings for minor
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require the department to report, for the institution of
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interest will be adequately served in the circumstances by a
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suitable written notice or warning.
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(6) 499.081 Carriers in interstate commerce exempted from
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are engaged in the usual course of business as common carriers.
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Section 2. Section 499.003, Florida Statutes, is amended;
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paragraphs (a) through (f) of subsection (1) of section 499.012,
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Florida Statutes, are redesignated as subsections (55), (56),
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(52), and (48), paragraph (c) of subsection (48), and subsection
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(53), respectively, of that section and amended; paragraphs (f)
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through (j) and (l) through (m) of subsection (3) of section
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499.029, Florida Statutes, are redesignated as subsections (25),
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(26), (27), (35), (40), and (41), and, respectively, of that
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section and amended; and subsection (1) of section 499.0661,
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Florida Statutes, is redesignated as subsection (38) of that
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section and amended, to read:
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(1) "Advertisement" means any representation disseminated
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in any manner or by any means, other than by labeling, for the
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purpose of inducing, or which is likely to induce, directly or
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indirectly, the purchase of drugs, devices, or cosmetics.
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(2) "Affiliated group" means an affiliated group as defined
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by s. 1504 of the Internal Revenue Code of 1986, as amended,
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which is composed of chain drug entities, including at least 50
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retail pharmacies, warehouses, or repackagers, which are members
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of the same affiliated group. The affiliated group must disclose
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the names of all its members to the department.
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(3)(2) "Affiliated party" means:
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(a) A director, officer, trustee, partner, or committee
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member of a permittee or applicant or a subsidiary or service
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corporation of the permittee or applicant;
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(b) A person who, directly or indirectly, manages,
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controls, or oversees the operation of a permittee or applicant,
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regardless of whether such person is a partner, shareholder,
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manager, member, officer, director, independent contractor, or
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employee of the permittee or applicant;
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(c) A person who has filed or is required to file a
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personal information statement pursuant to s. 499.012(9) s.
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499.012(4) or is required to be identified in an application for
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a permit or to renew a permit pursuant to s. 499.012(8) s.
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499.012(3); or
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(d) The five largest natural shareholders that own at least
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5 percent of the permittee or applicant.
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(4)(3) "Applicant" means a person applying for a permit or
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(5)(4) "Authenticate" means to affirmatively verify upon
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receipt before any distribution of a prescription legend drug
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occurs that each transaction listed on the pedigree paper has
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occurred.
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(a) A wholesale distributor is not required to open a
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sealed, medical convenience kit to authenticate a pedigree paper
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for a prescription drug contained within the kit.
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(b) Authentication of a prescription drug included in a
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sealed, medical convenience kit shall be limited to verifying the
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transaction and pedigree information received.
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(6)(5) "Certificate of free sale" means a document prepared
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by the department which certifies a drug, device, or cosmetic,
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that is registered with the department, as one that can be
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legally sold in the state.
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(7) "Chain pharmacy warehouse" means a wholesale
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distributor permitted pursuant to s. 499.01 that maintains a
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physical location for prescription drugs that functions solely as
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a central warehouse to perform intracompany transfers of such
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drugs to a member of its affiliated group.
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(8)(6) "Closed pharmacy" means a pharmacy that is licensed
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under chapter 465 and purchases prescription drugs for use by a
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limited patient population and not for wholesale distribution or
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sale to the public. The term does not include retail pharmacies.
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(9)(7) "Color" includes black, white, and intermediate
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grays.
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(10)(8) "Color additive" means, with the exception of any
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material that has been or hereafter is exempt under the federal
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act, a material that:
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(a) Is a dye pigment, or other substance, made by a process
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of synthesis or similar artifice, or extracted, isolated, or
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otherwise derived, with or without intermediate or final change
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of identity from a vegetable, animal, mineral, or other source;
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or
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(b) When added or applied to a drug or cosmetic or to the
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human body, or any part thereof, is capable alone, or through
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reaction with other substances, of imparting color thereto;
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except that the term does not include any material which has been
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or hereafter is exempt under the federal act.
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(11)(9) "Compressed medical gas" means any liquefied or
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vaporized gas that is a prescription drug, whether it is alone or
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in combination with other gases.
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(12)(10) "Contraband prescription legend drug" means any
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adulterated drug, as defined in s. 499.006, any counterfeit drug,
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as defined in this section, and also means any prescription
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legend drug for which a pedigree paper does not exist, or for
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which the pedigree paper in existence has been forged,
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counterfeited, falsely created, or contains any altered, false,
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or misrepresented matter.
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(13)(11) "Cosmetic" means an article, with the exception of
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soap, that is:
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(a) Intended to be rubbed, poured, sprinkled, or sprayed
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on; introduced into; or otherwise applied to the human body or
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any part thereof for cleansing, beautifying, promoting
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attractiveness, or altering the appearance; or
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(b) Intended for use as a component of any such article;
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except that the term does not include soap.
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(14)(12) "Counterfeit drug," "counterfeit device," or
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"counterfeit drug, counterfeit device, or counterfeit cosmetic"
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means a drug, device, or cosmetic which, or the container, seal,
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or labeling of which, without authorization, bears the trademark,
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trade name, or other identifying mark, imprint, or device, or any
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likeness thereof, of a drug, device, or cosmetic manufacturer,
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processor, packer, or distributor other than the person that in
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fact manufactured, processed, packed, or distributed that drug,
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device, or cosmetic and which thereby falsely purports or is
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represented to be the product of, or to have been packed or
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distributed by, that other drug, device, or cosmetic
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manufacturer, processor, packer, or distributor.
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(15)(13) "Department" means the Department of Health.
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(16)(14) "Device" means any instrument, apparatus,
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implement, machine, contrivance, implant, in vitro reagent, or
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other similar or related article, including its components,
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parts, or accessories, which is:
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(a) Recognized in the current edition of the United States
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Pharmacopoeia and National Formulary, or any supplement thereof,
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(b) Intended for use in the diagnosis, cure, mitigation,
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treatment, therapy, or prevention of disease in humans or other
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animals, or
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(c) Intended to affect the structure or any function of the
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body of humans or other animals,
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and that which does not achieve any of its principal intended
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purposes through chemical action within or on the body of humans
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or other animals and which is not dependent upon being
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metabolized for the achievement of any of its principal intended
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purposes.
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(17)(15) "Distribute or distribution" or "distribution"
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means to sell; offer to sell; give away; transfer, whether by
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passage of title, physical movement, or both; deliver; or offer
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to deliver. The term does not mean to administer or dispense.
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(18) "Drop shipment" means the sale of a prescription drug
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from a manufacturer to a wholesale distributor, where the
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wholesale distributor takes title to, but not possession of, the
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prescription drug and the manufacturer of the prescription drug
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ships the prescription drug directly to a chain pharmacy
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warehouse or a person authorized by law to purchase prescription
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drugs for the purpose of administering or dispensing the drug, as
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defined in s. 465.003.
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(16) "Diverted from the legal channels of distribution for
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prescription drugs" means an adulterated drug pursuant to s.
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499.006(10).
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(19)(17) "Drug" means an article that is:
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(a) Recognized in the current edition of the United States
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Pharmacopoeia and National Formulary, official Homeopathic
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Pharmacopoeia of the United States, or any supplement to any of
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those publications;
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(b) Intended for use in the diagnosis, cure, mitigation,
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treatment, therapy, or prevention of disease in humans or other
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animals;
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(c) Intended to affect the structure or any function of the
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body of humans or other animals; or
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(d) Intended for use as a component of any article
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specified in paragraph (a), paragraph (b), or paragraph (c), but
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does not include devices or their components, parts, or
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accessories.
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(20)(18) "Establishment" means a place of business at one
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general physical location.
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(21)(19) "Federal act" means the Federal Food, Drug, and
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Cosmetic Act, 21 U.S.C. ss. 301 et seq.; 52 Stat. 1040 et seq.
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(22)(20) "Freight forwarder" means a person who receives
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prescription legend drugs which are owned by another person and
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designated by that person for export, and exports those
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prescription legend drugs.
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(23)(21) "Health care entity" means a closed pharmacy or
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any person, organization, or business entity that provides
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diagnostic, medical, surgical, or dental treatment or care, or
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chronic or rehabilitative care, but does not include any
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wholesale distributor or retail pharmacy licensed under state law
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to deal in prescription drugs.
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(24)(f) "Health care facility" means a health care facility
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licensed under chapter 395.
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(25)(h) "Hospice" means a corporation licensed under part
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IV of chapter 400.
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(26)(i) "Hospital" means a facility as defined in s.
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395.002 and licensed under chapter 395.
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(27)(22) "Immediate container" does not include package
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liners.
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(28)(23) "Label" means a display of written, printed, or
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graphic matter upon the immediate container of any drug, device,
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or cosmetic. A requirement made by or under authority of this
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sections that any word, statement, or other information appear on
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the label is not complied with unless such word, statement, or
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other information also appears on the outside container or
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wrapper, if any, of the retail package of such drug, device, or
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cosmetic or is easily legible through the outside container or
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wrapper.
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(29)(24) "Labeling" means all labels and other written,
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printed, or graphic matters:
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(a) Upon a drug, device, or cosmetic, or any of its
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containers or wrappers; or
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(b) Accompanying or related to such drug, device, or
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cosmetic.
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(25) "Legend drug," "prescription drug," or "medicinal
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drug" means any drug, including, but not limited to, finished
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dosage forms, or active ingredients subject to, defined by, or
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described by s. 503(b) of the Federal Food, Drug, and Cosmetic
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(c).
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(26) "Legend drug label" means any display of written,
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printed, or graphic matter upon the immediate container of any
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legend drug prior to its dispensing to an individual patient
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pursuant to a prescription of a practitioner authorized by law to
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prescribe.
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(30)(27) "Manufacture" means the preparation, deriving,
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compounding, propagation, processing, producing, or fabrication
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of any drug, device, or cosmetic.
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(31)(28) "Manufacturer" means:
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(a) A person who prepares, derives, manufactures, or
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produces a drug, device, or cosmetic.
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(b) The holder or holders of a New Drug Application (NDA),
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an Abbreviated New Drug Application (ANDA), a Biologics License
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Application (BLA), or a New Animal Drug Application (NADA),
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provided such application has become effective or is otherwise
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approved consistent with s. 499.023; a private label distributor
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for whom the private label distributor's prescription drugs are
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originally manufactured and labeled for the distributor and have
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not been repackaged; or the distribution point for the
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manufacturer, contract manufacturer, or private label distributor
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whether the establishment is a member of the manufacturer's
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affiliated group or is a contract distribution site.
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The term excludes pharmacies that are operating in compliance
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with pharmacy practice standards as defined in chapter 465 and
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rules adopted under that chapter.
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(32)(29) "New drug" means:
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(a) Any drug the composition of which is such that the drug
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is not generally recognized, among experts qualified by
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scientific training and experience to evaluate the safety and
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effectiveness of drugs, as safe and effective for use under the
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conditions prescribed, recommended, or suggested in the labeling
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of that drug; or
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(b) Any drug the composition of which is such that the
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drug, as a result of investigations to determine its safety and
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effectiveness for use under certain conditions, has been
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recognized for use under such conditions, but which drug has not,
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other than in those investigations, been used to a material
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extent or for a material time under such conditions.
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(33) "Normal distribution chain" means a wholesale
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distribution of a prescription drug in which the wholesale
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distributor or its wholly owned subsidiary purchases and receives
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the specific unit of the prescription drug directly from the
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manufacturer and distributes the prescription drug directly, or
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through up to two intracompany transfers, to a chain pharmacy
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warehouse or a person authorized by law to purchase prescription
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drugs for the purpose of administering or dispensing the drug, as
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defined in s. 465.003. For purposes of this subsection, the term
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"intracompany" means any transaction or transfer between any
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parent, division, or subsidiary wholly owned by a corporate
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entity.
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(34)(j) "Nursing home" means a facility licensed under part
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II of chapter 400.
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(35)(30) "Official compendium" means the current edition of
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the official United States Pharmacopoeia and National Formulary,
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or any supplement thereto.
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(36)(31) "Pedigree paper" means:
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(a) Effective July 1, 2006, A document in written or
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electronic form approved by the department which contains of
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Health and containing information required by s. 499.01212
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regarding the sale and that records each distribution of any
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given prescription legend drug, from sale by a pharmaceutical
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manufacturer, through acquisition and sale by any wholesaler or
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repackager, until final sale to a pharmacy or other person
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administering or dispensing the drug. The information required to
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be included on the form approved by the department pursuant to
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this paragraph must at least detail the amount of the legend
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drug; its dosage form and strength; its lot numbers; the name and
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address of each owner of the legend drug and his or her
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signature; its shipping information, including the name and
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address of each person certifying delivery or receipt of the
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legend drug; an invoice number, a shipping document number, or
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another number uniquely identifying the transaction; and a
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certification that the recipient wholesaler has authenticated the
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pedigree papers. If the manufacturer or repackager has uniquely
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serialized the individual legend drug unit, that identifier must
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also be included on the form approved pursuant to this paragraph.
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It must also include the name, address, telephone number and, if
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available, e-mail contact information of each wholesaler involved
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in the chain of the legend drug's custody; or
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(b) A statement, under oath, in written or electronic form,
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confirming that a wholesale distributor purchases and receives
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the specific unit of the prescription drug directly from the
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manufacturer of the prescription drug and distributes the
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prescription drug directly, or through an intracompany transfer,
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to a chain pharmacy warehouse or a person authorized by law to
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purchase prescription drugs for the purpose of administering or
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dispensing the drug, as defined in s. 465.003. For purposes of
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this subsection, the term "chain pharmacy warehouse" means a
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wholesale distributor permitted pursuant to s. 499.01 that
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maintains a physical location for prescription drugs that
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functions solely as a central warehouse to perform intracompany
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transfers of such drugs to a member of its affiliated group as
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described in s. 499.0121(6)(f)1.
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1. The information required to be included pursuant to this
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paragraph must include:
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a. The following statement: "This wholesale distributor
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purchased the specific unit of the prescription drug directly
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from the manufacturer."
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b. The manufacturer's national drug code identifier and the
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name and address of the wholesaler and the purchaser of the
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prescription drug.
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c. The name of the prescription drug as it appears on the
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label.
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d. The quantity, dosage form, and strength of the
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prescription drug.
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2. The wholesale distributor must also maintain and make
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available to the department, upon request, the point of origin of
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the prescription drugs, including intracompany transfers; the
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date of the shipment from the manufacturer to the wholesale
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distributor; the lot numbers of such drugs; and the invoice
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numbers from the manufacturer.
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The department may adopt rules and forms relating to the
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requirements of this subsection.
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(37)(1) DEFINITION.--As used in this section, the term
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"Permittee" means any person holding a permit issued pursuant to
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s. 499.012.
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(38)(32) "Person" means any individual, child, joint
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venture, syndicate, fiduciary, partnership, corporation, division
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of a corporation, firm, trust, business trust, company, estate,
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public or private institution, association, organization, group,
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city, county, city and county, political subdivision of this
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state, other governmental agency within this state, and any
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representative, agent, or agency of any of the foregoing, or any
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other group or combination of the foregoing.
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(39)(l) "Pharmacist" means a person licensed under chapter
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465.
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(40)(m) "Pharmacy" means an entity licensed under chapter
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465.
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(41)(33) "Prepackaged drug product" means a drug that
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originally was in finished packaged form sealed by a manufacturer
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and that is placed in a properly labeled container by a pharmacy
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or practitioner authorized to dispense pursuant to chapter 465
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for the purpose of dispensing in the establishment in which the
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prepackaging occurred.
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(42) "Prescription drug" means a prescription, medicinal,
520
or legend drug, including, but not limited to, finished dosage
521
forms or active ingredients subject to, defined by, or described
522
by s. 503(b) of the Federal Food, Drug, and Cosmetic Act or s.
524
or subsection (54).
525
(43) "Prescription drug label" means any display of
526
written, printed, or graphic matter upon the immediate container
527
of any prescription drug prior to its dispensing to an individual
528
patient pursuant to a prescription of a practitioner authorized
529
by law to prescribe.
530
(44)(34) "Prescription label" means any display of written,
531
printed, or graphic matter upon the immediate container of any
532
prescription legend drug dispensed pursuant to a prescription of
533
a practitioner authorized by law to prescribe.
534
(45)(35) "Prescription medical oxygen" means oxygen USP
535
which is a drug that can only be sold on the order or
536
prescription of a practitioner authorized by law to prescribe.
537
The label of prescription medical oxygen must comply with current
538
labeling requirements for oxygen under the Federal Food, Drug,
539
and Cosmetic Act.
540
(46)(d) "Primary wholesale distributor wholesaler" means
541
any wholesale distributor that:
542
(a)1. Purchased 90 percent or more of the total dollar
543
volume of its purchases of prescription drugs directly from
544
manufacturers in the previous year; and
545
(b)1.2.a. Directly purchased prescription drugs from not
546
fewer than 50 different prescription drug manufacturers in the
547
previous year; or
548
2.b. Has, or the affiliated group, as defined in s. 1504 of
549
the Internal Revenue Code, of which the wholesale distributor is
550
a member has, not fewer than 250 employees.
551
(c)(e) For purposes of this subsection, "directly from
552
manufacturers a manufacturer" means:
553
1. Purchases made by the wholesale distributor directly
554
from the manufacturer of prescription drugs; and
555
2. Transfers from a member of an affiliated group, as
556
defined in s. 1504 of the Internal Revenue Code, of which the
557
wholesale distributor is a member, if:
558
a. The affiliated group purchases 90 percent or more of the
559
total dollar volume of its purchases of prescription drugs from
560
the manufacturer in the previous year; and
561
b. The wholesale distributor discloses to the department
562
the names of all members of the affiliated group of which the
563
wholesale distributor is a member and the affiliated group agrees
564
in writing to provide records on prescription drug purchases by
565
the members of the affiliated group not later than 48 hours after
566
the department requests access to such records, regardless of the
567
location where the records are stored.
568
(47)(36) "Proprietary drug," or "OTC drug," means a patent
569
or over-the-counter drug in its unbroken, original package, which
570
drug is sold to the public by, or under the authority of, the
571
manufacturer or primary distributor thereof, is not misbranded
573
purchased without a prescription.
574
(48)(37) "Repackage" includes repacking or otherwise
575
changing the container, wrapper, or labeling to further the
576
distribution of the drug, device, or cosmetic.
577
(49)(38) "Repackager" means a person who repackages. The
578
term excludes pharmacies that are operating in compliance with
579
pharmacy practice standards as defined in chapter 465 and rules
580
adopted under that chapter.
581
(50)(c) "Retail pharmacy" means a community pharmacy
582
licensed under chapter 465 that purchases prescription drugs at
583
fair market prices and provides prescription services to the
584
public.
585
(51)(f) "Secondary wholesale distributor wholesaler" means
586
a wholesale distributor that is not a primary wholesale
587
distributor wholesaler.
588
(53)(39) "Veterinary prescription drug" means a
589
prescription legend drug intended solely for veterinary use. The
590
label of the drug must bear the statement, "Caution: Federal law
591
restricts this drug to sale by or on the order of a licensed
592
veterinarian."
593
(40) "Veterinary prescription drug wholesaler" means any
594
person engaged in wholesale distribution of veterinary
595
prescription drugs in or into this state.
596
(54)(a) "Wholesale distribution" means distribution of
597
prescription drugs to persons other than a consumer or patient,
598
but does not include:
599
(a)1. Any of the following activities, which is not a
600
violation of s. 499.005(21) if such activity is conducted in
602
1.a. The purchase or other acquisition by a hospital or
603
other health care entity that is a member of a group purchasing
604
organization of a prescription drug for its own use from the
605
group purchasing organization or from other hospitals or health
606
care entities that are members of that organization.
607
2.b. The sale, purchase, or trade of a prescription drug or
608
an offer to sell, purchase, or trade a prescription drug by a
609
charitable organization described in s. 501(c)(3) of the Internal
610
Revenue Code of 1986, as amended and revised, to a nonprofit
611
affiliate of the organization to the extent otherwise permitted
612
by law.
613
3.c. The sale, purchase, or trade of a prescription drug or
614
an offer to sell, purchase, or trade a prescription drug among
615
hospitals or other health care entities that are under common
616
control. For purposes of this subparagraph section, "common
617
control" means the power to direct or cause the direction of the
618
management and policies of a person or an organization, whether
619
by ownership of stock, by voting rights, by contract, or
620
otherwise.
621
4.d. The sale, purchase, trade, or other transfer of a
622
prescription drug from or for any federal, state, or local
623
government agency or any entity eligible to purchase prescription
624
drugs at public health services prices pursuant to Pub. L. No.
625
102-585, s. 602 to a contract provider or its subcontractor for
626
eligible patients of the agency or entity under the following
627
conditions:
628
a.(I) The agency or entity must obtain written
629
authorization for the sale, purchase, trade, or other transfer of
630
a prescription drug under this subparagraph sub-subparagraph from
631
the State Surgeon General or his or her designee.
632
b.(II) The contract provider or subcontractor must be
633
authorized by law to administer or dispense prescription drugs.
634
c.(III) In the case of a subcontractor, the agency or
635
entity must be a party to and execute the subcontract.
636
d.(IV) A contract provider or subcontractor must maintain
637
separate and apart from other prescription drug inventory any
638
prescription drugs of the agency or entity in its possession.
639
e.(V) The contract provider and subcontractor must maintain
640
and produce immediately for inspection all records of movement or
641
transfer of all the prescription drugs belonging to the agency or
642
entity, including, but not limited to, the records of receipt and
643
disposition of prescription drugs. Each contractor and
644
subcontractor dispensing or administering these drugs must
645
maintain and produce records documenting the dispensing or
646
administration. Records that are required to be maintained
647
include, but are not limited to, a perpetual inventory itemizing
648
drugs received and drugs dispensed by prescription number or
649
administered by patient identifier, which must be submitted to
650
the agency or entity quarterly.
651
f.(VI) The contract provider or subcontractor may
652
administer or dispense the prescription drugs only to the
653
eligible patients of the agency or entity or must return the
654
prescription drugs for or to the agency or entity. The contract
655
provider or subcontractor must require proof from each person
656
seeking to fill a prescription or obtain treatment that the
657
person is an eligible patient of the agency or entity and must,
658
at a minimum, maintain a copy of this proof as part of the
659
records of the contractor or subcontractor required under sub-
660
subparagraph e. sub-sub-subparagraph (V).
661
g.(VII) In addition to the departmental inspection
662
authority set forth in s. 499.051, the establishment of the
663
contract provider and subcontractor and all records pertaining to
664
prescription drugs subject to this subparagraph sub-subparagraph
665
shall be subject to inspection by the agency or entity. All
666
records relating to prescription drugs of a manufacturer under
667
this subparagraph sub-subparagraph shall be subject to audit by
668
the manufacturer of those drugs, without identifying individual
669
patient information.
670
(b)2. Any of the following activities, which is not a
671
violation of s. 499.005(21) if such activity is conducted in
672
accordance with rules established by the department:
673
1.a. The sale, purchase, or trade of a prescription drug
674
among federal, state, or local government health care entities
675
that are under common control and are authorized to purchase such
676
prescription drug.
677
2.b. The sale, purchase, or trade of a prescription drug or
678
an offer to sell, purchase, or trade a prescription drug for
679
emergency medical reasons. For purposes of this subparagraph sub-
680
subparagraph, the term "emergency medical reasons" includes
681
transfers of prescription drugs by a retail pharmacy to another
682
retail pharmacy to alleviate a temporary shortage.
683
3.c. The transfer of a prescription drug acquired by a
684
medical director on behalf of a licensed emergency medical
685
services provider to that emergency medical services provider and
686
its transport vehicles for use in accordance with the provider's
687
license under chapter 401.
688
4.d. The revocation of a sale or the return of a
689
prescription drug to the person's prescription drug wholesale
690
supplier.
691
5.e. The donation of a prescription drug by a health care
692
entity to a charitable organization that has been granted an
693
exemption under s. 501(c)(3) of the Internal Revenue Code of
694
1986, as amended, and that is authorized to possess prescription
695
drugs.
696
6.f. The transfer of a prescription drug by a person
697
authorized to purchase or receive prescription drugs to a person
698
licensed or permitted to handle reverse distributions or
699
destruction under the laws of the jurisdiction in which the
700
person handling the reverse distribution or destruction receives
701
the drug.
702
7.g. The transfer of a prescription drug by a hospital or
703
other health care entity to a person licensed under this part
704
chapter to repackage prescription drugs for the purpose of
705
repackaging the prescription drug for use by that hospital, or
706
other health care entity and other health care entities that are
707
under common control, if ownership of the prescription drugs
708
remains with the hospital or other health care entity at all
709
times. In addition to the recordkeeping requirements of s.
710
499.0121(6), the hospital or health care entity that transfers
711
prescription drugs pursuant to this subparagraph sub-subparagraph
712
must reconcile all drugs transferred and returned and resolve any
713
discrepancies in a timely manner.
714
(c)3. The distribution of prescription drug samples by
715
manufacturers' representatives or distributors' representatives
716
conducted in accordance with s. 499.028.
717
(d)4. The sale, purchase, or trade of blood and blood
718
components intended for transfusion. As used in this paragraph
719
subparagraph, the term "blood" means whole blood collected from a
720
single donor and processed either for transfusion or further
721
manufacturing, and the term "blood components" means that part of
722
the blood separated by physical or mechanical means.
723
(e)5. The lawful dispensing of a prescription drug in
724
accordance with chapter 465.
725
(f)6. The sale, purchase, or trade of a prescription drug
726
between pharmacies as a result of a sale, transfer, merger, or
727
consolidation of all or part of the business of the pharmacies
728
from or with another pharmacy, whether accomplished as a purchase
729
and sale of stock or of business assets.
730
(54)(b) "Wholesale distributor" means any person engaged in
731
wholesale distribution of prescription drugs in or into this
732
state, including, but not limited to, manufacturers; repackagers;
733
own-label distributors; jobbers; private-label distributors;
734
brokers; warehouses, including manufacturers' and distributors'
735
warehouses, chain drug warehouses, and wholesale drug warehouses;
736
independent wholesale drug traders; exporters; retail pharmacies;
737
and the agents thereof that conduct wholesale distributions.
738
Section 3. Subsections (4), (10), (11), (12), (14), (15),
739
(18), (19), (20), (22), (24), (28), and (29) of section 499.005,
740
Florida Statutes, are amended to read:
741
499.005 Prohibited acts.--It is unlawful for a person to
742
perform or cause the performance of any of the following acts in
743
this state:
744
(4) The sale, distribution, purchase, trade, holding, or
745
offering of any drug, device, or cosmetic in violation of this
747
(10) Forging; counterfeiting; simulating; falsely
748
representing any drug, device, or cosmetic; or, without the
749
authority of the manufacturer, using any mark, stamp, tag, label,
750
or other identification device authorized or required by rules
752
(11) The use, on the labeling of any drug or in any
753
advertisement relating to such drug, of any representation or
754
suggestion that an application of the drug is effective when it
755
is not or that the drug complies with this part ss. 499.001-
756
499.081 when it does not.
757
(12) The possession of any drug in violation of this part
759
(14) The purchase or receipt of a prescription legend drug
760
from a person that is not authorized under this chapter to
761
distribute prescription legend drugs to that purchaser or
762
recipient.
763
(15) The sale or transfer of a prescription legend drug to
764
a person that is not authorized under the law of the jurisdiction
765
in which the person receives the drug to purchase or possess
766
prescription legend drugs from the person selling or transferring
767
the prescription legend drug.
768
(18) Failure to maintain records as required by this part
770
sections.
771
(19) Providing the department with false or fraudulent
772
records, or making false or fraudulent statements, regarding any
773
matter within the provisions of this part chapter.
774
(20) The importation of a prescription legend drug except
775
as provided by s. 801(d) of the Federal Food, Drug, and Cosmetic
776
Act.
777
(22) Failure to obtain a permit or registration, or
778
operating without a valid permit when a permit or registration is
780
(24) The distribution of a prescription legend device to
781
the patient or ultimate consumer without a prescription or order
782
from a practitioner licensed by law to use or prescribe the
783
device.
784
(28) Failure to acquire obtain or deliver pass on a
785
pedigree paper as required under this part.
786
(29) The receipt of a prescription drug pursuant to a
787
wholesale distribution without having previously received or
788
simultaneously either first receiving a pedigree paper that was
789
attested to as accurate and complete by the wholesale distributor
790
as required under this part or complying with the provisions of
791
s. 499.0121(6)(d)5.
792
Section 4. Section 499.0051, Florida Statutes, is amended;
793
section 499.0052, Florida Statutes, is redesignated as subsection
794
(7) of that section and amended; section 499.00535, Florida
795
Statutes, is redesignated as subsection (9) of that section and
796
amended; section 499.00545, Florida Statutes, is redesignated as
797
subsection (10) of that section and amended; section 499.069,
798
Florida Statutes, is redesignated as subsection (11) of that
799
section and amended; and section 499.0691, Florida Statutes, is
800
redesignated as subsections (12) through (15) of that section and
801
amended, to read:
802
499.0051 Criminal acts involving contraband or adulterated
803
drugs.--
804
(1) FAILURE TO MAINTAIN OR DELIVER PEDIGREE PAPERS.--
805
(a) A person, other than a manufacturer, engaged in the
806
wholesale distribution of prescription legend drugs who fails to
807
deliver to another person complete and accurate pedigree papers
808
concerning a prescription legend drug or contraband prescription
809
legend drug prior to, or simultaneous with, the transfer of
810
transferring the prescription legend drug or contraband
811
prescription legend drug to another person commits a felony of
812
the third degree, punishable as provided in s. 775.082, s.
814
(b) A person engaged in the wholesale distribution of
815
prescription legend drugs who fails to acquire complete and
816
accurate pedigree papers concerning a prescription legend drug or
817
contraband prescription legend drug prior to, or simultaneous
818
with, the receipt of obtaining the prescription legend drug or
819
contraband prescription legend drug from another person commits a
820
felony of the third degree, punishable as provided in s. 775.082,
822
(c) Any person who knowingly destroys, alters, conceals, or
823
fails to maintain complete and accurate pedigree papers
824
concerning any prescription legend drug or contraband
825
prescription legend drug in his or her possession commits a
826
felony of the third degree, punishable as provided in s. 775.082,
828
(2) FAILURE TO AUTHENTICATE PEDIGREE PAPERS.--Effective
829
July 1, 2006:
830
(a) A person engaged in the wholesale distribution of
831
prescription legend drugs who is in possession of pedigree papers
832
concerning prescription legend drugs or contraband prescription
833
legend drugs and who fails to authenticate the matters contained
834
in the pedigree papers and who nevertheless attempts to further
835
distribute prescription legend drugs or contraband prescription
836
legend drugs commits a felony of the third degree, punishable as
838
(b) A person in possession of pedigree papers concerning
839
prescription legend drugs or contraband prescription legend drugs
840
who falsely swears or certifies that he or she has authenticated
841
the matters contained in the pedigree papers commits a felony of
842
the third degree, punishable as provided in s. 775.082, s.
844
(3) KNOWING FORGERY OF PEDIGREE PAPERS.--A person who
845
knowingly forges, counterfeits, or falsely creates any pedigree
846
paper; who falsely represents any factual matter contained on any
847
pedigree paper; or who knowingly omits to record material
848
information required to be recorded in a pedigree paper, commits
849
a felony of the second degree, punishable as provided in s.
851
(4) KNOWING PURCHASE OR RECEIPT OF PRESCRIPTION LEGEND DRUG
852
FROM UNAUTHORIZED PERSON.--A person who knowingly purchases or
853
receives from a person not authorized to distribute prescription
854
legend drugs under this chapter a prescription legend drug in a
855
wholesale distribution transaction commits a felony of the second
857
858
(5) KNOWING SALE OR TRANSFER OF PRESCRIPTION LEGEND DRUG TO
859
UNAUTHORIZED PERSON.--A person who knowingly sells or transfers
860
to a person not authorized to purchase or possess prescription
861
legend drugs, under the law of the jurisdiction in which the
862
person receives the drug, a prescription legend drug in a
863
wholesale distribution transaction commits a felony of the second
865
866
(6) KNOWING SALE OR DELIVERY, OR POSSESSION WITH INTENT TO
867
SELL, CONTRABAND PRESCRIPTION LEGEND DRUGS.--A person who is
868
knowingly in actual or constructive possession of any amount of
869
contraband prescription legend drugs, who knowingly sells or
870
delivers, or who possesses with intent to sell or deliver any
871
amount of contraband prescription legend drugs, commits a felony
872
of the second degree, punishable as provided in s. 775.082, s.
874
(7)499.0052 KNOWING TRAFFICKING IN CONTRABAND PRESCRIPTION
875
LEGEND DRUGS.--A person who knowingly sells, purchases,
876
manufactures, delivers, or brings into this state, or who is
877
knowingly in actual or constructive possession of any amount of
878
contraband prescription legend drugs valued at $25,000 or more
879
commits a felony of the first degree, punishable as provided in
881
(a) Upon conviction, each defendant shall be ordered to pay
882
a mandatory fine according to the following schedule:
883
1.(1) If the value of contraband prescription legend drugs
884
involved is $25,000 or more, but less than $100,000, the
885
defendant shall pay a mandatory fine of $25,000. If the defendant
886
is a corporation or other person that is not a natural person, it
887
shall pay a mandatory fine of $75,000.
888
2.(2) If the value of contraband prescription legend drugs
889
involved is $100,000 or more, but less than $250,000, the
890
defendant shall pay a mandatory fine of $100,000. If the
891
defendant is a corporation or other person that is not a natural
892
person, it shall pay a mandatory fine of $300,000.
893
3.(3) If the value of contraband prescription legend drugs
894
involved is $250,000 or more, the defendant shall pay a mandatory
895
fine of $200,000. If the defendant is a corporation or other
896
person that is not a natural person, it shall pay a mandatory
897
fine of $600,000.
898
(b) As used in this subsection section, the term "value"
899
means the market value of the property at the time and place of
900
the offense or, if such cannot be satisfactorily ascertained, the
901
cost of replacement of the property within a reasonable time
902
after the offense. Amounts of value of separate contraband
903
prescription legend drugs involved in distinct transactions for
904
the distribution of the contraband prescription legend drugs
905
committed pursuant to one scheme or course of conduct, whether
906
involving the same person or several persons, may be aggregated
907
in determining the punishment of the offense.
908
(8)(7) KNOWING FORGERY OF PRESCRIPTION OR PRESCRIPTION
909
LEGEND DRUG LABELS.--A person who knowingly forges, counterfeits,
910
or falsely creates any prescription label or prescription legend
911
drug label, or who falsely represents any factual matter
912
contained on any prescription label or prescription legend drug
913
label, commits a felony of the first degree, punishable as
915
(9)499.00535 KNOWING Sale or purchase of contraband
916
prescription legend drugs resulting in great bodily harm.--A
917
person who knowingly sells, purchases, manufactures, delivers, or
918
brings into this state, or who is knowingly in actual or
919
constructive possession of any amount of contraband prescription
920
legend drugs, and whose acts in violation of this subsection
921
section result in great bodily harm to a person, commits a felony
923
924
(10)499.00545 Knowing Sale or purchase of contraband
925
prescription legend drugs resulting in death.--A person who
926
knowingly manufactures, sells, purchases, delivers, or brings
927
into this state, or who is knowingly in actual or constructive
928
possession of any amount of contraband prescription legend drugs,
929
and whose acts in violation of this subsection section result in
930
the death of a person, commits a felony of the first degree,
931
punishable by a term of years not exceeding life, as provided in
933
(11)499.069 Criminal punishment for violations of s.
934
499.005 related to devices and cosmetics; dissemination of false
935
advertisement.--
936
(a)(1) Any person who violates any of the provisions of s.
937
499.005 with respect to a device or cosmetic commits a
938
misdemeanor of the second degree, punishable as provided in s.
940
conviction of such person under this subsection section has
941
become final, such person is guilty of a misdemeanor of the first
944
any person who violates s. 499.005(8) or (10) subsection (8) or
945
subsection (10) of s. 499.005 with respect to a device or
946
cosmetic commits a felony of the third degree, punishable as
949
(b)(2) A publisher, radio broadcast licensee, or agency or
950
medium for the dissemination of an advertisement, except the
951
manufacturer, wholesaler, or seller of the article to which a
952
false advertisement relates, is not liable under this subsection
953
section by reason of the dissemination by him or her of such
954
false advertisement, unless he or she has refused, on the request
955
of the department, to furnish to the department the name and post
956
office address of the manufacturer, wholesaler, seller, or
957
advertising agency that asked him or her to disseminate such
958
advertisement.
959
(12)499.0691 ADULTERATED AND MISBRANDED DRUGS; FALSE
960
ADVERTISEMENT; FAILURE TO MAINTAIN RECORDS RELATING TO DRUGS
961
Criminal punishment for violations related to drugs;
962
dissemination of false advertisement.--(1) Any person who
963
violates any of the following provisions commits a misdemeanor of
964
the second degree, punishable as provided in s. 775.082 or s.
965
775.083; but, if the violation is committed after a conviction of
966
such person under this subsection section has become final, such
967
person commits a misdemeanor of the first degree, punishable as
970
(a) The manufacture, repackaging, sale, delivery, or
971
holding or offering for sale of any drug that is adulterated or
972
misbranded or has otherwise been rendered unfit for human or
973
animal use.
974
(b) The adulteration or misbranding of any drug intended
975
for further distribution.
976
(c) The receipt of any drug that is adulterated or
977
misbranded, and the delivery or proffered delivery of such drug,
978
for pay or otherwise.
979
(d) The dissemination of any false or misleading
980
advertisement of a drug.
981
(e) The use, on the labeling of any drug or in any
982
advertisement relating to such drug, of any representation or
983
suggestion that an application of the drug is effective when it
984
is not or that the drug complies with this part ss. 499.001-
985
499.081 when it does not.
986
(f) The purchase or receipt of a compressed medical gas
987
from a person that is not authorized under this chapter to
988
distribute compressed medical gases.
989
(g) Charging a dispensing fee for dispensing,
990
administering, or distributing a prescription drug sample.
991
(h) The failure to maintain records related to a drug as
993
this part those sections, except for pedigree papers, invoices,
994
or shipping documents related to prescription legend drugs.
995
(i) The possession of any drug in violation of this part
997
deficiency in pedigree papers.
998
(13) REFUSAL TO ALLOW INSPECTION; SELLING, PURCHASING, OR
999
TRADING DRUG SAMPLES; FAILURE TO MAINTAIN RECORDS RELATING TO
1000
PRESCRIPTION DRUGS.--(2) Any person who violates any of the
1001
following provisions commits a felony of the third degree,
1004
(a) The refusal or constructive refusal to allow:
1005
1. The department to enter or inspect an establishment in
1006
which drugs are manufactured, processed, repackaged, sold,
1007
brokered, or held;
1008
2. Inspection of any record of that establishment;
1009
3. The department to enter and inspect any vehicle that is
1010
being used to transport drugs; or
1011
4. The department to take samples of any drug.
1012
(b) The sale, purchase, or trade, or the offer to sell,
1013
purchase, or trade, a drug sample as defined in s. 499.028; the
1014
distribution of a drug sample in violation of s. 499.028; or the
1015
failure to otherwise comply with s. 499.028.
1016
(c) Providing the department with false or fraudulent
1017
records, or making false or fraudulent statements, regarding any
1018
matter within the provisions of this part chapter related to a
1019
drug.
1020
(d) The failure to receive, maintain, or provide invoices
1021
and shipping documents, other than pedigree papers, if
1022
applicable, related to the distribution of a prescription legend
1023
drug.
1024
(e) The importation of a prescription legend drug for
1025
wholesale distribution, except as provided by s. 801(d) of the
1026
Federal Food, Drug, and Cosmetic Act.
1027
(f) The wholesale distribution of a any prescription drug
1028
that was:
1029
1. Purchased by a public or private hospital or other
1030
health care entity; or
1031
2. Donated or supplied at a reduced price to a charitable
1032
organization.
1033
(g) The failure to obtain a permit as a prescription drug
1034
wholesale distributor wholesaler when a permit is required by
1036
(h) Knowingly possessing any adulterated or misbranded
1037
prescription legend drug outside of a designated quarantine area.
1038
(i) The purchase or sale of a prescription drug drugs for
1039
wholesale distribution in exchange for currency, as defined in s.
1040
560.103(6).
1041
(14) OTHER VIOLATIONS.--(3) Any person who violates any of
1042
the following provisions commits a felony of the second degree,
1045
(a) Knowingly manufacturing, repackaging, selling,
1046
delivering, or holding or offering for sale any drug that is
1047
adulterated or misbranded or has otherwise been rendered unfit
1048
for human or animal use.
1049
(b) Knowingly adulterating a drug that is intended for
1050
further distribution.
1051
(c) Knowingly receiving a drug that is adulterated and
1052
delivering or proffering delivery of such drug for pay or
1053
otherwise.
1054
(d) Committing any act that causes a drug to be a
1055
counterfeit drug, or selling, dispensing, or knowingly holding
1056
for sale a counterfeit drug.
1057
(e) Forging, counterfeiting, simulating, or falsely
1058
representing any drug, or, without the authority of the
1059
manufacturer, using any mark, stamp, tag, label, or other
1060
identification device authorized or required by rules adopted
1062
(f) Knowingly obtaining or attempting to obtain a
1063
prescription drug for wholesale distribution by fraud, deceit,
1064
misrepresentation, or subterfuge, or engaging in
1065
misrepresentation or fraud in the distribution of a drug.
1066
(g) Removing a pharmacy's dispensing label from a dispensed
1067
prescription drug with the intent to further distribute the
1068
prescription drug.
1069
(h) Knowingly distributing a prescription drug that was
1070
previously dispensed by a licensed pharmacy, unless such
1071
distribution was authorized in chapter 465 or the rules adopted
1072
under chapter 465.
1073
(15) FALSE ADVERTISEMENT.--(4) A publisher, radio
1074
broadcast licensee, or agency or medium for the dissemination of
1075
an advertisement, except the manufacturer, repackager, wholesale
1076
distributor wholesaler, or seller of the article to which a false
1077
advertisement relates, is not liable under subsection (12),
1078
subsection (13), or subsection (14) this section by reason of the
1079
dissemination by him or her of such false advertisement, unless
1080
he or she has refused, on the request of the department, to
1081
furnish to the department the name and post office address of the
1082
manufacturer, repackager, wholesale distributor wholesaler,
1083
seller, or advertising agency that asked him or her to
1084
disseminate such advertisement.
1085
Section 5. Section 499.0054, Florida Statutes, is amended;
1086
section 499.0055, Florida Statutes, is redesignated as subsection
1087
(2) of that section and amended; and section 499.0057, Florida
1088
Statutes, is redesignated as subsection (3) of that section and
1089
amended, to read:
1090
499.0054 Advertising and labeling of drugs, devices, and
1091
cosmetics; exemptions.--
1092
(1) It is a violation of the Florida Drug and Cosmetic Act
1093
to perform or cause the performance of any of the following acts:
1094
(a)(1) The dissemination of any false advertisement of any
1095
drug, device, or cosmetic. An advertisement is false if it is
1096
false or misleading in any way.
1097
(b)(2) The distribution in commerce of any drug, device, or
1098
cosmetic, if its labeling or advertising is in violation of this
1100
(c)(3) The manufacturing, repackaging, packaging, selling,
1101
delivery, holding, or offering for sale of any drug, device, or
1102
cosmetic for which the advertising or labeling is false or
1103
misleading.
1104
(d)(4) The advertising of any drug, device, or cosmetic
1105
that is adulterated or misbranded.
1106
(e)(5) The receiving in commerce of any drug, device, or
1107
cosmetic that is falsely advertised or labeled or the delivering
1108
or proffering for delivery of any such drug, device, or cosmetic.
1109
(f)(6) The advertising or labeling of any product
1110
containing ephedrine, a salt of ephedrine, an isomer of
1111
ephedrine, or a salt of an isomer of ephedrine, for the
1112
indication of stimulation, mental alertness, weight loss,
1113
appetite control, energy, or other indications not approved by
1114
the pertinent United States Food and Drug Administration Over-
1115
the-Counter Final or Tentative Final Monograph or approved new
1116
drug application under the federal act. In determining compliance
1117
with this requirement, the department may consider the following
1118
factors:
1119
1.(a) The packaging of the product.
1120
2.(b) The name and labeling of the product.
1121
3.(c) The manner of distribution, advertising, and
1122
promotion of the product, including verbal representations at the
1123
point of sale.
1124
4.(d) The duration, scope, and significance of abuse of the
1125
particular product.
1126
(g)(7) The advertising of any drug or device represented to
1127
have any effect in any of the following conditions, disorders,
1128
diseases, or processes:
1129
1.(a) Blood disorders.
1130
2.(b) Bone or joint diseases.
1131
3.(c) Kidney diseases or disorders.
1132
4.(d) Cancer.
1133
5.(e) Diabetes.
1134
6.(f) Gall bladder diseases or disorders.
1135
7.(g) Heart and vascular diseases.
1136
8.(h) High blood pressure.
1137
9.(i) Diseases or disorders of the ear or auditory
1138
apparatus, including hearing loss or deafness.
1139
10.(j) Mental disease or mental retardation.
1140
11.(k) Paralysis.
1141
12.(l) Prostate gland disorders.
1142
13.(m) Conditions of the scalp affecting hair loss.
1143
14.(n) Baldness.
1144
15.(o) Endocrine disorders.
1145
16.(p) Sexual impotence.
1146
17.(q) Tumors.
1147
18.(r) Venereal diseases.
1148
19.(s) Varicose ulcers.
1149
20.(t) Breast enlargement.
1150
21.(u) Purifying blood.
1151
22.(v) Metabolic disorders.
1152
23.(w) Immune system disorders or conditions affecting the
1153
immune system.
1154
24.(x) Extension of life expectancy.
1155
25.(y) Stress and tension.
1156
26.(z) Brain stimulation or performance.
1157
27.(aa) The body's natural defense mechanisms.
1158
28.(bb) Blood flow.
1159
29.(cc) Depression.
1160
30.(dd) Human immunodeficiency virus or acquired immune
1161
deficiency syndrome or related disorders or conditions.
1162
(h)(8) The representation or suggestion in labeling or
1163
advertising that an article is approved under this part ss.
1165
(2)499.0055 False or misleading advertisement.--In
1166
determining whether an advertisement is false or misleading, the
1167
department shall review the representations made or suggested by
1168
statement, word, design, device, sound, or any combination
1169
thereof within the advertisement and the extent to which the
1170
advertisement fails to reveal material facts with respect to
1171
consequences that can result from the use of the drug, device, or
1172
cosmetic to which the advertisement relates under the conditions
1173
of use prescribed in the labeling or advertisement.
1174
(3)499.0057 Advertisement exemptions.--
1175
(a)(1) An advertisement that is not prohibited under
1176
paragraph (1)(a) s. 499.0054(1) is not prohibited under paragraph
1177
(1)(g) s. 499.0054(7) if it is disseminated:
1178
1. To the public solely to advertise the product for those
1179
indications that are safe and effective indications and the
1180
product is safe and effective for self-medication, as established
1181
by the United States Food and Drug Administration; or
1182
2. if it is disseminated Only to members of the medical,
1183
dental, pharmaceutical, or veterinary professions or appears only
1184
in the scientific periodicals of these professions.
1186
the rules adopted under this part those sections creates no legal
1187
presumption that a drug or device is safe or effective.
1188
Section 6. Subsections (3), (10), and (11) of section
1189
499.006, Florida Statutes, are amended to read:
1190
499.006 Adulterated drug or device.--A drug or device is
1191
adulterated:
1192
(3) If it is a drug and the methods used in, or the
1193
facilities or controls used for, its manufacture, processing,
1194
packing, or holding do not conform to, or are not operated or
1195
administered in conformity with, current good manufacturing
1196
practices to assure that the drug meets the requirements of this
1198
strength, and meets the standard of quality and purity, which it
1199
purports or is represented to possess;
1200
(10) If it is a prescription legend drug for which the
1201
required pedigree paper is nonexistent, fraudulent, or incomplete
1203
applicable rules, or that has been purchased, held, sold, or
1204
distributed at any time by a person not authorized under federal
1205
or state law to do so; or
1206
(11) If it is a prescription drug subject to, defined by,
1207
or described by s. 503(b) of the Federal Food, Drug, and Cosmetic
1208
Act which has been returned by a veterinarian to a limited
1209
prescription drug veterinary wholesale distributor wholesaler.
1210
Section 7. Section 499.007, Florida Statutes, is amended to
1211
read:
1212
499.007 Misbranded drug or device.--A drug or device is
1213
misbranded:
1214
(1) If its labeling is in any way false or misleading.
1215
(2) Unless, If in package form, it does not bear bears a
1216
label containing:
1217
(a) The name and place of business of the manufacturer,
1218
repackager, or distributor of the finished dosage form of the
1219
drug. For the purpose of this paragraph, the finished dosage form
1220
of a prescription medicinal drug is that form of the drug which
1221
is, or is intended to be, dispensed or administered to the
1222
patient and requires no further manufacturing or processing other
1223
than packaging, reconstitution, and labeling; and
1224
(b) An accurate statement of the quantity of the contents
1225
in terms of weight, measure, or numerical count.; However, under
1226
this section, reasonable variations are permitted, and the
1227
department shall establish by rule exemptions for small packages.
1228
(3) If it is an active pharmaceutical ingredient in bulk
1229
form and does not bear a label containing:
1230
(a) The name and place of business of the manufacturer,
1231
repackager, or distributor; and
1232
(b) An accurate statement of the quantity of the contents
1233
in terms of weight, measure, or numerical count.
1234
(4)(3) If any word, statement, or other information
1236
the label or labeling is not prominently placed thereon with such
1237
conspicuousness as compared with other words, statements,
1238
designs, or devices in the labeling, and in such terms, as to
1239
render the word, statement, or other information likely to be
1240
read and understood under customary conditions of purchase and
1241
use.
1242
(5)(4) If it is a drug and is not designated solely by a
1243
name recognized in an official compendium and, unless its label
1244
does not bear bears:
1245
(a) The common or usual name of the drug, if any; and
1246
(b) In case it is fabricated from two or more ingredients,
1247
the common or usual name and quantity of each active ingredient.
1248
(6)(5) If Unless its labeling does not bear bears:
1249
(a) Adequate directions for use; and
1250
(b) Adequate warnings against use in those pathological
1251
conditions in which its use may be dangerous to health or against
1252
use by children if its use may be dangerous to health, or against
1253
unsafe dosage or methods or duration of administration or
1254
application, in such manner and form as are necessary for the
1255
protection of users.
1256
(7)(6) If it purports to be a drug the name of which is
1257
recognized in the official compendium and, unless it is not
1258
packaged and labeled as prescribed therein.; However, the method
1259
of packaging may be modified with the consent of the department.
1260
(8)(7) If it has been found by the department to be a drug
1261
liable to deterioration and, unless it is not packaged in such
1262
form and manner, and its label bears a statement of such
1263
precautions, as the department by rule requires as necessary to
1264
protect the public health. Such rule may not be established for
1265
any drug recognized in an official compendium until the
1266
department has informed the appropriate body charged with the
1267
revision of such compendium of the need for such packaging or
1268
labeling requirements and that body has failed within a
1269
reasonable time to prescribe such requirements.
1270
(9)(8) If it is:
1271
(a) A drug and its container or finished dosage form is so
1272
made, formed, or filled as to be misleading;
1273
(b) An imitation of another drug; or
1274
(c) Offered for sale under the name of another drug.
1275
(10)(9) If it is dangerous to health when used in the
1276
dosage or with the frequency or duration prescribed, recommended,
1277
or suggested in the labeling of the drug.
1278
(11)(10) If it is, purports to be, or is represented as a
1279
drug composed wholly or partly of insulin and, unless:
1280
(a) it is not from a batch with respect to which a
1281
certificate has been issued pursuant to s. 506 of the federal
1282
act, which; and
1283
(b) The certificate is in effect with respect to the drug.
1284
(12)(11) If it is, purports to be, or is represented as a
1285
drug composed wholly or partly of any kind of antibiotic
1286
requiring certification under the federal act and unless:
1287
(a) it is not from a batch with respect to which a
1288
certificate has been issued pursuant to s. 507 of the federal
1289
act, which; and
1290
(b) the certificate is in effect with respect to the drug.;
1291
1292
However, this subsection does not apply to any drug or class of
1293
drugs exempted by regulations adopted under s. 507(c) or (d) of
1294
the federal act.
1295
(13)(12) If it is a drug intended for use by humans which
1296
is a habit-forming drug or which, because of its toxicity or
1297
other potentiality for harmful effect, or the method of its use,
1298
or the collateral measures necessary to its use, is not safe for
1299
use except under the supervision of a practitioner licensed by
1300
law to administer such drugs,; or which is limited by an
1301
effective application under s. 505 of the federal act to use
1302
under the professional supervision of a practitioner licensed by
1303
law to prescribe such drug, if unless it is not dispensed only:
1304
(a) Upon the written prescription of a practitioner
1305
licensed by law to prescribe such drug;
1306
(b) Upon an oral prescription of such practitioner, which
1307
is reduced promptly to writing and filled by the pharmacist; or
1308
(c) By refilling any such written or oral prescription, if
1309
such refilling is authorized by the prescriber either in the
1310
original prescription or by oral order which is reduced promptly
1311
to writing and filled by the pharmacist.
1312
1313
This subsection does not relieve any person from any requirement
1314
prescribed by law with respect to controlled substances as
1315
defined in the applicable federal and state laws.
1316
(14)(13) If it is a drug that is subject to paragraph
1317
(13)(12)(a), and if, at any time before it is dispensed, its
1318
label does not fails to bear the statement:
1319
(a) "Caution: Federal Law Prohibits Dispensing Without
1320
Prescription";
1321
(b) "Rx Only";
1322
(c) The prescription symbol followed by the word "Only"; or
1323
(d) "Caution: State Law Prohibits Dispensing Without
1324
Prescription."
1325
(15)(14) If it is a drug that is not subject to paragraph
1326
(13)(12)(a), if at any time before it is dispensed its label
1327
bears the statement of caution required in subsection (14) (13).
1328
(16)(15) If it is a color additive, the intended use of
1329
which in or on drugs is for the purpose of coloring only and,
1330
unless its packaging and labeling are not in conformity with the
1331
packaging and labeling requirements that apply to such color
1332
additive and are prescribed under the federal act.
1333
(17) A drug dispensed by filling or refilling a written or
1334
oral prescription of a practitioner licensed by law to prescribe
1335
such drug is exempt from the requirements of this section, except
1336
subsections (1), (9) (8), (11) (10), and (12) (11) and the
1337
packaging requirements of subsections (7) (6) and (8) (7), if the
1338
drug bears a label that contains the name and address of the
1339
dispenser or seller, the prescription number and the date the
1340
prescription was written or filled, the name of the prescriber
1341
and the name of the patient, and the directions for use and
1342
cautionary statements. This exemption does not apply to any drug
1343
dispensed in the course of the conduct of a business of
1344
dispensing drugs pursuant to diagnosis by mail or to any drug
1345
dispensed in violation of subsection (13) (12). The department
1347
499.064 from subsection (13) (12) if compliance with that
1348
subsection is not necessary to protect the public health, safety,
1349
and welfare.
1350
Section 8. Subsection (1) of section 499.008, Florida
1351
Statutes, is amended and subsection (5) is added to that section
1352
to read:
1353
499.008 Adulterated cosmetics.--A cosmetic is adulterated:
1354
(1) If it bears or contains any poisonous or deleterious
1355
substance that is injurious to users under the conditions of use
1356
prescribed in the labeling or advertisement thereof or under such
1357
conditions of use as are customary or usual; however, this
1358
subsection does not apply to coal-tar hair dye:
1359
(a) The label of which bears the following legend
1360
conspicuously displayed thereon: "Caution: This product contains
1361
ingredients which may cause skin irritation on certain
1362
individuals, and a preliminary test according to accompanying
1363
directions should first be made. This product must not be used
1364
for dyeing the eyelashes or eyebrows; to do so may cause
1365
blindness"; and
1366
(b) The labeling of which bears adequate directions for
1367
such preliminary testing.
1368
1369
For the purposes of this subsection and subsection (4), the term
1370
"hair dye" does not include eyelash dyes or eyebrow dyes.
1371
(5) For the purposes of subsections (1) and (4), the term
1372
"hair dye" does not include eyelash dyes or eyebrow dyes.
1373
Section 9. Subsections (2), (3), and (5) of section
1374
499.009, Florida Statutes, are amended to read:
1375
499.009 Misbranded cosmetics.--A cosmetic is misbranded:
1376
(2) Unless, If in package form, it does not bear bears a
1377
label containing:
1378
(a) The name and place of business of the manufacturer,
1379
packer, or distributor;
1380
(b) An accurate statement of the quantity of the contents
1381
in terms of weight, measure, or numerical count; however, under
1382
this paragraph reasonable variations are permitted, and the
1383
department shall establish by rule exemptions for small packages;
1384
and
1385
(c) A declaration of ingredients in descending order of
1386
predominance, or as otherwise required by federal law.
1387
(3) If any word, statement, or other information required
1389
on the label or labeling is not prominently placed thereon with
1390
such conspicuousness as compared with other words, statements,
1391
designs, or devices in the labeling, and in such terms, as to
1392
render the word, statement, or other information likely to be
1393
read and understood by an individual under customary conditions
1394
of purchase and use.
1395
(5) Unless, If it is a color additive, its packaging and
1396
labeling are not in conformity with the packaging and labeling
1397
requirements applicable to that color additive prescribed under
1398
the federal act. This subsection does not apply to packages of
1399
color additives that, with respect to their use for cosmetics,
1400
are marketed and intended for use only in or on hair dyes.
1401
Section 10. Section 499.01, Florida Statutes, is amended;
1402
the introductory paragraph and paragraphs (a) through (h) of
1403
subsection (2) of section 499.012, Florida Statutes, are
1404
redesignated as the introductory paragraph and paragraphs (d),
1405
(n), (e), (f), (c), (i), (k), and (l), respectively, of
1406
subsection (2) of that section and amended; paragraphs (b)
1407
through (e) of subsection (2) of section 499.013, Florida
1408
Statutes, are redesignated as paragraphs (p), (o), (q), and (r),
1409
respectively, of subsection (2) of that section and amended; and
1410
section 499.014, Florida Statutes, is redesignated as paragraph
1411
(g) of subsection (2) of that section and amended, to read:
1412
499.01 Permits; applications; renewal; general
1413
requirements.--
1414
(1) Prior to operating, a permit is required for each
1415
person and establishment that intends to operate as:
1416
(a) A prescription drug manufacturer;
1417
(b) A prescription drug repackager;
1418
(c) A nonresident prescription drug manufacturer;
1419
(d) A prescription drug wholesale distributor;
1420
(e) An out-of-state prescription drug wholesale
1421
distributor;
1422
(f) A retail pharmacy drug wholesale distributor;
1423
(g) A restricted prescription drug distributor;
1424
(h) A complimentary drug distributor;
1425
(i) A freight forwarder;
1426
(j) A veterinary prescription drug retail establishment;
1427
(k) A veterinary prescription drug wholesale distributor;
1428
(l) A limited prescription drug veterinary wholesale
1429
distributor;
1430
(m) A medical oxygen retail establishment;
1431
(n) A compressed medical gas wholesale distributor;
1432
(o) A compressed medical gas manufacturer;
1433
(p)(c) An over-the-counter drug manufacturer;
1434
(d) A compressed medical gas manufacturer;
1435
(q)(e) A device manufacturer;
1436
(r)(f) A cosmetic manufacturer;
1437
(s) A third party logistic provider; or
1438
(t) A health care clinic establishment.
1439
(g) A prescription drug wholesaler;
1440
(h) A veterinary prescription drug wholesaler;
1441
(i) A compressed medical gas wholesaler;
1442
(j) An out-of-state prescription drug wholesaler;
1443
(k) A nonresident prescription drug manufacturer;
1444
(l) A freight forwarder;
1445
(m) A retail pharmacy drug wholesaler;
1446
(n) A veterinary legend drug retail establishment;
1447
(o) A medical oxygen retail establishment;
1448
(p) A complimentary drug distributor;
1449
(q) A restricted prescription drug distributor; or
1450
(r) A limited prescription drug veterinary wholesaler.
1451
(2) The following types of wholesaler permits are
1452
established:
1453
(a) Prescription drug manufacturer permit.--A prescription
1454
drug manufacturer permit is required for any person that
1455
manufactures a prescription drug in this state.
1456
1. A person that operates an establishment permitted as a
1457
prescription drug manufacturer may engage in wholesale
1458
distribution of prescription drugs manufactured at that
1459
establishment and must comply with all the provisions of this
1460
part and the rules adopted under this part that apply to a
1461
wholesale distributor.
1462
2. A prescription drug manufacturer must comply with all
1463
appropriate state and federal good manufacturing practices.
1464
(b) Prescription drug repackager permit.--A prescription
1465
drug repackager permit is required for any person that repackages
1466
a prescription drug in this state.
1467
1. A person that operates an establishment permitted as a
1468
prescription drug repackager may engage in wholesale distribution
1469
of prescription drugs repackaged at that establishment and must
1470
comply with all the provisions of this part and the rules adopted
1471
under this part that apply to a wholesale distributor.
1472
2. A prescription drug repackager must comply with all
1473
appropriate state and federal good manufacturing practices.
1474
(c)(e) Nonresident prescription drug manufacturer
1475
permit.--A nonresident prescription drug manufacturer permit is
1476
required for any person that is a manufacturer of prescription
1477
drugs, or the distribution point for a manufacturer of
1478
prescription drugs, and located outside of this state, or that is
1479
an entity to whom an approved new drug application has been
1480
issued by the United States Food and Drug Administration, or the
1481
contracted manufacturer of the approved new drug application
1482
holder, and located outside the United States, which engages in
1483
the wholesale distribution in this state of the prescription
1484
drugs it manufactures or is responsible for manufacturing. Each
1485
such manufacturer or entity must be permitted by the department
1486
and comply with all the provisions required of a wholesale
1489
1. A person that distributes prescription drugs that it did
1490
not manufacture must also obtain an out-of-state prescription
1491
drug wholesale distributor wholesaler permit pursuant to this
1492
section to engage in the wholesale distribution of the
1493
prescription drugs manufactured by another person and comply with
1494
the requirements of an out-of-state prescription drug wholesale
1495
distributor wholesaler.
1496
2. Any such person must comply with the licensing or
1497
permitting requirements of the jurisdiction in which the
1498
establishment is located and the federal act, and any product
1499
wholesaled into this state must comply with this part ss.
1501
from a foreign country into this state, the nonresident
1502
prescription drug manufacturer must provide to the department a
1503
list identifying each prescription drug it intends to import and
1504
document approval by the United States Food and Drug
1505
Administration for such importation.
1506
3. A nonresident prescription drug manufacturer permit is
1507
not required for a manufacturer to distribute a prescription drug
1508
active pharmaceutical ingredient that it manufactures to a
1509
prescription drug manufacturer permitted in this state in limited
1510
quantities intended for research and development and not for
1511
resale, or human use other than lawful clinical trials and
1512
biostudies authorized and regulated by federal law. A
1513
manufacturer claiming to be exempt from the permit requirements
1514
of this subparagraph and the prescription drug manufacturer
1515
purchasing and receiving the active pharmaceutical ingredient
1516
shall comply with the recordkeeping requirements of s.
1518
prescription drug manufacturer purchasing and receiving the
1519
active pharmaceutical ingredient shall maintain on file a record
1520
of the FDA registration number; the out-of-state license, permit,
1521
or registration number; and, if available, a copy of the most
1522
current FDA inspection report, for all manufacturers from whom
1523
they purchase active pharmaceutical ingredients under this
1524
section. The department shall specify by rule the allowable
1525
number of transactions within a given period of time and the
1526
amount of active pharmaceutical ingredients that qualify as
1527
limited quantities for purposes of this exemption. The failure to
1528
comply with the requirements of this subparagraph, or rules
1529
adopted by the department to administer this subparagraph, for
1530
the purchase of prescription drug active pharmaceutical
1531
ingredients is a violation of s. 499.005(14).
1532
(d)(a) A Prescription drug wholesale distributor
1533
wholesaler's permit.--A prescription drug wholesale distributor
1534
wholesaler is a wholesale distributor that may engage in the
1535
wholesale distribution of prescription drugs. A prescription drug
1536
wholesale distributor wholesaler that applies to the department
1537
for a new permit or the renewal of a permit must submit a bond of
1538
$100,000, or other equivalent means of security acceptable to the
1539
department, such as an irrevocable letter of credit or a deposit
1540
in a trust account or financial institution, payable to the
1541
Florida Drug, Device, and Cosmetic Trust Fund. The purpose of the
1542
bond is to secure payment of any administrative penalties imposed
1543
by the department and any fees and costs incurred by the
1544
department regarding that permit which are authorized under state
1545
law and which the permittee fails to pay 30 days after the fine
1546
or costs become final. The department may make a claim against
1547
such bond or security until 1 year after the permittee's license
1548
ceases to be valid or until 60 days after any administrative or
1550
which involves the permittee is concluded, including any appeal,
1551
whichever occurs later. The department may adopt rules for
1552
issuing a prescription drug wholesale distributor-broker
1553
wholesaler-broker permit to a person who engages in the wholesale
1554
distribution of prescription drugs and does not take physical
1555
possession of any prescription drugs.
1556
(e)(c) An Out-of-state prescription drug wholesale
1557
distributor wholesaler's permit.--An out-of-state prescription
1558
drug wholesale distributor wholesaler is a wholesale distributor
1559
located outside this state which engages in the wholesale
1560
distribution of prescription drugs into this state and which must
1561
be permitted by the department and comply with all the provisions
1562
required of a wholesale distributor under this part ss. 499.001-
1563
499.081. An out-of-state prescription drug wholesale distributor
1564
wholesaler that applies to the department for a new permit or the
1565
renewal of a permit must submit a bond of $100,000, or other
1566
equivalent means of security acceptable to the department, such
1567
as an irrevocable letter of credit or a deposit in a trust
1568
account or financial institution, payable to the Florida Drug,
1569
Device, and Cosmetic Trust Fund. The purpose of the bond is to
1570
secure payment of any administrative penalties imposed by the
1571
department and any fees and costs incurred by the department
1572
regarding that permit which are authorized under state law and
1573
which the permittee fails to pay 30 days after the fine or costs
1574
become final. The department may make a claim against such bond
1575
or security until 1 year after the permittee's license ceases to
1576
be valid or until 60 days after any administrative or legal
1578
involves the permittee is concluded, including any appeal,
1579
whichever occurs later.
1580
1. The out-of-state prescription drug wholesale distributor
1581
wholesaler must maintain at all times a license or permit to
1582
engage in the wholesale distribution of prescription drugs in
1583
compliance with laws of the state in which it is a resident.
1584
2. An out-of-state prescription drug wholesale distributor
1585
wholesaler's permit is not required for an intracompany sale or
1586
transfer of a prescription drug from an out-of-state
1587
establishment that is duly licensed as a prescription drug
1588
wholesale distributor wholesaler, in its state of residence, to a
1589
licensed prescription drug wholesale distributor wholesaler in
1590
this state, if both wholesale distributors wholesalers conduct
1591
wholesale distributions of prescription drugs under the same
1592
business name. The recordkeeping requirements of ss. s.
1594
(f)(d) A Retail pharmacy drug wholesale distributor
1595
wholesaler's permit.--A retail pharmacy drug wholesale
1596
distributor wholesaler is a retail pharmacy engaged in wholesale
1597
distribution of prescription drugs within this state under the
1598
following conditions:
1599
1. The pharmacy must obtain a retail pharmacy drug
1600
wholesale distributor wholesaler's permit pursuant to this part
1602
sections.
1603
2. The wholesale distribution activity does not exceed 30
1604
percent of the total annual purchases of prescription drugs. If
1605
the wholesale distribution activity exceeds the 30-percent
1606
maximum, the pharmacy must obtain a prescription drug wholesale
1607
distributor wholesaler's permit.
1608
3. The transfer of prescription drugs that appear in any
1609
schedule contained in chapter 893 is subject to chapter 893 and
1610
the federal Comprehensive Drug Abuse Prevention and Control Act
1611
of 1970.
1612
4. The transfer is between a retail pharmacy and another
1613
retail pharmacy, or a Modified Class II institutional pharmacy,
1614
or a health care practitioner licensed in this state and
1615
authorized by law to dispense or prescribe prescription drugs.
1616
5. All records of sales of prescription drugs subject to
1617
this section must be maintained separate and distinct from other
1618
records and comply with the recordkeeping requirements of this
1620
(g)499.014 Restricted prescription drug distributor permit
1621
Distribution of legend drugs by hospitals, health care entities,
1622
charitable organizations, and return or destruction companies;
1623
permits, general requirements.--
1624
(1) A restricted prescription drug distributor permit is
1625
required for any person that engages in the distribution of a
1626
prescription legend drug, which distribution is not considered
1627
"wholesale distribution" under s. 499.003(53)(a) s.
1628
499.012(1)(a)1.
1629
1.(2) A person who engages in the receipt or distribution
1630
of a prescription legend drug in this state for the purpose of
1631
processing its return or its destruction must obtain a permit as
1632
a restricted prescription drug distributor if such person is not
1633
the person initiating the return, the prescription drug wholesale
1634
supplier of the person initiating the return, or the manufacturer
1635
of the drug.
1636
2.(3) Storage, handling, and recordkeeping of these
1637
distributions must comply with the requirements for wholesale
1638
distributors under s. 499.0121, but not except those set forth in
1640
3.(4) A person who applies for a permit as a restricted
1641
prescription drug distributor, or for the renewal of such a
1642
permit, must provide to the department the information required
1644
4.(5) The department may issue permits to restricted
1645
prescription drug distributors and may adopt rules regarding the
1646
distribution of prescription drugs by hospitals, health care
1647
entities, charitable organizations, or other persons not involved
1648
in wholesale distribution, which rules are necessary for the
1649
protection of the public health, safety, and welfare.
1650
(h) Complimentary drug distributor permit.--A complimentary
1651
drug distributor permit is required for any person that engages
1652
in the distribution of a complimentary drug, subject to the
1653
requirements of s. 499.028.
1654
(i)(f) Freight forwarder permit.--A freight forwarder
1655
permit is required for any person that engages in the
1656
distribution of a prescription legend drug as a freight forwarder
1657
unless the person is a common carrier. The storage, handling, and
1658
recordkeeping of such distributions must comply with the
1659
requirements for wholesale distributors under s. 499.0121, but
1661
freight forwarder must provide the source of the prescription
1662
legend drugs with a validated airway bill, bill of lading, or
1663
other appropriate documentation to evidence the exportation of
1664
the product.
1665
(j) Veterinary prescription drug retail establishment
1666
permit.--A veterinary prescription drug retail establishment
1667
permit is required for any person that sells veterinary
1668
prescription drugs to the public but does not include a pharmacy
1669
licensed under chapter 465.
1670
1. The sale to the public must be based on a valid written
1671
order from a veterinarian licensed in this state who has a valid
1672
client-veterinarian relationship with the purchaser's animal.
1673
2. Veterinary prescription drugs may not be sold in excess
1674
of the amount clearly indicated on the order or beyond the date
1675
indicated on the order.
1676
3. An order may not be valid for more than 1 year.
1677
4. A veterinary prescription drug retail establishment may
1678
not purchase, sell, trade, or possess human prescription drugs or
1679
any controlled substance as defined in chapter 893.
1680
5. A veterinary prescription drug retail establishment must
1681
sell a veterinary prescription drug in the original, sealed
1682
manufacturer's container with all labeling intact and legible.
1683
The department may adopt by rule additional labeling requirements
1684
for the sale of a veterinary prescription drug.
1685
6. A veterinary prescription drug retail establishment must
1686
comply with all of the wholesale distribution requirements of s.
1687
1688
7. Prescription drugs sold by a veterinary prescription
1689
drug retail establishment pursuant to a practitioner's order may
1690
not be returned into the retail establishment's inventory.
1691
(k)(g) A veterinary prescription drug wholesale distributor
1692
wholesaler permit.--A veterinary prescription drug wholesale
1693
distributor wholesaler permit is required for any person that
1694
engages in the distribution of veterinary prescription drugs in
1695
or into this state. A veterinary prescription drug wholesale
1696
distributor wholesaler that also distributes prescription drugs
1697
subject to, defined by, or described by s. 503(b) of the Federal
1698
Food, Drug, and Cosmetic Act which it did not manufacture must
1699
obtain a permit as a prescription drug wholesale distributor
1700
wholesaler, an out-of-state prescription drug wholesale
1701
distributor wholesaler, or a limited prescription drug veterinary
1702
wholesale distributor wholesaler in lieu of the veterinary
1703
prescription drug wholesale distributor wholesaler permit. A
1704
veterinary prescription drug wholesale distributor wholesaler
1705
must comply with the requirements for wholesale distributors
1707
s. 499.0121(6)(d).
1708
(l)(h) Limited prescription drug veterinary wholesale
1709
distributor wholesaler permit.--Unless engaging in the activities
1710
of and permitted as a prescription drug manufacturer, nonresident
1711
prescription drug manufacturer, prescription drug wholesale
1712
distributor wholesaler, or out-of-state prescription drug
1713
wholesale distributor wholesaler, a limited prescription drug
1714
veterinary wholesale distributor wholesaler permit is required
1715
for any person that engages in the distribution in or into this
1716
state of veterinary prescription drugs and prescription drugs
1717
subject to, defined by, or described by s. 503(b) of the Federal
1718
Food, Drug, and Cosmetic Act under the following conditions:
1719
1. The person is engaged in the business of wholesaling
1720
prescription and veterinary prescription legend drugs to persons:
1721
a. Licensed as veterinarians practicing on a full-time
1722
basis;
1723
b. Regularly and lawfully engaged in instruction in
1724
veterinary medicine;
1725
c. Regularly and lawfully engaged in law enforcement
1726
activities;
1727
d. For use in research not involving clinical use; or
1728
e. For use in chemical analysis or physical testing or for
1729
purposes of instruction in law enforcement activities, research,
1730
or testing.
1731
2. No more than 30 percent of total annual prescription
1732
drug sales may be prescription drugs approved for human use which
1733
are subject to, defined by, or described by s. 503(b) of the
1734
Federal Food, Drug, and Cosmetic Act.
1735
3. The person does not distribute is not permitted,
1736
licensed, or otherwise authorized in any jurisdiction state to
1737
wholesale prescription drugs subject to, defined by, or described
1738
by s. 503(b) of the Federal Food, Drug, and Cosmetic Act to any
1739
person who is authorized to sell, distribute, purchase, trade, or
1740
use these drugs on or for humans.
1741
4. A limited prescription drug veterinary wholesale
1742
distributor wholesaler that applies to the department for a new
1743
permit or the renewal of a permit must submit a bond of $20,000,
1744
or other equivalent means of security acceptable to the
1745
department, such as an irrevocable letter of credit or a deposit
1746
in a trust account or financial institution, payable to the
1747
Florida Drug, Device, and Cosmetic Trust Fund. The purpose of the
1748
bond is to secure payment of any administrative penalties imposed
1749
by the department and any fees and costs incurred by the
1750
department regarding that permit which are authorized under state
1751
law and which the permittee fails to pay 30 days after the fine
1752
or costs become final. The department may make a claim against
1753
such bond or security until 1 year after the permittee's license
1754
ceases to be valid or until 60 days after any administrative or
1756
which involves the permittee is concluded, including any appeal,
1757
whichever occurs later.
1758
5. A limited prescription drug veterinary wholesale
1759
distributor wholesaler must maintain at all times a license or
1760
permit to engage in the wholesale distribution of prescription
1761
drugs in compliance with laws of the state in which it is a
1762
resident.
1763
6. A limited prescription drug veterinary wholesale
1764
distributor wholesaler must comply with the requirements for
1766
except that a limited prescription drug veterinary wholesale
1767
distributor wholesaler is not required to provide a pedigree
1769
wholesale distribution of a prescription drug to a veterinarian.
1770
7. A limited prescription drug veterinary wholesale
1771
distributor wholesaler may not return to inventory for subsequent
1772
wholesale distribution any prescription drug subject to, defined
1773
by, or described by s. 503(b) of the Federal Food, Drug, and
1774
Cosmetic Act which has been returned by a veterinarian.
1775
8. An out-of-state prescription drug wholesaler's permit or
1776
A limited prescription drug veterinary wholesale distributor
1777
wholesaler permit is not required for an intracompany sale or
1778
transfer of a prescription drug from an out-of-state
1779
establishment that is duly licensed to engage in the wholesale
1780
distribution of prescription drugs in its state of residence to a
1781
licensed limited prescription drug veterinary wholesale
1782
distributor wholesaler in this state if both wholesale
1783
distributors wholesalers conduct wholesale distributions of
1784
prescription drugs under the same business name. The
1786
must be followed for this transaction.
1787
(m) Medical oxygen retail establishment permit.--A medical
1788
oxygen retail establishment permit is required for any person
1789
that sells medical oxygen to patients only. The sale must be
1790
based on an order from a practitioner authorized by law to
1791
prescribe. The term does not include a pharmacy licensed under
1792
chapter 465.
1793
1. A medical oxygen retail establishment may not possess,
1794
purchase, sell, or trade any prescription drug other than medical
1795
oxygen.
1796
2. A medical oxygen retail establishment may refill medical
1797
oxygen for an individual patient based on an order from a
1798
practitioner authorized by law to prescribe. A medical oxygen
1799
retail establishment that refills medical oxygen must comply with
1800
all appropriate state and federal good manufacturing practices.
1801
3. A medical oxygen retail establishment must comply with
1802
all of the wholesale distribution requirements of s. 499.0121.
1803
4. Prescription medical oxygen sold by a medical oxygen
1804
retail establishment pursuant to a practitioner's order may not
1805
be returned into the retail establishment's inventory.
1806
(n)(b) A compressed medical gas wholesale distributor
1807
wholesaler's permit.--A compressed medical gas wholesale
1808
distributor wholesaler is a wholesale distributor that is limited
1809
to the wholesale distribution of compressed medical gases to
1810
other than the consumer or patient. The compressed medical gas
1811
must be in the original sealed container that was purchased by
1812
that wholesale distributor wholesaler. A compressed medical gas
1813
wholesale distributor wholesaler may not possess or engage in the
1814
wholesale distribution of any prescription drug other than
1815
compressed medical gases. The department shall adopt rules that
1816
govern the wholesale distribution of prescription medical oxygen
1817
for emergency use. With respect to the emergency use of
1818
prescription medical oxygen, those rules may not be inconsistent
1819
with rules and regulations of federal agencies unless the
1820
Legislature specifically directs otherwise.
1821
(o)(c) Compressed medical gas manufacturer permit.--A
1822
compressed medical gas manufacturer manufacturer's permit is
1823
required for any person that engages in the manufacture of
1824
compressed medical gases or repackages compressed medical gases
1825
from one container to another.
1826
1. A compressed medical gas manufacturer permittee may not
1827
manufacture or possess any prescription drug other than
1828
compressed medical gases.
1829
2. A compressed medical gas manufacturer permittee may
1830
engage in wholesale distribution of compressed medical gases
1831
manufactured at that establishment and must comply with all the
1833
under this part those sections that apply to a wholesale
1834
distributor.
1835
3. A compressed medical gas manufacturer permittee must
1836
comply with all appropriate state and federal good manufacturing
1837
practices.
1838
(p)(b) Over-the-counter drug manufacturer permit.--An over-
1839
the-counter drug manufacturer manufacturer's permit is required
1840
for any person that engages in the manufacture or repackaging of
1841
an over-the-counter drug.
1842
1. An over-the-counter drug manufacturer permittee may not
1843
possess or purchase prescription drugs.
1844
2. A pharmacy is exempt from obtaining an over-the-counter
1845
drug manufacturer manufacturer's permit if it is operating in
1846
compliance with pharmacy practice standards as defined in chapter
1847
465 and the rules adopted under that chapter.
1848
3. An over-the-counter drug manufacturer permittee must
1849
comply with all appropriate state and federal good manufacturing
1850
practices.
1851
(q)(d) Device manufacturer permit.--A device manufacturer
1852
manufacturer's permit is required for any person that engages in
1853
the manufacture, repackaging, or assembly of medical devices for
1854
human use in this state, except that a permit is not required if
1855
the person is engaged only in manufacturing, repackaging, or
1856
assembling a medical device pursuant to a practitioner's order
1857
for a specific patient.
1858
1. A manufacturer or repackager of medical devices in this
1859
state must comply with all appropriate state and federal good
1860
manufacturing practices and quality system rules.
1861
2. The department shall adopt rules related to storage,
1862
handling, and recordkeeping requirements for manufacturers of
1863
medical devices for human use.
1864
(r)(e) Cosmetic manufacturer permit.--A cosmetic
1865
manufacturer manufacturer's permit is required for any person
1866
that manufactures or repackages cosmetics in this state. A person
1867
that only labels or changes the labeling of a cosmetic but does
1868
not open the container sealed by the manufacturer of the product
1869
is exempt from obtaining a permit under this paragraph.
1870
(s) Third party logistics provider permit.--A third party
1871
logistics provider permit is required for any person that
1872
contracts with a prescription drug wholesale distributor or
1873
prescription drug manufacturer to provide warehousing,
1874
distribution, or other logistics services on behalf of a
1875
manufacturer or wholesale distributor, but who does not take
1876
title to the prescription drug or have responsibility to direct
1877
the sale or disposition of the prescription drug. Each third
1878
party logistics provider permittee shall comply with all of the
1879
provisions required of a wholesale distributor under this part,
1880
with the exception of s. 499.01212 for those wholesale
1881
distributions described in s. 499.01212(3)(a), and other rules
1882
that the department requires.
1883
(t) Health care clinic establishment permit.--Effective
1884
January 1, 2009, a health care clinic establishment permit is
1885
required for the purchase of a prescription drug by a place of
1886
business at one general physical location owned and operated by a
1887
professional corporation or professional limited liability
1888
company described in chapter 621, or a corporation that employs a
1889
veterinarian as a qualifying practitioner. For the purpose of
1890
this paragraph, the term "qualifying practitioner" means a
1891
licensed health care practitioner defined in s. 456.001 or a
1892
veterinarian licensed under chapter 474, who is authorized under
1893
the appropriate practice act to prescribe and administer a
1894
prescription drug.
1895
1. An establishment must provide, as part of the
1896
application required under s. 499.012, designation of a
1897
qualifying practitioner who will be responsible for complying
1898
with all legal and regulatory requirements related to the
1899
purchase, recordkeeping, storage, and handling of the
1900
prescription drugs. In addition, the designated qualifying
1901
practitioner shall be the practitioner whose name, establishment
1902
address, and license number is used on all distribution documents
1903
for prescription drugs purchased or returned by the health care
1904
clinic establishment. Upon initial appointment of a qualifying
1905
practitioner, the qualifying practitioner and the health care
1906
clinic establishment shall notify the department on a form
1907
furnished by the department within 10 days after such employment.
1908
In addition, the qualifying practitioner and health care clinic
1909
establishment shall notify the department within 10 days after
1910
any subsequent change.
1911
2. The health care clinic establishment must employ a
1912
qualifying practitioner at each establishment.
1913
3. In addition to the remedies and penalties provided in
1914
this part, a violation of this chapter by the health care clinic
1915
establishment or qualifying practitioner constitutes grounds for
1916
discipline of the qualifying practitioner by the appropriate
1917
regulatory board.
1918
4. The purchase of prescription drugs by the health care
1919
clinic establishment is prohibited during any period of time when
1920
the establishment does not comply with this paragraph.
1921
5. A health care clinic establishment permit is not a
1922
pharmacy permit or otherwise subject to chapter 465. A health
1923
care clinic establishment that meets the criteria of a modified
1924
Class II institutional pharmacy under s. 465.019 is not eligible
1925
to be permitted under this paragraph.
1926
6. This paragraph does not prohibit a qualifying
1927
practitioner from purchasing prescription drugs.
1928
Section 11. Section 499.012, Florida Statutes, is amended
1929
and subsections (2) through (8) of section 499.01, Florida
1930
States, are redesignated as subsections (1) through (7) of that
1931
section and amended, to read:
1932
499.012 Permit application Wholesale distribution;
1933
definitions; permits; applications; general requirements.--
1934
(1) As used in this section, the term:
1935
(2)(a) A permit issued pursuant to this part ss. 499.001-
1936
499.081 may be issued only to a natural person who is at least 18
1937
years of age or to an applicant that is not a natural person if
1938
each person who, directly or indirectly, manages, controls, or
1939
oversees the operation of that applicant is at least 18 years of
1940
age.
1941
(b) An establishment that is a place of residence may not
1942
receive a permit and may not operate under this part ss. 499.001-
1943
1944
(c) A person that applies for or renews a permit to
1945
manufacture or distribute prescription legend drugs may not use a
1946
name identical to the name used by any other establishment or
1947
licensed person authorized to purchase prescription drugs in this
1948
state, except that a restricted drug distributor permit issued to
1949
a health care entity will be issued in the name in which the
1950
institutional pharmacy permit is issued and a retail pharmacy
1951
drug wholesale distributor wholesaler will be issued a permit in
1952
the name of its retail pharmacy permit.
1953
(d) A permit for a prescription drug manufacturer,
1954
prescription drug repackager, prescription drug wholesale
1955
distributor wholesaler, limited prescription drug veterinary
1956
wholesale distributor wholesaler, or retail pharmacy drug
1957
wholesale distributor wholesaler may not be issued to the address
1958
of a health care entity or to a pharmacy licensed under chapter
1959
465, except as provided in this paragraph. The department may
1960
issue a prescription drug manufacturer permit to an applicant at
1961
the same address as a licensed nuclear pharmacy, which is a
1962
health care entity, for the purpose of manufacturing prescription
1963
drugs used in positron emission tomography or other
1964
radiopharmaceuticals, as listed in a rule adopted by the
1965
department pursuant to this paragraph. The purpose of this
1966
exemption is to assure availability of state-of-the-art
1967
pharmaceuticals that would pose a significant danger to the
1968
public health if manufactured at a separate establishment address
1969
from the nuclear pharmacy from which the prescription drugs are
1970
dispensed. The department may also issue a retail pharmacy drug
1971
wholesale distributor wholesaler permit to the address of a
1972
community pharmacy licensed under chapter 465 which does not meet
1973
the definition of a closed pharmacy in s. 499.003.
1974
(e) A county or municipality may not issue an occupational
1975
license for any licensing period beginning on or after October 1,
1976
2003, for any establishment that requires a permit pursuant to
1978
a current permit issued by the department for the establishment.
1979
Upon presentation of the requisite permit issued by the
1980
department, an occupational license may be issued by the
1981
municipality or county in which application is made. The
1982
department shall furnish to local agencies responsible for
1983
issuing occupational licenses a current list of all
1984
establishments licensed pursuant to this part ss. 499.001-
1985
1986
(2)(3) Notwithstanding subsection (6) (7), a permitted
1987
person in good standing may change the type of permit issued to
1988
that person by completing a new application for the requested
1989
permit, paying the amount of the difference in the permit fees if
1990
the fee for the new permit is more than the fee for the original
1991
permit, and meeting the applicable permitting conditions for the
1992
new permit type. The new permit expires on the expiration date of
1993
the original permit being changed; however, a new permit for a
1994
prescription drug wholesale distributor wholesaler, an out-of-
1995
state prescription drug wholesale distributor wholesaler, or a
1996
retail pharmacy drug wholesale distributor wholesaler shall
1997
expire on the expiration date of the original permit or 1 year
1998
after the date of issuance of the new permit, whichever is
1999
earlier. A refund may not be issued if the fee for the new permit
2000
is less than the fee that was paid for the original permit.
2001
(3)(4) A written application for a permit or to renew a
2002
permit must be filed with the department on forms furnished by
2003
the department. The department shall establish, by rule, the form
2004
and content of the application to obtain or renew a permit. The
2005
applicant must submit to the department with the application a
2006
statement that swears or affirms that the information is true and
2007
correct.
2008
(4)(5)(a) Except for a permit for a prescription drug
2009
wholesale distributor wholesaler or an out-of-state prescription
2010
drug wholesale distributor wholesaler, an application for a
2011
permit must include:
2012
1. The name, full business address, and telephone number of
2013
the applicant;
2014
2. All trade or business names used by the applicant;
2015
3. The address, telephone numbers, and the names of contact
2016
persons for each facility used by the applicant for the storage,
2017
handling, and distribution of prescription drugs;
2018
4. The type of ownership or operation, such as a
2019
partnership, corporation, or sole proprietorship; and
2020
5. The names of the owner and the operator of the
2021
establishment, including:
2022
a. If an individual, the name of the individual;
2023
b. If a partnership, the name of each partner and the name
2024
of the partnership;
2025
c. If a corporation, the name and title of each corporate
2026
officer and director, the corporate names, and the name of the
2027
state of incorporation;
2028
d. If a sole proprietorship, the full name of the sole
2029
proprietor and the name of the business entity;
2030
e. If a limited liability company, the name of each member,
2031
the name of each manager, the name of the limited liability
2032
company, and the name of the state in which the limited liability
2033
company was organized; and
2034
f. Any other relevant information that the department
2035
requires.
2036
(b) Upon approval of the application by the department and
2037
payment of the required fee, the department shall issue a permit
2038
to the applicant, if the applicant meets the requirements of this
2040
sections.
2041
(c) Any change in information required under paragraph (a)
2042
must be submitted to the department before the change occurs.
2043
(d) The department shall consider, at a minimum, the
2044
following factors in reviewing the qualifications of persons to
2046
1. The applicant's having been found guilty, regardless of
2047
adjudication, in a court of this state or other jurisdiction, of
2048
a violation of a law that directly relates to a drug, device, or
2049
cosmetic. A plea of nolo contendere constitutes a finding of
2050
guilt for purposes of this subparagraph.
2051
2. The applicant's having been disciplined by a regulatory
2052
agency in any state for any offense that would constitute a
2054
3. Any felony conviction of the applicant under a federal,
2055
state, or local law;
2056
4. The applicant's past experience in manufacturing or
2057
distributing drugs, devices, or cosmetics;
2058
5. The furnishing by the applicant of false or fraudulent
2059
material in any application made in connection with manufacturing
2060
or distributing drugs, devices, or cosmetics;
2061
6. Suspension or revocation by a federal, state, or local
2062
government of any permit currently or previously held by the
2063
applicant for the manufacture or distribution of any drugs,
2064
devices, or cosmetics;
2065
7. Compliance with permitting requirements under any
2066
previously granted permits;
2067
8. Compliance with requirements to maintain or make
2068
available to the state permitting authority or to federal, state,
2069
or local law enforcement officials those records required under
2070
this section; and
2071
9. Any other factors or qualifications the department
2072
considers relevant to and consistent with the public health and
2073
safety.
2074
(5)(6) Except for a permit permits for a prescription drug
2075
wholesale distributor wholesalers or an out-of-state prescription
2076
drug wholesale distributor wholesalers:
2077
(a) The department shall adopt rules for the biennial
2078
renewal of permits.
2079
(b) The department shall renew a permit upon receipt of the
2080
renewal application and renewal fee if the applicant meets the
2082
the rules adopted under this part those sections.
2083
(c) A permit, unless sooner suspended or revoked,
2084
automatically expires 2 years after the last day of the
2085
anniversary month in which the permit was originally issued. A
2087
by making application for renewal on forms furnished by the
2088
department and paying the appropriate fees. If a renewal
2089
application and fee are submitted and postmarked after the
2090
expiration date of the permit, the permit may be renewed only
2091
upon payment of a late renewal delinquent fee of $100, plus the
2092
required renewal fee, not later than 60 days after the expiration
2093
date.
2094
(d) Failure to renew a permit in accordance with this
2095
section precludes any future renewal of that permit. If a permit
2096
issued pursuant to this part section has expired and cannot be
2097
renewed, before an establishment may engage in activities that
2099
establishment must submit an application for a new permit, pay
2100
the applicable application fee, the initial permit fee, and all
2101
applicable penalties, and be issued a new permit by the
2102
department.
2103
(6)(7) A permit issued by the department is
2104
nontransferable. Each permit is valid only for the person or
2105
governmental unit to which it is issued and is not subject to
2106
sale, assignment, or other transfer, voluntarily or
2107
involuntarily; nor is a permit valid for any establishment other
2108
than the establishment for which it was originally issued.
2110
must notify the department before making a change of address. The
2111
department shall set a change of location fee not to exceed $100.
2112
(b)1. An application for a new permit is required when a
2113
majority of the ownership or controlling interest of a permitted
2114
establishment is transferred or assigned or when a lessee agrees
2115
to undertake or provide services to the extent that legal
2116
liability for operation of the establishment will rest with the
2117
lessee. The application for the new permit must be made before
2118
the date of the sale, transfer, assignment, or lease.
2119
2. A permittee that is authorized to distribute
2120
prescription legend drugs may transfer such drugs to the new
2121
owner or lessee under subparagraph 1. only after the new owner or
2122
lessee has been approved for a permit to distribute prescription
2123
legend drugs.
2124
(c) If an establishment permitted under this part ss.
2126
writing before the effective date of closure and must:
2127
1. Return the permit to the department;
2128
2. If the permittee is authorized to distribute
2129
prescription legend drugs, indicate the disposition of such
2130
drugs, including the name, address, and inventory, and provide
2131
the name and address of a person to contact regarding access to
2132
records that are required to be maintained under this part ss.
2134
drugs may be made only to persons authorized to possess
2136
2137
The department may revoke the permit of any person that fails to
2138
comply with the requirements of this subsection.
2139
(7)(8) A permit must be posted in a conspicuous place on
2140
the licensed premises.
2141
(8)(3) An application for a permit or to renew a permit for
2142
a prescription drug wholesale distributor wholesaler or an out-
2143
of-state prescription drug wholesale distributor wholesaler
2144
submitted to the department must include:
2145
(a) The name, full business address, and telephone number
2146
of the applicant.
2147
(b) All trade or business names used by the applicant.
2148
(c) The address, telephone numbers, and the names of
2149
contact persons for each facility used by the applicant for the
2150
storage, handling, and distribution of prescription drugs.
2151
(d) The type of ownership or operation, such as a
2152
partnership, corporation, or sole proprietorship.
2153
(e) The names of the owner and the operator of the
2154
establishment, including:
2155
1. If an individual, the name of the individual.
2156
2. If a partnership, the name of each partner and the name
2157
of the partnership.
2158
3. If a corporation:
2159
a. The name, address, and title of each corporate officer
2160
and director.
2161
b. The name and address of the corporation, resident agent
2162
of the corporation, the resident agent's address, and the
2163
corporation's state of incorporation.
2164
c. The name and address of each shareholder of the
2165
corporation that owns 5 percent or more of the outstanding stock
2166
of the corporation.
2167
4. If a sole proprietorship, the full name of the sole
2168
proprietor and the name of the business entity.
2169
5. If a limited liability company:
2170
a. The name and address of each member.
2171
b. The name and address of each manager.
2172
c. The name and address of the limited liability company,
2173
the resident agent of the limited liability company, and the name
2174
of the state in which the limited liability company was
2175
organized.
2176
(f) If applicable, the name and address of each member of
2177
the affiliated group of which the applicant is a member.
2178
(g)1. For an application for a new permit, the estimated
2179
annual dollar volume of prescription drug sales of the applicant,
2180
the estimated annual percentage of the applicant's total company
2181
sales that are prescription drugs, the applicant's estimated
2182
annual total dollar volume of purchases of prescription drugs,
2183
and the applicant's estimated annual total dollar volume of
2184
prescription drug purchases directly from manufacturers.
2185
2. For an application to renew a permit, the total dollar
2186
volume of prescription drug sales in the previous year, the total
2187
dollar volume of prescription drug sales made in the previous 6
2188
months, the percentage of total company sales that were
2189
prescription drugs in the previous year, the total dollar volume
2190
of purchases of prescription drugs in the previous year, and the
2191
total dollar volume of prescription drug purchases directly from
2192
manufacturers in the previous year.
2193
2194
Such portions of the information required pursuant to this
2195
paragraph which are a trade secret, as defined in s. 812.081,
2196
shall be maintained by the department as trade secret information
2197
is required to be maintained under s. 499.051.
2198
(h) The tax year of the applicant.
2199
(i) A copy of the deed for the property on which
2200
applicant's establishment is located, if the establishment is
2201
owned by the applicant, or a copy of the applicant's lease for
2202
the property on which applicant's establishment is located that
2203
has an original term of not less than 1 calendar year, if the
2204
establishment is not owned by the applicant.
2205
(j) A list of all licenses and permits issued to the
2206
applicant by any other state which authorize the applicant to
2207
purchase or possess prescription drugs.
2208
(k) The name of the manager of the establishment that is
2209
applying for the permit or to renew the permit, the next four
2210
highest ranking employees responsible for prescription drug
2211
wholesale operations for the establishment, and the name of all
2212
affiliated parties for the establishment, together with the
2213
personal information statement and fingerprints required pursuant
2214
to subsection (9) (4) for each of such persons.
2215
(l) The name of each of the applicant's designated
2216
representatives as required by subsection (16) (11), together
2217
with the personal information statement and fingerprints required
2218
pursuant to subsection (9) (4) for each such person.
2219
(m) For an applicant that is a secondary wholesale
2220
distributor wholesaler, each of the following:
2221
1. A personal background information statement containing
2222
the background information and fingerprints required pursuant to
2223
subsection (9) (4) for each person named in the applicant's
2224
response to paragraphs (k) and (l) and for each affiliated party
2225
of the applicant.
2226
2. If any of the five largest shareholders of the
2227
corporation seeking the permit is a corporation, the name,
2228
address, and title of each corporate officer and director of each
2229
such corporation; the name and address of such corporation; the
2230
name of such corporation's resident agent, such corporation's
2231
resident agent's address, and such corporation's state of its
2232
incorporation; and the name and address of each shareholder of
2233
such corporation that owns 5 percent or more of the stock of such
2234
corporation.
2235
3. The name and address of all financial institutions in
2236
which the applicant has an account which is used to pay for the
2237
operation of the establishment or to pay for drugs purchased for
2238
the establishment, together with the names of all persons that
2239
are authorized signatories on such accounts. The portions of the
2240
information required pursuant to this subparagraph which are a
2241
trade secret, as defined in s. 812.081, shall be maintained by
2242
the department as trade secret information is required to be
2243
maintained under s. 499.051.
2244
4. The sources of all funds and the amounts of such funds
2245
used to purchase or finance purchases of prescription drugs or to
2246
finance the premises on which the establishment is to be located.
2247
5. If any of the funds identified in subparagraph 4. were
2248
borrowed, copies of all promissory notes or loans used to obtain
2249
such funds.
2250
(n) Any other relevant information that the department
2251
requires, including, but not limited to, any information related
2252
to whether the applicant satisfies the definition of a primary
2253
wholesale distributor wholesaler or a secondary wholesale
2254
distributor wholesaler.
2255
(9)(4)(a) Each person required by subsection (8) (3) to
2256
provide a personal information statement and fingerprints shall
2257
provide the following information to the department on forms
2258
prescribed by the department:
2259
1. The person's places of residence for the past 7 years.
2260
2. The person's date and place of birth.
2261
3. The person's occupations, positions of employment, and
2262
offices held during the past 7 years.
2263
4. The principal business and address of any business,
2264
corporation, or other organization in which each such office of
2265
the person was held or in which each such occupation or position
2266
of employment was carried on.
2267
5. Whether the person has been, during the past 7 years,
2268
the subject of any proceeding for the revocation of any license
2269
and, if so, the nature of the proceeding and the disposition of
2270
the proceeding.
2271
6. Whether, during the past 7 years, the person has been
2272
enjoined, either temporarily or permanently, by a court of
2273
competent jurisdiction from violating any federal or state law
2274
regulating the possession, control, or distribution of
2275
prescription drugs, together with details concerning any such
2276
event.
2277
7. A description of any involvement by the person with any
2278
business, including any investments, other than the ownership of
2279
stock in a publicly traded company or mutual fund, during the
2280
past 7 years, which manufactured, administered, prescribed,
2281
distributed, or stored pharmaceutical products and any lawsuits
2282
in which such businesses were named as a party.
2283
8. A description of any felony criminal offense of which
2284
the person, as an adult, was found guilty, regardless of whether
2285
adjudication of guilt was withheld or whether the person pled
2286
guilty or nolo contendere. A criminal offense committed in
2287
another jurisdiction which would have been a felony in this state
2288
must be reported. If the person indicates that a criminal
2289
conviction is under appeal and submits a copy of the notice of
2290
appeal of that criminal offense, the applicant must, within 15
2291
days after the disposition of the appeal, submit to the
2292
department a copy of the final written order of disposition.
2293
9. A photograph of the person taken in the previous 30
2294
days.
2295
10. A set of fingerprints for the person on a form and
2296
under procedures specified by the department, together with
2297
payment of an amount equal to the costs incurred by the
2298
department for the criminal record check of the person.
2299
11. The name, address, occupation, and date and place of
2300
birth for each member of the person's immediate family who is 18
2301
years of age or older. As used in this subparagraph, the term
2302
"member of the person's immediate family" includes the person's
2303
spouse, children, parents, siblings, the spouses of the person's
2304
children, and the spouses of the person's siblings.
2305
12. Any other relevant information that the department
2306
requires.
2307
(b) The information required pursuant to paragraph (a)
2308
shall be provided under oath.
2309
(c) The department shall submit the fingerprints provided
2310
by a person for initial licensure to the Department of Law
2311
Enforcement for a statewide criminal record check and for
2312
forwarding to the Federal Bureau of Investigation for a national
2313
criminal record check of the person. The department shall submit
2314
the fingerprints provided by a person as a part of a renewal
2315
application to the Department of Law Enforcement for a statewide
2316
criminal record check, and for forwarding to the Federal Bureau
2317
of Investigation for a national criminal record check, for the
2318
initial renewal of a permit after January 1, 2004; for any
2319
subsequent renewal of a permit, the department shall submit the
2320
required information for a statewide and national criminal record
2321
check of the person. Any person who as a part of an initial
2322
permit application or initial permit renewal after January 1,
2323
2004, submits to the department a set of fingerprints required
2324
for the criminal record check required in this paragraph shall
2325
not be required to provide a subsequent set of fingerprints for a
2326
criminal record check to the department, if the person has
2327
undergone a criminal record check as a condition of the issuance
2328
of an initial permit or the initial renewal of a permit of an
2329
applicant after January 1, 2004.
2330
(10)(5) The department may deny an application for a permit
2331
or refuse to renew a permit for a prescription drug wholesale
2332
distributor wholesaler or an out-of-state prescription drug
2333
wholesale distributor wholesaler if:
2334
(a) The applicant has not met the requirements for the
2335
permit.
2336
(b) The management, officers, or directors of the applicant
2337
or any affiliated party are found by the department to be
2338
incompetent or untrustworthy.
2339
(c) The applicant is so lacking in experience in managing a
2340
wholesale distributor as to make the issuance of the proposed
2341
permit hazardous to the public health.
2342
(d) The applicant is so lacking in experience in managing a
2343
wholesale distributor as to jeopardize the reasonable promise of
2344
successful operation of the wholesale distributor.
2345
(e) The applicant is lacking in experience in the
2346
distribution of prescription drugs.
2347
(f) The applicant's past experience in manufacturing or
2348
distributing prescription drugs indicates that the applicant
2349
poses a public health risk.
2350
(g) The applicant is affiliated directly or indirectly
2351
through ownership, control, or other business relations, with any
2352
person or persons whose business operations are or have been
2353
detrimental to the public health.
2354
(h) The applicant, or any affiliated party, has been found
2355
guilty of or has pleaded guilty or nolo contendere to any felony
2356
or crime punishable by imprisonment for 1 year or more under the
2357
laws of the United States, any state, or any other country,
2358
regardless of whether adjudication of guilt was withheld.
2359
(i) The applicant or any affiliated party has been charged
2360
with a felony in a state or federal court and the disposition of
2361
that charge is pending during the application review or renewal
2362
review period.
2363
(j) The applicant has furnished false or fraudulent
2364
information or material in any application made in this state or
2365
any other state in connection with obtaining a permit or license
2366
to manufacture or distribute drugs, devices, or cosmetics.
2367
(k) That a federal, state, or local government permit
2368
currently or previously held by the applicant, or any affiliated
2369
party, for the manufacture or distribution of any drugs, devices,
2370
or cosmetics has been disciplined, suspended, or revoked and has
2371
not been reinstated.
2372
(l) The applicant does not possess the financial or
2373
physical resources to operate in compliance with the permit being
2374
sought, this chapter, and the rules adopted under this chapter.
2375
(m) The applicant or any affiliated party receives,
2376
directly or indirectly, financial support and assistance from a
2377
person who was an affiliated party of a permittee whose permit
2378
was subject to discipline or was suspended or revoked, other than
2379
through the ownership of stock in a publicly traded company or a
2380
mutual fund.
2381
(n) The applicant or any affiliated party receives,
2382
directly or indirectly, financial support and assistance from a
2383
person who has been found guilty of any violation of this part
2385
any rules adopted under any of this part those sections or those
2386
chapters, any federal or state drug law, or any felony where the
2387
underlying facts related to drugs, regardless of whether the
2388
person has been pardoned, had her or his civil rights restored,
2389
or had adjudication withheld, other than through the ownership of
2390
stock in a publicly traded company or a mutual fund.
2391
(o) The applicant for renewal of a permit under s.
2393
has not actively engaged in the wholesale distribution of
2394
prescription drugs, as demonstrated by the regular and systematic
2395
distribution of prescription drugs throughout the year as
2396
evidenced by not fewer than 12 wholesale distributions in the
2397
previous year and not fewer than three wholesale distributions in
2398
the previous 6 months.
2399
(p) Information obtained in response to s. 499.01(2)(d)
2400
paragraph (2)(a) or s. 499.01(2)(e) paragraph (2)(c) demonstrates
2401
it would not be in the best interest of the public health,
2402
safety, and welfare to issue a permit.
2403
(q) The applicant does not possess the financial standing
2404
and business experience for the successful operation of the
2405
applicant.
2406
(r) The applicant or any affiliated party has failed to
2407
comply with the requirements for manufacturing or distributing
2409
federal laws, similar laws in other states, or the rules adopted
2410
under such laws.
2411
(11)(6) Upon approval of the application by the department
2412
and payment of the required fee, the department shall issue or
2413
renew a prescription drug wholesale distributor wholesaler or an
2414
out-of-state prescription drug wholesale distributor wholesaler
2415
permit to the applicant.
2416
(12)(7) For a permit permits for a prescription drug
2417
wholesale distributor wholesalers or an out-of-state prescription
2418
drug wholesale distributor wholesalers:
2419
(a) The department shall adopt rules for the annual renewal
2420
of permits. At least 90 days before the expiration of a permit,
2421
the department shall forward a permit renewal notification and
2422
renewal application to the prescription drug wholesale
2423
distributor wholesaler or out-of-state prescription drug
2424
wholesale distributor wholesaler at the mailing address of the
2425
permitted establishment on file with the department. The permit
2426
renewal notification must state conspicuously the date on which
2427
the permit for the establishment will expire and that the
2428
establishment may not operate unless the permit for the
2429
establishment is renewed timely.
2430
(b) A permit, unless sooner suspended or revoked,
2431
automatically expires 1 year after the last day of the
2432
anniversary month in which the permit was originally issued. A
2433
permit may be renewed by making application for renewal on forms
2434
furnished by the department and paying the appropriate fees. If a
2435
renewal application and fee are submitted and postmarked after 45
2436
days prior to the expiration date of the permit, the permit may
2437
be renewed only upon payment of a late renewal fee of $100, plus
2438
the required renewal fee. A permittee that has submitted a
2439
renewal application in accordance with this paragraph may
2440
continue to operate under its permit, unless the permit is
2441
suspended or revoked, until final disposition of the renewal
2442
application.
2443
(c) Failure to renew a permit in accordance with this
2444
section precludes any future renewal of that permit. If a permit
2445
issued pursuant to this section has expired and cannot be
2446
renewed, before an establishment may engage in activities that
2448
establishment must submit an application for a new permit; pay
2449
the applicable application fee, initial permit fee, and all
2450
applicable penalties; and be issued a new permit by the
2451
department.
2452
(13)(8) A person that engages in wholesale distribution of
2453
prescription drugs in this state must have a wholesale
2454
distributor's permit issued by the department, except as noted in
2455
this section. Each establishment must be separately permitted
2456
except as noted in this subsection.
2457
(a) A separate establishment permit is not required when a
2458
permitted prescription drug wholesale distributor wholesaler
2459
consigns a prescription drug to a pharmacy that is permitted
2460
under chapter 465 and located in this state, provided that:
2461
1. The consignor wholesale distributor wholesaler notifies
2462
the department in writing of the contract to consign prescription
2463
drugs to a pharmacy along with the identity and location of each
2464
consignee pharmacy;
2465
2. The pharmacy maintains its permit under chapter 465;
2466
3. The consignor wholesale distributor wholesaler, which
2467
has no legal authority to dispense prescription drugs, complies
2468
with all wholesale distribution requirements of ss. s. 499.0121
2469
and 499.01212 with respect to the consigned drugs and maintains
2470
records documenting the transfer of title or other completion of
2471
the wholesale distribution of the consigned prescription drugs;
2472
4. The distribution of the prescription drug is otherwise
2473
lawful under this chapter and other applicable law;
2474
5. Open packages containing prescription drugs within a
2475
pharmacy are the responsibility of the pharmacy, regardless of
2476
how the drugs are titled; and
2477
6. The pharmacy dispenses the consigned prescription drug
2478
in accordance with the limitations of its permit under chapter
2479
465 or returns the consigned prescription drug to the consignor
2480
wholesale distributor wholesaler. In addition, a person who holds
2481
title to prescription drugs may transfer the drugs to a person
2482
permitted or licensed to handle the reverse distribution or
2483
destruction of drugs. Any other distribution by and means of the
2484
consigned prescription drug by any person, not limited to the
2485
consignor wholesale distributor wholesaler or consignee pharmacy,
2486
to any other person is prohibited.
2487
(b) A wholesale distributor's permit is not required for
2488
the one-time transfer of title of a pharmacy's lawfully acquired
2489
prescription drug inventory by a pharmacy with a valid permit
2490
issued under chapter 465 to a consignor prescription drug
2491
wholesale distributor wholesaler, permitted under this chapter,
2492
in accordance with a written consignment agreement between the
2493
pharmacy and that wholesale distributor wholesaler if: the
2494
permitted pharmacy and the permitted prescription drug wholesale
2495
distributor wholesaler comply with all of the provisions of
2496
paragraph (a) and the prescription drugs continue to be within
2497
the permitted pharmacy's inventory for dispensing in accordance
2498
with the limitations of the pharmacy permit under chapter 465. A
2499
consignor drug wholesale distributor wholesaler may not use the
2500
pharmacy as a wholesale distributor through which it distributes
2501
the prescription legend drugs to other pharmacies. Nothing in
2502
this section is intended to prevent a wholesale drug distributor
2503
from obtaining this inventory in the event of nonpayment by the
2504
pharmacy.
2505
(c) A separate establishment permit is not required when a
2506
permitted prescription drug wholesale distributor operates
2507
temporary transit storage facilities for the sole purpose of
2508
storage, for a period not to exceed 12 hours, of a delivery of
2509
prescription drugs when the wholesale distributor was temporarily
2510
unable to complete the delivery to the recipient.
2511
(d)(c) The department shall require information from each
2512
wholesale distributor as part of the permit and renewal of such
2513
permit, as required under s. 499.01 or this section.
2514
(14)(9) Personnel employed in wholesale distribution must
2515
have appropriate education and experience to enable them to
2516
perform their duties in compliance with state permitting
2517
requirements.
2518
(15)(10) The name of a permittee or establishment on a
2519
prescription drug wholesale distributor wholesaler permit or an
2520
out-of-state prescription drug wholesale distributor wholesaler
2521
permit may not include any indicia of attainment of any
2522
educational degree, any indicia that the permittee or
2523
establishment possesses a professional license, or any name or
2524
abbreviation that the department determines is likely to cause
2525
confusion or mistake or that the department determines is
2526
deceptive, including that of any other entity authorized to
2527
purchase prescription drugs.
2528
(16)(11)(a) Each establishment that is issued an initial or
2529
renewal permit as a prescription drug wholesale distributor
2530
wholesaler or an out-of-state prescription drug wholesale
2531
distributor wholesaler must designate in writing to the
2532
department at least one natural person to serve as the designated
2533
representative of the wholesale distributor wholesaler. Such
2534
person must have an active certification as a designated
2535
representative from the department.
2536
(b) To be certified as a designated representative, a
2537
natural person must:
2538
1. Submit an application on a form furnished by the
2539
department and pay the appropriate fees;
2540
2. Be at least 18 years of age;
2541
3. Have not less than 2 years of verifiable full-time work
2542
experience in a pharmacy licensed in this state or another state,
2543
where the person's responsibilities included, but were not
2544
limited to, recordkeeping for prescription drugs, or have not
2545
less than 2 years of verifiable full-time managerial experience
2546
with a prescription drug wholesale distributor wholesaler
2547
licensed in this state or in another state;
2548
4. Receive a passing score of at least 75 percent on an
2549
examination given by the department regarding federal laws
2550
governing distribution of prescription drugs and this part ss.
2552
the wholesale distribution of prescription drugs. This
2553
requirement shall be effective 1 year after the results of the
2554
initial examination are mailed to the persons that took the
2555
examination. The department shall offer such examinations at
2556
least four times each calendar year; and
2557
5. Provide the department with a personal information
2558
statement and fingerprints pursuant to subsection (9)(4).
2559
(c) The department may deny an application for
2560
certification as a designated representative or may suspend or
2561
revoke a certification of a designated representative pursuant to
2562
s. 499.067.
2563
(d) A designated representative:
2564
1. Must be actively involved in and aware of the actual
2565
daily operation of the wholesale distributor.
2566
2. Must be employed full time in a managerial position by
2567
the wholesale distributor.
2568
3. Must be physically present at the establishment during
2569
normal business hours, except for time periods when absent due to
2570
illness, family illness or death, scheduled vacation, or other
2571
authorized absence.
2572
4. May serve as a designated representative for only one
2573
wholesale distributor at any one time.
2574
(e) A wholesale distributor must notify the department when
2575
a designated representative leaves the employ of the wholesale
2576
distributor. Such notice must be provided to the department
2577
within 10 business days after the last day of designated
2578
representative's employment with the wholesale distributor.
2579
(f) A wholesale distributor may not operate under a
2580
prescription drug wholesale distributor wholesaler permit or an
2581
out-of-state prescription drug wholesale distributor wholesaler
2582
permit for more than 10 business days after the designated
2583
representative leaves the employ of the wholesale distributor,
2584
unless the wholesale distributor employs another designated
2585
representative and notifies the department within 10 business
2586
days of the identity of the new designated representative.
2587
Section 12. Section 499.01201, Florida Statutes, is amended
2588
to read:
2589
499.01201 Agency for Health Care Administration review and
2590
use of statute and rule violation or compliance
2591
data.--Notwithstanding any other provisions of law to the
2592
contrary, the Agency for Health Care Administration may not:
2593
(1) Review or use any violation or alleged violation of s.
2595
sections that section, as a ground for denying or withholding any
2596
payment of a Medicaid reimbursement to a pharmacy licensed under
2597
chapter 465; or
2598
(2) Review or use compliance with s. 499.0121(6) or s.
2599
499.01212, or any rules adopted under those sections that
2600
section, as the subject of any audit of Medicaid-related records
2601
held by a pharmacy licensed under chapter 465.
2602
Section 13. Section 499.0121, Florida Statutes, is amended,
2603
and subsection (4) of section 499.013, Florida Statutes, is
2604
redesignated as paragraph (d) of subsection (6) of that section
2605
and amended, to read:
2606
499.0121 Storage and handling of prescription drugs;
2607
recordkeeping.--The department shall adopt rules to implement
2608
this section as necessary to protect the public health, safety,
2609
and welfare. Such rules shall include, but not be limited to,
2610
requirements for the storage and handling of prescription drugs
2611
and for the establishment and maintenance of prescription drug
2612
distribution records.
2613
(1) ESTABLISHMENTS.--An establishment at which prescription
2614
drugs are stored, warehoused, handled, held, offered, marketed,
2615
or displayed must:
2616
(a) Be of suitable size and construction to facilitate
2617
cleaning, maintenance, and proper operations;
2618
(b) Have storage areas designed to provide adequate
2619
lighting, ventilation, temperature, sanitation, humidity, space,
2620
equipment, and security conditions;
2621
(c) Have a quarantine area for storage of prescription
2622
drugs that are outdated, damaged, deteriorated, misbranded, or
2623
adulterated, or that are in immediate or sealed, secondary
2624
containers that have been opened;
2625
(d) Be maintained in a clean and orderly condition; and
2626
(e) Be free from infestation by insects, rodents, birds, or
2627
vermin of any kind.
2628
(2) SECURITY.--
2629
(a) An establishment that is used for wholesale drug
2630
distribution must be secure from unauthorized entry.
2631
1. Access from outside the premises must be kept to a
2632
minimum and be well-controlled.
2633
2. The outside perimeter of the premises must be well-
2634
lighted.
2635
3. Entry into areas where prescription drugs are held must
2636
be limited to authorized personnel.
2637
(b) An establishment that is used for wholesale drug
2638
distribution must be equipped with:
2639
1. An alarm system to detect entry after hours; however,
2640
the department may exempt by rule establishments that only hold a
2641
permit as prescription drug wholesale distributor-brokers
2642
wholesaler-brokers and establishments that only handle medical
2643
oxygen; and
2644
2. A security system that will provide suitable protection
2645
against theft and diversion. When appropriate, the security
2646
system must provide protection against theft or diversion that is
2647
facilitated or hidden by tampering with computers or electronic
2648
records.
2649
(c) Any vehicle that contains prescription drugs must be
2650
secure from unauthorized access to the prescription drugs in the
2651
vehicle.
2652
(3) STORAGE.--All prescription drugs shall be stored at
2653
appropriate temperatures and under appropriate conditions in
2654
accordance with requirements, if any, in the labeling of such
2655
drugs, or with requirements in the official compendium.
2656
(a) If no storage requirements are established for a
2657
prescription drug, the drug may be held at "controlled" room
2658
temperature, as defined in the official compendium, to help
2659
ensure that its identity, strength, quality, and purity are not
2660
adversely affected.
2661
(b) Appropriate manual, electromechanical, or electronic
2662
temperature and humidity recording equipment, devices, or logs
2663
must be used to document proper storage of prescription drugs.
2664
(c) The recordkeeping requirements in subsection (6) must
2665
be followed for all stored prescription drugs.
2666
(4) EXAMINATION OF MATERIALS AND RECORDS.--
2667
(a) Upon receipt, each outside shipping container must be
2668
visually examined for identity and to prevent the acceptance of
2669
contaminated prescription drugs that are otherwise unfit for
2670
distribution. This examination must be adequate to reveal
2671
container damage that would suggest possible contamination or
2672
other damage to the contents.
2673
(b) Each outgoing shipment must be carefully inspected for
2674
identity of the prescription drug products and to ensure that
2675
there is no delivery of prescription drugs that have expired or
2676
been damaged in storage or held under improper conditions.
2677
(c) The recordkeeping requirements in subsection (6) must
2678
be followed for all incoming and outgoing prescription drugs.
2679
(d) Upon receipt, a wholesale distributor wholesaler must
2680
review records required under this section for the acquisition of
2681
prescription drugs for accuracy and completeness, considering the
2682
total facts and circumstances surrounding the transactions and
2683
the wholesale distributors involved. This includes authenticating
2684
each transaction listed on a pedigree paper, as defined in s.
2686
(5) RETURNED, DAMAGED, OR OUTDATED PRESCRIPTION DRUGS.--
2687
(a)1. Prescription drugs that are outdated, damaged,
2688
deteriorated, misbranded, or adulterated must be quarantined and
2689
physically separated from other prescription drugs until they are
2690
destroyed or returned to their supplier. A quarantine section
2691
must be separate and apart from other sections where prescription
2692
drugs are stored so that prescription drugs in this section are
2693
not confused with usable prescription drugs.
2694
2. Prescription drugs must be examined at least every 12
2695
months, and drugs for which the expiration date has passed must
2696
be removed and quarantined.
2697
(b) Any prescription drugs of which the immediate or sealed
2698
outer containers or sealed secondary containers have been opened
2699
or used must be identified as such and must be quarantined and
2700
physically separated from other prescription drugs until they are
2701
either destroyed or returned to the supplier.
2702
(c) If the conditions under which a prescription drug has
2703
been returned cast doubt on the drug's safety, identity,
2704
strength, quality, or purity, the drug must be destroyed or
2705
returned to the supplier, unless examination, testing, or other
2706
investigation proves that the drug meets appropriate standards of
2707
safety, identity, strength, quality, and purity. In determining
2708
whether the conditions under which a drug has been returned cast
2709
doubt on the drug's safety, identity, strength, quality, or
2710
purity, the wholesale drug distributor must consider, among other
2711
things, the conditions under which the drug has been held,
2712
stored, or shipped before or during its return and the conditions
2713
of the drug and its container, carton, or labeling, as a result
2714
of storage or shipping.
2715
(d) The recordkeeping requirements in subsection (6) must
2716
be followed for all outdated, damaged, deteriorated, misbranded,
2717
or adulterated prescription drugs.
2718
(6) RECORDKEEPING.--The department shall adopt rules that
2719
require keeping such records of prescription drugs as are
2720
necessary for the protection of the public health.
2721
(a) Wholesale drug distributors must establish and maintain
2722
inventories and records of all transactions regarding the receipt
2723
and distribution or other disposition of prescription drugs.
2724
These records must provide a complete audit trail from receipt to
2725
sale or other disposition, be readily retrievable for inspection,
2726
and include, at a minimum, the following information:
2727
1. The source of the drugs, including the name and
2728
principal address of the seller or transferor, and the address of
2729
the location from which the drugs were shipped;
2730
2. The name, principal address, and state license permit or
2731
registration number of the person authorized to purchase
2732
prescription drugs;
2733
3. The name, strength, dosage form, and quantity of the
2734
drugs received and distributed or disposed of;
2735
4. The dates of receipt and distribution or other
2736
disposition of the drugs; and
2737
5. Any financial documentation supporting the transaction.
2738
(b) Inventories and records must be made available for
2739
inspection and photocopying by authorized federal, state, or
2740
local officials for a period of 2 years following disposition of
2741
the drugs or 3 years after the creation of the records, whichever
2742
period is longer.
2743
(c) Records described in this section that are kept at the
2744
inspection site or that can be immediately retrieved by computer
2745
or other electronic means must be readily available for
2746
authorized inspection during the retention period. Records that
2747
are kept at a central location outside of this state and that are
2748
not electronically retrievable must be made available for
2749
inspection within 2 working days after a request by an authorized
2750
official of a federal, state, or local law enforcement agency.
2751
Records that are maintained at a central location within this
2752
state must be maintained at an establishment that is permitted
2754
available.
2755
(d)(4) Each manufacturer or repackager of medical devices,
2756
over-the-counter drugs, or cosmetics must maintain records that
2757
include the name and principal address of the seller or
2758
transferor of the product, the address of the location from which
2759
the product was shipped, the date of the transaction, the name
2760
and quantity of the product involved, and the name and principal
2761
address of the person who purchased the product.
2762
(e) A wholesale distributor must maintain pedigree papers
2763
separate and distinct from other records required under this
2764
chapter.
2765
(d)1. Effective July 1, 2006, each person who is engaged in
2766
the wholesale distribution of a prescription drug and who is not
2767
the manufacturer of that drug must, before each wholesale
2768
distribution of such drug, provide to the person who receives the
2769
drug a pedigree paper as defined in s. 499.003(31).
2770
2. A repackager must comply with this paragraph.
2771
3. The pedigree paper requirements in this paragraph do not
2772
apply to compressed medical gases or veterinary legend drugs.
2773
4. Each wholesale distributor of prescription drugs must
2774
maintain separate and distinct from other required records all
2775
statements that are required under subparagraph 1.
2776
5. Subparagraph 1. is satisfied when a wholesale
2777
distributor takes title to, but not possession of, a prescription
2778
drug and the prescription drug's manufacturer ships the
2779
prescription drug directly to a person authorized by law to
2780
purchase prescription drugs for the purpose of administering or
2781
dispensing the drug, as defined in s. 465.003, or a member of an
2782
affiliated group, as described in paragraph (f), with the
2783
exception of a repackager.
2784
a. The wholesale distributor must deliver to the recipient
2785
of the prescription drug, within 14 days after the shipment
2786
notification from the manufacturer, an invoice and the following
2787
sworn statement: "This wholesale distributor purchased the
2788
specific unit of the prescription drug listed on the invoice
2789
directly from the manufacturer, and the specific unit of
2790
prescription drug was shipped by the manufacturer directly to a
2791
person authorized by law to administer or dispense the legend
2792
drug, as defined in s. 465.003, Florida Statutes, or a member of
2793
an affiliated group, as described in s. 499.0121(6)(f), Florida
2794
Statutes, with the exception of a repackager." The invoice must
2795
contain a unique cross-reference to the shipping document sent by
2796
the manufacturer to the recipient of the prescription drug.
2797
b. The manufacturer of the prescription drug shipped
2798
directly to the recipient under this section must provide and the
2799
recipient of the prescription drug must acquire, within 14 days
2800
after receipt of the prescription drug, a shipping document from
2801
the manufacturer that contains, at a minimum:
2802
(I) The name and address of the manufacturer, including the
2803
point of origin of the shipment, and the names and addresses of
2804
the wholesaler and the purchaser.
2805
(II) The name of the prescription drug as it appears on the
2806
label.
2807
(III) The quantity, dosage form, and strength of the
2808
prescription drug.
2809
(IV) The date of the shipment from the manufacturer.
2810
c. The wholesale distributor must also maintain and make
2811
available to the department, upon request, the lot number of such
2812
drug if not contained in the shipping document acquired by the
2813
recipient.
2814
6. Failure of the manufacturer to provide, the recipient to
2815
acquire, or the wholesale distributor to deliver, the
2816
documentation required under subparagraph 5. shall constitute
2817
failure to acquire or deliver a pedigree paper under s. 499.0051.
2818
Forgery by the manufacturer, the recipient, or the wholesale
2819
distributor of the documentation required to be acquired or
2820
delivered under subparagraph 5. shall constitute forgery of a
2821
pedigree paper under s. 499.0051.
2822
7. The department may, by rule, specify alternatives to
2823
compliance with subparagraph 1. for a prescription drug in the
2824
inventory of a permitted prescription drug wholesaler as of June
2825
30, 2006, and the return of a prescription drug purchased prior
2826
to July 1, 2006. The department may specify time limits for such
2827
alternatives.
2828
(7)(e) PRESCRIPTION DRUG PURCHASE LIST.--Each wholesale
2829
distributor, except for a manufacturer, shall annually provide
2830
the department with a written list of all wholesale distributors
2831
and manufacturers from whom the wholesale distributor purchases
2832
prescription drugs. A wholesale distributor, except a
2833
manufacturer, shall notify the department not later than 10 days
2834
after any change to either list. Such portions of the information
2835
required pursuant to this subsection paragraph which are a trade
2836
secret, as defined in s. 812.081, shall be maintained by the
2837
department as trade secret information is required to be
2838
maintained under s. 499.051.
2839
(f)1. This paragraph applies only to an affiliated group,
2840
as defined by s. 1504 of the Internal Revenue Code of 1986, as
2841
amended, which is composed of chain drug entities, including at
2842
least 50 retail pharmacies, warehouses, or repackagers, which are
2843
members of the same affiliated group, if the affiliated group:
2844
a. Discloses to the department the names of all its
2845
members; and
2846
b. Agrees in writing to provide records on prescription
2847
drug purchases by members of the affiliated group not later than
2848
48 hours after the department requests such records, regardless
2849
of the location where the records are stored.
2850
2. Each warehouse within the affiliated group must comply
2851
with all applicable federal and state drug wholesale permit
2852
requirements and must purchase, receive, hold, and distribute
2853
prescription drugs only to a retail pharmacy or warehouse within
2854
the affiliated group. Such a warehouse is exempt from providing a
2855
pedigree paper in accordance with paragraph (d) to its affiliated
2856
group member warehouse or retail pharmacy, provided that:
2857
a. Any affiliated group member that purchases or receives a
2858
prescription drug from outside the affiliated group must receive
2859
a pedigree paper if the prescription drug is distributed in or
2860
into this state and a pedigree paper is required under this
2861
section and must authenticate the documentation as required in
2862
subsection (4), regardless of whether the affiliated group member
2863
is directly subject to regulation under this chapter; and
2864
b. The affiliated group makes available to the department
2865
on request all records related to the purchase or acquisition of
2866
prescription drugs by members of the affiliated group, regardless
2867
of the location where the records are stored, if the prescription
2868
drugs were distributed in or into this state.
2869
3. If a repackager repackages prescription drugs solely for
2870
distribution to its affiliated group members for the exclusive
2871
distribution to and among retail pharmacies that are members of
2872
the affiliated group to which the repackager is a member:
2873
a. The repackager must:
2874
(I) In lieu of the written statement required by paragraph
2875
(d), for all repackaged prescription drugs distributed in or into
2876
this state, state in writing under oath with each distribution of
2877
a repackaged prescription drug to an affiliated group member
2878
warehouse or repackager: "All repackaged prescription drugs are
2879
purchased by the affiliated group directly from the manufacturer
2880
or from a prescription drug wholesaler that purchased the
2881
prescription drugs directly from the manufacturer.";
2882
(II) Purchase all prescription drugs it repackages:
2883
(A) Directly from the manufacturer; or
2884
(B) From a prescription drug wholesaler that purchased the
2885
prescription drugs directly from the manufacturer; and
2886
(III) Maintain records in accordance with this section to
2887
document that it purchased the prescription drugs directly from
2888
the manufacturer or that its prescription drug wholesale supplier
2889
purchased the prescription drugs directly from the manufacturer.
2890
b. All members of the affiliated group must provide to
2891
agents of the department on request records of purchases by all
2892
members of the affiliated group of prescription drugs that have
2893
been repackaged, regardless of the location where the records are
2894
stored or where the repackager is located.
2895
(8)(7) WRITTEN POLICIES AND PROCEDURES.--Wholesale drug
2896
distributors must establish, maintain, and adhere to written
2897
policies and procedures, which must be followed for the receipt,
2898
security, storage, inventory, and distribution of prescription
2899
drugs, including policies and procedures for identifying,
2900
recording, and reporting losses or thefts, and for correcting all
2901
errors and inaccuracies in inventories. Wholesale drug
2902
distributors must include in their written policies and
2903
procedures:
2904
(a) A procedure whereby the oldest approved stock of a
2905
prescription drug product is distributed first. The procedure may
2906
permit deviation from this requirement, if the deviation is
2907
temporary and appropriate.
2908
(b) A procedure to be followed for handling recalls and
2909
withdrawals of prescription drugs. Such procedure must be
2910
adequate to deal with recalls and withdrawals due to:
2911
1. Any action initiated at the request of the Food and Drug
2912
Administration or any other federal, state, or local law
2913
enforcement or other government agency, including the department.
2914
2. Any voluntary action by the manufacturer or repackager
2915
to remove defective or potentially defective drugs from the
2916
market; or
2917
3. Any action undertaken to promote public health and
2918
safety by replacing existing merchandise with an improved product
2919
or new package design.
2920
(c) A procedure to ensure that wholesale drug distributors
2921
prepare for, protect against, and handle any crisis that affects
2922
security or operation of any facility if a strike, fire, flood,
2923
or other natural disaster, or a local, state, or national
2924
emergency, occurs.
2925
(d) A procedure to ensure that any outdated prescription
2926
drugs are segregated from other drugs and either returned to the
2927
manufacturer or repackager or destroyed. This procedure must
2928
provide for written documentation of the disposition of outdated
2929
prescription drugs. This documentation must be maintained for 2
2930
years after disposition of the outdated drugs.
2931
(9)(8) RESPONSIBLE PERSONS.--Wholesale drug distributors
2932
must establish and maintain lists of officers, directors,
2933
managers, designated representatives, and other persons in charge
2934
of wholesale drug distribution, storage, and handling, including
2935
a description of their duties and a summary of their
2936
qualifications.
2937
(10)(9) COMPLIANCE WITH FEDERAL, STATE, AND LOCAL LAW.--A
2938
wholesale drug distributor must operate in compliance with
2939
applicable federal, state, and local laws and regulations.
2940
(a) A wholesale drug distributor must allow the department
2941
and authorized federal, state, and local officials to enter and
2942
inspect its premises and delivery vehicles, and to audit its
2943
records and written operating procedures, at reasonable times and
2944
in a reasonable manner, to the extent authorized by law.
2945
(b) A wholesale drug distributor that deals in controlled
2946
substances must register with the Drug Enforcement Administration
2947
and must comply with all applicable state, local, and federal
2948
laws. A wholesale drug distributor that distributes any substance
2949
controlled under chapter 893 must notify the department when
2950
registering with the Drug Enforcement Administration pursuant to
2951
that chapter and must provide the department with its DEA number.
2952
(11)(10) SALVAGING AND REPROCESSING.--A wholesale drug
2953
distributor is subject to any applicable federal, state, or local
2954
laws or regulations that relate to prescription drug product
2955
salvaging or reprocessing.
2956
(12)(11) SHIPPING AND TRANSPORTATION.--The person
2957
responsible for shipment and transportation of a prescription
2958
drug in a wholesale distribution may use a common carrier; its
2959
own vehicle or employee acting within the scope of employment if
2960
authorized under s. 499.03 for the possession of prescription
2961
drugs in this state; or, in the case of a prescription drug
2962
intended for domestic distribution, an independent contractor who
2963
must be the agent of the authorized seller or recipient
2964
responsible for shipping and transportation as set forth in a
2965
written contract between the parties. A person selling a
2966
prescription drug for export must obtain documentation, such as a
2967
validated airway bill, bill of lading, or other appropriate
2968
documentation that the prescription drug was exported. A person
2969
responsible for shipping or transporting prescription drugs is
2970
not required to maintain documentation from a common carrier that
2971
the designated recipient received the prescription drugs;
2972
however, the person must obtain such documentation from the
2973
common carrier and make it available to the department upon
2974
request of the department.
2975
(13)(12) DUE DILIGENCE OF SUPPLIERS.--Prior to purchasing
2976
any prescription drugs from another wholesale drug distributor, a
2977
prescription drug wholesale distributor wholesaler, an out-of-
2978
state prescription drug wholesale distributor wholesaler, or a
2979
prescription drug repackager must:
2980
(a) Enter an agreement with the selling wholesale drug
2981
distributor by which the selling wholesale drug distributor will
2982
indemnify the purchasing wholesale drug distributor for any loss
2983
caused to the purchasing wholesale drug distributor related to
2984
the purchase of drugs from the selling wholesale drug distributor
2985
which are determined to be counterfeit or to have been
2986
distributed in violation of any federal or state law governing
2987
the distribution of drugs.
2988
(b) Determine that the selling wholesale drug distributor
2989
has insurance coverage of not less than the greater of 1 percent
2990
of the amount of total dollar volume of the prescription drug
2991
sales reported to the department under s. 499.012(8)(g) s.
2992
499.012(3)(g) or $500,000; however the coverage need not exceed
2993
$2 million.
2994
(c) Obtain information from the selling wholesale drug
2995
distributor, including the length of time the selling wholesale
2996
drug distributor has been licensed in this state, a copy of the
2997
selling wholesale drug distributor's licenses or permits, and
2998
background information concerning the ownership of the selling
2999
wholesale drug distributor, including the experience of the
3000
wholesale distributor in the wholesale distribution of
3001
prescription drugs.
3002
(d) Verify that the selling wholesale drug distributor's
3003
Florida permit is valid.
3004
(e) Inspect the selling wholesale drug distributor's
3005
licensed establishment to document that it has a policies and
3006
procedures manual relating to the distribution of drugs, the
3007
appropriate temperature controlled environment for drugs
3008
requiring temperature control, an alarm system, appropriate
3009
access restrictions, and procedures to ensure that records
3010
related to the wholesale distribution of prescription drugs are
3011
maintained as required by law:
3012
1. Before purchasing any drug from the wholesale drug
3013
distributor, and at least once each subsequent year; or
3014
2. Before purchasing any drug from the wholesale drug
3015
distributor, and each subsequent year obtain a complete copy of
3016
the most recent inspection report for the establishment which was
3017
prepared by the department or the regulatory authority
3018
responsible for wholesale drug distributors in the state in which
3019
the establishment is located.
3020
Section 14. Section 499.01211, Florida Statutes, is amended
3021
to read:
3022
499.01211 Drug Wholesale Distributor Wholesaler Advisory
3023
Council.--
3024
(1) There is created the Drug Wholesale Distributor
3025
Wholesaler Advisory Council within the department. The council
3026
shall meet at least once each calendar quarter. Staff for the
3027
council shall be provided by the department. The council shall
3028
consist of 11 members who shall serve without compensation. The
3029
council shall elect a chairperson and a vice chairperson
3030
annually.
3031
(2) The State Surgeon General, or his or her designee, and
3032
the Secretary of Health Care Administration, or her or his
3033
designee, shall be members of the council. The State Surgeon
3034
General shall appoint nine additional members to the council who
3035
shall be appointed to a term of 4 years each, as follows:
3036
(a) Three different persons each of whom is employed by a
3037
different prescription drug wholesale distributor wholesaler
3038
licensed under this part chapter which operates nationally and is
3039
a primary wholesale distributor wholesaler, as defined in s.
3041
(b) One person employed by a prescription drug wholesale
3042
distributor wholesaler licensed under this part chapter which is
3043
a secondary wholesale distributor wholesaler, as defined in s.
3045
(c) One person employed by a retail pharmacy chain located
3046
in this state.
3047
(d) One person who is a member of the Board of Pharmacy and
3048
is a pharmacist licensed under chapter 465.
3049
(e) One person who is a physician licensed pursuant to
3050
chapter 458 or chapter 459.
3051
(f) One person who is an employee of a hospital licensed
3052
pursuant to chapter 395 and is a pharmacist licensed pursuant to
3053
chapter 465.
3054
(g) One person who is an employee of a pharmaceutical
3055
manufacturer.
3058
annually, provide input to the department regarding all proposed
3060
recommendations to the department to improve the protection of
3061
the prescription drugs and public health, make recommendations to
3062
improve coordination with other states' regulatory agencies and
3063
the federal government concerning the wholesale distribution of
3064
drugs, and make recommendations to minimize the impact of
3065
regulation of the wholesale distribution industry while ensuring
3066
protection of the public health.
3067
Section 15. Section 499.01212, Florida Statutes, is created
3068
to read:
3069
499.01212 Pedigree paper.--
3070
(1) APPLICATION.--Each person who is engaged in the
3071
wholesale distribution of a prescription drug must, prior to or
3072
simultaneous with each wholesale distribution, provide a pedigree
3073
paper to the person who receives the drug.
3074
(2) FORMAT.--A pedigree paper must contain the following
3075
information:
3076
(a) For the wholesale distribution of a prescription drug
3077
within the normal distribution chain:
3078
1. The following statement: "This wholesale distributor
3079
purchased the specific unit of the prescription drug directly
3080
from the manufacturer."
3081
2. The manufacturer's national drug code identifier and the
3082
name and address of the wholesale distributor and the purchaser
3083
of the prescription drug.
3084
3. The name of the prescription drug as it appears on the
3085
label.
3086
4. The quantity, dosage form, and strength of the
3087
prescription drug.
3088
3089
The wholesale distributor must also maintain and make available
3090
to the department, upon request, the point of origin of the
3091
prescription drugs, including intracompany transfers, the date of
3092
the shipment from the manufacturer to the wholesale distributor,
3093
the lot numbers of such drugs, and the invoice numbers from the
3094
manufacturer.
3095
(b) For all other wholesale distributions of prescription
3096
drugs:
3097
1. The quantity, dosage form, and strength of the
3098
prescription drugs.
3099
2. The lot numbers of the prescription drugs.
3100
3. The name and address of each owner of the prescription
3101
drug and his or her signature.
3102
4. Shipping information, including the name and address of
3103
each person certifying delivery or receipt of the prescription
3104
drug.
3105
5. An invoice number, a shipping document number, or
3106
another number uniquely identifying the transaction.
3107
6. A certification that the recipient wholesale distributor
3108
has authenticated the pedigree papers.
3109
7. The unique serialization of the prescription drug, if
3110
the manufacturer or repackager has uniquely serialized the
3111
individual prescription drug unit.
3112
8. The name, address, telephone number, and, if available,
3113
e-mail contact information of each wholesale distributor involved
3114
in the chain of the prescription drug's custody.
3115
(3) EXCEPTIONS.--A pedigree paper is not required for:
3116
(a) The wholesale distribution of a prescription drug by
3117
the manufacturer or by a third party logistics provider
3118
performing a wholesale distribution of a prescription drug for a
3119
manufacturer.
3120
(b) The wholesale distribution of a prescription drug by a
3121
freight forwarder.
3122
(c) The wholesale distribution of a prescription drug by a
3123
limited prescription drug veterinary wholesale distributor to a
3124
veterinarian.
3125
(d) The wholesale distribution of a compressed medical gas.
3126
(e) The wholesale distribution of a veterinary prescription
3127
drug.
3128
(f) A drop shipment, provided:
3129
1. The wholesale distributor delivers to the recipient of
3130
the prescription drug, within 14 days after the shipment
3131
notification from the manufacturer, an invoice and the following
3132
sworn statement: "This wholesale distributor purchased the
3133
specific unit of the prescription drug listed on the invoice
3134
directly from the manufacturer, and the specific unit of
3135
prescription drug was shipped by the manufacturer directly to a
3136
person authorized by law to administer or dispense the legend
3137
drug, as defined in s. 465.003, Florida Statutes, or a member of
3138
an affiliated group, with the exception of a repackager." The
3139
invoice must contain a unique cross-reference to the shipping
3140
document sent by the manufacturer to the recipient of the
3141
prescription drug.
3142
2. The manufacturer of the prescription drug shipped
3143
directly to the recipient provides and the recipient of the
3144
prescription drug acquires, within 14 days after receipt of the
3145
prescription drug, a shipping document from the manufacturer that
3146
contains, at a minimum:
3147
a. The name and address of the manufacturer, including the
3148
point of origin of the shipment, and the names and addresses of
3149
the wholesale distributor and the purchaser.
3150
b. The name of the prescription drug as it appears on the
3151
label.
3152
c. The quantity, dosage form, and strength of the
3153
prescription drug.
3154
d. The date of the shipment from the manufacturer.
3155
3. The wholesale distributor maintains and makes available
3156
to the department, upon request, the lot number of such drug if
3157
not contained in the shipping document acquired by the recipient.
3158
3159
Failure of the manufacturer to provide, the recipient to acquire,
3160
or the wholesale distributor to deliver the documentation
3161
required under this paragraph shall constitute failure to acquire
3163
Forgery by the manufacturer, the recipient, or the wholesale
3164
distributor of the documentation required to be acquired or
3165
delivered under this paragraph shall constitute forgery of a
3166
pedigree paper under s. 499.0051.
3167
4. The wholesale distributor that takes title to, but not
3168
possession of, the prescription drug is not a member of the
3169
affiliated group that receives the prescription drug directly
3170
from the manufacturer.
3171
(g) The wholesale distribution of a prescription drug by a
3172
warehouse within an affiliated group to a warehouse or retail
3173
pharmacy within its affiliated group, provided:
3174
1. Any affiliated group member that purchases or receives a
3175
prescription drug from outside the affiliated group must receive
3176
a pedigree paper if the prescription drug is distributed in or
3177
into this state and a pedigree paper is required under this
3178
section and must authenticate the documentation as required in s.
3179
499.0121(4), regardless of whether the affiliated group member is
3180
directly subject to regulation under this part; and
3181
2. The affiliated group makes available, within 48 hours,
3182
to the department on request to one or more of its members all
3183
records related to the purchase or acquisition of prescription
3184
drugs by members of the affiliated group, regardless of the
3185
location where the records are stored, if the prescription drugs
3186
were distributed in or into this state.
3187
(h) The repackaging of prescription drugs by a repackager
3188
solely for distribution to its affiliated group members for the
3189
exclusive distribution to and among retail pharmacies that are
3190
members of the affiliated group to which the repackager is a
3191
member.
3192
1. The repackager must:
3193
a. For all repackaged prescription drugs distributed in or
3194
into this state, state in writing under oath with each
3195
distribution of a repackaged prescription drug to an affiliated
3196
group member warehouse or repackager: "All repackaged
3197
prescription drugs are purchased by the affiliated group directly
3198
from the manufacturer or from a prescription drug wholesale
3199
distributor that purchased the prescription drugs directly from
3200
the manufacturer."
3201
b. Purchase all prescription drugs it repackages:
3202
(I) Directly from the manufacturer; or
3203
(II) From a prescription drug wholesale distributor that
3204
purchased the prescription drugs directly from the manufacturer.
3205
c. Maintain records in accordance with this section to
3206
document that it purchased the prescription drugs directly from
3207
the manufacturer or that its prescription drug wholesale supplier
3208
purchased the prescription drugs directly from the manufacturer.
3209
2. All members of the affiliated group must provide, within
3210
48 hours, to agents of the department on request to one or more
3211
of its members records of purchases by all members of the
3212
affiliated group of prescription drugs that have been repackaged,
3213
regardless of the location at which the records are stored or at
3214
which the repackager is located.
3215
Section 16. Section 499.0122, Florida Statutes, is
3216
repealed.
3217
Section 17. Section 499.013, Florida Statutes, is repealed.
3218
Section 18. Subsections (1), (3), (4), (6), (8), and (9) of
3219
section 499.015, Florida Statutes, are amended to read:
3220
499.015 Registration of drugs, devices, and cosmetics;
3221
issuance of certificates of free sale.--
3222
(1)(a) Except for those persons exempted from the
3224
person who manufactures, packages, repackages, labels, or
3225
relabels a drug, device, or cosmetic in this state must register
3226
such drug, device, or cosmetic biennially with the department;
3227
pay a fee in accordance with the fee schedule provided by s.
3228
499.041; and comply with this section. The registrant must list
3229
each separate and distinct drug, device, or cosmetic at the time
3230
of registration.
3231
(b) The department may not register any product that does
3232
not comply with the Federal Food, Drug, and Cosmetic Act, as
3233
amended, or Title 21 C.F.R. Registration of a product by the
3234
department does not mean that the product does in fact comply
3235
with all provisions of the Federal Food, Drug, and Cosmetic Act,
3236
as amended.
3237
(3) Except for those persons exempted from the definition
3239
not sell any product that he or she has failed to register in
3240
conformity with this section. Such failure to register subjects
3241
such drug, device, or cosmetic product to seizure and
3243
subjects such person to the penalties and remedies provided in
3245
(4) Unless a registration is renewed, it expires 2 years
3246
after the last day of the month in which it was issued. The
3247
department may issue a stop-sale notice or order against a person
3248
that is subject to the requirements of this section and that
3249
fails to comply with this section within 31 days after the date
3250
the registration expires. The notice or order shall prohibit such
3251
person from selling or causing to be sold any drugs, devices, or
3253
she complies with the requirements of this section.
3254
(6) The department may issue a certificate of free sale for
3255
any product that is required to be registered under this part ss.
3257
(8) Notwithstanding any requirements set forth in this part
3259
registered with the federal Food and Drug Administration is
3260
exempt from this section and s. 499.041(6) if:
3261
(a) The manufacturer's medical devices are approved for
3262
marketing by, or listed with the federal Food and Drug
3263
Administration in accordance with federal law for commercial
3264
distribution; or
3265
(b) The manufacturer subcontracts with a manufacturer of
3266
medical devices to manufacture components of such devices.
3267
(9) However, the manufacturer must submit evidence of such
3268
registration, listing, or approval with its initial application
3269
for a permit to do business in this state, as required in s.
3271
submitted at the time of renewal of the permit. Evidence of
3272
approval, listing, and registration by the federal Food and Drug
3273
Administration must include:
3274
(a) For Class II devices, a copy of the pre-market
3275
notification letter (510K);
3276
(b) For Class III devices, a Federal Drug Administration
3277
pre-market approval number;
3278
(c) For a manufacturer who subcontracts with a manufacturer
3279
of medical devices to manufacture components of such devices, a
3280
Federal Drug Administration registration number; or
3281
(d) For a manufacturer of medical devices whose devices are
3282
exempt from pre-market approval by the Federal Drug
3283
Administration, a Federal Drug Administration registration
3284
number.
3285
Section 19. Subsections (3), (5), and (6) of section
3286
499.024, Florida Statutes, are amended to read:
3287
499.024 Drug product classification.--The State Surgeon
3288
General shall adopt rules to classify drug products intended for
3289
use by humans which the United States Food and Drug
3290
Administration has not classified in the federal act or the Code
3291
of Federal Regulations.
3292
(3) Any product that falls under the definition of drug in
3294
under the authority of this section. This section does not
3295
subject portable emergency oxygen inhalators to classification;
3296
however, this section does not exempt any person from ss. 499.01
3297
and 499.015.
3298
(5) The department may by rule reclassify drugs subject to
3300
necessary to protect the public health.
3301
(6) The department may adopt rules that exempt from any
3302
labeling or packaging requirements of this part ss. 499.001-
3303
499.081 drugs classified under this section if those requirements
3304
are not necessary to protect the public health.
3305
Section 20. Subsections (7), (12), and (15) of section
3306
499.028, Florida Statutes, are amended to read:
3307
499.028 Drug samples or complimentary drugs; starter packs;
3308
permits to distribute.--
3309
(7) A drug manufacturer or distributor must report to the
3310
department any conviction of itself or of its assigns, agents,
3311
employees, or representatives for a violation of s. 503(c)(1) of
3313
the sale, purchase, or trade of a drug sample or the offer to
3314
sell, purchase, or trade a drug sample.
3315
(12) The department may suspend or revoke a permit issued
3316
under this section, after giving notice and an opportunity to be
3317
heard pursuant to chapter 120, when:
3318
(a) Such permit was obtained by misrepresentation or fraud
3319
or through a mistake of the department.
3320
(b) The holder of the permit has distributed or disposed of
3321
any prescription legend drug, directly or through its agents,
3322
employees, or independent contractors, to any person not
3323
authorized to possess such drug.
3324
(c) The holder of the permit, or its agents, employees, or
3325
independent contractors, has distributed or possessed any
3326
prescription legend drug except in the usual course of its
3327
business.
3328
(d) The holder of the permit, or its agents, employees, or
3329
independent contractors, has distributed any prescription legend
3330
drug that is misbranded or adulterated under this part ss.
3332
(e) The holder of the permit, or its agents, employees, or
3333
independent contractors, has distributed any prescription legend
3334
drug without written request, when a written request is required
3335
by this section.
3336
(f) The holder of the permit has in its employ, or uses as
3337
agent or independent contractor for the purpose of distributing
3338
or disposing of drugs, any person who has:
3339
1. Violated the requirements of this section or any rule
3340
adopted under this section.
3341
2. Been convicted in any of the courts of this state, the
3342
United States, or any other state of a felony or any other crime
3343
involving moral turpitude or involving those drugs named or
3344
described in chapter 893.
3345
(15) A person may not possess a prescription drug sample
3346
unless:
3347
(a) The drug sample was prescribed to her or him as
3348
evidenced by the label required in s. 465.0276(5).
3349
(b) She or he is the employee of a complimentary drug
3350
distributor that holds a permit issued under this part ss.
3352
(c) She or he is a person to whom prescription drug samples
3353
may be distributed pursuant to this section.
3354
(d) He or she is an officer or employee of a federal,
3355
state, or local government acting within the scope of his or her
3356
employment.
3357
Section 21. Subsections (2) and (3) of section 499.029,
3358
Florida Statutes, are amended to read:
3359
499.029 Cancer Drug Donation Program.--
3360
(2) There is created a Cancer Drug Donation Program within
3361
the department of Health for the purpose of authorizing and
3362
facilitating the donation of cancer drugs and supplies to
3363
eligible patients.
3364
(3) As used in this section:
3365
(a) "Cancer drug" means a prescription drug that has been
3366
approved under s. 505 of the federal Food, Drug, and Cosmetic Act
3367
and is used to treat cancer or its side effects or is used to
3368
treat the side effects of a prescription drug used to treat
3369
cancer or its side effects. "Cancer drug" does not include a
3370
substance listed in Schedule II, Schedule III, Schedule IV, or
3371
Schedule V of s. 893.03.
3372
(b) "Closed drug delivery system" means a system in which
3373
the actual control of the unit-dose medication package is
3374
maintained by the facility rather than by the individual patient.
3375
(c) "Department" means the Department of Health.
3376
(c)(d) "Donor" means a patient or patient representative
3377
who donates cancer drugs or supplies needed to administer cancer
3378
drugs that have been maintained within a closed drug delivery
3379
system; health care facilities, nursing homes, hospices, or
3380
hospitals with closed drug delivery systems; or pharmacies, drug
3381
manufacturers, medical device manufacturers or suppliers, or
3382
wholesalers of drugs or supplies, in accordance with this
3383
section. "Donor" includes a physician licensed under chapter 458
3384
or chapter 459 who receives cancer drugs or supplies directly
3385
from a drug manufacturer, wholesale distributor drug wholesaler,
3386
or pharmacy.
3387
(d)(e) "Eligible patient" means a person who the department
3388
determines is eligible to receive cancer drugs from the program.
3389
(e)(k) "Participant facility" means a class II hospital
3390
pharmacy that has elected to participate in the program and that
3391
accepts donated cancer drugs and supplies under the rules adopted
3392
by the department for the program.
3393
(f)(n) "Prescribing practitioner" means a physician
3394
licensed under chapter 458 or chapter 459 or any other medical
3395
professional with authority under state law to prescribe cancer
3396
medication.
3397
(o) "Prescription drug" means a drug as defined in s.
3398
465.003(8).
3399
(g)(p) "Program" means the Cancer Drug Donation Program
3400
created by this section.
3401
(h)(q) "Supplies" means any supplies used in the
3402
administration of a cancer drug.
3403
Section 22. Subsection (1) of section 499.03, Florida
3404
Statutes, is amended to read:
3405
499.03 Possession of certain drugs without prescriptions
3406
unlawful; exemptions and exceptions.--
3407
(1) A person may not possess, or possess with intent to
3408
sell, dispense, or deliver, any habit-forming, toxic, harmful, or
3410
prescription legend drug as defined in s. 499.003(42) s.
3411
499.003(25), unless the possession of the drug has been obtained
3412
by a valid prescription of a practitioner licensed by law to
3413
prescribe the drug. However, this section does not apply to the
3414
delivery of such drugs to persons included in any of the classes
3415
named in this subsection, or to the agents or employees of such
3416
persons, for use in the usual course of their businesses or
3417
practices or in the performance of their official duties, as the
3418
case may be; nor does this section apply to the possession of
3419
such drugs by those persons or their agents or employees for such
3420
use:
3421
(a) A licensed pharmacist or any person under the licensed
3422
pharmacist's supervision while acting within the scope of the
3423
licensed pharmacist's practice;
3424
(b) A licensed practitioner authorized by law to prescribe
3425
prescription legend drugs or any person under the licensed
3426
practitioner's supervision while acting within the scope of the
3427
licensed practitioner's practice;
3428
(c) A qualified person who uses prescription legend drugs
3429
for lawful research, teaching, or testing, and not for resale;
3430
(d) A licensed hospital or other institution that procures
3431
such drugs for lawful administration or dispensing by
3432
practitioners;
3433
(e) An officer or employee of a federal, state, or local
3434
government; or
3435
(f) A person that holds a valid permit issued by the
3437
authorizes that person to possess prescription drugs.
3438
Section 23. Section 499.032, Florida Statutes, is amended
3439
to read:
3440
499.032 Phenylalanine; prescription
3441
required.--Phenylalanine restricted formula is declared to be a
3442
prescription legend drug and may be dispensed only upon the
3443
prescription of a practitioner authorized by law to prescribe
3444
prescription medicinal drugs.
3445
Section 24. Subsection (1) of section 499.033, Florida
3446
Statutes, is amended to read:
3447
499.033 Ephedrine; prescription required.--Ephedrine is
3448
declared to be a prescription drug.
3449
(1) Except as provided in subsection (2), any product that
3450
contains any quantity of ephedrine, a salt of ephedrine, an
3451
optical isomer of ephedrine, or a salt of an optical isomer of
3452
ephedrine may be dispensed only upon the prescription of a duly
3453
licensed practitioner authorized by the laws of the state to
3454
prescribe prescription medicinal drugs.
3455
Section 25. Subsections (1) and (3) of section 499.039,
3456
Florida Statutes, are amended to read:
3457
499.039 Sale, distribution, or transfer of harmful chemical
3458
substances; penalties; authority for enforcement.--It is unlawful
3459
for a person to sell, deliver, or give to a person under the age
3460
of 18 years any compound, liquid, or chemical containing toluol,
3461
hexane, trichloroethylene, acetone, toluene, ethyl acetate,
3462
methyl ethyl ketone, trichloroethane, isopropanol, methyl
3463
isobutyl ketone, ethylene glycol monomethyl ether acetate,
3464
cyclohexanone, nitrous oxide, diethyl ether, alkyl nitrites
3465
(butyl nitrite), or any similar substance for the purpose of
3466
inducing by breathing, inhaling, or ingesting a condition of
3467
intoxication or which is intended to distort or disturb the
3468
auditory, visual, or other physical or mental processes.
3469
(1) On the first violation of this section, the department
3471
violation has not caused temporary or permanent physical or
3472
mental injury to the user.
3473
(3) The department of Health shall adopt rules to implement
3474
this section.
3475
Section 26. Section 499.04, Florida Statutes, is amended to
3476
read:
3477
499.04 Fee authority.--The department may collect fees for
3478
all drug, device, and cosmetic applications, permits, product
3479
registrations, and free-sale certificates. The total amount of
3480
fees collected from all permits, applications, product
3481
registrations, and free-sale certificates must be adequate to
3482
fund the expenses incurred by the department in carrying out this
3484
establish a schedule of fees that are within the ranges provided
3485
in this section and shall adjust those fees from time to time
3486
based on the costs associated with administering this part ss.
3488
deposited into the Florida Drug, Device, and Cosmetic Trust Fund
3489
for the sole purpose of carrying out the provisions of this part
3491
Section 27. Subsections (1) through (5), (8), and (10) of
3492
section 499.041, Florida Statutes, are amended to read:
3493
499.041 Schedule of fees for drug, device, and cosmetic
3494
applications and permits, product registrations, and free-sale
3495
certificates.--
3496
(1) The department shall assess applicants requiring a
3497
manufacturing permit an annual fee within the ranges established
3498
in this section for the specific type of manufacturer.
3499
(a) The fee for a prescription drug manufacturer
3500
manufacturer's permit may not be less than $500 or more than $750
3501
annually.
3502
(b) The fee for a device manufacturer manufacturer's permit
3503
may not be less than $500 or more than $600 annually.
3504
(c) The fee for a cosmetic manufacturer manufacturer's
3505
permit may not be less than $250 or more than $400 annually.
3506
(d) The fee for an over-the-counter drug manufacturer
3507
manufacturer's permit may not be less than $300 or more than $400
3508
annually.
3509
(e) The fee for a compressed medical gas manufacturer
3510
manufacturer's permit may not be less than $400 or more than $500
3511
annually.
3512
(f) The fee for a prescription drug repackager repackager's
3513
permit may not be less than $500 or more than $750 annually.
3514
(g) A manufacturer may not be required to pay more than one
3515
fee per establishment to obtain an additional manufacturing
3516
permit, but each manufacturer must pay the highest fee applicable
3517
to his or her operation in each establishment.
3518
(2) The department shall assess an applicant that is
3519
required to have a wholesaling permit an annual fee within the
3520
ranges established in this section for the specific type of
3521
wholesaling.
3522
(a) The fee for a prescription drug wholesale distributor
3523
wholesaler's permit may not be less than $300 or more than $800
3524
annually.
3525
(b) The fee for a compressed medical gas wholesale
3526
distributor wholesaler's permit may not be less than $200 or more
3527
than $300 annually.
3528
(c) The fee for an out-of-state prescription drug wholesale
3529
distributor wholesaler's permit may not be less than $300 or more
3530
than $800 annually.
3531
(d) The fee for a nonresident prescription drug
3532
manufacturer manufacturer's permit may not be less than $300 or
3533
more than $500 annually.
3534
(e) The fee for a retail pharmacy drug wholesale
3535
distributor wholesaler's permit may not be less than $35 or more
3536
than $50 annually.
3537
(f) The fee for a freight forwarder forwarder's permit may
3538
not be less than $200 or more than $300 annually.
3539
(g) The fee for a veterinary prescription drug wholesale
3540
distributor wholesaler's permit may not be less than $300 or more
3541
than $500 annually.
3542
(h) The fee for a limited prescription drug veterinary
3543
wholesale distributor wholesaler's permit may not be less than
3544
$300 or more than $500 annually.
3545
(i) The fee for a third part logistics provider permit may
3546
not be less than $200 or more than $300 annually.
3547
(3) The department shall assess an applicant that is
3548
required to have a retail establishment permit an annual fee
3549
within the ranges established in this section for the specific
3550
type of retail establishment.
3551
(a) The fee for a veterinary prescription legend drug
3552
retail establishment permit may not be less than $200 or more
3553
than $300 annually.
3554
(b) The fee for a medical oxygen retail establishment
3555
permit may not be less than $200 or more than $300 annually.
3556
(c) The fee for a health care clinic establishment permit
3557
may not be less than $125 or more than $250 annually.
3558
(4) The department shall assess an applicant that is
3559
required to have a restricted prescription drug distributor
3560
distributor's permit an annual fee of not less than $200 or more
3561
than $300.
3562
(5) In addition to the fee charged for a permit required by
3564
applicants an initial application fee of $150 for each new permit
3565
issued by the department which requires an onsite inspection.
3566
(8) The department shall assess an out-of-state
3567
prescription drug wholesale distributor wholesaler applicant or
3568
permittee an onsite inspection fee of not less than $1,000 or
3569
more than $3,000 annually, to be based on the actual cost of the
3570
inspection if an onsite inspection is performed by agents of the
3571
department.
3572
(10) The department shall assess other fees as provided in
3574
Section 28. Section 499.05, Florida Statutes, is amended;
3575
subsection (3) of section 499.013, Florida Statutes, is
3576
redesignated as paragraph (k) of subsection (1) of that section
3577
and amended; paragraph (b) of subsection (2) of section 499.0122,
3578
Florida Statutes, is redesignated as paragraph (l) of subsection
3579
(1) of that section and amended; and subsection (12) of section
3580
499.012, Florida Statutes, is redesignated as paragraph (m) of
3581
subsection (1) of that section and amended, to read:
3582
499.05 Rules.--
3583
(1) The department shall adopt rules to implement and
3585
(a) The definition of terms used in this part ss. 499.001-
3586
499.081, and used in the rules adopted under this part ss.
3588
ordinary meaning.
3589
(b) Labeling requirements for drugs, devices, and
3590
cosmetics.
3591
(c) The establishment of fees authorized in this part ss.
3593
(d) The identification of permits that require an initial
3594
application and onsite inspection or other prerequisites for
3595
permitting which demonstrate that the establishment and person
3596
are in compliance with the requirements of this part ss. 499.001-
3597
3598
(e) The application processes and forms for product
3599
registration.
3600
(f) Procedures for requesting and issuing certificates of
3601
free sale.
3602
(g) Inspections and investigations conducted under s.
3603
499.051, and the identification of information claimed to be a
3604
trade secret and exempt from the public records law as provided
3605
in s. 499.051(7).
3606
(h) The establishment of a range of penalties, as provided
3608
the potential impact of a violation of this part ss. 499.001-
3609
499.081; and a process for the uncontested settlement of alleged
3610
violations.
3611
(i) Additional conditions that qualify as an emergency
3613
(j) Procedures and forms relating to the pedigree paper
3614
requirement of s. 499.01212.
3615
(k)(3) The department may adopt such rules as are necessary
3616
for The protection of the public health, safety, and welfare
3617
regarding good manufacturing practices that manufacturers and
3618
repackagers must follow to ensure the safety of the products.
3619
(l)(b) The department shall adopt rules relating to
3620
Information required from each retail establishment pursuant to
3622
prescriptions or orders.
3623
(m)(12) The department may adopt rules governing The
3624
recordkeeping, storage, and handling with respect to each of the
3625
distributions of prescription drugs specified in s.
3626
499.003(53)(a)-(d) subparagraphs (1)(a)1.-4.
3627
(n) Alternatives to compliance with s. 499.01212 for a
3628
prescription drug in the inventory of a permitted prescription
3629
drug wholesale distributor as of June 30, 2006, and the return of
3630
a prescription drug purchased prior to July 1, 2006. The
3631
department may specify time limits for such alternatives.
3632
(2) With respect to products in interstate commerce, those
3633
rules must not be inconsistent with rules and regulations of
3634
federal agencies unless specifically otherwise directed by the
3635
Legislature.
3636
(3) The department shall adopt rules regulating
3637
recordkeeping for and the storage, handling, and distribution of
3638
medical devices and over-the-counter drugs to protect the public
3639
from adulterated products.
3640
Section 29. Section 499.051, Florida Statutes, is amended
3641
to read:
3642
499.051 Inspections and investigations.--
3643
(1) The agents of the department of Health and of the
3644
Department of Law Enforcement, after they present proper
3645
identification, may inspect, monitor, and investigate any
3647
during business hours for the purpose of enforcing this part ss.
3649
department that protect the public health, safety, and welfare.
3650
(2) In addition to the authority set forth in subsection
3651
(1), the department and any duly designated officer or employee
3652
of the department may enter and inspect any other establishment
3653
for the purpose of determining compliance with this part ss.
3655
regarding any drug, device, or cosmetic product.
3656
(3) Any application for a permit or product registration or
3657
for renewal of such permit or registration made pursuant to this
3659
sections constitutes permission for any entry or inspection of
3660
the premises in order to verify compliance with this part those
3661
sections and rules; to discover, investigate, and determine the
3662
existence of compliance; or to elicit, receive, respond to, and
3663
resolve complaints and violations.
3664
(4) Any application for a permit made pursuant to s.
3666
section those sections constitutes permission for agents of the
3667
department of Health and the Department of Law Enforcement, after
3668
presenting proper identification, to inspect, review, and copy
3669
any financial document or record related to the manufacture,
3670
repackaging, or distribution of a drug as is necessary to verify
3672
adopted by the department to administer this part those sections,
3673
in order to discover, investigate, and determine the existence of
3674
compliance, or to elicit, receive, respond to, and resolve
3675
complaints and violations.
3676
(5) The authority to inspect under this section includes
3677
the authority to access, review, and copy any and all financial
3678
documents related to the activity of manufacturing, repackaging,
3679
or distributing prescription drugs.
3680
(6) The authority to inspect under this section includes
3681
the authority to secure:
3682
(a) Samples or specimens of any drug, device, or cosmetic;
3683
or
3684
(b) Such other evidence as is needed for any action to
3686
this part those sections.
3687
(7) The complaint and all information obtained pursuant to
3688
the investigation by the department are confidential and exempt
3689
from the provisions of s. 119.07(1) and s. 24(a), Art. I of the
3690
State Constitution until the investigation and the enforcement
3691
action are completed. However, trade secret information contained
3692
therein as defined by s. 812.081(1)(c) shall remain confidential
3693
and exempt from the provisions of s. 119.07(1) and s. 24(a), Art.
3694
I of the State Constitution, as long as the information is
3695
retained by the department. This subsection does not prohibit the
3696
department from using such information for regulatory or
3697
enforcement proceedings under this chapter or from providing such
3698
information to any law enforcement agency or any other regulatory
3699
agency. However, the receiving agency shall keep such records
3700
confidential and exempt as provided in this subsection. In
3701
addition, this subsection is not intended to prevent compliance
3703
pedigree papers required in that section subsection shall not be
3704
deemed a trade secret.
3705
Section 30. Section 499.052, Florida Statutes, is amended
3706
to read:
3707
499.052 Records of interstate shipment.--For the purpose of
3709
interstate commerce and persons receiving drugs, devices, or
3710
cosmetics in interstate commerce must, upon the request, in the
3711
manner set out below, by an officer or employee duly designated
3712
by the department, permit the officer or employee to have access
3713
to and to copy all records showing the movement in interstate
3714
commerce of any drug, device, or cosmetic, and the quantity,
3715
shipper, and consignee thereof.
3716
Section 31. Subsection (4) of section 499.055, Florida
3717
Statutes, is amended to read:
3718
499.055 Reports and dissemination of information by
3719
department.--
3720
(4) The department shall publish on the department's
3721
website and update at least monthly:
3722
(a) A list of the prescription drug wholesale distributors
3723
wholesalers, out-of-state prescription drug wholesale
3724
distributors wholesalers, and retail pharmacy drug wholesale
3725
distributors wholesalers against whom the department has
3726
initiated enforcement action pursuant to this part ss. 499.001-
3727
499.081 to suspend or revoke a permit, seek an injunction, or
3728
otherwise file an administrative complaint and the permit number
3729
of each such wholesale distributor wholesaler.
3730
(b) A list of the prescription drug wholesale distributors
3731
wholesalers, out-of-state prescription drug wholesale
3732
distributors wholesalers, and retail pharmacy drug wholesale
3733
distributors wholesalers to which the department has issued a
3734
permit, including the date on which each permit will expire.
3735
(c) A list of the prescription drug wholesale distributor
3736
wholesalers, out-of-state prescription drug wholesale distributor
3737
wholesalers, and retail pharmacy drug wholesale distributor
3738
wholesalers' permits that have been returned to the department,
3739
were suspended, were revoked, have expired, or were not renewed
3740
in the previous year.
3741
Section 32. Subsections (1) and (3) of section 499.06,
3742
Florida Statutes, are amended to read:
3743
499.06 Embargoing, detaining, or destroying article or
3744
processing equipment which is in violation of law or rule.--
3745
(1) When a duly authorized agent of the department finds,
3746
or has probable cause to believe, that any drug, device, or
3747
cosmetic is in violation of any provision of this part ss.
3749
so as to be dangerous, unwholesome, or fraudulent within the
3751
enforce a stop-sale, stop-use, removal, or hold order, which
3752
order gives notice that such article or processing equipment is,
3753
or is suspected of being, in violation and has been detained or
3754
embargoed, and which order warns all persons not to remove, use,
3755
or dispose of such article or processing equipment by sale or
3756
otherwise until permission for removal, use, or disposal is given
3757
by such agent or the court. It is unlawful for any person to
3758
remove, use, or dispose of such detained or embargoed article or
3759
processing equipment by sale or otherwise without such
3760
permission; and such act is a felony of the second degree,
3762
(3) If the court finds that the detained or embargoed
3763
article or processing equipment is in violation, such article or
3764
processing equipment shall, after entry of the court order, be
3765
destroyed or made sanitary at the expense of the claimant
3766
thereof, under the supervision of such agent; and all court
3767
costs, fees, and storage and other proper expenses shall be taxed
3768
against the claimant of such article or processing equipment or
3769
her or his agent. However, when the violation can be corrected by
3770
proper labeling of the article or sanitizing of the processing
3771
equipment, and after such costs, fees, and expenses have been
3772
paid and a good and sufficient bond, conditioned that such
3773
article be so labeled or processed or such processing equipment
3774
be so sanitized, has been executed, the court may by order direct
3775
that such article or processing equipment be delivered to the
3776
claimant thereof for such labeling, processing, or sanitizing,
3777
under the supervision of an agent of the department. The expense
3778
of such supervision shall be paid by the claimant. Such bond
3779
shall be returned to the claimant of the article or processing
3780
equipment upon representation to the court by the department that
3781
the article or processing equipment is no longer in violation of
3783
supervision have been paid.
3784
Section 33. Section 499.062, Florida Statutes, is amended;
3785
section 499.063, Florida Statutes, is redesignated as section (2)
3786
of that section and amended; and section 499.064, Florida
3787
Statutes, is redesignated as paragraphs (a) and (b) of subsection
3788
(2) of that section and amended, to read:
3789
499.062 Cause for Seizure and condemnation of drugs,
3790
devices, or cosmetics.--
3791
(1) Any article of any drug, device, or cosmetic that is
3793
subject to seizure and condemnation by the department or by its
3794
duly authorized agents designated for that purpose in regard to
3795
drugs, devices, or cosmetics.
3796
(2)499.063 Seizure; procedure; prohibition on sale or
3797
disposal of article; penalty.--Whenever a duly authorized officer
3798
or employee of the department finds cause, or has probable cause
3799
to believe that cause exists, for the seizure of any drug,
3801
he or she shall affix to the article a tag, stamp, or other
3802
appropriate marking, giving notice that the article is, or is
3803
suspected of being, subject to seizure under this part ss.
3805
by the department. Such officer or employee shall also warn all
3806
persons not to remove or dispose of the article, by sale or
3807
otherwise, until permission is given by the department or the
3808
court. Any person who violates this subsection section is guilty
3809
of a felony of the second degree, punishable as provided in s.
3811
(a)499.064 Condemnation and sale; release of seized
3812
article.--(1) When any article detained or seized under this
3813
subsection s. 499.063 has been found by the department to be
3814
subject to seizure and condemnation under s. 499.063, the
3815
department shall petition the court for an order of condemnation
3816
or sale, as the court directs. The proceeds of the sale of drugs,
3817
devices, and cosmetics, less the legal costs and charges, shall
3818
be deposited into the Florida Drug, Device, and Cosmetic Trust
3819
Fund.
3820
(b)(2) If the department finds that any article seized
3821
under this subsection s. 499.063 was not subject to seizure under
3822
that section, the department or the designated officer or
3823
employee shall remove the tag or marking.
3824
Section 34. Section 499.065, Florida Statutes, is amended
3825
to read:
3826
499.065 Inspections; imminent danger.--
3827
(1) Notwithstanding s. 499.051, the department shall
3828
inspect each prescription drug wholesale distributor
3829
establishment, prescription drug repackager establishment,
3830
veterinary prescription drug wholesale distributor establishment,
3831
limited prescription drug veterinary wholesale distributor
3832
wholesaler establishment, and retail pharmacy drug wholesale
3833
distributor wholesaler establishment that is required to be
3834
permitted under this part chapter as often as necessary to ensure
3835
compliance with applicable laws and rules. The department shall
3836
have the right of entry and access to these facilities at any
3837
reasonable time.
3838
(2) To protect the public from prescription drugs that are
3839
adulterated or otherwise unfit for human or animal consumption,
3840
the department may examine, sample, seize, and stop the sale or
3841
use of prescription drugs to determine the condition of those
3842
drugs. The department may immediately seize and remove any
3843
prescription drugs if the State Surgeon General or his or her
3844
designee determines that the prescription drugs represent a
3845
threat to the public health. The owner of any property seized
3846
under this section may, within 10 days after the seizure, apply
3847
to a court of competent jurisdiction for whatever relief is
3848
appropriate. At any time after 10 days, the department may
3849
destroy the drugs as contraband.
3850
(3) The department may determine that a prescription drug
3851
wholesale distributor establishment, prescription drug repackager
3852
establishment, veterinary prescription drug wholesale distributor
3853
establishment, limited prescription drug veterinary wholesale
3854
distributor wholesaler establishment, or retail pharmacy drug
3855
wholesale distributor wholesaler establishment that is required
3856
to be permitted under this part chapter is an imminent danger to
3857
the public health and shall require its immediate closure if the
3858
establishment fails to comply with applicable laws and rules and,
3859
because of the failure, presents an imminent threat to the
3860
public's health, safety, or welfare. Any establishment so deemed
3861
and closed shall remain closed until allowed by the department or
3862
by judicial order to reopen.
3863
(4) For purposes of this section, a refusal to allow entry
3864
to the department for inspection at reasonable times, or a
3865
failure or refusal to provide the department with required
3866
documentation for purposes of inspection, constitutes an imminent
3867
danger to the public health.
3868
Section 35. Subsections (1) through (4) of section 499.066,
3869
Florida Statutes, are amended to read:
3870
499.066 Penalties; remedies.--In addition to other
3871
penalties and other enforcement provisions:
3872
(1) The department may institute such suits or other legal
3873
proceedings as are required to enforce any provision of this part
3876
prosecution is provided, the department may provide the
3877
appropriate state attorney or other prosecuting agency having
3878
jurisdiction with respect to such prosecution with the relevant
3879
information in the department's possession.
3880
(2) If any person engaged in any activity covered by this
3882
those sections, any rule adopted under this part those sections,
3883
or a cease and desist order as provided by this part those
3884
sections, the department may obtain an injunction in the circuit
3885
court of the county in which the violation occurred or in which
3886
the person resides or has its principal place of business, and
3887
may apply in that court for such temporary and permanent orders
3888
as the department considers necessary to restrain the person from
3889
engaging in any such activities until the person complies with
3891
those sections, and the orders of the department authorized by
3892
this part those sections or to mandate compliance with this part
3894
sections, and any order or permit issued by the department under
3895
this part those sections.
3896
(3) The department may impose an administrative fine, not
3897
to exceed $5,000 per violation per day, for the violation of any
3899
this part those sections. Each day a violation continues
3900
constitutes a separate violation, and each separate violation is
3901
subject to a separate fine. All amounts collected pursuant to
3902
this section shall be deposited into the Florida Drug, Device,
3903
and Cosmetic Trust Fund and are appropriated for the use of the
3905
determining the amount of the fine to be levied for a violation,
3906
the department shall consider:
3907
(a) The severity of the violation;
3908
(b) Any actions taken by the person to correct the
3909
violation or to remedy complaints; and
3910
(c) Any previous violations.
3911
(4) The department shall deposit any rewards, fines, or
3912
collections that are due the department and which derive from
3913
joint enforcement activities with other state and federal
3915
893, or the federal act, into the Florida Drug, Device, and
3916
Cosmetic Trust Fund. The proceeds of those rewards, fines, and
3917
collections are appropriated for the use of the department in
3919
Section 36. Section 499.0661, Florida Statutes, is amended
3920
to read:
3921
499.0661 Cease and desist orders; removal of certain
3922
persons.--
3923
(1)(2) CEASE AND DESIST ORDERS.--
3924
(a) In addition to any authority otherwise provided in this
3925
chapter, the department may issue and serve a complaint stating
3926
charges upon any permittee or upon any affiliated party, whenever
3927
the department has reasonable cause to believe that the person or
3928
individual named therein is engaging in or has engaged in conduct
3929
that is:
3930
1. An act that demonstrates a lack of fitness or
3931
trustworthiness to engage in the business authorized under the
3933
hazardous to the public health, or constitutes business
3934
operations that are a detriment to the public health;
3935
2. A violation of any provision of this part ss. 499.001-
3936
3937
3. A violation of any rule of the department;
3938
4. A violation of any order of the department; or
3939
5. A breach of any written agreement with the department.
3940
(b) The complaint must contain a statement of facts and
3941
notice of opportunity for a hearing pursuant to ss. 120.569 and
3942
3943
(c) If a hearing is not requested within the time allowed
3945
department finds that any of the charges are proven, the
3946
department may enter an order directing the permittee or the
3947
affiliated party named in the complaint to cease and desist from
3948
engaging in the conduct complained of and take corrective action
3949
to remedy the effects of past improper conduct and assure future
3950
compliance.
3951
(d) A contested or default cease and desist order is
3952
effective when reduced to writing and served upon the permittee
3953
or affiliated party named therein. An uncontested cease and
3954
desist order is effective as agreed.
3955
(e) Whenever the department finds that conduct described in
3956
paragraph (a) is likely to cause an immediate threat to the
3957
public health, it may issue an emergency cease and desist order
3958
requiring the permittee or any affiliated party to immediately
3959
cease and desist from engaging in the conduct complained of and
3960
to take corrective and remedial action. The emergency order is
3961
effective immediately upon service of a copy of the order upon
3962
the permittee or affiliated party named therein and remains
3963
effective for 90 days. If the department begins nonemergency
3964
cease and desist proceedings under this subsection, the emergency
3965
order remains effective until the conclusion of the proceedings
3967
(2)(3) REMOVAL OF AFFILIATED PARTIES BY THE DEPARTMENT.--
3968
(a) The department may issue and serve a complaint stating
3969
charges upon any affiliated party and upon the permittee involved
3970
whenever the department has reason to believe that an affiliated
3971
party is engaging in or has engaged in conduct that constitutes:
3972
1. An act that demonstrates a lack of fitness or
3973
trustworthiness to engage in the business authorized under the
3975
hazardous to the public health, or constitutes business
3976
operations that are a detriment to the public health;
3978
however, if the violation constitutes a misdemeanor, a complaint
3979
may not be served as provided in this section until the
3980
affiliated party is notified in writing of the matter of the
3981
violation and has been afforded a reasonable period of time, as
3982
set forth in the notice, to correct the violation and has failed
3983
to do so;
3984
3. A violation of any other law involving fraud or moral
3985
turpitude which constitutes a felony;
3986
4. A willful violation of any rule of the department;
3987
5. A willful violation of any order of the department; or
3988
6. A material misrepresentation of fact, made knowingly and
3989
willfully or made with reckless disregard for the truth of the
3990
matter.
3991
(b) The complaint must contain a statement of facts and
3992
notice of opportunity for a hearing pursuant to ss. 120.569 and
3993
3994
(c) If a hearing is not requested within the time allotted
3996
department finds that any of the charges in the complaint are
3997
proven true, the department may enter an order removing the
3998
affiliated party or restricting or prohibiting participation by
3999
the person in the affairs of that permittee or of any other
4000
permittee.
4001
(d) A contested or default order of removal, restriction,
4002
or prohibition is effective when reduced to writing and served on
4003
the permittee and the affiliated party. An uncontested order of
4004
removal, restriction, or prohibition is effective as agreed.
4005
(e)1. The chief executive officer, designated
4006
representative, or the person holding the equivalent office, of a
4007
permittee shall promptly notify the department if she or he has
4008
actual knowledge that any affiliated party is charged with a
4009
felony in a state or federal court.
4010
2. Whenever any affiliated party is charged with a felony
4011
in a state or federal court or with the equivalent of a felony in
4012
the courts of any foreign country with which the United States
4013
maintains diplomatic relations, and the charge alleges violation
4014
of any law involving prescription drugs, pharmaceuticals, fraud,
4015
theft, or moral turpitude, the department may enter an emergency
4016
order suspending the affiliated party or restricting or
4017
prohibiting participation by the affiliated party in the affairs
4018
of the particular permittee or of any other permittee upon
4019
service of the order upon the permittee and the affiliated party
4020
charged. The order must contain notice of opportunity for a
4022
party may request a postsuspension hearing to show that continued
4023
service to or participation in the affairs of the permittee does
4024
not pose a threat to the public health or the interests of the
4025
permittee and does not threaten to impair public confidence in
4026
the permittee. In accordance with applicable departmental rules,
4027
the department shall notify the affiliated party whether the
4028
order suspending or prohibiting the person from participation in
4029
the affairs of a permittee will be rescinded or otherwise
4030
modified. The emergency order remains in effect, unless otherwise
4031
modified by the department, until the criminal charge is disposed
4032
of. The acquittal of the person charged, or the final, unappealed
4033
dismissal of all charges against the person, dissolves the
4034
emergency order but does not prohibit the department from
4035
instituting proceedings under paragraph (a). If the person
4036
charged is convicted or pleads guilty or nolo contendere, whether
4037
or not an adjudication of guilt is entered by the court, the
4038
emergency order shall become final.
4039
(f) Any affiliated party removed pursuant to this section
4040
is not eligible for reemployment by the permittee or to be an
4041
affiliated party of any permittee except upon the written consent
4042
of the department. Any affiliated party who is removed,
4043
restricted, or prohibited from participating in the affairs of a
4044
permittee pursuant to this section may petition the department
4045
for modification or termination of the removal, restriction, or
4046
prohibition.
4047
Section 37. Section 499.067, Florida Statutes, is amended
4048
to read:
4049
499.067 Denial, suspension, or revocation of permit,
4050
certification, or registration.--
4051
(1)(a) The department may deny, suspend, or revoke a permit
4052
if it finds that there has been a substantial failure to comply
4054
or chapter 893, the rules adopted under this part any of those
4055
sections or those chapters, any final order of the department, or
4056
applicable federal laws or regulations or other state laws or
4057
rules governing drugs, devices, or cosmetics.
4058
(b) The department may deny an application for a permit or
4059
certification, or suspend or revoke a permit or certification, if
4060
the department finds that:
4061
1. The applicant is not of good moral character or that it
4062
would be a danger or not in the best interest of the public
4063
health, safety, and welfare if the applicant were issued a permit
4064
or certification.
4065
2. The applicant has not met the requirements for the
4066
permit or certification.
4067
3. The applicant is not eligible for a permit or
4068
certification for any of the reasons enumerated in s. 499.012 s.
4070
4. The applicant, permittee, or person certified under s.
4073
5. The applicant, permittee, or person certified under s.
4076
(2) The department may deny, suspend, or revoke any
4077
registration required by the provisions of this part ss. 499.001-
4078
499.081 for the violation of any provision of this part ss.
4080
sections.
4081
(3) The department may revoke or suspend a permit:
4082
(a) If the permit was obtained by misrepresentation or
4083
fraud or through a mistake of the department;
4084
(b) If the permit was procured, or attempted to be
4085
procured, for any other person by making or causing to be made
4086
any false representation; or
4087
(c) If the permittee has violated any provision of this
4089
sections.
4090
(4) If any permit issued under this part ss. 499.001-
4091
499.081 is revoked or suspended, the owner, manager, operator, or
4092
proprietor of the establishment shall cease to operate as the
4093
permit authorized, from the effective date of the suspension or
4094
revocation until the person is again registered with the
4095
department and possesses the required permit. If a permit is
4096
revoked or suspended, the owner, manager, or proprietor shall
4097
remove all signs and symbols that identify the operation as
4098
premises permitted as a drug wholesaling establishment; drug,
4099
device, or cosmetic manufacturing establishment; or retail
4100
establishment. The department shall determine the length of time
4101
for which the permit is to be suspended. If a permit is revoked,
4102
the person that owns or operates the establishment may not apply
4104
of 1 year after the date of the revocation. A revocation of a
4105
permit may be permanent if the department considers that to be in
4106
the best interest of the public health.
4107
(5) The department may deny, suspend, or revoke a permit
4109
permittee to purchase prescription drugs, if any owner, officer,
4110
employee, or other person who participates in administering or
4111
operating the establishment has been found guilty of any
4113
chapter 501, or chapter 893, any rules adopted under this part
4114
any of those sections or those chapters, or any federal or state
4115
drug law, regardless of whether the person has been pardoned, had
4116
her or his civil rights restored, or had adjudication withheld.
4117
(6) The department shall deny, suspend, or revoke the
4118
permit of any person or establishment if the assignment, sale,
4119
transfer, or lease of an establishment permitted under this part
4121
action, or criminal prosecution.
4122
(7) Notwithstanding s. 120.60(5), if a permittee fails to
4124
the permit of the permittee and shall provide notice of the
4125
intended agency action by posting a notice at the department's
4126
headquarters and by mailing a copy of the notice of intended
4127
agency action by certified mail to the most recent mailing
4128
address on record with the department and, if the permittee is
4129
not a natural person, to the permittee's registered agent on file
4130
with the Department of State.
4131
Section 38. Paragraph (a) of subsection (1) of section
4132
409.9201, Florida Statutes, is amended to read:
4133
409.9201 Medicaid fraud.--
4134
(1) As used in this section, the term:
4135
(a) "Prescription Legend drug" means any drug, including,
4136
but not limited to, finished dosage forms or active ingredients
4137
that are subject to, defined by, or described by s. 503(b) of the
4138
Federal Food, Drug, and Cosmetic Act or by s. 465.003(8), s.
4140
499.0122(1)(b) or (c).
4141
4142
The value of individual items of the legend drugs or goods or
4143
services involved in distinct transactions committed during a
4144
single scheme or course of conduct, whether involving a single
4145
person or several persons, may be aggregated when determining the
4146
punishment for the offense.
4147
Section 39. Paragraph (c) of subsection (9) of section
4148
460.403, Florida Statutes, is amended to read:
4149
460.403 Definitions.--As used in this chapter, the term:
4150
(9)
4151
(c)1. Chiropractic physicians may adjust, manipulate, or
4152
treat the human body by manual, mechanical, electrical, or
4153
natural methods; by the use of physical means or physiotherapy,
4154
including light, heat, water, or exercise; by the use of
4155
acupuncture; or by the administration of foods, food
4156
concentrates, food extracts, and items for which a prescription
4157
is not required and may apply first aid and hygiene, but
4158
chiropractic physicians are expressly prohibited from prescribing
4159
or administering to any person any legend drug except as
4160
authorized under subparagraph 2., from performing any surgery
4161
except as stated herein, or from practicing obstetrics.
4162
2. Notwithstanding the prohibition against prescribing and
4163
administering legend drugs under subparagraph 1., or s.
4165
physicians may order, store, and administer, for emergency
4166
purposes only at the chiropractic physician's office or place of
4167
business, prescription medical oxygen and may also order, store,
4168
and administer the following topical anesthetics in aerosol form:
4169
a. Any solution consisting of 25 percent ethylchloride and
4170
75 percent dichlorodifluoromethane.
4171
b. Any solution consisting of 15 percent
4172
dichlorodifluoromethane and 85 percent
4173
trichloromonofluoromethane.
4174
4175
However, this paragraph does not authorize a chiropractic
4176
physician to prescribe medical oxygen as defined in chapter 499.
4177
Section 40. Subsection (3) of section 465.0265, Florida
4178
Statutes, is amended to read:
4179
465.0265 Centralized prescription filling.--
4180
(3) The filling, delivery, and return of a prescription by
4181
one pharmacy for another pursuant to this section shall not be
4182
construed as the filling of a transferred prescription as set
4183
forth in s. 465.026 or as a wholesale distribution as set forth
4185
Section 41. Section 794.075, Florida Statutes, is amended
4186
to read:
4187
794.075 Sexual predators; erectile dysfunction drugs.--
4188
(1) A person may not possess a prescription drug, as
4190
treating erectile dysfunction if the person is designated as a
4191
sexual predator under s. 775.21.
4192
(2) A person who violates a provision of this section for
4193
the first time commits a misdemeanor of the second degree,
4195
violates a provision of this section a second or subsequent time
4196
commits a misdemeanor of the first degree, punishable as provided
4198
Section 42. Paragraph (a) of subsection (1) of section
4199
895.02, Florida Statutes, is amended to read:
4201
term:
4202
(1) "Racketeering activity" means to commit, to attempt to
4203
commit, to conspire to commit, or to solicit, coerce, or
4204
intimidate another person to commit:
4205
(a) Any crime that is chargeable by indictment or
4206
information under the following provisions of the Florida
4207
Statutes:
4208
1. Section 210.18, relating to evasion of payment of
4209
cigarette taxes.
4210
2. Section 403.727(3)(b), relating to environmental
4211
control.
4213
fraud.
4214
4. Section 414.39, relating to public assistance fraud.
4216
compensation.
4217
6. Section 443.071(4), relating to creation of a fictitious
4218
employer scheme to commit unemployment compensation fraud.
4219
7. Section 465.0161, relating to distribution of medicinal
4220
drugs without a permit as an Internet pharmacy.
4223
and adulterated drugs.
4224
9. Part IV of chapter 501, relating to telemarketing.
4225
10. Chapter 517, relating to sale of securities and
4226
investor protection.
4228
to dogracing and horseracing.
4229
12. Chapter 550, relating to jai alai frontons.
4230
13. Section 551.109, relating to slot machine gaming.
4231
14. Chapter 552, relating to the manufacture, distribution,
4232
and use of explosives.
4233
15. Chapter 560, relating to money transmitters, if the
4234
violation is punishable as a felony.
4235
16. Chapter 562, relating to beverage law enforcement.
4236
17. Section 624.401, relating to transacting insurance
4237
without a certificate of authority, s. 624.437(4)(c)1., relating
4238
to operating an unauthorized multiple-employer welfare
4239
arrangement, or s. 626.902(1)(b), relating to representing or
4240
aiding an unauthorized insurer.
4241
18. Section 655.50, relating to reports of currency
4242
transactions, when such violation is punishable as a felony.
4243
19. Chapter 687, relating to interest and usurious
4244
practices.
4246
real estate timeshare plans.
4247
21. Chapter 782, relating to homicide.
4248
22. Chapter 784, relating to assault and battery.
4249
23. Chapter 787, relating to kidnapping or human
4250
trafficking.
4251
24. Chapter 790, relating to weapons and firearms.
4254
trafficking.
4255
26. Chapter 806, relating to arson.
4256
27. Section 810.02(2)(c), relating to specified burglary of
4257
a dwelling or structure.
4258
28. Chapter 812, relating to theft, robbery, and related
4259
crimes.
4260
29. Chapter 815, relating to computer-related crimes.
4261
30. Chapter 817, relating to fraudulent practices, false
4262
pretenses, fraud generally, and credit card crimes.
4263
31. Chapter 825, relating to abuse, neglect, or
4264
exploitation of an elderly person or disabled adult.
4265
32. Section 827.071, relating to commercial sexual
4266
exploitation of children.
4267
33. Chapter 831, relating to forgery and counterfeiting.
4268
34. Chapter 832, relating to issuance of worthless checks
4269
and drafts.
4270
35. Section 836.05, relating to extortion.
4271
36. Chapter 837, relating to perjury.
4272
37. Chapter 838, relating to bribery and misuse of public
4273
office.
4274
38. Chapter 843, relating to obstruction of justice.
4276
s. 847.07, relating to obscene literature and profanity.
4278
849.25, relating to gambling.
4279
41. Chapter 874, relating to criminal street gangs.
4280
42. Chapter 893, relating to drug abuse prevention and
4281
control.
4282
43. Chapter 896, relating to offenses related to financial
4283
transactions.
4285
a witness, victim, or informant, and retaliation against a
4286
witness, victim, or informant.
4288
jurors and evidence.
4289
Section 43. Paragraphs (d), (f), (h), (i), and (j) of
4290
subsection (3) of section 921.0022, Florida Statutes, are amended
4291
to read:
4292
921.0022 Criminal Punishment Code; offense severity ranking
4293
chart.--
4294
(3) OFFENSE SEVERITY RANKING CHART
4295
(d) LEVEL 4
4296
| FloridaStatute | FelonyDegree | Description |
4297
| 316.1935(3)(a) | 2nd | Driving at high speed or with wanton disregard for safety while fleeing or attempting to elude law enforcement officer who is in a patrol vehicle with siren and lights activated. |
4298
| 499.0051(1) | 3rd | Failure to maintain or deliver pedigree papers. |
4299
| 499.0051(2) | 3rd | Failure to authenticate pedigree papers. |
4300
| 499.0051(6) | 2nd | Knowing sale or delivery, or possession with intent to sell, contraband prescription legend drugs. |
4301
| 784.07(2)(b) | 3rd | Battery of law enforcement officer, firefighter, intake officer, etc. |
4302
| 784.074(1)(c) | 3rd | Battery of sexually violent predators facility staff. |
4303
| 784.075 | 3rd | Battery on detention or commitment facility staff. |
4304
| 784.078 | 3rd | Battery of facility employee by throwing, tossing, or expelling certain fluids or materials. |
4305
| 784.08(2)(c) | 3rd | Battery on a person 65 years of age or older. |
4306
| 784.081(3) | 3rd | Battery on specified official or employee. |
4307
| 784.082(3) | 3rd | Battery by detained person on visitor or other detainee. |
4308
| 784.083(3) | 3rd | Battery on code inspector. |
4309
| 784.085 | 3rd | Battery of child by throwing, tossing, projecting, or expelling certain fluids or materials. |
4310
| 787.03(1) | 3rd | Interference with custody; wrongly takes minor from appointed guardian. |
4311
| 787.04(2) | 3rd | Take, entice, or remove child beyond state limits with criminal intent pending custody proceedings. |
4312
| 787.04(3) | 3rd | Carrying child beyond state lines with criminal intent to avoid producing child at custody hearing or delivering to designated person. |
4313
| 790.115(1) | 3rd | Exhibiting firearm or weapon within 1,000 feet of a school. |
4314
| 790.115(2)(b) | 3rd | Possessing electric weapon or device, destructive device, or other weapon on school property. |
4315
| 790.115(2)(c) | 3rd | Possessing firearm on school property. |
4316
| 800.04(7)(d) | 3rd | Lewd or lascivious exhibition; offender less than 18 years. |
4317
| 810.02(4)(a) | 3rd | Burglary, or attempted burglary, of an unoccupied structure; unarmed; no assault or battery. |
4318
| 810.02(4)(b) | 3rd | Burglary, or attempted burglary, of an unoccupied conveyance; unarmed; no assault or battery. |
4319
| 810.06 | 3rd | Burglary; possession of tools. |
4320
| 810.08(2)(c) | 3rd | Trespass on property, armed with firearm or dangerous weapon. |
4321
| 812.014(2)(c)3. | 3rd | Grand theft, 3rd degree $10,000 or more but less than $20,000. |
4322
| 812.014(2)(c)4.-10. | 3rd | Grand theft, 3rd degree, a will, firearm, motor vehicle, livestock, etc. |
4323
| 812.0195(2) | 3rd | Dealing in stolen property by use of the Internet; property stolen $300 or more. |
4324
| 817.563(1) | 3rd | Sell or deliver substance other than controlled substance agreed upon, excluding s. 893.03(5) drugs. |
4325
| 817.568(2)(a) | 3rd | Fraudulent use of personal identification information. |
4326
| 817.625(2)(a) | 3rd | Fraudulent use of scanning device or reencoder. |
4327
| 828.125(1) | 2nd | Kill, maim, or cause great bodily harm or permanent breeding disability to any registered horse or cattle. |
4328
| 837.02(1) | 3rd | Perjury in official proceedings. |
4329
| 837.021(1) | 3rd | Make contradictory statements in official proceedings. |
4330
| 838.022 | 3rd | Official misconduct. |
4331
| 839.13(2)(a) | 3rd | Falsifying records of an individual in the care and custody of a state agency. |
4332
| 839.13(2)(c) | 3rd | Falsifying records of the Department of Children and Family Services. |
4333
| 843.021 | 3rd | Possession of a concealed handcuff key by a person in custody. |
4334
| 843.025 | 3rd | Deprive law enforcement, correctional, or correctional probation officer of means of protection or communication. |
4335
| 843.15(1)(a) | 3rd | Failure to appear while on bail for felony (bond estreature or bond jumping). |
4336
| 874.05(1) | 3rd | Encouraging or recruiting another to join a criminal street gang. |
4337
| 893.13(2)(a)1. | 2nd | Purchase of cocaine (or other s. 893.03(1)(a), (b), or (d), (2)(a), (2)(b), or (2)(c)4. drugs). |
4338
| 914.14(2) | 3rd | Witnesses accepting bribes. |
4339
| 914.22(1) | 3rd | Force, threaten, etc., witness, victim, or informant. |
4340
| 914.23(2) | 3rd | Retaliation against a witness, victim, or informant, no bodily injury. |
4341
| 918.12 | 3rd | Tampering with jurors. |
4342
| 934.215 | 3rd | Use of two-way communications device to facilitate commission of a crime. |
4343
4344
(f) LEVEL 6
4345
| FloridaStatute | FelonyDegree | Description |
4346
| 316.193(2)(b) | 3rd | Felony DUI, 4th or subsequent conviction. |
4347
| 499.0051(3) | 2nd | Knowing forgery of pedigree papers. |
4348
| 499.0051(4) | 2nd | Knowing purchase or receipt of prescription legend drug from unauthorized person. |
4349
| 499.0051(5) | 2nd | Knowing sale or transfer of prescription legend drug to unauthorized person. |
4350
| 775.0875(1) | 3rd | Taking firearm from law enforcement officer. |
4351
| 784.021(1)(a) | 3rd | Aggravated assault; deadly weapon without intent to kill. |
4352
| 784.021(1)(b) | 3rd | Aggravated assault; intent to commit felony. |
4353
| 784.041 | 3rd | Felony battery; domestic battery by strangulation. |
4354
| 784.048(3) | 3rd | Aggravated stalking; credible threat. |
4355
| 784.048(5) | 3rd | Aggravated stalking of person under 16. |
4356
| 784.07(2)(c) | 2nd | Aggravated assault on law enforcement officer. |
4357
| 784.074(1)(b) | 2nd | Aggravated assault on sexually violent predators facility staff. |
4358
| 784.08(2)(b) | 2nd | Aggravated assault on a person 65 years of age or older. |
4359
| 784.081(2) | 2nd | Aggravated assault on specified official or employee. |
4360
| 784.082(2) | 2nd | Aggravated assault by detained person on visitor or other detainee. |
4361
| 784.083(2) | 2nd | Aggravated assault on code inspector. |
4362
4363
| 790.115(2)(d) | 2nd | Discharging firearm or weapon on school property. |
4364
| 790.161(2) | 2nd | Make, possess, or throw destructive device with intent to do bodily harm or damage property. |
4365
| 790.164(1) | 2nd | False report of deadly explosive, weapon of mass destruction, or act of arson or violence to state property. |
4366
| 790.19 | 2nd | Shooting or throwing deadly missiles into dwellings, vessels, or vehicles. |
4367
| 794.011(8)(a) | 3rd | Solicitation of minor to participate in sexual activity by custodial adult. |
4368
| 794.05(1) | 2nd | Unlawful sexual activity with specified minor. |
4369
| 800.04(5)(d) | 3rd | Lewd or lascivious molestation; victim 12 years of age or older but less than 16 years; offender less than 18 years. |
4370
| 800.04(6)(b) | 2nd | Lewd or lascivious conduct; offender 18 years of age or older. |
4371
| 806.031(2) | 2nd | Arson resulting in great bodily harm to firefighter or any other person. |
4372
| 810.02(3)(c) | 2nd | Burglary of occupied structure; unarmed; no assault or battery. |
4373
| 812.014(2)(b)1. | 2nd | Property stolen $20,000 or more, but less than $100,000, grand theft in 2nd degree. |
4374
| 812.014(6) | 2nd | Theft; property stolen $3,000 or more; coordination of others. |
4375
| 812.015(9)(a) | 2nd | Retail theft; property stolen $300 or more; second or subsequent conviction. |
4376
| 812.015(9)(b) | 2nd | Retail theft; property stolen $3,000 or more; coordination of others. |
4377
| 812.13(2)(c) | 2nd | Robbery, no firearm or other weapon (strong-arm robbery). |
4378
| 817.034(4)(a)1. | 1st | Communications fraud, value greater than $50,000. |
4379
| 817.4821(5) | 2nd | Possess cloning paraphernalia with intent to create cloned cellular telephones. |
4380
| 825.102(1) | 3rd | Abuse of an elderly person or disabled adult. |
4381
| 825.102(3)(c) | 3rd | Neglect of an elderly person or disabled adult. |
4382
| 825.1025(3) | 3rd | Lewd or lascivious molestation of an elderly person or disabled adult. |
4383
| 825.103(2)(c) | 3rd | Exploiting an elderly person or disabled adult and property is valued at less than $20,000. |
4384
| 827.03(1) | 3rd | Abuse of a child. |
4385
| 827.03(3)(c) | 3rd | Neglect of a child. |
4386
| 827.071(2)&(3) | 2nd | Use or induce a child in a sexual performance, or promote or direct such performance. |
4387
| 836.05 | 2nd | Threats; extortion. |
4388
| 836.10 | 2nd | Written threats to kill or do bodily injury. |
4389
| 843.12 | 3rd | Aids or assists person to escape. |
4390
| 847.0135(2) | 3rd | Facilitates sexual conduct of or with a minor or the visual depiction of such conduct. |
4391
| 914.23 | 2nd | Retaliation against a witness, victim, or informant, with bodily injury. |
4392
| 944.35(3)(a)2. | 3rd | Committing malicious battery upon or inflicting cruel or inhuman treatment on an inmate or offender on community supervision, resulting in great bodily harm. |
4393
| 944.40 | 2nd | Escapes. |
4394
| 944.46 | 3rd | Harboring, concealing, aiding escaped prisoners. |
4395
| 944.47(1)(a)5. | 2nd | Introduction of contraband (firearm, weapon, or explosive) into correctional facility. |
4396
| 951.22(1) | 3rd | Intoxicating drug, firearm, or weapon introduced into county facility. |
4397
4398
(h) LEVEL 8
4399
| FloridaStatute | FelonyDegree | Description |
4400
| 316.193(3)(c)3.a. | 2nd | DUI manslaughter. |
4401
| 316.1935(4)(b) | 1st | Aggravated fleeing or attempted eluding with serious bodily injury or death. |
4402
| 327.35(3)(c)3. | 2nd | Vessel BUI manslaughter. |
4403
| 499.0051(8) 499.0051(7) | 1st | Knowing forgery of prescription labels or prescription legend drug labels. |
4404
4405
| 560.123(8)(b)2. | 2nd | Failure to report currency or payment instruments totaling or exceeding $20,000, but less than $100,000 by money transmitter. |
4406
| 560.125(5)(b) | 2nd | Money transmitter business by unauthorized person, currency or payment instruments totaling or exceeding $20,000, but less than $100,000. |
4407
| 655.50(10)(b)2. | 2nd | Failure to report financial transactions totaling or exceeding $20,000, but less than $100,000 by financial institutions. |
4408
| 777.03(2)(a) | 1st | Accessory after the fact, capital felony. |
4409
| 782.04(4) | 2nd | Killing of human without design when engaged in act or attempt of any felony other than arson, sexual battery, robbery, burglary, kidnapping, aircraft piracy, or unlawfully discharging bomb. |
4410
| 782.051(2) | 1st | Attempted felony murder while perpetrating or attempting to perpetrate a felony not enumerated in s. 782.04(3). |
4411
| 782.071(1)(b) | 1st | Committing vehicular homicide and failing to render aid or give information. |
4412
| 782.072(2) | 1st | Committing vessel homicide and failing to render aid or give information. |
4413
| 790.161(3) | 1st | Discharging a destructive device which results in bodily harm or property damage. |
4414
| 794.011(5) | 2nd | Sexual battery, victim 12 years or over, offender does not use physical force likely to cause serious injury. |
4415
| 794.08(3) | 2nd | Female genital mutilation, removal of a victim younger than 18 years of age from this state. |
4416
| 800.04(4) | 2nd | Lewd or lascivious battery. |
4417
| 806.01(1) | 1st | Maliciously damage dwelling or structure by fire or explosive, believing person in structure. |
4418
| 810.02(2)(a) | 1st,PBL | Burglary with assault or battery. |
4419
| 810.02(2)(b) | 1st,PBL | Burglary; armed with explosives or dangerous weapon. |
4420
| 810.02(2)(c) | 1st | Burglary of a dwelling or structure causing structural damage or $1,000 or more property damage. |
4421
| 812.014(2)(a)2. | 1st | Property stolen; cargo valued at $50,000 or more, grand theft in 1st degree. |
4422
| 812.13(2)(b) | 1st | Robbery with a weapon. |
4423
| 812.135(2)(c) | 1st | Home-invasion robbery, no firearm, deadly weapon, or other weapon. |
4424
| 817.568(6) | 2nd | Fraudulent use of personal identification information of an individual under the age of 18. |
4425
| 825.102(2) | 2nd | Aggravated abuse of an elderly person or disabled adult. |
4426
| 825.1025(2) | 2nd | Lewd or lascivious battery upon an elderly person or disabled adult. |
4427
| 825.103(2)(a) | 1st | Exploiting an elderly person or disabled adult and property is valued at $100,000 or more. |
4428
| 837.02(2) | 2nd | Perjury in official proceedings relating to prosecution of a capital felony. |
4429
| 837.021(2) | 2nd | Making contradictory statements in official proceedings relating to prosecution of a capital felony. |
4430
| 860.121(2)(c) | 1st | Shooting at or throwing any object in path of railroad vehicle resulting in great bodily harm. |
4431
| 860.16 | 1st | Aircraft piracy. |
4432
| 893.13(1)(b) | 1st | Sell or deliver in excess of 10 grams of any substance specified in s. 893.03(1)(a) or (b). |
4433
4434
4435
| 893.135(1)(a)2. | 1st | Trafficking in cannabis, more than 2,000 lbs., less than 10,000 lbs. |
4436
| 893.135(1)(b)1.b. | 1st | Trafficking in cocaine, more than 200 grams, less than 400 grams. |
4437
| 893.135(1)(c)1.b. | 1st | Trafficking in illegal drugs, more than 14 grams, less than 28 grams. |
4438
| 893.135(1)(d)1.b. | 1st | Trafficking in phencyclidine, more than 200 grams, less than 400 grams. |
4439
| 893.135(1)(e)1.b. | 1st | Trafficking in methaqualone, more than 5 kilograms, less than 25 kilograms. |
4440
| 893.135(1)(f)1.b. | 1st | Trafficking in amphetamine, more than 28 grams, less than 200 grams. |
4441
| 893.135(1)(g)1.b. | 1st | Trafficking in flunitrazepam, 14 grams or more, less than 28 grams. |
4442
| 893.135(1)(h)1.b. | 1st | Trafficking in gamma-hydroxybutyric acid (GHB), 5 kilograms or more, less than 10 kilograms. |
4443
| 893.135(1)(j)1.b. | 1st | Trafficking in 1,4-Butanediol, 5 kilograms or more, less than 10 kilograms. |
4444
| 893.135(1)(k)2.b. | 1st | Trafficking in Phenethylamines, 200 grams or more, less than 400 grams. |
4445
| 895.03(1) | 1st | Use or invest proceeds derived from pattern of racketeering activity. |
4446
| 895.03(2) | 1st | Acquire or maintain through racketeering activity any interest in or control of any enterprise or real property. |
4447
| 895.03(3) | 1st | Conduct or participate in any enterprise through pattern of racketeering activity. |
4448
| 896.101(5)(b) | 2nd | Money laundering, financial transactions totaling or exceeding $20,000, but less than $100,000. |
4449
| 896.104(4)(a)2. | 2nd | Structuring transactions to evade reporting or registration requirements, financial transactions totaling or exceeding $20,000 but less than $100,000. |
4450
4451
(i) LEVEL 9
4452
| FloridaStatute | FelonyDegree | Description |
4453
| 316.193(3)(c)3.b. | 1st | DUI manslaughter; failing to render aid or give information. |
4454
| 327.35(3)(c)3.b. | 1st | BUI manslaughter; failing to render aid or give information. |
4455
| 499.0051(9) 499.00535 | 1st | Knowing sale or purchase of contraband prescription legend drugs resulting in great bodily harm. |
4456
| 560.123(8)(b)3. | 1st | Failure to report currency or payment instruments totaling or exceeding $100,000 by money transmitter. |
4457
| 560.125(5)(c) | 1st | Money transmitter business by unauthorized person, currency, or payment instruments totaling or exceeding $100,000. |
4458
| 655.50(10)(b)3. | 1st | Failure to report financial transactions totaling or exceeding $100,000 by financial institution. |
4459
| 775.0844 | 1st | Aggravated white collar crime. |
4460
| 782.04(1) | 1st | Attempt, conspire, or solicit to commit premeditated murder. |
4461
| 782.04(3) | 1st,PBL | Accomplice to murder in connection with arson, sexual battery, robbery, burglary, and other specified felonies. |
4462
| 782.051(1) | 1st | Attempted felony murder while perpetrating or attempting to perpetrate a felony enumerated in s. 782.04(3). |
4463
| 782.07(2) | 1st | Aggravated manslaughter of an elderly person or disabled adult. |
4464
| 787.01(1)(a)1. | 1st,PBL | Kidnapping; hold for ransom or reward or as a shield or hostage. |
4465
| 787.01(1)(a)2. | 1st,PBL | Kidnapping with intent to commit or facilitate commission of any felony. |
4466
| 787.01(1)(a)4. | 1st,PBL | Kidnapping with intent to interfere with performance of any governmental or political function. |
4467
| 787.02(3)(a) | 1st | False imprisonment; child under age 13; perpetrator also commits aggravated child abuse, sexual battery, or lewd or lascivious battery, molestation, conduct, or exhibition. |
4468
| 790.161 | 1st | Attempted capital destructive device offense. |
4469
| 790.166(2) | 1st,PBL | Possessing, selling, using, or attempting to use a weapon of mass destruction. |
4470
| 794.011(2) | 1st | Attempted sexual battery; victim less than 12 years of age. |
4471
| 794.011(2) | Life | Sexual battery; offender younger than 18 years and commits sexual battery on a person less than 12 years. |
4472
| 794.011(4) | 1st | Sexual battery; victim 12 years or older, certain circumstances. |
4473
| 794.011(8)(b) | 1st | Sexual battery; engage in sexual conduct with minor 12 to 18 years by person in familial or custodial authority. |
4474
| 794.08(2) | 1st | Female genital mutilation; victim younger than 18 years of age. |
4475
| 800.04(5)(b) | Life | Lewd or lascivious molestation; victim less than 12 years; offender 18 years or older. |
4476
| 812.13(2)(a) | 1st,PBL | Robbery with firearm or other deadly weapon. |
4477
| 812.133(2)(a) | 1st,PBL | Carjacking; firearm or other deadly weapon. |
4478
| 812.135(2)(b) | 1st | Home-invasion robbery with weapon. |
4479
| 817.568(7) | 2nd,PBL | Fraudulent use of personal identification information of an individual under the age of 18 by his or her parent, legal guardian, or person exercising custodial authority. |
4480
| 827.03(2) | 1st | Aggravated child abuse. |
4481
| 847.0145(1) | 1st | Selling, or otherwise transferring custody or control, of a minor. |
4482
| 847.0145(2) | 1st | Purchasing, or otherwise obtaining custody or control, of a minor. |
4483
| 859.01 | 1st | Poisoning or introducing bacteria, radioactive materials, viruses, or chemical compounds into food, drink, medicine, or water with intent to kill or injure another person. |
4484
| 893.135 | 1st | Attempted capital trafficking offense. |
4485
| 893.135(1)(a)3. | 1st | Trafficking in cannabis, more than 10,000 lbs. |
4486
| 893.135(1)(b)1.c. | 1st | Trafficking in cocaine, more than 400 grams, less than 150 kilograms. |
4487
| 893.135(1)(c)1.c. | 1st | Trafficking in illegal drugs, more than 28 grams, less than 30 kilograms. |
4488
| 893.135(1)(d)1.c. | 1st | Trafficking in phencyclidine, more than 400 grams. |
4489
| 893.135(1)(e)1.c. | 1st | Trafficking in methaqualone, more than 25 kilograms. |
4490
| 893.135(1)(f)1.c. | 1st | Trafficking in amphetamine, more than 200 grams. |
4491
| 893.135(1)(h)1.c. | 1st | Trafficking in gamma-hydroxybutyric acid (GHB), 10 kilograms or more. |
4492
| 893.135(1)(j)1.c. | 1st | Trafficking in 1,4-Butanediol, 10 kilograms or more. |
4493
| 893.135(1)(k)2.c. | 1st | Trafficking in Phenethylamines, 400 grams or more. |
4494
| 896.101(5)(c) | 1st | Money laundering, financial instruments totaling or exceeding $100,000. |
4495
| 896.104(4)(a)3. | 1st | Structuring transactions to evade reporting or registration requirements, financial transactions totaling or exceeding $100,000. |
4496
4497
(j) LEVEL 10
4498
| FloridaStatute | FelonyDegree | Description |
4499
| 499.0051(10) 499.00545 | 1st | Knowing sale or purchase of contraband prescription legend drugs resulting in death. |
4500
| 782.04(2) | 1st,PBL | Unlawful killing of human; act is homicide, unpremeditated. |
4501
| 787.01(1)(a)3. | 1st,PBL | Kidnapping; inflict bodily harm upon or terrorize victim. |
4502
| 787.01(3)(a) | Life | Kidnapping; child under age 13, perpetrator also commits aggravated child abuse, sexual battery, or lewd or lascivious battery, molestation, conduct, or exhibition. |
4503
| 782.07(3) | 1st | Aggravated manslaughter of a child. |
4504
| 794.011(3) | Life | Sexual battery; victim 12 years or older, offender uses or threatens to use deadly weapon or physical force to cause serious injury. |
4505
| 812.135(2)(a) | 1st,PBL | Home-invasion robbery with firearm or other deadly weapon. |
4506
| 876.32 | 1st | Treason against the state. |
4507
4508
Section 44. This act shall take effect July 1, 2008.
CODING: Words stricken are deletions; words underlined are additions.