Florida Senate - 2008 CS for SB 2756
By the Committee on Health Regulation; and Senator Peaden
588-06443-08 20082756c1
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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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providing requirements for obtaining a permit to operate
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in certain capacities; deleting certain permit
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requirements; amending and redesignating provisions of ss.
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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; amending the
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provisions to conform; amending and redesignating
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provisions of s. 499.01, F.S., relating to such functions
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as provisions of that section; conforming provisions and
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cross-references to changes made by the act; amending s.
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499.01201, F.S.; conforming provisions to changes made by
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the act; amending s. 499.0121, F.S., relating to storage
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and handling of prescription drugs and recordkeeping;
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directing the department to adopt rules requiring a
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wholesale distributor to maintain pedigree papers separate
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and 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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conforming provisions to changes made by the act; amending
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s. 499.05, F.S.; conforming provisions to changes made by
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the act; requiring the department to adopt rules with
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regard to 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; 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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in the usual course of business as 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 (n) of subsection (3) of section
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499.029, Florida Statutes, are redesignated as subsections (25),
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(23), (26), (27), (35), (40), (41), and (43), respectively, of
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that 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
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described in s. 499.01212(2)(b) has occurred. A wholesale
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distributor is not required to open a sealed, medical convenience
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kit to authenticate a pedigree paper for a prescription drug
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contained within the kit.
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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)(g) "Health care clinic" means a health care clinic
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licensed under part X of chapter 400.
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(24)(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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(25)(f) "Health care facility" means a health care facility
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licensed under chapter 395.
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(26)(h) "Hospice" means a corporation licensed under part
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IV of chapter 400.
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(27)(i) "Hospital" means a facility as defined in s.
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395.002 and licensed under chapter 395.
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(28)(22) "Immediate container" does not include package
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liners.
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(29)(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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(30)(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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(31)(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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(32)(28) "Manufacturer" means a person who prepares,
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derives, manufactures, or produces a drug, device, or cosmetic.
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"Manufacturer" also means the holder or holders of a New Drug
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Application (NDA), an Abbreviated New Drug Application (ANDA), a
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Biologics License Application (BLA), or a New Animal Drug
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Application (NADA), provided that such application has become
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effective or is otherwise approved consistent with s. 499.023; a
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private label distributor for whom the private label
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distributor's prescription drugs are originally manufactured and
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labeled for the distributor and have not been repackaged; or the
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distribution point for the manufacturer, contract manufacturer or
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private label distributor whether the establishment is a member
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of the manufacturer's affiliated group or is a contract
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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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(33)(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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(34) "Normal distribution chain" means a wholesale
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distribution of a prescription drug where 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,
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"intracompany transfer" means any transaction or transfer between
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any parent, division, or subsidiary wholly owned by a corporate
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entity.
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(35)(j) "Nursing home" means a facility licensed under part
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II of chapter 400.
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(36)(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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(37)(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 that 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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(38)(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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(39)(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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(40) "Person authorized by law" to "purchase," "posses,"
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"administer" or "receive" prescription or legend drugs means:
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(a) A person authorized by law to administer the drug, as
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defined in s. 465.003; and
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(b) An entity of which a person authorized by law to
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administer the drug, as defined in s. 465.003, is a member,
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officer, employee or agent, including but not limited to, a
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professional corporation or a professional limited liability
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company described in chapter 621 of the Business Organizations
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Code, provided that:
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1. The entity provides to the seller of the drug with a
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copy of the license under which the person authorized to
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administer the drug may purchase the drug;
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2. The entity designates, to the seller of the drug, a
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person employed by the entity who will be responsible for
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complying with all legal and regulatory requirements with respect
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to the purchase, storage and handling of the drug; and
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3. If the entity fails to designate the person described in
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subparagraph 2., the person whose license was provided to the
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seller under subparagraph 1. is deemed the person responsible for
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complying with all legal and regulatory requirements with respect
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to the purchase, storage and handling of the drug.
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(41)(l) "Pharmacist" means a person licensed under chapter
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465.
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(42)(m) "Pharmacy" means an entity licensed under chapter
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465.
519
(43)(33) "Prepackaged drug product" means a drug that
520
originally was in finished packaged form sealed by a manufacturer
521
and that is placed in a properly labeled container by a pharmacy
522
or practitioner authorized to dispense pursuant to chapter 465
523
for the purpose of dispensing in the establishment in which the
524
prepackaging occurred.
525
(44)(n) "Prescribing practitioner" means a physician
526
licensed under chapter 458 or chapter 459 or any other medical
527
professional with authority under state law to prescribe cancer
528
medication.
529
(45) "Prescription drug" means a prescription, medicinal,
530
or legend drug, including, but not limited to, finished dosage
531
forms or active ingredients subject to, defined by, or described
532
by s. 503(b) of the Federal Food, Drug, and Cosmetic Act or s.
534
or subsection (55).
535
(46) "Prescription drug label" means any display of
536
written, printed, or graphic matter upon the immediate container
537
of any prescription drug prior to its dispensing to an individual
538
patient pursuant to a prescription of a practitioner authorized
539
by law to prescribe.
540
(47)(34) "Prescription label" means any display of written,
541
printed, or graphic matter upon the immediate container of any
542
prescription legend drug dispensed pursuant to a prescription of
543
a practitioner authorized by law to prescribe.
544
(48)(35) "Prescription medical oxygen" means oxygen USP
545
which is a drug that can only be sold on the order or
546
prescription of a practitioner authorized by law to prescribe.
547
The label of prescription medical oxygen must comply with current
548
labeling requirements for oxygen under the Federal Food, Drug,
549
and Cosmetic Act.
550
(49)(d) "Primary wholesale distributor wholesaler" means
551
any wholesale distributor that:
552
(a)1. Purchased 90 percent or more of the total dollar
553
volume of its purchases of prescription drugs directly from
554
manufacturers in the previous year; and
555
(b)1.2.a. Directly purchased prescription drugs from not
556
fewer than 50 different prescription drug manufacturers in the
557
previous year; or
558
2.b. Has, or the affiliated group, as defined in s. 1504 of
559
the Internal Revenue Code, of which the wholesale distributor is
560
a member has, not fewer than 250 employees.
561
(c)(e) For purposes of this subsection, "directly from
562
manufacturers a manufacturer" means:
563
1. Purchases made by the wholesale distributor directly
564
from the manufacturer of prescription drugs; and
565
2. Transfers from a member of an affiliated group, as
566
defined in s. 1504 of the Internal Revenue Code, of which the
567
wholesale distributor is a member, if:
568
a. The affiliated group purchases 90 percent or more of the
569
total dollar volume of its purchases of prescription drugs from
570
the manufacturer in the previous year; and
571
b. The wholesale distributor discloses to the department
572
the names of all members of the affiliated group of which the
573
wholesale distributor is a member and the affiliated group agrees
574
in writing to provide records on prescription drug purchases by
575
the members of the affiliated group not later than 48 hours after
576
the department requests access to such records, regardless of the
577
location where the records are stored.
578
(50)(36) "Proprietary drug," or "OTC drug," means a patent
579
or over-the-counter drug in its unbroken, original package, which
580
drug is sold to the public by, or under the authority of, the
581
manufacturer or primary distributor thereof, is not misbranded
583
purchased without a prescription.
584
(51)(37) "Repackage" includes repacking or otherwise
585
changing the container, wrapper, or labeling to further the
586
distribution of the drug, device, or cosmetic.
587
(52)(38) "Repackager" means a person who repackages. The
588
term excludes pharmacies that are operating in compliance with
589
pharmacy practice standards as defined in chapter 465 and rules
590
adopted under that chapter.
591
(53)(c) "Retail pharmacy" means a community pharmacy
592
licensed under chapter 465 that purchases prescription drugs at
593
fair market prices and provides prescription services to the
594
public.
595
(54)(f) "Secondary wholesale distributor wholesaler" means
596
a wholesale distributor that is not a primary wholesale
597
distributor wholesaler.
598
(55)(39) "Veterinary prescription drug" means a
599
prescription legend drug intended solely for veterinary use. The
600
label of the drug must bear the statement, "Caution: Federal law
601
restricts this drug to sale by or on the order of a licensed
602
veterinarian."
603
(40) "Veterinary prescription drug wholesaler" means any
604
person engaged in wholesale distribution of veterinary
605
prescription drugs in or into this state.
606
(56)(a) "Wholesale distribution" means distribution of
607
prescription drugs to persons other than a consumer or patient,
608
but does not include:
609
(a)1. Any of the following activities, which is not a
610
violation of s. 499.005(21) if such activity is conducted in
612
1.a. The purchase or other acquisition by a hospital or
613
other health care entity that is a member of a group purchasing
614
organization of a prescription drug for its own use from the
615
group purchasing organization or from other hospitals or health
616
care entities that are members of that organization.
617
2.b. The sale, purchase, or trade of a prescription drug or
618
an offer to sell, purchase, or trade a prescription drug by a
619
charitable organization described in s. 501(c)(3) of the Internal
620
Revenue Code of 1986, as amended and revised, to a nonprofit
621
affiliate of the organization to the extent otherwise permitted
622
by law.
623
3.c. The sale, purchase, or trade of a prescription drug or
624
an offer to sell, purchase, or trade a prescription drug among
625
hospitals or other health care entities that are under common
626
control. For purposes of this subparagraph section, "common
627
control" means the power to direct or cause the direction of the
628
management and policies of a person or an organization, whether
629
by ownership of stock, by voting rights, by contract, or
630
otherwise.
631
4.d. The sale, purchase, trade, or other transfer of a
632
prescription drug from or for any federal, state, or local
633
government agency or any entity eligible to purchase prescription
634
drugs at public health services prices pursuant to Pub. L. No.
635
102-585, s. 602 to a contract provider or its subcontractor for
636
eligible patients of the agency or entity under the following
637
conditions:
638
a.(I) The agency or entity must obtain written
639
authorization for the sale, purchase, trade, or other transfer of
640
a prescription drug under this subparagraph sub-subparagraph from
641
the State Surgeon General or his or her designee.
642
b.(II) The contract provider or subcontractor must be
643
authorized by law to administer or dispense prescription drugs.
644
c.(III) In the case of a subcontractor, the agency or
645
entity must be a party to and execute the subcontract.
646
d.(IV) A contract provider or subcontractor must maintain
647
separate and apart from other prescription drug inventory any
648
prescription drugs of the agency or entity in its possession.
649
e.(V) The contract provider and subcontractor must maintain
650
and produce immediately for inspection all records of movement or
651
transfer of all the prescription drugs belonging to the agency or
652
entity, including, but not limited to, the records of receipt and
653
disposition of prescription drugs. Each contractor and
654
subcontractor dispensing or administering these drugs must
655
maintain and produce records documenting the dispensing or
656
administration. Records that are required to be maintained
657
include, but are not limited to, a perpetual inventory itemizing
658
drugs received and drugs dispensed by prescription number or
659
administered by patient identifier, which must be submitted to
660
the agency or entity quarterly.
661
f.(VI) The contract provider or subcontractor may
662
administer or dispense the prescription drugs only to the
663
eligible patients of the agency or entity or must return the
664
prescription drugs for or to the agency or entity. The contract
665
provider or subcontractor must require proof from each person
666
seeking to fill a prescription or obtain treatment that the
667
person is an eligible patient of the agency or entity and must,
668
at a minimum, maintain a copy of this proof as part of the
669
records of the contractor or subcontractor required under sub-
670
subparagraph e. sub-sub-subparagraph (V).
671
g.(VII) In addition to the departmental inspection
672
authority set forth in s. 499.051, the establishment of the
673
contract provider and subcontractor and all records pertaining to
674
prescription drugs subject to this subparagraph sub-subparagraph
675
shall be subject to inspection by the agency or entity. All
676
records relating to prescription drugs of a manufacturer under
677
this subparagraph sub-subparagraph shall be subject to audit by
678
the manufacturer of those drugs, without identifying individual
679
patient information.
680
(b)2. Any of the following activities, which is not a
681
violation of s. 499.005(21) if such activity is conducted in
682
accordance with rules established by the department:
683
1.a. The sale, purchase, or trade of a prescription drug
684
among federal, state, or local government health care entities
685
that are under common control and are authorized to purchase such
686
prescription drug.
687
2.b. The sale, purchase, or trade of a prescription drug or
688
an offer to sell, purchase, or trade a prescription drug for
689
emergency medical reasons. For purposes of this subparagraph sub-
690
subparagraph, the term "emergency medical reasons" includes
691
transfers of prescription drugs by a retail pharmacy to another
692
retail pharmacy to alleviate a temporary shortage.
693
3.c. The transfer of a prescription drug acquired by a
694
medical director on behalf of a licensed emergency medical
695
services provider to that emergency medical services provider and
696
its transport vehicles for use in accordance with the provider's
697
license under chapter 401.
698
4.d. The revocation of a sale or the return of a
699
prescription drug to the person's prescription drug wholesale
700
supplier.
701
5.e. The donation of a prescription drug by a health care
702
entity to a charitable organization that has been granted an
703
exemption under s. 501(c)(3) of the Internal Revenue Code of
704
1986, as amended, and that is authorized to possess prescription
705
drugs.
706
6.f. The transfer of a prescription drug by a person
707
authorized to purchase or receive prescription drugs to a person
708
licensed or permitted to handle reverse distributions or
709
destruction under the laws of the jurisdiction in which the
710
person handling the reverse distribution or destruction receives
711
the drug.
712
7.g. The transfer of a prescription drug by a hospital or
713
other health care entity to a person licensed under this part
714
chapter to repackage prescription drugs for the purpose of
715
repackaging the prescription drug for use by that hospital, or
716
other health care entity and other health care entities that are
717
under common control, if ownership of the prescription drugs
718
remains with the hospital or other health care entity at all
719
times. In addition to the recordkeeping requirements of s.
720
499.0121(6), the hospital or health care entity that transfers
721
prescription drugs pursuant to this subparagraph sub-subparagraph
722
must reconcile all drugs transferred and returned and resolve any
723
discrepancies in a timely manner.
724
(c)3. The distribution of prescription drug samples by
725
manufacturers' representatives or distributors' representatives
726
conducted in accordance with s. 499.028.
727
(d)4. The sale, purchase, or trade of blood and blood
728
components intended for transfusion. As used in this paragraph
729
subparagraph, the term "blood" means whole blood collected from a
730
single donor and processed either for transfusion or further
731
manufacturing, and the term "blood components" means that part of
732
the blood separated by physical or mechanical means.
733
(e)5. The lawful dispensing of a prescription drug in
734
accordance with chapter 465.
735
(f)6. The sale, purchase, or trade of a prescription drug
736
between pharmacies as a result of a sale, transfer, merger, or
737
consolidation of all or part of the business of the pharmacies
738
from or with another pharmacy, whether accomplished as a purchase
739
and sale of stock or of business assets.
740
(57)(b) "Wholesale distributor" means any person engaged in
741
wholesale distribution of prescription drugs in or into this
742
state, including, but not limited to, manufacturers; repackagers;
743
own-label distributors; jobbers; private-label distributors;
744
brokers; warehouses, including manufacturers' and distributors'
745
warehouses, chain drug warehouses, and wholesale drug warehouses;
746
independent wholesale drug traders; exporters; retail pharmacies;
747
and the agents thereof that conduct wholesale distributions.
748
Section 3. Subsections (4), (10), (11), (12), (14), (15),
749
(18), (19), (20), (22), (24), (28), and (29) of section 499.005,
750
Florida Statutes, are amended to read:
751
499.005 Prohibited acts.--It is unlawful for a person to
752
perform or cause the performance of any of the following acts in
753
this state:
754
(4) The sale, distribution, purchase, trade, holding, or
755
offering of any drug, device, or cosmetic in violation of this
757
(10) Forging; counterfeiting; simulating; falsely
758
representing any drug, device, or cosmetic; or, without the
759
authority of the manufacturer, using any mark, stamp, tag, label,
760
or other identification device authorized or required by rules
762
(11) The use, on the labeling of any drug or in any
763
advertisement relating to such drug, of any representation or
764
suggestion that an application of the drug is effective when it
765
is not or that the drug complies with this part ss. 499.001-
766
499.081 when it does not.
767
(12) The possession of any drug in violation of this part
769
(14) The purchase or receipt of a prescription legend drug
770
from a person that is not authorized under this chapter to
771
distribute prescription legend drugs to that purchaser or
772
recipient.
773
(15) The sale or transfer of a prescription legend drug to
774
a person that is not authorized under the law of the jurisdiction
775
in which the person receives the drug to purchase or possess
776
prescription legend drugs from the person selling or transferring
777
the prescription legend drug.
778
(18) Failure to maintain records as required by this part
780
sections.
781
(19) Providing the department with false or fraudulent
782
records, or making false or fraudulent statements, regarding any
783
matter within the provisions of this part chapter.
784
(20) The importation of a prescription legend drug except
785
as provided by s. 801(d) of the Federal Food, Drug, and Cosmetic
786
Act.
787
(22) Failure to obtain a permit or registration, or
788
operating without a valid permit when a permit or registration is
790
(24) The distribution of a prescription legend device to
791
the patient or ultimate consumer without a prescription or order
792
from a practitioner licensed by law to use or prescribe the
793
device.
794
(28) Failure to acquire obtain or deliver pass on a
795
pedigree paper as required under this part.
796
(29) The receipt of a prescription drug pursuant to a
797
wholesale distribution without having previously received or
798
simultaneously either first receiving a pedigree paper that was
799
attested to as accurate and complete by the wholesale distributor
800
as required under this part or complying with the provisions of
801
s. 499.0121(6)(d)5.
802
Section 4. Section 499.0051, Florida Statutes, is amended;
803
section 499.0052, Florida Statutes, is redesignated as subsection
804
(7) of that section and amended; section 499.00535, Florida
805
Statutes, is redesignated as subsection (9) of that section and
806
amended; section 499.00545, Florida Statutes, is redesignated as
807
subsection (10) of that section and amended; section 499.069,
808
Florida Statutes, is redesignated as subsection (11) of that
809
section and amended; and section 499.0691, Florida Statutes, is
810
redesignated as subsections (12) through (15) of that section and
811
amended, to read:
812
499.0051 Criminal acts involving contraband or adulterated
813
drugs.--
814
(1) FAILURE TO MAINTAIN OR DELIVER PEDIGREE PAPERS.--
815
(a) A person, other than a manufacturer, engaged in the
816
wholesale distribution of prescription legend drugs who fails to
817
deliver to another person complete and accurate pedigree papers
818
concerning a prescription legend drug or contraband prescription
819
legend drug prior to, or simultaneous with, the transfer of
820
transferring the prescription legend drug or contraband
821
prescription legend drug to another person commits a felony of
822
the third degree, punishable as provided in s. 775.082, s.
824
(b) A person engaged in the wholesale distribution of
825
prescription legend drugs who fails to acquire complete and
826
accurate pedigree papers concerning a prescription legend drug or
827
contraband prescription legend drug prior to, or simultaneous
828
with, the receipt of obtaining the prescription legend drug or
829
contraband prescription legend drug from another person commits a
830
felony of the third degree, punishable as provided in s. 775.082,
832
(c) Any person who knowingly destroys, alters, conceals, or
833
fails to maintain complete and accurate pedigree papers
834
concerning any prescription legend drug or contraband
835
prescription legend drug in his or her possession commits a
836
felony of the third degree, punishable as provided in s. 775.082,
838
(2) FAILURE TO AUTHENTICATE PEDIGREE PAPERS.--Effective
839
July 1, 2006:
840
(a) A person engaged in the wholesale distribution of
841
prescription legend drugs who is in possession of pedigree papers
842
concerning prescription legend drugs or contraband prescription
843
legend drugs and who fails to authenticate the matters contained
844
in the pedigree papers and who nevertheless attempts to further
845
distribute prescription legend drugs or contraband prescription
846
legend drugs commits a felony of the third degree, punishable as
848
(b) A person in possession of pedigree papers concerning
849
prescription legend drugs or contraband prescription legend drugs
850
who falsely swears or certifies that he or she has authenticated
851
the matters contained in the pedigree papers commits a felony of
852
the third degree, punishable as provided in s. 775.082, s.
854
(3) KNOWING FORGERY OF PEDIGREE PAPERS.--A person who
855
knowingly forges, counterfeits, or falsely creates any pedigree
856
paper; who falsely represents any factual matter contained on any
857
pedigree paper; or who knowingly omits to record material
858
information required to be recorded in a pedigree paper, commits
859
a felony of the second degree, punishable as provided in s.
861
(4) KNOWING PURCHASE OR RECEIPT OF PRESCRIPTION LEGEND DRUG
862
FROM UNAUTHORIZED PERSON.--A person who knowingly purchases or
863
receives from a person not authorized to distribute prescription
864
legend drugs under this chapter a prescription legend drug in a
865
wholesale distribution transaction commits a felony of the second
867
868
(5) KNOWING SALE OR TRANSFER OF PRESCRIPTION LEGEND DRUG TO
869
UNAUTHORIZED PERSON.--A person who knowingly sells or transfers
870
to a person not authorized to purchase or possess prescription
871
legend drugs, under the law of the jurisdiction in which the
872
person receives the drug, a prescription legend drug in a
873
wholesale distribution transaction commits a felony of the second
875
876
(6) KNOWING SALE OR DELIVERY, OR POSSESSION WITH INTENT TO
877
SELL, CONTRABAND PRESCRIPTION LEGEND DRUGS.--A person who is
878
knowingly in actual or constructive possession of any amount of
879
contraband prescription legend drugs, who knowingly sells or
880
delivers, or who possesses with intent to sell or deliver any
881
amount of contraband prescription legend drugs, commits a felony
882
of the second degree, punishable as provided in s. 775.082, s.
884
(7)499.0052 KNOWING TRAFFICKING IN CONTRABAND PRESCRIPTION
885
LEGEND DRUGS.--A person who knowingly sells, purchases,
886
manufactures, delivers, or brings into this state, or who is
887
knowingly in actual or constructive possession of any amount of
888
contraband prescription legend drugs valued at $25,000 or more
889
commits a felony of the first degree, punishable as provided in
891
(a) Upon conviction, each defendant shall be ordered to pay
892
a mandatory fine according to the following schedule:
893
1.(1) If the value of contraband prescription legend drugs
894
involved is $25,000 or more, but less than $100,000, the
895
defendant shall pay a mandatory fine of $25,000. If the defendant
896
is a corporation or other person that is not a natural person, it
897
shall pay a mandatory fine of $75,000.
898
2.(2) If the value of contraband prescription legend drugs
899
involved is $100,000 or more, but less than $250,000, the
900
defendant shall pay a mandatory fine of $100,000. If the
901
defendant is a corporation or other person that is not a natural
902
person, it shall pay a mandatory fine of $300,000.
903
3.(3) If the value of contraband prescription legend drugs
904
involved is $250,000 or more, the defendant shall pay a mandatory
905
fine of $200,000. If the defendant is a corporation or other
906
person that is not a natural person, it shall pay a mandatory
907
fine of $600,000.
908
(b) As used in this subsection section, the term "value"
909
means the market value of the property at the time and place of
910
the offense or, if such cannot be satisfactorily ascertained, the
911
cost of replacement of the property within a reasonable time
912
after the offense. Amounts of value of separate contraband
913
prescription legend drugs involved in distinct transactions for
914
the distribution of the contraband prescription legend drugs
915
committed pursuant to one scheme or course of conduct, whether
916
involving the same person or several persons, may be aggregated
917
in determining the punishment of the offense.
918
(8)(7) KNOWING FORGERY OF PRESCRIPTION OR PRESCRIPTION
919
LEGEND DRUG LABELS.--A person who knowingly forges, counterfeits,
920
or falsely creates any prescription label or prescription legend
921
drug label, or who falsely represents any factual matter
922
contained on any prescription label or prescription legend drug
923
label, commits a felony of the first degree, punishable as
925
(9)499.00535 KNOWING Sale or purchase of contraband
926
prescription legend drugs resulting in great bodily harm.--A
927
person who knowingly sells, purchases, manufactures, delivers, or
928
brings into this state, or who is knowingly in actual or
929
constructive possession of any amount of contraband prescription
930
legend drugs, and whose acts in violation of this subsection
931
section result in great bodily harm to a person, commits a felony
933
934
(10)499.00545 Knowing Sale or purchase of contraband
935
prescription legend drugs resulting in death.--A person who
936
knowingly manufactures, sells, purchases, delivers, or brings
937
into this state, or who is knowingly in actual or constructive
938
possession of any amount of contraband prescription legend drugs,
939
and whose acts in violation of this subsection section result in
940
the death of a person, commits a felony of the first degree,
941
punishable by a term of years not exceeding life, as provided in
943
(11)499.069 Criminal punishment for VIOLATIONS OF S.
944
499.005 RELATED TO DEVICES AND COSMETICS; DISSEMINATION OF FALSE
945
ADVERTISEMENT.--
946
(a)(1) Any person who violates any of the provisions of s.
947
499.005 with respect to a device or cosmetic commits a
948
misdemeanor of the second degree, punishable as provided in s.
950
conviction of such person under this subsection section has
951
become final, such person is guilty of a misdemeanor of the first
954
any person who violates s. 499.005(8) or (10) subsection (8) or
955
subsection (10) of s. 499.005 with respect to a device or
956
cosmetic commits a felony of the third degree, punishable as
959
(b)(2) A publisher, radio broadcast licensee, or agency or
960
medium for the dissemination of an advertisement, except the
961
manufacturer, wholesaler, or seller of the article to which a
962
false advertisement relates, is not liable under this subsection
963
section by reason of the dissemination by him or her of such
964
false advertisement, unless he or she has refused, on the request
965
of the department, to furnish to the department the name and post
966
office address of the manufacturer, wholesaler, seller, or
967
advertising agency that asked him or her to disseminate such
968
advertisement.
969
(12)499.0691 ADULTERATED AND MISBRANDED DRUGS; FALSE
970
ADVERTISEMENT; FAILURE TO MAINTAIN RECORDS RELATING TO DRUGS
971
Criminal punishment for violations related to drugs;
972
dissemination of false advertisement.--(1) Any person who
973
violates any of the following provisions commits a misdemeanor of
974
the second degree, punishable as provided in s. 775.082 or s.
975
775.083; but, if the violation is committed after a conviction of
976
such person under this subsection section has become final, such
977
person commits a misdemeanor of the first degree, punishable as
980
(a) The manufacture, repackaging, sale, delivery, or
981
holding or offering for sale of any drug that is adulterated or
982
misbranded or has otherwise been rendered unfit for human or
983
animal use.
984
(b) The adulteration or misbranding of any drug intended
985
for further distribution.
986
(c) The receipt of any drug that is adulterated or
987
misbranded, and the delivery or proffered delivery of such drug,
988
for pay or otherwise.
989
(d) The dissemination of any false or misleading
990
advertisement of a drug.
991
(e) The use, on the labeling of any drug or in any
992
advertisement relating to such drug, of any representation or
993
suggestion that an application of the drug is effective when it
994
is not or that the drug complies with this part ss. 499.001-
995
499.081 when it does not.
996
(f) The purchase or receipt of a compressed medical gas
997
from a person that is not authorized under this chapter to
998
distribute compressed medical gases.
999
(g) Charging a dispensing fee for dispensing,
1000
administering, or distributing a prescription drug sample.
1001
(h) The failure to maintain records related to a drug as
1003
this part those sections, except for pedigree papers, invoices,
1004
or shipping documents related to prescription legend drugs.
1005
(i) The possession of any drug in violation of this part
1007
deficiency in pedigree papers.
1008
(13) REFUSAL TO ALLOW INSPECTION; SELLING, PURCHASING, OR
1009
TRADING DRUG SAMPLES; FAILURE TO MAINTAIN RECORDS RELATING TO
1010
PRESCRIPTION DRUGS.--(2) Any person who violates any of the
1011
following provisions commits a felony of the third degree,
1014
(a) The refusal or constructive refusal to allow:
1015
1. The department to enter or inspect an establishment in
1016
which drugs are manufactured, processed, repackaged, sold,
1017
brokered, or held;
1018
2. Inspection of any record of that establishment;
1019
3. The department to enter and inspect any vehicle that is
1020
being used to transport drugs; or
1021
4. The department to take samples of any drug.
1022
(b) The sale, purchase, or trade, or the offer to sell,
1023
purchase, or trade, a drug sample as defined in s. 499.028; the
1024
distribution of a drug sample in violation of s. 499.028; or the
1025
failure to otherwise comply with s. 499.028.
1026
(c) Providing the department with false or fraudulent
1027
records, or making false or fraudulent statements, regarding any
1028
matter within the provisions of this part chapter related to a
1029
drug.
1030
(d) The failure to receive, maintain, or provide invoices
1031
and shipping documents, other than pedigree papers, if
1032
applicable, related to the distribution of a prescription legend
1033
drug.
1034
(e) The importation of a prescription legend drug for
1035
wholesale distribution, except as provided by s. 801(d) of the
1036
Federal Food, Drug, and Cosmetic Act.
1037
(f) The wholesale distribution of a any prescription drug
1038
that was:
1039
1. Purchased by a public or private hospital or other
1040
health care entity; or
1041
2. Donated or supplied at a reduced price to a charitable
1042
organization.
1043
(g) The failure to obtain a permit as a prescription drug
1044
wholesale distributor wholesaler when a permit is required by
1046
(h) Knowingly possessing any adulterated or misbranded
1047
prescription legend drug outside of a designated quarantine area.
1048
(i) The purchase or sale of a prescription drug drugs for
1049
wholesale distribution in exchange for currency, as defined in s.
1050
560.103(6).
1051
(14) OTHER VIOLATIONS.--(3) Any person who violates any of
1052
the following provisions commits a felony of the second degree,
1055
(a) Knowingly manufacturing, repackaging, selling,
1056
delivering, or holding or offering for sale any drug that is
1057
adulterated or misbranded or has otherwise been rendered unfit
1058
for human or animal use.
1059
(b) Knowingly adulterating a drug that is intended for
1060
further distribution.
1061
(c) Knowingly receiving a drug that is adulterated and
1062
delivering or proffering delivery of such drug for pay or
1063
otherwise.
1064
(d) Committing any act that causes a drug to be a
1065
counterfeit drug, or selling, dispensing, or knowingly holding
1066
for sale a counterfeit drug.
1067
(e) Forging, counterfeiting, simulating, or falsely
1068
representing any drug, or, without the authority of the
1069
manufacturer, using any mark, stamp, tag, label, or other
1070
identification device authorized or required by rules adopted
1072
(f) Knowingly obtaining or attempting to obtain a
1073
prescription drug for wholesale distribution by fraud, deceit,
1074
misrepresentation, or subterfuge, or engaging in
1075
misrepresentation or fraud in the distribution of a drug.
1076
(g) Removing a pharmacy's dispensing label from a dispensed
1077
prescription drug with the intent to further distribute the
1078
prescription drug.
1079
(h) Knowingly distributing a prescription drug that was
1080
previously dispensed by a licensed pharmacy, unless such
1081
distribution was authorized in chapter 465 or the rules adopted
1082
under chapter 465.
1083
(15) FALSE ADVERTISEMENT.--(4) A publisher, radio
1084
broadcast licensee, or agency or medium for the dissemination of
1085
an advertisement, except the manufacturer, repackager, wholesale
1086
distributor wholesaler, or seller of the article to which a false
1087
advertisement relates, is not liable under subsection (12),
1088
subsection (13), or subsection (14) this section by reason of the
1089
dissemination by him or her of such false advertisement, unless
1090
he or she has refused, on the request of the department, to
1091
furnish to the department the name and post office address of the
1092
manufacturer, repackager, wholesale distributor wholesaler,
1093
seller, or advertising agency that asked him or her to
1094
disseminate such advertisement.
1095
Section 5. Section 499.0054, Florida Statutes, is amended;
1096
section 499.0055, Florida Statutes, is redesignated as subsection
1097
(2) of that section and amended; and section 499.0057, Florida
1098
Statutes, is redesignated as subsection (3) of that section and
1099
amended, to read:
1100
499.0054 Advertising and labeling of drugs, devices, and
1101
cosmetics; exemptions.--
1102
(1) It is a violation of the Florida Drug and Cosmetic Act
1103
to perform or cause the performance of any of the following acts:
1104
(a)(1) The dissemination of any false advertisement of any
1105
drug, device, or cosmetic. An advertisement is false if it is
1106
false or misleading in any way.
1107
(b)(2) The distribution in commerce of any drug, device, or
1108
cosmetic, if its labeling or advertising is in violation of this
1110
(c)(3) The manufacturing, repackaging, packaging, selling,
1111
delivery, holding, or offering for sale of any drug, device, or
1112
cosmetic for which the advertising or labeling is false or
1113
misleading.
1114
(d)(4) The advertising of any drug, device, or cosmetic
1115
that is adulterated or misbranded.
1116
(e)(5) The receiving in commerce of any drug, device, or
1117
cosmetic that is falsely advertised or labeled or the delivering
1118
or proffering for delivery of any such drug, device, or cosmetic.
1119
(f)(6) The advertising or labeling of any product
1120
containing ephedrine, a salt of ephedrine, an isomer of
1121
ephedrine, or a salt of an isomer of ephedrine, for the
1122
indication of stimulation, mental alertness, weight loss,
1123
appetite control, energy, or other indications not approved by
1124
the pertinent United States Food and Drug Administration Over-
1125
the-Counter Final or Tentative Final Monograph or approved new
1126
drug application under the federal act. In determining compliance
1127
with this requirement, the department may consider the following
1128
factors:
1129
1.(a) The packaging of the product.
1130
2.(b) The name and labeling of the product.
1131
3.(c) The manner of distribution, advertising, and
1132
promotion of the product, including verbal representations at the
1133
point of sale.
1134
4.(d) The duration, scope, and significance of abuse of the
1135
particular product.
1136
(g)(7) The advertising of any drug or device represented to
1137
have any effect in any of the following conditions, disorders,
1138
diseases, or processes:
1139
1.(a) Blood disorders.
1140
2.(b) Bone or joint diseases.
1141
3.(c) Kidney diseases or disorders.
1142
4.(d) Cancer.
1143
5.(e) Diabetes.
1144
6.(f) Gall bladder diseases or disorders.
1145
7.(g) Heart and vascular diseases.
1146
8.(h) High blood pressure.
1147
9.(i) Diseases or disorders of the ear or auditory
1148
apparatus, including hearing loss or deafness.
1149
10.(j) Mental disease or mental retardation.
1150
11.(k) Paralysis.
1151
12.(l) Prostate gland disorders.
1152
13.(m) Conditions of the scalp affecting hair loss.
1153
14.(n) Baldness.
1154
15.(o) Endocrine disorders.
1155
16.(p) Sexual impotence.
1156
17.(q) Tumors.
1157
18.(r) Venereal diseases.
1158
19.(s) Varicose ulcers.
1159
20.(t) Breast enlargement.
1160
21.(u) Purifying blood.
1161
22.(v) Metabolic disorders.
1162
23.(w) Immune system disorders or conditions affecting the
1163
immune system.
1164
24.(x) Extension of life expectancy.
1165
25.(y) Stress and tension.
1166
26.(z) Brain stimulation or performance.
1167
27.(aa) The body's natural defense mechanisms.
1168
28.(bb) Blood flow.
1169
29.(cc) Depression.
1170
30.(dd) Human immunodeficiency virus or acquired immune
1171
deficiency syndrome or related disorders or conditions.
1172
(h)(8) The representation or suggestion in labeling or
1173
advertising that an article is approved under this part ss.
1175
(2)499.0055 False or misleading advertisement.--In
1176
determining whether an advertisement is false or misleading, the
1177
department shall review the representations made or suggested by
1178
statement, word, design, device, sound, or any combination
1179
thereof within the advertisement and the extent to which the
1180
advertisement fails to reveal material facts with respect to
1181
consequences that can result from the use of the drug, device, or
1182
cosmetic to which the advertisement relates under the conditions
1183
of use prescribed in the labeling or advertisement.
1184
(3)499.0057 Advertisement exemptions.--
1185
(a)(1) An advertisement that is not prohibited under
1186
paragraph (1)(a) s. 499.0054(1) is not prohibited under paragraph
1187
(1)(g) s. 499.0054(7) if it is disseminated:
1188
1. To the public solely to advertise the product for those
1189
indications that are safe and effective indications and the
1190
product is safe and effective for self-medication, as established
1191
by the United States Food and Drug Administration; or
1192
2. if it is disseminated Only to members of the medical,
1193
dental, pharmaceutical, or veterinary professions or appears only
1194
in the scientific periodicals of these professions.
1196
the rules adopted under this part those sections creates no legal
1197
presumption that a drug or device is safe or effective.
1198
Section 6. Subsections (3), (10), and (11) of section
1199
499.006, Florida Statutes, are amended to read:
1200
499.006 Adulterated drug or device.--A drug or device is
1201
adulterated:
1202
(3) If it is a drug and the methods used in, or the
1203
facilities or controls used for, its manufacture, processing,
1204
packing, or holding do not conform to, or are not operated or
1205
administered in conformity with, current good manufacturing
1206
practices to assure that the drug meets the requirements of this
1208
strength, and meets the standard of quality and purity, which it
1209
purports or is represented to possess;
1210
(10) If it is a prescription legend drug for which the
1211
required pedigree paper is nonexistent, fraudulent, or incomplete
1213
applicable rules, or that has been purchased, held, sold, or
1214
distributed at any time by a person not authorized under federal
1215
or state law to do so; or
1216
(11) If it is a prescription drug subject to, defined by,
1217
or described by s. 503(b) of the Federal Food, Drug, and Cosmetic
1218
Act which has been returned by a veterinarian to a limited
1219
prescription drug veterinary wholesale distributor wholesaler.
1220
Section 7. Section 499.007, Florida Statutes, is amended to
1221
read:
1222
499.007 Misbranded drug or device.--A drug or device is
1223
misbranded:
1224
(1) If its labeling is in any way false or misleading.
1225
(2) Unless, If in package form, it does not bear bears a
1226
label containing:
1227
(a) The name and place of business of the manufacturer,
1228
repackager, or distributor of the finished dosage form of the
1229
drug. For the purpose of this paragraph, the finished dosage form
1230
of a prescription medicinal drug is that form of the drug which
1231
is, or is intended to be, dispensed or administered to the
1232
patient and requires no further manufacturing or processing other
1233
than packaging, reconstitution, and labeling; and
1234
(b) An accurate statement of the quantity of the contents
1235
in terms of weight, measure, or numerical count.; However, under
1236
this section, reasonable variations are permitted, and the
1237
department shall establish by rule exemptions for small packages.
1238
(3) If it is an active pharmaceutical ingredient in bulk
1239
form and does not bear a label containing:
1240
(a) The name and place of business of the manufacturer,
1241
repackager, or distributor; and
1242
(b) An accurate statement of the quantity of the contents
1243
in terms of weight, measure, or numerical count.
1244
(4)(3) If any word, statement, or other information
1246
the label or labeling is not prominently placed thereon with such
1247
conspicuousness as compared with other words, statements,
1248
designs, or devices in the labeling, and in such terms, as to
1249
render the word, statement, or other information likely to be
1250
read and understood under customary conditions of purchase and
1251
use.
1252
(5)(4) If it is a drug and is not designated solely by a
1253
name recognized in an official compendium and, unless its label
1254
does not bear bears:
1255
(a) The common or usual name of the drug, if any; and
1256
(b) In case it is fabricated from two or more ingredients,
1257
the common or usual name and quantity of each active ingredient.
1258
(6)(5) If Unless its labeling does not bear bears:
1259
(a) Adequate directions for use; and
1260
(b) Adequate warnings against use in those pathological
1261
conditions in which its use may be dangerous to health or against
1262
use by children if its use may be dangerous to health, or against
1263
unsafe dosage or methods or duration of administration or
1264
application, in such manner and form as are necessary for the
1265
protection of users.
1266
(7)(6) If it purports to be a drug the name of which is
1267
recognized in the official compendium and, unless it is not
1268
packaged and labeled as prescribed therein.; However, the method
1269
of packaging may be modified with the consent of the department.
1270
(8)(7) If it has been found by the department to be a drug
1271
liable to deterioration and, unless it is not packaged in such
1272
form and manner, and its label bears a statement of such
1273
precautions, as the department by rule requires as necessary to
1274
protect the public health. Such rule may not be established for
1275
any drug recognized in an official compendium until the
1276
department has informed the appropriate body charged with the
1277
revision of such compendium of the need for such packaging or
1278
labeling requirements and that body has failed within a
1279
reasonable time to prescribe such requirements.
1280
(9)(8) If it is:
1281
(a) A drug and its container or finished dosage form is so
1282
made, formed, or filled as to be misleading;
1283
(b) An imitation of another drug; or
1284
(c) Offered for sale under the name of another drug.
1285
(10)(9) If it is dangerous to health when used in the
1286
dosage or with the frequency or duration prescribed, recommended,
1287
or suggested in the labeling of the drug.
1288
(11)(10) If it is, purports to be, or is represented as a
1289
drug composed wholly or partly of insulin and, unless:
1290
(a) it is not from a batch with respect to which a
1291
certificate has been issued pursuant to s. 506 of the federal
1292
act, which; and
1293
(b) The certificate is in effect with respect to the drug.
1294
(12)(11) If it is, purports to be, or is represented as a
1295
drug composed wholly or partly of any kind of antibiotic
1296
requiring certification under the federal act and unless:
1297
(a) it is not from a batch with respect to which a
1298
certificate has been issued pursuant to s. 507 of the federal
1299
act, which; and
1300
(b) the certificate is in effect with respect to the drug.;
1301
1302
However, this subsection does not apply to any drug or class of
1303
drugs exempted by regulations adopted under s. 507(c) or (d) of
1304
the federal act.
1305
(13)(12) If it is a drug intended for use by humans which
1306
is a habit-forming drug or which, because of its toxicity or
1307
other potentiality for harmful effect, or the method of its use,
1308
or the collateral measures necessary to its use, is not safe for
1309
use except under the supervision of a practitioner licensed by
1310
law to administer such drugs,; or which is limited by an
1311
effective application under s. 505 of the federal act to use
1312
under the professional supervision of a practitioner licensed by
1313
law to prescribe such drug, if unless it is not dispensed only:
1314
(a) Upon the written prescription of a practitioner
1315
licensed by law to prescribe such drug;
1316
(b) Upon an oral prescription of such practitioner, which
1317
is reduced promptly to writing and filled by the pharmacist; or
1318
(c) By refilling any such written or oral prescription, if
1319
such refilling is authorized by the prescriber either in the
1320
original prescription or by oral order which is reduced promptly
1321
to writing and filled by the pharmacist.
1322
1323
This subsection does not relieve any person from any requirement
1324
prescribed by law with respect to controlled substances as
1325
defined in the applicable federal and state laws.
1326
(14)(13) If it is a drug that is subject to paragraph
1327
(13)(12)(a), and if, at any time before it is dispensed, its
1328
label does not fails to bear the statement:
1329
(a) "Caution: Federal Law Prohibits Dispensing Without
1330
Prescription";
1331
(b) "Rx Only";
1332
(c) The prescription symbol followed by the word "Only"; or
1333
(d) "Caution: State Law Prohibits Dispensing Without
1334
Prescription."
1335
(15)(14) If it is a drug that is not subject to paragraph
1336
(13)(12)(a), if at any time before it is dispensed its label
1337
bears the statement of caution required in subsection (14) (13).
1338
(16)(15) If it is a color additive, the intended use of
1339
which in or on drugs is for the purpose of coloring only and,
1340
unless its packaging and labeling are not in conformity with the
1341
packaging and labeling requirements that apply to such color
1342
additive and are prescribed under the federal act.
1343
(17) A drug dispensed by filling or refilling a written or
1344
oral prescription of a practitioner licensed by law to prescribe
1345
such drug is exempt from the requirements of this section, except
1346
subsections (1), (9) (8), (11) (10), and (12) (11) and the
1347
packaging requirements of subsections (7) (6) and (8) (7), if the
1348
drug bears a label that contains the name and address of the
1349
dispenser or seller, the prescription number and the date the
1350
prescription was written or filled, the name of the prescriber
1351
and the name of the patient, and the directions for use and
1352
cautionary statements. This exemption does not apply to any drug
1353
dispensed in the course of the conduct of a business of
1354
dispensing drugs pursuant to diagnosis by mail or to any drug
1355
dispensed in violation of subsection (13) (12). The department
1357
499.064 from subsection (13) (12) if compliance with that
1358
subsection is not necessary to protect the public health, safety,
1359
and welfare.
1360
Section 8. Subsection (1) of section 499.008, Florida
1361
Statutes, is amended and subsection (5) is added to that section
1362
to read:
1363
499.008 Adulterated cosmetics.--A cosmetic is adulterated:
1364
(1) If it bears or contains any poisonous or deleterious
1365
substance that is injurious to users under the conditions of use
1366
prescribed in the labeling or advertisement thereof or under such
1367
conditions of use as are customary or usual; however, this
1368
subsection does not apply to coal-tar hair dye:
1369
(a) The label of which bears the following legend
1370
conspicuously displayed thereon: "Caution: This product contains
1371
ingredients which may cause skin irritation on certain
1372
individuals, and a preliminary test according to accompanying
1373
directions should first be made. This product must not be used
1374
for dyeing the eyelashes or eyebrows; to do so may cause
1375
blindness"; and
1376
(b) The labeling of which bears adequate directions for
1377
such preliminary testing.
1378
1379
For the purposes of this subsection and subsection (4), the term
1380
"hair dye" does not include eyelash dyes or eyebrow dyes.
1381
(5) For the purposes of subsections (1) and (4), the term
1382
"hair dye" does not include eyelash dyes or eyebrow dyes.
1383
Section 9. Subsections (2), (3), and (5) of section
1384
499.009, Florida Statutes, are amended to read:
1385
499.009 Misbranded cosmetics.--A cosmetic is misbranded:
1386
(2) Unless, If in package form, it does not bear bears a
1387
label containing:
1388
(a) The name and place of business of the manufacturer,
1389
packer, or distributor;
1390
(b) An accurate statement of the quantity of the contents
1391
in terms of weight, measure, or numerical count; however, under
1392
this paragraph reasonable variations are permitted, and the
1393
department shall establish by rule exemptions for small packages;
1394
and
1395
(c) A declaration of ingredients in descending order of
1396
predominance, or as otherwise required by federal law.
1397
(3) If any word, statement, or other information required
1399
on the label or labeling is not prominently placed thereon with
1400
such conspicuousness as compared with other words, statements,
1401
designs, or devices in the labeling, and in such terms, as to
1402
render the word, statement, or other information likely to be
1403
read and understood by an individual under customary conditions
1404
of purchase and use.
1405
(5) Unless, If it is a color additive, its packaging and
1406
labeling are not in conformity with the packaging and labeling
1407
requirements applicable to that color additive prescribed under
1408
the federal act. This subsection does not apply to packages of
1409
color additives that, with respect to their use for cosmetics,
1410
are marketed and intended for use only in or on hair dyes.
1411
Section 10. Section 499.01, Florida Statutes, is amended;
1412
the introductory paragraph and paragraphs (a) through (h) of
1413
subsection (2) of section 499.012, Florida Statutes, are
1414
redesignated as the introductory paragraph and paragraphs (d),
1415
(n), (e), (f), (c), (i), (k), and (l), respectively, of
1416
subsection (2) of that section and amended; paragraphs (b)
1417
through (e) of subsection (2) of section 499.013, Florida
1418
Statutes, are redesignated as paragraphs (p), (o), (q), and (r),
1419
respectively, of subsection (2) of that section and amended; and
1420
section 499.014, Florida Statutes, is redesignated as paragraph
1421
(g) of subsection (2) of that section and amended, to read:
1422
499.01 Permits; applications; renewal; general
1423
requirements.--
1424
(1) Prior to operating, a permit is required for each
1425
person and establishment that intends to operate as:
1426
(a) A prescription drug manufacturer;
1427
(b) A prescription drug repackager;
1428
(c) A nonresident prescription drug manufacturer;
1429
(d) A prescription drug wholesale distributor;
1430
(e) An out-of-state prescription drug wholesale
1431
distributor;
1432
(f) A retail pharmacy drug wholesale distributor;
1433
(g) A restricted prescription drug distributor;
1434
(h) A complimentary drug distributor;
1435
(i) A freight forwarder;
1436
(j) A veterinary prescription drug retail establishment;
1437
(k) A veterinary prescription drug wholesale distributor;
1438
(l) A limited prescription drug veterinary wholesale
1439
distributor;
1440
(m) A medical oxygen retail establishment;
1441
(n) A compressed medical gas wholesale distributor;
1442
(o) A compressed medical gas manufacturer;
1443
(p)(c) An over-the-counter drug manufacturer;
1444
(d) A compressed medical gas manufacturer;
1445
(q)(e) A device manufacturer; or
1446
(r)(f) A cosmetic manufacturer.;
1447
(g) A prescription drug wholesaler;
1448
(h) A veterinary prescription drug wholesaler;
1449
(i) A compressed medical gas wholesaler;
1450
(j) An out-of-state prescription drug wholesaler;
1451
(k) A nonresident prescription drug manufacturer;
1452
(l) A freight forwarder;
1453
(m) A retail pharmacy drug wholesaler;
1454
(n) A veterinary legend drug retail establishment;
1455
(o) A medical oxygen retail establishment;
1456
(p) A complimentary drug distributor;
1457
(q) A restricted prescription drug distributor; or
1458
(r) A limited prescription drug veterinary wholesaler.
1459
(2) The following types of wholesaler permits are
1460
established:
1461
(a) Prescription drug manufacturer permit.--A prescription
1462
drug manufacturer permit is required for any person that
1463
manufactures a prescription drug in this state.
1464
1. A person that operates an establishment permitted as a
1465
prescription drug manufacturer may engage in wholesale
1466
distribution of prescription drugs manufactured at that
1467
establishment and must comply with all the provisions of this
1468
part and the rules adopted under this part that apply to a
1469
wholesale distributor.
1470
2. A prescription drug manufacturer must comply with all
1471
appropriate state and federal good manufacturing practices.
1472
(b) Prescription drug repackager permit.--A prescription
1473
drug repackager permit is required for any person that repackages
1474
a prescription drug in this state.
1475
1. A person that operates an establishment permitted as a
1476
prescription drug repackager may engage in wholesale distribution
1477
of prescription drugs repackaged at that establishment and must
1478
comply with all the provisions of this part and the rules adopted
1479
under this part that apply to a wholesale distributor.
1480
2. A prescription drug repackager must comply with all
1481
appropriate state and federal good manufacturing practices.
1482
(c)(e) Nonresident prescription drug manufacturer
1483
permit.--A nonresident prescription drug manufacturer permit is
1484
required for any person that is a manufacturer of prescription
1485
drugs, or the distribution point for a manufacturer of
1486
prescription drugs, and located outside of this state, or that is
1487
an entity to whom an approved new drug application has been
1488
issued by the United States Food and Drug Administration, or the
1489
contracted manufacturer of the approved new drug application
1490
holder, and located outside the United States, which engages in
1491
the wholesale distribution in this state of the prescription
1492
drugs it manufactures or is responsible for manufacturing. Each
1493
such manufacturer or entity must be permitted by the department
1494
and comply with all the provisions required of a wholesale
1497
1. A person that distributes prescription drugs that it did
1498
not manufacture must also obtain an out-of-state prescription
1499
drug wholesale distributor wholesaler permit pursuant to this
1500
section to engage in the wholesale distribution of the
1501
prescription drugs manufactured by another person and comply with
1502
the requirements of an out-of-state prescription drug wholesale
1503
distributor wholesaler.
1504
2. Any such person must comply with the licensing or
1505
permitting requirements of the jurisdiction in which the
1506
establishment is located and the federal act, and any product
1507
wholesaled into this state must comply with this part ss.
1509
from a foreign country into this state, the nonresident
1510
prescription drug manufacturer must provide to the department a
1511
list identifying each prescription drug it intends to import and
1512
document approval by the United States Food and Drug
1513
Administration for such importation.
1514
(d)(a) A Prescription drug wholesale distributor
1515
wholesaler's permit.--A prescription drug wholesale distributor
1516
wholesaler is a wholesale distributor that may engage in the
1517
wholesale distribution of prescription drugs. A prescription drug
1518
wholesale distributor wholesaler that applies to the department
1519
for a new permit or the renewal of a permit must submit a bond of
1520
$100,000, or other equivalent means of security acceptable to the
1521
department, such as an irrevocable letter of credit or a deposit
1522
in a trust account or financial institution, payable to the
1523
Florida Drug, Device, and Cosmetic Trust Fund. The purpose of the
1524
bond is to secure payment of any administrative penalties imposed
1525
by the department and any fees and costs incurred by the
1526
department regarding that permit which are authorized under state
1527
law and which the permittee fails to pay 30 days after the fine
1528
or costs become final. The department may make a claim against
1529
such bond or security until 1 year after the permittee's license
1530
ceases to be valid or until 60 days after any administrative or
1532
which involves the permittee is concluded, including any appeal,
1533
whichever occurs later. The department may adopt rules for
1534
issuing a prescription drug wholesale distributor-broker
1535
wholesaler-broker permit to a person who engages in the wholesale
1536
distribution of prescription drugs and does not take physical
1537
possession of any prescription drugs.
1538
(e)(c) An Out-of-state prescription drug wholesale
1539
distributor wholesaler's permit.--An out-of-state prescription
1540
drug wholesale distributor wholesaler is a wholesale distributor
1541
located outside this state which engages in the wholesale
1542
distribution of prescription drugs into this state and which must
1543
be permitted by the department and comply with all the provisions
1544
required of a wholesale distributor under this part ss. 499.001-
1545
499.081. An out-of-state prescription drug wholesale distributor
1546
wholesaler that applies to the department for a new permit or the
1547
renewal of a permit must submit a bond of $100,000, or other
1548
equivalent means of security acceptable to the department, such
1549
as an irrevocable letter of credit or a deposit in a trust
1550
account or financial institution, payable to the Florida Drug,
1551
Device, and Cosmetic Trust Fund. The purpose of the bond is to
1552
secure payment of any administrative penalties imposed by the
1553
department and any fees and costs incurred by the department
1554
regarding that permit which are authorized under state law and
1555
which the permittee fails to pay 30 days after the fine or costs
1556
become final. The department may make a claim against such bond
1557
or security until 1 year after the permittee's license ceases to
1558
be valid or until 60 days after any administrative or legal
1560
involves the permittee is concluded, including any appeal,
1561
whichever occurs later.
1562
1. The out-of-state prescription drug wholesale distributor
1563
wholesaler must maintain at all times a license or permit to
1564
engage in the wholesale distribution of prescription drugs in
1565
compliance with laws of the state in which it is a resident.
1566
2. An out-of-state prescription drug wholesale distributor
1567
wholesaler's permit is not required for an intracompany sale or
1568
transfer of a prescription drug from an out-of-state
1569
establishment that is duly licensed as a prescription drug
1570
wholesale distributor wholesaler, in its state of residence, to a
1571
licensed prescription drug wholesale distributor wholesaler in
1572
this state, if both wholesale distributors wholesalers conduct
1573
wholesale distributions of prescription drugs under the same
1574
business name. The recordkeeping requirements of ss. s.
1576
(f)(d) A Retail pharmacy drug wholesale distributor
1577
wholesaler's permit.--A retail pharmacy drug wholesale
1578
distributor wholesaler is a retail pharmacy engaged in wholesale
1579
distribution of prescription drugs within this state under the
1580
following conditions:
1581
1. The pharmacy must obtain a retail pharmacy drug
1582
wholesale distributor wholesaler's permit pursuant to this part
1584
sections.
1585
2. The wholesale distribution activity does not exceed 30
1586
percent of the total annual purchases of prescription drugs. If
1587
the wholesale distribution activity exceeds the 30-percent
1588
maximum, the pharmacy must obtain a prescription drug wholesale
1589
distributor wholesaler's permit.
1590
3. The transfer of prescription drugs that appear in any
1591
schedule contained in chapter 893 is subject to chapter 893 and
1592
the federal Comprehensive Drug Abuse Prevention and Control Act
1593
of 1970.
1594
4. The transfer is between a retail pharmacy and another
1595
retail pharmacy, or a Modified Class II institutional pharmacy,
1596
or a health care practitioner licensed in this state and
1597
authorized by law to dispense or prescribe prescription drugs.
1598
5. All records of sales of prescription drugs subject to
1599
this section must be maintained separate and distinct from other
1600
records and comply with the recordkeeping requirements of this
1602
(g)499.014 Restricted prescription drug distributor permit
1603
Distribution of legend drugs by hospitals, health care entities,
1604
charitable organizations, and return or destruction companies;
1605
permits, general requirements.--
1606
(1) A restricted prescription drug distributor permit is
1607
required for any person that engages in the distribution of a
1608
prescription legend drug, which distribution is not considered
1609
"wholesale distribution" under s. 499.003(56)(a) s.
1610
499.012(1)(a)1.
1611
1.(2) A person who engages in the receipt or distribution
1612
of a prescription legend drug in this state for the purpose of
1613
processing its return or its destruction must obtain a permit as
1614
a restricted prescription drug distributor if such person is not
1615
the person initiating the return, the prescription drug wholesale
1616
supplier of the person initiating the return, or the manufacturer
1617
of the drug.
1618
2.(3) Storage, handling, and recordkeeping of these
1619
distributions must comply with the requirements for wholesale
1620
distributors under s. 499.0121, but not except those set forth in
1622
3.(4) A person who applies for a permit as a restricted
1623
prescription drug distributor, or for the renewal of such a
1624
permit, must provide to the department the information required
1626
4.(5) The department may issue permits to restricted
1627
prescription drug distributors and may adopt rules regarding the
1628
distribution of prescription drugs by hospitals, health care
1629
entities, charitable organizations, or other persons not involved
1630
in wholesale distribution, which rules are necessary for the
1631
protection of the public health, safety, and welfare.
1632
(h) Complimentary drug distributor permit.--A complimentary
1633
drug distributor permit is required for any person that engages
1634
in the distribution of a complimentary drug, subject to the
1635
requirements of s. 499.028.
1636
(i)(f) Freight forwarder permit.--A freight forwarder
1637
permit is required for any person that engages in the
1638
distribution of a prescription legend drug as a freight forwarder
1639
unless the person is a common carrier. The storage, handling, and
1640
recordkeeping of such distributions must comply with the
1641
requirements for wholesale distributors under s. 499.0121, but
1643
freight forwarder must provide the source of the prescription
1644
legend drugs with a validated airway bill, bill of lading, or
1645
other appropriate documentation to evidence the exportation of
1646
the product.
1647
(j) Veterinary prescription drug retail establishment
1648
permit.--A veterinary prescription drug retail establishment
1649
permit is required for any person that sells veterinary
1650
prescription drugs to the public but does not include a pharmacy
1651
licensed under chapter 465.
1652
1. The sale to the public must be based on a valid written
1653
order from a veterinarian licensed in this state who has a valid
1654
client-veterinarian relationship with the purchaser's animal.
1655
2. Veterinary prescription drugs may not be sold in excess
1656
of the amount clearly indicated on the order or beyond the date
1657
indicated on the order.
1658
3. An order may not be valid for more than 1 year.
1659
4. A veterinary prescription drug retail establishment may
1660
not purchase, sell, trade, or possess human prescription drugs or
1661
any controlled substance as defined in chapter 893.
1662
5. A veterinary prescription drug retail establishment must
1663
sell a veterinary prescription drug in the original, sealed
1664
manufacturer's container with all labeling intact and legible.
1665
The department may adopt by rule additional labeling requirements
1666
for the sale of a veterinary prescription drug.
1667
6. A veterinary prescription drug retail establishment must
1668
comply with all of the wholesale distribution requirements of s.
1669
1670
7. Prescription drugs sold by a veterinary prescription
1671
drug retail establishment pursuant to a practitioner's order may
1672
not be returned into the retail establishment's inventory.
1673
(k)(g) A veterinary prescription drug wholesale distributor
1674
wholesaler permit.--A veterinary prescription drug wholesale
1675
distributor wholesaler permit is required for any person that
1676
engages in the distribution of veterinary prescription drugs in
1677
or into this state. A veterinary prescription drug wholesale
1678
distributor wholesaler that also distributes prescription drugs
1679
subject to, defined by, or described by s. 503(b) of the Federal
1680
Food, Drug, and Cosmetic Act which it did not manufacture must
1681
obtain a permit as a prescription drug wholesale distributor
1682
wholesaler, an out-of-state prescription drug wholesale
1683
distributor wholesaler, or a limited prescription drug veterinary
1684
wholesale distributor wholesaler in lieu of the veterinary
1685
prescription drug wholesale distributor wholesaler permit. A
1686
veterinary prescription drug wholesale distributor wholesaler
1687
must comply with the requirements for wholesale distributors
1689
s. 499.0121(6)(d).
1690
(l)(h) Limited prescription drug veterinary wholesale
1691
distributor wholesaler permit.--Unless engaging in the activities
1692
of and permitted as a prescription drug manufacturer, nonresident
1693
prescription drug manufacturer, prescription drug wholesale
1694
distributor wholesaler, or out-of-state prescription drug
1695
wholesale distributor wholesaler, a limited prescription drug
1696
veterinary wholesale distributor wholesaler permit is required
1697
for any person that engages in the distribution in or into this
1698
state of veterinary prescription drugs and prescription drugs
1699
subject to, defined by, or described by s. 503(b) of the Federal
1700
Food, Drug, and Cosmetic Act under the following conditions:
1701
1. The person is engaged in the business of wholesaling
1702
prescription and veterinary prescription legend drugs to persons:
1703
a. Licensed as veterinarians practicing on a full-time
1704
basis;
1705
b. Regularly and lawfully engaged in instruction in
1706
veterinary medicine;
1707
c. Regularly and lawfully engaged in law enforcement
1708
activities;
1709
d. For use in research not involving clinical use; or
1710
e. For use in chemical analysis or physical testing or for
1711
purposes of instruction in law enforcement activities, research,
1712
or testing.
1713
2. No more than 30 percent of total annual prescription
1714
drug sales may be prescription drugs approved for human use which
1715
are subject to, defined by, or described by s. 503(b) of the
1716
Federal Food, Drug, and Cosmetic Act.
1717
3. The person does not distribute is not permitted,
1718
licensed, or otherwise authorized in any jurisdiction state to
1719
wholesale prescription drugs subject to, defined by, or described
1720
by s. 503(b) of the Federal Food, Drug, and Cosmetic Act to any
1721
person who is authorized to sell, distribute, purchase, trade, or
1722
use these drugs on or for humans.
1723
4. A limited prescription drug veterinary wholesale
1724
distributor wholesaler that applies to the department for a new
1725
permit or the renewal of a permit must submit a bond of $20,000,
1726
or other equivalent means of security acceptable to the
1727
department, such as an irrevocable letter of credit or a deposit
1728
in a trust account or financial institution, payable to the
1729
Florida Drug, Device, and Cosmetic Trust Fund. The purpose of the
1730
bond is to secure payment of any administrative penalties imposed
1731
by the department and any fees and costs incurred by the
1732
department regarding that permit which are authorized under state
1733
law and which the permittee fails to pay 30 days after the fine
1734
or costs become final. The department may make a claim against
1735
such bond or security until 1 year after the permittee's license
1736
ceases to be valid or until 60 days after any administrative or
1738
which involves the permittee is concluded, including any appeal,
1739
whichever occurs later.
1740
5. A limited prescription drug veterinary wholesale
1741
distributor wholesaler must maintain at all times a license or
1742
permit to engage in the wholesale distribution of prescription
1743
drugs in compliance with laws of the state in which it is a
1744
resident.
1745
6. A limited prescription drug veterinary wholesale
1746
distributor wholesaler must comply with the requirements for
1748
except that a limited prescription drug veterinary wholesale
1749
distributor wholesaler is not required to provide a pedigree
1751
wholesale distribution of a prescription drug to a veterinarian.
1752
7. A limited prescription drug veterinary wholesale
1753
distributor wholesaler may not return to inventory for subsequent
1754
wholesale distribution any prescription drug subject to, defined
1755
by, or described by s. 503(b) of the Federal Food, Drug, and
1756
Cosmetic Act which has been returned by a veterinarian.
1757
8. An out-of-state prescription drug wholesaler's permit or
1758
A limited prescription drug veterinary wholesale distributor
1759
wholesaler permit is not required for an intracompany sale or
1760
transfer of a prescription drug from an out-of-state
1761
establishment that is duly licensed to engage in the wholesale
1762
distribution of prescription drugs in its state of residence to a
1763
licensed limited prescription drug veterinary wholesale
1764
distributor wholesaler in this state if both wholesale
1765
distributors wholesalers conduct wholesale distributions of
1766
prescription drugs under the same business name. The
1768
must be followed for this transaction.
1769
(m) Medical oxygen retail establishment permit.--A medical
1770
oxygen retail establishment permit is required for any person
1771
that sells medical oxygen to patients only. The sale must be
1772
based on an order from a practitioner authorized by law to
1773
prescribe. The term does not include a pharmacy licensed under
1774
chapter 465.
1775
1. A medical oxygen retail establishment may not possess,
1776
purchase, sell, or trade any prescription drug other than medical
1777
oxygen.
1778
2. A medical oxygen retail establishment may refill medical
1779
oxygen for an individual patient based on an order from a
1780
practitioner authorized by law to prescribe. A medical oxygen
1781
retail establishment that refills medical oxygen must comply with
1782
all appropriate state and federal good manufacturing practices.
1783
3. A medical oxygen retail establishment must comply with
1784
all of the wholesale distribution requirements of s. 499.0121.
1785
4. Prescription medical oxygen sold by a medical oxygen
1786
retail establishment pursuant to a practitioner's order may not
1787
be returned into the retail establishment's inventory.
1788
(n)(b) A compressed medical gas wholesale distributor
1789
wholesaler's permit.--A compressed medical gas wholesale
1790
distributor wholesaler is a wholesale distributor that is limited
1791
to the wholesale distribution of compressed medical gases to
1792
other than the consumer or patient. The compressed medical gas
1793
must be in the original sealed container that was purchased by
1794
that wholesale distributor wholesaler. A compressed medical gas
1795
wholesale distributor wholesaler may not possess or engage in the
1796
wholesale distribution of any prescription drug other than
1797
compressed medical gases. The department shall adopt rules that
1798
govern the wholesale distribution of prescription medical oxygen
1799
for emergency use. With respect to the emergency use of
1800
prescription medical oxygen, those rules may not be inconsistent
1801
with rules and regulations of federal agencies unless the
1802
Legislature specifically directs otherwise.
1803
(o)(c) Compressed medical gas manufacturer permit.--A
1804
compressed medical gas manufacturer manufacturer's permit is
1805
required for any person that engages in the manufacture of
1806
compressed medical gases or repackages compressed medical gases
1807
from one container to another.
1808
1. A compressed medical gas manufacturer permittee may not
1809
manufacture or possess any prescription drug other than
1810
compressed medical gases.
1811
2. A compressed medical gas manufacturer permittee may
1812
engage in wholesale distribution of compressed medical gases
1813
manufactured at that establishment and must comply with all the
1815
under this part those sections that apply to a wholesale
1816
distributor.
1817
3. A compressed medical gas manufacturer permittee must
1818
comply with all appropriate state and federal good manufacturing
1819
practices.
1820
(p)(b) Over-the-counter drug manufacturer permit.--An over-
1821
the-counter drug manufacturer manufacturer's permit is required
1822
for any person that engages in the manufacture or repackaging of
1823
an over-the-counter drug.
1824
1. An over-the-counter drug manufacturer permittee may not
1825
possess or purchase prescription drugs.
1826
2. A pharmacy is exempt from obtaining an over-the-counter
1827
drug manufacturer manufacturer's permit if it is operating in
1828
compliance with pharmacy practice standards as defined in chapter
1829
465 and the rules adopted under that chapter.
1830
3. An over-the-counter drug manufacturer permittee must
1831
comply with all appropriate state and federal good manufacturing
1832
practices.
1833
(q)(d) Device manufacturer permit.--A device manufacturer
1834
manufacturer's permit is required for any person that engages in
1835
the manufacture, repackaging, or assembly of medical devices for
1836
human use in this state, except that a permit is not required if
1837
the person is engaged only in manufacturing, repackaging, or
1838
assembling a medical device pursuant to a practitioner's order
1839
for a specific patient.
1840
1. A manufacturer or repackager of medical devices in this
1841
state must comply with all appropriate state and federal good
1842
manufacturing practices and quality system rules.
1843
2. The department shall adopt rules related to storage,
1844
handling, and recordkeeping requirements for manufacturers of
1845
medical devices for human use.
1846
(r)(e) Cosmetic manufacturer permit.--A cosmetic
1847
manufacturer manufacturer's permit is required for any person
1848
that manufactures or repackages cosmetics in this state. A person
1849
that only labels or changes the labeling of a cosmetic but does
1850
not open the container sealed by the manufacturer of the product
1851
is exempt from obtaining a permit under this paragraph.
1852
Section 11. Section 499.012, Florida Statutes, is amended
1853
and subsections (2) through (8) of section 499.01, Florida
1854
States, are redesignated as subsections (1) through (7) of that
1855
section and amended, to read:
1856
499.012 Permit application Wholesale distribution;
1857
definitions; permits; applications; general requirements.--
1858
(1) As used in this section, the term:
1859
(2)(a) A permit issued pursuant to this part ss. 499.001-
1860
499.081 may be issued only to a natural person who is at least 18
1861
years of age or to an applicant that is not a natural person if
1862
each person who, directly or indirectly, manages, controls, or
1863
oversees the operation of that applicant is at least 18 years of
1864
age.
1865
(b) An establishment that is a place of residence may not
1866
receive a permit and may not operate under this part ss. 499.001-
1867
1868
(c) A person that applies for or renews a permit to
1869
manufacture or distribute prescription legend drugs may not use a
1870
name identical to the name used by any other establishment or
1871
licensed person authorized to purchase prescription drugs in this
1872
state, except that a restricted drug distributor permit issued to
1873
a health care entity will be issued in the name in which the
1874
institutional pharmacy permit is issued and a retail pharmacy
1875
drug wholesale distributor wholesaler will be issued a permit in
1876
the name of its retail pharmacy permit.
1877
(d) A permit for a prescription drug manufacturer,
1878
prescription drug repackager, prescription drug wholesale
1879
distributor wholesaler, limited prescription drug veterinary
1880
wholesale distributor wholesaler, or retail pharmacy drug
1881
wholesale distributor wholesaler may not be issued to the address
1882
of a health care entity or to a pharmacy licensed under chapter
1883
465, except as provided in this paragraph. The department may
1884
issue a prescription drug manufacturer permit to an applicant at
1885
the same address as a licensed nuclear pharmacy, which is a
1886
health care entity, for the purpose of manufacturing prescription
1887
drugs used in positron emission tomography or other
1888
radiopharmaceuticals, as listed in a rule adopted by the
1889
department pursuant to this paragraph. The purpose of this
1890
exemption is to assure availability of state-of-the-art
1891
pharmaceuticals that would pose a significant danger to the
1892
public health if manufactured at a separate establishment address
1893
from the nuclear pharmacy from which the prescription drugs are
1894
dispensed. The department may also issue a retail pharmacy drug
1895
wholesale distributor wholesaler permit to the address of a
1896
community pharmacy licensed under chapter 465 which does not meet
1897
the definition of a closed pharmacy in s. 499.003.
1898
(e) A county or municipality may not issue an occupational
1899
license for any licensing period beginning on or after October 1,
1900
2003, for any establishment that requires a permit pursuant to
1902
a current permit issued by the department for the establishment.
1903
Upon presentation of the requisite permit issued by the
1904
department, an occupational license may be issued by the
1905
municipality or county in which application is made. The
1906
department shall furnish to local agencies responsible for
1907
issuing occupational licenses a current list of all
1908
establishments licensed pursuant to this part ss. 499.001-
1909
1910
(2)(3) Notwithstanding subsection (6) (7), a permitted
1911
person in good standing may change the type of permit issued to
1912
that person by completing a new application for the requested
1913
permit, paying the amount of the difference in the permit fees if
1914
the fee for the new permit is more than the fee for the original
1915
permit, and meeting the applicable permitting conditions for the
1916
new permit type. The new permit expires on the expiration date of
1917
the original permit being changed; however, a new permit for a
1918
prescription drug wholesale distributor wholesaler, an out-of-
1919
state prescription drug wholesale distributor wholesaler, or a
1920
retail pharmacy drug wholesale distributor wholesaler shall
1921
expire on the expiration date of the original permit or 1 year
1922
after the date of issuance of the new permit, whichever is
1923
earlier. A refund may not be issued if the fee for the new permit
1924
is less than the fee that was paid for the original permit.
1925
(3)(4) A written application for a permit or to renew a
1926
permit must be filed with the department on forms furnished by
1927
the department. The department shall establish, by rule, the form
1928
and content of the application to obtain or renew a permit. The
1929
applicant must submit to the department with the application a
1930
statement that swears or affirms that the information is true and
1931
correct.
1932
(4)(5)(a) Except for a permit for a prescription drug
1933
wholesale distributor wholesaler or an out-of-state prescription
1934
drug wholesale distributor wholesaler, an application for a
1935
permit must include:
1936
1. The name, full business address, and telephone number of
1937
the applicant;
1938
2. All trade or business names used by the applicant;
1939
3. The address, telephone numbers, and the names of contact
1940
persons for each facility used by the applicant for the storage,
1941
handling, and distribution of prescription drugs;
1942
4. The type of ownership or operation, such as a
1943
partnership, corporation, or sole proprietorship; and
1944
5. The names of the owner and the operator of the
1945
establishment, including:
1946
a. If an individual, the name of the individual;
1947
b. If a partnership, the name of each partner and the name
1948
of the partnership;
1949
c. If a corporation, the name and title of each corporate
1950
officer and director, the corporate names, and the name of the
1951
state of incorporation;
1952
d. If a sole proprietorship, the full name of the sole
1953
proprietor and the name of the business entity;
1954
e. If a limited liability company, the name of each member,
1955
the name of each manager, the name of the limited liability
1956
company, and the name of the state in which the limited liability
1957
company was organized; and
1958
f. Any other relevant information that the department
1959
requires.
1960
(b) Upon approval of the application by the department and
1961
payment of the required fee, the department shall issue a permit
1962
to the applicant, if the applicant meets the requirements of this
1964
sections.
1965
(c) Any change in information required under paragraph (a)
1966
must be submitted to the department before the change occurs.
1967
(d) The department shall consider, at a minimum, the
1968
following factors in reviewing the qualifications of persons to
1970
1. The applicant's having been found guilty, regardless of
1971
adjudication, in a court of this state or other jurisdiction, of
1972
a violation of a law that directly relates to a drug, device, or
1973
cosmetic. A plea of nolo contendere constitutes a finding of
1974
guilt for purposes of this subparagraph.
1975
2. The applicant's having been disciplined by a regulatory
1976
agency in any state for any offense that would constitute a
1978
3. Any felony conviction of the applicant under a federal,
1979
state, or local law;
1980
4. The applicant's past experience in manufacturing or
1981
distributing drugs, devices, or cosmetics;
1982
5. The furnishing by the applicant of false or fraudulent
1983
material in any application made in connection with manufacturing
1984
or distributing drugs, devices, or cosmetics;
1985
6. Suspension or revocation by a federal, state, or local
1986
government of any permit currently or previously held by the
1987
applicant for the manufacture or distribution of any drugs,
1988
devices, or cosmetics;
1989
7. Compliance with permitting requirements under any
1990
previously granted permits;
1991
8. Compliance with requirements to maintain or make
1992
available to the state permitting authority or to federal, state,
1993
or local law enforcement officials those records required under
1994
this section; and
1995
9. Any other factors or qualifications the department
1996
considers relevant to and consistent with the public health and
1997
safety.
1998
(5)(6) Except for a permit permits for a prescription drug
1999
wholesale distributor wholesalers or an out-of-state prescription
2000
drug wholesale distributor wholesalers:
2001
(a) The department shall adopt rules for the biennial
2002
renewal of permits.
2003
(b) The department shall renew a permit upon receipt of the
2004
renewal application and renewal fee if the applicant meets the
2006
the rules adopted under this part those sections.
2007
(c) A permit, unless sooner suspended or revoked,
2008
automatically expires 2 years after the last day of the
2009
anniversary month in which the permit was originally issued. A
2011
by making application for renewal on forms furnished by the
2012
department and paying the appropriate fees. If a renewal
2013
application and fee are submitted and postmarked after the
2014
expiration date of the permit, the permit may be renewed only
2015
upon payment of a late renewal delinquent fee of $100, plus the
2016
required renewal fee, not later than 60 days after the expiration
2017
date.
2018
(d) Failure to renew a permit in accordance with this
2019
section precludes any future renewal of that permit. If a permit
2020
issued pursuant to this part section has expired and cannot be
2021
renewed, before an establishment may engage in activities that
2023
establishment must submit an application for a new permit, pay
2024
the applicable application fee, the initial permit fee, and all
2025
applicable penalties, and be issued a new permit by the
2026
department.
2027
(6)(7) A permit issued by the department is
2028
nontransferable. Each permit is valid only for the person or
2029
governmental unit to which it is issued and is not subject to
2030
sale, assignment, or other transfer, voluntarily or
2031
involuntarily; nor is a permit valid for any establishment other
2032
than the establishment for which it was originally issued.
2034
must notify the department before making a change of address. The
2035
department shall set a change of location fee not to exceed $100.
2036
(b)1. An application for a new permit is required when a
2037
majority of the ownership or controlling interest of a permitted
2038
establishment is transferred or assigned or when a lessee agrees
2039
to undertake or provide services to the extent that legal
2040
liability for operation of the establishment will rest with the
2041
lessee. The application for the new permit must be made before
2042
the date of the sale, transfer, assignment, or lease.
2043
2. A permittee that is authorized to distribute
2044
prescription legend drugs may transfer such drugs to the new
2045
owner or lessee under subparagraph 1. only after the new owner or
2046
lessee has been approved for a permit to distribute prescription
2047
legend drugs.
2048
(c) If an establishment permitted under this part ss.
2050
writing before the effective date of closure and must:
2051
1. Return the permit to the department;
2052
2. If the permittee is authorized to distribute
2053
prescription legend drugs, indicate the disposition of such
2054
drugs, including the name, address, and inventory, and provide
2055
the name and address of a person to contact regarding access to
2056
records that are required to be maintained under this part ss.
2058
drugs may be made only to persons authorized to possess
2060
2061
The department may revoke the permit of any person that fails to
2062
comply with the requirements of this subsection.
2063
(7)(8) A permit must be posted in a conspicuous place on
2064
the licensed premises.
2065
(8)(3) An application for a permit or to renew a permit for
2066
a prescription drug wholesale distributor wholesaler or an out-
2067
of-state prescription drug wholesale distributor wholesaler
2068
submitted to the department must include:
2069
(a) The name, full business address, and telephone number
2070
of the applicant.
2071
(b) All trade or business names used by the applicant.
2072
(c) The address, telephone numbers, and the names of
2073
contact persons for each facility used by the applicant for the
2074
storage, handling, and distribution of prescription drugs.
2075
(d) The type of ownership or operation, such as a
2076
partnership, corporation, or sole proprietorship.
2077
(e) The names of the owner and the operator of the
2078
establishment, including:
2079
1. If an individual, the name of the individual.
2080
2. If a partnership, the name of each partner and the name
2081
of the partnership.
2082
3. If a corporation:
2083
a. The name, address, and title of each corporate officer
2084
and director.
2085
b. The name and address of the corporation, resident agent
2086
of the corporation, the resident agent's address, and the
2087
corporation's state of incorporation.
2088
c. The name and address of each shareholder of the
2089
corporation that owns 5 percent or more of the outstanding stock
2090
of the corporation.
2091
4. If a sole proprietorship, the full name of the sole
2092
proprietor and the name of the business entity.
2093
5. If a limited liability company:
2094
a. The name and address of each member.
2095
b. The name and address of each manager.
2096
c. The name and address of the limited liability company,
2097
the resident agent of the limited liability company, and the name
2098
of the state in which the limited liability company was
2099
organized.
2100
(f) If applicable, the name and address of each member of
2101
the affiliated group of which the applicant is a member.
2102
(g)1. For an application for a new permit, the estimated
2103
annual dollar volume of prescription drug sales of the applicant,
2104
the estimated annual percentage of the applicant's total company
2105
sales that are prescription drugs, the applicant's estimated
2106
annual total dollar volume of purchases of prescription drugs,
2107
and the applicant's estimated annual total dollar volume of
2108
prescription drug purchases directly from manufacturers.
2109
2. For an application to renew a permit, the total dollar
2110
volume of prescription drug sales in the previous year, the total
2111
dollar volume of prescription drug sales made in the previous 6
2112
months, the percentage of total company sales that were
2113
prescription drugs in the previous year, the total dollar volume
2114
of purchases of prescription drugs in the previous year, and the
2115
total dollar volume of prescription drug purchases directly from
2116
manufacturers in the previous year.
2117
2118
Such portions of the information required pursuant to this
2119
paragraph which are a trade secret, as defined in s. 812.081,
2120
shall be maintained by the department as trade secret information
2121
is required to be maintained under s. 499.051.
2122
(h) The tax year of the applicant.
2123
(i) A copy of the deed for the property on which
2124
applicant's establishment is located, if the establishment is
2125
owned by the applicant, or a copy of the applicant's lease for
2126
the property on which applicant's establishment is located that
2127
has an original term of not less than 1 calendar year, if the
2128
establishment is not owned by the applicant.
2129
(j) A list of all licenses and permits issued to the
2130
applicant by any other state which authorize the applicant to
2131
purchase or possess prescription drugs.
2132
(k) The name of the manager of the establishment that is
2133
applying for the permit or to renew the permit, the next four
2134
highest ranking employees responsible for prescription drug
2135
wholesale operations for the establishment, and the name of all
2136
affiliated parties for the establishment, together with the
2137
personal information statement and fingerprints required pursuant
2138
to subsection (9) (4) for each of such persons.
2139
(l) The name of each of the applicant's designated
2140
representatives as required by subsection (16) (11), together
2141
with the personal information statement and fingerprints required
2142
pursuant to subsection (9) (4) for each such person.
2143
(m) For an applicant that is a secondary wholesale
2144
distributor wholesaler, each of the following:
2145
1. A personal background information statement containing
2146
the background information and fingerprints required pursuant to
2147
subsection (9) (4) for each person named in the applicant's
2148
response to paragraphs (k) and (l) and for each affiliated party
2149
of the applicant.
2150
2. If any of the five largest shareholders of the
2151
corporation seeking the permit is a corporation, the name,
2152
address, and title of each corporate officer and director of each
2153
such corporation; the name and address of such corporation; the
2154
name of such corporation's resident agent, such corporation's
2155
resident agent's address, and such corporation's state of its
2156
incorporation; and the name and address of each shareholder of
2157
such corporation that owns 5 percent or more of the stock of such
2158
corporation.
2159
3. The name and address of all financial institutions in
2160
which the applicant has an account which is used to pay for the
2161
operation of the establishment or to pay for drugs purchased for
2162
the establishment, together with the names of all persons that
2163
are authorized signatories on such accounts. The portions of the
2164
information required pursuant to this subparagraph which are a
2165
trade secret, as defined in s. 812.081, shall be maintained by
2166
the department as trade secret information is required to be
2167
maintained under s. 499.051.
2168
4. The sources of all funds and the amounts of such funds
2169
used to purchase or finance purchases of prescription drugs or to
2170
finance the premises on which the establishment is to be located.
2171
5. If any of the funds identified in subparagraph 4. were
2172
borrowed, copies of all promissory notes or loans used to obtain
2173
such funds.
2174
(n) Any other relevant information that the department
2175
requires, including, but not limited to, any information related
2176
to whether the applicant satisfies the definition of a primary
2177
wholesale distributor wholesaler or a secondary wholesale
2178
distributor wholesaler.
2179
(9)(4)(a) Each person required by subsection (8) (3) to
2180
provide a personal information statement and fingerprints shall
2181
provide the following information to the department on forms
2182
prescribed by the department:
2183
1. The person's places of residence for the past 7 years.
2184
2. The person's date and place of birth.
2185
3. The person's occupations, positions of employment, and
2186
offices held during the past 7 years.
2187
4. The principal business and address of any business,
2188
corporation, or other organization in which each such office of
2189
the person was held or in which each such occupation or position
2190
of employment was carried on.
2191
5. Whether the person has been, during the past 7 years,
2192
the subject of any proceeding for the revocation of any license
2193
and, if so, the nature of the proceeding and the disposition of
2194
the proceeding.
2195
6. Whether, during the past 7 years, the person has been
2196
enjoined, either temporarily or permanently, by a court of
2197
competent jurisdiction from violating any federal or state law
2198
regulating the possession, control, or distribution of
2199
prescription drugs, together with details concerning any such
2200
event.
2201
7. A description of any involvement by the person with any
2202
business, including any investments, other than the ownership of
2203
stock in a publicly traded company or mutual fund, during the
2204
past 7 years, which manufactured, administered, prescribed,
2205
distributed, or stored pharmaceutical products and any lawsuits
2206
in which such businesses were named as a party.
2207
8. A description of any felony criminal offense of which
2208
the person, as an adult, was found guilty, regardless of whether
2209
adjudication of guilt was withheld or whether the person pled
2210
guilty or nolo contendere. A criminal offense committed in
2211
another jurisdiction which would have been a felony in this state
2212
must be reported. If the person indicates that a criminal
2213
conviction is under appeal and submits a copy of the notice of
2214
appeal of that criminal offense, the applicant must, within 15
2215
days after the disposition of the appeal, submit to the
2216
department a copy of the final written order of disposition.
2217
9. A photograph of the person taken in the previous 30
2218
days.
2219
10. A set of fingerprints for the person on a form and
2220
under procedures specified by the department, together with
2221
payment of an amount equal to the costs incurred by the
2222
department for the criminal record check of the person.
2223
11. The name, address, occupation, and date and place of
2224
birth for each member of the person's immediate family who is 18
2225
years of age or older. As used in this subparagraph, the term
2226
"member of the person's immediate family" includes the person's
2227
spouse, children, parents, siblings, the spouses of the person's
2228
children, and the spouses of the person's siblings.
2229
12. Any other relevant information that the department
2230
requires.
2231
(b) The information required pursuant to paragraph (a)
2232
shall be provided under oath.
2233
(c) The department shall submit the fingerprints provided
2234
by a person for initial licensure to the Department of Law
2235
Enforcement for a statewide criminal record check and for
2236
forwarding to the Federal Bureau of Investigation for a national
2237
criminal record check of the person. The department shall submit
2238
the fingerprints provided by a person as a part of a renewal
2239
application to the Department of Law Enforcement for a statewide
2240
criminal record check, and for forwarding to the Federal Bureau
2241
of Investigation for a national criminal record check, for the
2242
initial renewal of a permit after January 1, 2004; for any
2243
subsequent renewal of a permit, the department shall submit the
2244
required information for a statewide and national criminal record
2245
check of the person. Any person who as a part of an initial
2246
permit application or initial permit renewal after January 1,
2247
2004, submits to the department a set of fingerprints required
2248
for the criminal record check required in this paragraph shall
2249
not be required to provide a subsequent set of fingerprints for a
2250
criminal record check to the department, if the person has
2251
undergone a criminal record check as a condition of the issuance
2252
of an initial permit or the initial renewal of a permit of an
2253
applicant after January 1, 2004.
2254
(10)(5) The department may deny an application for a permit
2255
or refuse to renew a permit for a prescription drug wholesale
2256
distributor wholesaler or an out-of-state prescription drug
2257
wholesale distributor wholesaler if:
2258
(a) The applicant has not met the requirements for the
2259
permit.
2260
(b) The management, officers, or directors of the applicant
2261
or any affiliated party are found by the department to be
2262
incompetent or untrustworthy.
2263
(c) The applicant is so lacking in experience in managing a
2264
wholesale distributor as to make the issuance of the proposed
2265
permit hazardous to the public health.
2266
(d) The applicant is so lacking in experience in managing a
2267
wholesale distributor as to jeopardize the reasonable promise of
2268
successful operation of the wholesale distributor.
2269
(e) The applicant is lacking in experience in the
2270
distribution of prescription drugs.
2271
(f) The applicant's past experience in manufacturing or
2272
distributing prescription drugs indicates that the applicant
2273
poses a public health risk.
2274
(g) The applicant is affiliated directly or indirectly
2275
through ownership, control, or other business relations, with any
2276
person or persons whose business operations are or have been
2277
detrimental to the public health.
2278
(h) The applicant, or any affiliated party, has been found
2279
guilty of or has pleaded guilty or nolo contendere to any felony
2280
or crime punishable by imprisonment for 1 year or more under the
2281
laws of the United States, any state, or any other country,
2282
regardless of whether adjudication of guilt was withheld.
2283
(i) The applicant or any affiliated party has been charged
2284
with a felony in a state or federal court and the disposition of
2285
that charge is pending during the application review or renewal
2286
review period.
2287
(j) The applicant has furnished false or fraudulent
2288
information or material in any application made in this state or
2289
any other state in connection with obtaining a permit or license
2290
to manufacture or distribute drugs, devices, or cosmetics.
2291
(k) That a federal, state, or local government permit
2292
currently or previously held by the applicant, or any affiliated
2293
party, for the manufacture or distribution of any drugs, devices,
2294
or cosmetics has been disciplined, suspended, or revoked and has
2295
not been reinstated.
2296
(l) The applicant does not possess the financial or
2297
physical resources to operate in compliance with the permit being
2298
sought, this chapter, and the rules adopted under this chapter.
2299
(m) The applicant or any affiliated party receives,
2300
directly or indirectly, financial support and assistance from a
2301
person who was an affiliated party of a permittee whose permit
2302
was subject to discipline or was suspended or revoked, other than
2303
through the ownership of stock in a publicly traded company or a
2304
mutual fund.
2305
(n) The applicant or any affiliated party receives,
2306
directly or indirectly, financial support and assistance from a
2307
person who has been found guilty of any violation of this part
2309
any rules adopted under any of this part those sections or those
2310
chapters, any federal or state drug law, or any felony where the
2311
underlying facts related to drugs, regardless of whether the
2312
person has been pardoned, had her or his civil rights restored,
2313
or had adjudication withheld, other than through the ownership of
2314
stock in a publicly traded company or a mutual fund.
2315
(o) The applicant for renewal of a permit under s.
2317
has not actively engaged in the wholesale distribution of
2318
prescription drugs, as demonstrated by the regular and systematic
2319
distribution of prescription drugs throughout the year as
2320
evidenced by not fewer than 12 wholesale distributions in the
2321
previous year and not fewer than three wholesale distributions in
2322
the previous 6 months.
2323
(p) Information obtained in response to s. 499.01(2)(d)
2324
paragraph (2)(a) or s. 499.01(2)(e) paragraph (2)(c) demonstrates
2325
it would not be in the best interest of the public health,
2326
safety, and welfare to issue a permit.
2327
(q) The applicant does not possess the financial standing
2328
and business experience for the successful operation of the
2329
applicant.
2330
(r) The applicant or any affiliated party has failed to
2331
comply with the requirements for manufacturing or distributing
2333
federal laws, similar laws in other states, or the rules adopted
2334
under such laws.
2335
(11)(6) Upon approval of the application by the department
2336
and payment of the required fee, the department shall issue or
2337
renew a prescription drug wholesale distributor wholesaler or an
2338
out-of-state prescription drug wholesale distributor wholesaler
2339
permit to the applicant.
2340
(12)(7) For a permit permits for a prescription drug
2341
wholesale distributor wholesalers or an out-of-state prescription
2342
drug wholesale distributor wholesalers:
2343
(a) The department shall adopt rules for the annual renewal
2344
of permits. At least 90 days before the expiration of a permit,
2345
the department shall forward a permit renewal notification and
2346
renewal application to the prescription drug wholesale
2347
distributor wholesaler or out-of-state prescription drug
2348
wholesale distributor wholesaler at the mailing address of the
2349
permitted establishment on file with the department. The permit
2350
renewal notification must state conspicuously the date on which
2351
the permit for the establishment will expire and that the
2352
establishment may not operate unless the permit for the
2353
establishment is renewed timely.
2354
(b) A permit, unless sooner suspended or revoked,
2355
automatically expires 1 year after the last day of the
2356
anniversary month in which the permit was originally issued. A
2357
permit may be renewed by making application for renewal on forms
2358
furnished by the department and paying the appropriate fees. If a
2359
renewal application and fee are submitted and postmarked after 45
2360
days prior to the expiration date of the permit, the permit may
2361
be renewed only upon payment of a late renewal fee of $100, plus
2362
the required renewal fee. A permittee that has submitted a
2363
renewal application in accordance with this paragraph may
2364
continue to operate under its permit, unless the permit is
2365
suspended or revoked, until final disposition of the renewal
2366
application.
2367
(c) Failure to renew a permit in accordance with this
2368
section precludes any future renewal of that permit. If a permit
2369
issued pursuant to this section has expired and cannot be
2370
renewed, before an establishment may engage in activities that
2372
establishment must submit an application for a new permit; pay
2373
the applicable application fee, initial permit fee, and all
2374
applicable penalties; and be issued a new permit by the
2375
department.
2376
(13)(8) A person that engages in wholesale distribution of
2377
prescription drugs in this state must have a wholesale
2378
distributor's permit issued by the department, except as noted in
2379
this section. Each establishment must be separately permitted
2380
except as noted in this subsection.
2381
(a) A separate establishment permit is not required when a
2382
permitted prescription drug wholesale distributor wholesaler
2383
consigns a prescription drug to a pharmacy that is permitted
2384
under chapter 465 and located in this state, provided that:
2385
1. The consignor wholesale distributor wholesaler notifies
2386
the department in writing of the contract to consign prescription
2387
drugs to a pharmacy along with the identity and location of each
2388
consignee pharmacy;
2389
2. The pharmacy maintains its permit under chapter 465;
2390
3. The consignor wholesale distributor wholesaler, which
2391
has no legal authority to dispense prescription drugs, complies
2392
with all wholesale distribution requirements of ss. s. 499.0121
2393
and 499.01212 with respect to the consigned drugs and maintains
2394
records documenting the transfer of title or other completion of
2395
the wholesale distribution of the consigned prescription drugs;
2396
4. The distribution of the prescription drug is otherwise
2397
lawful under this chapter and other applicable law;
2398
5. Open packages containing prescription drugs within a
2399
pharmacy are the responsibility of the pharmacy, regardless of
2400
how the drugs are titled; and
2401
6. The pharmacy dispenses the consigned prescription drug
2402
in accordance with the limitations of its permit under chapter
2403
465 or returns the consigned prescription drug to the consignor
2404
wholesale distributor wholesaler. In addition, a person who holds
2405
title to prescription drugs may transfer the drugs to a person
2406
permitted or licensed to handle the reverse distribution or
2407
destruction of drugs. Any other distribution by and means of the
2408
consigned prescription drug by any person, not limited to the
2409
consignor wholesale distributor wholesaler or consignee pharmacy,
2410
to any other person is prohibited.
2411
(b) A wholesale distributor's permit is not required for
2412
the one-time transfer of title of a pharmacy's lawfully acquired
2413
prescription drug inventory by a pharmacy with a valid permit
2414
issued under chapter 465 to a consignor prescription drug
2415
wholesale distributor wholesaler, permitted under this chapter,
2416
in accordance with a written consignment agreement between the
2417
pharmacy and that wholesale distributor wholesaler if: the
2418
permitted pharmacy and the permitted prescription drug wholesale
2419
distributor wholesaler comply with all of the provisions of
2420
paragraph (a) and the prescription drugs continue to be within
2421
the permitted pharmacy's inventory for dispensing in accordance
2422
with the limitations of the pharmacy permit under chapter 465. A
2423
consignor drug wholesale distributor wholesaler may not use the
2424
pharmacy as a wholesale distributor through which it distributes
2425
the prescription legend drugs to other pharmacies. Nothing in
2426
this section is intended to prevent a wholesale drug distributor
2427
from obtaining this inventory in the event of nonpayment by the
2428
pharmacy.
2429
(c) The department shall require information from each
2430
wholesale distributor as part of the permit and renewal of such
2431
permit, as required under s. 499.01 or this section.
2432
(14)(9) Personnel employed in wholesale distribution must
2433
have appropriate education and experience to enable them to
2434
perform their duties in compliance with state permitting
2435
requirements.
2436
(15)(10) The name of a permittee or establishment on a
2437
prescription drug wholesale distributor wholesaler permit or an
2438
out-of-state prescription drug wholesale distributor wholesaler
2439
permit may not include any indicia of attainment of any
2440
educational degree, any indicia that the permittee or
2441
establishment possesses a professional license, or any name or
2442
abbreviation that the department determines is likely to cause
2443
confusion or mistake or that the department determines is
2444
deceptive, including that of any other entity authorized to
2445
purchase prescription drugs.
2446
(16)(11)(a) Each establishment that is issued an initial or
2447
renewal permit as a prescription drug wholesale distributor
2448
wholesaler or an out-of-state prescription drug wholesale
2449
distributor wholesaler must designate in writing to the
2450
department at least one natural person to serve as the designated
2451
representative of the wholesale distributor wholesaler. Such
2452
person must have an active certification as a designated
2453
representative from the department.
2454
(b) To be certified as a designated representative, a
2455
natural person must:
2456
1. Submit an application on a form furnished by the
2457
department and pay the appropriate fees;
2458
2. Be at least 18 years of age;
2459
3. Have not less than 2 years of verifiable full-time work
2460
experience in a pharmacy licensed in this state or another state,
2461
where the person's responsibilities included, but were not
2462
limited to, recordkeeping for prescription drugs, or have not
2463
less than 2 years of verifiable full-time managerial experience
2464
with a prescription drug wholesale distributor wholesaler
2465
licensed in this state or in another state;
2466
4. Receive a passing score of at least 75 percent on an
2467
examination given by the department regarding federal laws
2468
governing distribution of prescription drugs and this part ss.
2470
the wholesale distribution of prescription drugs. This
2471
requirement shall be effective 1 year after the results of the
2472
initial examination are mailed to the persons that took the
2473
examination. The department shall offer such examinations at
2474
least four times each calendar year; and
2475
5. Provide the department with a personal information
2476
statement and fingerprints pursuant to subsection (9)(4).
2477
(c) The department may deny an application for
2478
certification as a designated representative or may suspend or
2479
revoke a certification of a designated representative pursuant to
2480
s. 499.067.
2481
(d) A designated representative:
2482
1. Must be actively involved in and aware of the actual
2483
daily operation of the wholesale distributor.
2484
2. Must be employed full time in a managerial position by
2485
the wholesale distributor.
2486
3. Must be physically present at the establishment during
2487
normal business hours, except for time periods when absent due to
2488
illness, family illness or death, scheduled vacation, or other
2489
authorized absence.
2490
4. May serve as a designated representative for only one
2491
wholesale distributor at any one time.
2492
(e) A wholesale distributor must notify the department when
2493
a designated representative leaves the employ of the wholesale
2494
distributor. Such notice must be provided to the department
2495
within 10 business days after the last day of designated
2496
representative's employment with the wholesale distributor.
2497
(f) A wholesale distributor may not operate under a
2498
prescription drug wholesale distributor wholesaler permit or an
2499
out-of-state prescription drug wholesale distributor wholesaler
2500
permit for more than 10 business days after the designated
2501
representative leaves the employ of the wholesale distributor,
2502
unless the wholesale distributor employs another designated
2503
representative and notifies the department within 10 business
2504
days of the identity of the new designated representative.
2505
Section 12. Section 499.01201, Florida Statutes, is amended
2506
to read:
2507
499.01201 Agency for Health Care Administration review and
2508
use of statute and rule violation or compliance
2509
data.--Notwithstanding any other provisions of law to the
2510
contrary, the Agency for Health Care Administration may not:
2511
(1) Review or use any violation or alleged violation of s.
2513
sections that section, as a ground for denying or withholding any
2514
payment of a Medicaid reimbursement to a pharmacy licensed under
2515
chapter 465; or
2516
(2) Review or use compliance with s. 499.0121(6) or s.
2517
499.01212, or any rules adopted under those sections that
2518
section, as the subject of any audit of Medicaid-related records
2519
held by a pharmacy licensed under chapter 465.
2520
Section 13. Section 499.0121, Florida Statutes, is amended,
2521
and subsection (4) of section 499.013, Florida Statutes, is
2522
redesignated as paragraph (d) of subsection (6) of that section
2523
and amended, to read:
2524
499.0121 Storage and handling of prescription drugs;
2525
recordkeeping.--The department shall adopt rules to implement
2526
this section as necessary to protect the public health, safety,
2527
and welfare. Such rules shall include, but not be limited to,
2528
requirements for the storage and handling of prescription drugs
2529
and for the establishment and maintenance of prescription drug
2530
distribution records.
2531
(1) ESTABLISHMENTS.--An establishment at which prescription
2532
drugs are stored, warehoused, handled, held, offered, marketed,
2533
or displayed must:
2534
(a) Be of suitable size and construction to facilitate
2535
cleaning, maintenance, and proper operations;
2536
(b) Have storage areas designed to provide adequate
2537
lighting, ventilation, temperature, sanitation, humidity, space,
2538
equipment, and security conditions;
2539
(c) Have a quarantine area for storage of prescription
2540
drugs that are outdated, damaged, deteriorated, misbranded, or
2541
adulterated, or that are in immediate or sealed, secondary
2542
containers that have been opened;
2543
(d) Be maintained in a clean and orderly condition; and
2544
(e) Be free from infestation by insects, rodents, birds, or
2545
vermin of any kind.
2546
(2) SECURITY.--
2547
(a) An establishment that is used for wholesale drug
2548
distribution must be secure from unauthorized entry.
2549
1. Access from outside the premises must be kept to a
2550
minimum and be well-controlled.
2551
2. The outside perimeter of the premises must be well-
2552
lighted.
2553
3. Entry into areas where prescription drugs are held must
2554
be limited to authorized personnel.
2555
(b) An establishment that is used for wholesale drug
2556
distribution must be equipped with:
2557
1. An alarm system to detect entry after hours; however,
2558
the department may exempt by rule establishments that only hold a
2559
permit as prescription drug wholesale distributor-brokers
2560
wholesaler-brokers and establishments that only handle medical
2561
oxygen; and
2562
2. A security system that will provide suitable protection
2563
against theft and diversion. When appropriate, the security
2564
system must provide protection against theft or diversion that is
2565
facilitated or hidden by tampering with computers or electronic
2566
records.
2567
(c) Any vehicle that contains prescription drugs must be
2568
secure from unauthorized access to the prescription drugs in the
2569
vehicle.
2570
(3) STORAGE.--All prescription drugs shall be stored at
2571
appropriate temperatures and under appropriate conditions in
2572
accordance with requirements, if any, in the labeling of such
2573
drugs, or with requirements in the official compendium.
2574
(a) If no storage requirements are established for a
2575
prescription drug, the drug may be held at "controlled" room
2576
temperature, as defined in the official compendium, to help
2577
ensure that its identity, strength, quality, and purity are not
2578
adversely affected.
2579
(b) Appropriate manual, electromechanical, or electronic
2580
temperature and humidity recording equipment, devices, or logs
2581
must be used to document proper storage of prescription drugs.
2582
(c) The recordkeeping requirements in subsection (6) must
2583
be followed for all stored prescription drugs.
2584
(4) EXAMINATION OF MATERIALS AND RECORDS.--
2585
(a) Upon receipt, each outside shipping container must be
2586
visually examined for identity and to prevent the acceptance of
2587
contaminated prescription drugs that are otherwise unfit for
2588
distribution. This examination must be adequate to reveal
2589
container damage that would suggest possible contamination or
2590
other damage to the contents.
2591
(b) Each outgoing shipment must be carefully inspected for
2592
identity of the prescription drug products and to ensure that
2593
there is no delivery of prescription drugs that have expired or
2594
been damaged in storage or held under improper conditions.
2595
(c) The recordkeeping requirements in subsection (6) must
2596
be followed for all incoming and outgoing prescription drugs.
2597
(d) Upon receipt, a wholesale distributor wholesaler must
2598
review records required under this section for the acquisition of
2599
prescription drugs for accuracy and completeness, considering the
2600
total facts and circumstances surrounding the transactions and
2601
the wholesale distributors involved. This includes authenticating
2602
each transaction listed on a pedigree paper, as defined in s.
2604
(5) RETURNED, DAMAGED, OR OUTDATED PRESCRIPTION DRUGS.--
2605
(a)1. Prescription drugs that are outdated, damaged,
2606
deteriorated, misbranded, or adulterated must be quarantined and
2607
physically separated from other prescription drugs until they are
2608
destroyed or returned to their supplier. A quarantine section
2609
must be separate and apart from other sections where prescription
2610
drugs are stored so that prescription drugs in this section are
2611
not confused with usable prescription drugs.
2612
2. Prescription drugs must be examined at least every 12
2613
months, and drugs for which the expiration date has passed must
2614
be removed and quarantined.
2615
(b) Any prescription drugs of which the immediate or sealed
2616
outer containers or sealed secondary containers have been opened
2617
or used must be identified as such and must be quarantined and
2618
physically separated from other prescription drugs until they are
2619
either destroyed or returned to the supplier.
2620
(c) If the conditions under which a prescription drug has
2621
been returned cast doubt on the drug's safety, identity,
2622
strength, quality, or purity, the drug must be destroyed or
2623
returned to the supplier, unless examination, testing, or other
2624
investigation proves that the drug meets appropriate standards of
2625
safety, identity, strength, quality, and purity. In determining
2626
whether the conditions under which a drug has been returned cast
2627
doubt on the drug's safety, identity, strength, quality, or
2628
purity, the wholesale drug distributor must consider, among other
2629
things, the conditions under which the drug has been held,
2630
stored, or shipped before or during its return and the conditions
2631
of the drug and its container, carton, or labeling, as a result
2632
of storage or shipping.
2633
(d) The recordkeeping requirements in subsection (6) must
2634
be followed for all outdated, damaged, deteriorated, misbranded,
2635
or adulterated prescription drugs.
2636
(6) RECORDKEEPING.--The department shall adopt rules that
2637
require keeping such records of prescription drugs as are
2638
necessary for the protection of the public health.
2639
(a) Wholesale drug distributors must establish and maintain
2640
inventories and records of all transactions regarding the receipt
2641
and distribution or other disposition of prescription drugs.
2642
These records must provide a complete audit trail from receipt to
2643
sale or other disposition, be readily retrievable for inspection,
2644
and include, at a minimum, the following information:
2645
1. The source of the drugs, including the name and
2646
principal address of the seller or transferor, and the address of
2647
the location from which the drugs were shipped;
2648
2. The name, principal address, and state license permit or
2649
registration number of the person authorized to purchase
2650
prescription drugs;
2651
3. The name, strength, dosage form, and quantity of the
2652
drugs received and distributed or disposed of;
2653
4. The dates of receipt and distribution or other
2654
disposition of the drugs; and
2655
5. Any financial documentation supporting the transaction.
2656
(b) Inventories and records must be made available for
2657
inspection and photocopying by authorized federal, state, or
2658
local officials for a period of 2 years following disposition of
2659
the drugs or 3 years after the creation of the records, whichever
2660
period is longer.
2661
(c) Records described in this section that are kept at the
2662
inspection site or that can be immediately retrieved by computer
2663
or other electronic means must be readily available for
2664
authorized inspection during the retention period. Records that
2665
are kept at a central location outside of this state and that are
2666
not electronically retrievable must be made available for
2667
inspection within 2 working days after a request by an authorized
2668
official of a federal, state, or local law enforcement agency.
2669
Records that are maintained at a central location within this
2670
state must be maintained at an establishment that is permitted
2672
available.
2673
(d)(4) Each manufacturer or repackager of medical devices,
2674
over-the-counter drugs, or cosmetics must maintain records that
2675
include the name and principal address of the seller or
2676
transferor of the product, the address of the location from which
2677
the product was shipped, the date of the transaction, the name
2678
and quantity of the product involved, and the name and principal
2679
address of the person who purchased the product.
2680
(e) A wholesale distributor must maintain pedigree papers
2681
separate and distinct from other records required under this
2682
chapter.
2683
(d)1. Effective July 1, 2006, each person who is engaged in
2684
the wholesale distribution of a prescription drug and who is not
2685
the manufacturer of that drug must, before each wholesale
2686
distribution of such drug, provide to the person who receives the
2687
drug a pedigree paper as defined in s. 499.003(31).
2688
2. A repackager must comply with this paragraph.
2689
3. The pedigree paper requirements in this paragraph do not
2690
apply to compressed medical gases or veterinary legend drugs.
2691
4. Each wholesale distributor of prescription drugs must
2692
maintain separate and distinct from other required records all
2693
statements that are required under subparagraph 1.
2694
5. Subparagraph 1. is satisfied when a wholesale
2695
distributor takes title to, but not possession of, a prescription
2696
drug and the prescription drug's manufacturer ships the
2697
prescription drug directly to a person authorized by law to
2698
purchase prescription drugs for the purpose of administering or
2699
dispensing the drug, as defined in s. 465.003, or a member of an
2700
affiliated group, as described in paragraph (f), with the
2701
exception of a repackager.
2702
a. The wholesale distributor must deliver to the recipient
2703
of the prescription drug, within 14 days after the shipment
2704
notification from the manufacturer, an invoice and the following
2705
sworn statement: "This wholesale distributor purchased the
2706
specific unit of the prescription drug listed on the invoice
2707
directly from the manufacturer, and the specific unit of
2708
prescription drug was shipped by the manufacturer directly to a
2709
person authorized by law to administer or dispense the legend
2710
drug, as defined in s. 465.003, Florida Statutes, or a member of
2711
an affiliated group, as described in s. 499.0121(6)(f), Florida
2712
Statutes, with the exception of a repackager." The invoice must
2713
contain a unique cross-reference to the shipping document sent by
2714
the manufacturer to the recipient of the prescription drug.
2715
b. The manufacturer of the prescription drug shipped
2716
directly to the recipient under this section must provide and the
2717
recipient of the prescription drug must acquire, within 14 days
2718
after receipt of the prescription drug, a shipping document from
2719
the manufacturer that contains, at a minimum:
2720
(I) The name and address of the manufacturer, including the
2721
point of origin of the shipment, and the names and addresses of
2722
the wholesaler and the purchaser.
2723
(II) The name of the prescription drug as it appears on the
2724
label.
2725
(III) The quantity, dosage form, and strength of the
2726
prescription drug.
2727
(IV) The date of the shipment from the manufacturer.
2728
c. The wholesale distributor must also maintain and make
2729
available to the department, upon request, the lot number of such
2730
drug if not contained in the shipping document acquired by the
2731
recipient.
2732
6. Failure of the manufacturer to provide, the recipient to
2733
acquire, or the wholesale distributor to deliver, the
2734
documentation required under subparagraph 5. shall constitute
2735
failure to acquire or deliver a pedigree paper under s. 499.0051.
2736
Forgery by the manufacturer, the recipient, or the wholesale
2737
distributor of the documentation required to be acquired or
2738
delivered under subparagraph 5. shall constitute forgery of a
2739
pedigree paper under s. 499.0051.
2740
7. The department may, by rule, specify alternatives to
2741
compliance with subparagraph 1. for a prescription drug in the
2742
inventory of a permitted prescription drug wholesaler as of June
2743
30, 2006, and the return of a prescription drug purchased prior
2744
to July 1, 2006. The department may specify time limits for such
2745
alternatives.
2746
(7)(e) PRESCRIPTION DRUG PURCHASE LIST.--Each wholesale
2747
distributor, except for a manufacturer, shall annually provide
2748
the department with a written list of all wholesale distributors
2749
and manufacturers from whom the wholesale distributor purchases
2750
prescription drugs. A wholesale distributor, except a
2751
manufacturer, shall notify the department not later than 10 days
2752
after any change to either list. Such portions of the information
2753
required pursuant to this subsection paragraph which are a trade
2754
secret, as defined in s. 812.081, shall be maintained by the
2755
department as trade secret information is required to be
2756
maintained under s. 499.051.
2757
(f)1. This paragraph applies only to an affiliated group,
2758
as defined by s. 1504 of the Internal Revenue Code of 1986, as
2759
amended, which is composed of chain drug entities, including at
2760
least 50 retail pharmacies, warehouses, or repackagers, which are
2761
members of the same affiliated group, if the affiliated group:
2762
a. Discloses to the department the names of all its
2763
members; and
2764
b. Agrees in writing to provide records on prescription
2765
drug purchases by members of the affiliated group not later than
2766
48 hours after the department requests such records, regardless
2767
of the location where the records are stored.
2768
2. Each warehouse within the affiliated group must comply
2769
with all applicable federal and state drug wholesale permit
2770
requirements and must purchase, receive, hold, and distribute
2771
prescription drugs only to a retail pharmacy or warehouse within
2772
the affiliated group. Such a warehouse is exempt from providing a
2773
pedigree paper in accordance with paragraph (d) to its affiliated
2774
group member warehouse or retail pharmacy, provided that:
2775
a. Any affiliated group member that purchases or receives a
2776
prescription drug from outside the affiliated group must receive
2777
a pedigree paper if the prescription drug is distributed in or
2778
into this state and a pedigree paper is required under this
2779
section and must authenticate the documentation as required in
2780
subsection (4), regardless of whether the affiliated group member
2781
is directly subject to regulation under this chapter; and
2782
b. The affiliated group makes available to the department
2783
on request all records related to the purchase or acquisition of
2784
prescription drugs by members of the affiliated group, regardless
2785
of the location where the records are stored, if the prescription
2786
drugs were distributed in or into this state.
2787
3. If a repackager repackages prescription drugs solely for
2788
distribution to its affiliated group members for the exclusive
2789
distribution to and among retail pharmacies that are members of
2790
the affiliated group to which the repackager is a member:
2791
a. The repackager must:
2792
(I) In lieu of the written statement required by paragraph
2793
(d), for all repackaged prescription drugs distributed in or into
2794
this state, state in writing under oath with each distribution of
2795
a repackaged prescription drug to an affiliated group member
2796
warehouse or repackager: "All repackaged prescription drugs are
2797
purchased by the affiliated group directly from the manufacturer
2798
or from a prescription drug wholesaler that purchased the
2799
prescription drugs directly from the manufacturer.";
2800
(II) Purchase all prescription drugs it repackages:
2801
(A) Directly from the manufacturer; or
2802
(B) From a prescription drug wholesaler that purchased the
2803
prescription drugs directly from the manufacturer; and
2804
(III) Maintain records in accordance with this section to
2805
document that it purchased the prescription drugs directly from
2806
the manufacturer or that its prescription drug wholesale supplier
2807
purchased the prescription drugs directly from the manufacturer.
2808
b. All members of the affiliated group must provide to
2809
agents of the department on request records of purchases by all
2810
members of the affiliated group of prescription drugs that have
2811
been repackaged, regardless of the location where the records are
2812
stored or where the repackager is located.
2813
(8)(7) WRITTEN POLICIES AND PROCEDURES.--Wholesale drug
2814
distributors must establish, maintain, and adhere to written
2815
policies and procedures, which must be followed for the receipt,
2816
security, storage, inventory, and distribution of prescription
2817
drugs, including policies and procedures for identifying,
2818
recording, and reporting losses or thefts, and for correcting all
2819
errors and inaccuracies in inventories. Wholesale drug
2820
distributors must include in their written policies and
2821
procedures:
2822
(a) A procedure whereby the oldest approved stock of a
2823
prescription drug product is distributed first. The procedure may
2824
permit deviation from this requirement, if the deviation is
2825
temporary and appropriate.
2826
(b) A procedure to be followed for handling recalls and
2827
withdrawals of prescription drugs. Such procedure must be
2828
adequate to deal with recalls and withdrawals due to:
2829
1. Any action initiated at the request of the Food and Drug
2830
Administration or any other federal, state, or local law
2831
enforcement or other government agency, including the department.
2832
2. Any voluntary action by the manufacturer or repackager
2833
to remove defective or potentially defective drugs from the
2834
market; or
2835
3. Any action undertaken to promote public health and
2836
safety by replacing existing merchandise with an improved product
2837
or new package design.
2838
(c) A procedure to ensure that wholesale drug distributors
2839
prepare for, protect against, and handle any crisis that affects
2840
security or operation of any facility if a strike, fire, flood,
2841
or other natural disaster, or a local, state, or national
2842
emergency, occurs.
2843
(d) A procedure to ensure that any outdated prescription
2844
drugs are segregated from other drugs and either returned to the
2845
manufacturer or repackager or destroyed. This procedure must
2846
provide for written documentation of the disposition of outdated
2847
prescription drugs. This documentation must be maintained for 2
2848
years after disposition of the outdated drugs.
2849
(9)(8) RESPONSIBLE PERSONS.--Wholesale drug distributors
2850
must establish and maintain lists of officers, directors,
2851
managers, designated representatives, and other persons in charge
2852
of wholesale drug distribution, storage, and handling, including
2853
a description of their duties and a summary of their
2854
qualifications.
2855
(10)(9) COMPLIANCE WITH FEDERAL, STATE, AND LOCAL LAW.--A
2856
wholesale drug distributor must operate in compliance with
2857
applicable federal, state, and local laws and regulations.
2858
(a) A wholesale drug distributor must allow the department
2859
and authorized federal, state, and local officials to enter and
2860
inspect its premises and delivery vehicles, and to audit its
2861
records and written operating procedures, at reasonable times and
2862
in a reasonable manner, to the extent authorized by law.
2863
(b) A wholesale drug distributor that deals in controlled
2864
substances must register with the Drug Enforcement Administration
2865
and must comply with all applicable state, local, and federal
2866
laws. A wholesale drug distributor that distributes any substance
2867
controlled under chapter 893 must notify the department when
2868
registering with the Drug Enforcement Administration pursuant to
2869
that chapter and must provide the department with its DEA number.
2870
(11)(10) SALVAGING AND REPROCESSING.--A wholesale drug
2871
distributor is subject to any applicable federal, state, or local
2872
laws or regulations that relate to prescription drug product
2873
salvaging or reprocessing.
2874
(12)(11) SHIPPING AND TRANSPORTATION.--The person
2875
responsible for shipment and transportation of a prescription
2876
drug in a wholesale distribution may use a common carrier; its
2877
own vehicle or employee acting within the scope of employment if
2878
authorized under s. 499.03 for the possession of prescription
2879
drugs in this state; or, in the case of a prescription drug
2880
intended for domestic distribution, an independent contractor who
2881
must be the agent of the authorized seller or recipient
2882
responsible for shipping and transportation as set forth in a
2883
written contract between the parties. A person selling a
2884
prescription drug for export must obtain documentation, such as a
2885
validated airway bill, bill of lading, or other appropriate
2886
documentation that the prescription drug was exported. A person
2887
responsible for shipping or transporting prescription drugs is
2888
not required to maintain documentation from a common carrier that
2889
the designated recipient received the prescription drugs;
2890
however, the person must obtain such documentation from the
2891
common carrier and make it available to the department upon
2892
request of the department.
2893
(13)(12) DUE DILIGENCE OF SUPPLIERS.--Prior to purchasing
2894
any prescription drugs from another wholesale drug distributor, a
2895
prescription drug wholesale distributor wholesaler, an out-of-
2896
state prescription drug wholesale distributor wholesaler, or a
2897
prescription drug repackager must:
2898
(a) Enter an agreement with the selling wholesale drug
2899
distributor by which the selling wholesale drug distributor will
2900
indemnify the purchasing wholesale drug distributor for any loss
2901
caused to the purchasing wholesale drug distributor related to
2902
the purchase of drugs from the selling wholesale drug distributor
2903
which are determined to be counterfeit or to have been
2904
distributed in violation of any federal or state law governing
2905
the distribution of drugs.
2906
(b) Determine that the selling wholesale drug distributor
2907
has insurance coverage of not less than the greater of 1 percent
2908
of the amount of total dollar volume of the prescription drug
2909
sales reported to the department under s. 499.012(8)(g) s.
2910
499.012(3)(g) or $500,000; however the coverage need not exceed
2911
$2 million.
2912
(c) Obtain information from the selling wholesale drug
2913
distributor, including the length of time the selling wholesale
2914
drug distributor has been licensed in this state, a copy of the
2915
selling wholesale drug distributor's licenses or permits, and
2916
background information concerning the ownership of the selling
2917
wholesale drug distributor, including the experience of the
2918
wholesale distributor in the wholesale distribution of
2919
prescription drugs.
2920
(d) Verify that the selling wholesale drug distributor's
2921
Florida permit is valid.
2922
(e) Inspect the selling wholesale drug distributor's
2923
licensed establishment to document that it has a policies and
2924
procedures manual relating to the distribution of drugs, the
2925
appropriate temperature controlled environment for drugs
2926
requiring temperature control, an alarm system, appropriate
2927
access restrictions, and procedures to ensure that records
2928
related to the wholesale distribution of prescription drugs are
2929
maintained as required by law:
2930
1. Before purchasing any drug from the wholesale drug
2931
distributor, and at least once each subsequent year; or
2932
2. Before purchasing any drug from the wholesale drug
2933
distributor, and each subsequent year obtain a complete copy of
2934
the most recent inspection report for the establishment which was
2935
prepared by the department or the regulatory authority
2936
responsible for wholesale drug distributors in the state in which
2937
the establishment is located.
2938
Section 14. Section 499.01211, Florida Statutes, is amended
2939
to read:
2940
499.01211 Drug Wholesale Distributor Wholesaler Advisory
2941
Council.--
2942
(1) There is created the Drug Wholesale Distributor
2943
Wholesaler Advisory Council within the department. The council
2944
shall meet at least once each calendar quarter. Staff for the
2945
council shall be provided by the department. The council shall
2946
consist of 11 members who shall serve without compensation. The
2947
council shall elect a chairperson and a vice chairperson
2948
annually.
2949
(2) The State Surgeon General, or his or her designee, and
2950
the Secretary of Health Care Administration, or her or his
2951
designee, shall be members of the council. The State Surgeon
2952
General shall appoint nine additional members to the council who
2953
shall be appointed to a term of 4 years each, as follows:
2954
(a) Three different persons each of whom is employed by a
2955
different prescription drug wholesale distributor wholesaler
2956
licensed under this part chapter which operates nationally and is
2957
a primary wholesale distributor wholesaler, as defined in s.
2959
(b) One person employed by a prescription drug wholesale
2960
distributor wholesaler licensed under this part chapter which is
2961
a secondary wholesale distributor wholesaler, as defined in s.
2963
(c) One person employed by a retail pharmacy chain located
2964
in this state.
2965
(d) One person who is a member of the Board of Pharmacy and
2966
is a pharmacist licensed under chapter 465.
2967
(e) One person who is a physician licensed pursuant to
2968
chapter 458 or chapter 459.
2969
(f) One person who is an employee of a hospital licensed
2970
pursuant to chapter 395 and is a pharmacist licensed pursuant to
2971
chapter 465.
2972
(g) One person who is an employee of a pharmaceutical
2973
manufacturer.
2976
annually, provide input to the department regarding all proposed
2978
recommendations to the department to improve the protection of
2979
the prescription drugs and public health, make recommendations to
2980
improve coordination with other states' regulatory agencies and
2981
the federal government concerning the wholesale distribution of
2982
drugs, and make recommendations to minimize the impact of
2983
regulation of the wholesale distribution industry while ensuring
2984
protection of the public health.
2985
Section 15. Section 499.01212, Florida Statutes, is created
2986
to read:
2987
499.01212 Pedigree paper.--
2988
(1) APPLICATION.--Each person who is engaged in the
2989
wholesale distribution of a prescription drug must, prior to or
2990
simultaneous with each wholesale distribution, provide a pedigree
2991
paper to the person who receives the drug.
2992
(2) FORMAT.--A pedigree paper must contain the following
2993
information:
2994
(a) For the wholesale distribution of a prescription drug
2995
within the normal distribution chain:
2996
1. The following statement: "This wholesale distributor
2997
purchased the specific unit of the prescription drug directly
2998
from the manufacturer."
2999
2. The name of the prescription drug as it appears on the
3000
label.
3001
3. The quantity, dosage form, and strength of the
3002
prescription drug.
3003
3004
The wholesale distributor must also maintain and make available
3005
to the department, upon request, the point of origin of the
3006
prescription drugs, including intracompany transfers, the date of
3007
the shipment from the manufacturer to the wholesale distributor,
3008
the lot numbers of such drugs, and the invoice numbers from the
3009
manufacturer.
3010
(b) For all other wholesale distributions of prescription
3011
drugs:
3012
1. The quantity, dosage form, and strength of the
3013
prescription drugs.
3014
2. The lot numbers of the prescription drugs.
3015
3. The name and address of each owner of the prescription
3016
drug and his or her signature.
3017
4. Shipping information, including the name and address of
3018
each person certifying delivery or receipt of the prescription
3019
drug.
3020
5. An invoice number, a shipping document number, or
3021
another number uniquely identifying the transaction.
3022
6. A certification that the recipient wholesale distributor
3023
has authenticated the pedigree papers.
3024
7. The unique serialization of the prescription drug, if
3025
the manufacturer or repackager has uniquely serialized the
3026
individual prescription drug unit.
3027
8. The name, address, telephone number, and, if available,
3028
e-mail contact information of each wholesale distributor involved
3029
in the chain of the prescription drug's custody.
3030
(3) EXCEPTIONS.--A pedigree paper is not required for:
3031
(a) The wholesale distribution of a prescription drug by
3032
the manufacturer.
3033
(b) The wholesale distribution of a compressed medical gas.
3034
(c) The wholesale distribution of a veterinary prescription
3035
drug.
3036
(d) A drop shipment, provided:
3037
1. The wholesale distributor delivers to the recipient of
3038
the prescription drug, within 14 days after the shipment
3039
notification from the manufacturer, an invoice and the following
3040
sworn statement: "This wholesale distributor purchased the
3041
specific unit of the prescription drug listed on the invoice
3042
directly from the manufacturer, and the specific unit of
3043
prescription drug was shipped by the manufacturer directly to a
3044
person authorized by law to administer or dispense the legend
3045
drug, as defined in s. 465.003, Florida Statutes, or a member of
3046
an affiliated group, with the exception of a repackager." The
3047
invoice must contain a unique cross-reference to the shipping
3048
document sent by the manufacturer to the recipient of the
3049
prescription drug.
3050
2. The manufacturer of the prescription drug shipped
3051
directly to the recipient provides and the recipient of the
3052
prescription drug acquires, within 14 days after receipt of the
3053
prescription drug, a shipping document from the manufacturer that
3054
contains, at a minimum:
3055
a. The name and address of the manufacturer, including the
3056
point of origin of the shipment, and the names and addresses of
3057
the wholesale distributor and the purchaser.
3058
b. The name of the prescription drug as it appears on the
3059
label.
3060
c. The quantity, dosage form, and strength of the
3061
prescription drug.
3062
d. The date of the shipment from the manufacturer.
3063
3. The wholesale distributor maintains and makes available
3064
to the department, upon request, the lot number of such drug if
3065
not contained in the shipping document acquired by the recipient.
3066
3067
Failure of the manufacturer to provide, the recipient to acquire,
3068
or the wholesale distributor to deliver the documentation
3069
required under this paragraph shall constitute failure to acquire
3071
Forgery by the manufacturer, the recipient, or the wholesale
3072
distributor of the documentation required to be acquired or
3073
delivered under this paragraph shall constitute forgery of a
3074
pedigree paper under s. 499.0051.
3075
4. The wholesale distributor that takes title to, but not
3076
possession of, the prescription drug is not a member of the
3077
affiliated group that receives the prescription drug directly
3078
from the manufacturer.
3079
(e) The wholesale distribution of a prescription drug by a
3080
warehouse within an affiliated group to a warehouse or retail
3081
pharmacy within its affiliated group, provided:
3082
1. Any affiliated group member that purchases or receives a
3083
prescription drug from outside the affiliated group must receive
3084
a pedigree paper if the prescription drug is distributed in or
3085
into this state and a pedigree paper is required under this
3086
section and must authenticate the documentation as required in s.
3087
499.0121(4), regardless of whether the affiliated group member is
3088
directly subject to regulation under this part; and
3089
2. The affiliated group makes available, within 48 hours,
3090
to the department on request to one or more of its members all
3091
records related to the purchase or acquisition of prescription
3092
drugs by members of the affiliated group, regardless of the
3093
location where the records are stored, if the prescription drugs
3094
were distributed in or into this state.
3095
(f) The repackaging of prescription drugs by a repackager
3096
solely for distribution to its affiliated group members for the
3097
exclusive distribution to and among retail pharmacies that are
3098
members of the affiliated group to which the repackager is a
3099
member.
3100
1. The repackager must:
3101
a. For all repackaged prescription drugs distributed in or
3102
into this state, state in writing under oath with each
3103
distribution of a repackaged prescription drug to an affiliated
3104
group member warehouse or repackager: "All repackaged
3105
prescription drugs are purchased by the affiliated group directly
3106
from the manufacturer or from a prescription drug wholesale
3107
distributor that purchased the prescription drugs directly from
3108
the manufacturer."
3109
b. Purchase all prescription drugs it repackages:
3110
(I) Directly from the manufacturer; or
3111
(II) From a prescription drug wholesale distributor that
3112
purchased the prescription drugs directly from the manufacturer.
3113
c. Maintain records in accordance with this section to
3114
document that it purchased the prescription drugs directly from
3115
the manufacturer or that its prescription drug wholesale supplier
3116
purchased the prescription drugs directly from the manufacturer.
3117
2. All members of the affiliated group must provide, within
3118
48 hours, to agents of the department on request to one or more
3119
of its members records of purchases by all members of the
3120
affiliated group of prescription drugs that have been repackaged,
3121
regardless of the location at which the records are stored or at
3122
which the repackager is located.
3123
Section 16. Section 499.0122, Florida Statutes, is
3124
repealed.
3125
Section 17. Section 499.013, Florida Statutes, is repealed.
3126
Section 18. Subsections (1), (3), (4), (6), (8), and (9) of
3127
section 499.015, Florida Statutes, are amended to read:
3128
499.015 Registration of drugs, devices, and cosmetics;
3129
issuance of certificates of free sale.--
3130
(1)(a) Except for those persons exempted from the
3132
person who manufactures, packages, repackages, labels, or
3133
relabels a drug, device, or cosmetic in this state must register
3134
such drug, device, or cosmetic biennially with the department;
3135
pay a fee in accordance with the fee schedule provided by s.
3136
499.041; and comply with this section. The registrant must list
3137
each separate and distinct drug, device, or cosmetic at the time
3138
of registration.
3139
(b) The department may not register any product that does
3140
not comply with the Federal Food, Drug, and Cosmetic Act, as
3141
amended, or Title 21 C.F.R. Registration of a product by the
3142
department does not mean that the product does in fact comply
3143
with all provisions of the Federal Food, Drug, and Cosmetic Act,
3144
as amended.
3145
(3) Except for those persons exempted from the definition
3147
not sell any product that he or she has failed to register in
3148
conformity with this section. Such failure to register subjects
3149
such drug, device, or cosmetic product to seizure and
3151
subjects such person to the penalties and remedies provided in
3153
(4) Unless a registration is renewed, it expires 2 years
3154
after the last day of the month in which it was issued. The
3155
department may issue a stop-sale notice or order against a person
3156
that is subject to the requirements of this section and that
3157
fails to comply with this section within 31 days after the date
3158
the registration expires. The notice or order shall prohibit such
3159
person from selling or causing to be sold any drugs, devices, or
3161
she complies with the requirements of this section.
3162
(6) The department may issue a certificate of free sale for
3163
any product that is required to be registered under this part ss.
3165
(8) Notwithstanding any requirements set forth in this part
3167
registered with the federal Food and Drug Administration is
3168
exempt from this section and s. 499.041(6) if:
3169
(a) The manufacturer's medical devices are approved for
3170
marketing by, or listed with the federal Food and Drug
3171
Administration in accordance with federal law for commercial
3172
distribution; or
3173
(b) The manufacturer subcontracts with a manufacturer of
3174
medical devices to manufacture components of such devices.
3175
(9) However, the manufacturer must submit evidence of such
3176
registration, listing, or approval with its initial application
3177
for a permit to do business in this state, as required in s.
3179
submitted at the time of renewal of the permit. Evidence of
3180
approval, listing, and registration by the federal Food and Drug
3181
Administration must include:
3182
(a) For Class II devices, a copy of the pre-market
3183
notification letter (510K);
3184
(b) For Class III devices, a Federal Drug Administration
3185
pre-market approval number;
3186
(c) For a manufacturer who subcontracts with a manufacturer
3187
of medical devices to manufacture components of such devices, a
3188
Federal Drug Administration registration number; or
3189
(d) For a manufacturer of medical devices whose devices are
3190
exempt from pre-market approval by the Federal Drug
3191
Administration, a Federal Drug Administration registration
3192
number.
3193
Section 19. Subsections (3), (5), and (6) of section
3194
499.024, Florida Statutes, are amended to read:
3195
499.024 Drug product classification.--The State Surgeon
3196
General shall adopt rules to classify drug products intended for
3197
use by humans which the United States Food and Drug
3198
Administration has not classified in the federal act or the Code
3199
of Federal Regulations.
3200
(3) Any product that falls under the definition of drug in
3202
under the authority of this section. This section does not
3203
subject portable emergency oxygen inhalators to classification;
3204
however, this section does not exempt any person from ss. 499.01
3205
and 499.015.
3206
(5) The department may by rule reclassify drugs subject to
3208
necessary to protect the public health.
3209
(6) The department may adopt rules that exempt from any
3210
labeling or packaging requirements of this part ss. 499.001-
3211
499.081 drugs classified under this section if those requirements
3212
are not necessary to protect the public health.
3213
Section 20. Subsections (7), (12), and (15) of section
3214
499.028, Florida Statutes, are amended to read:
3215
499.028 Drug samples or complimentary drugs; starter packs;
3216
permits to distribute.--
3217
(7) A drug manufacturer or distributor must report to the
3218
department any conviction of itself or of its assigns, agents,
3219
employees, or representatives for a violation of s. 503(c)(1) of
3221
the sale, purchase, or trade of a drug sample or the offer to
3222
sell, purchase, or trade a drug sample.
3223
(12) The department may suspend or revoke a permit issued
3224
under this section, after giving notice and an opportunity to be
3225
heard pursuant to chapter 120, when:
3226
(a) Such permit was obtained by misrepresentation or fraud
3227
or through a mistake of the department.
3228
(b) The holder of the permit has distributed or disposed of
3229
any prescription legend drug, directly or through its agents,
3230
employees, or independent contractors, to any person not
3231
authorized to possess such drug.
3232
(c) The holder of the permit, or its agents, employees, or
3233
independent contractors, has distributed or possessed any
3234
prescription legend drug except in the usual course of its
3235
business.
3236
(d) The holder of the permit, or its agents, employees, or
3237
independent contractors, has distributed any prescription legend
3238
drug that is misbranded or adulterated under this part ss.
3240
(e) The holder of the permit, or its agents, employees, or
3241
independent contractors, has distributed any prescription legend
3242
drug without written request, when a written request is required
3243
by this section.
3244
(f) The holder of the permit has in its employ, or uses as
3245
agent or independent contractor for the purpose of distributing
3246
or disposing of drugs, any person who has:
3247
1. Violated the requirements of this section or any rule
3248
adopted under this section.
3249
2. Been convicted in any of the courts of this state, the
3250
United States, or any other state of a felony or any other crime
3251
involving moral turpitude or involving those drugs named or
3252
described in chapter 893.
3253
(15) A person may not possess a prescription drug sample
3254
unless:
3255
(a) The drug sample was prescribed to her or him as
3256
evidenced by the label required in s. 465.0276(5).
3257
(b) She or he is the employee of a complimentary drug
3258
distributor that holds a permit issued under this part ss.
3260
(c) She or he is a person to whom prescription drug samples
3261
may be distributed pursuant to this section.
3262
(d) He or she is an officer or employee of a federal,
3263
state, or local government acting within the scope of his or her
3264
employment.
3265
Section 21. Subsections (2) and (3) of section 499.029,
3266
Florida Statutes, are amended to read:
3267
499.029 Cancer Drug Donation Program.--
3268
(2) There is created a Cancer Drug Donation Program within
3269
the department of Health for the purpose of authorizing and
3270
facilitating the donation of cancer drugs and supplies to
3271
eligible patients.
3272
(3) As used in this section:
3273
(a) "Cancer drug" means a prescription drug that has been
3274
approved under s. 505 of the federal Food, Drug, and Cosmetic Act
3275
and is used to treat cancer or its side effects or is used to
3276
treat the side effects of a prescription drug used to treat
3277
cancer or its side effects. "Cancer drug" does not include a
3278
substance listed in Schedule II, Schedule III, Schedule IV, or
3279
Schedule V of s. 893.03.
3280
(b) "Closed drug delivery system" means a system in which
3281
the actual control of the unit-dose medication package is
3282
maintained by the facility rather than by the individual patient.
3283
(c) "Department" means the Department of Health.
3284
(c)(d) "Donor" means a patient or patient representative
3285
who donates cancer drugs or supplies needed to administer cancer
3286
drugs that have been maintained within a closed drug delivery
3287
system; health care facilities, nursing homes, hospices, or
3288
hospitals with closed drug delivery systems; or pharmacies, drug
3289
manufacturers, medical device manufacturers or suppliers, or
3290
wholesalers of drugs or supplies, in accordance with this
3291
section. "Donor" includes a physician licensed under chapter 458
3292
or chapter 459 who receives cancer drugs or supplies directly
3293
from a drug manufacturer, wholesale distributor drug wholesaler,
3294
or pharmacy.
3295
(d)(e) "Eligible patient" means a person who the department
3296
determines is eligible to receive cancer drugs from the program.
3297
(e)(k) "Participant facility" means a class II hospital
3298
pharmacy that has elected to participate in the program and that
3299
accepts donated cancer drugs and supplies under the rules adopted
3300
by the department for the program.
3301
(o) "Prescription drug" means a drug as defined in s.
3302
465.003(8).
3303
(f)(p) "Program" means the Cancer Drug Donation Program
3304
created by this section.
3305
(g)(q) "Supplies" means any supplies used in the
3306
administration of a cancer drug.
3307
Section 22. Subsection (1) of section 499.03, Florida
3308
Statutes, is amended to read:
3309
499.03 Possession of certain drugs without prescriptions
3310
unlawful; exemptions and exceptions.--
3311
(1) A person may not possess, or possess with intent to
3312
sell, dispense, or deliver, any habit-forming, toxic, harmful, or
3314
prescription legend drug as defined in s. 499.003(45) s.
3315
499.003(25), unless the possession of the drug has been obtained
3316
by a valid prescription of a practitioner licensed by law to
3317
prescribe the drug. However, this section does not apply to the
3318
delivery of such drugs to persons included in any of the classes
3319
named in this subsection, or to the agents or employees of such
3320
persons, for use in the usual course of their businesses or
3321
practices or in the performance of their official duties, as the
3322
case may be; nor does this section apply to the possession of
3323
such drugs by those persons or their agents or employees for such
3324
use:
3325
(a) A licensed pharmacist or any person under the licensed
3326
pharmacist's supervision while acting within the scope of the
3327
licensed pharmacist's practice;
3328
(b) A licensed practitioner authorized by law to prescribe
3329
prescription legend drugs or any person under the licensed
3330
practitioner's supervision while acting within the scope of the
3331
licensed practitioner's practice;
3332
(c) A qualified person who uses prescription legend drugs
3333
for lawful research, teaching, or testing, and not for resale;
3334
(d) A licensed hospital or other institution that procures
3335
such drugs for lawful administration or dispensing by
3336
practitioners;
3337
(e) An officer or employee of a federal, state, or local
3338
government; or
3339
(f) A person that holds a valid permit issued by the
3341
authorizes that person to possess prescription drugs.
3342
Section 23. Section 499.032, Florida Statutes, is amended
3343
to read:
3344
499.032 Phenylalanine; prescription
3345
required.--Phenylalanine restricted formula is declared to be a
3346
prescription legend drug and may be dispensed only upon the
3347
prescription of a practitioner authorized by law to prescribe
3348
prescription medicinal drugs.
3349
Section 24. Subsection (1) of section 499.033, Florida
3350
Statutes, is amended to read:
3351
499.033 Ephedrine; prescription required.--Ephedrine is
3352
declared to be a prescription drug.
3353
(1) Except as provided in subsection (2), any product that
3354
contains any quantity of ephedrine, a salt of ephedrine, an
3355
optical isomer of ephedrine, or a salt of an optical isomer of
3356
ephedrine may be dispensed only upon the prescription of a duly
3357
licensed practitioner authorized by the laws of the state to
3358
prescribe prescription medicinal drugs.
3359
Section 25. Subsections (1) and (3) of section 499.039,
3360
Florida Statutes, are amended to read:
3361
499.039 Sale, distribution, or transfer of harmful chemical
3362
substances; penalties; authority for enforcement.--It is unlawful
3363
for a person to sell, deliver, or give to a person under the age
3364
of 18 years any compound, liquid, or chemical containing toluol,
3365
hexane, trichloroethylene, acetone, toluene, ethyl acetate,
3366
methyl ethyl ketone, trichloroethane, isopropanol, methyl
3367
isobutyl ketone, ethylene glycol monomethyl ether acetate,
3368
cyclohexanone, nitrous oxide, diethyl ether, alkyl nitrites
3369
(butyl nitrite), or any similar substance for the purpose of
3370
inducing by breathing, inhaling, or ingesting a condition of
3371
intoxication or which is intended to distort or disturb the
3372
auditory, visual, or other physical or mental processes.
3373
(1) On the first violation of this section, the department
3375
violation has not caused temporary or permanent physical or
3376
mental injury to the user.
3377
(3) The department of Health shall adopt rules to implement
3378
this section.
3379
Section 26. Section 499.04, Florida Statutes, is amended to
3380
read:
3381
499.04 Fee authority.--The department may collect fees for
3382
all drug, device, and cosmetic applications, permits, product
3383
registrations, and free-sale certificates. The total amount of
3384
fees collected from all permits, applications, product
3385
registrations, and free-sale certificates must be adequate to
3386
fund the expenses incurred by the department in carrying out this
3388
establish a schedule of fees that are within the ranges provided
3389
in this section and shall adjust those fees from time to time
3390
based on the costs associated with administering this part ss.
3392
deposited into the Florida Drug, Device, and Cosmetic Trust Fund
3393
for the sole purpose of carrying out the provisions of this part
3395
Section 27. Subsections (1) through (5), (8), and (10) of
3396
section 499.041, Florida Statutes, are amended to read:
3397
499.041 Schedule of fees for drug, device, and cosmetic
3398
applications and permits, product registrations, and free-sale
3399
certificates.--
3400
(1) The department shall assess applicants requiring a
3401
manufacturing permit an annual fee within the ranges established
3402
in this section for the specific type of manufacturer.
3403
(a) The fee for a prescription drug manufacturer
3404
manufacturer's permit may not be less than $500 or more than $750
3405
annually.
3406
(b) The fee for a device manufacturer manufacturer's permit
3407
may not be less than $500 or more than $600 annually.
3408
(c) The fee for a cosmetic manufacturer manufacturer's
3409
permit may not be less than $250 or more than $400 annually.
3410
(d) The fee for an over-the-counter drug manufacturer
3411
manufacturer's permit may not be less than $300 or more than $400
3412
annually.
3413
(e) The fee for a compressed medical gas manufacturer
3414
manufacturer's permit may not be less than $400 or more than $500
3415
annually.
3416
(f) The fee for a prescription drug repackager repackager's
3417
permit may not be less than $500 or more than $750 annually.
3418
(g) A manufacturer may not be required to pay more than one
3419
fee per establishment to obtain an additional manufacturing
3420
permit, but each manufacturer must pay the highest fee applicable
3421
to his or her operation in each establishment.
3422
(2) The department shall assess an applicant that is
3423
required to have a wholesaling permit an annual fee within the
3424
ranges established in this section for the specific type of
3425
wholesaling.
3426
(a) The fee for a prescription drug wholesale distributor
3427
wholesaler's permit may not be less than $300 or more than $800
3428
annually.
3429
(b) The fee for a compressed medical gas wholesale
3430
distributor wholesaler's permit may not be less than $200 or more
3431
than $300 annually.
3432
(c) The fee for an out-of-state prescription drug wholesale
3433
distributor wholesaler's permit may not be less than $300 or more
3434
than $800 annually.
3435
(d) The fee for a nonresident prescription drug
3436
manufacturer manufacturer's permit may not be less than $300 or
3437
more than $500 annually.
3438
(e) The fee for a retail pharmacy drug wholesale
3439
distributor wholesaler's permit may not be less than $35 or more
3440
than $50 annually.
3441
(f) The fee for a freight forwarder forwarder's permit may
3442
not be less than $200 or more than $300 annually.
3443
(g) The fee for a veterinary prescription drug wholesale
3444
distributor wholesaler's permit may not be less than $300 or more
3445
than $500 annually.
3446
(h) The fee for a limited prescription drug veterinary
3447
wholesale distributor wholesaler's permit may not be less than
3448
$300 or more than $500 annually.
3449
(3) The department shall assess an applicant that is
3450
required to have a retail establishment permit an annual fee
3451
within the ranges established in this section for the specific
3452
type of retail establishment.
3453
(a) The fee for a veterinary prescription legend drug
3454
retail establishment permit may not be less than $200 or more
3455
than $300 annually.
3456
(b) The fee for a medical oxygen retail establishment
3457
permit may not be less than $200 or more than $300 annually.
3458
(4) The department shall assess an applicant that is
3459
required to have a restricted prescription drug distributor
3460
distributor's permit an annual fee of not less than $200 or more
3461
than $300.
3462
(5) In addition to the fee charged for a permit required by
3464
applicants an initial application fee of $150 for each new permit
3465
issued by the department which requires an onsite inspection.
3466
(8) The department shall assess an out-of-state
3467
prescription drug wholesale distributor wholesaler applicant or
3468
permittee an onsite inspection fee of not less than $1,000 or
3469
more than $3,000 annually, to be based on the actual cost of the
3470
inspection if an onsite inspection is performed by agents of the
3471
department.
3472
(10) The department shall assess other fees as provided in
3474
Section 28. Section 499.05, Florida Statutes, is amended;
3475
subsection (3) of section 499.013, Florida Statutes, is
3476
redesignated as paragraph (k) of subsection (1) of that section
3477
and amended; paragraph (b) of subsection (2) of section 499.0122,
3478
Florida Statutes, is redesignated as paragraph (l) of subsection
3479
(1) of that section and amended; and subsection (12) of section
3480
499.012, Florida Statutes, is redesignated as paragraph (m) of
3481
subsection (1) of that section and amended, to read:
3482
499.05 Rules.--
3483
(1) The department shall adopt rules to implement and
3485
(a) The definition of terms used in this part ss. 499.001-
3486
499.081, and used in the rules adopted under this part ss.
3488
ordinary meaning.
3489
(b) Labeling requirements for drugs, devices, and
3490
cosmetics.
3491
(c) The establishment of fees authorized in this part ss.
3493
(d) The identification of permits that require an initial
3494
application and onsite inspection or other prerequisites for
3495
permitting which demonstrate that the establishment and person
3496
are in compliance with the requirements of this part ss. 499.001-
3497
3498
(e) The application processes and forms for product
3499
registration.
3500
(f) Procedures for requesting and issuing certificates of
3501
free sale.
3502
(g) Inspections and investigations conducted under s.
3503
499.051, and the identification of information claimed to be a
3504
trade secret and exempt from the public records law as provided
3505
in s. 499.051(7).
3506
(h) The establishment of a range of penalties, as provided
3508
the potential impact of a violation of this part ss. 499.001-
3509
499.081; and a process for the uncontested settlement of alleged
3510
violations.
3511
(i) Additional conditions that qualify as an emergency
3513
(j) Procedures and forms relating to the pedigree paper
3514
requirement of s. 499.01212.
3515
(k)(3) The department may adopt such rules as are necessary
3516
for The protection of the public health, safety, and welfare
3517
regarding good manufacturing practices that manufacturers and
3518
repackagers must follow to ensure the safety of the products.
3519
(l)(b) The department shall adopt rules relating to
3520
Information required from each retail establishment pursuant to
3522
prescriptions or orders.
3523
(m)(12) The department may adopt rules governing The
3524
recordkeeping, storage, and handling with respect to each of the
3525
distributions of prescription drugs specified in s.
3526
499.003(56)(a)-(d) subparagraphs (1)(a)1.-4.
3527
(n) Alternatives to compliance with s. 499.01212 for a
3528
prescription drug in the inventory of a permitted prescription
3529
drug wholesale distributor as of June 30, 2006, and the return of
3530
a prescription drug purchased prior to July 1, 2006. The
3531
department may specify time limits for such alternatives.
3532
(2) With respect to products in interstate commerce, those
3533
rules must not be inconsistent with rules and regulations of
3534
federal agencies unless specifically otherwise directed by the
3535
Legislature.
3536
(3) The department shall adopt rules regulating
3537
recordkeeping for and the storage, handling, and distribution of
3538
medical devices and over-the-counter drugs to protect the public
3539
from adulterated products.
3540
Section 29. Section 499.051, Florida Statutes, is amended
3541
to read:
3542
499.051 Inspections and investigations.--
3543
(1) The agents of the department of Health and of the
3544
Department of Law Enforcement, after they present proper
3545
identification, may inspect, monitor, and investigate any
3547
during business hours for the purpose of enforcing this part ss.
3549
department that protect the public health, safety, and welfare.
3550
(2) In addition to the authority set forth in subsection
3551
(1), the department and any duly designated officer or employee
3552
of the department may enter and inspect any other establishment
3553
for the purpose of determining compliance with this part ss.
3555
regarding any drug, device, or cosmetic product.
3556
(3) Any application for a permit or product registration or
3557
for renewal of such permit or registration made pursuant to this
3559
sections constitutes permission for any entry or inspection of
3560
the premises in order to verify compliance with this part those
3561
sections and rules; to discover, investigate, and determine the
3562
existence of compliance; or to elicit, receive, respond to, and
3563
resolve complaints and violations.
3564
(4) Any application for a permit made pursuant to s.
3566
section those sections constitutes permission for agents of the
3567
department of Health and the Department of Law Enforcement, after
3568
presenting proper identification, to inspect, review, and copy
3569
any financial document or record related to the manufacture,
3570
repackaging, or distribution of a drug as is necessary to verify
3572
adopted by the department to administer this part those sections,
3573
in order to discover, investigate, and determine the existence of
3574
compliance, or to elicit, receive, respond to, and resolve
3575
complaints and violations.
3576
(5) The authority to inspect under this section includes
3577
the authority to access, review, and copy any and all financial
3578
documents related to the activity of manufacturing, repackaging,
3579
or distributing prescription drugs.
3580
(6) The authority to inspect under this section includes
3581
the authority to secure:
3582
(a) Samples or specimens of any drug, device, or cosmetic;
3583
or
3584
(b) Such other evidence as is needed for any action to
3586
this part those sections.
3587
(7) The complaint and all information obtained pursuant to
3588
the investigation by the department are confidential and exempt
3589
from the provisions of s. 119.07(1) and s. 24(a), Art. I of the
3590
State Constitution until the investigation and the enforcement
3591
action are completed. However, trade secret information contained
3592
therein as defined by s. 812.081(1)(c) shall remain confidential
3593
and exempt from the provisions of s. 119.07(1) and s. 24(a), Art.
3594
I of the State Constitution, as long as the information is
3595
retained by the department. This subsection does not prohibit the
3596
department from using such information for regulatory or
3597
enforcement proceedings under this chapter or from providing such
3598
information to any law enforcement agency or any other regulatory
3599
agency. However, the receiving agency shall keep such records
3600
confidential and exempt as provided in this subsection. In
3601
addition, this subsection is not intended to prevent compliance
3603
pedigree papers required in that section subsection shall not be
3604
deemed a trade secret.
3605
Section 30. Section 499.052, Florida Statutes, is amended
3606
to read:
3607
499.052 Records of interstate shipment.--For the purpose of
3609
interstate commerce and persons receiving drugs, devices, or
3610
cosmetics in interstate commerce must, upon the request, in the
3611
manner set out below, by an officer or employee duly designated
3612
by the department, permit the officer or employee to have access
3613
to and to copy all records showing the movement in interstate
3614
commerce of any drug, device, or cosmetic, and the quantity,
3615
shipper, and consignee thereof.
3616
Section 31. Subsection (4) of section 499.055, Florida
3617
Statutes, is amended to read:
3618
499.055 Reports and dissemination of information by
3619
department.--
3620
(4) The department shall publish on the department's
3621
website and update at least monthly:
3622
(a) A list of the prescription drug wholesale distributors
3623
wholesalers, out-of-state prescription drug wholesale
3624
distributors wholesalers, and retail pharmacy drug wholesale
3625
distributors wholesalers against whom the department has
3626
initiated enforcement action pursuant to this part ss. 499.001-
3627
499.081 to suspend or revoke a permit, seek an injunction, or
3628
otherwise file an administrative complaint and the permit number
3629
of each such wholesale distributor wholesaler.
3630
(b) A list of the prescription drug wholesale distributors
3631
wholesalers, out-of-state prescription drug wholesale
3632
distributors wholesalers, and retail pharmacy drug wholesale
3633
distributors wholesalers to which the department has issued a
3634
permit, including the date on which each permit will expire.
3635
(c) A list of the prescription drug wholesale distributor
3636
wholesalers, out-of-state prescription drug wholesale distributor
3637
wholesalers, and retail pharmacy drug wholesale distributor
3638
wholesalers' permits that have been returned to the department,
3639
were suspended, were revoked, have expired, or were not renewed
3640
in the previous year.
3641
Section 32. Subsections (1) and (3) of section 499.06,
3642
Florida Statutes, are amended to read:
3643
499.06 Embargoing, detaining, or destroying article or
3644
processing equipment which is in violation of law or rule.--
3645
(1) When a duly authorized agent of the department finds,
3646
or has probable cause to believe, that any drug, device, or
3647
cosmetic is in violation of any provision of this part ss.
3649
so as to be dangerous, unwholesome, or fraudulent within the
3651
enforce a stop-sale, stop-use, removal, or hold order, which
3652
order gives notice that such article or processing equipment is,
3653
or is suspected of being, in violation and has been detained or
3654
embargoed, and which order warns all persons not to remove, use,
3655
or dispose of such article or processing equipment by sale or
3656
otherwise until permission for removal, use, or disposal is given
3657
by such agent or the court. It is unlawful for any person to
3658
remove, use, or dispose of such detained or embargoed article or
3659
processing equipment by sale or otherwise without such
3660
permission; and such act is a felony of the second degree,
3662
(3) If the court finds that the detained or embargoed
3663
article or processing equipment is in violation, such article or
3664
processing equipment shall, after entry of the court order, be
3665
destroyed or made sanitary at the expense of the claimant
3666
thereof, under the supervision of such agent; and all court
3667
costs, fees, and storage and other proper expenses shall be taxed
3668
against the claimant of such article or processing equipment or
3669
her or his agent. However, when the violation can be corrected by
3670
proper labeling of the article or sanitizing of the processing
3671
equipment, and after such costs, fees, and expenses have been
3672
paid and a good and sufficient bond, conditioned that such
3673
article be so labeled or processed or such processing equipment
3674
be so sanitized, has been executed, the court may by order direct
3675
that such article or processing equipment be delivered to the
3676
claimant thereof for such labeling, processing, or sanitizing,
3677
under the supervision of an agent of the department. The expense
3678
of such supervision shall be paid by the claimant. Such bond
3679
shall be returned to the claimant of the article or processing
3680
equipment upon representation to the court by the department that
3681
the article or processing equipment is no longer in violation of
3683
supervision have been paid.
3684
Section 33. Section 499.062, Florida Statutes, is amended;
3685
section 499.063, Florida Statutes, is redesignated as section (2)
3686
of that section and amended; and section 499.064, Florida
3687
Statutes, is redesignated as paragraphs (a) and (b) of subsection
3688
(2) of that section and amended, to read:
3689
499.062 Cause for Seizure and condemnation of drugs,
3690
devices, or cosmetics.--
3691
(1) Any article of any drug, device, or cosmetic that is
3693
subject to seizure and condemnation by the department or by its
3694
duly authorized agents designated for that purpose in regard to
3695
drugs, devices, or cosmetics.
3696
(2)499.063 Seizure; procedure; prohibition on sale or
3697
disposal of article; penalty.--Whenever a duly authorized officer
3698
or employee of the department finds cause, or has probable cause
3699
to believe that cause exists, for the seizure of any drug,
3701
he or she shall affix to the article a tag, stamp, or other
3702
appropriate marking, giving notice that the article is, or is
3703
suspected of being, subject to seizure under this part ss.
3705
by the department. Such officer or employee shall also warn all
3706
persons not to remove or dispose of the article, by sale or
3707
otherwise, until permission is given by the department or the
3708
court. Any person who violates this subsection section is guilty
3709
of a felony of the second degree, punishable as provided in s.
3711
(a)499.064 Condemnation and sale; release of seized
3712
article.--(1) When any article detained or seized under this
3713
subsection s. 499.063 has been found by the department to be
3714
subject to seizure and condemnation under s. 499.063, the
3715
department shall petition the court for an order of condemnation
3716
or sale, as the court directs. The proceeds of the sale of drugs,
3717
devices, and cosmetics, less the legal costs and charges, shall
3718
be deposited into the Florida Drug, Device, and Cosmetic Trust
3719
Fund.
3720
(b)(2) If the department finds that any article seized
3721
under this subsection s. 499.063 was not subject to seizure under
3722
that section, the department or the designated officer or
3723
employee shall remove the tag or marking.
3724
Section 34. Section 499.065, Florida Statutes, is amended
3725
to read:
3726
499.065 Inspections; imminent danger.--
3727
(1) Notwithstanding s. 499.051, the department shall
3728
inspect each prescription drug wholesale distributor
3729
establishment, prescription drug repackager establishment,
3730
veterinary prescription drug wholesale distributor establishment,
3731
limited prescription drug veterinary wholesale distributor
3732
wholesaler establishment, and retail pharmacy drug wholesale
3733
distributor wholesaler establishment that is required to be
3734
permitted under this part chapter as often as necessary to ensure
3735
compliance with applicable laws and rules. The department shall
3736
have the right of entry and access to these facilities at any
3737
reasonable time.
3738
(2) To protect the public from prescription drugs that are
3739
adulterated or otherwise unfit for human or animal consumption,
3740
the department may examine, sample, seize, and stop the sale or
3741
use of prescription drugs to determine the condition of those
3742
drugs. The department may immediately seize and remove any
3743
prescription drugs if the State Surgeon General or his or her
3744
designee determines that the prescription drugs represent a
3745
threat to the public health. The owner of any property seized
3746
under this section may, within 10 days after the seizure, apply
3747
to a court of competent jurisdiction for whatever relief is
3748
appropriate. At any time after 10 days, the department may
3749
destroy the drugs as contraband.
3750
(3) The department may determine that a prescription drug
3751
wholesale distributor establishment, prescription drug repackager
3752
establishment, veterinary prescription drug wholesale distributor
3753
establishment, limited prescription drug veterinary wholesale
3754
distributor wholesaler establishment, or retail pharmacy drug
3755
wholesale distributor wholesaler establishment that is required
3756
to be permitted under this part chapter is an imminent danger to
3757
the public health and shall require its immediate closure if the
3758
establishment fails to comply with applicable laws and rules and,
3759
because of the failure, presents an imminent threat to the
3760
public's health, safety, or welfare. Any establishment so deemed
3761
and closed shall remain closed until allowed by the department or
3762
by judicial order to reopen.
3763
(4) For purposes of this section, a refusal to allow entry
3764
to the department for inspection at reasonable times, or a
3765
failure or refusal to provide the department with required
3766
documentation for purposes of inspection, constitutes an imminent
3767
danger to the public health.
3768
Section 35. Subsections (1) through (4) of section 499.066,
3769
Florida Statutes, are amended to read:
3770
499.066 Penalties; remedies.--In addition to other
3771
penalties and other enforcement provisions:
3772
(1) The department may institute such suits or other legal
3773
proceedings as are required to enforce any provision of this part
3776
prosecution is provided, the department may provide the
3777
appropriate state attorney or other prosecuting agency having
3778
jurisdiction with respect to such prosecution with the relevant
3779
information in the department's possession.
3780
(2) If any person engaged in any activity covered by this
3782
those sections, any rule adopted under this part those sections,
3783
or a cease and desist order as provided by this part those
3784
sections, the department may obtain an injunction in the circuit
3785
court of the county in which the violation occurred or in which
3786
the person resides or has its principal place of business, and
3787
may apply in that court for such temporary and permanent orders
3788
as the department considers necessary to restrain the person from
3789
engaging in any such activities until the person complies with
3791
those sections, and the orders of the department authorized by
3792
this part those sections or to mandate compliance with this part
3794
sections, and any order or permit issued by the department under
3795
this part those sections.
3796
(3) The department may impose an administrative fine, not
3797
to exceed $5,000 per violation per day, for the violation of any
3799
this part those sections. Each day a violation continues
3800
constitutes a separate violation, and each separate violation is
3801
subject to a separate fine. All amounts collected pursuant to
3802
this section shall be deposited into the Florida Drug, Device,
3803
and Cosmetic Trust Fund and are appropriated for the use of the
3805
determining the amount of the fine to be levied for a violation,
3806
the department shall consider:
3807
(a) The severity of the violation;
3808
(b) Any actions taken by the person to correct the
3809
violation or to remedy complaints; and
3810
(c) Any previous violations.
3811
(4) The department shall deposit any rewards, fines, or
3812
collections that are due the department and which derive from
3813
joint enforcement activities with other state and federal
3815
893, or the federal act, into the Florida Drug, Device, and
3816
Cosmetic Trust Fund. The proceeds of those rewards, fines, and
3817
collections are appropriated for the use of the department in
3819
Section 36. Section 499.0661, Florida Statutes, is amended
3820
to read:
3821
499.0661 Cease and desist orders; removal of certain
3822
persons.--
3823
(1)(2) CEASE AND DESIST ORDERS.--
3824
(a) In addition to any authority otherwise provided in this
3825
chapter, the department may issue and serve a complaint stating
3826
charges upon any permittee or upon any affiliated party, whenever
3827
the department has reasonable cause to believe that the person or
3828
individual named therein is engaging in or has engaged in conduct
3829
that is:
3830
1. An act that demonstrates a lack of fitness or
3831
trustworthiness to engage in the business authorized under the
3833
hazardous to the public health, or constitutes business
3834
operations that are a detriment to the public health;
3835
2. A violation of any provision of this part ss. 499.001-
3836
3837
3. A violation of any rule of the department;
3838
4. A violation of any order of the department; or
3839
5. A breach of any written agreement with the department.
3840
(b) The complaint must contain a statement of facts and
3841
notice of opportunity for a hearing pursuant to ss. 120.569 and
3842
3843
(c) If a hearing is not requested within the time allowed
3845
department finds that any of the charges are proven, the
3846
department may enter an order directing the permittee or the
3847
affiliated party named in the complaint to cease and desist from
3848
engaging in the conduct complained of and take corrective action
3849
to remedy the effects of past improper conduct and assure future
3850
compliance.
3851
(d) A contested or default cease and desist order is
3852
effective when reduced to writing and served upon the permittee
3853
or affiliated party named therein. An uncontested cease and
3854
desist order is effective as agreed.
3855
(e) Whenever the department finds that conduct described in
3856
paragraph (a) is likely to cause an immediate threat to the
3857
public health, it may issue an emergency cease and desist order
3858
requiring the permittee or any affiliated party to immediately
3859
cease and desist from engaging in the conduct complained of and
3860
to take corrective and remedial action. The emergency order is
3861
effective immediately upon service of a copy of the order upon
3862
the permittee or affiliated party named therein and remains
3863
effective for 90 days. If the department begins nonemergency
3864
cease and desist proceedings under this subsection, the emergency
3865
order remains effective until the conclusion of the proceedings
3867
(2)(3) REMOVAL OF AFFILIATED PARTIES BY THE DEPARTMENT.--
3868
(a) The department may issue and serve a complaint stating
3869
charges upon any affiliated party and upon the permittee involved
3870
whenever the department has reason to believe that an affiliated
3871
party is engaging in or has engaged in conduct that constitutes:
3872
1. An act that demonstrates a lack of fitness or
3873
trustworthiness to engage in the business authorized under the
3875
hazardous to the public health, or constitutes business
3876
operations that are a detriment to the public health;
3878
however, if the violation constitutes a misdemeanor, a complaint
3879
may not be served as provided in this section until the
3880
affiliated party is notified in writing of the matter of the
3881
violation and has been afforded a reasonable period of time, as
3882
set forth in the notice, to correct the violation and has failed
3883
to do so;
3884
3. A violation of any other law involving fraud or moral
3885
turpitude which constitutes a felony;
3886
4. A willful violation of any rule of the department;
3887
5. A willful violation of any order of the department; or
3888
6. A material misrepresentation of fact, made knowingly and
3889
willfully or made with reckless disregard for the truth of the
3890
matter.
3891
(b) The complaint must contain a statement of facts and
3892
notice of opportunity for a hearing pursuant to ss. 120.569 and
3893
3894
(c) If a hearing is not requested within the time allotted
3896
department finds that any of the charges in the complaint are
3897
proven true, the department may enter an order removing the
3898
affiliated party or restricting or prohibiting participation by
3899
the person in the affairs of that permittee or of any other
3900
permittee.
3901
(d) A contested or default order of removal, restriction,
3902
or prohibition is effective when reduced to writing and served on
3903
the permittee and the affiliated party. An uncontested order of
3904
removal, restriction, or prohibition is effective as agreed.
3905
(e)1. The chief executive officer, designated
3906
representative, or the person holding the equivalent office, of a
3907
permittee shall promptly notify the department if she or he has
3908
actual knowledge that any affiliated party is charged with a
3909
felony in a state or federal court.
3910
2. Whenever any affiliated party is charged with a felony
3911
in a state or federal court or with the equivalent of a felony in
3912
the courts of any foreign country with which the United States
3913
maintains diplomatic relations, and the charge alleges violation
3914
of any law involving prescription drugs, pharmaceuticals, fraud,
3915
theft, or moral turpitude, the department may enter an emergency
3916
order suspending the affiliated party or restricting or
3917
prohibiting participation by the affiliated party in the affairs
3918
of the particular permittee or of any other permittee upon
3919
service of the order upon the permittee and the affiliated party
3920
charged. The order must contain notice of opportunity for a
3922
party may request a postsuspension hearing to show that continued
3923
service to or participation in the affairs of the permittee does
3924
not pose a threat to the public health or the interests of the
3925
permittee and does not threaten to impair public confidence in
3926
the permittee. In accordance with applicable departmental rules,
3927
the department shall notify the affiliated party whether the
3928
order suspending or prohibiting the person from participation in
3929
the affairs of a permittee will be rescinded or otherwise
3930
modified. The emergency order remains in effect, unless otherwise
3931
modified by the department, until the criminal charge is disposed
3932
of. The acquittal of the person charged, or the final, unappealed
3933
dismissal of all charges against the person, dissolves the
3934
emergency order but does not prohibit the department from
3935
instituting proceedings under paragraph (a). If the person
3936
charged is convicted or pleads guilty or nolo contendere, whether
3937
or not an adjudication of guilt is entered by the court, the
3938
emergency order shall become final.
3939
(f) Any affiliated party removed pursuant to this section
3940
is not eligible for reemployment by the permittee or to be an
3941
affiliated party of any permittee except upon the written consent
3942
of the department. Any affiliated party who is removed,
3943
restricted, or prohibited from participating in the affairs of a
3944
permittee pursuant to this section may petition the department
3945
for modification or termination of the removal, restriction, or
3946
prohibition.
3947
Section 37. Section 499.067, Florida Statutes, is amended
3948
to read:
3949
499.067 Denial, suspension, or revocation of permit,
3950
certification, or registration.--
3951
(1)(a) The department may deny, suspend, or revoke a permit
3952
if it finds that there has been a substantial failure to comply
3954
or chapter 893, the rules adopted under this part any of those
3955
sections or those chapters, any final order of the department, or
3956
applicable federal laws or regulations or other state laws or
3957
rules governing drugs, devices, or cosmetics.
3958
(b) The department may deny an application for a permit or
3959
certification, or suspend or revoke a permit or certification, if
3960
the department finds that:
3961
1. The applicant is not of good moral character or that it
3962
would be a danger or not in the best interest of the public
3963
health, safety, and welfare if the applicant were issued a permit
3964
or certification.
3965
2. The applicant has not met the requirements for the
3966
permit or certification.
3967
3. The applicant is not eligible for a permit or
3968
certification for any of the reasons enumerated in s. 499.012 s.
3970
4. The applicant, permittee, or person certified under s.
3973
5. The applicant, permittee, or person certified under s.
3976
(2) The department may deny, suspend, or revoke any
3977
registration required by the provisions of this part ss. 499.001-
3978
499.081 for the violation of any provision of this part ss.
3980
sections.
3981
(3) The department may revoke or suspend a permit:
3982
(a) If the permit was obtained by misrepresentation or
3983
fraud or through a mistake of the department;
3984
(b) If the permit was procured, or attempted to be
3985
procured, for any other person by making or causing to be made
3986
any false representation; or
3987
(c) If the permittee has violated any provision of this
3989
sections.
3990
(4) If any permit issued under this part ss. 499.001-
3991
499.081 is revoked or suspended, the owner, manager, operator, or
3992
proprietor of the establishment shall cease to operate as the
3993
permit authorized, from the effective date of the suspension or
3994
revocation until the person is again registered with the
3995
department and possesses the required permit. If a permit is
3996
revoked or suspended, the owner, manager, or proprietor shall
3997
remove all signs and symbols that identify the operation as
3998
premises permitted as a drug wholesaling establishment; drug,
3999
device, or cosmetic manufacturing establishment; or retail
4000
establishment. The department shall determine the length of time
4001
for which the permit is to be suspended. If a permit is revoked,
4002
the person that owns or operates the establishment may not apply
4004
of 1 year after the date of the revocation. A revocation of a
4005
permit may be permanent if the department considers that to be in
4006
the best interest of the public health.
4007
(5) The department may deny, suspend, or revoke a permit
4009
permittee to purchase prescription drugs, if any owner, officer,
4010
employee, or other person who participates in administering or
4011
operating the establishment has been found guilty of any
4013
chapter 501, or chapter 893, any rules adopted under this part
4014
any of those sections or those chapters, or any federal or state
4015
drug law, regardless of whether the person has been pardoned, had
4016
her or his civil rights restored, or had adjudication withheld.
4017
(6) The department shall deny, suspend, or revoke the
4018
permit of any person or establishment if the assignment, sale,
4019
transfer, or lease of an establishment permitted under this part
4021
action, or criminal prosecution.
4022
(7) Notwithstanding s. 120.60(5), if a permittee fails to
4024
the permit of the permittee and shall provide notice of the
4025
intended agency action by posting a notice at the department's
4026
headquarters and by mailing a copy of the notice of intended
4027
agency action by certified mail to the most recent mailing
4028
address on record with the department and, if the permittee is
4029
not a natural person, to the permittee's registered agent on file
4030
with the Department of State.
4031
Section 38. Paragraph (a) of subsection (1) of section
4032
409.9201, Florida Statutes, is amended to read:
4033
409.9201 Medicaid fraud.--
4034
(1) As used in this section, the term:
4035
(a) "Legend drug" means any drug, including, but not
4036
limited to, finished dosage forms or active ingredients that are
4037
subject to, defined by, or described by s. 503(b) of the Federal
4040
(c).
4041
4042
The value of individual items of the legend drugs or goods or
4043
services involved in distinct transactions committed during a
4044
single scheme or course of conduct, whether involving a single
4045
person or several persons, may be aggregated when determining the
4046
punishment for the offense.
4047
Section 39. Paragraph (c) of subsection (9) of section
4048
460.403, Florida Statutes, is amended to read:
4049
460.403 Definitions.--As used in this chapter, the term:
4050
(9)
4051
(c)1. Chiropractic physicians may adjust, manipulate, or
4052
treat the human body by manual, mechanical, electrical, or
4053
natural methods; by the use of physical means or physiotherapy,
4054
including light, heat, water, or exercise; by the use of
4055
acupuncture; or by the administration of foods, food
4056
concentrates, food extracts, and items for which a prescription
4057
is not required and may apply first aid and hygiene, but
4058
chiropractic physicians are expressly prohibited from prescribing
4059
or administering to any person any legend drug except as
4060
authorized under subparagraph 2., from performing any surgery
4061
except as stated herein, or from practicing obstetrics.
4062
2. Notwithstanding the prohibition against prescribing and
4063
administering legend drugs under subparagraph 1., or s.
4065
physicians may order, store, and administer, for emergency
4066
purposes only at the chiropractic physician's office or place of
4067
business, prescription medical oxygen and may also order, store,
4068
and administer the following topical anesthetics in aerosol form:
4069
a. Any solution consisting of 25 percent ethylchloride and
4070
75 percent dichlorodifluoromethane.
4071
b. Any solution consisting of 15 percent
4072
dichlorodifluoromethane and 85 percent
4073
trichloromonofluoromethane.
4074
4075
However, this paragraph does not authorize a chiropractic
4076
physician to prescribe medical oxygen as defined in chapter 499.
4077
Section 40. Subsection (3) of section 465.0265, Florida
4078
Statutes, is amended to read:
4079
465.0265 Centralized prescription filling.--
4080
(3) The filling, delivery, and return of a prescription by
4081
one pharmacy for another pursuant to this section shall not be
4082
construed as the filling of a transferred prescription as set
4083
forth in s. 465.026 or as a wholesale distribution as set forth
4085
Section 41. Section 794.075, Florida Statutes, is amended
4086
to read:
4087
794.075 Sexual predators; erectile dysfunction drugs.--
4088
(1) A person may not possess a prescription drug, as
4090
treating erectile dysfunction if the person is designated as a
4091
sexual predator under s. 775.21.
4092
(2) A person who violates a provision of this section for
4093
the first time commits a misdemeanor of the second degree,
4095
violates a provision of this section a second or subsequent time
4096
commits a misdemeanor of the first degree, punishable as provided
4098
Section 42. Paragraph (a) of subsection (1) of section
4099
895.02, Florida Statutes, is amended to read:
4101
term:
4102
(1) "Racketeering activity" means to commit, to attempt to
4103
commit, to conspire to commit, or to solicit, coerce, or
4104
intimidate another person to commit:
4105
(a) Any crime that is chargeable by indictment or
4106
information under the following provisions of the Florida
4107
Statutes:
4108
1. Section 210.18, relating to evasion of payment of
4109
cigarette taxes.
4110
2. Section 403.727(3)(b), relating to environmental
4111
control.
4113
fraud.
4114
4. Section 414.39, relating to public assistance fraud.
4116
compensation.
4117
6. Section 443.071(4), relating to creation of a fictitious
4118
employer scheme to commit unemployment compensation fraud.
4119
7. Section 465.0161, relating to distribution of medicinal
4120
drugs without a permit as an Internet pharmacy.
4123
and adulterated drugs.
4124
9. Part IV of chapter 501, relating to telemarketing.
4125
10. Chapter 517, relating to sale of securities and
4126
investor protection.
4128
to dogracing and horseracing.
4129
12. Chapter 550, relating to jai alai frontons.
4130
13. Section 551.109, relating to slot machine gaming.
4131
14. Chapter 552, relating to the manufacture, distribution,
4132
and use of explosives.
4133
15. Chapter 560, relating to money transmitters, if the
4134
violation is punishable as a felony.
4135
16. Chapter 562, relating to beverage law enforcement.
4136
17. Section 624.401, relating to transacting insurance
4137
without a certificate of authority, s. 624.437(4)(c)1., relating
4138
to operating an unauthorized multiple-employer welfare
4139
arrangement, or s. 626.902(1)(b), relating to representing or
4140
aiding an unauthorized insurer.
4141
18. Section 655.50, relating to reports of currency
4142
transactions, when such violation is punishable as a felony.
4143
19. Chapter 687, relating to interest and usurious
4144
practices.
4146
real estate timeshare plans.
4147
21. Chapter 782, relating to homicide.
4148
22. Chapter 784, relating to assault and battery.
4149
23. Chapter 787, relating to kidnapping or human
4150
trafficking.
4151
24. Chapter 790, relating to weapons and firearms.
4154
trafficking.
4155
26. Chapter 806, relating to arson.
4156
27. Section 810.02(2)(c), relating to specified burglary of
4157
a dwelling or structure.
4158
28. Chapter 812, relating to theft, robbery, and related
4159
crimes.
4160
29. Chapter 815, relating to computer-related crimes.
4161
30. Chapter 817, relating to fraudulent practices, false
4162
pretenses, fraud generally, and credit card crimes.
4163
31. Chapter 825, relating to abuse, neglect, or
4164
exploitation of an elderly person or disabled adult.
4165
32. Section 827.071, relating to commercial sexual
4166
exploitation of children.
4167
33. Chapter 831, relating to forgery and counterfeiting.
4168
34. Chapter 832, relating to issuance of worthless checks
4169
and drafts.
4170
35. Section 836.05, relating to extortion.
4171
36. Chapter 837, relating to perjury.
4172
37. Chapter 838, relating to bribery and misuse of public
4173
office.
4174
38. Chapter 843, relating to obstruction of justice.
4176
s. 847.07, relating to obscene literature and profanity.
4178
849.25, relating to gambling.
4179
41. Chapter 874, relating to criminal street gangs.
4180
42. Chapter 893, relating to drug abuse prevention and
4181
control.
4182
43. Chapter 896, relating to offenses related to financial
4183
transactions.
4185
a witness, victim, or informant, and retaliation against a
4186
witness, victim, or informant.
4188
jurors and evidence.
4189
Section 43. Paragraphs (d), (f), (h), (i), and (j) of
4190
subsection (3) of section 921.0022, Florida Statutes, are amended
4191
to read:
4192
921.0022 Criminal Punishment Code; offense severity ranking
4193
chart.--
4194
(3) OFFENSE SEVERITY RANKING CHART
4195
(d) LEVEL 4
4196
| FloridaStatute | FelonyDegree | Description |
4197
| 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. |
4198
| 499.0051(1) | 3rd | Failure to maintain or deliver pedigree papers. |
4199
| 499.0051(2) | 3rd | Failure to authenticate pedigree papers. |
4200
| 499.0051(6) | 2nd | Knowing sale or delivery, or possession with intent to sell, contraband prescription legend drugs. |
4201
| 784.07(2)(b) | 3rd | Battery of law enforcement officer, firefighter, intake officer, etc. |
4202
| 784.074(1)(c) | 3rd | Battery of sexually violent predators facility staff. |
4203
| 784.075 | 3rd | Battery on detention or commitment facility staff. |
4204
| 784.078 | 3rd | Battery of facility employee by throwing, tossing, or expelling certain fluids or materials. |
4205
| 784.08(2)(c) | 3rd | Battery on a person 65 years of age or older. |
4206
| 784.081(3) | 3rd | Battery on specified official or employee. |
4207
| 784.082(3) | 3rd | Battery by detained person on visitor or other detainee. |
4208
| 784.083(3) | 3rd | Battery on code inspector. |
4209
| 784.085 | 3rd | Battery of child by throwing, tossing, projecting, or expelling certain fluids or materials. |
4210
| 787.03(1) | 3rd | Interference with custody; wrongly takes minor from appointed guardian. |
4211
| 787.04(2) | 3rd | Take, entice, or remove child beyond state limits with criminal intent pending custody proceedings. |
4212
| 787.04(3) | 3rd | Carrying child beyond state lines with criminal intent to avoid producing child at custody hearing or delivering to designated person. |
4213
| 790.115(1) | 3rd | Exhibiting firearm or weapon within 1,000 feet of a school. |
4214
| 790.115(2)(b) | 3rd | Possessing electric weapon or device, destructive device, or other weapon on school property. |
4215
| 790.115(2)(c) | 3rd | Possessing firearm on school property. |
4216
| 800.04(7)(d) | 3rd | Lewd or lascivious exhibition; offender less than 18 years. |
4217
| 810.02(4)(a) | 3rd | Burglary, or attempted burglary, of an unoccupied structure; unarmed; no assault or battery. |
4218
| 810.02(4)(b) | 3rd | Burglary, or attempted burglary, of an unoccupied conveyance; unarmed; no assault or battery. |
4219
| 810.06 | 3rd | Burglary; possession of tools. |
4220
| 810.08(2)(c) | 3rd | Trespass on property, armed with firearm or dangerous weapon. |
4221
| 812.014(2)(c)3. | 3rd | Grand theft, 3rd degree $10,000 or more but less than $20,000. |
4222
| 812.014(2)(c)4.-10. | 3rd | Grand theft, 3rd degree, a will, firearm, motor vehicle, livestock, etc. |
4223
| 812.0195(2) | 3rd | Dealing in stolen property by use of the Internet; property stolen $300 or more. |
4224
| 817.563(1) | 3rd | Sell or deliver substance other than controlled substance agreed upon, excluding s. 893.03(5) drugs. |
4225
| 817.568(2)(a) | 3rd | Fraudulent use of personal identification information. |
4226
| 817.625(2)(a) | 3rd | Fraudulent use of scanning device or reencoder. |
4227
| 828.125(1) | 2nd | Kill, maim, or cause great bodily harm or permanent breeding disability to any registered horse or cattle. |
4228
| 837.02(1) | 3rd | Perjury in official proceedings. |
4229
| 837.021(1) | 3rd | Make contradictory statements in official proceedings. |
4230
| 838.022 | 3rd | Official misconduct. |
4231
| 839.13(2)(a) | 3rd | Falsifying records of an individual in the care and custody of a state agency. |
4232
| 839.13(2)(c) | 3rd | Falsifying records of the Department of Children and Family Services. |
4233
| 843.021 | 3rd | Possession of a concealed handcuff key by a person in custody. |
4234
| 843.025 | 3rd | Deprive law enforcement, correctional, or correctional probation officer of means of protection or communication. |
4235
| 843.15(1)(a) | 3rd | Failure to appear while on bail for felony (bond estreature or bond jumping). |
4236
| 874.05(1) | 3rd | Encouraging or recruiting another to join a criminal street gang. |
4237
| 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). |
4238
| 914.14(2) | 3rd | Witnesses accepting bribes. |
4239
| 914.22(1) | 3rd | Force, threaten, etc., witness, victim, or informant. |
4240
| 914.23(2) | 3rd | Retaliation against a witness, victim, or informant, no bodily injury. |
4241
| 918.12 | 3rd | Tampering with jurors. |
4242
| 934.215 | 3rd | Use of two-way communications device to facilitate commission of a crime. |
4243
4244
(f) LEVEL 6
4245
| FloridaStatute | FelonyDegree | Description |
4246
| 316.193(2)(b) | 3rd | Felony DUI, 4th or subsequent conviction. |
4247
| 499.0051(3) | 2nd | Knowing forgery of pedigree papers. |
4248
| 499.0051(4) | 2nd | Knowing purchase or receipt of prescription legend drug from unauthorized person. |
4249
| 499.0051(5) | 2nd | Knowing sale or transfer of prescription legend drug to unauthorized person. |
4250
| 775.0875(1) | 3rd | Taking firearm from law enforcement officer. |
4251
| 784.021(1)(a) | 3rd | Aggravated assault; deadly weapon without intent to kill. |
4252
| 784.021(1)(b) | 3rd | Aggravated assault; intent to commit felony. |
4253
| 784.041 | 3rd | Felony battery; domestic battery by strangulation. |
4254
| 784.048(3) | 3rd | Aggravated stalking; credible threat. |
4255
| 784.048(5) | 3rd | Aggravated stalking of person under 16. |
4256
| 784.07(2)(c) | 2nd | Aggravated assault on law enforcement officer. |
4257
| 784.074(1)(b) | 2nd | Aggravated assault on sexually violent predators facility staff. |
4258
| 784.08(2)(b) | 2nd | Aggravated assault on a person 65 years of age or older. |
4259
| 784.081(2) | 2nd | Aggravated assault on specified official or employee. |
4260
| 784.082(2) | 2nd | Aggravated assault by detained person on visitor or other detainee. |
4261
| 784.083(2) | 2nd | Aggravated assault on code inspector. |
4262
4263
| 790.115(2)(d) | 2nd | Discharging firearm or weapon on school property. |
4264
| 790.161(2) | 2nd | Make, possess, or throw destructive device with intent to do bodily harm or damage property. |
4265
| 790.164(1) | 2nd | False report of deadly explosive, weapon of mass destruction, or act of arson or violence to state property. |
4266
| 790.19 | 2nd | Shooting or throwing deadly missiles into dwellings, vessels, or vehicles. |
4267
| 794.011(8)(a) | 3rd | Solicitation of minor to participate in sexual activity by custodial adult. |
4268
| 794.05(1) | 2nd | Unlawful sexual activity with specified minor. |
4269
| 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. |
4270
| 800.04(6)(b) | 2nd | Lewd or lascivious conduct; offender 18 years of age or older. |
4271
| 806.031(2) | 2nd | Arson resulting in great bodily harm to firefighter or any other person. |
4272
| 810.02(3)(c) | 2nd | Burglary of occupied structure; unarmed; no assault or battery. |
4273
| 812.014(2)(b)1. | 2nd | Property stolen $20,000 or more, but less than $100,000, grand theft in 2nd degree. |
4274
| 812.014(6) | 2nd | Theft; property stolen $3,000 or more; coordination of others. |
4275
| 812.015(9)(a) | 2nd | Retail theft; property stolen $300 or more; second or subsequent conviction. |
4276
| 812.015(9)(b) | 2nd | Retail theft; property stolen $3,000 or more; coordination of others. |
4277
| 812.13(2)(c) | 2nd | Robbery, no firearm or other weapon (strong-arm robbery). |
4278
| 817.034(4)(a)1. | 1st | Communications fraud, value greater than $50,000. |
4279
| 817.4821(5) | 2nd | Possess cloning paraphernalia with intent to create cloned cellular telephones. |
4280
| 825.102(1) | 3rd | Abuse of an elderly person or disabled adult. |
4281
| 825.102(3)(c) | 3rd | Neglect of an elderly person or disabled adult. |
4282
| 825.1025(3) | 3rd | Lewd or lascivious molestation of an elderly person or disabled adult. |
4283
| 825.103(2)(c) | 3rd | Exploiting an elderly person or disabled adult and property is valued at less than $20,000. |
4284
| 827.03(1) | 3rd | Abuse of a child. |
4285
| 827.03(3)(c) | 3rd | Neglect of a child. |
4286
| 827.071(2)&(3) | 2nd | Use or induce a child in a sexual performance, or promote or direct such performance. |
4287
| 836.05 | 2nd | Threats; extortion. |
4288
| 836.10 | 2nd | Written threats to kill or do bodily injury. |
4289
| 843.12 | 3rd | Aids or assists person to escape. |
4290
| 847.0135(2) | 3rd | Facilitates sexual conduct of or with a minor or the visual depiction of such conduct. |
4291
| 914.23 | 2nd | Retaliation against a witness, victim, or informant, with bodily injury. |
4292
| 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. |
4293
| 944.40 | 2nd | Escapes. |
4294
| 944.46 | 3rd | Harboring, concealing, aiding escaped prisoners. |
4295
| 944.47(1)(a)5. | 2nd | Introduction of contraband (firearm, weapon, or explosive) into correctional facility. |
4296
| 951.22(1) | 3rd | Intoxicating drug, firearm, or weapon introduced into county facility. |
4297
4298
(h) LEVEL 8
4299
| FloridaStatute | FelonyDegree | Description |
4300
| 316.193(3)(c)3.a. | 2nd | DUI manslaughter. |
4301
| 316.1935(4)(b) | 1st | Aggravated fleeing or attempted eluding with serious bodily injury or death. |
4302
| 327.35(3)(c)3. | 2nd | Vessel BUI manslaughter. |
4303
| 499.0051(8) 499.0051(7) | 1st | Knowing forgery of prescription labels or prescription legend drug labels. |
4304
4305
| 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. |
4306
| 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. |
4307
| 655.50(10)(b)2. | 2nd | Failure to report financial transactions totaling or exceeding $20,000, but less than $100,000 by financial institutions. |
4308
| 777.03(2)(a) | 1st | Accessory after the fact, capital felony. |
4309
| 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. |
4310
| 782.051(2) | 1st | Attempted felony murder while perpetrating or attempting to perpetrate a felony not enumerated in s. 782.04(3). |
4311
| 782.071(1)(b) | 1st | Committing vehicular homicide and failing to render aid or give information. |
4312
| 782.072(2) | 1st | Committing vessel homicide and failing to render aid or give information. |
4313
| 790.161(3) | 1st | Discharging a destructive device which results in bodily harm or property damage. |
4314
| 794.011(5) | 2nd | Sexual battery, victim 12 years or over, offender does not use physical force likely to cause serious injury. |
4315
| 794.08(3) | 2nd | Female genital mutilation, removal of a victim younger than 18 years of age from this state. |
4316
| 800.04(4) | 2nd | Lewd or lascivious battery. |
4317
| 806.01(1) | 1st | Maliciously damage dwelling or structure by fire or explosive, believing person in structure. |
4318
| 810.02(2)(a) | 1st,PBL | Burglary with assault or battery. |
4319
| 810.02(2)(b) | 1st,PBL | Burglary; armed with explosives or dangerous weapon. |
4320
| 810.02(2)(c) | 1st | Burglary of a dwelling or structure causing structural damage or $1,000 or more property damage. |
4321
| 812.014(2)(a)2. | 1st | Property stolen; cargo valued at $50,000 or more, grand theft in 1st degree. |
4322
| 812.13(2)(b) | 1st | Robbery with a weapon. |
4323
| 812.135(2)(c) | 1st | Home-invasion robbery, no firearm, deadly weapon, or other weapon. |
4324
| 817.568(6) | 2nd | Fraudulent use of personal identification information of an individual under the age of 18. |
4325
| 825.102(2) | 2nd | Aggravated abuse of an elderly person or disabled adult. |
4326
| 825.1025(2) | 2nd | Lewd or lascivious battery upon an elderly person or disabled adult. |
4327
| 825.103(2)(a) | 1st | Exploiting an elderly person or disabled adult and property is valued at $100,000 or more. |
4328
| 837.02(2) | 2nd | Perjury in official proceedings relating to prosecution of a capital felony. |
4329
| 837.021(2) | 2nd | Making contradictory statements in official proceedings relating to prosecution of a capital felony. |
4330
| 860.121(2)(c) | 1st | Shooting at or throwing any object in path of railroad vehicle resulting in great bodily harm. |
4331
| 860.16 | 1st | Aircraft piracy. |
4332
| 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). |
4333
4334
4335
| 893.135(1)(a)2. | 1st | Trafficking in cannabis, more than 2,000 lbs., less than 10,000 lbs. |
4336
| 893.135(1)(b)1.b. | 1st | Trafficking in cocaine, more than 200 grams, less than 400 grams. |
4337
| 893.135(1)(c)1.b. | 1st | Trafficking in illegal drugs, more than 14 grams, less than 28 grams. |
4338
| 893.135(1)(d)1.b. | 1st | Trafficking in phencyclidine, more than 200 grams, less than 400 grams. |
4339
| 893.135(1)(e)1.b. | 1st | Trafficking in methaqualone, more than 5 kilograms, less than 25 kilograms. |
4340
| 893.135(1)(f)1.b. | 1st | Trafficking in amphetamine, more than 28 grams, less than 200 grams. |
4341
| 893.135(1)(g)1.b. | 1st | Trafficking in flunitrazepam, 14 grams or more, less than 28 grams. |
4342
| 893.135(1)(h)1.b. | 1st | Trafficking in gamma-hydroxybutyric acid (GHB), 5 kilograms or more, less than 10 kilograms. |
4343
| 893.135(1)(j)1.b. | 1st | Trafficking in 1,4-Butanediol, 5 kilograms or more, less than 10 kilograms. |
4344
| 893.135(1)(k)2.b. | 1st | Trafficking in Phenethylamines, 200 grams or more, less than 400 grams. |
4345
| 895.03(1) | 1st | Use or invest proceeds derived from pattern of racketeering activity. |
4346
| 895.03(2) | 1st | Acquire or maintain through racketeering activity any interest in or control of any enterprise or real property. |
4347
| 895.03(3) | 1st | Conduct or participate in any enterprise through pattern of racketeering activity. |
4348
| 896.101(5)(b) | 2nd | Money laundering, financial transactions totaling or exceeding $20,000, but less than $100,000. |
4349
| 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. |
4350
4351
(i) LEVEL 9
4352
| FloridaStatute | FelonyDegree | Description |
4353
| 316.193(3)(c)3.b. | 1st | DUI manslaughter; failing to render aid or give information. |
4354
| 327.35(3)(c)3.b. | 1st | BUI manslaughter; failing to render aid or give information. |
4355
| 499.0051(9) 499.00535 | 1st | Knowing sale or purchase of contraband prescription legend drugs resulting in great bodily harm. |
4356
| 560.123(8)(b)3. | 1st | Failure to report currency or payment instruments totaling or exceeding $100,000 by money transmitter. |
4357
| 560.125(5)(c) | 1st | Money transmitter business by unauthorized person, currency, or payment instruments totaling or exceeding $100,000. |
4358
| 655.50(10)(b)3. | 1st | Failure to report financial transactions totaling or exceeding $100,000 by financial institution. |
4359
| 775.0844 | 1st | Aggravated white collar crime. |
4360
| 782.04(1) | 1st | Attempt, conspire, or solicit to commit premeditated murder. |
4361
| 782.04(3) | 1st,PBL | Accomplice to murder in connection with arson, sexual battery, robbery, burglary, and other specified felonies. |
4362
| 782.051(1) | 1st | Attempted felony murder while perpetrating or attempting to perpetrate a felony enumerated in s. 782.04(3). |
4363
| 782.07(2) | 1st | Aggravated manslaughter of an elderly person or disabled adult. |
4364
| 787.01(1)(a)1. | 1st,PBL | Kidnapping; hold for ransom or reward or as a shield or hostage. |
4365
| 787.01(1)(a)2. | 1st,PBL | Kidnapping with intent to commit or facilitate commission of any felony. |
4366
| 787.01(1)(a)4. | 1st,PBL | Kidnapping with intent to interfere with performance of any governmental or political function. |
4367
| 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. |
4368
| 790.161 | 1st | Attempted capital destructive device offense. |
4369
| 790.166(2) | 1st,PBL | Possessing, selling, using, or attempting to use a weapon of mass destruction. |
4370
| 794.011(2) | 1st | Attempted sexual battery; victim less than 12 years of age. |
4371
| 794.011(2) | Life | Sexual battery; offender younger than 18 years and commits sexual battery on a person less than 12 years. |
4372
| 794.011(4) | 1st | Sexual battery; victim 12 years or older, certain circumstances. |
4373
| 794.011(8)(b) | 1st | Sexual battery; engage in sexual conduct with minor 12 to 18 years by person in familial or custodial authority. |
4374
| 794.08(2) | 1st | Female genital mutilation; victim younger than 18 years of age. |
4375
| 800.04(5)(b) | Life | Lewd or lascivious molestation; victim less than 12 years; offender 18 years or older. |
4376
| 812.13(2)(a) | 1st,PBL | Robbery with firearm or other deadly weapon. |
4377
| 812.133(2)(a) | 1st,PBL | Carjacking; firearm or other deadly weapon. |
4378
| 812.135(2)(b) | 1st | Home-invasion robbery with weapon. |
4379
| 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. |
4380
| 827.03(2) | 1st | Aggravated child abuse. |
4381
| 847.0145(1) | 1st | Selling, or otherwise transferring custody or control, of a minor. |
4382
| 847.0145(2) | 1st | Purchasing, or otherwise obtaining custody or control, of a minor. |
4383
| 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. |
4384
| 893.135 | 1st | Attempted capital trafficking offense. |
4385
| 893.135(1)(a)3. | 1st | Trafficking in cannabis, more than 10,000 lbs. |
4386
| 893.135(1)(b)1.c. | 1st | Trafficking in cocaine, more than 400 grams, less than 150 kilograms. |
4387
| 893.135(1)(c)1.c. | 1st | Trafficking in illegal drugs, more than 28 grams, less than 30 kilograms. |
4388
| 893.135(1)(d)1.c. | 1st | Trafficking in phencyclidine, more than 400 grams. |
4389
| 893.135(1)(e)1.c. | 1st | Trafficking in methaqualone, more than 25 kilograms. |
4390
| 893.135(1)(f)1.c. | 1st | Trafficking in amphetamine, more than 200 grams. |
4391
| 893.135(1)(h)1.c. | 1st | Trafficking in gamma-hydroxybutyric acid (GHB), 10 kilograms or more. |
4392
| 893.135(1)(j)1.c. | 1st | Trafficking in 1,4-Butanediol, 10 kilograms or more. |
4393
| 893.135(1)(k)2.c. | 1st | Trafficking in Phenethylamines, 400 grams or more. |
4394
| 896.101(5)(c) | 1st | Money laundering, financial instruments totaling or exceeding $100,000. |
4395
| 896.104(4)(a)3. | 1st | Structuring transactions to evade reporting or registration requirements, financial transactions totaling or exceeding $100,000. |
4396
4397
(j) LEVEL 10
4398
| FloridaStatute | FelonyDegree | Description |
4399
| 499.0051(10) 499.00545 | 1st | Knowing sale or purchase of contraband prescription legend drugs resulting in death. |
4400
| 782.04(2) | 1st,PBL | Unlawful killing of human; act is homicide, unpremeditated. |
4401
| 787.01(1)(a)3. | 1st,PBL | Kidnapping; inflict bodily harm upon or terrorize victim. |
4402
| 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. |
4403
| 782.07(3) | 1st | Aggravated manslaughter of a child. |
4404
| 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. |
4405
| 812.135(2)(a) | 1st,PBL | Home-invasion robbery with firearm or other deadly weapon. |
4406
| 876.32 | 1st | Treason against the state. |
4407
4408
Section 44. This act shall take effect July 1, 2008.
CODING: Words stricken are deletions; words underlined are additions.