Senate Bill sb2698
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Florida Senate - 2003 SB 2698
By Senator Peaden
2-1448-03
1 A bill to be entitled
2 An act relating to the Florida Drug and
3 Cosmetic Act; amending s. 499.003, F.S.;
4 providing definitions; amending s. 499.005,
5 F.S.; prohibiting the removal of a dispensing
6 label from a legend drug; prohibiting the
7 distribution of a previously dispensed legend
8 drug without authorization; prohibiting certain
9 transactions for cash; amending s. 499.006,
10 F.S.; providing that a legend drug is
11 adulterated if certain documentation cannot be
12 verified; amending s. 499.007, F.S.; revising
13 certain labeling requirements; amending s.
14 499.01, F.S.; providing permit requirements for
15 prescription drug repackagers, nonresident
16 prescription drug manufacturers, and freight
17 forwarders; authorizing the Department of
18 Health to issue certain permits to an applicant
19 at the same address as a licensed nuclear
20 pharmacy and a community pharmacy; revising
21 requirements for permit applications and
22 renewals; requiring annual renewal of certain
23 permits; amending s. 499.012, F.S.; authorizing
24 a hospital or other health care entity to
25 transfer a prescription drug to a licensed
26 repackager under certain circumstances;
27 providing certain restrictions on the sale of
28 drug acquisitions to unaffiliated wholesalers;
29 increasing the amount of the bond that must be
30 obtained by prescription drug wholesalers;
31 authorizing the Department of Health to adopt
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1 rules by which it may assess an applicant's
2 experience and financial viability; requiring
3 that applicants undergo criminal history record
4 checks; providing requirements for out-of-state
5 prescription drug wholesalers; requiring a
6 performance bond and a criminal history record
7 check; providing licensing and permitting
8 requirements for nonresident prescription drug
9 manufacturers; providing requirements for a
10 freight forwarder's permit; amending s.
11 499.0121, F.S.; providing additional
12 recordkeeping requirements; requiring certain
13 written statements; providing requirements for
14 shipping and transporting a prescription drug
15 in wholesale distribution; amending s.
16 499.0122, F.S.; providing permit requirement
17 for an establishment that refills medical
18 oxygen for an individual patient; creating s.
19 499.0123, F.S.; requiring a prescription drug
20 wholesaler to designate a representative;
21 requiring such representative to be certified
22 by the department; providing requirements for
23 certification; requiring a criminal history
24 record check amending s. 499.013, F.S.;
25 providing permit requirements for a
26 prescription drug repackager; amending s.
27 499.041, F.S.; revising the schedule of fees
28 for an application or permit; providing fees
29 for nonresident prescription drug manufacturers
30 and out-of-state prescription drug wholesalers;
31 amending s. 499.051, F.S.; requiring the
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1 department to maintain the confidentiality of
2 certain financial documents; authorizing such
3 documents to be used for regulatory or
4 enforcement proceedings; amending s. 499.066,
5 F.S.; providing for the jurisdiction of the
6 department to impose penalties and take
7 enforcement actions; amending s. 499.067, F.S.;
8 providing for the denial, suspension, or
9 revocation of a certification; specifying
10 additional grounds for such denial, suspension,
11 or revocation; specifying circumstances under
12 which the department is not required to publish
13 notice of intended agency action; amending s.
14 499.069, F.S.; providing enhanced penalties for
15 certain violations; requiring the department to
16 establish a Drug Wholesale Advisory Board;
17 providing for membership; providing duties;
18 providing for board members to be reimbursed
19 for per diem and travel expenses; providing for
20 severability; providing an effective date.
21
22 Be It Enacted by the Legislature of the State of Florida:
23
24 Section 1. Section 499.003, Florida Statutes, is
25 amended to read:
26 499.003 Definitions of terms used in ss.
27 499.001-499.081.--As used in ss. 499.001-499.081, the term:
28 (1) "Advertisement" means any representation
29 disseminated in any manner or by any means, other than by
30 labeling, for the purpose of inducing, or which is likely to
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1 induce, directly or indirectly, the purchase of drugs,
2 devices, or cosmetics.
3 (2) "Affiliated group" has the same meaning as in s.
4 1504 of the Internal Revenue Code.
5 (3) "Affiliated person" means any person who directly
6 or indirectly manages, controls, or oversees the operation of
7 a corporation or other business entity that is a permittee or
8 applicant, regardless of whether such person is a partner,
9 shareholder, owner, officer, director, agent, independent
10 contractor, or employee of the entity.
11 (4) "Applicant" means a person applying for a permit
12 or certification under ss. 499.001-499.081 in the form of a
13 sole proprietorship, corporation, partnership, or other
14 business entity, and any owner, officer, director, agent,
15 managing employee, general manager, or affiliated person, or
16 any partner or shareholder having an ownership interest equal
17 to 5 percent or more in the corporation, partnership, or other
18 business entity.
19 (5)(2) "Certificate of free sale" means a document
20 prepared by the department which certifies a drug, device, or
21 cosmetic, that is registered with the department, as one that
22 can be legally sold in the state.
23 (6)(3) "Closed pharmacy" means a pharmacy that is
24 licensed under chapter 465 and purchases prescription drugs
25 for use by a limited patient population and not for wholesale
26 distribution or sale to the public. The term does not include
27 retail pharmacies.
28 (7)(4) "Color" includes black, white, and intermediate
29 grays.
30 (8)(5) "Color additive" means a material that:
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1 (a) Is a dye pigment, or other substance, made by a
2 process of synthesis or similar artifice, or extracted,
3 isolated, or otherwise derived, with or without intermediate
4 or final change of identity from a vegetable, animal, mineral,
5 or other source; or
6 (b) When added or applied to a drug or cosmetic or to
7 the human body, or any part thereof, is capable alone, or
8 through reaction with other substances, of imparting color
9 thereto;
10
11 except that the term does not include any material which has
12 been or hereafter is exempt under the federal act.
13 (9)(6) "Compressed medical gas" means any liquefied or
14 vaporized gas that is classified as a prescription drug or
15 medical device, whether it is alone or in combination with
16 other gases.
17 (10)(7) "Cosmetic" means an article that is:
18 (a) Intended to be rubbed, poured, sprinkled, or
19 sprayed on; introduced into; or otherwise applied to the human
20 body or any part thereof for cleansing, beautifying, promoting
21 attractiveness, or altering the appearance; or
22 (b) Intended for use as a component of any such
23 article;
24
25 except that the term does not include soap.
26 (11)(8) "Counterfeit drug, counterfeit device, or
27 counterfeit cosmetic" means a drug, device, or cosmetic which,
28 or the container, seal, or labeling of which, without
29 authorization, bears the trademark, trade name, or other
30 identifying mark, imprint, or device, or any likeness thereof,
31 of a drug, device, or cosmetic manufacturer, processor,
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1 packer, or distributor other than the person that in fact
2 manufactured, processed, packed, or distributed that drug,
3 device, or cosmetic and which thereby falsely purports or is
4 represented to be the product of, or to have been packed or
5 distributed by, that other drug, device, or cosmetic
6 manufacturer, processor, packer, or distributor.
7 (12)(9) "Department" means the Department of Health.
8 (13)(10) "Device" means any instrument, apparatus,
9 implement, machine, contrivance, implant, in vitro reagent, or
10 other similar or related article, including its components,
11 parts, or accessories, which is:
12 (a) Recognized in the current edition of the United
13 States Pharmacopoeia and National Formulary, or any supplement
14 thereof,
15 (b) Intended for use in the diagnosis, cure,
16 mitigation, treatment, therapy, or prevention of disease in
17 humans or other animals, or
18 (c) Intended to affect the structure or any function
19 of the body of humans or other animals,
20
21 and which does not achieve any of its principal intended
22 purposes through chemical action within or on the body of
23 humans or other animals and which is not dependent upon being
24 metabolized for the achievement of any of its principal
25 intended purposes.
26 (14)(11) "Distribute or distribution" means to sell;
27 offer to sell; give away; transfer, whether by passage of
28 title, physical movement, or both; deliver; or offer to
29 deliver. The term does not mean to administer or dispense.
30 (15)(12) "Drug" means an article that is:
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1 (a) Recognized in the current edition of the United
2 States Pharmacopoeia and National Formulary, official
3 Homeopathic Pharmacopoeia of the United States, or any
4 supplement to any of those publications;
5 (b) Intended for use in the diagnosis, cure,
6 mitigation, treatment, therapy, or prevention of disease in
7 humans or other animals;
8 (c) Intended to affect the structure or any function
9 of the body of humans or other animals; or
10 (d) Intended for use as a component of any article
11 specified in paragraph (a), paragraph (b), or paragraph (c),
12 but does not include devices or their components, parts, or
13 accessories.
14 (16)(13) "Establishment" means a place of business at
15 one general physical location.
16 (17)(14) "Federal act" means the Federal Food, Drug,
17 and Cosmetic Act, 21 U.S.C. ss. 301 et seq.; 52 Stat. 1040 et
18 seq.
19 (18) "Freight forwarder" means a person who receives
20 legend drugs that are owned by another person and designated
21 by that person for export, and who exports those legend drugs.
22 (19)(15) "Health care entity" means a closed pharmacy
23 or any person, organization, or business entity that provides
24 diagnostic, medical, surgical, or dental treatment or care, or
25 chronic or rehabilitative care, but does not include any
26 wholesale distributor or retail pharmacy licensed under state
27 law to deal in prescription drugs.
28 (20)(16) "Immediate container" does not include
29 package liners.
30 (21)(17) "Label" means a display of written, printed,
31 or graphic matter upon the immediate container of any drug,
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1 device, or cosmetic. A requirement made by or under authority
2 of ss. 499.001-499.081 or rules adopted under those sections
3 that any word, statement, or other information appear on the
4 label is not complied with unless such word, statement, or
5 other information also appears on the outside container or
6 wrapper, if any, of the retail package of such drug, device,
7 or cosmetic or is easily legible through the outside container
8 or wrapper.
9 (22)(18) "Labeling" means all labels and other
10 written, printed, or graphic matters:
11 (a) Upon a drug, device, or cosmetic, or any of its
12 containers or wrappers; or
13 (b) Accompanying or related to such drug, device, or
14 cosmetic.
15 (23)(19) "Legend drug," "prescription drug," or
16 "medicinal drug" means any drug, including, but not limited
17 to, finished dosage forms, or active ingredients subject to,
18 defined by, or described by s. 503(b) of the Federal Food,
19 Drug, and Cosmetic Act or s. 465.003(8), s. 499.007(12), or s.
20 499.0122(1)(b) or (c).
21 (24)(20) "Manufacture" means the preparation,
22 deriving, compounding, propagation, processing, producing, or
23 fabrication of any drug, device, or cosmetic. The term
24 includes repackaging or otherwise changing the container,
25 wrapper, or labeling to further the distribution of the drug,
26 device, or cosmetic.
27 (25)(21) "Manufacturer" means a person who prepares,
28 derives, manufactures, or produces a drug, device, or
29 cosmetic. The term excludes pharmacies that are operating in
30 compliance with pharmacy practice standards as defined in
31 chapter 465 and rules adopted under that chapter.
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1 (26)(22) "New drug" means:
2 (a) Any drug the composition of which is such that the
3 drug is not generally recognized, among experts qualified by
4 scientific training and experience to evaluate the safety and
5 effectiveness of drugs, as safe and effective for use under
6 the conditions prescribed, recommended, or suggested in the
7 labeling of that drug; or
8 (b) Any drug the composition of which is such that the
9 drug, as a result of investigations to determine its safety
10 and effectiveness for use under certain conditions, has been
11 recognized for use under such conditions, but which drug has
12 not, other than in those investigations, been used to a
13 material extent or for a material time under such conditions.
14 (27)(23) "Official compendium" means the current
15 edition of the official United States Pharmacopoeia and
16 National Formulary, or any supplement thereto.
17 (28)(24) "Person" means any individual, child, joint
18 venture, syndicate, fiduciary, partnership, corporation,
19 division of a corporation, firm, trust, business trust,
20 company, estate, public or private institution, association,
21 organization, group, city, county, city and county, political
22 subdivision of this state, other governmental agency within
23 this state, and any representative, agent, or agency of any of
24 the foregoing, or any other group or combination of the
25 foregoing.
26 (29)(25) "Prepackaged drug product" means a drug that
27 originally was in finished packaged form sealed by a
28 manufacturer and that is placed in a properly labeled
29 container by a pharmacy or practitioner authorized to dispense
30 pursuant to chapter 465 for the purpose of dispensing in the
31 establishment in which the prepackaging occurred.
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1 (30)(26) "Prescription medical oxygen" means oxygen
2 USP which is a drug that can only be sold on the order or
3 prescription of a practitioner authorized by law to prescribe.
4 The label of prescription medical oxygen must comply with
5 current labeling requirements for oxygen under the Federal
6 Food, Drug, and Cosmetic Act.
7 (31)(27) "Proprietary drug," or "OTC drug," means a
8 patent or over-the-counter drug in its unbroken, original
9 package, which drug is sold to the public by, or under the
10 authority of, the manufacturer or primary distributor thereof,
11 is not misbranded under the provisions of ss. 499.001-499.081,
12 and can be purchased without a prescription.
13 (32)(28) "Veterinary prescription drug" means a legend
14 drug intended solely for veterinary use. The label of the
15 drug must bear the statement, "Caution: Federal law restricts
16 this drug to sale by or on the order of a licensed
17 veterinarian."
18 Section 2. Section 499.005, Florida Statutes, is
19 amended to read:
20 499.005 Prohibited acts.--It is unlawful for any
21 person to perform or cause the performance of any of the
22 following acts in this state:
23 (1) The manufacture, repackaging, sale, delivery, or
24 holding or offering for sale of any drug, device, or cosmetic
25 that is adulterated or misbranded or has otherwise been
26 rendered unfit for human or animal use.
27 (2) The adulteration or misbranding of any drug,
28 device, or cosmetic.
29 (3) The receipt of any drug, device, or cosmetic that
30 is adulterated or misbranded, and the delivery or proffered
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1 delivery of such drug, device, or cosmetic, for pay or
2 otherwise.
3 (4) The sale, distribution, purchase, trade, holding,
4 or offering of any drug, device, or cosmetic in violation of
5 ss. 499.001-499.081.
6 (5) The dissemination of any false or misleading
7 advertisement of a drug, device, or cosmetic.
8 (6) The refusal or constructive refusal:
9 (a) To allow the department to enter or inspect an
10 establishment in which drugs, devices, or cosmetics are
11 manufactured, processed, repackaged, sold, brokered, or held;
12 (b) To allow inspection of any record of that
13 establishment;
14 (c) To allow the department to enter and inspect any
15 vehicle that is being used to transport drugs, devices, or
16 cosmetics; or
17 (d) To allow the department to take samples of any
18 drug, device, or cosmetic.
19 (7) The giving of a false guaranty or false
20 undertaking with respect to a drug, device, or cosmetic,
21 except by a person who relied on a guaranty or undertaking to
22 the same effect signed by, and containing the name and address
23 of, the person residing in this state from whom she or he
24 received in good faith the drug, device, or cosmetic.
25 (8) Committing any act that causes a drug, device, or
26 cosmetic to be a counterfeit drug, device, or cosmetic; or
27 selling, dispensing, or holding for sale a counterfeit drug,
28 device, or cosmetic.
29 (9) The alteration, mutilation, destruction,
30 obliteration, or removal of the whole or any part of the
31 labeling of a drug, device, or cosmetic, or the doing of any
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1 other act with respect to a drug, device, or cosmetic, if the
2 act is done while the drug, device, or cosmetic is held for
3 sale and the act results in the drug, device, or cosmetic
4 being misbranded.
5 (10) Forging; counterfeiting; simulating; falsely
6 representing any drug, device, or cosmetic; or, without the
7 authority of the manufacturer, using any mark, stamp, tag,
8 label, or other identification device authorized or required
9 by rules adopted under ss. 499.001-499.081.
10 (11) The use, on the labeling of any drug or in any
11 advertisement relating to such drug, of any representation or
12 suggestion that an application of the drug is effective when
13 it is not or that the drug complies with ss. 499.001-499.081
14 when it does not.
15 (12) The possession of any drug in violation of ss.
16 499.001-499.081.
17 (13) The sale, delivery, holding, or offering for sale
18 of any self-testing kits designed to tell persons their status
19 concerning human immunodeficiency virus or acquired immune
20 deficiency syndrome or related disorders or conditions. This
21 prohibition shall not apply to home access HIV test kits
22 approved for distribution and sale by the United States Food
23 and Drug Administration.
24 (14) The purchase or receipt of a legend drug from a
25 person that is not authorized under this chapter to distribute
26 legend drugs to that purchaser or recipient.
27 (15) The sale or transfer of a legend drug to a person
28 that is not authorized under the law of the jurisdiction in
29 which the person receives the drug to purchase or possess
30 legend drugs from the person selling or transferring the
31 legend drug.
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1 (16) The purchase or receipt of a compressed medical
2 gas from a person that is not authorized under this chapter to
3 distribute compressed medical gases.
4 (17) The sale, purchase, or trade, or the offer to
5 sell, purchase, or trade, a drug sample as defined in s.
6 499.028; the distribution of a drug sample in violation of s.
7 499.028; or the failure to otherwise comply with s. 499.028.
8 (18) Failure to maintain records as required by ss.
9 499.001-499.081 and rules adopted under those sections.
10 (19) Providing the department with false or fraudulent
11 records, or making false or fraudulent statements, regarding
12 any matter within the provisions of this chapter.
13 (20) The importation of a legend drug except as
14 provided by s. 801(d) of the Federal Food, Drug, and Cosmetic
15 Act.
16 (21) The wholesale distribution of any prescription
17 drug that was:
18 (a) Purchased by a public or private hospital or other
19 health care entity; or
20 (b) Donated or supplied at a reduced price to a
21 charitable organization.
22 (22) Failure to obtain a permit or registration, or
23 operating without a valid permit when a permit or registration
24 is required by ss. 499.001-499.081 for that activity.
25 (23) Obtaining or attempting to obtain a prescription
26 drug or device by fraud, deceit, misrepresentation or
27 subterfuge, or engaging in misrepresentation or fraud in the
28 distribution of a drug or device.
29 (24) The distribution of a legend device to the
30 patient or ultimate consumer without a prescription or order
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1 from a practitioner licensed by law to use or prescribe the
2 device.
3 (25) Charging a dispensing fee for dispensing,
4 administering, or distributing a prescription drug sample.
5 (26) Removing a pharmacy's dispensing label from a
6 dispensed legend drug with the intent to further distribute
7 the legend drug.
8 (27) The knowing distribution of a previously
9 dispensed legend drug unless authorized under chapter 465 and
10 rules adopted under chapter 465.
11 (28) The failure to obtain or pass on a statement as
12 required under s. 499.0121(6)(d).
13 (29) The purchase or sale of legend drugs in a
14 wholesale transaction for cash; except through the use of a
15 funds transfer as defined in chapter 670 which is documented
16 and may be verified through a financial institution.
17 Section 3. Section 499.006, Florida Statutes, is
18 amended to read:
19 499.006 Adulterated drug or device.--A drug or device
20 is adulterated:
21 (1) If it consists in whole or in part of any filthy,
22 putrid, or decomposed substance;
23 (2) If it has been produced, prepared, packed, or held
24 under conditions whereby it could have been contaminated with
25 filth or rendered injurious to health;
26 (3) If it is a drug and the methods used in, or the
27 facilities or controls used for, its manufacture, processing,
28 packing, or holding do not conform to, or are not operated or
29 administered in conformity with, current good manufacturing
30 practices to assure that the drug meets the requirements of
31 ss. 499.001-499.081 and that the drug has the identity and
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1 strength, and meets the standard of quality and purity, which
2 it purports or is represented to possess;
3 (4) If it is a drug and its container is composed, in
4 whole or in part, of any poisonous or deleterious substance
5 which could render the contents injurious to health;
6 (5) If it is a drug and it bears or contains, for the
7 purpose of coloring only, a color additive that is unsafe
8 within the meaning of the federal act; or, if it is a color
9 additive, the intended use of which in or on drugs is for the
10 purpose of coloring only, and it is unsafe within the meaning
11 of the federal act;
12 (6) If it purports to be, or is represented as, a drug
13 the name of which is recognized in the official compendium,
14 and its strength differs from, or its quality or purity falls
15 below, the standard set forth in such compendium. The
16 determination as to strength, quality, or purity must be made
17 in accordance with the tests or methods of assay set forth in
18 such compendium, or, when such tests or methods of assay are
19 absent or inadequate, in accordance with those tests or
20 methods of assay prescribed under authority of the federal
21 act. A drug defined in the official compendium is not
22 adulterated under this subsection merely because it differs
23 from the standard of strength, quality, or purity set forth
24 for that drug in such compendium if its difference in
25 strength, quality, or purity from such standard is plainly
26 stated on its label;
27 (7) If it is not subject to subsection (6) and its
28 strength differs from, or its purity or quality falls below
29 the standard of, that which it purports or is represented to
30 possess; or
31 (8) If it is a drug:
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1 (a) With which any substance has been mixed or packed
2 so as to reduce the quality or strength of the drug; or
3 (b) For which any substance has been substituted
4 wholly or in part;.
5 (9) If it is a drug or device for which the expiration
6 date has passed; or.
7 (10) If it is a legend drug and verifiable
8 documentation does not support that it has been purchased,
9 held, sold, or distributed at all times by a person authorized
10 under federal or state law to do so.
11 Section 4. Subsection (2) of section 499.007, Florida
12 Statutes, is amended to read:
13 499.007 Misbranded drug or device.--A drug or device
14 is misbranded:
15 (2) Unless, if in package form, it bears a label
16 containing:
17 (a) The name and place of business of the manufacturer
18 or distributor; in addition, for a medicinal drug, as defined
19 in s. 499.003, the label must contain the name and place of
20 business of the manufacturer of the finished dosage form of
21 the drug. For the purpose of this paragraph, the finished
22 dosage form of a medicinal drug is that form of the drug which
23 is, or is intended to be, dispensed or administered to the
24 patient and requires no further manufacturing or processing
25 other than packaging, reconstitution, and labeling; and
26 (b) An accurate statement of the quantity of the
27 contents in terms of weight, measure, or numerical count;
28 however, under this section, reasonable variations are
29 permitted, and the department shall establish by rule
30 exemptions for small packages.
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1 A drug dispensed by filling or refilling a written or oral
2 prescription of a practitioner licensed by law to prescribe
3 such drug is exempt from the requirements of this section,
4 except subsections (1), (8), (10), and (11) and the packaging
5 requirements of subsections (6) and (7), if the drug bears a
6 label that contains the name and address of the dispenser or
7 seller, the prescription number and the date the prescription
8 was written or filled, the name of the prescriber and the name
9 of the patient, and the directions for use and cautionary
10 statements. This exemption does not apply to any drug
11 dispensed in the course of the conduct of a business of
12 dispensing drugs pursuant to diagnosis by mail or to any drug
13 dispensed in violation of subsection (12). The department
14 may, by rule, exempt drugs subject to ss. 499.062-499.064 from
15 subsection (12) if compliance with that subsection is not
16 necessary to protect the public health, safety, and welfare.
17 Section 5. Section 499.01, Florida Statutes, is
18 amended to read:
19 499.01 Permits; applications; renewal; general
20 requirements.--
21 (1) Any person that is required under ss.
22 499.001-499.081 to have a permit must apply to the department
23 on forms furnished by the department.
24 (a) A permit issued pursuant to ss. 499.001-499.081
25 may be issued only to a fictitious person registered with the
26 Division of Corporations. Each person affiliated with the
27 applicant for a permit or the permittee must be an individual
28 who is at least 18 years of age or to a corporation that is
29 registered pursuant to chapter 607 or chapter 617 and each
30 officer of which is at least 18 years of age.
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1 (b) An establishment that is a place of residence may
2 not receive a permit and may not operate under ss.
3 499.001-499.081.
4 (c) A person that applies for or renews a permit to
5 manufacture or distribute legend drugs may not use a name
6 identical to the name used by any other establishment or
7 licensed person authorized to purchase prescription drugs in
8 this state, except that a restricted drug distributor permit
9 issued to a health care entity will be issued in the name in
10 which the institutional pharmacy permit is issued and a retail
11 pharmacy drug wholesaler will be issued a permit in the name
12 of its retail pharmacy permit.
13 (d) A permit is required for each person and
14 establishment that intends to operate and prior to operating
15 operates as a:
16 1. Prescription drug manufacturer;
17 2. Prescription drug repackager;
18 3.2. Over-the-counter drug manufacturer;
19 4.3. Compressed medical gas manufacturer;
20 5.4. Device manufacturer;
21 6.5. Cosmetic manufacturer;
22 7.6. Prescription drug wholesaler;
23 8.7. Compressed medical gas wholesaler;
24 9.8. Out-of-state prescription drug wholesaler;
25 10. Nonresident prescription drug manufacturer;
26 11.9. Retail pharmacy drug wholesaler;
27 12.10. Veterinary legend drug retail establishment;
28 13.11. Medical oxygen retail establishment;
29 14.12. Complimentary drug distributor; or
30 15.13. Restricted prescription drug distributor; or.
31 16. Freight fowarder.
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1 (e) The department may not issue a permit for a
2 prescription drug manufacturer, prescription drug repackager,
3 prescription drug wholesaler, or retail pharmacy wholesaler
4 may not be issued to the address of a health care entity or to
5 a pharmacy licensed under chapter 465, except as follows. The
6 department may issue a prescription drug manufacturer permit
7 to an applicant at the same address as a licensed nuclear
8 pharmacy, which is a health care entity, for the purpose of
9 manufacturing prescription drugs used in positron emission
10 tomography or other radiopharmaceuticals as listed in a rule
11 adopted by the department pursuant to this paragraph. The
12 purpose of this exemption is to assure availability of
13 state-of-the-art pharmaceuticals that would pose a significant
14 danger to the public health if manufactured at a separate
15 establishment address from the nuclear pharmacy from which the
16 prescription drugs are dispensed. The department may also
17 issue a retail pharmacy wholesaler permit to the address of a
18 community pharmacy licensed under chapter 465 which does not
19 meet the definition of a closed pharmacy in s. 499.003.
20 (f) Notwithstanding subsection (4), a permitted person
21 in good standing may change the type of permit issued to that
22 person by completing a new application for the requested
23 permit, paying the amount of the difference in the permit fees
24 if the fee for the new permit is more than the fee for the
25 original permit, and meeting the applicable permitting
26 conditions for the new permit type. The new permit expires on
27 the expiration date of the original permit being changed. A
28 refund may not be issued if the biennial fee for the new
29 permit is less than the original permit for which a fee was
30 paid.
31
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1 (2) The department shall establish, by rule, the form
2 and content of the application to obtain or renew a permit.
3 The applicant must submit to the department with the
4 application a statement that swears or affirms that the
5 information is true and correct.
6 (a) Information that an applicant must provide
7 includes, but need not be limited to:
8 1. The name, full business address, and telephone
9 number of the applicant;
10 2. All trade or business names used by the applicant;
11 3. The address, telephone numbers, and the names of
12 contact persons for each facility used by the applicant for
13 the storage, handling, and distribution of prescription drugs;
14 4. The type of ownership or operation, such as a
15 partnership, corporation, or sole proprietorship; and
16 5. The names of the owner and the operator of the
17 establishment, including:
18 a. If an individual, the name of the individual;
19 b. If a partnership, the name of each partner and the
20 name of the partnership;
21 c. If a corporation, the name and title of each
22 corporate officer and director, the corporate names, and the
23 name of the state of incorporation;
24 d. If a sole proprietorship, the full name of the sole
25 proprietor and the name of the business entity; and
26 e. If a limited liability company, the name of each
27 member and manager;
28 f. If a parent corporation or other entity owns the
29 applicant, the names of all officers and directors of this
30 entity; and
31
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1 g.e. Any other relevant information that the
2 department requires.
3 (b) Upon approval of the application by the department
4 and payment of the required fee, the department shall issue a
5 permit to the applicant, if the applicant meets the
6 requirements of ss. 499.001-499.081 and rules adopted under
7 those sections.
8 (b)(c) Any change in information required under
9 paragraph (a) must be submitted to the department before the
10 change occurs.
11 (d) The department shall consider, at a minimum, the
12 following factors in reviewing the qualifications of persons
13 to be permitted under ss. 499.001-499.081:
14 1. The applicant's having been found guilty,
15 regardless of adjudication, in a court of this state or other
16 jurisdiction, of a violation of a law that directly relates to
17 a drug, device, or cosmetic. A plea of nolo contendere
18 constitutes a finding of guilt for purposes of this
19 subparagraph.
20 2. The applicant's having been disciplined by a
21 regulatory agency in any state for any offense that would
22 constitute a violation of ss. 499.001-499.081.
23 3. Any felony conviction of the applicant under a
24 federal, state, or local law;
25 4. The applicant's past experience in manufacturing or
26 distributing drugs, devices, or cosmetics;
27 5. The furnishing by the applicant of false or
28 fraudulent material in any application made in connection with
29 manufacturing or distributing drugs, devices, or cosmetics;
30 6. Suspension or revocation by a federal, state, or
31 local government of any permit currently or previously held by
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1 the applicant for the manufacture or distribution of any
2 drugs, devices, or cosmetics;
3 7. Compliance with permitting requirements under any
4 previously granted permits;
5 8. Compliance with requirements to maintain or make
6 available to the state permitting authority or to federal,
7 state, or local law enforcement officials those records
8 required under this section; and
9 9. Any other factors or qualifications the department
10 considers relevant to and consistent with the public health
11 and safety.
12 (3) The department shall adopt rules for the annual
13 renewal of permits established under s. 499.012, except for
14 the compressed medical gases wholesaler permit, and for the
15 biennial renewal of the compressed medical gases permit and
16 other permits established under ss. 499.001-499.081.
17 (a) The department shall renew a permit upon receipt
18 of the renewal application and renewal fee if the applicant
19 meets the requirements established under ss. 499.001-499.081
20 and the rules adopted under those sections.
21 (a)(b) A permit, unless sooner suspended or revoked,
22 automatically expires 1 year after the last day of the
23 anniversary month in which a wholesaler permit was originally
24 issued or, in the case of other permits, 2 years after the
25 last day of the anniversary month in which the permit was
26 originally issued. A permit issued under ss. 499.001-499.081
27 must be renewed by making application for renewal on forms
28 furnished by the department and paying the appropriate fees.
29 If a renewal application and fee are not submitted and
30 postmarked 90 days prior to by the expiration date of the
31 permit, the applicant must submit permit may be reinstated
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1 only upon payment of a delinquent fee of $100, plus the
2 required renewal fee, within 60 days after the expiration
3 date.
4 (b)(c) A wholesaler that does not have an active
5 permit must cease operating as a wholesaler until a valid and
6 active permit is issued to the person at that establishment.
7 Failure to renew a permit, other than a wholesaler permit in
8 accordance with this section precludes any future renewal of
9 that permit. Continuing to engage in activities that require
10 a permit under ss. 499.001-499.081 after the expiration date
11 of the permit requires a new permit application and payment of
12 an application fee, initial permit fee, and applicable
13 penalties.
14 (4) A permit issued by the department is
15 nontransferable. Each permit is valid only for the person or
16 governmental unit to which it is issued and is not subject to
17 sale, assignment, or other transfer, voluntarily or
18 involuntarily; nor is a permit valid for any establishment
19 other than the establishment for which it was originally
20 issued.
21 (a) A person permitted under ss. 499.001-499.081 must
22 notify the department before making a change of address. The
23 department shall set a change of location fee not to exceed
24 $100.
25 (b)1. An application for a new permit is required when
26 a majority of the ownership or controlling interest of a
27 permitted establishment is transferred or assigned or when a
28 lessee agrees to undertake or provide services to the extent
29 that legal liability for operation of the establishment will
30 rest with the lessee. The application for the new permit must
31
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1 be made before the date of the sale, transfer, assignment, or
2 lease.
3 2. A permittee that is authorized to distribute legend
4 drugs may transfer such drugs to the new owner or lessee under
5 subparagraph 1. only after the new owner or lessee has been
6 approved for a permit to distribute legend drugs.
7 (c) The department shall deny, suspend, or revoke the
8 permit of any person or establishment if the assignment, sale,
9 transfer, or lease of an establishment permitted under ss.
10 499.001-499.081 will avoid an administrative penalty, civil
11 action, or criminal prosecution.
12 (c)(d) If an establishment permitted under ss.
13 499.001-499.081 closes, the owner must notify the department
14 in writing before the effective date of closure and must:
15 1. Return the permit to the department;
16 2. If the permittee is authorized to distribute legend
17 drugs, indicate the disposition of such drugs, including the
18 name, address, and inventory, and provide the name and address
19 of a person to contact regarding access to records that are
20 required to be maintained under ss. 499.001-499.081. Transfer
21 of ownership of legend drugs may be made only to persons
22 authorized to possess legend drugs under ss. 499.001-499.081.
23 (5) A permit must be posted in a conspicuous place on
24 the licensed premise.
25 Section 6. Subsections (1) and (2) of section 499.012,
26 Florida Statutes, are amended to read:
27 499.012 Wholesale distribution; definitions; permits;
28 general requirements.--
29 (1) As used in this section, the term:
30
31
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1 (a) "Wholesale distribution" means distribution of
2 prescription drugs to persons other than a consumer or
3 patient, but does not include:
4 1. Any of the following activities, which is not a
5 violation of s. 499.005(21) if such activity is conducted in
6 accordance with s. 499.014:
7 a. The purchase or other acquisition by a hospital or
8 other health care entity that is a member of a group
9 purchasing organization of a prescription drug for its own use
10 from the group purchasing organization or from other hospitals
11 or health care entities that are members of that organization.
12 b. The sale, purchase, or trade of a prescription drug
13 or an offer to sell, purchase, or trade a prescription drug by
14 a charitable organization described in s. 501(c)(3) of the
15 Internal Revenue Code of 1986, as amended and revised, to a
16 nonprofit affiliate of the organization to the extent
17 otherwise permitted by law.
18 c. The sale, purchase, or trade of a prescription drug
19 or an offer to sell, purchase, or trade a prescription drug
20 among hospitals or other health care entities that are under
21 common control. For purposes of this section, "common control"
22 means the power to direct or cause the direction of the
23 management and policies of a person or an organization,
24 whether by ownership of stock, by voting rights, by contract,
25 or otherwise.
26 d. The sale, purchase, trade, or other transfer of a
27 prescription drug from or for any federal, state, or local
28 government agency or any entity eligible to purchase
29 prescription drugs at public health services prices pursuant
30 to Pub. L. No. 102-585, s. 602 to a contract provider or its
31
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1 subcontractor for eligible patients of the agency or entity
2 under the following conditions:
3 (I) The agency or entity must obtain written
4 authorization for the sale, purchase, trade, or other transfer
5 of a prescription drug under this sub-subparagraph from the
6 Secretary of Health or his or her designee.
7 (II) The contract provider or subcontractor must be
8 authorized by law to administer or dispense prescription
9 drugs.
10 (III) In the case of a subcontractor, the agency or
11 entity must be a party to and execute the subcontract.
12 (IV) A contract provider or subcontractor must
13 maintain separate and apart from other prescription drug
14 inventory any prescription drugs of the agency or entity in
15 its possession.
16 (V) The contract provider and subcontractor must
17 maintain and produce immediately for inspection all records of
18 movement or transfer of all the prescription drugs belonging
19 to the agency or entity, including, but not limited to, the
20 records of receipt and disposition of prescription drugs. Each
21 contractor and subcontractor dispensing or administering these
22 drugs must maintain and produce records documenting the
23 dispensing or administration. Records that are required to be
24 maintained include, but are not limited to, a perpetual
25 inventory itemizing drugs received and drugs dispensed by
26 prescription number or administered by patient identifier,
27 which must be submitted to the agency or entity quarterly.
28 (VI) The contract provider or subcontractor may
29 administer or dispense the prescription drugs only to the
30 eligible patients of the agency or entity or must return the
31 prescription drugs for or to the agency or entity. The
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1 contract provider or subcontractor must require proof from
2 each person seeking to fill a prescription or obtain treatment
3 that the person is an eligible patient of the agency or entity
4 and must, at a minimum, maintain a copy of this proof as part
5 of the records of the contractor or subcontractor required
6 under sub-sub-subparagraph (V).
7 (VII) In addition to the departmental inspection
8 authority set forth in s. 499.051, the establishment of the
9 contract provider and subcontractor and all records pertaining
10 to prescription drugs subject to this sub-subparagraph shall
11 be subject to inspection by the agency or entity. All records
12 relating to prescription drugs of a manufacturer under this
13 sub-subparagraph shall be subject to audit by the manufacturer
14 of those drugs, without identifying individual patient
15 information.
16 2. Any of the following activities, which is not a
17 violation of s. 499.005(21) if such activity is conducted in
18 accordance with rules established by the department:
19 a. The sale, purchase, or trade of a prescription drug
20 among federal, state, or local government health care entities
21 that are under common control and are authorized to purchase
22 such prescription drug.
23 b. The sale, purchase, or trade of a prescription drug
24 or an offer to sell, purchase, or trade a prescription drug
25 for emergency medical reasons. For purposes of this
26 sub-subparagraph, the term "emergency medical reasons"
27 includes transfers of prescription drugs by a retail pharmacy
28 to another retail pharmacy to alleviate a temporary shortage.
29 c. The transfer of a prescription drug acquired by a
30 medical director on behalf of a licensed emergency medical
31 services provider to that emergency medical services provider
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1 and its transport vehicles for use in accordance with the
2 provider's license under chapter 401.
3 d. The revocation of a sale or the return of a
4 prescription drug to the person's prescription drug wholesale
5 supplier.
6 e. The donation of a prescription drug by a health
7 care entity to a charitable organization that has been granted
8 an exemption under s. 501(c)(3) of the Internal Revenue Code
9 of 1986, as amended, and that is authorized to possess
10 prescription drugs.
11 f. The transfer of a prescription drug by a person
12 authorized to purchase or receive prescription drugs to a
13 person licensed or permitted to handle reverse distributions
14 or destruction under the laws of the jurisdiction in which the
15 person handling the reverse distribution or destruction
16 receives the drug.
17 g. The transfer of a prescription drug by a hospital
18 or other health care entity to a person licensed under this
19 chapter to repackage prescription drugs for the purpose of
20 repackaging the prescription drug for use by that hospital, or
21 other health care entity and other health care entities under
22 common control, if ownership of the prescription drug remains
23 with the hospital or other health care entity at all times. In
24 addition to the recordkeeping requirements of s. 499.0121(6),
25 the hospital or health care entity that transfers prescription
26 drugs pursuant to this sub-subparagraph must reconcile all
27 drugs transferred and returned, and resolve any discrepancies
28 in a timely manner.
29 3. The distribution of prescription drug samples by
30 manufacturers' representatives or distributors'
31 representatives conducted in accordance with s. 499.028.
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1 4. The sale, purchase, or trade of blood and blood
2 components intended for transfusion. As used in this
3 subparagraph, the term "blood" means whole blood collected
4 from a single donor and processed either for transfusion or
5 further manufacturing, and the term "blood components" means
6 that part of the blood separated by physical or mechanical
7 means.
8 5. The lawful dispensing of a prescription drug in
9 accordance with chapter 465.
10 (b) "Wholesale distributor" means any person engaged
11 in wholesale distribution of prescription drugs in or into
12 this state, including, but not limited to, manufacturers;
13 repackers; own-label distributors; jobbers; private-label
14 distributors; brokers; warehouses, including manufacturers'
15 and distributors' warehouses, chain drug warehouses, and
16 wholesale drug warehouses; independent wholesale drug traders;
17 exporters; retail pharmacies; and the agents thereof that
18 conduct wholesale distributions.
19 (c) "Retail pharmacy" means a community pharmacy
20 licensed under chapter 465 that purchases prescription drugs
21 at fair market prices and provides prescription services to
22 the public.
23 (2) The following types of wholesaler permits are
24 established:
25 (a) A prescription drug wholesaler's permit. A
26 prescription drug wholesaler is a wholesale distributor that
27 may engage in the wholesale distribution of prescription
28 drugs. A prescription drug wholesaler may not wholesale more
29 than 10 percent of its annual prescription drug acquisitions
30 in dollars, net of returns, to other prescription drug
31 wholesalers located in or outside this state which are not
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1 members of the same affiliated group. A prescription drug
2 wholesaler that submits an initial application or renewal
3 application applies to the department after October 1, 2003
4 January 1, 1993, must submit a performance bond or evidence of
5 a performance bond of $100,000 for each application $200,
6 payable to the Florida Drug, Device, and Cosmetic Trust Fund.
7 The purpose of the bond is to secure payment of any
8 administrative penalties imposed by the department, as well as
9 and any fees or costs incurred by the department, regarding
10 that permit as authorized under state law. This bond will be
11 refunded to the permittee when the permit is returned to the
12 department and the permittee ceases to engage in prescription
13 drug wholesaling activities unless the function as a business.
14 A permittee that fails to notify the department before
15 changing the address of the business, fails to notify the
16 department before closing the business pursuant to s.
17 499.01(4)(d), or fails to notify the department before a
18 change of ownership or controlling interest, or fails to
19 provide records related to the wholesale distribution of
20 prescription drugs required by s. 499.0121(6) forfeits its
21 bond. The department may adopt rules for issuing a
22 prescription drug wholesaler-broker permit to a person who
23 engages in the wholesale distribution of prescription drugs
24 and does not take physical possession of any prescription
25 drugs. The department may also adopt rules for requiring
26 additional information from initial applicants and renewal
27 applicants, and minimum standards to assess their ownership,
28 experience, and financial viability for distributing
29 prescription drugs. These rules must include, but need not be
30 limited to:
31
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1 1. Identifying information of an applicant and his or
2 her spouse, children over 18 years of age, siblings, parents,
3 siblings-in-law, and parents-in-law; and the business
4 background concerning prescription drugs for each of these
5 persons;
6 2. Designation of a representative who has
7 demonstrated, through testing and certification standards
8 established by rule, a minimum proficiency in the laws and
9 rules related to the wholesale distribution of prescription
10 drugs as set forth in s. 499.0123;
11 3. Information and supporting documentation regarding
12 the financing of the physical establishment, equipment, and
13 prescription drug inventory;
14 4. Information regarding the dollar volume of
15 prescription drug wholesaling activities of the applicant and
16 those activities as a percentage of total operations for the
17 applicant's establishment;
18 5. Information regarding the dollar volume of
19 purchases of prescription drugs directly from manufacturers;
20 and
21 6. Names and addresses of all members comprising the
22 affiliated group, if applicable.
23
24 An applicant must submit a complete set of fingerprints to the
25 department for the purpose of conducting a criminal history
26 record check of the applicant, but in the case of a
27 corporation, fingerprint cards must be submitted for the five
28 highest corporate officers and any person who participates in
29 administering or operating the prescription drug activities of
30 the applicant's establishment. The department shall submit the
31 fingerprints to the Department of Law Enforcement for a state
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1 criminal background investigation and for forwarding to the
2 Federal Bureau of Investigation for a national criminal
3 history record check. The cost of the state and national
4 criminal record check shall be borne by the applicant in
5 addition to the permit application fee. The department shall
6 adopt rules regarding the frequency of the submission of
7 fingerprints and associated fees, which may not exceed the
8 actual cost of processing by the Department of Law Enforcement
9 and Federal Bureau of Investigation.
10 (b) A compressed medical gas wholesaler's permit. A
11 compressed medical gas wholesaler is a wholesale distributor
12 that is limited to the wholesale distribution of compressed
13 medical gases to other than the consumer or patient. The
14 compressed medical gas must be in the original sealed
15 container that was purchased by that wholesaler. A compressed
16 medical gas wholesaler may not possess or engage in the
17 wholesale distribution of any prescription drug other than
18 compressed medical gases. The department shall adopt rules
19 that govern the wholesale distribution of prescription medical
20 oxygen for emergency use. With respect to the emergency use of
21 prescription medical oxygen, those rules may not be
22 inconsistent with rules and regulations of federal agencies
23 unless the Legislature specifically directs otherwise.
24 (c) An out-of-state prescription drug wholesaler's
25 permit. An out-of-state prescription drug wholesaler is a
26 wholesale distributor located outside this state which engages
27 in the wholesale distribution of prescription drugs into this
28 state and which must be permitted by the department and comply
29 with all the provisions required of a wholesale distributor
30 under ss. 499.001-499.081, except those set forth in s.
31 499.0123. An out-of-state prescription drug wholesaler may not
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1 wholesale more than 10 percent of its annual prescription drug
2 acquisitions in dollars, net of returns, to prescription drug
3 wholesalers located in or outside this state which are not
4 members of the same affiliated group. An out-of-state
5 prescription drug wholesaler that submits an initial
6 application or renewal application to the department after
7 October 1, 2003, must submit a performance bond or evidence of
8 a performance bond of $100,000 for each application, payable
9 to the Florida Drug, Device, and Cosmetic Trust Fund. The
10 purpose of the bond is to secure payment of any administrative
11 penalties imposed by the department, as well as any fees or
12 costs incurred by the department, regarding that permit as
13 authorized under state law. This bond shall be refunded to the
14 permittee when the permit is returned to the department and
15 the permittee ceases to engage in prescription drug
16 wholesaling activities, unless the permittee fails to notify
17 the department before closing the business pursuant to s.
18 499.01(4)(d), fails to notify the department before a change
19 of ownership or controlling interest, or fails to provide
20 records related to the wholesale distribution of prescription
21 drugs required by s. 499.0121(6). The department may also
22 adopt rules for requiring additional information from initial
23 applicants and renewal applicants to assess their ownership,
24 experience, and financial viability for distributing
25 prescription drugs as set forth in paragraph (a).
26 1. An applicant must submit a complete set of
27 fingerprints to the department for the purpose of conducting a
28 criminal history record check of the applicant, but in the
29 case of a corporation, fingerprint cards must be submitted for
30 the five highest corporate officers and any person who
31 participates in administering or operating the prescription
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1 drug activities of the applicant's establishment. The
2 department shall submit the fingerprints to the Department of
3 Law Enforcement for a state criminal background investigation
4 and for forwarding to the Federal Bureau of Investigation for
5 a national criminal history record check. The cost of the
6 state and national criminal record check shall be borne by the
7 applicant in addition to the permit application fee. The
8 department shall adopt rules regarding the frequency of the
9 submission of fingerprints and associated fees, which may not
10 exceed the actual cost of processing by the Department of Law
11 Enforcement and Federal Bureau of Investigation.
12 2.1. The out-of-state drug wholesaler must maintain at
13 all times a license or permit to engage in the wholesale
14 distribution of prescription drugs in compliance with laws of
15 the state in which it is a resident.
16 2. An out-of-state prescription drug wholesaler's
17 permit is not required for an intracompany sale or transfer of
18 a prescription drug from an out-of-state establishment that is
19 duly licensed as a prescription drug wholesaler, in its state
20 of residence, to a licensed prescription drug wholesaler in
21 this state, if both wholesalers are under common control. The
22 recordkeeping requirements of s. 499.0121(6) must be followed
23 for this transaction.
24 3. The department may adopt rules that allow
25 out-of-state drug wholesalers to obtain a drug wholesale
26 permit on the basis of reciprocity to the extent that an
27 out-of-state drug wholesaler:
28 a. Possesses a valid permit granted by another state
29 that has requirements comparable to those that a drug
30 wholesaler in this state must meet as prerequisites to
31 obtaining a permit under the laws of this state.
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1 b. Can show that the other state from which the
2 wholesaler holds a permit would extend reciprocal treatment
3 under its own laws to a drug wholesaler of this state.
4 (d) Nonresident prescription drug manufacturer. A
5 nonresident prescription drug manufacturer is a manufacturer
6 of prescription drugs or the distribution point for a
7 manufacturer of prescription drugs located outside this state,
8 an entity to whom an approved new drug application has been
9 issued by the Federal Drug Administration, or a contracted
10 manufacturer of the approved new drug application holder
11 located out of the United States which engages in the
12 wholesale distribution of the prescription drugs it
13 manufactures or is responsible for manufacturing into this
14 state and which must be permitted by the department and comply
15 with all the provisions required of a wholesale distributor
16 under ss. 499.001-499.081, except s. 499.0121(6)(d). A person
17 who also distributes prescription drugs that it did not
18 manufacture must also obtain an out-of-state prescription drug
19 wholesaler permit pursuant to paragraph (b) to engage in the
20 wholesale distribution of the prescription drugs manufactured
21 by another person and must comply with the requirements of an
22 out-of-state prescription drug wholesaler.
23 1. The nonresident manufacturer must comply with the
24 licensing or permitting requirements of the jurisdiction in
25 which the establishment is located and the federal act, and
26 any product wholesaled into this state must comply with ss.
27 499.001-499.081.
28 2. If a nonresident manufacturer intends to import
29 from a foreign country into this state, the nonresident
30 prescription drug manufacturer must provide to the department
31 a list identifying each prescription drug it intends to import
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1 and document approval by Federal Drug Administration for such
2 importation.
3 (e)(d) A retail pharmacy wholesaler's permit. A retail
4 pharmacy wholesaler is a retail pharmacy engaged in wholesale
5 distribution of prescription drugs within this state under the
6 following conditions:
7 1. The pharmacy must obtain a retail pharmacy
8 wholesaler's permit pursuant to ss. 499.001-499.081 and the
9 rules adopted under those sections.
10 2. The wholesale distribution activity does not exceed
11 30 percent of the total annual purchases of prescription
12 drugs. If the wholesale distribution activity exceeds the
13 30-percent maximum, the pharmacy must obtain a prescription
14 drug wholesaler's permit.
15 3. The transfer of prescription drugs that appear in
16 any schedule contained in chapter 893 is subject to chapter
17 893 and the federal Comprehensive Drug Abuse Prevention and
18 Control Act of 1970.
19 4. The transfer is between a retail pharmacy and
20 another retail pharmacy, or a Modified Class II institutional
21 pharmacy, or a health care practitioner licensed in this state
22 and authorized by law to dispense or prescribe prescription
23 drugs.
24 5. All records of sales of prescription drugs subject
25 to this section must be maintained separate and distinct from
26 other records and comply with the recordkeeping requirements
27 of ss. 499.001-499.081.
28 (f) A freight forwarder's permit. A freight
29 forwarder's permit is required for any person that engages in
30 the distribution of a legend drug as a freight forwarder or
31 transporter unless the transporter is a common carrier.
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1 1. Storage, handling, and recordkeeping of these
2 distributions must comply with the requirements for wholesale
3 distributors under s. 499.0121, except those set forth in s.
4 499.0121(6)(d). A freight forwarder must provide the source of
5 the legend drugs with a validated airway bill, bill of lading,
6 or other appropriate documentation to evidence the exportation
7 of the product.
8 2. A person who applies for a permit as a freight
9 forwarder, or for the renewal of such a permit, must provide
10 to the department the information required under s. 499.01.
11 Section 7. Subsections (4) and (6) of section
12 499.0121, Florida Statutes, are amended, and subsection (11)
13 is added to that section, to read:
14 499.0121 Storage and handling of prescription drugs;
15 recordkeeping.--The department shall adopt rules to implement
16 this section as necessary to protect the public health,
17 safety, and welfare. Such rules shall include, but not be
18 limited to, requirements for the storage and handling of
19 prescription drugs and for the establishment and maintenance
20 of prescription drug distribution records.
21 (4) EXAMINATION OF MATERIALS AND RECORDS.--
22 (a) Upon receipt, each outside shipping container must
23 be visually examined for identity and to prevent the
24 acceptance of contaminated prescription drugs that are
25 otherwise unfit for distribution. This examination must be
26 adequate to reveal container damage that would suggest
27 possible contamination or other damage to the contents.
28 (b) Each outgoing shipment must be carefully inspected
29 for identity of the prescription drug products and to ensure
30 that there is no delivery of prescription drugs that have
31
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1 expired or been damaged in storage or held under improper
2 conditions.
3 (c) The recordkeeping requirements in subsection (6)
4 must be followed for all incoming and outgoing prescription
5 drugs.
6 (d) Upon receipt, a wholesaler must review records
7 required under this section for the acquisition of
8 prescription drugs for accuracy and completeness.
9 (e) If a wholesaler documents that it has performed
10 the required examination for a particular purchase and the
11 results of the review did not disclose a reasonable suspicion
12 of adulterated or misbranded prescription drugs, but an
13 adulterated or misbranded prescription drug was acquired and
14 subsequently distributed, these facts shall be considered by
15 the department in mitigation of any administrative penalties;
16 however, the prescription drug may be subject to recall or
17 seizure or both. Repeat occurrences of adulterated or
18 misbranded drugs are grounds for the department to impose
19 penalties authorized under this chapter.
20 (6) RECORDKEEPING.--The department shall adopt rules
21 that require keeping such records of prescription drugs as are
22 necessary for the protection of the public health.
23 (a) Wholesale drug distributors must establish and
24 maintain inventories and records of all transactions regarding
25 the receipt and distribution or other disposition of
26 prescription drugs. These records must provide a complete
27 audit trail from receipt to sale or other disposition, be
28 readily retrievable for inspection, and include, at a minimum,
29 the following information:
30
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1 1. The source of the drugs, including the name and
2 principal address of the seller or transferor, and the address
3 of the location from which the drugs were shipped;
4 2. The name, principal address, and state license
5 permit or registration number of the person authorized to
6 purchase prescription drugs;
7 3. The name, strength, dosage form, and quantity of
8 the drugs received and distributed or disposed of; and
9 4. The dates of receipt and distribution or other
10 disposition of the drugs.
11 5. Financial documentation supporting the transaction,
12 if applicable.
13 (b) Inventories and records must be made available for
14 inspection and photocopying by authorized federal, state, or
15 local officials for a period of 2 years following disposition
16 of the drugs or 3 years after the date the drugs were created,
17 whichever period is longer.
18 (c) Records described in this section that are kept at
19 the inspection site or that can be immediately retrieved by
20 computer or other electronic means must be readily available
21 for authorized inspection during the retention period.
22 Records that are kept at a central location outside of this
23 state and that are not electronically retrievable must be made
24 available for inspection within 2 working days after a request
25 by an authorized official of a federal, state, or local law
26 enforcement agency. Records that are maintained at a central
27 location within this state must be maintained at an
28 establishment that is permitted pursuant to ss.
29 499.001-499.081 and must be readily available.
30 (d)1. Any person who distributes a prescription drug
31 that he or she did not manufacture must provide at the time of
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1 the distribution to each purchaser or recipient that is a
2 wholesale distributor a written statement:
3 a. On the invoice or transfer document which states:
4 (I) If the establishment is not a member of an
5 affiliated group, "This establishment purchased the specific
6 unit(s) of the prescription drug(s) represented on this
7 document directly from the manufacturer."
8 (II) If the establishment is a member of an affiliated
9 group, "This establishment or a member of our affiliated group
10 that is licensed or permitted as a drug wholesaler purchased
11 the specific unit(s) of the prescription drug(s) represented
12 on this document directly from the manufacturer."
13 b. That identifies each previous wholesale distributor
14 of that unit of the drug, beginning with the manufacturer of
15 the drug.
16 2. For purposes of subsection (3), a repackager that
17 purchased a specific unit of prescription drug that it
18 repackages directly from the manufacturer must comply with
19 paragraph (3)(a). For purposes of subsection (3), a repackager
20 that does not obtain a specific unit of a prescription drug
21 that it repackages directly from the manufacturer must comply
22 with paragraph (3)(b).
23 3.(d)1. Each person who is engaged in the wholesale
24 distribution of a prescription drug, and who is not an
25 authorized distributor of record of such drug, must provide to
26 each wholesale distributor of such drug, before the sale is
27 made to such wholesale distributor, a written statement
28 identifying each previous sale of the drug. The written
29 statement identifying all sales of such drug must accompany
30 the drug for each subsequent wholesale distribution of the
31
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1 drug to a wholesale distributor. The department shall adopt
2 rules relating to the requirements of this written statement.
3 4.2. Each wholesale distributor of prescription drugs
4 must maintain separate and distinct from other required
5 records all statements that are required under subparagraph 1.
6 5.3. In order to verify compliance with subparagraph
7 1., each manufacturer of a prescription drug sold in this
8 state must maintain at its corporate offices a current list of
9 authorized distributors and must make such list available to
10 the department upon request distribution documentation
11 concerning its sales of prescription drugs, regardless of
12 whether the prescription drug was sold directly by the
13 manufacturer to a person in this state.
14
15 For the purposes of this subsection, the term "authorized
16 distributors of record" means those distributors with whom a
17 manufacturer has established an ongoing relationship to
18 distribute the manufacturer's products.
19 (11) SHIPPING AND TRANSPORTATION.--The person
20 responsible for shipment and transportation of a prescription
21 drug in a wholesale distribution may use a common carrier; its
22 own vehicle or employee acting within the scope of employment
23 if authorized under s. 499.03 for the possession of
24 prescription drugs in this state; or, in the case of a
25 prescription drug intended for domestic distribution, an
26 independent contractor who shall be the agent of the
27 authorized seller or recipient responsible for shipping and
28 transportation as set forth in a written contract between the
29 parties. A person selling a prescription drug for export must
30 obtain documentation, such as a validated airway bill, bill of
31 lading, or other appropriate documentation that the
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1 prescription drug was exported. A person responsible for
2 shipping or transporting prescription drugs is not required to
3 maintain documentation from a common carrier that the
4 designated recipient received the prescription drugs; however,
5 the person must obtain such documentation from the common
6 carrier and make it available to the department upon request
7 of the department.
8 Section 8. Paragraph (a) of subsection (1) of section
9 499.0122, Florida Statutes, is amended to read:
10 499.0122 Medical oxygen and veterinary legend drug
11 retail establishments; definitions, permits, general
12 requirements.--
13 (1) As used in this section, the term:
14 (a) "Medical oxygen retail establishment" means a
15 person licensed to sell medical oxygen to patients only. The
16 sale must be based on an order from a practitioner authorized
17 by law to prescribe. The term does not include a pharmacy
18 licensed under chapter 465.
19 1. A medical oxygen retail establishment may not
20 possess, purchase, sell, or trade any legend drug other than
21 medical oxygen.
22 2. A medical oxygen retail establishment may refill
23 medical oxygen for an individual patient based on an order
24 from a practitioner authorized by law to prescribe if the
25 establishment is also permitted as a compressed medical gases
26 manufacturer. A medical oxygen retail establishment that
27 refills medical oxygen must comply with all appropriate state
28 and federal good manufacturing practices.
29 Section 9. Section 499.0123, Florida Statutes, is
30 created to read:
31
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1 499.0123 Designated representative; certification and
2 general requirements.--
3 (1) An applicant for a prescription drug wholesaler
4 permit shall designate at least one natural person to serve as
5 the representative of the wholesaler. The designated
6 representative must have an active certification from the
7 department as a designated representative under this section.
8 (2) Upon receipt of an application on a form furnished
9 by the department and submission of the appropriate fees, the
10 department may certify a person as a designated representative
11 for the purposes of this chapter under the following
12 conditions:
13 (a) The person must provide verifiable evidence of at
14 least 1 year's experience in the management of a licensed
15 prescription drug wholesaler or licensed pharmacy where the
16 responsibilities included, but were not limited to,
17 recordkeeping for prescription drugs;
18 (b) The person must have received a score of at least
19 75 percent on an examination given by the department or its
20 agent regarding federal and state drug laws and wholesaler
21 practices;
22 (c) The person is at least 21 years of age; and
23 (d) The person is of good moral character such that
24 his or her presence in a wholesale establishment does not
25 jeopardize the public health and the person does not have any
26 deficiencies under s. 499.067(1)(b)1.-11.
27 (3) The designated representative must submit a
28 complete set of fingerprints to the department for the purpose
29 of conducting a criminal history record check for
30 certification and recertification. The department shall submit
31 the fingerprints to the Department of Law Enforcement for a
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1 state criminal background investigation and for forwarding to
2 the Federal Bureau of Investigation for a national criminal
3 history record check. The cost of the state and national
4 criminal record check shall be borne by the applicant in
5 addition to the certification application fee. The department
6 shall develop rules regarding the frequency of the submission
7 of fingerprints and associated fees which may not exceed the
8 actual cost of processing by the Department of Law Enforcement
9 and Federal Bureau of Investigation.
10 (4) The department may deny an application for
11 certification, or suspend or revoke a certification, under
12 this section based on the provisions in s. 499.067(1)(b)1.-11.
13 (5) The natural person's certification is valid for 2
14 years unless the certification is suspended or revoked.
15 (6) A representative of a wholesaler designated
16 pursuant to this section:
17 (a) Must be actively involved in and aware of the
18 actual daily operation of the wholesaler;
19 (b) Must be employed full time in a managerial
20 position with the wholesaler;
21 (c) Must be physically present at the facility of the
22 wholesaler during regular business hours, except when the
23 absence of the representative is authorized, including sick
24 leave, vacation leave, and other authorized absences; and
25 (d) May serve in this representative capacity for only
26 one applicant and permitted establishment at a time.
27 (7) A wholesaler that is required to designate a
28 representative pursuant to this section may not open or
29 operate a facility unless that representative is actually
30 employed full time in the operation of the wholesaler and is
31 physically present at the permitted establishment of the
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1 wholesaler during regular working hours, not including sick
2 leave, vacation leave and other authorized absences from work.
3 If the natural person designated as the representative of a
4 wholesaler leaves the employ of the wholesaler, thus leaving
5 the wholesaler without a representative in violation of this
6 section, the wholesaler shall:
7 (a) Immediately cease conducting business in
8 prescription drugs until another certified representative is
9 employed and the wholesaler notifies the department in writing
10 of the identity of the new representative; and
11 (b) Not later than 48 hours after that person leaves
12 its employ, notify the department that the person designated
13 as the representative of the wholesaler has left the employ of
14 the wholesaler.
15 (8) Among other penalties authorized by law, a
16 wholesaler that operates without a representative in violation
17 of this section is subject to the immediate suspension of its
18 license until it employs a person certified under this section
19 to be its representative.
20 (9) The department shall adopt rules for the
21 application content and process and for the testing required
22 under this section.
23 Section 10. Paragraph (a) of subsection (2) of section
24 499.013, Florida Statutes, is amended to read:
25 499.013 Manufacturers of drugs, devices, and
26 cosmetics; definitions, permits, and general requirements.--
27 (2) Any person that engages in the manufacture of
28 drugs, devices, or cosmetics in this state must first obtain
29 one of the following permits and may engage only in the
30 activity allowed under that permit:
31
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1 (a) A prescription drug manufacturer's permit is
2 required for any person that manufactures a prescription drug
3 in this state; however, a person performing the manufacturing
4 operations of repackaging prescription drugs must obtain a
5 prescription drug repackager permit.
6 1. A person that operates an establishment permitted
7 as a prescription drug manufacturer or prescription drug
8 repackager may engage in wholesale distribution of
9 prescription drugs manufactured at that establishment and must
10 comply with all the provisions of ss. 499.001-499.081 and the
11 rules adopted under those sections that apply to a wholesale
12 distributor.
13 2. A prescription drug manufacturer permittee or
14 prescription drug repackager must comply with all appropriate
15 state and federal good manufacturing practices.
16 Section 11. Section 499.041, Florida Statutes, is
17 amended to read:
18 499.041 Schedule of fees for drug, device, and
19 cosmetic applications and permits, product registrations, and
20 free-sale certificates.--
21 (1) The department shall assess applicants requiring a
22 manufacturing permit an annual fee within the ranges
23 established in this section for the specific type of
24 manufacturer.
25 (a) The fee for a prescription drug manufacturer's
26 permit may not be less than $500 or more than $600 annually.
27 (b) The fee for a device manufacturer's permit may not
28 be less than $500 or more than $600 annually.
29 (c) The fee for a cosmetic manufacturer's permit may
30 not be less than $250 or more than $400 annually.
31
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1 (d) The fee for an over-the-counter drug
2 manufacturer's permit may not be less than $300 or more than
3 $400 annually.
4 (e) The fee for a compressed medical gas
5 manufacturer's permit may not be less than $400 or more than
6 $500 annually.
7 (f) The fee for a prescription drug repackager's
8 permit may not be less than $600 or more than $750 annually.
9 (g)(f) A manufacturer may not be required to pay more
10 than one fee per establishment to obtain an additional
11 manufacturing permit, but each manufacturer must pay the
12 highest fee applicable to his or her operation in each
13 establishment.
14 (2) The department shall assess an applicant that is
15 required to have a wholesaling permit an annual fee within the
16 ranges established in this section for the specific type of
17 wholesaling.
18 (a) The fee for a prescription drug wholesaler's
19 permit may not be less than $750 $300 or more than $950 $400
20 annually;
21 (b) The fee for a compressed medical gas wholesaler's
22 permit may not be less than $200 or more than $300 annually;
23 (c) The fee for an out-of-state prescription drug
24 wholesaler's permit may not be less than $400 $200 or more
25 than $600 $300 annually;
26 (d) The fee for a nonresident prescription drug
27 manufacturer's permit may not be less than $300 or more than
28 $500 annually; however, a nonresident prescription drug
29 manufacturer that distributes its prescription drugs from
30 multiple distribution establishments throughout the country
31 may obtain additional permits for each establishment
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1 distributing the manufacturer's prescription drugs into this
2 state under the manufacturer's name at a cost of $50 per
3 additional establishment.
4 (e)(d) The fee for a retail pharmacy wholesaler's
5 permit may not be less than $35 or more than $50 annually.
6 (f) The fee for a freight forwarder's permit may not
7 be less than $200 or more than $300 annually.
8 (3) The department shall assess an applicant that is
9 required to have a retail establishment permit an annual fee
10 within the ranges established in this section for the specific
11 type of retail establishment.
12 (a) The fee for a veterinary legend drug retail
13 establishment permit may not be less than $200 or more than
14 $300 annually;
15 (b) The fee for a medical oxygen retail establishment
16 permit may not be less than $200 or more than $300 annually.
17 However, a medical oxygen retail establishment permit shall be
18 issued to a compressed medical gases manufacturer or to a
19 compressed medical gases wholesaler at an annual cost of $25.
20 (4) The department shall assess an applicant that is
21 required to have a restricted prescription drug distributor's
22 permit an annual fee of not less than $200 or more than $300.
23 (5) In addition to the fee charged for a permit
24 required by ss. 499.001-499.081, beginning January 1, 1993,
25 the department shall assess applicants an initial application
26 fee of $150 for each new permit issued by the department which
27 requires an onsite inspection.
28 (6) A person that is required to register drugs,
29 devices, or cosmetic products under s. 499.015 shall pay an
30 annual product registration fee of not less than $5 or more
31 than $15 for each separate and distinct product in package
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1 form. The registration fee is in addition to the fee charged
2 for a free-sale certificate.
3 (7) The department shall assess an applicant that
4 requests a free-sale certificate a fee of $25. A fee of $2
5 will be charged for each signature copy of a free-sale
6 certificate that is obtained at the same time the free-sale
7 certificate is issued.
8 (8) The department shall assess an out-of-state
9 prescription drug wholesaler applicant or permittee an on-site
10 inspection fee of not less than $1,000 or more than $3,000
11 annually, to be based on the actual cost of the inspection, if
12 an on-site inspection is performed by agents of the
13 department.
14 (9) The department shall assess a person applying for
15 certification as a wholesaler representative a fee of $150,
16 plus the cost of processing the criminal history record check.
17 (10)(8) The department shall assess other fees as
18 provided in ss. 499.001-499.081.
19 Section 12. Subsection (2) of section 499.051, Florida
20 Statutes, is amended, and subsection (6) is added to that
21 section, to read:
22 499.051 Inspections and investigations.--
23 (2) In addition to the authority set forth in
24 subsection (1), the department and any duly designated officer
25 or employee of the department may enter and inspect any other
26 establishment for the purpose of determining compliance with
27 ss. 499.001-499.081 and rules adopted under those sections
28 regarding any drug, device, or cosmetic product. The authority
29 to enter and inspect does not extend to the practice of the
30 profession of pharmacy, as defined in chapter 465 and the
31 rules adopted under that chapter, in a pharmacy permitted
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1 under chapter 465. The Department of Business and Professional
2 Regulation shall conduct routine inspections of retail
3 pharmacy wholesalers at the time of the regular pharmacy
4 permit inspection and shall send the inspection report
5 regarding drug wholesale activity to the Department of Health.
6 (6) The authority to inspect under this section
7 includes the authority to access, review, and copy financial
8 documents related to activity regulated under this chapter.
9 The department shall maintain the confidentiality of financial
10 documents, other than invoices, accessed or copied and in the
11 possession of the department. This subsection does not
12 prohibit the department from using such information for
13 regulatory or enforcement proceedings under this chapter or
14 from providing such information to any law enforcement agency
15 or any other regulatory agency. However, the receiving agency
16 shall keep such records confidential as provided in this
17 subsection.
18 Section 13. Subsection (7) is added to section
19 499.066, Florida Statutes, to read:
20 499.066 Penalties; remedies.--In addition to other
21 penalties and other enforcement provisions:
22 (7) Resignation or termination of an affiliated party
23 does not affect the department's jurisdiction to proceed with
24 action to suspend or revoke a permit, impose other penalties,
25 or take other enforcement actions authorized by law.
26 Section 14. Section 499.067, Florida Statutes, is
27 amended to read:
28 499.067 Denial, suspension, or revocation of permit,
29 certification, or registration.--
30 (1)(a) The department may deny, suspend, or revoke a
31 permit if it finds that there has been a substantial failure
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1 to comply with ss. 499.001-499.081 or chapter 465, chapter
2 501, or chapter 893, the rules adopted under any of those
3 sections or chapters, any final order of the department, or
4 applicable federal laws or regulations or other state laws or
5 rules governing drugs, devices, or cosmetics.
6 (b) The department may deny an application for a
7 permit or certification if it is shown that:
8 1. The applicant is not of good moral character or
9 that it would be a danger or not in the best interest of the
10 public health, safety, and welfare if the applicant were
11 issued a permit;.
12 2. The applicant has not met the requirements for the
13 permit or certification;
14 3. The applicant has been found guilty, regardless of
15 adjudication, in a court of this state or other jurisdiction,
16 of a violation of a law that directly relates to a drug,
17 device, or cosmetic. A plea of nolo contendere constitutes a
18 finding of guilt for purposes of this subparagraph;
19 4. The applicant has been disciplined by a regulatory
20 agency in any state for any offense that would constitute a
21 violation of ss. 499.001-499.081;
22 5. The applicant has a felony conviction under a
23 federal, state, or local law;
24 6. The applicant's past experience in manufacturing or
25 distributing drugs, devices, or cosmetics poses a public
26 health risk;
27 7. The applicant furnished false or fraudulent
28 material in any application made in connection with
29 manufacturing or distributing drugs, devices, or cosmetics;
30 8. Any permit currently or previously held by the
31 applicant for the manufacture or distribution of any drugs,
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1 devices, or cosmetics was suspended or revoked by a federal,
2 state, or local government;
3 9. The applicant failed to comply with permitting
4 requirements under any previously granted permits;
5 10. The applicant failed to comply with requirements
6 to maintain or make available to the state permitting
7 authority or to federal, state, or local law enforcement
8 officials those records required under this chapter;
9 11. The applicant or any affiliated person of the
10 applicant has been arrested for a crime that is a felony and
11 the disposition of the charge is pending during the
12 application review period;
13 12. The applicant is lacking in prescription drug
14 wholesaling experience;
15 13. The applicant does not possess the financial or
16 physical resources to operate in compliance with this chapter
17 and the rules adopted under this chapter;
18 14. The applicant receives directly or indirectly
19 financial support and assistance from a person who was an
20 affiliated person of a permit that authorized the wholesale
21 distribution of prescription drugs which was suspended or
22 revoked, other than through the ownership of stock in a
23 publicly traded company or a mutual fund;
24 15. The applicant receives directly or indirectly
25 financial support and assistance from a person who has been
26 found guilty of any violation of ss. 499.001-499.081 or
27 chapter 465, chapter 501, or chapter 893, any rules adopted
28 under any of those sections or chapters, any federal or state
29 drug law, or any felony where the underlying facts related to
30 drugs, regardless of whether the person has been pardoned, had
31 her or his civil rights restored, or had adjudication
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1 withheld, other than through the ownership of stock in a
2 publicly traded company or a mutual fund;
3 16. The applicant for renewal of a permit under s.
4 499.012(2)(a) or (c) has not actively engaged in the wholesale
5 distribution of prescription drug as demonstrated by the
6 regular and systematic distribution of prescription drugs
7 throughout the year as evidenced by at least 12 transactions
8 annually; or
9 17. Information obtained in response to s.
10 499.012(2)(a) or (c), demonstrates it would not be in the best
11 interest of the public health, safety, and welfare to issue
12 the applicant a permit.
13 (2) The department may deny, suspend, or revoke any
14 registration required by the provisions of ss. 499.001-499.081
15 for the violation of any provision of ss. 499.001-499.081 or
16 of any rules adopted under those sections.
17 (3) The department may revoke or suspend a permit:
18 (a) If the permit was obtained by misrepresentation or
19 fraud or through a mistake of the department;
20 (b) If the permit was procured, or attempted to be
21 procured, for any other person by making or causing to be made
22 any false representation; or
23 (c) If the permittee has violated any provision of ss.
24 499.001-499.081 or rules adopted under those sections; or.
25 (d) If a prescription drug wholesaler or out-of-state
26 prescription drug wholesaler permittee wholesales more than 10
27 percent of annual prescription drug purchases, net of returns,
28 to other wholesalers that are not members of the same
29 affiliated group.
30 (4) If any permit issued under ss. 499.001-499.081 is
31 revoked or suspended, the owner, manager, operator, or
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1 proprietor of the establishment shall cease to operate as the
2 permit authorized, from the effective date of the suspension
3 or revocation until the person is again registered with the
4 department and possesses the required permit. If a permit is
5 revoked or suspended, the owner, manager, or proprietor shall
6 remove all signs and symbols that identify the operation as
7 premises permitted as a drug wholesaling establishment; drug,
8 device, or cosmetic manufacturing establishment; or retail
9 establishment. The department shall determine the length of
10 time for which the permit is to be suspended. If a permit is
11 revoked, the person that owns or operates the establishment
12 may not apply for any permit under ss. 499.001-499.081 for a
13 period of 1 year after the date of the revocation. A
14 revocation of a permit may be permanent if the department
15 considers that to be in the best interest of the public
16 health.
17 (5) The department may deny, suspend, or revoke a
18 permit issued under ss. 499.001-499.081 which authorizes the
19 permittee to purchase prescription drugs, if any owner,
20 officer, employee, or other person who participates in
21 administering or operating the establishment has been found
22 guilty of any violation of ss. 499.001-499.081 or chapter 465,
23 chapter 501, or chapter 893, any rules adopted under any of
24 those sections or chapters, or any federal or state drug law,
25 regardless of whether the person has been pardoned, had her or
26 his civil rights restored, or had adjudication withheld.
27 (6) The department shall deny, suspend, or revoke the
28 permit of any person or establishment if the assignment, sale,
29 transfer, or lease of an establishment permitted under ss.
30 499.001-499.081 will avoid an administrative penalty, civil
31 action, or criminal prosecution.
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1 (7) Section 120.60(5) to the contrary notwithstanding
2 and pursuant to s. 499.01(4), the department is not required
3 to publish notice of the intended agency action to revoke a
4 permit and of the opportunity for hearing in a newspaper if
5 the person moved or ceased operations but did not notify the
6 department and the department mailed a certified letter to the
7 most recent mailing address on record with the department and
8 to the registered agent listed by the Division of Corporations
9 for the permittee, but service was not accomplished.
10 Section 15. Section 499.069, Florida Statutes, is
11 amended to read:
12 499.069 Punishment for violations of s. 499.005;
13 dissemination of false advertisement.--
14 (1) Any person who violates any of the provisions of
15 s. 499.005 with respect to a device or cosmetic commits is
16 guilty of a misdemeanor of the second degree, punishable as
17 provided in s. 775.082 or s. 775.083; but, if the violation is
18 committed after a conviction of such person under this section
19 has become final, such person commits is guilty of a
20 misdemeanor of the first degree, punishable as provided in s.
21 775.082 or s. 775.083 or as otherwise provided in ss.
22 499.001-499.081, except that any person who violates
23 subsection (8) or, subsection (10), subsection (14),
24 subsection (15), or subsection (17) of s. 499.005 with respect
25 to a device or cosmetic commits is guilty of a felony of the
26 third degree, punishable as provided in s. 775.082, s.
27 775.083, or s. 775.084, or as otherwise provided in ss.
28 499.001-499.081.
29 (2) Any person who violates any of the provisions of
30 s. 499.005 with respect to a drug commits a felony of the
31 third degree, punishable as provided in s. 775.082, s.
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1 775.083, or s. 775.084, or as otherwise provided in ss.
2 499.001-499.081. A person is not subject to the penalties of
3 subsection (1) for having violated any of the provisions of s.
4 499.005 if he or she establishes a guaranty or undertaking,
5 which guaranty or undertaking is signed by and contains the
6 name and address of the person residing in the state, or the
7 manufacturer, from whom he or she received the article in good
8 faith, to the effect that such article is not adulterated or
9 misbranded within the meaning of ss. 499.001-499.081, citing
10 such sections.
11 (3) A publisher, radio broadcast licensee, or agency
12 or medium for the dissemination of an advertisement, except
13 the manufacturer, wholesaler, or seller of the article to
14 which a false advertisement relates, is not liable under this
15 section by reason of the dissemination by him or her of such
16 false advertisement, unless he or she has refused, on the
17 request of the department, to furnish to the department the
18 name and post office address of the manufacturer, wholesaler,
19 seller, or advertising agency that asked him or her to
20 disseminate such advertisement.
21 Section 16. The Department of Health shall form a Drug
22 Wholesaler Advisory Board to meet at least annually, for the
23 purpose of reviewing and providing input into the drug
24 wholesaler licensing requirements and process, and to advise
25 the department on issues affecting the wholesale distribution
26 of drugs within or into this state.
27 (1) The Secretary of Health shall appoint members to
28 the board as follows:
29 (a) Two persons representing prescription drug
30 wholesalers;
31
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1 (b) One person representing prescription drug
2 manufacturers;
3 (c) One person representing pharmacies in this state;
4 (d) One person from the Agency for Health Care
5 Administration; and
6 (e) Two persons from the Department of Health.
7 (2) Members shall be appointed to 4-year terms and may
8 be reappointed.
9 (3) The members shall elect a chair among the members
10 of the board who shall serve for 1 year or until a successor
11 is elected.
12 (4) The members of the advisory committee shall serve
13 without compensation, but are entitled to reimbursement for
14 travel and per diem expenses as provided in section 112.061,
15 Florida Statutes, while in the performance of their official
16 duties.
17 Section 17. If any provision of this act or its
18 application to any person or circumstance is held invalid, the
19 invalidity does not affect other provisions or applications of
20 the act which can be given effect without the invalid
21 provision or application, and to this end the provisions of
22 this act are severable.
23 Section 18. This act shall take effect July 1, 2003.
24
25 *****************************************
26 SENATE SUMMARY
27 Revises various provisions of the Florida Drug and
Cosmetic Act. Provides for the regulation of prescription
28 drug repackagers, nonresident prescription drug
manufacturers, and freight forwarders. Revises permit
29 requirements for prescription drug wholesalers. Increases
permit and certification fees. Provides enhanced
30 penalties for certain violations. Establishes the Drug
Wholesale Advisory Board. (See bill for details.)
31
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