House Bill 4477
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Florida House of Representatives - 1998 HB 4477
By Representative Rodriguez-Chomat
1 A bill to be entitled
2 An act relating to the Department of Health;
3 amending s. 499.003, F.S.; providing
4 definitions; amending s. 499.005, F.S.;
5 clarifying prohibited acts; amending s. 499.01,
6 F.S.; conforming listed permits; amending s.
7 499.012, F.S.; deleting definitions; clarifying
8 wholesale distribution and permitting
9 requirements; authorizing transfers for
10 government purposes in certain situations;
11 authorizing a retail pharmacy to transfer
12 limited quantities of prescription drugs
13 without a wholesaler permit; amending s.
14 499.0121, F.S.; clarifying existing rulemaking
15 authority for the storage and handling of
16 drugs; providing for notification to the
17 department; amending s. 499.0122, F.S.;
18 providing for an expiration date of a
19 practitioner's order for medical oxygen;
20 deleting a definition; clarifying provisions
21 related to the sale of veterinary drugs to the
22 public; amending s. 499.013, F.S.; providing an
23 exemption from permitting requirements;
24 amending s. 499.014, F.S.; revising statutory
25 references; amending s. 499.015, F.S.; revising
26 statutory references; amending s. 499.024,
27 F.S.; providing drug product classification;
28 revising statutory references; amending s.
29 499.028, F.S.; authorizing government officers
30 and employees to possess complimentary
31 prescription drugs when acting within the scope
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1 of employment; amending s. 499.03, F.S.;
2 revising statutory references; prohibiting
3 possession of certain drugs unless they are
4 lawfully dispensed pursuant to a valid
5 prescription; amending s. 499.041, F.S.;
6 deleting a fee; providing that fees are
7 nonrefundable; amending s. 499.051, F.S.;
8 authorizing agents of the Department of Health
9 to inspect and investigate at any time, if
10 necessary, to protect the public health;
11 deleting a requirement that the Department of
12 Business and Professional Regulation inspect
13 retail pharmacy wholesalers; amending s.
14 499.066, F.S.; authorizing immediate
15 effectiveness of cease and desist order with
16 provision for motion to abate or modify the
17 order; amending s. 499.069, F.S.; correcting
18 cross-references to the prohibited acts for
19 criminal punishment; creating s. 499.072, F.S.;
20 creating the Drug Regulation Advisory Group;
21 providing membership; providing per diem and
22 travel expenses; providing purpose and duties;
23 authorizing the department to publish
24 compliance policy guidelines setting forth the
25 group's recommendations; amending s. 499.62,
26 F.S.; providing an intracompany exception to
27 permitting ether; providing an effective date.
28
29 Be It Enacted by the Legislature of the State of Florida:
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1 Section 1. Section 499.003, Florida Statutes, is
2 amended to read:
3 499.003 Definitions of terms used in ss.
4 499.001-499.081.--As used in ss. 499.001-499.081, the term:
5 (1) "Advertisement" means any representation
6 disseminated in any manner or by any means, other than by
7 labeling, for the purpose of inducing, or which is likely to
8 induce, directly or indirectly, the purchase of drugs,
9 devices, or cosmetics.
10 (2) "Authorized distributor of record" means a
11 distributor with whom a manufacturer has established an
12 ongoing relationship to distribute the manufacturer's
13 products.
14 (3)(2) "Certificate of free sale" means a document
15 prepared by the department which certifies a drug, device, or
16 cosmetic, that is registered with the department, as one that
17 can be legally sold in the state.
18 (4)(3) "Closed pharmacy" means a pharmacy that is
19 licensed under chapter 465 and purchases prescription drugs
20 for use by a limited patient population and not for wholesale
21 distribution or sale to the public. The term does not include
22 retail pharmacies.
23 (5)(4) "Color" includes black, white, and intermediate
24 grays.
25 (6)(5) "Color additive" means a material that:
26 (a) Is a dye pigment, or other substance, made by a
27 process of synthesis or similar artifice, or extracted,
28 isolated, or otherwise derived, with or without intermediate
29 or final change of identity from a vegetable, animal, mineral,
30 or other source; or
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1 (b) When added or applied to a drug or cosmetic or to
2 the human body, or any part thereof, is capable alone, or
3 through reaction with other substances, of imparting color
4 thereto;
5
6 except that the term does not include any material which has
7 been or hereafter is exempt under the federal act.
8 (7) "Common control" means the power to direct or
9 cause the direction of the management and policies of a person
10 or an organization, whether by ownership of stock, by voting
11 rights, by contract, or otherwise.
12 (8)(6) "Compressed medical gas" means any liquefied or
13 vaporized gas that is a prescription drug, whether it is alone
14 or in combination with other gases.
15 (9)(7) "Cosmetic" means an article that is:
16 (a) Intended to be rubbed, poured, sprinkled, or
17 sprayed on; introduced into; or otherwise applied to the human
18 body or any part thereof for cleansing, beautifying, promoting
19 attractiveness, or altering the appearance; or
20 (b) Intended for use as a component of any such
21 article;
22
23 except that the term does not include soap.
24 (10)(8) "Counterfeit drug, counterfeit device, or
25 counterfeit cosmetic" means a drug, device, or cosmetic which,
26 or the container, seal, or labeling of which, without
27 authorization, bears the trademark, trade name, or other
28 identifying mark, imprint, or device, or any likeness thereof,
29 of a drug, device, or cosmetic manufacturer, processor,
30 packer, or distributor other than the person that in fact
31 manufactured, processed, packed, or distributed that drug,
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1 device, or cosmetic and which thereby falsely purports or is
2 represented to be the product of, or to have been packed or
3 distributed by, that other drug, device, or cosmetic
4 manufacturer, processor, packer, or distributor.
5 (11)(9) "Department" means the Department of Health
6 and Rehabilitative Services.
7 (12)(10) "Device" means any instrument, apparatus,
8 implement, machine, contrivance, implant, in vitro reagent, or
9 other similar or related article, including its components,
10 parts, or accessories, which is:
11 (a) Recognized in the current edition of the United
12 States Pharmacopoeia and National Formulary, or any supplement
13 thereof,
14 (b) Intended for use in the diagnosis, cure,
15 mitigation, treatment, therapy, or prevention of disease in
16 humans or other animals, or
17 (c) Intended to affect the structure or any function
18 of the body of humans or other animals,
19
20 and which does not achieve any of its principal intended
21 purposes through chemical action within or on the body of
22 humans or other animals and which is not dependent upon being
23 metabolized for the achievement of any of its principal
24 intended purposes.
25 (13)(11) "Drug" means an article that is:
26 (a) Recognized in the current edition of the United
27 States Pharmacopoeia and National Formulary, official
28 Homeopathic Pharmacopoeia of the United States, or any
29 supplement to any of those publications;
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1 (b) Intended for use in the diagnosis, cure,
2 mitigation, treatment, therapy, or prevention of disease in
3 humans or other animals;
4 (c) Intended to affect the structure or any function
5 of the body of humans or other animals; or
6 (d) Intended for use as a component of any article
7 specified in paragraph (a), paragraph (b), or paragraph (c),
8 but does not include devices or their components, parts, or
9 accessories.
10 (14)(12) "Establishment" means a place of business at
11 one general physical location.
12 (15)(13) "Federal act" means the Federal Food, Drug,
13 and Cosmetic Act, 21 U.S.C. ss. 301 et seq.; 52 Stat. 1040 et
14 seq.
15 (16)(14) "Health care entity" means a closed pharmacy
16 or any person, organization, or business entity that provides
17 diagnostic, medical, surgical, or dental treatment or care, or
18 chronic or rehabilitative care, but does not include any
19 wholesale distributor or retail pharmacy licensed under state
20 law to deal in prescription drugs.
21 (17)(15) "Immediate container" does not include
22 package liners.
23 (18)(16) "Investigational drug" means any drug
24 recommended by the Florida Drug Technical Review Panel for a
25 specific use under a protocol approved by the department and
26 intended solely for investigational use in the state by
27 experts qualified by scientific training and experience to
28 investigate the safety and effectiveness of drugs.
29 (19)(17) "Label" means a display of written, printed,
30 or graphic matter upon the immediate container of any drug,
31 device, or cosmetic. A requirement made by or under authority
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1 of ss. 499.001-499.081 or rules adopted under those sections
2 that any word, statement, or other information appear on the
3 label is not complied with unless such word, statement, or
4 other information also appears on the outside container or
5 wrapper, if any, of the retail package of such drug, device,
6 or cosmetic or is easily legible through the outside container
7 or wrapper.
8 (20)(18) "Labeling" means all labels and other
9 written, printed, or graphic matters:
10 (a) Upon a drug, device, or cosmetic, or any of its
11 containers or wrappers; or
12 (b) Accompanying or related to such drug, device, or
13 cosmetic.
14 (21)(19) "Legend drug," "prescription drug," or
15 "medicinal drug" means any drug, including, but not limited
16 to, finished dosage forms, or active ingredients subject to,
17 defined by, or described by s. 503(b) of the Federal Food,
18 Drug, and Cosmetic Act or s. 465.003(7), s. 499.007(12), or s.
19 499.0122(1)(b) or (c).
20 (22)(20) "Manufacture" means the preparation,
21 deriving, compounding, propagation, processing, producing, or
22 fabrication of any drug, device, or cosmetic. The term
23 includes repackaging or otherwise changing the container,
24 wrapper, or labeling to further the distribution of the drug,
25 device, or cosmetic.
26 (23)(21) "Manufacturer" means a person who prepares,
27 derives, manufactures, or produces a drug, device, or
28 cosmetic. The term excludes pharmacies that are operating in
29 compliance with pharmacy practice standards as defined in
30 chapter 465 and rules adopted under that chapter.
31 (24)(22) "New drug" means:
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1 (a) Any drug the composition of which is such that the
2 drug is not generally recognized, among experts qualified by
3 scientific training and experience to evaluate the safety and
4 effectiveness of drugs, as safe and effective for use under
5 the conditions prescribed, recommended, or suggested in the
6 labeling of that drug; or
7 (b) Any drug the composition of which is such that the
8 drug, as a result of investigations to determine its safety
9 and effectiveness for use under certain conditions, has been
10 recognized for use under such conditions, but which drug has
11 not, other than in those investigations, been used to a
12 material extent or for a material time under such conditions.
13 (25)(23) "Official compendium" means the current
14 edition of the official United States Pharmacopoeia and
15 National Formulary, or any supplement thereto.
16 (26)(24) "Person" means any individual, child, joint
17 venture, syndicate, fiduciary, partnership, corporation,
18 division of a corporation, firm, trust, business trust,
19 company, estate, public or private institution, association,
20 organization, group, city, county, city and county, political
21 subdivision of this state, other governmental agency within
22 this state, and any representative, agent, or agency of any of
23 the foregoing, or any other group or combination of the
24 foregoing.
25 (27)(25) "Prepackaged drug product" means a drug that
26 originally was in finished packaged form sealed by a
27 manufacturer and hat is placed in a properly labeled container
28 by a pharmacy or practitioner authorized to dispense pursuant
29 to chapter 465 for the purpose of dispensing in the
30 establishment in which the prepackaging occurred.
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1 (28)(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 (29)(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 (30) "Retail pharmacy" means a community pharmacy
14 permitted under chapter 465 which purchases prescription drugs
15 only at fair market prices and not for its own use and
16 provides prescription services to the public. A retail
17 pharmacy may not also be a health care entity.
18 (31)(28) "Technical panel" means the Florida Drug
19 Technical Review Panel.
20 (32)(29) "Veterinary legend drug" or "veterinary
21 prescription drug" means a legend drug intended solely for
22 veterinary use. The label of the drug must bear the
23 statement, "Caution: Federal law restricts this drug to sale
24 by or on the order of a licensed veterinarian."
25 (33) "Wholesale distribution" means the distribution
26 of a prescription drug to a person other than a consumer or
27 patient.
28 (34) "Wholesale distributor" means any person engaged
29 in wholesale distribution of prescription drugs in or into
30 this state, including manufacturers; repackers; own-label
31 distributors; jobbers; private-label distributors; brokers;
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1 warehouses, including manufacturers' and distributors'
2 warehouses, drug chain warehouses, and wholesale drug
3 warehouses; independent wholesale drug traders; exporters;
4 retail pharmacies; and the agents thereof that conduct
5 wholesale distributions.
6 Section 2. Section 499.005, Florida Statutes, is
7 amended to read:
8 499.005 Prohibited acts.--It is unlawful to perform or
9 cause the performance of any of the following acts in this
10 state:
11 (1) The manufacture, repackaging, sale, delivery, or
12 holding or offering for sale of any drug, device, or cosmetic
13 that is adulterated or misbranded or has otherwise been
14 rendered unfit for human or animal use.
15 (2) The adulteration or misbranding of any drug,
16 device, or cosmetic.
17 (3) The receipt of any drug, device, or cosmetic that
18 is adulterated or misbranded, and the delivery or proffered
19 delivery of such drug, device, or cosmetic, for pay or
20 otherwise.
21 (4) The sale, distribution, purchase, trade, holding,
22 or offering of any drug, device, or cosmetic in violation of
23 ss. 499.001-499.081.
24 (5) The dissemination of any false or misleading
25 advertisement of a drug, device, or cosmetic.
26 (6) The refusal:
27 (a) To allow the department to enter or inspect an
28 establishment in which drugs, devices, or cosmetics are
29 manufactured, processed, repackaged, sold, brokered, or held;
30 (b) To allow inspection of any record of that
31 establishment;
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1 (c) To allow the department to enter and inspect any
2 vehicle that is being used to transport drugs, devices, or
3 cosmetics; or
4 (d) To allow the department to take samples of any
5 drug, device, or cosmetic.
6 (7) The giving of a false guaranty or false
7 undertaking with respect to a drug, device, or cosmetic,
8 except by a person who relied on a guaranty or undertaking to
9 the same effect signed by, and containing the name and address
10 of, the person residing in this state from whom she or he
11 received in good faith the drug, device, or cosmetic.
12 (8) Committing any act that causes a drug, device, or
13 cosmetic to be a counterfeit drug, device, or cosmetic; or
14 selling, dispensing, or holding for sale a counterfeit drug,
15 device, or cosmetic.
16 (9) The alteration, mutilation, destruction,
17 obliteration, or removal of the whole or any part of the
18 labeling of a drug, device, or cosmetic, or the doing of any
19 other act with respect to a drug, device, or cosmetic, if the
20 act is done while the drug, device, or cosmetic is held for
21 sale and the act results in the drug, device, or cosmetic
22 being misbranded.
23 (10) Forging; counterfeiting; simulating; falsely
24 representing any drug, device, or cosmetic; or, without the
25 authority of the manufacturer, using any mark, stamp, tag,
26 label, or other identification device authorized or required
27 by rules adopted under ss. 499.001-499.081.
28 (11) The use, on the labeling of any drug or in any
29 advertisement relating to such drug, of any representation or
30 suggestion that an application of the drug is effective when
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1 it is not or that the drug complies with ss. 499.001-499.081
2 when it does not.
3 (12) The possession of any drug in violation of ss.
4 499.001-499.081.
5 (13) The sale, delivery, holding, or offering for sale
6 of any self-testing kits designed to tell persons their status
7 concerning human immunodeficiency virus or acquired immune
8 deficiency syndrome or related disorders or conditions. This
9 prohibition shall not apply to home access HIV test kits
10 approved for distribution and sale by the United States Food
11 and Drug Administration.
12 (14) The purchase or receipt of a legend drug from a
13 person that is not authorized under this chapter the law of
14 the state in which the person resides to distribute legend
15 drugs.
16 (15) The sale or transfer of a legend drug to a person
17 that is not authorized under the law of the jurisdiction in
18 which the person receives the drug resides to purchase or
19 possess legend drugs.
20 (16) The purchase or receipt of a compressed medical
21 gas from a person that is not authorized under this chapter
22 the law of the state in which the person resides to distribute
23 compressed medical gases.
24 (17) The sale, purchase, or trade, or the offer to
25 sell, purchase, or trade, a drug sample as defined in s.
26 499.028; the distribution of a drug sample in violation of s.
27 499.028; or the failure to otherwise comply with s. 499.028.
28 (18) Failure to maintain records as required by ss.
29 499.001-499.081 and rules adopted under those sections.
30 (19) Providing the department with false or fraudulent
31 records, or making false or fraudulent statements, regarding
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1 any matter within the provisions of chapter 499 a drug,
2 device, or cosmetic.
3 (20) The importation of a legend drug except as
4 provided by s. 801(d) of the Federal Food, Drug, and Cosmetic
5 Act.
6 (21) The wholesale distribution of any prescription
7 drug that was:
8 (a) Purchased by a public or private hospital or other
9 health care entity; or
10 (b) Donated or supplied at a reduced price to a
11 charitable organization.
12 (22) Failure to obtain a permit or registration, or
13 operating without a valid permit, when a permit or
14 registration is as required by ss. 499.001-499.081 for that
15 activity.
16 (23) The distribution of a legend device to the
17 patient or ultimate consumer without a prescription or order
18 from a practitioner licensed by law to use or prescribe the
19 device.
20 Section 3. Subsection (1) of section 499.01, Florida
21 Statutes, is amended to read:
22 499.01 Permits; applications; renewal; general
23 requirements.--
24 (1) Any person that is required under ss.
25 499.001-499.081 to have a permit must apply to the department
26 on forms furnished by the department.
27 (a) A permit issued pursuant to ss. 499.001-499.081
28 may be issued only to an individual who is at least 18 years
29 of age or to a corporation that is registered pursuant to
30 chapter 607 or chapter 617 and each officer of which is at
31 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 retail pharmacy drug wholesaler will
9 be issued a permit in the name of its retail pharmacy permit.
10 (d) A permit is required for each establishment that
11 operates as a:
12 1. Prescription drug manufacturer;
13 2. Over-the-counter drug manufacturer;
14 3. Compressed medical gas manufacturer;
15 4. Device manufacturer;
16 5. Cosmetic manufacturer;
17 6. Prescription drug wholesaler;
18 7. Compressed medical gas wholesaler;
19 8. Out-of-state prescription drug wholesaler;
20 9. Restricted prescription drug distributor Retail
21 pharmacy drug wholesaler;
22 10. Veterinary legend drug retail establishment;
23 11. Medical oxygen retail establishment; or
24 12. Complimentary drug distributor.
25 Section 4. Section 499.012, Florida Statutes, is
26 amended to read:
27 499.012 Wholesale distribution; definitions; permits;
28 general requirements.--
29 (1) As used in this section and for the purposes of s.
30 499.005(21), the term wholesale distribution does not include:
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1 (a) The following activities provided the activity is
2 conducted under the provisions of s. 499.014 "Wholesale
3 distribution" means distribution of prescription drugs to
4 persons other than a consumer or patient, but does not
5 include:
6 1. The purchase or other acquisition by a hospital or
7 other health care entity that is a member of a group
8 purchasing organization of a prescription drug for its own use
9 from the group purchasing organization or from other hospitals
10 or health care entities that are members of that organization;
11 2. The sale, purchase, or trade of a prescription drug
12 or an offer to sell, purchase, or trade a prescription drug by
13 a charitable organization described in s. 501(c)(3) of the
14 Internal Revenue Code of 1986, as amended and revised, to a
15 nonprofit affiliate of the organization to the extent
16 otherwise permitted by law;
17 3. The sale, purchase, or trade of a prescription drug
18 or an offer to sell, purchase, or trade a prescription drug
19 among hospitals or other health care entities that are under
20 common control. For purposes of this section, "common
21 control" means the power to direct or cause the direction of
22 the management and policies of a person or an organization,
23 whether by ownership of stock, by voting rights, by contract,
24 or otherwise.
25 (b) The following activities when performed under
26 rules adopted by the department:
27 1.4. The sale, purchase, or trade of a prescription
28 drug among federal, state, or local government health care
29 entities that are under common control and are authorized to
30 purchase such prescription drug.
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1 2. The sale, purchase, trade, or other transfer of a
2 prescription drug from or for a federal, state, or local
3 government agency or any entity eligible to purchase
4 prescription drugs at public health services prices under s.
5 602 of Pub. L. No 102-585 to a contract provider or its
6 subcontractor for eligible patients of the entity under the
7 following conditions:
8 a. The entity obtains written authorization for the
9 sale, purchase, trade, or other transfer of a prescription
10 drug under this paragraph from the Secretary of the Department
11 of Health. This written authorization must be based on a
12 favorable recommendation by the Drug Regulation Advisory Group
13 that has reviewed the entity's submission to the department of
14 a detailed plan and justification for the sale, purchase,
15 trade, or other transfer of a prescription drug under this
16 paragraph and must enhance the public's health by improving
17 needed access, quality, or safety because current patient drug
18 delivery systems are inadequate;
19 b. The contract provider or subcontractor must be
20 authorized by law to administer or dispense prescription
21 drugs;
22 c. In the case of a subcontractor, the entity must be
23 a part of and execute the subcontract;
24 d. A contract provider or subcontractor must maintain
25 separate and apart any prescription drugs of the entity in its
26 possession from other prescription drug inventory;
27 e. The contract provider and subcontractor shall
28 maintain and produce immediately for inspection all records of
29 movement or transfer of all the prescription drugs belonging
30 to the entity including, but not limited to, the records of
31 receipt and disposition of prescription drugs. Each contractor
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1 and subcontractor dispensing or administering these drugs
2 shall maintain and produce records documenting the dispensing
3 or administration. Records required to be maintained include a
4 perpetual inventory itemizing drugs received and drugs
5 dispensed by prescription number or administered by patient
6 identifier, which shall be submitted to the entity monthly;
7 f. The contract provider or subcontractor shall either
8 administer or dispense the prescription drugs only to the
9 eligible patients of the entity or shall return the
10 prescription drug for or to the entity. The contract provider
11 or subcontractor shall require proof from each person seeking
12 to fill a prescription or obtain treatment that the person is
13 an eligible patient of the entity and shall at a minimum
14 maintain a copy of this proof as part of the records of the
15 contractor or subcontractor required by sub-subparagraph 2.d.;
16 and
17 g. In addition to the department's inspection
18 authority provided in s. 499.051, the establishment of the
19 contract provider and subcontractor and all records pertaining
20 to prescription drugs subject to this subparagraph are subject
21 to inspection by the entity.
22 3.5. The sale, purchase, or trade of a prescription
23 drug or an offer to sell, purchase, or trade a prescription
24 drug for emergency medical reasons; for purposes of this
25 subparagraph, the term "emergency medical reasons" includes
26 transfers of prescription drugs by a retail pharmacy to
27 another retail pharmacy to alleviate a temporary shortage.;
28 4.6. The transfer purchase or acquisition of a
29 prescription drug acquired by a medical director on behalf of
30 a licensed an emergency medical services provider to that
31 medical director for use by emergency medical services
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1 provider and its transport vehicles for use pursuant to the
2 provider's license under providers acting within the scope of
3 their professional practice pursuant to chapter 401.
4 5.7. The dispensing of a prescription drug pursuant to
5 a prescription under chapter 465.;
6 6.8. The distribution of prescription drug samples by
7 manufacturers' representatives or distributors'
8 representatives conducted under s. 499.028.; or
9 7.9. The sale, purchase, or trade of blood and blood
10 components intended for transfusion. As used in this section,
11 the term "blood" means whole blood collected from a single
12 donor and processed either for transfusion or further
13 manufacturing, and the term "blood components" means that part
14 of the blood separated by physical or mechanical means.
15 (b) "Wholesale distributor" means any person engaged
16 in wholesale distribution of prescription drugs in or into
17 this state, including, but not limited to, manufacturers;
18 repackers; own-label distributors; jobbers; private-label
19 distributors; brokers; warehouses, including manufacturers'
20 and distributors' warehouses, chain drug warehouses, and
21 wholesale drug warehouses; independent wholesale drug traders;
22 exporters; retail pharmacies; and the agents thereof that
23 conduct wholesale distributions.
24 (c) "Retail pharmacy" means a community pharmacy
25 licensed under chapter 465 that purchases prescription drugs
26 at fair market prices and provides prescription services to
27 the public.
28 (2) The following types of wholesaler permits are
29 established:
30 (a) A prescription drug wholesaler's permit. A
31 prescription drug wholesaler is a wholesale distributor that
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1 may engage in the wholesale distribution of prescription
2 drugs. A prescription drug wholesaler that applies to the
3 department after January 1, 1993, must submit a bond of $200,
4 payable to the Florida Drug, Device, and Cosmetic Trust Fund.
5 This bond will be refunded to the permittee when the permit is
6 returned to the department and the permittee ceases to
7 function as a business. A permittee that fails to notify the
8 department before changing the address of the business, fails
9 to notify the department before closing the business, or fails
10 to notify the department before a change of ownership forfeits
11 its bond.
12 (b) A compressed medical gas wholesaler's permit. A
13 compressed medical gas wholesaler is a wholesale distributor
14 that is limited to the wholesale distribution of compressed
15 medical gases to other than the consumer or patient. The
16 compressed medical gas must be in the original sealed
17 container that was purchased by that wholesaler. A compressed
18 medical gas wholesaler may not possess or engage in the
19 wholesale distribution of any prescription drug other than
20 compressed medical gases. The department shall adopt rules
21 that govern the wholesale distribution of prescription medical
22 oxygen for emergency use. With respect to the emergency use
23 of prescription medical oxygen, those rules may not be
24 inconsistent with rules and regulations of federal agencies
25 unless the Legislature specifically directs otherwise.
26 (c) An out-of-state prescription drug wholesaler's
27 permit. An out-of-state prescription drug wholesaler is a
28 wholesale distributor located outside this state which engages
29 in the wholesale distribution of prescription drugs into this
30 state and which must be permitted by the department and comply
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1 with all the provisions required of a wholesale distributor
2 under ss. 499.001-499.081.
3 1. The out-of-state drug wholesaler must maintain at
4 all times a license or permit to engage in the wholesale
5 distribution of prescription drugs in compliance with laws of
6 the state in which it is a resident.
7 2. An out-of-state prescription drug wholesaler's
8 permit is not required for an intracompany sale or transfer of
9 a prescription drug from an out-of-state establishment that is
10 duly licensed as a prescription drug wholesaler, in its state
11 of residence, to a licensed prescription drug wholesaler in
12 this state, if both wholesalers are under common control. The
13 recordkeeping requirements of s. 499.0121(6) must be followed
14 for this transaction.
15 3. The department may adopt rules that allow
16 out-of-state drug wholesalers to obtain a drug wholesale
17 permit on the basis of reciprocity to the extent that an
18 out-of-state drug wholesaler:
19 a. Possesses a valid permit granted by another state
20 that has requirements comparable to those that a drug
21 wholesaler in this state must meet as prerequisites to
22 obtaining a permit under the laws of this state.
23 b. Can show that the other state from which the
24 wholesaler holds a permit would extend reciprocal treatment
25 under its own laws to a drug wholesaler of this state.
26 (d) A retail pharmacy wholesaler's permit. A retail
27 pharmacy wholesaler is a retail pharmacy engaged in wholesale
28 distribution of prescription drugs within this state under the
29 following conditions:
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1 1. The pharmacy must obtain a retail pharmacy
2 wholesaler's permit pursuant to ss. 499.001-499.081 and the
3 rules adopted under those sections.
4 2. The wholesale distribution activity does not exceed
5 30 percent of the total annual purchases of prescription
6 drugs. If the wholesale distribution activity exceeds the
7 30-percent maximum, the pharmacy must obtain a prescription
8 drug wholesaler's permit.
9 3. The transfer of prescription drugs that appear in
10 any schedule contained in chapter 893 is subject to chapter
11 893 and the federal Comprehensive Drug Abuse Prevention and
12 Control Act of 1970.
13 4. The transfer is between a retail pharmacy and
14 another retail pharmacy or a health care practitioner licensed
15 in this state and authorized by law to dispense or prescribe
16 prescription drugs.
17 5. All records of sales of prescription drugs subject
18 to this section must be maintained separate and distinct from
19 other records and comply with the recordkeeping requirements
20 of ss. 499.001-499.081.
21 (3) A person that engages in wholesale distribution of
22 prescription drugs in this state must first have a wholesale
23 distributor's permit issued by the department, except as noted
24 in this section. Each establishment must be separately
25 permitted except as noted in this subsection.
26 (a) A separate establishment permit is not required
27 when a permitted prescription drug wholesaler consigns a
28 prescription drug to a pharmacy that is permitted under
29 chapter 465 and located in this state, provided that:
30 1. The consignor wholesaler notifies the department in
31 writing of the contract to consign prescription drugs to a
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1 pharmacy along with the identity and location of each
2 consignee pharmacy;
3 2. The pharmacy maintains its permit under chapter
4 465;
5 3. The consignor wholesaler, which has no legal
6 authority to dispense prescription drugs, complies with all
7 wholesale distribution requirements of s. 499.0121 with
8 respect to the consigned drugs and maintains records
9 documenting the transfer of title or other completion of the
10 wholesale distribution of the consigned prescription drugs;
11 4. The distribution of the prescription drug is
12 otherwise lawful under this chapter and other applicable law;
13 5. Open packages containing prescription drugs within
14 a pharmacy are the responsibility of the pharmacy, regardless
15 of how the drugs are titled; and
16 6. The pharmacy dispenses the consigned prescription
17 drug in accordance with the limitations of its permit under
18 chapter 465 or returns the consigned prescription drug to the
19 consignor wholesaler. In addition, a person who holds title to
20 prescription drugs may transfer the drugs to a person
21 permitted or licensed to handle the reverse distribution or
22 destruction of drugs. Any other distribution by and means of
23 the consigned prescription drug by any person, not limited to
24 the consignor wholesaler or consignee pharmacy, to any other
25 person is prohibited.
26 (b) A wholesale distributor's permit is not required
27 for the one-time transfer of title of a pharmacy's lawfully
28 acquired prescription drug inventory by a pharmacy with a
29 valid permit issued under chapter 465 to a consignor
30 prescription drug wholesaler, permitted under this chapter, in
31 accordance with a written consignment agreement between the
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1 pharmacy and that wholesaler if: the permitted pharmacy and
2 the permitted prescription drug wholesaler comply with all of
3 the provisions of paragraph (a) and the prescription drugs
4 continue to be within the permitted pharmacy's inventory for
5 dispensing in accordance with the limitations of the pharmacy
6 permit under chapter 465. A consignor drug wholesaler may not
7 use the pharmacy as a wholesale distributor through which it
8 distributes the legend drugs to other pharmacies. Nothing in
9 this section is intended to prevent a wholesale drug
10 distributor from obtaining this inventory in the event of
11 nonpayment by the pharmacy.
12 (c) A retail pharmacy may distribute approved drugs as
13 in s. 499.023, up to 5 percent of its retail pharmacy
14 purchases of prescription drugs prescribed to other licensed
15 pharmacies in this state or to health care practitioners
16 licensed and located in this state and authorized by law to
17 dispense or prescribe prescription drugs without obtaining a
18 permit under this section. If wholesale distribution activity
19 exceeds the 5-percent threshold or the intended distribution
20 is to a person not authorized under this paragraph, a
21 prescription drug wholesaler's permit must be obtained as
22 provided by law. All records of prescription drug
23 distributions under this section must be maintained separate
24 and distinct from dispensing or other records and must comply
25 with the recordkeeping requirements of s. 499.0121 and the
26 rules adopted thereunder.
27 (d)(c) The department shall require information from
28 each wholesale distributor as part of the permit and renewal
29 of such permit, as required under s. 499.01.
30 (4) Personnel employed in wholesale distribution must
31 have appropriate education and experience to enable them to
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1 perform their duties in compliance with state permitting
2 requirements.
3 Section 5. Subsections (6) and (7) of section
4 499.0121, Florida Statutes, are amended to read:
5 499.0121 Storage and handling of prescription
6 drugs.--The department shall adopt such rules relating to
7 wholesale drug distribution as are necessary to protect the
8 public health, safety, and welfare. Such rules shall include,
9 but not be limited to, requirements for the storage and
10 handling of prescription drugs and for the establishment and
11 maintenance of prescription drug distribution records.
12 (6) RECORDKEEPING.--The department shall adopt rules
13 that require keeping such records of prescription drugs as are
14 necessary for the protection of the public health. Records
15 that document the distribution of prescription drugs must be
16 prepared at the time of the distribution.
17 (a) Wholesale drug distributors must establish and
18 maintain inventories and records of all transactions regarding
19 the receipt and distribution or other disposition of
20 prescription drugs. These records must provide a complete
21 audit trail from receipt to sale or other disposition, be
22 readily retrievable for inspection, and include, at a minimum,
23 the following information:
24 1. The source of the drugs, including the name and
25 principal address of the seller or transferor, and the address
26 of the location from which the drugs were shipped;
27 2. The name, principal address, and state license
28 permit or registration number of the person authorized to
29 purchase prescription drugs;
30 3. The name, strength, dosage form, and quantity of
31 the drugs received and distributed or disposed of; and
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1 4. The dates of receipt and distribution or other
2 disposition of the drugs.
3 (b) Inventories and records must be made available for
4 inspection and photocopying by authorized federal, state, or
5 local officials for a period of 2 years following disposition
6 of the drugs.
7 (c) Records described in this section that are kept at
8 the inspection site or that can be immediately retrieved by
9 computer or other electronic means must be readily available
10 for authorized inspection during the retention period.
11 Records that are kept at a central location outside of this
12 state and that are not electronically retrievable must be made
13 available for inspection within 2 working days after a request
14 by an authorized official of a federal, state, or local law
15 enforcement agency. Records that are maintained at a central
16 location within this state must be maintained at an
17 establishment that is permitted pursuant to ss.
18 499.001-499.081 and must be readily available.
19 (d)1. Each person who is engaged in the wholesale
20 distribution of a prescription drug, and who is not an
21 authorized distributor of record of such drug, must provide to
22 each wholesale distributor of such drug, before the sale is
23 made to such wholesale distributor, a written statement
24 identifying each previous sale of the drug. The written
25 statement identifying all sales of such drug must accompany
26 the drug for each subsequent wholesale distribution of the
27 drug to a wholesale distributor. The department shall adopt
28 rules relating to the requirements of this written statement.
29 A copy of the written statement must be maintained by each
30 recipient.
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1 2. Each wholesale distributor of prescription drugs
2 must maintain separate and distinct from other required
3 records all statements that are required under subparagraph 1.
4 3. Each manufacturer of a prescription drug sold in
5 this state must maintain at its corporate offices a current
6 list of authorized distributors and must make such list
7 available to the department upon request.
8
9 For the purposes of this subsection, the term "authorized
10 distributors of record" means those distributors with whom a
11 manufacturer has established an ongoing relationship to
12 distribute the manufacturer's products.
13 (7) WRITTEN POLICIES AND PROCEDURES.--Wholesale drug
14 distributors must establish, maintain, and adhere to written
15 policies and procedures, which must be followed for the
16 receipt, security, storage, inventory, and distribution of
17 prescription drugs, including policies and procedures for
18 identifying, recording, and reporting losses or thefts, and
19 for correcting all errors and inaccuracies in inventories.
20 Wholesale drug distributors must include in their written
21 policies and procedures:
22 (a) A procedure whereby the oldest approved stock of a
23 prescription drug product is distributed first. The procedure
24 may permit deviation from this requirement, if the deviation
25 is temporary and appropriate.
26 (b) A procedure to be followed for handling recalls
27 and withdrawals of prescription drugs. Such procedure must be
28 adequate to deal with recalls and withdrawals due to:
29 1. Any action initiated at the request of the Food and
30 Drug Administration or any other federal, state, or local law
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1 enforcement or other government agency, including the
2 department.
3 2. Any voluntary action by the manufacturer to remove
4 defective or potentially defective drugs from the market; or
5 3. Any action undertaken to promote public health and
6 safety by replacing existing merchandise with an improved
7 product or new package design.
8 (c) A procedure to ensure that wholesale drug
9 distributors prepare for, protect against, and handle any
10 crisis that affects security or operation of any facility if a
11 strike, fire, flood, or other natural disaster, or a local,
12 state, or national emergency, occurs. This procedure must
13 include notification to the department within 3 business days
14 after any occurrence that may have exposed prescription drugs
15 to damage or adulteration. Such notification may be verbal but
16 must be followed by written notification within 15 days after
17 the occurrence.
18 (d) A procedure to ensure that any outdated
19 prescription drugs are segregated from other drugs and either
20 returned to the manufacturer or destroyed. This procedure
21 must provide for written documentation of the disposition of
22 outdated prescription drugs. This documentation must be
23 maintained for 2 years after disposition of the outdated
24 drugs.
25 (e) A procedure to notify the department within 3
26 business days after the discovery of any loss or theft of
27 prescription drugs valued at $50,000 or more.
28 Section 6. Section 499.0122, Florida Statutes, is
29 amended to read:
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1 499.0122 Medical oxygen and veterinary legend drug
2 retail establishments; definitions, permits, general
3 requirements.--
4 (1) As used in this section, the term:
5 (a) "Medical oxygen retail establishment" means a
6 person licensed to sell medical oxygen to patients only. The
7 sale must be based on an order from a practitioner authorized
8 by law to prescribe. The term does not include a pharmacy
9 licensed to dispense under chapter 465.
10 1. A medical oxygen retail establishment may not
11 possess, purchase, sell, or trade any legend drug other than
12 medical oxygen.
13 2. A medical oxygen retail establishment may refill
14 medical oxygen for an individual patient based on an order
15 from a practitioner authorized by law to prescribe. An order
16 for medical oxygen is not valid for more than 1 year.
17 (b) "Prescription medical oxygen" means oxygen USP
18 that is a compressed medical gas and which can only be sold on
19 the order or prescription of a practitioner authorized by law
20 to prescribe. The label of prescription medical oxygen must
21 comply with current labeling requirements for oxygen under the
22 Federal Food, Drug, and Cosmetic Act.
23 (c) "Veterinary legend drug" means a legend drug
24 intended solely for veterinary use. The label of the drug
25 must bear the statement, "Caution: Federal law restricts this
26 drug to use by or on the order of a licensed veterinarian."
27 (c)(d) "Veterinary legend drug retail establishment"
28 means a person permitted to sell veterinary legend drugs to
29 the public or to veterinarians, but does not include a
30 pharmacy licensed under chapter 465.
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1 1. A veterinary legend drug retail establishment must
2 sell a veterinary legend drug The sale to the public must be
3 based on a valid written order from a veterinarian licensed in
4 this state who has a valid client-veterinarian-patient
5 relationship with the purchaser's animal.
6 2. Veterinary legend drugs may not be sold in excess
7 of the amount clearly indicated on the order or beyond the
8 date indicated on the order.
9 3. An order may not be valid for more than 1 year.
10 4. A veterinary legend drug retail establishment may
11 not purchase, sell, trade, or possess human prescription drugs
12 or any controlled substance as defined in chapter 893.
13 5. A veterinary legend drug retail establishment must
14 sell veterinary drugs in original, sealed manufacturer's
15 containers with all labeling intact and legible.
16 (2)(a) A person that engages in the retail sale of
17 medical oxygen or veterinary legend drugs in this state must
18 first have a retail establishment permit issued by the
19 department.
20 (b) The department shall adopt rules relating to
21 information required from each retail establishment pursuant
22 to s. 499.01(2).
23 (c) A retail establishment must comply with all of the
24 wholesale distribution requirements of s. 499.0121 except
25 those set forth in s. 499.0121(6)(d).
26 (d) Legend drugs sold by a retail establishment
27 pursuant to a practitioner's order may not be returned into
28 the retail establishment's inventory.
29 Section 7. Section 499.013, Florida Statutes, is
30 amended to read:
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1 499.013 Manufacturers of drugs, devices, and
2 cosmetics; definitions, permits, and general requirements.--
3 (1) As used in this section, the term "manufacture"
4 has the meaning assigned to it under s. 499.003. A pharmacy is
5 exempt from this definition if it is operating in compliance
6 with pharmacy practice standards as defined in chapter 465 and
7 the rules adopted under that chapter.
8 (2) Any person that engages in the manufacture of
9 drugs, devices, or cosmetics in this state must first obtain
10 one of the following permits and may engage only in the
11 activity allowed under that permit:
12 (a) A prescription drug manufacturer's permit is
13 required for any person that manufactures a prescription drug
14 in this state.
15 1. A person that operates an establishment permitted
16 as a prescription drug manufacturer may engage in wholesale
17 distribution of prescription drugs manufactured at that
18 establishment and must comply with all the provisions of ss.
19 499.001-499.081 and the rules adopted under those sections
20 that apply to a wholesale distributor.
21 2. A prescription drug manufacturer permittee must
22 comply with all appropriate state and federal good
23 manufacturing practices.
24 (b) A person authorized to distribute prescription
25 drugs under this chapter is exempt from obtaining a permit
26 under this section if the person performs the limited
27 manufacturing operation of attaching a manufacturer's package
28 insert to an individual unit for further distribution of
29 prescription drugs packaged by the manufacturer in multi-unit
30 packages under the following conditions:
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1 1. The person does not open the immediate container
2 sealed by the manufacturer;
3 2. The manufacturer has not stated the package cannot
4 be broken;
5 3. The prescription drug is not available from the
6 manufacturer in an individual unit;
7 4. The individual unit is fully labeled for further
8 distribution;
9 5. The person has complied with all appropriate
10 federal registration requirements and state and federal
11 current good manufacturing practices including, but not
12 limited to, fully labeling all individual units of a
13 multi-unit package concurrent with penetrating the secondary
14 container;
15 6. The individual unit is distributed only to a health
16 care practitioner or EMS service provider for the purpose of
17 administration and not for dispensing or further wholesale
18 distribution; and
19 7. Notification is provided to the department in
20 writing that the person intends to engage in this activity.
21 (c)(b) An over-the-counter drug manufacturer's permit
22 is required for any person that engages in the manufacture of
23 an over-the-counter drug.
24 1. An over-the-counter drug manufacturer permittee may
25 not possess or purchase prescription drugs.
26 2. A pharmacy is exempt from obtaining an
27 over-the-counter drug manufacturer's permit if it is operating
28 in compliance with pharmacy practice standards as defined in
29 chapter 465 and the rules adopted under that chapter.
30
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1 3. An over-the-counter drug manufacturer permittee
2 must comply with all appropriate state and federal good
3 manufacturing practices.
4 (d)(c) A compressed medical gas manufacturer's permit
5 is required for any person that engages in the manufacture of
6 compressed medical gases or repackages compressed medical
7 gases from one container to another.
8 1. A compressed medical gas manufacturer permittee may
9 not manufacture or possess any prescription drug other than
10 compressed medical gases.
11 2. A compressed medical gas manufacturer permittee may
12 engage in wholesale distribution of compressed medical gases
13 manufactured at that establishment and must comply with all
14 the provisions of ss. 499.001-499.081 and the rules adopted
15 under those sections that apply to a wholesale distributor.
16 3. A compressed medical gas manufacturer permittee
17 must comply with all appropriate state and federal good
18 manufacturing practices.
19 (e)(d) A device manufacturer's permit is required for
20 any person that engages in the manufacture or assembly of
21 medical devices for human use in this state.
22 1. A manufacturer of medical devices in this state
23 must comply with all appropriate state and federal good
24 manufacturing practices.
25 2. The department shall adopt rules related to
26 storage, handling, and recordkeeping requirements for
27 manufacturers of medical devices for human use.
28 (f)(e) A cosmetic manufacturer's permit is required
29 for any person that manufactures cosmetics in this state.
30 1. A person that only labels or changes the labeling
31 of a cosmetic but does not open the container sealed by the
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1 manufacturer of the product is exempt from obtaining a permit
2 under this paragraph.
3 2. The department may adopt such rules as are
4 necessary for the protection of the public health, safety, and
5 welfare regarding good manufacturing practices that cosmetic
6 manufacturers must follow to ensure the safety of the
7 products.
8 Section 8. Subsection (1) of section 499.014, Florida
9 Statutes, is amended to read:
10 499.014 Distribution of legend drugs by hospitals,
11 health care entities, and charitable organizations; permits,
12 general requirements.--
13 (1) A restricted prescription drug distributor permit
14 is required for any person that engages in the distribution of
15 a legend drug, which distribution is made in accordance with
16 and is not considered "wholesale distribution" under paragraph
17 (1)(a) subparagraph (1)(a)1., subparagraph (1)(a)2., or
18 subparagraph (1)(a)3. of s. 499.012.
19 Section 9. Subsections (1) and (3) of section 499.015,
20 Florida Statutes, are amended to read:
21 499.015 Registration of drugs, devices, and cosmetics;
22 issuance of certificates of free sale.--
23 (1) Except for those persons exempted from the
24 definition in s. 499.003(23) s. 499.003(21), any person who
25 manufactures, packages, repackages, labels, or relabels a
26 drug, device, or cosmetic in this state must register such
27 drug, device, or cosmetic biennially with the department; pay
28 a fee in accordance with the fee schedule provided by s.
29 499.041; and comply with this section. The registrant must
30 list each separate and distinct drug, device, or cosmetic at
31 the time of registration.
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1 (3) Except for those persons exempted from the
2 definition in s. 499.033(23) s. 499.003(21), a person may not
3 sell any product that he or she has failed to register in
4 conformity with this section. Such failure to register
5 subjects such drug, device, or cosmetic product to seizure and
6 condemnation as provided in ss. 499.062-499.064, and subjects
7 such person to the penalties and remedies provided in ss.
8 499.001-499.081.
9 Section 10. Section 499.024, Florida Statutes, is
10 amended to read:
11 499.024 Drug product classification.--The secretary
12 shall adopt rules to classify drug products intended for use
13 by humans which the United States Food and Drug Administration
14 has not classified in the federal act or the Code of Federal
15 Regulations.
16 (1) The Florida Drug Technical Review Panel may review
17 and make recommendations on products.
18 (2) Drug products must be classified as proprietary,
19 prescription, or investigational drugs.
20 (3) If a product is distributed without required
21 labeling, it is misbranded while held for sale.
22 (3)(4) Any product that falls under the drug
23 definition, s. 499.003(13) s. 499.003(11), may be classified
24 under the authority of this section. This section does not
25 subject portable emergency oxygen inhalators to
26 classification; however, this section does not exempt any
27 person from ss. 499.01 and 499.015.
28 (4)(5) Any product classified under the authority of
29 this section reverts to the federal classification, if
30 different, upon the federal regulation or act becoming
31 effective.
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1 (5)(6) The department may by rule reclassify drugs
2 subject to ss. 499.001-499.081 when such classification action
3 is necessary to protect the public health.
4 (6)(7) The department may adopt rules that exempt from
5 any labeling or packaging requirements of ss. 499.001-499.081
6 drugs classified under this section if those requirements are
7 not necessary to protect the public health.
8 Section 11. Paragraph (d) is added to subsection (15)
9 of section 499.028, Florida Statutes, to read:
10 499.028 Drug samples or complimentary drugs; starter
11 packs; permits to distribute.--
12 (15) A person may not possess a prescription drug
13 sample unless:
14 (d) He or she is an officer or employee of a federal,
15 state, or local government acting within the scope of his or
16 her employment.
17 Section 12. Section 499.03, Florida Statutes, is
18 amended to read:
19 499.03 Possession of new drugs or legend drugs without
20 prescriptions unlawful; exemptions and exceptions.--
21 (1) A person may not possess, or possess with intent
22 to sell, dispense, or deliver, any habit-forming, toxic,
23 harmful, or new drug subject to ss. 499.003(24) and 499.023 s.
24 499.003(22), or legend drug as defined in s. 499.003, unless
25 the possession of the drug has been lawfully dispensed
26 pursuant to obtained by a valid prescription of a practitioner
27 licensed by law to prescribe the drug. However, this section
28 does not apply to the delivery of such drugs to persons
29 included in any of the classes named in this subsection, or to
30 the agents or employees of such persons, for use in the usual
31 course of their businesses or practices or in the performance
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1 of their official duties, as the case may be; nor does this
2 section apply to the possession of such drugs by those persons
3 or their agents or employees for such use:
4 (a) A licensed pharmacist or any person under the
5 licensed pharmacist's supervision while acting within the
6 scope of the licensed pharmacist's practice and a pharmacy's
7 permit;
8 (b) A licensed practitioner authorized by law to
9 prescribe legend drugs or any person under the licensed
10 practitioner's supervision while acting within the scope of
11 the licensed practitioner's practice;
12 (c) A qualified person who uses legend drugs for
13 lawful research, teaching, or testing, and not for resale;
14 (d) A licensed hospital or other institution that
15 procures such drugs for lawful administration or dispensing by
16 practitioners;
17 (e) An officer or employee of a federal, state, or
18 local government; or
19 (f) A person that holds a valid permit issued by the
20 department pursuant to ss. 499.001-499.081 which authorizes
21 that person to possess prescription drugs.
22 (2) The possession of a drug under subsection (1) by
23 any person not exempted under this section, which drug is not
24 properly labeled to indicate that possession is by a valid
25 prescription of a practitioner licensed by law to prescribe
26 such drug, is prima facie evidence that such possession is
27 unlawful.
28 (3) Violation of subsection (1) is a misdemeanor of
29 the second degree, punishable as provided in s. 775.082 or s.
30 775.083, except that possession with the intent to sell,
31
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1 dispense, or deliver is a third degree felony, punishable as
2 provided in s. 775.082, s. 775.083, or s. 775.084.
3 Section 13. Subsection (2) of section 499.041, Florida
4 Statutes, is amended and a new subsection (12) is added to
5 that section to read:
6 499.041 Schedule of fees for drug, device, and
7 cosmetic applications and permits, investigational drug
8 applications, product registrations, and free-sale
9 certificates; trust fund.--
10 (2) The department shall assess an applicant that is
11 required to have a wholesaling permit an annual fee within the
12 ranges established in this section for the specific type of
13 wholesaling.
14 (a) The fee for a prescription drug wholesaler's
15 permit may not be less than $300 or more than $400 annually;
16 (b) The fee for a compressed medical gas wholesaler's
17 permit may not be less than $200 or more than $300 annually;
18 (c) The fee for an out-of-state prescription drug
19 wholesaler's permit may not be less than $200 or more than
20 $300 annually.;
21 (d) The fee for a retail pharmacy wholesaler's permit
22 may not be less than $35 or more than $50 annually.
23 (12) The fees provided in this section are not
24 refundable.
25 Section 14. Section 499.051, Florida Statutes, is
26 amended to read:
27 499.051 Inspections and investigations.--
28 (1) The agents of the Department of Health and
29 Rehabilitative Services and of the Department of Law
30 Enforcement, after they present proper identification, may
31 inspect, monitor, and investigate any establishment permitted
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1 pursuant to ss. 499.001-499.081 during business hours for the
2 purpose of enforcing ss. 499.001-499.081, chapters 465, 501,
3 and 893, and the rules of the department that protect the
4 public health, safety, and welfare.
5 (2) In addition to the authority set forth in
6 subsection (1), the department and any duly designated officer
7 or employee of the department may enter and inspect any other
8 establishment for the purpose of determining compliance with
9 ss. 499.001-499.081 and rules adopted under those sections
10 regarding any drug, device, or cosmetic product. The authority
11 to enter and inspect does not extend to the practice of the
12 profession of pharmacy, as defined in chapter 465 and the
13 rules adopted under that chapter, in a pharmacy permitted
14 under chapter 465. The Department of Business and Professional
15 Regulation shall conduct routine inspections of retail
16 pharmacy wholesalers at the time of the regular pharmacy
17 permit inspection and shall send the inspection report
18 regarding drug wholesale activity to the Department of Health
19 and Rehabilitative Services.
20 (3) Agents of the Department of Health, upon
21 presentation of proper identification, may inspect, monitor,
22 and investigate, consistent with the purposes of this chapter,
23 any establishment at any time under exigent circumstances if
24 necessary to protect the public health and safety.
25 (4)(3) Any application for a permit or product
26 registration or for renewal of such permit or registration
27 made pursuant to ss. 499.001-499.081 and rules adopted under
28 those sections constitutes permission for any entry or
29 inspection of the premises in order to verify compliance with
30 those sections and rules; to discover, investigate, and
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1 determine the existence of compliance; or to elicit, receive,
2 respond to, and resolve complaints and violations.
3 (5)(4) The authority to inspect under this section
4 includes the authority to secure:
5 (a) Samples or specimens of any drug, device, or
6 cosmetic; or
7 (b) Such other evidence as is needed for any action to
8 enforce ss. 499.001-499.081 and the rules adopted under those
9 sections.
10 (6)(5) The complaint and all information obtained
11 pursuant to the investigation by the department are
12 confidential and exempt from the provisions of s. 119.07(1)
13 and s. 24(a), Art. I of the State Constitution until the
14 investigation and the enforcement action are completed.
15 However, trade secret information contained therein as defined
16 by s. 812.081(1)(c) shall remain confidential and exempt from
17 the provisions of s. 119.07(1) and s. 24(a), Art. I of the
18 State Constitution, as long as the information is retained by
19 the department. This subsection does not prohibit the
20 department from using such information for regulatory or
21 enforcement proceedings under this chapter or from providing
22 such information to any law enforcement agency or any other
23 regulatory agency. However, the receiving agency shall keep
24 such records confidential and exempt as provided in this
25 subsection. In addition, this subsection is not intended to
26 prevent compliance with the provisions of s. 499.0121(6)(d),
27 and the pedigree papers required in that subsection shall not
28 be deemed a trade secret.
29 Section 15. Subsection (1) of section 499.066, Florida
30 Statutes, is amended to read:
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1 499.066 Penalties; remedies.--In addition to other
2 penalties and other enforcement provisions:
3 (1) When the department believes that any person has
4 violated ss. 499.001-499.081 or any rules adopted pursuant to
5 those sections, it may issue and deliver an order to cease and
6 desist from such violation. Such cease and desist order takes
7 effect immediately upon issuance and remains in effect until
8 the department takes final agency action. A cease and desist
9 order is reviewable at the request of the person to whom it is
10 directed as follows:
11 (a) If formal proceedings have been requested and the
12 matter has been referred to the Division of Administrative
13 Hearings, a motion to abate or modify the cease and desist
14 order may be filed with the division. Any interlocutory order
15 of the presiding administrative law judge is binding on the
16 parties until final agency action is taken by the department.
17 (b) If informal proceedings have been requested, the
18 department may consider and determine a request from the
19 affected person to abate or modify the cease and desist order.
20 (c) If a person is aggrieved by a cease and desist
21 order after seeking to have the order abated or modified under
22 paragraph (a) or paragraph (b), the person may seek
23 interlocutory judicial review by the appropriate district
24 court of appeal under the applicable rules of appellate
25 procedure.
26 Section 16. Subsection (1) of section 499.069, Florida
27 Statutes, is amended to read:
28 499.069 Punishment for violations of s. 499.005;
29 dissemination of false advertisement.--
30 (1) Any person who violates any of the provisions of
31 s. 499.005 is guilty of a misdemeanor of the second degree,
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1 punishable as provided in s. 775.082 or s. 775.083; but, if
2 the violation is committed after a conviction of such person
3 under this section has become final, such person is guilty of
4 a misdemeanor of the first degree, punishable as provided in
5 s. 775.082 or s. 775.083 or as otherwise provided in ss.
6 499.001-499.081, except that any person who violates
7 subsection (8), subsection (10), subsection (14), subsection
8 (15), subsection (16), or subsection (17) of s. 499.005 is
9 guilty of a felony of the third degree, punishable as provided
10 in s. 775.082, s. 775.083, or s. 775.084, or as otherwise
11 provided in ss. 499.001-499.081.
12 Section 17. Section 499.072, Florida Statutes, is
13 created to read:
14 499.072 Drug Regulation Advisory Group; Exemptions.--
15 (1) There is created an independent advisory group,
16 designated as the Drug Regulation Advisory Group. The group
17 consists of 11 members appointed by the Secretary of the
18 Department of Health as follows:
19 (a) One member representing the prescription drug
20 wholesale industry in this state.
21 (b) One member representing pharmaceutical
22 manufacturers, who may represent pharmaceutical manufacturers
23 nationwide.
24 (c) One member who is a practicing pharmacist.
25 (d) One member representing the Agency for Health Care
26 Administration.
27 (e) One member who is a currently licensed medical
28 doctor in this state.
29 (f) One consumer representative.
30 (g) One member representing the cosmetic industry.
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1 (h) One member representing the compressed medical gas
2 industry.
3 (i) One member representing the medical device
4 manufacturing industry.
5 (j) The Executive Director of the Board of Pharmacy
6 who is an ex officio member.
7 (k) One member representing the department who will
8 chair group meetings.
9 (2) Members serve a term of 4 years, with the
10 exception of the Executive Director of the Board of Pharmacy
11 and the department representative who may serve indefinitely.
12 Members of the group may be reappointed. A vacancy in
13 membership occurring before the expiration of a term must be
14 filled by a member appointed by the Secretary of the
15 Department of Health for a full term.
16 (3) The group will meet upon request of the
17 department, but no more than 4 times a year. Members of the
18 group serve without compensation, but may be reimbursed for
19 per diem and travel expenses as provided in s. 112.061.
20 (4) The purpose and duties of this group include:
21 (a) Making recommendations to the Secretary regarding
22 authorizations for the sale, purchase, trade or other transfer
23 of a prescription drug under s. 499.012(1)(b)2.
24 (b) Making recommendations to the department regarding
25 enforcement priorities under chapter 499.
26 (c) Briefing the department on industry trends that
27 affect chapter 499.
28 (d) Providing information and guidance on issues
29 submitted by the department to the group.
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1 (e) Facilitating the dissemination of relevant
2 information of current issues affecting the public health
3 within the scope and responsibility of chapter 499.
4 (5) The department may publish Compliance Policy
5 Guidelines that set forth enforcement priorities or other
6 recommendations of the Drug Regulation Advisory Group when it
7 is in the best interest of the public health.
8 Section 18. Subsection (2) of section 499.62, Florida
9 Statutes, is amended to read:
10 499.62 License or permit required of manufacturer,
11 distributor, dealer, or purchaser of ether.--
12 (2) Any person who manufactures, distributes, or deals
13 in ether in this state must possess a current valid license
14 issued by the department, except that:
15 (a) A manufacturer, distributor, or dealer who also
16 purchases ether in this state shall not be required to obtain
17 an additional permit as a purchaser of ether.
18 (b) A permit is not required for an establishment
19 located outside of this state which is only engaged in an
20 intracompany sale or transfer of ether from the out-of-state
21 establishment to a permitted person in this state if both
22 locations are under common control. The recordkeeping
23 requirements of s. 499.66 must be followed for this
24 transaction.
25 Section 19. This act shall take effect July 1, 1998.
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2 SENATE SUMMARY
3 Amends various sections of ch. 499, F.S., relating to the
Department of Health's regulation, inspection, and
4 permitting of persons dealing in prescription drugs,
cosmetics, and household products. Salient provisions
5 include clarifying prohibited acts; clarifying wholesale
distribution and permitting requirements; authorizing
6 transfers for government purposes under certain
conditions; authorizing a retail pharmacy to transfer
7 limited quantities of prescription drugs without a
wholesaler permit; clarifying existing rulemaking
8 authority for the storage and handling of drugs;
providing an expiration date of a practitioner's order
9 for medical oxygen; clarifying provisions relating to the
sale of veterinary drugs to the public; the authorization
10 of government officers and employees to possess
complimentary prescription drugs when acting within the
11 scope of employment; making fees for drug, device, and
cosmetic applications and permits nonrefundable;
12 authorization of department agents to inspect and
investigate during nonbusiness hours, if necessary, to
13 protect the public health; authorizing cease and desist
orders to take effect immediately with provision for the
14 person affected to move to abate or modify the order;
creation of the Drug Regulation Advisory Group to make
15 recommendations to the Secretary of the Department of
Health regarding authorizations for the sale, purchase,
16 trade, or transfer of prescription drugs and enforcement
priorities; and the deletion of a requirement that the
17 Department of Business and Professional Regulation
inspect retail pharmacy wholesalers. (See bill for
18 details.)
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