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2023 Florida Statutes (including 2023C)

Title XXXIII REGULATION OF TRADE, COMMERCE, INVESTMENTS, AND SOLICITATIONS
Chapter 499 FLORIDA DRUG AND COSMETIC ACT Entire Chapter
SECTION 01
Permits.
F.S. 499.01
499.01 Permits.—
1(1) Before operating, a permit is required for each person and establishment that intends to operate as:
(a) A prescription drug manufacturer;
(b) A prescription drug repackager;
(c) A nonresident prescription drug manufacturer;
(d) A nonresident prescription drug repackager;
(e) A prescription drug wholesale distributor;
(f) An out-of-state prescription drug wholesale distributor;
(g) A retail pharmacy drug wholesale distributor;
(h) A restricted prescription drug distributor;
(i) A complimentary drug distributor;
(j) A freight forwarder;
(k) A veterinary prescription drug retail establishment;
(l) A veterinary prescription drug wholesale distributor;
(m) A limited prescription drug veterinary wholesale distributor;
(n) An over-the-counter drug manufacturer;
(o) A device manufacturer;
(p) A cosmetic manufacturer;
(q) A third party logistics provider; or
(r) A health care clinic establishment.
1(2) The following permits are established:
(a) Prescription drug manufacturer permit.—A prescription drug manufacturer permit is required for any person that is a manufacturer of a prescription drug and that manufactures or distributes such prescription drugs in this state.
1. A person that operates an establishment permitted as a prescription drug manufacturer may engage in distribution of prescription drugs for which the person is the manufacturer and must comply with s. 499.0121 and all other provisions of this part and rules adopted under this part. The department shall adopt rules for issuing a virtual prescription drug manufacturer permit to a person who engages in the manufacture of prescription drugs but does not make or take physical possession of any prescription drugs. The rules adopted by the department under this section may exempt virtual manufacturers from certain establishment, security, and storage requirements set forth in s. 499.0121.
2. A prescription drug manufacturer must comply with all appropriate state and federal good manufacturing practices.
3. A blood establishment, as defined in s. 381.06014, operating in a manner consistent with the provisions of 21 C.F.R. parts 211 and 600-640, and manufacturing only the prescription drugs described in s. 499.003(48)(j) is not required to be permitted as a prescription drug manufacturer under this paragraph or to register products under s. 499.015.
(b) Prescription drug repackager permit.—A prescription drug repackager permit is required for any person that repackages a prescription drug in this state.
1. A person that operates an establishment permitted as a prescription drug repackager may engage in distribution of prescription drugs repackaged at that establishment and must comply with all of the provisions of this part and the rules adopted under this part that apply to a prescription drug manufacturer.
2. A prescription drug repackager must comply with all appropriate state and federal good manufacturing practices.
3. A prescription drug repackager permit is not required for distributing medicinal drugs or prepackaged drug products between entities under common control which each hold either an active Class III institutional pharmacy permit under chapter 465 or an active health care clinic establishment permit under paragraph (r). For purposes of this subparagraph, the term “common control” has the same meaning as in s. 499.003(48)(a)3.
1(c) Nonresident prescription drug manufacturer permit.—A nonresident prescription drug manufacturer permit is required for any person that is a manufacturer of prescription drugs, unless permitted as a third party logistics provider, located outside of this state or outside the United States and that engages in the distribution in this state of such prescription drugs. Each such manufacturer must be permitted by the department and comply with all of the provisions required of a prescription drug manufacturer under this part. The department shall adopt rules for issuing a virtual nonresident prescription drug manufacturer permit to a person who engages in the manufacture of prescription drugs but does not make or take physical possession of any prescription drugs. The rules adopted by the department under this section may exempt virtual nonresident manufacturers from certain establishment, security, and storage requirements set forth in s. 499.0121.
1. A person that distributes prescription drugs for which the person is not the manufacturer must also obtain an out-of-state prescription drug wholesale distributor permit or third party logistics provider permit pursuant to this section to engage in the distribution of such prescription drugs when required by this part. This subparagraph does not apply to a manufacturer that distributes prescription drugs only for the manufacturer of the prescription drugs where both manufacturers are affiliates.
2. Any such person must comply with the licensing or permitting requirements of the jurisdiction in which the establishment is located and the federal act, and any prescription drug distributed into this state must comply with this part. If a person intends to import prescription drugs from a foreign country into this state, the nonresident prescription drug manufacturer must provide to the department a list identifying each prescription drug it intends to import and document approval by the United States Food and Drug Administration for such importation.
(d) Nonresident prescription drug repackager permit.—A nonresident prescription drug repackager permit is required for any person located outside of this state, but within the United States or its territories, that repackages prescription drugs and engages in the distribution of such prescription drugs into this state.
1. A nonresident prescription drug repackager must comply with all of the provisions of this section and the rules adopted under this section that apply to a prescription drug manufacturer.
2. A nonresident prescription drug repackager must be permitted by the department and comply with all appropriate state and federal good manufacturing practices.
3. A nonresident prescription drug repackager must be registered as a drug establishment with the United States Food and Drug Administration.
(e) Prescription drug wholesale distributor permit.—A prescription drug wholesale distributor permit is required for any person who is a wholesale distributor of prescription drugs and that wholesale distributes such prescription drugs in this state. The department may adopt rules for issuing a prescription drug wholesale distributor-broker permit to a person who engages in the wholesale distribution of prescription drugs and does not take physical possession of any prescription drugs.
(f) Out-of-state prescription drug wholesale distributor permit.—An out-of-state prescription drug wholesale distributor permit is required for any person that is a wholesale distributor located outside this state, but within the United States or its territories, which engages in the wholesale distribution of prescription drugs into this state. The out-of-state prescription drug wholesale distributor must maintain at all times a license or permit to engage in the wholesale distribution of prescription drugs in compliance with laws of the state in which it is a resident. If the state from which the wholesale distributor distributes prescription drugs does not require a license to engage in the wholesale distribution of prescription drugs, the distributor must be licensed as a wholesale distributor as required by the federal act.
(g) Retail pharmacy drug wholesale distributor permit.—A retail pharmacy drug wholesale distributor is a retail pharmacy engaged in wholesale distribution of prescription drugs within this state under the following conditions:
1. The pharmacy must obtain a retail pharmacy drug wholesale distributor permit pursuant to this part and rules adopted under this part.
2. The wholesale distribution activity does not exceed 30 percent of the total annual purchases of prescription drugs. If the wholesale distribution activity exceeds the 30-percent maximum, the pharmacy must obtain a prescription drug wholesale distributor permit.
3. The transfer of prescription drugs that appear in any schedule contained in chapter 893 is subject to chapter 893 and the federal Comprehensive Drug Abuse Prevention and Control Act of 1970.
4. The transfer is between a retail pharmacy and another retail pharmacy, or a Modified Class II institutional pharmacy, or a health care practitioner licensed in this state and authorized by law to dispense or prescribe prescription drugs.
5. All records of sales of prescription drugs subject to this section must be maintained separate and distinct from other records and comply with the recordkeeping requirements of this part.
(h) Restricted prescription drug distributor permit.—
1. A restricted prescription drug distributor permit is required for:
a. Any person located in this state who engages in the distribution of a prescription drug, which distribution is not considered “wholesale distribution” under s. 499.003(48)(a).
b. Any person located in this state who engages in the receipt or distribution of a prescription drug in this state for the purpose of processing its return or its destruction if such person is not the person initiating the return, the prescription drug wholesale supplier of the person initiating the return, or the manufacturer of the drug.
c. A blood establishment located in this state which collects blood and blood components only from volunteer donors as defined in s. 381.06014 or pursuant to an authorized practitioner’s order for medical treatment or therapy and engages in the wholesale distribution of a prescription drug not described in s. 499.003(48)(j) to a health care entity. A mobile blood unit operated by a blood establishment permitted under this sub-subparagraph is not required to be separately permitted. The health care entity receiving a prescription drug distributed under this sub-subparagraph must be licensed as a closed pharmacy or provide health care services at that establishment. The blood establishment must operate in accordance with s. 381.06014 and may distribute only:
(I) Prescription drugs indicated for a bleeding or clotting disorder or anemia;
(II) Blood-collection containers approved under s. 505 of the federal act;
(III) Drugs that are blood derivatives, or a recombinant or synthetic form of a blood derivative;
(IV) Prescription drugs that are identified in rules adopted by the department and that are essential to services performed or provided by blood establishments and authorized for distribution by blood establishments under federal law; or
(V) To the extent authorized by federal law, drugs necessary to collect blood or blood components from volunteer blood donors; for blood establishment personnel to perform therapeutic procedures under the direction and supervision of a licensed physician; and to diagnose, treat, manage, and prevent any reaction of a volunteer blood donor or a patient undergoing a therapeutic procedure performed under the direction and supervision of a licensed physician,

as long as all of the health care services provided by the blood establishment are related to its activities as a registered blood establishment or the health care services consist of collecting, processing, storing, or administering human hematopoietic stem cells or progenitor cells or performing diagnostic testing of specimens if such specimens are tested together with specimens undergoing routine donor testing. The blood establishment may purchase and possess the drugs described in this sub-subparagraph without a health care clinic establishment permit.

2. Storage, handling, and recordkeeping of these distributions by a person required to be permitted as a restricted prescription drug distributor must be in accordance with the requirements for wholesale distributors under s. 499.0121.
3. A person who applies for a permit as a restricted prescription drug distributor, or for the renewal of such a permit, must provide to the department the information required under s. 499.012.
4. The department may adopt rules regarding the distribution of prescription drugs by hospitals, health care entities, charitable organizations, other persons not involved in wholesale distribution, and blood establishments, which rules are necessary for the protection of the public health, safety, and welfare.
5. A restricted prescription drug distributor permit is not required for distributions between pharmacies that each hold an active permit under chapter 465, have a common ownership, and are operating in a freestanding end-stage renal dialysis clinic, if such distributions are made to meet the immediate emergency medical needs of specifically identified patients and do not occur with such frequency as to amount to the regular and systematic supplying of that drug between the pharmacies. The department shall adopt rules establishing when the distribution of a prescription drug under this subparagraph amounts to the regular and systematic supplying of that drug.
6. A restricted prescription drug distributor permit is not required for distributing medicinal drugs or prepackaged drug products between entities under common control that each hold either an active Class III institutional pharmacy permit under chapter 465 or an active health care clinic establishment permit under paragraph (r). For purposes of this subparagraph, the term “common control” has the same meaning as in s. 499.003(48)(a)3.
(i) Complimentary drug distributor permit.—A complimentary drug distributor permit is required for any person that engages in the distribution of a complimentary drug, subject to the requirements of s. 499.028.
(j) Freight forwarder permit.—A freight forwarder permit is required for any person that engages in the distribution of a prescription drug as a freight forwarder unless the person is a common carrier. The storage, handling, and recordkeeping of such distributions must comply with the requirements for wholesale distributors under s. 499.0121. A freight forwarder must provide the source of the prescription drugs with a validated airway bill, bill of lading, or other appropriate documentation to evidence the exportation of the product.
(k) Veterinary prescription drug retail establishment permit.—A veterinary prescription drug retail establishment permit is required for any person that sells veterinary prescription drugs to the public but does not include a pharmacy licensed under chapter 465.
1. The sale to the public must be based on a valid written order from a veterinarian licensed in this state who has a valid client-veterinarian relationship with the purchaser’s animal.
2. Veterinary prescription drugs may not be sold in excess of the amount clearly indicated on the order or beyond the date indicated on the order.
3. An order may not be valid for more than 1 year.
4. A veterinary prescription drug retail establishment may not purchase, sell, trade, or possess human prescription drugs or any controlled substance as defined in chapter 893.
5. A veterinary prescription drug retail establishment must sell a veterinary prescription drug in the original, sealed manufacturer’s container with all labeling intact and legible. The department may adopt by rule additional labeling requirements for the sale of a veterinary prescription drug.
6. A veterinary prescription drug retail establishment must comply with all of the wholesale distribution requirements of s. 499.0121.
7. Prescription drugs sold by a veterinary prescription drug retail establishment pursuant to a practitioner’s order may not be returned into the retail establishment’s inventory.
(l) Veterinary prescription drug wholesale distributor permit.—A veterinary prescription drug wholesale distributor permit is required for any person that engages in the distribution of veterinary prescription drugs in or into this state. A veterinary prescription drug wholesale distributor that also distributes prescription drugs subject to, defined by, or described by s. 503(b) of the Federal Food, Drug, and Cosmetic Act which it did not manufacture must obtain a permit as a prescription drug wholesale distributor, an out-of-state prescription drug wholesale distributor, or a limited prescription drug veterinary wholesale distributor in lieu of the veterinary prescription drug wholesale distributor permit. A veterinary prescription drug wholesale distributor must comply with the requirements for wholesale distributors under s. 499.0121.
(m) Limited prescription drug veterinary wholesale distributor permit.—Unless engaging in the activities of and permitted as a prescription drug manufacturer, nonresident prescription drug manufacturer, prescription drug wholesale distributor, or out-of-state prescription drug wholesale distributor, a limited prescription drug veterinary wholesale distributor permit is required for any person that engages in the distribution in or into this state of veterinary prescription drugs and prescription drugs subject to, defined by, or described by s. 503(b) of the Federal Food, Drug, and Cosmetic Act under the following conditions:
1. The person is engaged in the business of wholesaling prescription and veterinary prescription drugs to persons:
a. Licensed as veterinarians practicing on a full-time basis;
b. Regularly and lawfully engaged in instruction in veterinary medicine;
c. Regularly and lawfully engaged in law enforcement activities;
d. For use in research not involving clinical use; or
e. For use in chemical analysis or physical testing or for purposes of instruction in law enforcement activities, research, or testing.
2. No more than 30 percent of total annual prescription drug sales may be prescription drugs approved for human use which are subject to, defined by, or described by s. 503(b) of the Federal Food, Drug, and Cosmetic Act.
3. The person does not distribute in any jurisdiction prescription drugs subject to, defined by, or described by s. 503(b) of the Federal Food, Drug, and Cosmetic Act to any person who is authorized to sell, distribute, purchase, trade, or use these drugs on or for humans.
4. A limited prescription drug veterinary wholesale distributor that applies to the department for a new permit or the renewal of a permit must submit a bond of $20,000, or other equivalent means of security acceptable to the department, such as an irrevocable letter of credit or a deposit in a trust account or financial institution, payable to the Professional Regulation Trust Fund. The purpose of the bond is to secure payment of any administrative penalties imposed by the department and any fees and costs incurred by the department regarding that permit which are authorized under state law and which the permittee fails to pay 30 days after the fine or costs become final. The department may make a claim against such bond or security until 1 year after the permittee’s license ceases to be valid or until 60 days after any administrative or legal proceeding authorized in this part which involves the permittee is concluded, including any appeal, whichever occurs later.
5. A limited prescription drug veterinary wholesale distributor must maintain at all times a license or permit to engage in the wholesale distribution of prescription drugs in compliance with laws of the state in which it is a resident.
6. A limited prescription drug veterinary wholesale distributor must comply with the requirements for wholesale distributors under s. 499.0121.
7. A limited prescription drug veterinary wholesale distributor may not return to inventory for subsequent wholesale distribution any prescription drug subject to, defined by, or described by s. 503(b) of the Federal Food, Drug, and Cosmetic Act which has been returned by a veterinarian.
8. A limited prescription drug veterinary wholesale distributor permit is not required for an intracompany sale or transfer of a prescription drug from an out-of-state establishment that is duly licensed to engage in the wholesale distribution of prescription drugs in its state of residence to a licensed limited prescription drug veterinary wholesale distributor in this state if both wholesale distributors conduct wholesale distributions of prescription drugs under the same business name. The recordkeeping requirements of s. 499.0121(6) must be followed for this transaction.
(n) Over-the-counter drug manufacturer permit.—An over-the-counter drug manufacturer permit is required for any person that engages in the manufacture or repackaging of an over-the-counter drug.
1. An over-the-counter drug manufacturer may not possess or purchase prescription drugs.
2. A pharmacy is exempt from obtaining an over-the-counter drug manufacturer permit if it is operating in compliance with pharmacy practice standards as defined in chapter 465 and rules adopted under that chapter.
3. An over-the-counter drug manufacturer must comply with all appropriate state and federal good manufacturing practices.
(o) Device manufacturer permit.—
1. A device manufacturer permit is required for any person that engages in the manufacture, repackaging, or assembly of medical devices for human use in this state, except that a permit is not required if:
a. The person is engaged only in manufacturing, repackaging, or assembling a medical device pursuant to a practitioner’s order for a specific patient; or
b. The person does not manufacture, repackage, or assemble any medical devices or components for such devices, except those devices or components which are exempt from registration pursuant to s. 499.015(8).
2. A manufacturer or repackager of medical devices in this state must comply with all appropriate state and federal good manufacturing practices and quality system rules.
3. The department shall adopt rules related to storage, handling, and recordkeeping requirements for manufacturers of medical devices for human use.
(p) Cosmetic manufacturer permit.—A cosmetic manufacturer permit is required for any person that manufactures or repackages cosmetics in this state. A person that only labels or changes the labeling of a cosmetic but does not open the container sealed by the manufacturer of the product is exempt from obtaining a permit under this paragraph. A person who manufactures cosmetics and has annual gross sales of $25,000 or less is exempt from the permit requirements of this paragraph. Upon request, an exempt cosmetic manufacturer must provide to the department written documentation to verify his or her annual gross sales, including all sales of cosmetic products at any location, regardless of the types of products sold or the number of persons involved in the operation.
1. An exempt cosmetic manufacturer may only:
a. Sell prepackaged cosmetics affixed with a label containing information required by the United States Food and Drug Administration.
b. Manufacture and sell cosmetics that are soaps, not otherwise exempt from the definition of cosmetics, lotions, moisturizers, and creams.
c. Sell cosmetics that are not adulterated or misbranded in accordance with 21 U.S.C. ss. 361 and 362.
d. Sell cosmetic products that are stored on the premises of the cosmetic manufacturing operation.
2. Each unit of cosmetics manufactured under this paragraph must contain, in contrasting color and not less than 10-point type, the following statement: “Made by a manufacturer exempt from Florida’s cosmetic manufacturing permit requirements.”
3. The department may investigate any complaint which alleges that an exempt cosmetic manufacturer has violated an applicable provision of this chapter or a rule adopted under this chapter. The department’s authorized officer or employee may enter and inspect the premises of an exempt cosmetic manufacturer to determine compliance with this chapter and department rules, as applicable. A refusal to permit an authorized officer or employee of the department to enter the premises or to conduct an inspection is a violation of s. 499.005(6) and is grounds for disciplinary action pursuant to s. 499.066.
4. This paragraph does not exempt any person from any state or federal tax law, rule, regulation, or certificate or from any county or municipal law or ordinance that applies to cosmetic manufacturing.
(q) Third party logistics provider permit.—A third party logistics provider permit is required for any person that contracts with a prescription drug wholesale distributor or prescription drug manufacturer to provide warehousing, distribution, or other logistics services on behalf of a manufacturer, wholesale distributor, or dispenser, but who does not take title to the prescription drug or have responsibility to direct the sale or disposition of the prescription drug. A third party logistics provider located outside of this state must be licensed in the state or territory from which the prescription drug is distributed by the third party logistics provider. If the state or territory from which the third party logistics provider originates does not require a license to operate as a third party logistics provider, the third party logistics provider must be licensed as a third party logistics provider as required by the federal act. Each third party logistics provider permittee shall comply with s. 499.0121 and other rules that the department requires.
(r) Health care clinic establishment permit.—A health care clinic establishment permit is required for the purchase of a prescription drug by a place of business at one general physical location that provides health care or veterinary services, which is owned and operated by a business entity that has been issued a federal employer tax identification number. For the purpose of this paragraph, the term “qualifying practitioner” means a licensed health care practitioner defined in s. 456.001, or a veterinarian licensed under chapter 474, who is authorized under the appropriate practice act to prescribe and administer a prescription drug.
1. An establishment must provide, as part of the application required under s. 499.012, designation of a qualifying practitioner who will be responsible for complying with all legal and regulatory requirements related to the purchase, recordkeeping, storage, and handling of the prescription drugs. In addition, the designated qualifying practitioner shall be the practitioner whose name, establishment address, and license number is used on all distribution documents for prescription drugs purchased or returned by the health care clinic establishment. Upon initial appointment of a qualifying practitioner, the qualifying practitioner and the health care clinic establishment shall notify the department on a form furnished by the department within 10 days after such employment. In addition, the qualifying practitioner and health care clinic establishment shall notify the department within 10 days after any subsequent change.
2. The health care clinic establishment must employ a qualifying practitioner at each establishment.
3. In addition to the remedies and penalties provided in this part, a violation of this chapter by the health care clinic establishment or qualifying practitioner constitutes grounds for discipline of the qualifying practitioner by the appropriate regulatory board.
4. The purchase of prescription drugs by the health care clinic establishment is prohibited during any period of time when the establishment does not comply with this paragraph.
5. A health care clinic establishment permit is not a pharmacy permit or otherwise subject to chapter 465. A health care clinic establishment that meets the criteria of a modified Class II institutional pharmacy under s. 465.019 is not eligible to be permitted under this paragraph.
6. This paragraph does not apply to the purchase of a prescription drug by a licensed practitioner under his or her license.
(3) A nonresident prescription drug manufacturer permit is not required for a manufacturer to distribute a prescription drug active pharmaceutical ingredient that it manufactures to a prescription drug manufacturer permitted in this state intended for research and development and not for resale or human use other than lawful clinical trials and biostudies authorized and regulated by federal law. A manufacturer claiming to be exempt from the permit requirements of this subsection and the prescription drug manufacturer purchasing and receiving the active pharmaceutical ingredient shall comply with the recordkeeping requirements of s. 499.0121(6). The prescription drug manufacturer purchasing and receiving the active pharmaceutical ingredient shall maintain on file a record of the FDA registration number; if available, the out-of-state license, permit, or registration number; and, if available, a copy of the most current FDA inspection report, for all manufacturers from whom they purchase active pharmaceutical ingredients under this section. The failure to comply with the requirements of this subsection, or rules adopted by the department to administer this subsection, for the purchase of prescription drug active pharmaceutical ingredients is a violation of s. 499.005(14), and a knowing failure is a violation of s. 499.0051(3).
(a) The immediate package or container of a prescription drug active pharmaceutical ingredient distributed into the state that is intended for research and development under this subsection shall bear a label prominently displaying the statement: “Caution: Research and Development Only—Not for Manufacturing, Compounding, or Resale.”
(b) A prescription drug manufacturer that obtains a prescription drug active pharmaceutical ingredient under this subsection for use in clinical trials and or biostudies authorized and regulated by federal law must create and maintain records detailing the specific clinical trials or biostudies for which the prescription drug active pharmaceutical ingredient was obtained.
(4)(a) A permit issued under this part is not required to distribute a prescription drug active pharmaceutical ingredient from an establishment located in the United States to an establishment located in this state permitted as a prescription drug manufacturer under this part for use by the recipient in preparing, deriving, processing, producing, or fabricating a prescription drug finished dosage form at the establishment in this state where the product is received under an approved and otherwise valid New Drug Approval Application, Abbreviated New Drug Application, New Animal Drug Application, or Therapeutic Biologic Application, provided that the application, active pharmaceutical ingredient, or finished dosage form has not been withdrawn or removed from the market in this country for public health reasons.
1. Any distributor claiming exemption from permitting requirements pursuant to this paragraph shall maintain a license, permit, or registration to engage in the wholesale distribution of prescription drugs under the laws of the state from which the product is distributed. If the state from which the prescription drugs are distributed does not require a license to engage in the wholesale distribution of prescription drugs, the distributor must be licensed as a wholesale distributor as required by the federal act.
2. Any distributor claiming exemption from permitting requirements pursuant to this paragraph and the prescription drug manufacturer purchasing and receiving the active pharmaceutical ingredient shall comply with the recordkeeping requirements of s. 499.0121(6).
(b) A permit issued under this part is not required to distribute a prescription drug that has not been repackaged from an establishment located in the United States to an establishment located in this state permitted as a prescription drug manufacturer under this part for research and development or to a holder of a letter of exemption issued by the department under s. 499.03(4) for research, teaching, or testing.
1. Any distributor claiming exemption from permitting requirements pursuant to this paragraph shall maintain a license, permit, or registration to engage in the wholesale distribution of prescription drugs under the laws of the state from which the product is distributed. If the state from which the prescription drugs are distributed does not require a license to engage in the wholesale distribution of prescription drugs, the distributor must be licensed as a wholesale distributor as required by the federal act.
2. All purchasers and recipients of any prescription drugs distributed pursuant to this paragraph shall ensure that the products are not resold or used, directly or indirectly, on humans except in lawful clinical trials and biostudies authorized and regulated by federal law.
3. Any distributor claiming exemption from permitting requirements pursuant to this paragraph, and the purchaser and recipient of the prescription drug, shall comply with the recordkeeping requirements of s. 499.0121(6).
4. The immediate package or container of any active pharmaceutical ingredient distributed into the state that is intended for teaching, testing, research, and development shall bear a label prominently displaying the statement: “Caution: Research, Teaching, or Testing Only – Not for Manufacturing, Compounding, or Resale.”
(c) An out-of-state prescription drug wholesale distributor permit is not required for an intracompany sale or transfer of a prescription drug from an out-of-state establishment that is duly licensed as a prescription drug wholesale distributor in its state of residence to a licensed prescription drug wholesale distributor in this state, if both wholesale distributors conduct wholesale distributions of prescription drugs under the same business name. The recordkeeping requirements of s. 499.0121(6) must be followed for such transactions.
(d) Persons receiving prescription drugs from a source claimed to be exempt from permitting requirements under this subsection shall maintain on file:
1. A record of the FDA establishment registration number, if any;
2. The resident state or federal license, registration, or permit that authorizes the source to distribute prescription drugs; and
3. A copy of the most recent resident state or FDA inspection report, for all distributors and establishments from whom they purchase or receive prescription drugs under this subsection.
(e) All persons claiming exemption from permitting requirements pursuant to this subsection who engage in the distribution of prescription drugs within or into the state are subject to this part, including ss. 499.005 and 499.0051, and shall make available, within 48 hours, to the department on request all records related to any prescription drugs distributed under this subsection, including those records described in s. 499.051(4), regardless of the location where the records are stored.
(f) A person purchasing and receiving a prescription drug from a person claimed to be exempt from licensing requirements pursuant to this subsection shall report to the department in writing within 14 days after receiving any product that is misbranded or adulterated or that fails to meet minimum standards set forth in the official compendium or state or federal good manufacturing practices for identity, purity, potency, or sterility, regardless of whether the product is thereafter rehabilitated, quarantined, returned, or destroyed.
(g) The department may adopt rules to administer this subsection which are necessary for the protection of the public health, safety, and welfare. Failure to comply with the requirements of this subsection, or rules adopted by the department to administer this subsection, is a violation of s. 499.005(14), and a knowing failure is a violation of s. 499.0051(3).
(h) This subsection does not relieve any person from any requirement prescribed by law with respect to controlled substances as defined in the applicable federal and state laws.
History.—s. 34, ch. 82-225; s. 108, ch. 83-218; s. 1, ch. 83-265; ss. 14, 15, 18, 19, 52, ch. 92-69; ss. 30, 31, 34, 35, ch. 98-151; ss. 37, 40, ch. 2000-242; s. 20, ch. 2001-53; s. 138, ch. 2001-277; ss. 11, 12, 13, 14, 18, 19, ch. 2003-155; s. 85, ch. 2004-5; ss. 2, 3, ch. 2004-328; ss. 2, 3, ch. 2006-92; ss. 22, 25, ch. 2007-6; ss. 10, 11, ch. 2008-207; s. 2, ch. 2009-221; ss. 23, 39, ch. 2010-161; s. 4, ch. 2012-37; s. 34, ch. 2012-61; s. 11, ch. 2012-143; s. 88, ch. 2013-15; s. 3, ch. 2014-89; s. 6, ch. 2016-212; s. 6, ch. 2018-95; s. 6, ch. 2019-99; s. 7, ch. 2021-135.
1Note.—

A. Section 11, ch. 2019-99, provides in part that “[i]mplementation of sections 2 through 10 of this act is contingent upon authorization granted under federal law, rule, or approval.” Section 11, ch. 2019-99, was codified as s. 499.02851. Section 12, ch. 2019-99, provides that “[t]his act shall take effect July 1, 2019.”

B. Subject to the contingency as to implementation in s. 11, ch. 2019-99, s. 6, ch. 2019-99, amends subsection (1) and paragraph (2)(c) and adds paragraph (2)(s), to read:

(1) Before operating, a permit is required for each person and establishment that intends to operate as:

(a) A prescription drug manufacturer;

(b) A prescription drug repackager;

(c) A nonresident prescription drug manufacturer;

(d) A nonresident prescription drug repackager;

(e) A prescription drug wholesale distributor;

(f) An out-of-state prescription drug wholesale distributor;

(g) A retail pharmacy drug wholesale distributor;

(h) A restricted prescription drug distributor;

(i) A complimentary drug distributor;

(j) A freight forwarder;

(k) A veterinary prescription drug retail establishment;

(l) A veterinary prescription drug wholesale distributor;

(m) A limited prescription drug veterinary wholesale distributor;

(n) An over-the-counter drug manufacturer;

(o) A device manufacturer;

(p) A cosmetic manufacturer;

(q) A third party logistics provider;

(r) A health care clinic establishment; or

(s) An international prescription drug wholesale distributor.

* * * * *

(c) Nonresident prescription drug manufacturer permit.—A nonresident prescription drug manufacturer permit is required for any person that is a manufacturer of prescription drugs, unless permitted as a third party logistics provider, located outside of this state or outside the United States and that engages in the distribution in this state of such prescription drugs. Each such manufacturer must be permitted by the department and comply with all of the provisions required of a prescription drug manufacturer under this part. The department shall adopt rules for issuing a virtual nonresident prescription drug manufacturer permit to a person who engages in the manufacture of prescription drugs but does not make or take physical possession of any prescription drugs. The rules adopted by the department under this section may exempt virtual nonresident manufacturers from certain establishment, security, and storage requirements set forth in s. 499.0121.

1. A person that distributes prescription drugs for which the person is not the manufacturer must also obtain an out-of-state prescription drug wholesale distributor permit, an international prescription drug wholesale distributor permit, or third party logistics provider permit pursuant to this section to engage in the distribution of such prescription drugs when required by this part. This subparagraph does not apply to a manufacturer that distributes prescription drugs only for the manufacturer of the prescription drugs where both manufacturers are affiliates.

2. Any such person must comply with the licensing or permitting requirements of the jurisdiction in which the establishment is located and the federal act, and any prescription drug distributed into this state must comply with this part. If a person intends to import prescription drugs from a foreign country into this state, the nonresident prescription drug manufacturer must provide to the department a list identifying each prescription drug it intends to import and document approval by the United States Food and Drug Administration for such importation.

3.a. A nonresident prescription drug manufacturer that has registered to participate in the International Prescription Drug Importation Program pursuant to this section is not required to provide the list and approval required by subparagraph 2. for prescription drugs imported under that program.

b. To participate as an exporter of prescription drugs into this state under the International Prescription Drug Importation Program established under s. 499.0285, a nonresident prescription drug manufacturer located outside of the United States must register with the Department of Business and Professional Regulation before engaging in any activities under that section. Such manufacturer must be licensed or permitted in a country with which the United States has a current mutual recognition agreement, cooperation agreement, memorandum of understanding, or other federal mechanism recognizing the country’s adherence to current good manufacturing practices for pharmaceutical products.

c. The department shall adopt rules governing the financial responsibility of a nonresident prescription drug manufacturer licensee or permittee. The rules will establish, at a minimum, financial reporting requirements, standards for financial capability to perform the functions governed by the permit, and requirements for ensuring permittees and their contractors can be held accountable for the financial consequences of any act of malfeasance or misfeasance or fraudulent or dishonest act or acts committed by the permittee or its contractors.

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(s) International prescription drug wholesale distributor.—

1. A wholesale distributor located outside of the United States must obtain an international prescription drug wholesale distributor permit to engage in the wholesale exportation and distribution of prescription drugs in the state under the International Prescription Drug Importation Program established in s. 499.0285. The wholesale distributor must be licensed or permitted to operate in a country with which the United States has a mutual recognition agreement, cooperation agreement, memorandum of understanding, or other federal mechanism recognizing the country’s adherence to current good manufacturing practices for pharmaceutical products. The wholesale distributor must maintain at all times a license or permit to engage in the wholesale distribution of prescription drugs in compliance with the laws of the jurisdiction in which it operates. An international prescription drug wholesale distributor permit may not be issued to a wholesale distributor if the jurisdiction in which the wholesale distributor operates does not require a license to engage in the wholesale distribution of prescription drugs.

2. The department shall adopt rules governing the financial responsibility of an international prescription drug wholesale distributor permittee. The rules will establish, at a minimum, financial reporting requirements, standards for financial capability to perform the functions governed by the permit, and requirements for ensuring permittees and their contractors can be held accountable for the financial consequences of any act of malfeasance or misfeasance or fraudulent or dishonest act or acts committed by the permittee or its contractors.

Note.—Subsection (2) intro. former s. 499.012(2) intro.; paragraph (2)(c) former s. 499.012(2)(e); paragraph (2)(d) former s. 499.012(2)(a); paragraph (2)(e) former s. 499.012(2)(c); paragraph (2)(f) former s. 499.012(2)(d); paragraph (2)(g) former s. 499.014; paragraph (2)(i) former s. 499.012(2)(f); paragraph (2)(k) former s. 499.012(2)(g); paragraph (2)(l) former s. 499.012(2)(h); paragraph (2)(n) former s. 499.012(2)(b); paragraph (2)(o) former s. 499.013(2)(c); paragraph (2)(p) former s. 499.013(2)(b); paragraph (2)(q) former s. 499.013(2)(d); paragraph (2)(r) former s. 499.013(2)(e).