§ 499.0285 — International Prescription Drug Importation Program

Florida § 499.0285

• Jurisdiction: Florida
• Title: XXXIII
• Ch. 499: FLORIDA DRUG AND COSMETIC ACT

Text

(1) PROGRAM ESTABLISHED. — The department shall establish a program for the importation of safe and effective prescription drugs from foreign nations with which the United States has current mutual recognition agreements, cooperation agreements, memoranda of understanding, or other federal mechanisms recognizing their adherence to current good manufacturing practices for pharmaceutical products.

(2) DEFINITIONS. — As used in this section, the term: (a) “Exporter” means an international prescription drug wholesale distributor, a nonresident prescription drug manufacturer registered to participate in the program, or an international export pharmacy that exports prescription drugs into this state under the program. (b) “Federal act” means the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. ss. 301 et seq.; 52 Stat. 1040 et seq. as amended by the Drug Quality and Security Act, 21 U.S.C. s. 351 et seq. (c) “Foreign recipient” means an entity other than the original prescription drug manufacturer which receives the prescription drug before its importation into this state under the program. (d) “Good manufacturing practice” refers to the good manufacturing practice regulations in 21 C.F.R. parts 210 and 211. (e) “Importer” means a wholesale distributor, pharmacy, or pharmacist importing prescription drugs into this state under the program. (f) “International export pharmacy” means a pharmacy located outside of the United States which holds an active and unencumbered permit under chapter 465 to export prescription drugs into this state under the program. (g) “International prescription drug wholesale distributor” means a prescription drug wholesale distributor located outside of the United States which holds an active and unencumbered permit under this part to export and distribute prescription drugs into this state under the program. (h) “Nonresident prescription drug manufacturer” means an entity located outside of the United States which holds an active and unencumbered permit under this part to manufacture prescription drugs and has registered with the department to export and distribute such prescription drugs into this state under the program. (i) “Pharmacist” means a person who holds an active and unencumbered license to practice pharmacy under chapter 465. (j) “Pharmacy” means an entity that holds an active and unencumbered permit under chapter 465. (k) “Prescription drug” has the same meaning as defined in this part, but is limited to drugs intended for human use. (l) “Program” means the International Prescription Drug Importation Program established under this section. (m) “Qualified laboratory” means a laboratory that has been approved by the department for the purposes of this section.

(3) ELIGIBLE PRESCRIPTION DRUGS. — An eligible importer may import a prescription drug from an eligible exporter if: (a) The drug meets the United States Food and Drug Administration’s standards related to safety, effectiveness, misbranding, and adulteration; (b) Importing the drug would not violate the patent laws of the United States; and (c) The drug is not: 1. A controlled substance as defined in 21 U.S.C. s. 802; 2. A biological product as defined in 42 U.S.C. s. 262; 3. An infused drug; 4. An intravenously injected drug; 5. A drug that is inhaled during surgery; or 6. A drug that is a parenteral drug, the importation of which is determined by the United States Secretary of Health and Human Services to pose a threat to the public health.

(4) EXPORTERS. — (a) The following entities may export prescription drugs into this state under the program: 1. An international prescription drug wholesale distributor. 2. A nonresident prescription drug manufacturer. 3. An international export pharmacy. (b) An eligible exporter must register with the department before exporting prescription drugs into this state under the program. (c) An exporter may not distribute, sell, or dispense prescription drugs imported under the program to any person residing outside of the state.

(5) IMPORTERS. — (a) The following entities may import prescription drugs under the program: 1. A wholesale distributor. 2. A pharmacy. 3. A pharmacist. (b) An eligible importer must register with the department before importing prescription drugs into this state under the program. (c) An importer may not distribute, sell, or dispense prescription drugs imported under the program to any person residing outside of the state.

(6) PRESCRIPTION DRUG SUPPLY CHAIN DOCUMENTATION. — (a) A participating importer must submit the following information and documentation to the department: 1. The name and quantity of the active ingredient of the prescription drug. 2. A description of the dosage form of the prescription drug. 3. The date on which the prescription drug is shipped. 4. The quantity of the prescription drug that is shipped. 5. The point of origin and destination of the prescription drug. 6. The price paid by the importer for the prescription drug. 7. Documentation from the exporter specifying: a. The original source of the prescription drug; and b. The quantity of each lot of the prescription drug originally received by the seller from that source. 8. The lot or control number assigned to the prescription drug by the manufacturer. 9. The name, address, telephone number, and professional license or permit number of the importer. 10. In the case of a prescription drug that is shipped directly by the first foreign recipient from the manufacturer: a. Documentation demonstrating that the prescription drug was received by the recipient from the manufacturer and subsequently shipped by the first foreign recipient to the importer. b. Documentation of the quantity of each lot of the prescription drug received by the first foreign recipient demonstrating that the quantity being imported into this state is not more than the quantity that was received by the first foreign recipient. c. For an initial imported shipment, documentation demonstrating that each batch of the prescription drug in the shipment was statistically sampled and tested for authenticity and degradation. 11. In the case of a prescription drug that is not shipped directly from the first foreign recipient, documentation demonstrating that each batch in each shipment offered for importation into this state was statistically sampled and tested for authenticity and degradation. 12. For an initial imported shipment of a specific drug by an importer, the department shall ensure that each batch of the drug in the shipment is statistically sampled and tested for authenticity and degradation in a manner consistent with the federal act. The agency may contract with a vendor for these functions. 13. For every subsequent imported shipment of that drug by that importer, the department shall ensure that a statistically valid sample of the shipment was tested for authenticity and degradation in a manner consistent with the federal act. 14. Certify that the drug: a. Is approved for marketing in the United States and is not adulterated or misbranded; and b. Meets all of the labeling requirements under 21 U.S.C. s. 352. 15. Maintain qualified laboratory records, including complete data derived from all tests necessary to ensure that the drug is in compliance with the requirements of this section. 16. Maintain documentation demonstrating that the testing required by this section was conducted at a qualified laboratory in accordance with the federal act and any other applicable federal and state laws and regulations governing laboratory qualifications. (b) All testing required by this section must be conducted in a qualified laboratory that meets the standards under the federal act and any other applicable federal and state laws and regulations governing laboratory qualifications for drug testing. (c) The vendor shall maintain information and documentation submitted under this section for a period of at least 7 years. (d) A participating importer must submit all of the following information to the department: 1. The name and quantity of the active ingredient of the drug. 2. A description of the dosage form of the drug. 3. The date on which the drug is received. 4. The quantity of the drug that is received. 5. The point of origin and destination of the drug. 6. The price paid by the importer for the drug. (e) A participating International Importation Drug supplier must submit the following information and documentation to the agency or the agency’s designated vendor specifying all of the following: 1. The original source of the drug, including: a. The name of the manufacturer of the drug. b. The date on which the drug was manufactured. c. The location (country, state or province, and city) where the drug was manufactured. 2. The date on which the drug is shipped. 3. The quantity of the drug that is shipped. 4. The quantity of each lot of the drug originally received and from which source. 5. The lot or control number and the batch number assigned to the drug by the manufacturer. 6. The name, address, and telephone number, and professional license or permit number of the importer. (f) The department may require any other information necessary to ensure the protection of the public health.

(7) IMMEDIATE SUSPENSION. — The department shall immediately suspend the importation of a specific prescription drug or the importation of prescription drugs by a specific importer if it discovers that any prescription drug or activity is in violation of this section. The department may revoke the suspension if, after conducting an investigation, it determines that the public is adequately protected from counterfeit or unsafe prescription drugs being imported into this state.

(8) RULEMAKING AUTHORITY. — The department shall adopt rules necessary to implement this section.

Legislative History

s. 10, ch. 2019-99.