(1) As used in this section, the term:(a) “Drug sample,” or “complimentary drug,” means a human prescription drug that is labeled “sample,” “not to be sold,” “complimentary,” or other words to that effect, that is provided as a courtesy, that is not intended to be sold, and that is intended to promote the sale of the drug.
(b) “Starter packs,” also known as “stock samples,” “trade packages,” “initial dose packs,” or “starter stocks,” means human prescription drugs that are generally distributed without charge by manufacturers or distributors to pharmacies to be placed in stock and sold at retail. Although starter packs are generally given without charge to the pharmacy, they are not intended to be a free sample to the consumer nor are they labeled as such. Starter packs are subject to regulation as prescription drugs under the Florida Drug and Cosmetic Act in the same manner as stock shipments of prescription drugs. Starter packs are not drug samples.
(2) A person may not sell, purchase, or trade or offer to sell, purchase, or trade any drug sample. An officer or executive of a drug manufacturer or distributor is not subject to criminal liability solely because of a sale, purchase, trade, or offer to sell, purchase, or trade of a drug sample in violation of this subsection by other employees of the manufacturer or distributor.
(3) Except as provided in this section, a representative of a drug manufacturer or distributor may not distribute any drug sample.(a) The manufacturer or distributor of a human prescription drug may, in accordance with this paragraph, distribute drug samples by mail or common carrier to practitioners licensed to prescribe such drugs or, at the request of a licensed practitioner, to pharmacies of hospitals or to pharmacies of other health care entities. Such a distribution of drug samples may only be made:1. In response to a written request for drug samples made on a form that meets the requirements of paragraph (b); and
2. Under a system that requires the recipient of the drug sample to execute a written receipt for the drug sample upon its delivery and to return the receipt to the manufacturer or distributor.
(b) A written request for a drug sample that is required by this section must contain:1. The name, address, professional designation, and signature of the practitioner who makes the request;
2. The name, strength, and dosage form of the drug sample requested and the quantity requested;
3. The name of the manufacturer of the drug sample requested; and
4. The date of the request.
(c) Each drug manufacturer or distributor that makes distributions by mail or common carrier under this paragraph must maintain, for a period of 3 years, the request forms submitted for such distributions and the receipts submitted for such distributions and must maintain a record of distributions of drug samples which identifies the drugs distributed and the recipients of the distributions. Forms, receipts, and records required to be maintained under this paragraph must be made available by the drug manufacturer or distributor to the department for its review and inspection.
(d) The manufacturer or distributor of a drug subject to paragraph (1)(a) may, by means other than mail or common carrier, distribute drug samples only if the manufacturer or distributor makes the distributions in accordance with paragraph (e) and carries out the activities described in subsections (4)-(9).
(e) Drug samples may only be distributed:1. To a practitioner authorized by law to prescribe such drugs if the practitioner makes a written request for the drug samples; or
2. At the written request of such a practitioner, to pharmacies of hospitals or to pharmacies of other health care entities. The written request for drug samples must be made on a form that contains the practitioner’s name, address, and professional designation, the name, strength, and dosage form of the drug sample requested, the quantity of drug samples requested, the name of the manufacturer or distributor of the drug sample, the date of the request, and the signature of the practitioner that makes the request.
(4) A drug manufacturer or distributor must store drug samples under the conditions described on their labels that will maintain the stability, integrity, and effectiveness of the drug samples and will assure that the drug samples remain free of contamination, deterioration, and adulteration.
(5) A drug manufacturer or distributor must conduct, at least annually, a complete and accurate inventory of all drug samples in the possession of representatives of the manufacturer or distributor. A drug manufacturer or distributor must maintain lists of the names and addresses of each of its representatives who distribute drug samples and of the sites where drug samples are stored. A drug manufacturer or distributor must maintain for at least 3 years records of all drug samples distributed, destroyed, or returned to the manufacturer or distributor, of all inventories maintained under this subsection, of all thefts or significant losses of drug samples, and of all requests made under 465.0276(4). (b) She or he is the employee of a complimentary drug distributor that holds a permit issued under this part.
(c) She or he is a person to whom prescription drug samples may be distributed pursuant to this section.
(d) He or she is an officer or employee of a federal, state, or local government acting within the scope of his or her employment.