Drug samples or complimentary drugs; starter packs; permits to distribute.

(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 subparagraph 1. for drug samples. The drug manufacturer or distributor must make available to the department upon request any record or list maintained under this subsection. The department shall provide to the Department of Business and Professional Regulation the names of those practitioners who have received an excessive or inappropriate quantity of such drugs.

(6) A drug manufacturer or distributor must notify the department of any significant loss of drug samples and any known theft of drug samples.

(7) A drug manufacturer or distributor must report to the department any conviction of itself or of its assigns, agents, employees, or representatives for a violation of s. 503(c)(1) of the federal act or of this part because of the sale, purchase, or trade of a drug sample or the offer to sell, purchase, or trade a drug sample.

(8) Drug manufacturers or distributors must provide to the department the name and telephone number of the individual responsible for responding to a request for information regarding drug samples.

(9) All out-of-date drug samples must be returned to the manufacturer or distributor of that drug sample.

(10) A manufacturer or distributor may not directly or through its agents, employees, or independent contractors, hold, distribute, or otherwise dispose of any complimentary drugs or drug samples in this state without first obtaining a complimentary drug distributor permit pursuant to this section.

(11)(a) Application for a permit by a manufacturer or distributor to hold, distribute, or otherwise dispose of drugs pursuant to this section must be made on a form prescribed by the department and must be accompanied by an application fee in an amount not exceeding $250 per year, as is determined by the department.

(b) A permit issued under this section expires 2 years after the date of issuance, unless sooner suspended or revoked.

(c) A permit is renewable biennially upon the filing of an application for renewal and the payment of a renewal fee of not more than $250 per year, as determined by the department, if the applicant meets the requirements established by this section and the rules adopted under this section.

(12) The department may suspend or revoke a permit issued under this section, after giving notice and an opportunity to be heard pursuant to chapter 120, when:

(a) Such permit was obtained by misrepresentation or fraud or through a mistake of the department.

(b) The holder of the permit has distributed or disposed of any prescription drug, directly or through its agents, employees, or independent contractors, to any person not authorized to possess such drug.

(c) The holder of the permit, or its agents, employees, or independent contractors, has distributed or possessed any prescription drug except in the usual course of its business.

(d) The holder of the permit, or its agents, employees, or independent contractors, has distributed any prescription drug that is misbranded or adulterated under this part.

(e) The holder of the permit, or its agents, employees, or independent contractors, has distributed any prescription drug without written request, when a written request is required by this section.

(f) The holder of the permit has in its employ, or uses as agent or independent contractor for the purpose of distributing or disposing of drugs, any person who has:

1. Violated the requirements of this section or any rule adopted under this section.

2. Been convicted in any of the courts of this state, the United States, or any other state of a felony or any other crime involving moral turpitude or involving those drugs named or described in chapter 893.

(13) The department may, pursuant to chapter 120, impose an administrative fine, not to exceed $5,000 per violation per day, for the violation of this section or rules adopted under this section. Each day such violation continues constitutes a separate violation, and each such separate violation is subject to a separate fine. All amounts collected under this section shall be deposited into the Professional Regulation Trust Fund. In determining the amount of fine to be levied for a violation, the following factors must be considered:

(a) The severity of the violation.

(b) Any actions taken by the permittee to correct the violation or to remedy complaints.

(c) Any previous violations.

(14) Chapter 893 applies to all drug samples that are controlled substances.

(15) A person may not possess a prescription drug sample unless:

(a) The drug sample was prescribed to her or him as evidenced by the label required in s. 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.