Fla. Admin. Code Ann. R. 61N-1.008 - Complimentary Human Prescription Drug Samples: Distribution and Disposal

(1) Charitable Donations of Prescription Drug Samples. A physician or other authorized recipient of prescription drug samples may donate samples received according to section 499.028, F.S., to a Restricted Prescription (Rx) Drug Distributors - Charitable Organization permittee; to a charitable institution in this state for administration or dispensing by the charitable institution provided the charitable institution is otherwise licensed to administer or dispense prescription drugs; or to a charitable organization outside of this state that is licensed by that state, if so required. The donation and transfer, however, must be made in accordance with these provisions and the laws or regulations of other applicable jurisdictions.

(a) The donation must be freely given and not encumbered by any expressed or implied requirement or expectation of reimbursement or payment of any kind so as not to constitute a sale, purchase, or trade.

(b) A donated sample must be suitable for use, i.e., not misbranded or adulterated and must be in its original, unopened package with its labeling intact.

(c) A complete and accurate donation record must be prepared and maintained by the donor and recipient. The donation record shall include the elements set forth in subsection 61N-1.012(15), F.A.C.:

(d) The recipient charitable organization shall provide the donor with a written certification that the recipient charitable organization is in conformity with all requirements of the state and federal regulations affecting receipt of prescription drug samples.

(2) Disposal. All complimentary or sample packages of prescription drugs which are expired shall be returned to the manufacturer or distributor. Complimentary or sample packages of prescription drugs which are otherwise unsuitable for the purpose of administering or dispensing may be returned to the manufacturer or distributor or may be destroyed in accordance with the provisions of subsection (4). Prescription drug samples may be sent to a reverse distributor if the manufacturer of the sample has authorized the reverse distributor to handle that manufacturer's prescription drug sample returns.

(3) Complimentary or sample packages of prescription drugs returned to the manufacturer or distributor from which obtained or to a reverse distributor acting on behalf of the manufacturer, must be documented with records which include the date of the return; the name, form and quantity of the substance by lot number; the name, address, and license or permit number, of the person making the return; and the name, address, and license or permit number, of the manufacturer or person to whom the prescription drug samples are returned.

(4) The destruction of complimentary or sample packages of prescription drugs which may be destroyed must be documented with a complete inventory identifying the items destroyed and a notation on the inventory as to the date and method of destruction.

Notes

Fla. Admin. Code Ann. R. 61N-1.008

Rulemaking Authority 499.01, 499.0121, 499.028, 499.05 FS. Law Implemented 499.028 FS.

New 12-12-82, Amended 7-8-84, Formerly 10D-45.445, Amended 11-26-86, 2-4-93, 7-1-96, Formerly 10D-45.0445, Amended 1-26-99, 4-17-01, Formerly 64F-12.008.

New 12-12-82, Amended 7-8-84, Formerly 10D-45.445, Amended 11-26-86, 2-4-93, 7-1-96, Formerly 10D-45.0445, Amended 1-26-99, 4-17-01, Formerly 64F-12.008.