61N-1.006. Drugs and Devices; Labeling Requirements

(1) The department adopts and incorporates by reference the labeling requirements for prescription drugs and over-the-counter drugs as set forth in the federal act at 21 U.S.C. ss. 301 et seq. and in Title 21 Code of Federal Regulations Parts 1-1299 (as of 2/10/21), http://www.flrules.org/Gateway/reference.asp?No=Ref-13233.

(a) The label on the immediate container of each unit dose repackaged drug product or multiple unit prepackaged drug product must contain the following:

1. Brand or generic name, or both;

2. Strength of drug;

3. Dosage form;

4. Manufacturer’s name and lot number or a control number if a log is maintained which cross references the control number with the manufacturer’s name and lot number; and

5. Expiration date.

(b) An authorized practitioner dispensing complimentary prescription drugs to his own patients may dispense them in the manufacturer’s package which shall also include the practitioner’s name, the patient’s name and the date dispensed. If complimentary prescription drugs are not dispensed in the manufacturer’s labeled package, they shall be dispensed in a container which bears a label containing the following:

1. Practitioner’s name and address;

2. Patient’s name;

3. Date dispensed;

4. Name and strength of drug;

5. Directions for use; and

6. Expiration date.

(c) A Veterinary Legend Drug Retail establishment shall attach a label to the original, sealed manufacturer’s container in a manner which leaves the manufacturer’s labeling intact and legible, upon the sale of a veterinary legend drug to a consumer. The label shall bear the following:

1. Name, address and veterinary legend drug retail establishment number;

2. Prescribing veterinarian’s name;

3. Name of the animal or kennel name if so authorized;

4. Date prescription filled or refilled;

5. Prescription number or other prescription identification adequate to readily identify the prescription; and

6. Directions for use.

(2) The department adopts and incorporates by reference the labeling requirements for medical devices as set forth in the federal act at 21 U.S.C. ss. 301 et seq. and in Title 21 Code of Federal Regulations Parts 800-895 (as of 4/26/21), incorporated by reference in subsection (1) of this rule.

Rulemaking Authority 499.01, 499.05 FS. Law Implemented  499.01, 499.007 FS. History–New 1-1-77, Amended 12-12-82, 7-8-84, Formerly 10D-45.39, Amended 11-26-86, 7-1-96, Formerly 10D-45.039, Amended 1-26-99, 4-17-01, 1-1-04, Formerly 64F-12.006, Amended 9-22-22.