The FDA's Position on Dispensing Veterinary Prescription Drugs and Labeling and Script Requirements

Dispensing Veterinary Prescription Drugs

Since adequate directions for safe and effective lay use cannot be written for animal prescription drug products, such products can only be sold on the prescription or other order of a licensed veterinarian (Section 503(f)). Prior to being sold or dispensed, they must remain in the possession of a person or firm regularly and lawfully engaged in the manufacture, transportation, storage, or wholesale or retail distribution of animal prescription drug products. The drug products may be distributed only by persons or firms authorized by State and local laws.

Sale (dispensing, shipping, or otherwise making available for use in animals) of an animal prescription drug product to the layperson may be made only by or on the bona fide prescription or other order of a licensed veterinarian. Sale of a animal prescription drug product to a layperson, except on a prescription or on order of a licensed practitioner, causes the product to be misbranded and subjects the seller to civil and/or criminal provisions of the Act.

A licensed veterinarian may legally use or dispense an animal prescription drug product only within the course of his/her professional practice where a valid veterinarian-client-patient relationship exists. Veterinarians employed by drug manufacturers or distributors may not legally dispense prescription drug products to laypersons unless they meet the above criteria. Similarly, practicing veterinarians or their employees may not legally sell animal prescription drug products to walk-in customers unless the same criteria are met. Federal regulations require that drug manufacturers provide at least the following information on the label of the finished package form of animal prescription drug products:

What information needs to be on the package label of animal Rx drugs?

• the statement, "Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian;"
• recommended or usual dosage;
• route of administration, if it is not for oral use;
• quantity or proportion of each active ingredient as well as the information required by section 502(e) of the Act;
• names of inactive ingredients if it is for other than oral use;
• an identifying lot or control number from which it is possible to determine the complete manufacturing history of the drug.

What needs to be included in the veterinarian’s prescription and included on the label of the dispensed product?

• name and address of the dispenser;
• serial number and date of the order or its filling;
•  name and address of the veterinarian who prescribed or ordered the drug product;
• directions for use; and
• any necessary warning and precautionary statements including withdrawal times.

Any additional requirements of State or local laws for dispensed animal drug products must also be followed.

To protect themselves and their clients, veterinarians should make efforts to ensure their instructions are followed, especially when they prescribe or recommend drugs for food-producing animals that require a withdrawal period.