Rx drug regulation

Animal prescription (Rx) drug labels contain the federally mandated statement:

"Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian."

The Food and Drug Administration determines if an animal drug should be marketed over-the-counter or by prescription.

FDA restricts drugs to prescription if the FDA determines that it is not possible to prepare adequate directions for use under which a layperson can use the drugs safely and effectively. Prescription drugs are not safe for animal use except under the professional supervision of a licensed veterinarian because of the drug's toxicity or other potential for harmful effects, or the method of its use, or the collateral measures necessary for its use.

The FDA regulates drug products sold by pharmacies, not the practice of pharmacy itself. FDA can take action if pharmacy drugs are adulterated or misbranded. Adulterated drugs include unapproved drugs and compounded drugs that do not meet FDA's compounding policies. Misbranded drugs include those prescription drugs that are sold without a valid prescription.

State agencies also have oversight for prescription drugs.

Internet pharmacies are regulated by the state Board of Pharmacy in which the pharmacy resides. Since Internet pharmacies send prescription drugs to consumers in additional states, Boards of Pharmacy in these additional states enforce their requirements for "out of state" pharmacies.

The state Board of Veterinary Medicine regulates the practice of veterinary medicine, including the prescribing and dispensing of drugs by veterinarians to animals.

Pharmacists are required to have a valid prescription before dispensing prescription drugs. Veterinarians must have a veterinarian-client-patient relationship to prescribe prescription drugs.

The AVMA helps veterinarians to report concerns to the proper regulatory agencies through use of the Prescribing and Dispensing Complaint Form (PDF). The AVMA is not a regulatory agency and cannot enforce regulations.

 

This information has been compiled by AVMA Scientific Activities Division staff.