Compounding of Animal Drugs

To be legally marketed, new animal drugs must be approved under section 512 of the FD&C Act, conditionally approved under section 571 of the FD&C Act, or included on the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species under section 572 of the FD&C Act. The FD&C Act does not generally distinguish between compounding and other methods … Read More

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, … Read More

Classifying RX and OTC Animal Drugs

Under the Act, the term “drug” means articles recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary; articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and articles other than food intended to affect the structure or any function of the … Read More

A Brief Overview of CVM’s Drug Approval Process

FDA is responsible for determining the marketing status (prescription, over-the-counter, or VFD) of animal drug products based on whether or not it is possible to prepare “adequate directions for use” under which a layperson can use the drugs safely and effectively. Prescription (Rx) products can be dispensed only by or upon the lawful written order of a licensed veterinarian. Safe … Read More