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Laws FDA Enforces

Under the Federal Food, Drug, and Cosmetic Act (the Act), FDA has the broad mandate to assure safety and effectiveness of drugs (including animal drugs), devices (including veterinary devices), and the safety of the food supply.

Two amendments to the Act expanded the veterinarian’s authority in the area of drug use:

  • The Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA), under which veterinarians can use approved animal drugs in an extra-label manner, and they may prescribe approved human drugs for use in animals, under certain specified conditions.
  • The Animal Drug Availability Act of 1996 (ADAA), which was enacted to help streamline the animal drug approval process. In addition to adding flexibility to the way FDA regulates animal drugs, ADAA authorized a new category, Veterinary Feed Directive (VFD) drugs, which may be used in animal feeds. The VFD category allows the approval and use of sophisticated new animal drugs in animal feed, on a veterinarian's order, while incorporating safeguards to ensure the safe use of such drugs.

Animal drugs must be safe and effective for their intended use. Section 512 of the FD&C Act, the basic statutory provision governing new animal drugs, provides that a new animal drug is unsafe unless the use of the drug has been approved, conditionally approved, or indexed and the use of a drug and its labeling conform to the approved application, conditionally approved application, or index listing. In certain circumstances, a new animal drug may be used for a legal extra-label use by or on the order of a veterinarian (see section 512(a)(4)(A) and 21 CFR Part 530). An investigational new animal drug may be exempt from the requirements of section 512 of the FD&C Act if the sponsor meets the requirements for an exemption under 21 CFR part 511. An unsafe new animal drug is adulterated and subject to the enforcement provisions of the Act. All FDA regulations are codified in Title 21 of the CODE OF FEDERAL REGULATIONS. Parts 500-599 of the CFR specifically address animal drugs and feeds and how to ensure that animal drugs are safe and effective for their intended uses and do not result in unsafe residues in foods from treated animals.

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