Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA)

FARAD exists because of AMDUCA. The Animal Medicinal Drug Use Clarification Act permits veterinarians to prescribe extra-label uses of certain approved new animal drugs and approved human drugs for animals under certain conditions. Under AMDUCA and its regulations published at Title 21, Code of Federal Regulations, Part 530 (21 CFR 530), any extra-label use of an approved new animal or human drug must be by or on the lawful order of a veterinarian within the context of a veterinarian-client-patient relationship (VCPR).

  1. Subpart A -- General Provisions
    1. Sec. 530.1--Scope.
    2. Sec. 530.2--Purpose.
    3. Sec. 530.3--Definitions.
    4. Sec. 530.4--Advertising and Promotion.
    5. Sec. 530.5--Veterinary Records.
  2. Subpart B -- Rules and Provisions for Extralabel Uses of Drugs in Animals
    1. Sec. 530.10--Provision Permitting Extralabel Use of Animal Drugs.
    2. Sec. 530.11--Limitations.
    3. Sec. 530.12--Labeling.
    4. Sec. 530.13--Extralabel Use From Compounding of Approved New Animal And Approved Human Drugs.
  3. Subpart C -- Specific Provisions Relating To Extralabel Uses of Animal and Human Drugs in Food-Producing Animals
    1. Sec. 530.20--Conditions For Permitted Extralabel Animal And Human Drug Use in Food-Producing Animals.
    2. Sec. 530.21--Prohibitions For Food-Producing Animals.
    3. Sec. 530.22--Safe Levels and Analytical Methods for Food-Producing Animals.
    4. Sec. 530.23--Procedure For Setting and Announcing Safe Levels.
    5. Sec. 530.24--Procedure for Announcing Analytical Methods for Drug Residue Quantification.
    6. Sec. 530.25--Orders Prohibiting Extralabel Uses For Drugs in Food-Producing Animals.
  4. Subpart D -- Extralabel Use of Human And Animal Drugs in Animals Not Intended for Human Consumption
    1. Sec. 530.30--Extralabel Drug Use in Nonfood Animals.
  5. Subpart E -- Safe Levels for Extralabel Use of Drugs in Animals and Drugs Prohibited From Extralabel Use in Animals
    1. Sec. 530.40--Safe Levels and Availability of Analytical Methods.
    2. Sec. 530.41--Drugs Prohibited for Extralabel Use In Animals.

 

Authority: Secs. 4, 5, 6 of the Fair Packaging and Labeling Act (15 U.S.C. 1453, 1454, 1455); secs. 201, 301, 501, 502, 503, 505, 507, 512, 701, and 721 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351, 352, 353, 355,357, 360b,371,379e).