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Regulatory Information
AMDUCA
PART 530—
EXTRALABEL DRUG USE IN ANIMALS

Extralabel Drug Use in Animals Final Rule

  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).


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