C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS › PART 530—EXTRALABEL DRUG USE IN ANIMALS › Subpart B—Rules and Provisions for Extralabel Uses of Drugs in Animals

21 C.F.R. § 530.13

Extralabel use from compounding of approved new animal and approved human drugs

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(a) This part applies to compounding of a product from approved animal or human drugs by a veterinarian or a pharmacist on the order of a veterinarian within the practice of veterinary medicine. Nothing in this part shall be construed as permitting compounding from bulk drugs.

(b) Extralabel use from compounding of approved new animal or human drugs is permitted if:

(1) All relevant portions of this part have been complied with;

(2) There is no approved new animal or approved new human drug that, when used as labeled or in conformity with criteria established in this part, will, in the available dosage form and concentration, appropriately treat the condition diagnosed. Compounding from a human drug for use in food-producing animals will not be permitted if an approved animal drug can be used for the compounding;

(3) The compounding is performed by a licensed pharmacist or veterinarian within the scope of a professional practice;

(4) Adequate procedures and processes are followed that ensure the safety and effectiveness of the compounded product;

(5) The scale of the compounding operation is commensurate with the established need for compounded products (e.g., similar to that of comparable practices); and

(6) All relevant State laws relating to the compounding of drugs for use in animals are followed.

(c) Guidance on the subject of compounding may be found in guidance documents issued by FDA.

Notes of Decisions
Cited in 1 case, 2011–2011 · leading case: United States v. Franck's Lab, Inc., 816 F. Supp. 2d 1209 (M.D. Fla. 2011).
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United States v. Franck's Lab, Inc., 816 F. Supp. 2d 1209 (M.D. Fla. 2011). · cites it 2× “” 21 C.F.R. § 530.13 (a) (emphasis added).' Despite this language, the regulations do not purport to regulate the practice of compounding, and instead refer parties to FDA’s non-binding guidance documents on the subject.”
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