Description
This guidance is intended for veterinarians, State-licensed pharmacies, and Federal facilities interested in compounding animal drugs from bulk drug substances for use in nonfood-producing animals, as antidotes in food-producing animals, or as sedatives or anesthetics in free-ranging wildlife under limited circumstances when no other medically appropriate treatment options exist.
Scope & Applicability
Product Classes
7Compounded without a patient-specific prescription
Compounded for use in free-ranging wildlife species
Compounded for use in free-ranging wildlife species
Compounded for treating toxicoses in food-producing animals
Raw materials used for compounding animal drugs
The category of products covered by this guidance.
Drugs produced by an outsourcing facility
Stakeholders
5Direct supervision of compounding
Authorized to order or use restricted drugs
State-licensed pharmacies or Federal facilities
Professional providing oversight for antimicrobial drug use; Veterinarian is to determine the actual duration that the drug will be used; Professional ordering the duration of use for antimicrobial drugs
Allowed value for reporter qualification
Regulatory Context
Attributes
4Scientifically-based period to ensure animals do not contain residues; Scientifically based period to ensure residues are not present
controls in place to maintain the strength, composition, and purity
Required information for RLD/RS and proposed products.; Product characteristic in ANDA background
determined by the treating veterinarian to justify compounding a copy
Identified Hazards
Hazards
3Potential for residues in meat, milk, or eggs from food-producing animals
Potential risks that would trigger enforcement action
risk in multidose drug products
Related CFR Sections (7)
- 21CFR201.105§ 201.105 Veterinary drugs.
A drug subject to the requirements of section 503(f)(1) of the act shall be exempt from section 502(f)(1) of the act if it is a designated medical gas (as defined in § 201.161(c)(1) ) or a medically appropriate combination of designated medical gases and is in compliance with § 201.161 , or if all tRead full regulation →
- 21CFR530.20§ 530.20 Conditions for permitted extralabel animal and human drug use in food-producing animals.
(a) The following conditions must be met for a permitted extralabel use in food-producing animals of approved new animal and human drugs:Read full regulation →
- 21CFR207.1§ 207.1 What definitions and interpretations of terms apply to this part?
The definitions and interpretations of terms in sections 201 and 510 of the Federal Food, Drug, and Cosmetic Act apply to the terms used in this part, if not otherwise defined in this section. The following definitions apply to this part:Read full regulation →
- 21CFR210.3§ 210.3 Definitions.
(a) The definitions and interpretations contained in section 201 of the act shall be applicable to such terms when used in this part and in parts 211 , 225 , and 226 of this chapter .Read full regulation →
- 21CFR514.80§ 514.80 Records and reports concerning experience with approved new animal drugs.
The following table outlines the purpose for each paragraph of this section:Read full regulation →
- 21CFR530.13§ 530.13 Extralabel use from compounding of approved new animal and approved human drugs.
(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.Read full regulation →
- 21CFR314.3§ 314.3 Definitions.
(a) The definitions and interpretations contained in section 201 of the Federal Food, Drug, and Cosmetic Act apply to those terms when used in this part and part 320 of this chapter .Read full regulation →
Related Warning Letters (10)
- 2025-09-30
New Animal Drug/Adulterated
Ogle Cattle Company, Inc.
- 2025-03-11
False & Misleading Claims/Misbranded
Aurora Pharmaceutical
- 2024-01-30
New Animal Drug/Adulterated
Marion Mullet Farm
- 2024-01-30
New Animal Drug/Adulterated
Martin Farm, Konrad Martin
- 2023-08-22
Illegal Drug Residue Animal Tissue/Adulterated
Knobbe Cattle Company Inc.
- 2022-05-31
Illegal Drug Residue Animal Tissue/Adulterated
Yippee Farms, LLC
- 2022-04-19
Illegal Drug Residue Animal Tissue/Adulterated
Riedstra Dairy, Ltd.
- 2022-02-22
Illegal Drug Residue Animal Tissue/Adulterated
Ulrich Farms
- 2020-04-28
Illegal Drug Residue
T & S Dairy
- 2020-02-11
Illegal Drug Residue Animal Tissue/Adulterated
Brad D. Smith Farm
See Also (8)
- Submission of Quality Metrics Data Guidance for Industry (Status: Draft)
- Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (Status: Final)
- Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (Status: Final)
- Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act (Status: Final)
- Drug Master Files Guidance for Industry (Status: Draft)
- Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products: Guidance for Industry (Status: Final)
- Risk Management Plans to Mitigate the Potential for Drug Shortages (Status: Draft)
- CVM GFI #253 Current Good Manufacturing Practice for Animal Cells, Tissues, and Cell- and Tissue-Based Products (Status: Final)