Description
The Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) is aware that many potential veterinary therapies may be produced using cell-based products. Developers of such products for veterinary use have approached CVM for clarification regarding the regulation of these products. This guidance for industry (GFI) describes CVM’s current thinking on cell-based products for animal use that meet the definition of a “new animal drug.”
Scope & Applicability
Product Classes
8Articles containing, consisting of, or derived from stem cells for use in animals.
The category of products covered by this guidance.
Referred to as ASCPs throughout the document; Articles containing, consisting of, or derived from stem cells for use in animals.
Cells collected from a donor animal of one species and used in a recipient animal of a different species
Cells collected from a donor animal and used in a recipient animal of the same species, but different individuals
Cells collected from and administered to the same animal
Autologous products meeting specific risk criteria such as more than minimal manipulation
Autologous products that are minimally manipulated and for homologous use in nonfood-producing animals
Stakeholders
2Entity responsible for submitting NDINs
Entity responsible for submitting applications under section 524B
Regulatory Context
Attributes
3Type of ACTP requiring donor eligibility determination
Cell source attribute for mesenchymal stromal cell products.
Cell source attribute for mesenchymal stromal cell products.
Identified Hazards
Hazards
4Statutory status of a new animal drug unless approved, conditionally approved, or indexed.
Risk associated with intended pharmacology or off-target effects
Safety evaluation for ASCPs
Microorganism inadvertently introduced into production
Related CFR Sections (4)
- 21CFR511.1§ 511.1 New animal drugs for investigational use exempt from section 512(a) of the Federal Food, Drug, and Cosmetic Act.
(a) New animal drugs for tests in vitro and in laboratory research animals.Read full regulation →
- 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 →
- 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 →
- 21CFR514.8§ 514.8 Supplements and other changes to an approved application.
(a) Definitions.Read full regulation →
Related Warning Letters (10)
- 2025-12-23
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Misbranded
Darmerica, LLC
- 2025-12-23
CGMP/Finished Pharmaceuticals/Adulterated
SV Labs Corporation
- 2025-12-23
CGMP/Finished Pharmaceuticals/Adulterated
Guangdong Renhe Guozhuang Biotechnology Co., Ltd.
- 2025-12-23
CGMP/Finished Pharmaceuticals/Adulterated
Medinatura New Mexico, Inc.
- 2025-12-16
CGMP/Finished Pharmaceuticals/Adulterated
Sklar Personal Care Inc.
- 2025-12-16
CGMP/Deviations/Biologics License Application (BLA)
Microvascular Tissue, Inc.
- 2025-12-16
Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
Green Valley Fertility Partners
- 2025-12-11
CGMP/Finished Pharmaceuticals/Adulterated
Catalent Indiana, LLC
- 2025-12-09
Unapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA)
BioXtek LLC
- 2025-12-09
CGMP/Finished Pharmaceuticals/Adulterated
DeVere Manufacturing Inc.
See Also (8)
- Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products: Guidance for Industry (Status: Final)
- CVM GFI #104 Content and Format of Effectiveness and Target Animal Safety Technical Sections and Final Study Reports For Submission (Status: Final)
- CVM GFI #217 Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Animals (Status: Final)
- CVM GFI #201 SECG for The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (Status: Final)
- CVM GFI #229 Evaluating the Effectiveness of New Animal Drugs for the Reduction of Pathogenic Shiga Toxin-Producing E. coli in Cattle (Status: Final)
- CVM GFI #256 - Compounding Animal Drugs from Bulk Drug Substances (Status: Final)
- Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act (Status: Final)
- CVM GFI #120 Veterinary Feed Directive Regulation Questions and Answers (Status: Final)