Animal Cells, Tissues, and Cell- and Tissue-Based Products (ACTPs)

ACTPs are articles containing, consisting of, or derived from cells or tissues that are intended for implantation, transplantation, infusion, transfer, or other means of administration to an animal recipient. Examples include animal stem cells, differentiated cells, and tissues such as blood, platelet-rich plasma, and amnion.

Guidances for Industry (GFIs)

In June 2015, FDA CVM issued GFI #218, which discusses the approval requirements for ACTPs that meet the legal definition of a “drug” and how the agency intends to regulate them.

In September 2021, FDA CVM issued two draft guidance documents that, if finalized, will help developers and manufacturers of ACTPs understand current good manufacturing practice (CGMP). 

• Draft GFI #253 provides manufacturers of ACTPs with recommendations on aspects of manufacturing that are unique to ACTPs and on how to meet CGMP. 
• Draft GFI #254 is intended to help developers, veterinarians, and others who determine donor eligibility for ACTPs. Selecting an appropriate donor is critical to ensuring the quality of an ACTP and to preventing the spread of diseases from donor to animal recipient and to humans who handle the product. 

The concepts and principles for ACTPs outlined in the two draft GFIs are consistent with FDA’s regulations and guidance documents for similar human products. FDA also issued letters to veterinarians and universities informing them of the two draft guidance documents. Some veterinarians participate in the manufacturing of ACTPs, and many universities conduct research on these products. Therefore, both groups should be aware of the information covered in the two documents.

Information for Developers and Consumers

CVM is committed to engaging with industry, academia, animal owners/producers, and other stakeholders to increase the transparency of our regulatory process. You can find additional information on the regulation of ACTPs below. 

• CVM’s FDA-TRACK goals for emerging technologies
• FDA’s Role in Veterinary Regenerative Medicine
• The Unified Website for Biotechnology Regulation
• CVM listing of clinical field studies for ACTPs
• Animal Biologicals and Jurisdiction 
• Presentation on FDA Guidance 218: Cell-Based Products for Animal Use
• FDA CVM Public Webinar on the Development of ACTPs
• Animal Biotechnology Products Resource Center
• Q&A for Pet Owners on Animal Cells, Tissues, and Cell- and Tissue-Based Products (ACTPs)
• Q&A for Developers of Animal Cells, Tissues, and Cell- and Tissue-Based Products (ACTPs)

Information about Marketed Products

Approvals

Currently, no ACTPs are FDA-approved.

Enforcement Discretion

FDA provides a list of those ACTPs that the agency has determined are low risk following a review of product-specific information.

• Animal Cells, Tissues, and Cell- and Tissue-Based Products (ACTPs): Lower Risk ACTPs

Regulatory Actions

FDA issued the following Warning Letters to companies that were illegally marketing ACTPs without FDA approval:

• AniCell Biotech
• Vet Cellect Bio Products, LLC
• VetraGenics, LLC

CVM Publications Related to ACTPs

• “Questions and Challenges in the Development of Mesenchymal Stromal/Stem Cell-Based Therapies in Veterinary Medicine”
• “Characterization of Canine Adipose-Derived Mesenchymal Stromal/Stem Cells in Serum-Free Medium”
• “A serum-free medium formulation efficiently supports isolation and propagation of canine adipose-derived mesenchymal stem/stromal cells”
• “Microfluidic separation of canine adipose-derived mesenchymal stromal cells”

If you have questions about a process or product, please contact the agency at [email protected]. 

If you would like to provide feedback regarding CVM’s regulation of biotechnology products, please email [email protected].