Description
This guidance provides establishments that manufacture animal cells, tissues, and cell- and tissue-based products meeting the definition of a new animal drug (ACTPs) with recommendations for meeting current good manufacturing practice (CGMP) requirements. All new animal drugs, including ACTPs, must be manufactured in accordance with CGMPs to ensure that such drugs meet the requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as to safety, and have the identity, strength, quality, and purity characteristics which they purport to or are represented to possess.
Scope & Applicability
Product Classes
2ACTP products mentioned in abbreviations.
Animal Cell- and Tissue-based Products
Stakeholders
10The party receiving the imported goods, responsible for submitting evidence.
An establishment that performs processing steps on ACTPs.
Person who documents the determination for distribution availability.
outsourced operation provider
entity responsible for donor tissue recovery; Entity responsible for obtaining cells or tissues
Authorized representative conducting the inspection
Employees handling RTE foods or cleaning equipment
Qualified personnel for recovery operations on live animals
Entity performing testing under agreement
Potential HCT/P donor screening
Regulatory Context
Attributes
7Property of a device that may be changed via established protocols
Measurement of potency for biological products
specifications for the purity, strength, and composition of dietary supplements
Information that should appear on the label or accompany the ACTP.
parameters that could have an adverse effect on ACTPs
parameters that could have an adverse effect on ACTPs
ACTP availability for distribution only after donor eligibility is established
Identified Hazards
Hazards
4Example of a disease agent causing donor ineligibility
Safety concern regarding viral contamination
Microorganisms or particulate matter that could adversely affect the device.
Risk associated with construction, traffic flow, and shared equipment.; Risk from raw food to RTE food or from insanitary objects; Personnel handling RTE foods touch contaminated surfaces
Related CFR Sections (5)
- 21CFR211.180§ 211.180 General requirements.
(a) Any production, control, or distribution record that is required to be maintained in compliance with this part and is specifically associated with a batch of a drug product shall be retained for at least 1 year after the expiration date of the batch or, in the case of certain OTC drug products lRead full regulation →
- 21CFR201.17§ 201.17 Drugs; location of expiration date.
When an expiration date of a drug is required, e.g., expiration dating of drug products required by § 211.137 of this chapter , it shall appear on the immediate container and also the outer package, if any, unless it is easily legible through such outer package. However, when single-dose containers 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 →
- 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 →
- 21CFR207.17§ 207.17 Who must register?
(a) Unless exempt under section 510(g) of the Federal Food, Drug, and Cosmetic Act or this part, all manufacturers, repackers, relabelers, and salvagers must register each domestic establishment that manufactures, repacks, relabels, or salvages a drug, or an animal feed bearing or containing a new aRead 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.
- 2025-12-11
CGMP/Finished Pharmaceuticals/Adulterated
Catalent Indiana, LLC
- 2025-12-09
CGMP/Finished Pharmaceuticals/Adulterated
DeVere Manufacturing Inc.
- 2025-12-09
CGMP/Finished Pharmaceuticals/Adulterated
CDL Services, Inc. DBA Technichem
- 2025-12-09
CGMP/Finished Pharmaceuticals/Adulterated
Seaway Pharma Inc.
See Also (8)
- CPG Sec. 425.300 Computerized Drug Processing; Source Code for Process Control Application Programs (Status: Final)
- Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations (Status: Final)
- Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products (Status: Final)
- BLA for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System: Guidance for Industry (Status: Final)
- Submission of Quality Metrics Data Guidance for Industry (Status: Draft)
- Contract Manufacturing Arrangements for Drugs: Quality Agreements Guidance for Industry: Guidance for Industry (Status: Final)
- Current Good Manufacturing Practice Requirements for Combination Products: Guidance for Industry and FDA Staff (Status: Final)
- Development and Submission of Near Infrared Analytical Procedures (Status: Final)