Description
This guidance provides recommendations to holders of new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) who intend to make post-approval chemistry, manufacturing, and controls (CMC) changes in accordance with section 506A of the Federal Food, Drug, and Cosmetic Act (the Act) and 21 CFR 514.8. The guidance covers recommended reporting categories for post-approval changes for animal drugs. Recommendations are provided for post-approval changes in: (1) components and composition, (2) manufacturing sites, (3) manufacturing process, (4) specifications, (5) container closure system, as well as (6) miscellaneous changes and (7) multiple related changes.
Scope & Applicability
Product Classes
10The primary product category covered by this guidance; Subject of the bioequivalence guidance for poorly soluble APIs.
Profile class code SVL
Injectable products requiring 100% inspection.
New animal drug dosage forms intended for use in the manufacture of medicated feeds; The primary product category discussed for CMC considerations.; manufactured for homogeneity, segregation, and stability studies
Drug product category for packaging changes
Drug product category for packaging changes
Drug product category for packaging changes
administered parenterally
Materials derived from plants, animals, or microorganisms subject to section 512.
This table summarizes the recommended test documentation for Modified-Release Solid Oral Dosage Forms
Stakeholders
2Entity submitting development data and knowledge; Entity performing the work process for change
Firms whose only function is to perform a specific operation
Regulatory Context
Attributes
7Status of a facility's compliance with quality standards
Condition required for a manufacturing site to avoid a PAS for certain changes
established based on data from stability studies
Level and type of micro-organisms present in materials
levels of existing and new impurities; Characteristic of drug substance that may change with starting material redesignation; A comparison of the impurity profile of pre- and post-modification material to establish equivalence; Evaluation of the impurity profile for intermediates or drug substance; Potential to adversely affect drug substance quality; A description of the identified and unidentified impurities present in a drug substance.; The description of identified and unidentified impuritie
Risk factor to be assessed during manufacturing changes
A functional role of sodium in food
Identified Hazards
Hazards
2Potential impact on identity, strength, quality, purity, or potency
Safety concern regarding viral contamination
Related CFR Sections (4)
- 21CFR20.40§ 20.40 Filing a request for records.
(a) All requests for Food and Drug Administration records shall be made in writing by mailing or delivering the request to the Freedom of Information Staff at the address on the Agency's website at https://www.fda.gov , by faxing it to the fax number listed on the Agency's website at https://www.fdaRead full regulation →
- 21CFR558.3§ 558.3 Definitions and general considerations applicable to this part.
(a) Regulations in this part provide for approved uses of drugs and combinations of drugs in animal feeds. Approved combinations of such drugs are specifically identified or incorporated by cross-reference. Unless specifically provided for by the regulations, a combination of two or more drugs is noRead 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 →
- 21CFR514.8§ 514.8 Supplements and other changes to an approved application.
(a) Definitions.Read full regulation →
Related Warning Letters (10)
- 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.
- 2025-12-02
Compounding Pharmacy/Adulterated Drug Products
PQ Pharmacy, LLC
See Also (8)
- CVM GFI #57 Preparation and Submission of Veterinary Master Files (Status: Final)
- CVM GFI #213 New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209 (Status: Final)
- CVM GFI #181 Blue Bird Medicated Feed Labels (Status: Final)
- CVM GFI #240 Proprietary Names for New Animal Drugs (Status: Final)
- CVM GFI #191 Changes to Approved NADAs - New NADAs vs. Category II Supplemental NADAs (Status: Final)
- CVM GFI #273 Defining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food-Producing Animals (Status: Draft)
- PAC-ATLS: Postapproval Changes - Analytical Testing Laboratory Sites: Guidance for Industry (Status: Final)
- Potency Tests for Cellular and Gene Therapy Products: Final Guidance for Industry: (Status: Final)