Description
Section 512(b) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 360b) establishes the requirements for new animal drug approval. 21 CFR 514.1 specifies the proper form and the information required to be submitted. Included is a requirement under section 514.1(b)(5)(x) that an applicant submit data from stability studies completed as well as information about studies that are underway to substantiate the request for a specific expiration date and provide information on the stability of the drug products.
Scope & Applicability
Product Classes
10Guideline applies to pharmaceutical dosage forms and medicated feed products.; Regulation 21 CFR 211.94 is for pharmaceutical dosage forms; dosage forms studied at 25°C for stability; General aspects for determining the stability of drug components in finished drug preparations.; Soluble powders and drenches are considered pharmaceutical dosage forms; Stability Guidelines are mainly related to finished dosage forms
genetically engineered active ingredients administered to animals
dosage form dissolved in the recommended solvent system
offer specialized drug delivery systems and dosage form characteristics
stability study should include assays for the release pattern
Stability tests for mastitis preparations are basically the same as for solutions
Medicated milk replacers prepared using hard and soft water
Drenches for oral administration available as powders, solutions or suspensions
Medicated soluble powders for the preparation of drinking water
compressed feed material shaped into a cubic form for animal free-choice use
Stakeholders
1Entity submitting development data and knowledge; Entity performing the work process for change
Regulatory Context
Attributes
10Property of a device that may be changed via established protocols
Physical/chemical parameter for typical liquid feed supplement.
Layering of active ingredients which may require agitation.
Requirement for the drug chemical to be evenly spread in the matrix.
Physicochemical characteristic used to assure product acceptability.
A material attribute CPP, such as moisture content, should have the same target value across scales.
Measurement of potency for biological products
reporting stability data including conditions of storage
reporting stability data including label claim
LoD; minimum and maximum amount of DNA providing expected results in 95% of runs.
Identified Hazards
Hazards
5quality attributes impacted by sterilization such as degradation products
relevant known risk factor
A condition leading to the appearance of adulteration.
physical instability in suspensions after freezing
physical abnormality occurring after freezing that requires toxicity identification
Related CFR Sections (6)
- 21CFR226.58§ 226.58 Laboratory controls.
Laboratory controls shall include the establishment of adequate specifications and test procedures to assure that the drug components and the Type A medicated article(s) conform to appropriate standards of identity, strength, quality, and purity. Laboratory controls shall include:Read full regulation →
- 21CFR200.50§ 200.50 Ophthalmic preparations and dispensers.
- 21CFR514.1§ 514.1 Applications.
(a) Applications to be filed under section 512(b) of the act shall be submitted in the form and contain the information described in paragraph (b) of this section, as appropriate to support the particular submission. If any part of the application is in a foreign language, an accurate and complete ERead full regulation →
- 21CFR211.137§ 211.137 Expiration dating.
(a) To assure that a drug product meets applicable standards of identity, strength, quality, and purity at the time of use, it shall bear an expiration date determined by appropriate stability testing described in § 211.166 .Read full regulation →
- 21CFR211.166§ 211.166 Stability testing.
(a) There shall be a written testing program designed to assess the stability characteristics of drug products. The results of such stability testing shall be used in determining appropriate storage conditions and expiration dates. The written program shall be followed and shall include:Read full regulation →
- 21CFR211.94§ 211.94 Drug product containers and closures.
(a) Drug product containers and closures shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug beyond the official or established requirements.Read full regulation →
Related Warning Letters (6)
- 2025-06-03
CGMP/Finished Pharmaceuticals/Adulterated
Huangshi Hygienic Material Medicine Co., Ltd.
- 2024-11-26
CGMP/Finished Pharmaceuticals/Adulterated
Catwalk Cosmetic Laboratories Pty Ltd.
- 2024-11-19
CGMP/Finished Pharmaceuticals/Adulterated
Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd.
- 2023-11-21
CGMP/Finished Pharmaceuticals/Adulterated
AmLion Toothpaste Mfg. Sdn. Bhd.
- 2023-02-14
CGMP/Finished Pharmaceuticals/Adulterated
Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil
- 2020-12-29
CGMP/Finished Pharmaceuticals/Adulterated
Clientele, Inc.
See Also (8)
- CVM GFI #191 Changes to Approved NADAs - New NADAs vs. Category II Supplemental NADAs (Status: Final)
- Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4 Guidance for Industry: Guidance for Industry (Status: Final)
- 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 #135 Validation of Analytical Procedures for Type C Medicated Feeds (Status: Final)
- CVM GFI #123 Development of Data Supporting Approval of NSAIDS for Use in Animals (Status: Final)
- CVM GFI #136 Protocols for the Conduct of Method Transfer Studies for Type C Medicated Feed Assay Methods (Status: Final)
- CVM GFI #178 Recommended Design and Evaluation of Effectiveness Studies for Swine Respiratory Disease Claims (Status: Final)