Description
This guidance provides recommendations to sponsors submitting chemistry, manufacturing, and controls (CMC) information for Type A medicated articles. Type A medicated articles contain new animal drugs and provide for administration of these drugs in animal feed. Type A medicated articles are intended solely for use in the manufacture of another Type A medicated article or in the manufacture of a Type B or Type C medicated feed. Because Type A medicated articles are not directly administered to the animal, there are some issues specific to Type A medicated articles that do not apply to other new animal drug dosage forms. These unique considerations are highlighted in this guidance under the relevant Common Technical Document - Quality (CTD-Q) section headings.
Scope & Applicability
Product Classes
4New 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
Manufactured from Type A medicated articles; The intermediate pre-blend is not considered a Type B medicated feed
Final feed administered to animals
manufactured using Type A medicated article
Regulatory Context
Attributes
2Based on the oldest material added to the batch
Particle size specification included as a CQA of the finished article.
Related CFR Sections (4)
- 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 →
- 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 →
- 21CFR573.680§ 573.680 Mineral oil.
Mineral oil may be safely used in animal feed, subject to the provisions of this section.Read full regulation →
- 21CFR558.4§ 558.4 Requirement of a medicated feed mill license.
(a) A feed manufacturing facility must possess a medicated feed mill license in order to manufacture a Type B or Type C medicated feed from a Category II, Type A medicated article.Read full regulation →
See Also (8)
- CVM GFI #57 Preparation and Submission of Veterinary Master Files (Status: Final)
- CVM GFI #181 Blue Bird Medicated Feed Labels (Status: Final)
- CVM GFI #191 Changes to Approved NADAs - New NADAs vs. Category II Supplemental NADAs (Status: Final)
- CVM GFI #170 Animal Drug User Fees and Fee Waivers and Reductions (Status: Final)
- CVM GFI #273 Defining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food-Producing Animals (Status: Draft)
- CVM GFI #5 Drug Stability Guidelines (Status: Final)
- CVM GFI #169 Drug Substance Chemistry, Manufacturing, and Controls Information (Status: Final)
- CVM GFI #255 Elemental Impurities in Animal Drug Products Questions and Answers (Status: Final)