Description
FDA closely monitors the animal drug supply chain for supply disruptions or shortages in the United States. This guidance assists sponsors in providing FDA timely, informative notifications about changes in the production of animal drugs that will, in turn, help the Agency in its efforts to prevent or mitigate shortages of these products.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
1A product used to treat or prevent a serious animal disease where no adequate alternative exists.
Stakeholders
1Entity responsible for submitting applications under section 524B
Regulatory Context
Regulatory Activities
4Inspection coverage that may be difficult to obtain due to travel restrictions.
CBE supplement for reporting SOP changes
Major changes requiring FDA approval before implementation
Submission type for alternate manufacturer or new manufacturing facility.
Document Types
1Chemistry, Manufacturing, and Controls portion of the application; Chemistry, Manufacturing, and Controls section of the application
Technical Details
Substances
1examples of such components include but are not limited to the active moiety (API)
Testing Methods
1Alternative interim proposal to support manufacturing changes.
Identified Hazards
Hazards
1Actual or potential disruption in the supply chain for a drug product.
Related CFR Sections (2)
- 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 →
- 21CFR514.8§ 514.8 Supplements and other changes to an approved application.
(a) Definitions.Read full regulation →
See Also (8)
- CVM GFI #169 Drug Substance Chemistry, Manufacturing, and Controls Information (Status: Final)
- CVM GFI #191 Changes to Approved NADAs - New NADAs vs. Category II Supplemental NADAs (Status: Final)
- CVM GFI #265 Use of Data from Foreign Investigational Studies to Support Effectiveness of New Animal Drugs (Status: Final)
- CVM GFI #106 The Use of Published Literature in Support of New Animal Drug Approvals (Status: Final)
- CVM GFI #108 Registering with CVM’s Electronic Submission System (Status: Final)
- CVM GFI #273 Defining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food-Producing Animals (Status: Draft)
- Translation of Good Laboratory Practice Study Reports: Questions and Answers (Status: Draft)
- CVM GFI #61 Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species (Status: Final)