# Supplements and Other Changes to Approved New Animal Drug Applications
> **Food and Drug Administration** · Final rule. · Published 2006-12-13 · Effective 2007-02-12 · 71 FR 74766
## Document
- **Document number:** E6-21133
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 71 FR 74766
- **CFR reference:** 21 CFR 25
- **Publication date:** 2006-12-13
- **Effective date:** 2007-02-12
- **HHS docket:** Docket No. 1999N-1415
## Abstract

The Food and Drug Administration (FDA) is amending its regulations on supplements and other changes to approved new animal drug applications (NADAs) or abbreviated new animal drug applications (ANADAs) to implement the manufacturing changes provision of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). The final rule requires manufacturers to assess the effect of a manufacturing change on the identity, strength, quality, purity, and potency of a drug as those factors relate to the safety or effectiveness of the drug. The final rule sets forth requirements for changes requiring submission and approval of a supplement before the distribution of the drug made using the change, changes requiring the submission of a supplement at least 30 days prior to the distribution of the drug, changes requiring the submission of a supplement at the time of distribution of the drug, and changes to be described in an annual report.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2006/12/13/E6-21133/supplements-and-other-changes-to-approved-new-animal-drug-applications)
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