December 13, 2006
FDA Publishes Final Rule on Animal Drug Manufacturing Changes
The Food and Drug Administration Modernization Act of 1997 (http://www.fda.gov/cvm/fdama.html) amended the Federal Food, Drug, and Cosmetic Act to describe requirements and procedures for making and reporting manufacturing changes to approved new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs). In the Federal Register of October 1, 1999 (64 FR 53281), FDA published a proposed rule to implement these new requirements. In that same issue of the Federal Register (64 FR 53393), FDA also announced the availability of a related draft guidance for industry entitled "Chemistry, Manufacturing and Control Changes to an Approved NADA or ANADA" (GFI #83). FDA has evaluated all public comments received in response to these publications and has finalized the rule and related guidance document.
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.
The final rule was published in the December 13, 2006, Federal Register (http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-21133.htm). The final rule will become effective on February 12, 2007.
The related guidance document has been revised to conform to the final rule and, as appropriate, to comments received. It will be issued upon approval of information collection requirements that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act.
Additional information about the final rule is included in the December 13, 2006, Federal Register. Questions may be directed to Dr. Dennis M. Bensley, Jr. Center for Veterinary Medicine (HFV-140), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-6956, E-mail: dennis.bensley@fda.hhs.gov.
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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