🐾FDA Notice on Compounding Animal Drugs from Bulk Substances
Agency Information Collection Activities; Proposed Collection; Comment Request; Compounding Animal Drugs From Bulk Drug Substances
Summary
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the recordkeeping provisions set forth in Guidance for Industry, GFI #256--Compounding Animal Drugs from Bulk Substances.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
This notice highlights the regulatory provisions for compounding animal drugs, which requires businesses in the veterinary and pharmaceutical sectors to comply with documentation and reporting, impacting operational practices and costs. The mention of recordkeeping requirements indicates a need for compliance infrastructure.