1 May 2025
💊FDA Notice on Challenges for Compounding Outsourcing Facilities
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Obtaining Information To Understand Challenges and Opportunities Encountered by Compounding Outsourcing Facilities
Summary
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The text discusses an FDA information collection request that addresses the challenges and opportunities for compounding outsourcing facilities. It includes significant implications for compliance and regulatory requirements, particularly regarding adherence to Federal drug quality and safety standards, which directly affect business operations.