1 May 2025
💊FDA Notice on Pharmaceutical Supply Chain Compliance Requirements
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Pharmaceutical Distribution Supply Chain; Drug Supply Chain Security
Summary
The Food and Drug Administration (FDA, the Agency, or we) 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 (PRA).
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The document involves compliance and regulatory requirements for businesses in the pharmaceutical industry, specifically related to drug supply chain security and information collection under the FDA's oversight. Businesses must comply with recordkeeping and reporting requirements, which can have financial implications due to associated costs and the need for systems updates.