FDA Probes Custom Med Makers: Share Challenges, No Extra Costs Involved
Published Date: 5/1/2025
Notice
Summary
The FDA wants to learn more about the challenges and opportunities faced by compounding outsourcing facilities—places that make special medicines. They’ve asked the Office of Management and Budget to review their plan to collect this info, which helps improve safety and quality. This won’t cost businesses extra money but will ask for some helpful feedback soon.
Analyzed Economic Effects
1 provisions identified: 1 benefits, 0 costs, 0 mixed.
FDA Asks Compounding Facilities For Feedback
The FDA submitted a plan to the Office of Management and Budget under the Paperwork Reduction Act of 1995 to collect information from compounding outsourcing facilities (places that make special medicines). The agency says the collection is to better understand challenges and opportunities and will help improve safety and quality, and it states this will not impose extra monetary costs on businesses.
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