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  1. Economic Impact Analyses of FDA Regulations

Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act RIA (Proposed Rule)

We evaluated three categories of drug products for this proposed rule.  We would place all three of these categories of drug products on the Demonstrable Difficulties for Compounding Lists (DDC lists).  Currently, we are not aware of any marketing of compounded drugs in the three proposed categories of human drug products.  Therefore, we expect that the proposed rule would only create administrative costs to read and understand the rule for compounders. We seek comments on these assumptions and welcome feedback on any potential benefits that may result from this rulemaking.

Regulatory Impact Analysis

Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act RIA (Proposed Rule) (PDF 260 KB)

Federal Register: 89 FR 19776
Publication Date: 3/20/2024
Docket: FDA-2023-N-0061

 
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