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# Criteria on Difficult Compounding Lists
- URL: https://www.fdaweb.com/criteria-on-difficult-compounding-lists/
- Published: 2024-03-20T12:00:00.000Z
- Updated: 2026-09-14T14:25:52.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5156601

*Federal Register* notice: FDA is proposing to establish criteria for the lists of drug products or drug categories that present demonstrable difficulties for compounding under certain sections of the Federal Food, Drug, and Cosmetic Act. Additionally, the agency is proposing to identify the first three categories of drug products on both lists. Drug products or categories of drug products that appear on the lists cannot qualify for certain statutory exemptions, and therefore may not be compounded under, either Section 503A or Section 503B, respectively. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2024-03-20/pdf/2024-05801.pdf?ref=fdaweb.com).