1. Compounding Quality Act, 127 Stat 587 21 USC 301, §101 (2013).
2. Prescription requirement under section 503A of the Federal Food, Drug, and Cosmetic Act: guidance for industry,2016
3. Evaluation of bulk drug substances nominated for use in compounding under section 503B of the Federal Food, Drug and Cosmetic Act: guidance for industry,2019
4. Interim policy on compounding using bulk drug substances under section 503B of the Federal Food, Drug and Cosmetic Act: guidance for industry,2017
5. Drug products withdrawn or removed from the market for reasons of safety or effectiveness, 21 CFR, §216.24 (2018).