Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances

Summary

The Secretary of the Department of Health and Human Services (HHS) is announcing the availability of an "Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances." This document describes the Secretary of HHS's enforcement policy regarding the use of certain peptide bulk drug substances in compounding pursuant to section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) while the list of bulk drug substances that can be used in compounding under section 503A of the FD&C Act (the 503A bulks list) is developed through rulemaking.