The Food and Drug Administration (FDA) has released a new guidance document for the industry titled “Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” This document establishes the conditions for compounding certain drugs and explains the FDA’s current approach while developing a list of bulk drug substances permitted for use. This guidance replaces a previous version from 2017 and provides instructions on submitting comments to the FDA. The guidance clearly states it is not legally binding but shows the FDA's current thinking on this issue.
Simple Explanation
The FDA made new rules to help places that make medicine follow the law. They're deciding what ingredients can be used in medicine-making and shared their ideas, but these ideas are not final rules.