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FDA Compounding List

Meaning

The FDA Compounding List is the official, publicly maintained inventory by the U.S. Food and Drug Administration that identifies bulk drug substances which may be legally used by compounding pharmacies to prepare customized medications under specific sections of federal law. This list is a critical regulatory instrument ensuring that compounded preparations, including many bioidentical hormone formulations, are created using ingredients that have been reviewed for appropriate quality and clinical need. It provides a necessary framework for safe and legal compounding practice. The list distinguishes between substances that can and cannot be used by compounding pharmacies.