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Difficult-to-Compound List

Meaning

The Difficult-to-Compound List is a regulatory list established by the U.S. Food and Drug Administration (FDA) under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act. This list identifies specific drug products or categories that present demonstrable difficulties for compounding, making it challenging to ensure their safety and effectiveness when prepared outside of a manufacturing facility. Inclusion on this list prohibits compounding pharmacies from creating copies of these complex drug products. The list serves as a critical public health measure to protect patients from potentially unsafe or ineffective compounded medications.