What is the Origin of FDA Bulk Substance Lists?

This regulatory framework originated from the legislative response to ensure the quality and safety of compounded medications, particularly following amendments to the Food, Drug, and Cosmetic Act. The establishment of these lists aims to strike a balance between allowing patient access to necessary compounded formulations and maintaining federal oversight of drug quality. The lists are dynamic, subject to ongoing review and public nomination processes by the FDA.

What is the Mechanism of FDA Bulk Substance Lists?

The function of the lists is to provide a legal and clinical boundary for compounding activities, thereby governing the raw materials available for personalized hormonal therapies, such as bioidentical hormone replacement preparations. Pharmacists must ensure that the bulk drug substances they use are either approved by the FDA or appear on these lists, which ultimately serves as a mechanism to protect patient health by restricting the use of unproven or unsafe substances in custom-made medicines.

FDA Bulk Substance Lists ∞ Area

FDA Bulk Substance Lists

Meaning

The FDA Bulk Substance Lists refer to specific lists maintained by the U.S. Food and Drug Administration that identify drug substances permitted for use in compounding under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act. These lists delineate which active pharmaceutical ingredients (APIs) may be used by compounding pharmacies to prepare customized medications for individual patients. Inclusion on a list signifies that the substance meets specific criteria regarding its safety and effectiveness for compounding.