What is the Origin of Bulk Drug Substances List?

This regulatory framework was established to delineate the boundaries of traditional pharmacy compounding following legislative changes aimed at enhancing the quality and safety of compounded medications. The term's origin is administrative, stemming from the need to regulate the raw, or "bulk," active ingredients used outside of the standard drug approval process.

What is the Mechanism of Bulk Drug Substances List?

The list functions as a gatekeeping mechanism for compounded hormonal therapies and other custom medications. A substance must undergo a nomination and review process, where regulatory authorities evaluate its history of use, safety data, and the existence of an FDA-approved drug product that could serve as an alternative. This structured review ensures that compounding remains a viable option for patients with unique clinical needs while minimizing the risks associated with unapproved or inadequately characterized drug substances.

Bulk Drug Substances List

Meaning

The Bulk Drug Substances List, also known as the Positive List, is a compilation maintained by regulatory bodies like the FDA, detailing specific active pharmaceutical ingredients (APIs) that may be used in compounding non-sterile and sterile drug preparations. These substances are generally recognized as having a clinical need and meeting certain safety and efficacy criteria when compounded. Inclusion on this list provides clarity to compounding pharmacies regarding which substances are permissible for custom patient formulations, ensuring a degree of regulatory oversight and quality control.