On June 9, 2016, the U.S. Food and Drug Administration (“FDA”) published two final guidance documents on drug compounding under Sections 503A and 503B of the Food, Drug, and Cosmetic Act (“FDCA”).[1] These guidance documents cover two topics:

Through these topics, the FDA provides further insight into its current thinking on certain areas of drug compounding.

Interim Policy On Compounding Using Bulk Substances Under Section 503A

FDA has set forth an interim regulatory policy on compounding using bulk drug substances under Section 503A of the FDCA. By way of background, Section 503A includes certain restrictions on bulk substances that can be used in compounding[2] and directs FDA to develop a list of bulk drug substances that can be used in compounding under that section. While FDA works to finalize that list, it has prescribed an interim policy for compounding human drug products using bulk drug substances. In doing so, FDA has acknowledged that its earlier attempts to create a bulk drug substance list for Section 503A unnecessarily limited the drugs available to patients that needed compounded medication.[3] Until the bulk substance list is finalized, FDA assures that it will not take regulatory action for compounding drugs with certain bulk drug substances listed in guidance that meet certain criteria.

FDA’s interim policy also provides insight into those characteristics that FDA believes will qualify a bulk drug substance for inclusion in FDA’s bulk drug substances list for Section 503A, and those that will not. FDA further lays out its process for development of the final bulk drug substances list and has indicated that it will be publishing a notice of proposed rulemaking (“NPRM”) that identifies substances FDA proposes for placement on the Section 503A list. After publication of the NPRM, the public will have an opportunity to comment on the proposed rule before the list is finalized.[4]

Interim Policy On Compounding Using Bulk Substances Under Section 503B

Similar to its interim policy on compounding using bulk substances under Section 503A, FDA has issued an interim regulatory policy on compounding using bulk substances under Section 503B of the FDCA. Section 503B includes restrictions on the bulk drug substances that outsourcing facilities can use in compounding and directs FDA to develop a list of bulk drug substances that can be used in compounding under that section.

While FDA works to develop that list (which is separate from the bulk drug substances list for purposes of Section 503A), its interim policy provides guidance on those bulk substances that can be used for compounding, as well as insight into those characteristics that FDA believes will qualify a bulk drug substance for inclusion in FDA’s bulk drug substances list for Section 503B. The interim policy also details FDA’s process for development of the final bulk drug substances list for Section 503B, which includes the publication of the NPRM in the Federal Register that describes its proposed position on each substance it has evaluated and the rationale for the proposal, and opens its position for public comment. The interim policy will remain effective until FDA publishes its final list of bulk drug substances in the Federal Register.[5]