United States: FDA Solidifies Its Position On Certain Compounding Issues In New Guidance Documents

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]

Footnotes

[1] Official notices for each of the final guidance documents were published in the Federal Register on June 9, 2016.

[2] Under Section 503A, a bulk drug substance that is not the subject of an applicable USP or NF monograph or is not a component of an FDA-approved drug product cannot be used in compounding unless it appears on a list promulgated as a regulation pursuant to Section 503A(b)(1)(A)(i)(III) of the FDCA. This list has not yet been codified.

[3] In July 2014, FDA issued a guidance, Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug and Cosmetic Act, that indicated it would not exercise enforcement discretion and allow compounding with bulk drug substances that were not components of a commercially available drug or the subject of USP and NF monographs until the FDA's final list of bulk drug substances for Section 503A was published.

[4] FDA does not offer a timeline for when it will publish its NPRM.

[5] FDA does not offer a timeline for when the bulk drug substance list will be finalized.

If you have any questions about this Alert or would like more information, please contact Rachael G. Pontikes, Emily L. Hussey, any of the attorneys in our Pharmaceutical, Medical Device, Pharmacy and Food industry group or the attorney in the firm with whom you are regularly in contact.

Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.

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