Reed Smith Client Alerts

Days before U.S. Food & Drug Administration (“FDA”) Commissioner Scott Gottlieb, M.D., departed from FDA, the Agency published a statement from Dr. Gottlieb and Deputy Commissioner Anna Abram (the “Statement”) regarding the Agency’s proposed efforts in 2019 to improve the quality of compounded drugs.  Although it is unclear at this point how these efforts will be managed and implemented under the incoming acting commissioner, Dr. Norman “Ned” Sharpless, the Statement provides helpful insight into the timing of long-awaited Agency action in the compounding space, a summary of which is set forth below.

Authors: Rachael G. Pontikes Emily L. Hussey Kelly J. Kearney

Maintaining Quality and Compliance for Outsourcing Facilities and Traditional Compounding Pharmacies 

In 2019, FDA intends to establish a Center of Excellence on Compounding for Outsourcing Facilities to provide training on current Good Manufacturing Practices (“cGMP”) for FDA-registered outsourcing facilities.  Additionally, FDA is working to finalize its revised draft guidance, “Insanitary Conditions at Compounding Facilities,” which identifies certain insanitary conditions FDA intends to enforce against both traditional compounding pharmacies and outsourcing facilities.  In the meantime, FDA will continue to conduct risk-based inspections of compounding pharmacies and outsourcing facilities and will pursue other enforcement efforts to identify compounders that produce drugs under Agency-determined substandard conditions.

Regulating Compounding from Bulk Drug Substances

Over the years FDA, pursuant to the authority granted to it by the Federal Food, Drug, & Cosmetic Act (“FDCA”), has been working to develop lists of approved bulk drug substances that traditional compounding pharmacies and outsourcing facilities can use to compound drugs (the “503A Bulks List” and “503B Bulks List,” respectively).  Earlier this year, FDA issued a final rule establishing the criteria for evaluating bulk drug substances that were nominated for inclusion on the 503A Bulks List that pharmacists and physicians can use to compound drugs.  For the first time, FDA approved six bulk drug substances for compounding under Section 503A.  The Agency plans to build on these actions by issuing another proposed rule this year that will further amend the 503A Bulks List and will reflect FDA’s ongoing evaluation of the nominated bulk drug substances.  

In the 503B context, just last month FDA issued a final guidance for industry, “Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act,” which addressed FDA’s policies for developing the 503B Bulks List and set forth the Agency’s interpretation of “bulk substance for which there is a clinical need” (i.e., the statutory standard for compounding from bulk drug substances under Section 503B of the FDCA).  Like its plans for the 503A Bulks List, FDA plans to continue to develop the 503B Bulks List this year.