FDA Unveils Ramped-up Regulatory Initiatives for Drug Compounders

On September 26, 2017, FDA Commissioner Scott Gottlieb, M.D. released a statement about FDA’s recent efforts to continue to regulate drugs compounded by section 503B outsourcing facilities.¹ FDA’s efforts include:

• Publishing a report that provides a list of all the drugs that outsourcing facilities have compounded
• Publishing a guide entitled “Outsourcing Facility Information,” which is a compilation of key regulatory information applicable to outsourcing facilities
• Conducting the sixth intergovernmental meeting on drug compounding, allowing intergovernmental agencies to coordinate their regulatory efforts

FDA represents that these efforts are both an attempt to help the medical community identify what medications are compounded by outsourcing facilities, and to clarify the DQSA framework for outsourcing facilities.

FDA Is Now Publishing Section 503B Drug Reports

As an initial matter, FDA started posting a new report that provides a list of drugs that outsourcing facilities reportedly compound. Under the DQSA, outsourcing facilities are required to report to the FDA, upon initial registration and each June and December, the drug preparations that they have compounded during the previous six months. FDA is now making these reports public. The first report lists all drugs compounded by outsourcing facilities between December 2016 and May 2017.

FDA Publishes an “Outsourcing Facility Information” Guide

Additionally, FDA published a guide titled “Outsourcing Facility Information,” which is a compilation of the key regulatory information FDA believes is applicable to outsourcing facilities. This guide provides information regarding:

• The implications of becoming an outsourcing facility
• The guidance documents, regulations, and other informational resources available to outsourcing facilities
• The process for registering as an outsourcing facility and reporting to FDA
• The FDA inspection process for outsourcing facilities

Of note, this guide suggests that FDA is aware of a number of outsourcing facilities that compound both human and animal drugs. However, FDA makes it clear in this new guide that “[a]nimal drugs are not eligible for exemptions under section 503B of the FD&C Act and are generally subject to the adulteration, misbranding, and approval provisions of the FD&C Act.”² Further, FDA represents that it plans to address how it will exercise its enforcement discretion of animal compounding in outsourcing facilities when it finalizes its Compounding Animal Drugs from Bulk Drug Substances guidance.

FDA Conducts Sixth Intergovernmental Meeting on Drug Compounding

Finally, on September 26, 2017, FDA conducted its sixth intergovernmental meeting on drug compounding where it invited representatives from the board of pharmacy in all 50 states to discuss the regulations of compounded drugs. During the meeting, FDA outlined how it intends to coordinate the regulation of drug compounding with state boards of pharmacy. FDA indicated:

• The agency is attempting to make its “inspectional activities more transparent, including an educational session for states on how FDA inspects compounding facilities, and processes to give states additional opportunities to directly observe FDA inspections.”3
• FDA is actively working to revise the draft standard memorandum of understanding (MOU) between FDA and states to address the interstate distribution of compounded preparations

These efforts demonstrate that FDA is continuing to actively oversee the regulation of drug compounding, and is looking to work closer with state boards of pharmacy to coordinate its various enforcement initiatives. As such, drug compounders should continue to closely monitor their compliance with all applicable state and federal regulation and guidance.

1. FDA, Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to encourage compounding of better quality drugs under DQSA and help health care professionals access compounded medications needed for patient care from outsourcing facilities (available at: fda.gov).
2. FDA, Outsourcing Facility Information at 9, (available at: fda.gov).
3. FDA, Remarks for the 50 State Intergovernmental Meeting to Discuss Pharmacy Compounding (available at: fda.gov).

Client Alert 2017-229