As the FDA and industry prepare for Dr. Gottlieb’s departure from the FDA tomorrow, he and Deputy Commissioner Anna Abram issued a statement (here) on the FDA’s 2019 priorities to improve the quality of compounded drugs.  As the statement notes, compounded drug products are not FDA-approved and, thus, can pose a serious threat to the public if not prepared properly.  The FDA has taken action over the past year to clarify its position and policies relative to both 503A (traditional) and 503B (outsourcing) compounders.

Priorities for 2019

Maintaining Quality Manufacturing and Compliance

The FDA plans to establish a Center for Excellence for Compounding for Outsourcing Facilities that will provide training for cGMP for outsourcing facilities.  The Agency hope to provide guidance on areas of weakness and how to strengthen the conditions at, and the practices of, outsourcers to improve and ensure the quality of compounded products.  The FDA notes, “[I]n 2018, the FDA sent warning letters to twenty-three facilities for adulterated product violations.  These include insanitary conditions.  We also worked with compounders on fifty recalls of products from the marketplace that raised safety concerns.  Since 2018, the FDA has entered into four consent decrees of permanent injunction to address the risk of patient harm from exposure to unsafe compounded drugs.”

Regulating Compounding from Bulk Drug Substances

This has been a bone of contention in the compounding industry, particularly for the outsourcing facilities.  The FDA has issued regulations identifying what bulk drugs 503A and 503B firms can use for compounding.  The FDA indicates it will revise the list through comment and rulemaking as it reviews new nominations to the list.  503A compounders typically compound based on individual patient-specific prescriptions.  However, as the FDA notes, 503B firms do not compound on a patient-specific prescription basis but rather compound for healthcare facilities to hold as office stock.  The limitations placed on the bulk drugs that 503B outsourcers can use is intended to protect patients and the integrity of the drug review and approval process.

Finalizing our Memorandum of Understanding (MOU) with the States

The FDA has limited resources to inspect at compounding facilities, and these MOUs will aid in a cooperative relationship between the states and the FDA to provide greater assurance that the compounding facilities operate under appropriate regulations and conditions.

Compounding by Hospital and Health Systems

The Agency recognizes that such operations operate differently than traditional compounders or outsourcers and plans to issue a revised guidance “regarding hospital or health system compounding to provide further clarification on how the FDA intends to apply section 503A of the FD&C Act to drugs compounded at these facilities.”  The FDA will also address guidance for these types of facilities “that might be considering registering as an outsourcing facility under section 503B.”

Additional Compounding Priorities

The Agency also plans to hold public meetings and listening sessions for stakeholders to gain their input and listen to their concerns.

2019 may be another wild ride for compounders as it appears that the FDA will clearly have its eyes focused on this segment of the market.  We will keep you up to date on any significant developments in this arena.