Macro photo of tooth wheels with COMPLIANCE, REGULATIONS, STANDARDS, POLICIES and RULES words imprinted on metal surface

Bending, Breaking or Moving On: FDA Expands on its 2018 Compounding Policies Priorities

On September 7, 2018, FDA Commissioner Scott Gottlieb stated that the FDA will expand on their implementation of their 2018 Compounding Priorities Plan and that they feel like they must continue to balance the need to preserve access to appropriately compounded drugs for patients who have a medical need for these products with the need to help protect patients from poor quality compounded drugs that could potentially cause harm to patients.

In 2015, the FDA issued a draft Memorandum of Understanding (MOU) to implement a key public health protection in Section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act).  Section 503A directs the FDA to develop an MOU for use by the States to address certain interstate distributions of compounded drugs by traditional 503A compounders.  The 2015 MOU covered States’ investigations of complaints associated with compounded drugs distributed out of their state.  The FDA consulted with the National Association of Boards of Pharmacy and issued a new draft for comment.  The draft has taken steps to address concerns that pharmacies raised to previous draft MOU, particularly to impediments to access to compounded drugs.

The MOU addresses traditional compounders that distribute a certain percentage (known as inordinate amounts) of their compounded drugs interstate.  Under the 2015 draft MOU, the States were expected to take action against a traditional 503A compounder that distributed inordinate amounts (equal to or greater than 30%) of its compounded drugs interstate.  Under the newly revised draft MOU, States would agree to identify (but not necessarily take action against) compounders that distribute more than 50 percent of their total prescription orders for compounded drugs interstate and report certain information to the FDA about those compounders.  The information would include the volume of compounded drugs distributed interstate and the number of States in which the compounder is licensed.  From this information, FDA and the States would develop risk-based oversight priorities to have the greatest public health impact.  Based on the revised MOU approach, the State could consider whether to take action according to a more flexible, risk-based approach.  Also, the FDA intends to use this information to prioritize its inspections of 503A compounders based on risk.

There may be considerable pressure from pharmacies for States to sign the MOU as Section 503A of the DQSA limits distribution of compounded drugs outside the State by a pharmacist, pharmacy, or physician located in a State that has not entered into the MOU to 5 percent of its total prescription orders dispensed or distributed by the 503A compounder.  The MOU and the 5 percent limit do not apply to 503B outsourcing facilities.

When finalized, the revised MOU will provide details for State investigations of complaints associated with compounded drug products that have been distributed out of state.  States that enter into the MOU will investigate complaints and report to the FDA when they receive reports of serious adverse drug experiences or serious product quality issues.  States will continue to have day-to-day oversight over 503A, traditional compounding pharmacies and physicians located in their state, and the FDA will continue its oversight of 503B Outsourcers.  The FDA plans to use the information obtained from the States to focus inspection and enforcement resources and will continue to inspect 503A facilities on a risk-based schedule or for cause.

Over the next few months, the FDA will deliver several new policies and expand on the enforcement of existing policies (guidances and their interpretation of the DQSA) and will ask for comments on these documents from stakeholders.  The FDA will issue a new revised guidance further describing insanitary conditions (based on what they have seen during inspections of 503A and 503B facilities), that addresses concerns that were raised by providers around the potential implications of the Agency’s prior draft guidance, and a revised risk-based guidance on current good manufacturing practice (CGMP) requirements for outsourcing facilities.

It will be interesting to see these new guidances from the FDA and determine what the impacts may be on patient access and on the compounding industry.