FDA to Develop Agreement with State Boards to Better Track Compounded Medications Nationwide
Pursuant to Section 503A of the Food, Drug and Cosmetic Act the FDA is directed to develop a Memorandum of Understanding ("MOU") between itself and the states which would institute a system for state boards of pharmacy to track and report the circulation of disproportionate amounts of compounded medications to the FDA.
The FDA originally released a draft of the MOU in 2015 but this draft received backlash regarding concerns about patient access to certain medications.
A revised draft was released in September of 2018. One notable piece of the revised draft is the loosely defined term "distribution" which could significantly impact the amount of drugs that may be distributed by a compounding facility. Additionally if a state board elects not to sign the MOU, only 5% of total prescription orders dispensed or distributed by a 503A compounder in that state may be shipped out of state.
The FDA has indicated it plans to finalize the MOU with the states by the end of 2019.