Champions in Congress have acted to preserve access to patients that turn to compounding for lifesaving medications. This bipartisan legislation includes critical language which clarifies congressional intent on several compounding regulations implementing the Drug Quality and Security Act (DQSA) of 2013. The regulations addressed are among those on which Congress had asked FDA for additional clarity and expressed strong concern that FDA implementation actions were drastically decreasing patient access to vital compounded medications.
The language calls on FDA to do the following:
- Draft a new memorandum of understanding that does not include “dispensing” within the MOU. Congress expressed concern that the FDA draft MOU includes both “dispensing” and “distribution” of compounded medications. Congress made clear in the language that FDA does not possess this authority and specifically stated, “Congress only allowed the FDA to regulate distribution” under the MOU and “Congress did not intend to include dispensing of compounded drugs over state lines within the scope of the MOU.”
- Release new guidance to allow 503A pharmacists to compound for “office-use” for prescribers, hospitals and other health systems. Congress expressed concern that patient access is decreasing to compounded medications, due to FDA’s implementation actions of prohibiting all office-use compounding even where “this practice is authorized in the vast majority of states and was intended to be allowable under DQSA.”
- Cease inspecting state-licensed 503A pharmacies under current Good Manufacturing Practices (cGMPs). Congress instructed FDA to inspect 503A pharmacies under USP standards or other applicably pharmacy inspection standards adopted by state law or regulation. Congress also stated that it “reminds the FDA that compounding pharmacies are not drug manufacturers, but rather, are state licensed and regulated health care providers that are inspected by state boards of pharmacy pursuant to state laws and regulations.” Congress further stated, “compounding pharmacies are more appropriately inspected using USP standards or other pharmacy inspection standards adopted by state law or regulation in the state in which a pharmacy is licensed.”
IACP and Key Compounding Pharmacy would like to express our gratitude to the Representatives and Senators who worked tirelessly to preserve patient access to vital compounded medications, which can mean the different between life and death for the patients that depend upon these compounded medications.