FDA’s flawed memorandum of understanding on interstate shipments
UPDATE August 6, 2021: FDA extends MOU a year, until October 27, 2022. More details about our next steps coming shortly!
APC is requesting a delay in the October 26, 2021 enforcement date of FDA’s MOU on interstate shipments, given that several states have said they lack statutory authority to sign it without action by their state legislature.
In 1997, as part of the Food, Drug & Cosmetic Act, FDA was instructed to draft a memorandum of understanding with states regarding the interstate shipment of compounded drugs. It was expected to be a consensus document, created with input and endorsement of the states — an MOU they would be willing to sign.
Instead, inexplicably, the FDA drafted the MOU with little input from state boards of pharmacy, and released a document that, rather than having broad backing, puts states between a rock and a hard place:
- They can sign the MOU and commit to investigating, documenting, and reporting to FDA any time a pharmacy ships more than 50 percent of its compounded drugs to out-of-state patients.
- Don’t sign, and limit every pharmacy in the state to shipping no more than five percent of their prescription orders to other states.
Resources and information
- APC’s briefing paper
- APC: “Reining-in the FDA MOU Rumor Mill” (July 2021)
- APC Letter to FDA Requesting Extension of Enforcement Deadline (April 2021)
- NABP Compounding Pharmacy Information Sharing Project
- Joint Congressional Letter to FDA requesting MOU enforcement extension (July 2021)
- APC News Release on Final MOU (October 2020)
- The MOU itself