FDA’s flawed memorandum of understanding on interstate shipments
UPDATE: On February 23, 2022, FDA conceded that it must conduct formal notice-and-comment rulemaking to implement the MOU. The agency said it would suspend implementation of the MOU and engage in a formal rulemaking process, and it indicated in its filing that the process may take “several years” to complete. Read the full story here, in APC’s press release.
PREVIOUSLY: On September 21, 2021, U.S. District Court Judge Christopher Cooper issued a summary judgment in favor of a group of compounding pharmacies, ruling that FDA’s MOU on interstate shipments of compounded drugs violated the law, and the agency cannot enforce it. The MOU was remanded back to FDA, and the agency must “either certify that it will not have a significant economic effect on small businesses or prepare a regulatory flexibility analysis.”
- Read more about the judge’s ruling here.
- Watch as APC’s Scott Brunner joins our friends from Medisca for a conversation about the ruling … and what happens next.
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