APC Advocacy

FDA’s flawed memorandum of understanding on interstate shipments

The latest

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.”

The background

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:

  1. 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.
  2. Don’t sign, and limit every pharmacy in the state to shipping no more than five percent of their prescription orders to other states.

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