Lee Rosebush Comments on FDA Compounding Memorandum

News / October 28, 2020

Partner Lee Rosebush, who is chair of the Outsourcing Facility Association, is quoted in an article published Oct. 28, 2020, by Inside Health Policy. The article, “Pharmacy Group: FDA May Face Suits Over Compounding MOU,” reports on a recent Food and Drug Administration memorandum of understanding (MOU) that which subjects compounding pharmacies located in states that don’t sign the MOU to a 5% sales cap on the amount of compounded product that can be shipped out of state.

The MOU gives state pharmacy boards a key monitoring role and requires states to notify FDA when pharmacies within their states ship more than 50% of their compounds out of state. In states that choose to opt out of the MOU, compounding pharmacies will be limited to shipping no more than 5% of all compounded products out of state. States have one year to sign the MOU before FDA enforces the limits.

Lee Rosebush said that while the MOU’s impact on outsourcing facilities will be limited, it will still be interesting to see how many states actually sign on to the MOU, considering COVID-19's impact on state budget concerns and medication accessibility. “We will be monitoring states very closely for the next year to see how they respond,” Rosebush said.

Read the article (registration required).

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