The Memorandum of Understanding (MOU) would greatly impact interstate filling of compounded prescriptions by regulating 503(a) compounding pharmacies. As the majority of compounding pharmacies in the U.S. are 503(a) compounding facilities, the impact would be one felt throughout the nation by patient and practitioner alike. This would restrict majority of compounding pharmacies to no more than 5% of interstate sales per month. However, the if the state decides to take on any adverse events or quality issues, then their pharmacies may increase interstate sales to no more than 30%.
These numbers correlate to patient safety, that being 5% interstate sale is considered safe, 30% is only safe if the state agrees to the MOU of the FDA, and any
These numbers correlate to patient safety, that being 5% interstate sale is considered safe, 30% is only safe if the state agrees to the MOU of the FDA, and any