The FDA’s Recent Memorandum of Understanding
In May 2020, the FDA released its Memorandum of Understanding (MOU) about proposed regulations on distributing cBHRT drugs out of state. According to the MOU, the FDA will limit pharmacies to distributing only 5% of their compounded drugs out of state if they do not sign the document.
The FDA will allow pharmacies who do sign the MOU to distribute up to 50% of compounded drugs. Any failure to adhere to these regulations results in a state investigation and mandatory reporting to the FDA. Not only will these regulations impact cBHRT, but they will impact all compounded medication.
To advocate for patients, pharmacy groups, such as the Alliance for Pharmacy Compounding (APC) , voiced concerns about revising the MOU so that states and the government can reach an agreement. Until then, numerous states refused to sign the MOU.
The FDA Commissions The NASEM To Study cBHRT
In the spring of