FDA Grants MOU Extension

FDA today announced a one-year extension of states to sign the MOU. Following is additional information from FDA.

FDA is extending the period for states to decide whether to sign the final standard memorandum of understanding (MOU) entitled, “Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products Between the [insert State Board of Pharmacy or Other Appropriate State Agency] and the U.S. Food and Drug Administration” (final standard MOU) before FDA intends to begin enforcing the statutory 5 percent limit on distribution of compounded human drug products out of the State in which they are compounded in States that do not sign the final standard MOU. FDA is extending the period, which was scheduled to end on October 27, 2021, to October 27, 2022. States may sign the final standard MOU at any time, including after the period is scheduled to end on October 27, 2022.

See the posting here, which is slated to be published in the Federal Register on August 9, 2021.

NABP and pharmacy trade associations each requested a delay. Look for continuing updates from PCCA Public Affairs. Questions can be directed to