Tuesday, November 23, 2021

 "Nov. 2, 2021: Update – In October 2020, FDA was sued by seven compounding pharmacies in the U.S. District Court for the District of Columbia regarding the final standard Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products. In September 2021, the Court remanded the MOU to FDA to either certify that it will not have a significant economic effect on small businesses or prepare a regulatory flexibility analysis. FDA is evaluating the Court’s decision.

Before the Court’s decision, FDA extended the period 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, to October 27, 2022.

FDA plans to provide additional updates, as appropriate, with regard to the MOU."

quoted from https://www.fda.gov/drugs/human-drug-compounding/memorandum-understanding-addressing-certain-distributions-compounded-drugs

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