10/24/2022

Extension of Period Before FDA Enforcement of 5 Percent Limit on Out-of-State Distribution of Compounded Drugs

FDA issued a Federal Register notice: Extension of the Period Before the Food and Drug Administration Intends to Begin Enforcing the Statutory 5 Percent Limit on Out of State Distribution of Compounded Human Drug Products.

FDA is extending the period before it 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 have not entered into a standard memorandum of understanding (MOU) with FDA addressing certain distributions of compounded human drug products. FDA is extending the period, which was scheduled to end on October 27, 2022, until the effective date of a final rule regarding certain distributions of compounded human drug products and publication of an updated standard MOU.

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