Memoranda de entendimiento4/8/2023 District Court for the District of Columbia. Soon after issuing the standard MOU, FDA was sued by several compounding pharmacies in the U.S. The MOU is a key public health protection in the law and is anticipated to help enhance communication and maximize federal and state resources for oversight of compounded drugs produced by traditional pharmacies. The standard MOU was developed in consultation with the National Association of Boards of Pharmacy (NABP) as described in section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and was the product of more than 20 years of collaborative dialogue and stakeholder input. The standard MOU is an agreement that is intended to address interstate distribution of inordinate amounts of compounded drugs and complaint investigation by a state regulator relating to compounded drugs distributed outside the state.īackground: In October 2020, FDA made a standard MOU available for signature by states. Update: February 2022: FDA intends to undertake notice-and-comment rulemaking related to statutory provisions regarding certain distributions of compounded human drug products and a standard memorandum of understanding (MOU) between FDA and states. 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. Update: October 2022: 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.įDA 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.
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