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# FDA Evaluating Compounding MOU Court Action
- URL: https://www.fdaweb.com/fda-evaluating-compounding-mou-court-action/
- Published: 2021-11-03T12:00:00.000Z
- Updated: 2026-09-14T17:21:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150502

FDA says it is evaluating a DC federal court 9/2021 action remanding to the agency the Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products to either certify that it will not have a significant economic effect on small businesses or prepare a regulatory flexibility analysis. The court action came in response to a 10/2020 suit against the agency by seven compounding pharmacies.

FDA [says](https://www.fda.gov/drugs/human-drug-compounding/memorandum-understanding-addressing-certain-distributions-compounded-drugs?ref=fdaweb.com) that before the court ruling, the agency extended the period before it intends to begin enforcing the statutory 5% 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 memorandum of understanding (MOU) to 10/27/2022.

The agency says the MOU is an agreement between state boards of pharmacy or other state agencies and FDA that addresses the interstate distribution of inordinate amounts of compounded drugs and complaint investigations by a state regulator relating to compounded drugs distributed outside the state.

The MOU was developed in consultation with the National Association of Boards of Pharmacy, FDA says, and 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.”