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# FDA Denies Drug Compounding MOU Petition
- URL: https://www.fdaweb.com/fda-denies-drug-compounding-mou-petition/
- Published: 2020-05-14T12:00:00.000Z
- Updated: 2026-09-14T16:15:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146788

FDA has denied a 1/22 Crowell & Moring petition asking that it not finalize with states a drug compounding memorandum of understanding (MOU) or take any regulatory action against drug compounders based on a regulatory definition of “distribution” that includes “dispensing” until conditions specified in the petition are met. The conditions sought involved the agency promulgating a regulation with such a definition and issuing a final guidance describing the conditions under which it does not intend to take action against compounders, including specialty pharmacies, in states that have not signed the MOU for distributing more than 5% of their compounded drug products interstate.

The agency denial [letter](https://www.regulations.gov/contentStreamer?documentId=FDA-2020-P-0368-0004&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) says FDA has submitted to the Office of Management and Budget a proposed collection of information in connection with issuing a final standard MOU that it developed in collaboration with the National Association of Boards of Pharmacy for use by states in complying with compounding regulations. The proposal includes a definition of distributing an inordinate amount of compounded human drug products interstate.

FDA says that much of the petition was devoted to an examination and rejection of a definition of distribution that includes dispensing and it explains its thinking behind the definition within the context of congressional intent on legislation regulating drug compounding.

The letter also rejects the request for an enforcement guidance and says that in the drug compounding legislation “Congress enacted several conditions to differentiate compounders from commercial manufacturers and provided that only if compounders meet these conditions can the compounders qualify for exemption from certain requirements in the Federal Food, Drug, and Cosmetic Act. FDA intends to enforce the statutory limitations to address distribution of compounded drug products interstate. FDA intends to apply the statutory conditions to all types of drugs and all categories of compounding.”