Press Announcements > Federal judge enters consent decree against Alabama compounder Medistat

Press Announcements > Federal judge enters consent decree against Alabama compounder Medistat

The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.

U.S. District Judge William H. Steele entered a consent decree of permanent injunction yesterday between the United States and Medistat RX LLC of Foley, Alabama, the company’s co-owners, Mark D. Acker and Timothy L. Fickling, and quality manager and pharmacist-in-charge V. Elaine Waller.

The consent decree prohibits Medistat, its owners and pharmacist-in-charge from manufacturing, holding or distributing drugs until they comply with the Federal Food, Drug and Cosmetic Act (FD&C Act) and its regulations, in addition to other requirements.

Medistat manufactured and distributed purportedly sterile drug products that were adulterated because the drugs were made under insanitary conditions and in violation of current good manufacturing practice requirements under the FD&C Act. Drugs prepared, packed, or held under insanitary conditions may have been contaminated with filth or otherwise harmful if given to patients. Medistat also manufactured and distributed unapproved drugs and drugs that were misbranded because their labeling did not bear adequate directions for use, which are directions under which a consumer could use a drug safely and effectively for the purposes for which the drug is intended.

For more information, please visit: Medistat Consent Decree.