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# Consent Decree Against Florida Drug Outsourcer
- URL: https://www.fdaweb.com/consent-decree-against-florida-drug-outsourcer/
- Published: 2021-09-17T12:00:00.000Z
- Updated: 2026-09-14T17:15:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150169

The U.S. District Court for the Middle District of Florida has entered a consent decree against Premier Pharmacy Labs that prohibits it from producing or distributing any drugs until the company completes corrective actions and comes into FDA compliance. Under the consent decree, Premier Pharmacy may not resume compounding operations until it establishes and implements, among other things, a comprehensive quality control system and receives authorization from the agency.

According to the government’s complaint, Premier Pharmacy manufactured and distributed drugs made under insanitary conditions despite multiple FDA warnings. Premier stopped its drug manufacturing following a 6/2019 inspection, the agency says. After that inspection, Premier Pharmacy [recalled](http://email.prnewswire.com/ls/click?upn=3slWLw94I3jq-2B-2FedjFNgZFdo-2FTH3WGRpm58-2BpWhNXUJv11coekUnftzl3FyYy-2BN-2BQOn3qFl9DryIClMWBS5EH0d111qTWwUlVRe-2F5QH363xnw1TkPGKazLHMLUkYqZ2pg-2FO4lI2hhg-2BvtJGcbYZVsMi7wOdN0iFEphzA4hZN4DYi0anrCgu-2FdEIHp63ydmEPspaxgWSFwCn6KZ0E2XlHL-2B-2Fe8gOD3EJP0BCUF4TayT8-3DrKkh%5Ff0D7hj0BJ4b-2F7NuVqzPDs7FGiq8VLIwAX0sPSotqoLJejYqb1dmQHyCXe45PgGWVlP9SwAKClIkSlTRBPs5UCbLsWeM6giGpeXFAp9zFnyIvR61NXqA-2BiU0fKbsfQrpcJ45WXYc1KOkXl2g296qLYnLog9JoHItFBGgIMYCTMaKQg-2BR0lq3wc5FSS1OhSomHMpOEFm3naqtSfNBRh0omC1ViIvo9MaGkxksp0SydJZHTvtq82ehp-2BBmkSP-2F-2Fgk6ewzYmYHLv5gBxbDvlqemgWa1Zn1RJSREQ65nvUilMF53liXS12NONHbb2TulPSr1dpDVAXsr3-2FRFHrVKVzsbC1OmHyn3xc00hrzIGSHFeM04-3D&ref=fdaweb.com) all unexpired drugs intended to be sterile, based on the agency’s recommendation.

“Outsourcing facilities must follow good manufacturing practice to ensure patients are not exposed to poor quality, potentially harmful drugs,” CDER Office of Compliance director **Donald Ashley** is quoted as saying in a [release](https://content.govdelivery.com/accounts/USFDA/bulletins/2f20653?ref=fdaweb.com). “We will continue to take appropriate enforcement actions to ensure that companies follow important safety requirements to avoid putting patients’ health at risk.”