All NewsBio/Pharma News
All PublicationsPharmTechPharmTech Europe
MarketplaceICH Q9 Revision: A Comprehensive Resource on Quality Risk ManagementPeer-Reviewed ResearchPharmTech ProductsPharma InsightsSponsored PodcastsSponsored VideosSponsored eBooksWhitepapers
Webcasts
All VideosAsk the ExpertBehind The HeadlinesBuy, Sell, HoldDrug Digest VideosDrug Solutions PodcastPeer ExchangeSexy ScienceTech Talk
Conference CoverageConference ListingEvents
Subscribe
AnalyticsAnalyticsAnalytics
Data and Artificial Intelligence
Dosage FormsDosage FormsDosage FormsDosage FormsDosage Forms
Drug DevelopmentDrug DevelopmentDrug DevelopmentDrug DevelopmentDrug DevelopmentDrug Development
ManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturing
OutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcing
Quality SystemsQuality SystemsQuality SystemsQuality Systems
Spotlight -
  • Analytics
  • Dosage Forms
  • Drug Development
  • Manufacturing
  • Outsourcing
  • Quality Systems
IS1
  • Applied Clinical Trials

  • BioPharm International

  • Cannabis Science and Technology

  • Chromatography Online

  • Nutritional Outlook

  • Pharmaceutical Commerce

  • Pharmaceutical Executive

  • Pharm Tech

  • Spectroscopy Online

  • Turbo Machinery Magazine

AnalyticsAnalyticsAnalytics
Data and Artificial Intelligence
Dosage FormsDosage FormsDosage FormsDosage FormsDosage Forms
Drug DevelopmentDrug DevelopmentDrug DevelopmentDrug DevelopmentDrug DevelopmentDrug Development
ManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturing
OutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcing
Quality SystemsQuality SystemsQuality SystemsQuality Systems
IS1
  • Applied Clinical Trials

  • BioPharm International

  • Cannabis Science and Technology

  • Chromatography Online

  • Nutritional Outlook

  • Pharmaceutical Commerce

  • Pharmaceutical Executive

  • Pharm Tech

  • Spectroscopy Online

  • Turbo Machinery Magazine

    • Webcasts
    • Subscribe
Advertisement

Federal Court Enters Consent Decree Against Florida Compounder

September 21, 2021
By Pharmaceutical Technology Editors
News
Article

US District Court for the Middle District of Florida entered a consent decree of permanent injunction prohibiting Florida-based Premier Pharmacy Labs from producing or distributing drugs because of insanitary conditions.

FDA announced on Sept. 17, 2021 that the US District Court for the Middle District of Florida entered a consent decree of permanent injunction prohibitingFlorida-based Premier Pharmacy Labs from producing or distributing drugs because of insanitary conditions, including drugs intended to be sterile. Under the consent decree, Premier Pharmacy is required to not engage in compounding operations or distribution until corrective actions are completed and the company and its facility are in compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act). It must also establish and implement a comprehensive quality control system and receive authorization from FDA before it can resume operations.

“Premier Pharmacy and its owner placed patients at significant risk. Outsourcing facilities must follow good manufacturing practice to ensure patients are not exposed to poor quality, potentially harmful drugs,” said Donald D. Ashley, J.D., director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, in a press release. “We will continue to take appropriate enforcement actions to ensure that companies follow important safety requirements to avoid putting patients’ health at risk.”

FDA previously inspected the company’s facility in 2014, which resulted in a warning letter. A follow up inspection in 2016 led to a regulatory meeting with the company in 2018. Premier Pharmacy recalled affected sterile injectable products in April 2018, and another follow-up inspection was conducted by FDA in April 2019, which resulted in additional products recalled by the company in June 2019. The company deregistered as an outsourcing facility for compounded drugs in 2019.

Source: FDA

Recent Videos
Drug Digest: Patient Preference Drives Solid Dosage Trends
Behind the Headlines, Episode 17
Related Content

A lab technician in protective gear operates a tablet displaying a green checkmark in a high-tech pharmaceutical laboratory. | Image Credit: © greenbutterfly - stock.adobe.com

Companies Reveal Their Next Moves in Manufacturing

Patrick Lavery
May 29th 2025
Article

In discussions at INTERPHEX 2025, company representatives seized upon several common themes, most notably safety, sustainability, and the increasing utility of automation.


Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Felicity Thomas
June 25th 2024
Podcast

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.


Digital Transformation Strategies: Modernizing Business Processes, digital transformation strategies with an image of a digital roadmap for organizational change See Less | Image credit: ©Johannes – stock.adobe.com

Digital Transformation in Pharmaceutical Manufacturing

Israel Ortíz
May 28th 2025
Article

Leveraging computerized maintenance management systems software can enhance efficiency, improve quality control, ensure accurate documentation, and strengthen data integrity.


Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Felicity Thomas
May 28th 2024
Podcast

In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.


A doctor in a white lab coat shaking hand showing symbol of medicine innovation, treatment, discovery and healthcare analysis. | Image Credit: © chadchai - stock.adobe.com

Geopolitical Shifts Change Nature of Pharma Partnerships

Patrick Lavery
May 28th 2025
Article

The concerns of industry experts expressed at INTERPHEX in April 2025 are still pertinent in an uncertain global political climate.


Sanofi logo at one of skyscraper. Sanofi is a French biopharma company | Image Credit: © Robert - stock.adobe.com

Sanofi to Acquire Vigil Neuroscience to Expand Neurodegenerative Disease Pipeline

Christopher Cole
May 23rd 2025
Article

Sanofi is acquiring Vigil Neuroscience, a biotech firm focused on novel neurodegenerative disease therapies, to boost its early-stage neurology pipeline.

Related Content

A lab technician in protective gear operates a tablet displaying a green checkmark in a high-tech pharmaceutical laboratory. | Image Credit: © greenbutterfly - stock.adobe.com

Companies Reveal Their Next Moves in Manufacturing

Patrick Lavery
May 29th 2025
Article

In discussions at INTERPHEX 2025, company representatives seized upon several common themes, most notably safety, sustainability, and the increasing utility of automation.


Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Felicity Thomas
June 25th 2024
Podcast

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.


Digital Transformation Strategies: Modernizing Business Processes, digital transformation strategies with an image of a digital roadmap for organizational change See Less | Image credit: ©Johannes – stock.adobe.com

Digital Transformation in Pharmaceutical Manufacturing

Israel Ortíz
May 28th 2025
Article

Leveraging computerized maintenance management systems software can enhance efficiency, improve quality control, ensure accurate documentation, and strengthen data integrity.


Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Felicity Thomas
May 28th 2024
Podcast

In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.


A doctor in a white lab coat shaking hand showing symbol of medicine innovation, treatment, discovery and healthcare analysis. | Image Credit: © chadchai - stock.adobe.com

Geopolitical Shifts Change Nature of Pharma Partnerships

Patrick Lavery
May 28th 2025
Article

The concerns of industry experts expressed at INTERPHEX in April 2025 are still pertinent in an uncertain global political climate.


Sanofi logo at one of skyscraper. Sanofi is a French biopharma company | Image Credit: © Robert - stock.adobe.com

Sanofi to Acquire Vigil Neuroscience to Expand Neurodegenerative Disease Pipeline

Christopher Cole
May 23rd 2025
Article

Sanofi is acquiring Vigil Neuroscience, a biotech firm focused on novel neurodegenerative disease therapies, to boost its early-stage neurology pipeline.

About Us
Advertise
Contact Us
Editorial Info
Editorial Advisory Board
Do Not Sell My Personal Information
Privacy Policy
Terms and Conditions
Contact Info

2 Commerce Drive
Cranbury, NJ 08512

609-716-7777

Download on Apple
© 2025 MJH Life Sciences

All rights reserved.