Federal court enters consent decree against Texas compounder, Pharm D Solutions, LLC to cease the manufacturing of drugs intended to be sterile due to insanitary conditions

Federal court enters consent decree against Texas compounder, Pharm D Solutions, LLC to cease the manufacturing of drugs intended to be sterile due to insanitary conditions

U.S. District Judge Keith P. Ellison for the Southern District of Texas signed and entered a consent decree of permanent injunction, ordering a Texas-based company and its owners to stop producing compounded drugs intended to be sterile until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other requirements. According to the complaint, despite previous warnings from the U.S. Food and Drug Administration, Pharm D Solutions, LLC, as well as the company’s owners, Luis R. De Leon and Juan C. De Leon, continued to violate the law, putting patients at risk.

The consent decree requires Pharm D Solutions to cease all sterile compounding operations and distribution until it completes corrective actions, to ensure the company and its facility are in compliance with the FD&C Act, as well as recall all drugs intended to be sterile currently on the market. Under the consent decree, Pharm D may not resume sterile compounding operations until it establishes and implements, among other things, a comprehensive quality control system and receives authorization from the FDA.

The government alleges that Pharm D Solutions manufactured and distributed drugs, including drugs that were intended to be sterile, 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 rendered otherwise harmful to patients. Additionally, the complaint alleges that some products were adulterated because they had strengths different from what they were represented to possess.

According to the complaint, Pharm D Solutions also manufactured and distributed unapproved new drugs because the products did not follow all statutory requirements for outsourcing facilities. Some of Pharm D Solutions’ drugs were also misbranded because they did not include adequate directions for use.

The FDA conducted an initial inspection of Pharm D Solutions in May and June 2015 that resulted in a warning letter for insanitary conditions and other violations of the FD&C Act. The FDA conducted a follow-up inspection in August 2018. On September 10, 2018, following FDA’s recommendation, Pharm D Solutions recalled all unexpired drugs intended to be sterile and agreed to cease sterile operations until it made adequate corrections at its facility. The company resumed sterile operations on October 8, 2018, but again agreed to cease sterile operations on November 9, 2018 at FDA’s recommendation. However, Pharm D Solutions did not recall all unexpired drugs intended to be sterile, and the agency alerted health care professionals and patients not to use purportedly sterile drugs produced by the company. Despite the FDA’s warnings, Pharm D Solutions again resumed compounding purportedly sterile drugs in January 2019.

For more information, please visit: Pharm D Solutions, LLC consent decree .