Texas Compounder Ordered to Stop Manufacturing Drugs Intended to be Sterile

MAY 22, 2019
A federal judge in Texas has ordered Pharm D Solutions and its owners to stop producing compounded drugs intended to be sterile, because of unsanitary conditions.

A consent decree of permanent injunction signed by US District Judge Keith P. Ellison for the Southern District of Texas alleges that the company and owners Juan C. De Leon and Luis R. De Leon are in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other requirements, which puts patients at risk.

The complaint was filed by the Department of Justice on behalf of the FDA.

In a statement, the FDA said that Pharm D Solutions and its owners had received previous warnings, dating back to 2015.

The decree requires Pharm D Solutions to cease all sterile compounding operations and distribution until it completes corrective actions that ensure that the company and its facility are in compliance with the FD&C Act and recall all drugs intended to be sterile that are on the market.

In addition, Pharm D Solutions is prohibited from resuming sterile compounding operations until it establishes and implements, among other things, a comprehensive quality control system and receives authorization from the FDA.

“We understand that compounded drugs can be important for patients whose medical needs cannot be met by FDA-approved drug products, and we’re continuing efforts to advance policies to help further improve the quality of compounded products,” Acting FDA Commissioner Ned Sharpless, MD, said in a statement.

“These drugs are not approved by the FDA and have not been evaluated for safety or efficacy, so when they’re not appropriately compounded, they have the potential to cause patients harm," he said. "We’ll continue taking enforcement actions like the one we’re taking today, to ensure that these companies and products do not put patient health at risk."

The government alleges that Pharm D Solutions manufactured and distributed drugs, including those that were intended to be sterile, which were adulterated, because the drugs were made under unsanitary conditions and in violation of good manufacturing practice requirements under the FD&C Act.

Drugs prepared, packed, or held under unsanitary 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.

Pharm D Solutions also manufactured and distributed unapproved new drugs because the products did not follow all statutory requirements for outsourcing facilities, according to the complaint.

Some of the company’s drugs were also misbranded, because they did not include adequate directions for use.

“Compounders must follow quality manufacturing practices to ensure consumers are not exposed to potentially harmful drugs,” Donald D. Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, said in a statement. “Today’s action underscores the FDA’s continued commitment to taking appropriate enforcement actions against compounders and outsourcing facilities that violate the law and fail to adhere to important product and patient safety requirements.”

The FDA conducted an initial inspection of Pharm D Solutions in May and June 2015 that resulted in a warning letter for unsanitary conditions and other violations of the FD&C Act.

The agency conducted a follow-up inspection in August 2018. On September 10, 2018, following the 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 that time, 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, according to the agency.

Reference

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 [news release]. Silver Spring, MD; May 22, 2019. FDA website. https://www.fda.gov/news-events/press-announcements/federal-court-enters-consent-decree-against-texas-compounder-pharm-d-solutions-llc-cease. Accessed May 22, 2019.

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