Houston, Texas - 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.
“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,” said Acting FDA Commissioner Ned Sharpless, M.D. “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. 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 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.
“Despite previous warnings and promises to make corrections, Pharm D Solutions and its owners placed patients and their health at significant risk. Compounders must follow quality manufacturing practices to ensure consumers are not exposed to potentially harmful drugs,” said Donald D. Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “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 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’s 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.
The U.S. Department of Justice filed the complaint on behalf of the FDA.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
