A large compounding pharmacy in Texas has been ordered to stop production. On behalf of the FDA, U.S. District Judge Keith P. Ellison for the Southern District of Texas ordered Pharm D Solutions, LLC, along with the company’s owners, Luis R. De Leon and Juan C. De Leon, to stop producing compounded drugs intended to be sterile. This injunction holds until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other requirements.
Despite previous warnings from the FDA, Pharm D Solutions continued to violate the law, putting patients at risk, according to the complaint.
“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,” says Acting FDA Commissioner Ned Sharpless, MD, in a statement from the agency.
The consent decree requires Pharm D Solutions to cease all sterile compounding operations and distribution 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,” says Donald D. Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, in the 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 International Academy of Compounding Pharmacists (IACP) does not comment on enforcement actions, Scott Brunner, CAE, executive VP of IACP, tells Drug Topics. However, Pharm D Solutions is not a member of the organization, he says.
Pharm D Solutions’ drugs were made under insanitary conditions and in violation of current good manufacturing practice requirements under the FD&C Act, according to the FDA. In addition, some products were adulterated because they had strengths different from what they were represented to possess, according to the complaint.
Pharm D Solutions was manufacturing and distributing “unapproved new drugs” because the products did not follow all statutory requirements for outsourcing facilities, according to the FDA. “Some of Pharm D Solutions’ drugs were also misbranded because they did not include adequate directions for use,” the agency says.
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.
Even though the company resumed sterile operations on October 8, 2018, it 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 FDA says.