December 19, 2022: “The U.S. District Court for the Western District of Oklahoma entered a consent decree against Qualgen LLC, an outsourcing facility with a history of violations.
The consent decree prohibits the company from directly or indirectly distributing adulterated drugs in interstate commerce.
The consent decree entered against Qualgen, its majority owner, Shaun Riney, and its Director of Quality, Jasen Lavoie, follows a complaint filed by the U.S. Department of Justice on behalf of the U.S. Food and Drug Administration.
The complaint asserts that Qualgen introduced into interstate commerce adulterated drugs that were manufactured, processed, packed or held under conditions that violate current good manufacturing practice (CGMP) requirements.
“While drugs compounded by outsourcing facilities are not subject to pre-market review and approval by the FDA for safety and effectiveness, they must comply with rigorous manufacturing quality assurance requirements,” said Jill P. Furman, J.D., acting director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research.
“The FDA’s commitment to ensuring compliance with current good manufacturing practice requirements is a critical protection for patients. We will remain vigilant and hold all manufacturers accountable to best protect the public health.”
Under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act), a compounder can register as an outsourcing facility, which is defined as a facility at one geographic location or address that is engaged in the compounding of sterile drugs, has elected to register as an outsourcing facility and complies with all the requirements of section 503B of the FD&C Act.
Qualgen is registered with the FDA as an outsourcing facility.
Drugs compounded by an outsourcing facility can qualify for exemptions from FDA approval requirements and the requirement to label products with adequate directions for use, but not from CGMP requirements.
The agency inspected and cited Qualgen for violations of CGMP requirements during several inspections since 2015, issuing a safety alert in 2015 and a warning letterExternal Link Disclaimer in 2016.
The FDA’s most recent inspection of Qualgen’s Oklahoma facilities ended in September 2022. Qualgen manufactures and ships compounded drugs from its Oklahoma facilities.
Compounded drugs can serve an important role for patients whose medical needs cannot be met by an FDA-approved drug product.
Compounded drugs are not approved by the FDA and, therefore, have not been evaluated for safety or efficacy.
The case was filed by the U.S. Department of Justice’s Consumer Protection Branch, on behalf of the FDA.”