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The complaint states the company introduced adulterated drugs into interstate commerce that were manufactured, processed, packed, or held under conditions that defy current good manufacturing practice (CGMP) requirements.
The US District Court for the Western District of Oklahoma entered a consent decree against Qualgen LLC, an outsourcing facility with a history of violations, which prohibits the company from directly or indirectly distributing adulterated drugs in interstate commerce.
The consent decree follows a complaint filed by the US Department of Justice on behalf of FDA against Qualgen, its majority owner, Shaun Riney, and its Director of Quality, Jasen Lavoie. The complaint states the company introduced adulterated drugs into interstate commerce that were manufactured, processed, packed, or held under conditions that defy 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, JD, acting director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research, in a press release. “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.”
Looking at 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 currently registered with FDA as an outsourcing facility.
Drugs that are compounded by an outsourcing facility can qualify for exemptions from FDA approval requirements and the requirements to label products with adequate directions for use, but not from CGMP requirements, according to FDA.
During several inspections conducted since 2015, the agency cited Qualgen for violations of CGMP requirements, issuing a safety alert in 2015 and a warning letter in 2016. Most recently, FDA inspected Qualgen’s Oklahoma facilities, which ended in September 2022, where it manufacturers and ships compounded drugs.
Although compounded drugs can be crucial for patients whose medical needs cannot be met by an FDA-approved drug product, they are not approved by FDA themselves and have not been evaluated for safety or efficacy.