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Valerie DeBenedette is managing editor of Drug Topics.
Sterility concerns warrant warning from FDA to healthcare providers to stop using products produced by Pharm D.
The FDA is alerting health care professionals stop using sterile drug products produced and distributed by Pharm D Solutions LLC, Houston, TX. The agency says there is no assurance of sterility with the products and is advising healthcare professionals to immediately check their medical supplies, quarantine any of this company’s sterile drug products, and not administer them to patients.
The alert was addressed to patients as well as healthcare professionals. Patients who have received drug products produced by Pharm D and have concerns were advised to contact their healthcare professional.
Pharm D has had issues with its lack of sterility assurance for a few years. FDA issued a warning letter to the company in December 2016 following an inspection. During another inspection this August, FDA investigators observed insanitary conditions, including poor sterile production practices and deficient environmental monitoring. “These conditions raised concerns about the company’s ability to assure the sterility of its drug products,” according to the alert.
On September 10, at the recommendation of the FDA, Pharm D recalled all unexpired drug products intended to be sterile and agreed to cease sterile operations until it makes adequate corrections at its facility. The company resumed sterile operations in October, and started distributing products it labeled as sterile, but had not made adequate corrections at the facility.
“Pharm D agreed to cease sterile operations again on November 9, 2018, but has not agreed to FDA’s recommendation to recall all unexpired drug products intended to be sterile. These compounded drug products could put patients at risk,” according to an FDA statement.
Pharm D is registered as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act.