FDA Bans Pharmacy Owner from Compounding Sterile Drugs

The FDA has entered a permanent injunction against Paul W. Franck, who allegedly manufactured and distributed products that violated the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Franck, of Ocala, Florida, may not manufacture, hold, or distribute sterile drugs until he complies with the FD&C Act and other requirements.

“Mr. Franck risked the health of the American public by compounding drugs under unacceptable conditions,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, in a press release. “[This] action reflects the FDA’s continued efforts to take appropriate and aggressive enforcement action against those who put patients’ health at risk by choosing not to follow the law.”

Franck owned and operated several compounding pharmacies, such as Franck’s Compounding Lab and Trinity Care Solutions, for more than 20 years.

FDA investigations found several issues with Franck’s businesses:

• His drugs contained “filthy, putrid, or decomposed substances.”
• The products were produced or held in unsanitary conditions and were below quality and/or purity standards.
• Some of the labels were false or misleading, since purportedly sterile drugs actually contained bacterial contamination.

In 2014, Trinity Care Solutions had recalled all sterile drugs and ceased compounding operations after an FDA inspection found dead spiders, beetles, ants, wasps, and cockroaches in the ceiling panel above the sterile processing area. In addition, the compounding facility was not cleaning and sanitizing sterile compounding areas.

In 2012, contaminated ophthalmic drugs, compounded at Franck’s Compounding Lab, led to 47 cases of eye infections, including around 39 cases of temporary or permanent vision loss.

Also, 21 polo ponies died in 2009 after taking a product compounded by Franck’s Compounding Lab that contained 100 times the amount of selenium that should have been administered.