A federal judge has entered an order of permanent injunction on behalf of FDA against Paul W. Franck, the owner and operator of numerous compounding pharmacies in Florida over the past 20 years, FDA said in an April 29, 2016 press announcement. Franck allegedly “manufactured and distributed drug products that were adulterated and misbranded in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act),” FDA said. The order issued by the US Department of Justice prohibits Franck from distributing sterile drug products until he complies with the FD&C Act.
Franck owned and operated several compounding pharmacies including Franck’s Lab Inc., which did business as Franck’s Compounding Lab and Trinity Care Solutions. FDA said Franck manufactured drugs that were considered adulterated because they contained “filthy, putrid, or decomposed substances; were prepared, packed, or held under insanitary conditions; and fell below the quality and/or purity standards they purported to possess.” FDA also asserts Franck’s drug products were misbranded, because “drugs purporting to be sterile contained bacterial contamination.”
FDA has cited Franck’s compounding pharmacies in the past for compromising drug sterility. Trinity Care Solutions issued a recall and halted compounding activities in 2014 after inspection revealed multiple violations. FDA said its inspection of the Trinity facility revealed the presence of “dead spiders, beetles, ants, wasps, and cockroaches in the ceiling panel directly above the area where employees prepare for sterile processing.”
In 2012, FDA issued a warning letter to Franck’s Compounding Lab after contaminated ophthalmic drugs from the lab were linked to 47 cases of eye infections. At least 39 of those cases were linked to temporary or permanent vision loss. As a result, the lab issued a recall of all sterile products.
The injunction against Franck is just one of many discussions FDA has had in the past over ensuring quality in compounding pharmacies. In a letter on drug pricing to the Senate Special Committee on Aging in December 2015, Alan Coukell, senior director of The Pew Charitable Trusts, notes that in 2012 FDA increased its oversight of compounding facilities, which included conducting more than 200 inspections and issuing 60 warning letters that year alone. Coukell says that while oversight may have increased, compounded drugs may not meet the same approval standards for manufacturing safety and quality as new and generic drugs approved by FDA.
In early April 2016, FDA issued three draft guidance documents related to the compounding of human drugs under section 503A in the FD&C Act. Section 503A in the FD&C Act describes the proper CGMP conditions for compounding drugs in a state-licensed pharmacy, a federal facility, or a licensed physician. In the guidance documents, FDA described its policies for compounding drugs based on prescription requirements, hospital pharmacies, and outsourcing facilities.