Texas Compounding Pharmacy Faces Repeat Difficulties with FDA for Drug Contamination

A compounding pharmacy near Dallas, Texas, which has previously been in trouble with the Food and Drug Administration (FDA) for quality and safety issues, once again has problems with the federal drug regulator.

The FDA cited Downing Labs in Farmers Branch for failing to investigate the reasons its drugs failed sterility tests. The FDA’s inspection report said, “A variety of spore forming bacteria are routinely recovered from your environmental and personnel monitoring within the aseptic processing areas.” FDA inspectors also found that Downing Labs failed to properly investigate other failed tests including those for drug potency, according to the Dallas Morning News.

The paper reports that last year Downing Labs refused to recall some of its drugs after the FDA found contamination. But this time, the pharmacy quickly announced a voluntary recall of the potentially contaminated sterile drugs. Downing is recalling all sterile drug products “due to concerns over sterility assurance,” according to the Dallas Morning News. Downing told the FDA it will improve manufacturing and testing procedures.

Compounding pharmacies prepare individualized drugs for patients who, for a variety of reasons, cannot be treated with an available drug. The patient may need a liquid medicine rather than a pill, or the patient may be allergic to inactive ingredients in a standard pill, or may require a different strength of the active ingredient. Compounding pharmacies are supposed to produce custom medicines on an individual basis, by prescription, but in recent years, some have expanded their operations and sell drugs to physicians and hospitals. The FDA says this makes them more like conventional drug manufacturers, and they therefore should be subject to the oversight imposed on drug companies.

In 2012, compounding pharmacies became a national issue when contaminated steroid injections produced by a Massachusetts compounding pharmacy were responsible for a fungal meningitis outbreak that caused 64 deaths and more than 700 illnesses, the Dallas Morning News reports. In 2013, Congress passed legislation giving the FDA greater regulatory power over compounders. Since the law was enacted, the FDA has stepped up inspections and other enforcement actions.

Downing’s recalled drugs were sold across the U.S. and in the United Kingdom between April 20 and September 15, Downing said. The compounder advised patients not to take the recalled medicines and health care providers not to administer them. Downing said it has not received any reports of adverse reactions to the recalled drugs.

In July 2014, FDA inspectors found a number of contaminated drugs at Downing Labs, including pain relief medicines, steroids, local anesthetics and medications for intestinal conditions, liver disease and kidney disease. The FDA said the lab lacked safety procedures and proper testing procedures. In addition, labels on some bottles lacked required information such as the drug’s name, dosage, active ingredients and indication that this it is a compounded drug, according to the Dallas Morning News. Two compounding pharmacies that had operated at the same location shut down after inspections revealed problems, including contamination. One of the closed companies, ApotheCure, was successfully prosecuted for causing three deaths, the Dallas Morning News reports.

 

from Parker Waichman http://www.yourlawyer.com/blog/texas-compounding-pharmacy-faces-repeat-difficulties-with-fda-for-drug-contamination/