A Dallas, Texas compounding pharmacy that has previously been cited for safety issues by the Food and Drug Administration (FDA), once again faces problems with the federal drug regulator.
Downing Labs in Farmers Branch was cited for failing to investigate why its drugs failed sterility tests, in an inspection completed less than two weeks ago. The FDA’s inspection report to Downing 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 newspaper reports that last year Downing Labs refused to recall some of its drugs after the FDA found contamination. But in the current instance, the pharmacy announced a voluntary recall of the possibly contaminated sterile drugs and Downing said it will improve its procedures. Downing is recalling all sterile drug products “due to concerns over sterility assurance,” according to the Dallas Morning News.
The recalled products were sold across the U.S. and in the United Kingdom between April 20 and September 15, Downing said. The compounder advised patients and health care providers not to take or administer any of the drugs. Downing said it has not received any reports of adverse reactions to the recalled drugs.
Compounding pharmacies prepare individualized drugs for patients who 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, producing larger batches and selling drugs to physicians and hospitals. The FDA says such practices make them more like conventional drug manufacturers, and therefore they should be subject to the oversight imposed on drug manufacturers.
Compounding pharmacies became a national issue in 2012 when contaminated steroid injections from 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 response to the outbreak, Congress passed legislation giving the FDA greater power to regulate compounders. Since the law was enacted, the FDA has stepped up inspections and other enforcement actions.
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 was is a compounded drug, according to the Dallas Morning News. Two other compounding pharmacies that had operated at the same location shut down after inspections revealed numerous problems, including contamination. The Dallas Morning News reports that one of the closed companies, ApotheCure, was successfully prosecuted for causing three deaths.