Compounding Pharmacy Sterile Products Cited By FDA. A Dallas, Texas compounding pharmacy that has been embroiled in the debate about the safety of compounded drugs has once again been cited by the Food and Drug Administration (FDA) for issues with its products.
Downing Labs in Farmers Branch was cited for failing to investigate why its drugs failed sterility tests, the Dallas Morning News reports. The inspection was completed less than two weeks ago. “A variety of spore forming bacteria are routinely recovered from your environmental and personnel monitoring within the aseptic processing areas,” the FDA’s inspection report said. FDA inspectors also found that Downing Labs failed to properly investigate other failed tests like those for drug potency.
Last year, Downing Labs refused to recall some of its drugs after the FDA found contamination. But this time, the pharmacy announced a voluntary recall of sterile drugs and said it will make changes to its procedures. Downing Labs said it is recalling all sterile drug products “due to concerns over sterility assurance,” according to the Dallas Morning News.
The recalled products were sold nationwide and in the United Kingdom between April 20 and September 15, Downing said. The compounder asked patients and health care providers not to take or administer the drugs. Downing said it has not received any reports of adverse reactions to the recalled drugs.
Compounding Pharmacies Produce Drugs For Patients Not Commercially Available
Compounding pharmacies produce individualized drugs, usually in small batches, for patients who need a strength or formulation not commercially available. A patient may, for example, need a liquid medicine rather than a pill, or the patient may be allergic to ingredients in a standard pill, or may require a different strength. Compounding pharmacies previously produced medicines on an individual basis, by prescription, but in recent years, they have expanded to sell drugs to physicians and hospitals. The FDA argues that this makes them more like conventional drug manufacturers, though compounders operate largely outside the oversight applied to drug companies.
Compounding became a national issue in 2012 when contaminated steroid injections from a Massachusetts compounding pharmacy sickened more than 700 people and resulted in 64 deaths, the Dallas Morning News reports. In response to the outbreak, Congress passed legislation in late 2013 giving the FDA greater power to regulate compounders. Since the law was enacted, the FDA has stepped up inspections and other enforcement actions.
An FDA inspection in July 2014 found contaminated drugs at Downing Labs, including pain relief medicines, steroids, local anesthetics and medications that treat intestinal conditions, liver disease and kidney disease. The agency said the lab lacked safety procedures and proper testing. In addition, the FDA said labels on some bottles did not include required information such as the drug’s name, dosage, active ingredients and indication that this was a compounded drug, according to the Dallas Morning News. Two other compounding pharmacies that operated at the same location shut down after state and federal inspections revealed numerous problems, including contamination. One of those companies, ApotheCure, was successfully prosecuted for causing the deaths of three people, according to the Dallas Morning News.