Problems with Compounding Pharmacies Continue to Persist

Compounding pharmacy lawyers at Pintas & Mullins Law Firm report on the most recent recall initiated by a compounding pharmacy. Leiter’s is recalling three lots of its sterile injectable products due to sterility concerns.

The Leiter’s recall extends to the following products: two lots of Bevacizumab, expiration 11/03/2013, and one lot of Lidoxaine/phenylephrine, expiration 10/28/2013. Injecting non-sterile pharmaceuticals can result in extremely serious, even life-threatening injuries in patients, such as bacterial infections, which are significantly more dangerous in those with weakened immune systems, such as the very young and very old.

The independent laboratory responsible for the recall, Front Range, also promoted another compounding pharmacy to recall its products in late August 2013. Due to concerns over false lab results, JCB Laboratories recalled several lots of its sterile drug products as well. Most of the six recalled drugs were shipped to outpatient dialysis clinics. In addition to JCB and Leiter’s, more than 100 other compounding pharmacies use Front Range to verify drug sterility, quality, and expiration dating, and it is yet unclear if any more recalls will be announced.

The recall was not prompted by lack of sterility at Leiter’s facilities specifically; rather, the FDA investigated an independent laboratory that Leiter’s uses to test its products demonstrated insufficient sterility methods. These inadequacies may have resulted in unreliable laboratory results, leading to the sterility concerns.

Nearly one year after the devastating outbreak of fungal meningitis from the New England Compounding Center (NECC), reports of contamination and potential sterility issues from these facilities continue to emerge. The FDA recently requested and received clearance from Congress to go into these pharmacies, which, until last year, were overseen by state health boards, to tighten regulation.

So far in 2013 there have been 15 voluntary recalls of products manufactured at compounding pharmacies, which produce prescriptions for individualized patients rather than in bulk, as big pharma companies like Pfizer do. Originally, when compounding pharmacies were first established, they were producing unique prescriptions on an extremely small-scale; however, as pharmaceutical companies pushed drug treatment and Americans became increasingly medicated, compounding pharmacies began cropping up in every corner of the country, largely with little to no oversight.

In 2012, for example, there were only two recalls initiated by these facilities, one of which, from the above-mentioned NECC, resulted in about 63 deaths and over 700 illnesses from mold contamination. The new efforts put forward by the FDA include an array of new laws, including increased power to regulate and impose standards within compounding pharmacies. Applying more vigorous standards would benefit everyone, and starts with making clear which facilities are legitimate and which are operate illegally as large-scale drug manufacturers.

Many experts argue that legitimate compounding pharmacies (producing small amounts of unique, individualized prescriptions) should be subject exclusively to state regulation, as they have been since their inception. The larger-scale manufacturers, which many so-called compounding pharmacies are now, should (and most likely will) be subject to FDA oversight, just as Johnson & Johnson and Pfizer.

Currently, it is not clear exactly how these efforts will manifest. Some predict the FDA will create a new class of regulation for compounding pharmacies. Any which way, oversight and standards must change at these facilities so no one else is be harmed from biological contaminations of these products.

The FDA needs better tools to implement an adequate regulatory system based on transparent, organized, and effective standards. There should be no question about the role of compounding pharmacies in the U.S. healthcare system, what is expected of them and the quality of their products.

Compounding pharmacy lawyers at Pintas & Mullins Law Firm have decades of experience advocating on behalf of those sickened by contaminated drugs such as those produced at NECC last year. If you or a loved one was seriously injured or killed by an excessively dangerous drug, you may be entitled to significant compensation for any medical bills, lost wages, or wrongful death.