Compounding Problems

by Searcy Denney Scarola Barnhart & Shipley

In the production of pharmaceutical drugs there are large scale drug manufacturers which produce brand name and generic drugs, and there are compound pharmacies which are specialty pharmacies made to fill out unique orders for clients using already existing medications. Drug manufacturers fall under FDA standards and regulations, while compounding pharmacies fall under the state board of pharmacy’s regulatory jurisdiction. The primary uses of a traditional compound pharmacy are if a patient needs a very specific dose of a medication or if a patient needs to convert a normally solid medication into a liquid.

In recent years, drug manufacturers have been outsourcing their work to these compounding pharmacies. This outsourcing massively expanded the scope of compounding pharmacies beyond their traditional role. Because these compounding pharmacies are not under the jurisdiction of the FDA but rather the state board of pharmacy, some of these compound pharmacies can have less than satisfactory producing conditions for this outsourcing process. This was made apparent to the FDA and the world in general in 2012 when there was a massive fungal meningitis outbreak linked to the unsanitary manufacturing conditions of the New England Compounding Center (NECC). The outbreak left many patients horribly ill, and in some cases, dead. In response to this tragedy, Congress passed the Drug Quality and Security Act in November of 2012. This placed compounding pharmacies that are classified as out sourcing facilities under the FDA’s regulatory oversight.

But even after the NECC tragedy, drug companies are still trying to outsource production of their drugs while compounding pharmacies are still not raising their standards for production. In 2013, at least 30 compound pharmacies were cited for unsanitary conditions. These unsanitary conditions included instances of black particles floating in supposedly sterile medications. In the beginning of March 2014, three more compounding pharmacies were cited for unsanitary conditions.

This has also led to more compounding pharmacies trying to circumvent FDA control entirely. In order for a pharmacy to be classified as a traditional compounding pharmacy – thus not falling under the FDA’s regulatory umbrella, the pharmacy must create tailored medication in response to specific and individual prescriptions. Two out of the three companies cited in 2014, Nora Apothecary and Alternative Therapies Inc. and Wedgeworth Village Pharmacy Inc., were also recently cited by the FDA for making products without specific and individual prescriptions. This means that these compounding pharmacies were not exempt and were subject to FDA regulation. The FDA subsequently found that the sterilization procedures and overall sanitary condition of these companies’ facilities were severely lacking. This blatant attempt to dodge regulation is nothing new for the compounding pharmacy industry, as the FDA has run into repeated issues trying to get access to some compounder’s pharmacies and records.

Compounding pharmacies offer a much needed service to individuals who need tailored drugs. However, this does not excuse their attempts at skirting FDA oversight as  their unregulated and unsafe conditions in their factories can seriously harm patients. Thankfully, all of the companies that were found to have substandard conditions are not allowed to reopen until their factories are made safe and sanitary. Regardless,  the fact that these compounding pharmacies were able to manufacture and sell products that did not meet FDA standards for such a long period of time is disturbing.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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