FDA Urban Legends

As the GAWDA Medical Gases Consultants, we assist members in deciphering FDA regulations and answer their compliance questions. Some of the questions we receive start out, “When is FDA going to …” or “Is it true that …” These “what if” questions often are not based on a specific issue or circumstance and become industry rumors that get passed around like a chain letter. We call these FDA Urban Legends. Often they take on a life of their own, with the most popular rumors resurfacing on a regular basis. In this article, we will examine the two most popular FDA urban legend questions, and, I hope, put them to rest for now.

We frequently hear, “When is FDA going to require installation of dedicated medical tanks and equipment?” Our opinion and answer is probably never. Today, medical gas firms already have dedicated tanks, as all deliveries into their bulk tank should be medical. Firms should not be receiving medical and industrial grade product into the same tank, including CO2 and Nitrous Oxide. As long as each load into the tank is produced at an FDA registered and validated site, comes with a Certificate of Analysis, and the commingled product is analyzed to USP/NF requirements, then the bulk tank is maintained as medical.

It is a little different for fill manifolds. Today it is unacceptable to fill medical and industrial cylinders together on the same manifold. You can use one manifold for filling medical and industrial cylinders, just not at the same time. The vacuum cycle cleans the manifold and ensures there is no cross-contamination between racks of medical and industrial. Currently, FDA has questions about vacuum cycle effectiveness, and we predict FDA will require firms to qualify their fill manifold and vacuum systems in the near future. For a typical manual high-pressure fill manifold, this will not be a difficult task to do, and is something many companies already have undertaken.

Dedicated medical fill manifolds are becoming more commonplace. The systems we typically see share a vacuum pump with industrial manifolds. Such systems also must be qualified, especially the check valves. Today, the driving force behind companies installing dedicated manifolds and systems is that their medical business has grown large enough where a dedicated system makes good business and financial sense, not because of any specific regulatory requirement.

Another popular FDA urban legend is that hospitals, EMS and fire companies are exempt from cGMP requirements. The answer to this is both true and false. FDA regulations do not cover hospitals when they produce and dispense pharmaceuticals through their pharmacy or when these drugs are used inside the hospital, including medical gases filled by a hospital and used by patients inside the hospital or their ambulance. Medical gases produced by the hospital and used outside the hospital, such as with homecare patients, are under FDA regulations. Third-party EMS and fire and rescue groups have no exemption. The latest FDA (draft) guidance document specifically refers to EMS, which is a clear signal from FDA that EMS must comply with medical gas cGMP requirements.

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Meet the Author
GAWDA Medical Gases Consultant J. Robert Yeoman is managing director of B&R Compliance Associates LLC in Lehigh Valley, Pennsylvania. Members can reach him at 610-837-6782 and at bob.yeoman@brcompliance.com.