Response to Medical Gas Legislative Action

We learned of a new Michigan law which went into effect September 30, 2014 that established additional safeguards relative to the practice of drug compounding. The law was in response to several instances where tainted drugs from compounding pharmacies were found and, in one case, led to a nationwide outbreak of meningitis. Although the law was created in response to concerns with drug compounding, the law requires a “Pharmacist in Charge” (PIC) for all pharmaceutical manufacturers, wholesale distributors and durable medical equipment (DME) suppliers. GAWDA members’ medical gas facilities were inadvertently caught in the law’s net. We were concerned not only with the immediate inability to legally provide medical oxygen in Michigan, but also for the potential for other states to implement similar requirements. This law would add significant barriers to the safe distribution of medical gases without providing any benefit to the consumer.

Within ten days after learning of this new law, CGA and GAWDA sent a letter to Michigan Governor Rick Snyder on October 10 asking for an urgent meeting with his office and the Michigan Department of Licensing and Regulatory Affairs (LARA). The letter pointed out the unintended consequence of the law, including that medical gas firms would not be able to hire pharmacists and therefore will not be allowed to renew their facility licenses because “the vast majority of pharmacists are not educated nor have adequate experience in the manufacture, processing, packaging or holding of medical gases and as such would not qualify for this function under the Food Drug and Cosmetic Act under 21 CFR 211.25.” CGA requested an immediate exemption or, at a minimum, for LARA to use enforcement discretion until the rule could be modified to exempt and/or specifically address medical gas and medical gas-related equipment facilities.

Both the governor’s office and LARA were very responsive, and on October 16, they met in Lansing, Michigan, with me and Michael Tiller, CGA president. Frankly, the conversation had a rocky start when the director of LARA indicated he was not interested in listening to the presentation we prepared; and although the bill was not intended to cover medical gases, it did, and that medical gas firms would need to follow the new law and that there would be no exemption and no enforcement discretion. Although the debate was intense, it was kept at a friendly and supportive level.

Thankfully, during the conversation, the person within LARA in charge of enforcement found a paragraph in the existing umbrella law that exempted gases from the section of the law where the new law was being inserted.

We have received written confirmation from LARA stating that locations that “supply ONLY medical gases” and related gas handling equipment (concentrators, etc.) are exempt from Michigan Part 177, including the new Pharmacist in Charge (PIC) requirement. If other drugs or medical equipment are supplied from the location, a PIC is required.

Action Request for All Members

Although the outcome in Michigan was very favorable, we need to learn of new state laws that impact medical gas facilities well before the implementation date. This law was disguised as a bill focused on drug compounding. However, it did contain requirements that applied to us. Please watch for potential legislation in your state that could impact medical gases. Report potential bills to me and I will coordinate with CGA to be sure the legislators consider the unique aspects of medical gases.

Gases and Welding Distributors Association
Thomas Badstubner Meet the Author
GAWDA’s FDA & Medical Gases Consultant Thomas L. Badstubner is president of AsteRisk LLC in Blackstone, Massachusetts. Members can reach him at 508-883-0927 and tom@asteriskllc.com. The author would like to acknowledge the assistance of CGA’s Mike Tiller and John Willenbrock for their assistance with this article.