Appropriate Medical Gas Regulations

The latest developments

It has been over 26 years since the FDA issued official guidance for medical gases. Since then, a lot has changed about medical gas compliance. The agency has issued three unofficial series of medical gas documents since the 1989 guidance (Fresh Air, Gas What and the 2003 Draft Guidance). Even these newer documents are significantly out of date with the agency’s own practices today.

Through GAWDA’s affiliation with the Compressed Gas Association, we have identified over 80 sections of the current regulations that are clearly inappropriate or unsafe for medical gases. Examples of inappropriate regulations include: expiration dating, theoretical yield, labeling warnings, labeling specimen on fill records, etc.

In 2011 and 2012, CGA and GAWDA worked with Congress to require the FDA to consider appropriate regulations for medical gases. That effort resulted in a medical gases section in the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA). Among other things, FDASIA required the FDA to evaluate whether new regulations are required for medical gases. Congress instructed the agency to consult with industry and report their findings within 18 months.

During those 18 months, GAWDA and CGA representatives met with the FDA three times and made a convincing case that 21 CFR Parts 210/211 are inappropriate for medical gases. We gave specific references and examples to the FDA. We also drafted revised regulations and published two documents with the proposed regulations and rationale for the necessary changes (CGA M-15-2014, Standard for Appropriate and Effective Regulations for Medical Gases within 21 CFR Parts 201, 205, and 210/211 and CGA PS-42-2014, CGA Position Statement on Appropriate and Effective Regulations for Medical Gases within 21 CFR Parts 201, 205, and 210/211).

The FDA did not report back to Congress for three years. Finally, FDA’s Report to Congress declared that the existing “regulatory framework” is adequate. Even though they agreed with nearly every point in our presentations, their conclusion was that no new regulations are needed.
One of the agency’s positions is that the medical gas industry is relatively safe and therefore the new regulations are not needed to solve a safety problem. The agency would prefer to use guidance and enforcement discretion to handle the situations where the current regulations are inappropriate. There are two basic problems with the agency’s approach:

  1. Guidance and enforcement discretion by the agency should only be used to clarify regulations and not to exempt certain classes of drugs from the regulations altogether.
  2. Even if guidance and enforcement discretion were appropriate for the FDA, the state Boards of Pharmacy are typically required to enforce the actual federal regulations. This piecemeal approach results in inconsistent enforcement between the states.

We continue to work with Congress and the FDA to develop appropriate regulations. It is possible that the agency will develop a new type of guidance to make medical gas Good Manufacturing Practices more appropriate. We will inform you as this situation develops.

Thomas Badstubner Meet the Author
GAWDA’s FDA & Medical Gases Consultant Thomas L. Badstubner is president of AsteRisk LLC in Lewisville, Texas. Members can reach him at 508-883-0927 and tom@asteriskllc.com.