Medical Gases…The Sky Is Not Falling

There are several medical gas initiatives being planned by the Food and Drug Administration (FDA), Congress and United States Pharmacopeial Convention (USP).This article lists the major issues and their likely impact in the near term to our industry.

FDA – New Guidance
In May 2003, the FDA issued the Draft Guidance for Industry, Current Good Manufacturing Practice for Medical Gases. In January 2010, the FDA’s Guidance Agenda said that they intended to publish the Good Manufacturing Practices For Medical Gases during 2010. They made similar statements in 2009, 2008, 2007. When will the final guidance really be published? No one knows. While we would welcome refreshed guidance from the FDA on several key issues, most areas of Good Manufacturing Practices for Medical Gases are well-defined and predictable—from the FDA.

State Boards of Pharmacy
The National Association of Boards of Pharmacies (NABP) published model drug laws and encouraged the states to adopt the model statutes. The model laws are designed to protect against counterfeit drugs and secure the drug supply chain. Medical gases have highly secure supply chains due to the expense of the containers. The NABP model legislation clearly does not fit the distribution model for medical gases. The states have inconsistently adopted the model statutes. Please report any unusual enforcement actions to your GAWDA Medical Gases Consultant.

On September 27, 2007, the Food and Drug Administration Amendments Act of 2007 (FDAAA) was signed into law. A portion of the law required the FDA to develop standards and identify and validate effective technologies for the “purpose of securing the drug supply chain against counterfeit, diverted, subpotent, substandard, adulterated, misbranded or expired drugs.” The FDA has adopted Standardized Numerical Identification (SNI) on the labels to help the management of prescription drugs. Since these counterfeit issues do not apply to medical gases, GAWDA and CGA are working with the FDA to develop workable solutions for gases. We will publish recommendations, if any, when we get consensus with the FDA.

FDA – Safe Food Transportation Act (SFTA)
On August 10, 2005, the SFTA was signed into law. There was little action for five years. Now the FDA is considering promulgating regulations establishing sanitary food transportation practices. The FDA recently surveyed industry about the potential new SFTA regulations. It was clear from the survey that the FDA did not consider the unique aspects of food grade gases. GAWDA and CGA responded to the FDA with a joint letter explaining why our products have unique distribution and compliance issues. When the FDA issues guidance or regulations which apply to our industry, we will advise all GAWDA members.

FDA – Expiration Dates
Despite regulations requiring expiration dates on medical gases, the FDA is using “enforcement discretion” by not requiring expiration dates on medical gases. However, if we use an expiration date, the agency expects us to have a stability study justifying the expiration date. No satisfactory stability study has been completed. GAWDA and CGA have discussed this with the FDA. For now, the federal enforcement discretion is all that we can expect. Certain states (e.g. Florida) are enforcing expiration dates contrary to federal practices.

Should you use expiration dates or not? Ultimately, this will be a business decision and will include evaluating your local state enforcement, practices of others in the market and your customers’ expectations.

USP – New Medical Gas Monographs
USP published draft revised medical gas monographs in July 2009. We made significant suggestions to USP about how to improve the monographs. USP originally said they would publish the final revisions in June 2010. When the new standards are published, we will notify GAWDA members. We will then have six months to adopt the new standards. This will give us time to validate new analytical methods, change SOPs, etc.We recommend continuing to use the published USP monographs.

What to do
Though there are potential issues which could affect your medical gas business, no major changes seem to be required now. We will keep you informed as the medical gas compliance issues evolve.

Gases and Welding Distributors Association
Tom Badstubner Meet the Author
GAWDA’s FDA & Medical Gases Consultant Thomas L. Badstubner is president of AsteRisk LLC in Blackstone, Massachussetts. Members can reach him at 508-883-0927 and