What Is The Latest FDA Thinking About Expiration Dates?

The medical gas industry has widely different expiration date practices. Some GAWDA members (including some major gas companies) use expiration dates and some do not. The actual federal regulation is found in 21 CFR § 211.137:

Expiration dating (a) To assure that a drug product meets applicable standards of identity, strength, quality, and purity at the time of use, it shall bear an expiration date determined by appropriate stability testing described in Sec. 211.166….

So the regulation says that we must use expiration dates and that we must have a stability study to justify the expiration date. However, no one has performed a suitable stability study on medical oxygen. The FDA’s focus for a stability study is about valve leakage.

Enforcement Discretion
When the regulations simply are not practical, the FDA uses “enforcement discretion” to explain why they do not enforce certain requirements. Usually, this enforcement discretion is reasonable and in the best interest of industry.

Latest Agency Thinking
The regulation may not be the latest agency thinking about expiration dating. In a recent message from the FDA to a firm in the medical gas equipment business, the FDA stated, “The agency is currently developing guidance pertaining to stability testing and expiration dating of medical gases. Pending publication of FDA guidance on this subject, our policy has been to use enforcement discretion with respect to the requirement in 21 CFR 211.137 that medical gases, as drug products, bear an expiration date. Please be aware, however, that if a manufacturer chooses to apply an expiration date to a medical gas, it must be supported by a stability study as required by 21 CFR 211.166. If the choice is made to label the product with an expiration date, it could be on a separate sticker in a manner similar to the lot number.”

Recommended Practice
AsteRisk recommends that you consider not using an expiration date until the FDA and industry agree upon a stability study/expiration date practices. When the stability study is completed, we recommend that you adopt the industry accepted expiration date. Bear in mind that some states and some large customers disagree with the FDA’s position on expiration dates.

Gases and Welding Distributors Association
Tom Badstubner Meet the Author
Tom Badstubner is the president of AsteRisk LLC in Blackstone, Massachussetts. He serves as GAWDA’s FDA & Medical Gases Consultant.