What Is My FDA Compliance Exposure If Fire Departments Fill Medical Oxygen?

Any fire company, ambulance or emergency medical service (EMS) that fills medical oxygen cylinders is actually a “drug manufacturer.” This is true whether they cascade into “Medical E” style cylinders from “300” style cylinders or if they have a bulk tank, cryogenic pump and vaporizer.

The FDA has stated that these organizations are fully accountable for all CGMP regulations…except one. They are not required to register/list with the agency. Because they are not required to register/list with the FDA, they are almost never inspected. The FDA is exercising “enforcement discretion” with EMSs. The effect of this is that EMSs are typically not actually following Current Good Manufacturing Practices.

Also, the FDA has stated that an EMS may not sell the medical oxygen as a separate line item on an invoice. However, the cost of the oxygen can be included as a part of the entire service.

EMSs are required to have the same quality management system you are required to have:

  • Quality Control Unit
  • Lot number system for distribution and recall
  • Incoming raw material qualification/testing
  • Label security
  • Proper personnel training (CGMP and function specific)
  • Equipment cleaning and maintenance procedures
  • Approved written operations procedures
  • Quarantine system/area
  • Properly completed records: cylinder filling, pre-fill and post-fill testing, gauge. calibration, system maintenance, distribution, label issuance

In addition, an EMS will typically use similar equipment as you need, including:

  • An acceptable purity and identity analyzer with validation report
  • Certified zero and span gases for the analyzer
  • Vacuum pump
  • Calibrated and certified high-pressure and vacuum gauges which have the accuracy needed for safe filling operations. Two-inch regulator gauges usually are not accurate enough for high-pressure filling operations.
  • Calibrated and certified thermometer
  • Leak detection solution
  • Nitrogen, NF source for pressurizing the empty cylinder for the residual odor test.

What Is My Compliance Exposure?
Distribution — From a federal FDA perspective, this is one case where a drug manufacturer (you) is permitted to sell medical oxygen to a non-registered organization without a prescription. Some states have pharmacy regulations which prohibit selling oxygen to non-licensed organizations (e.g. Minnesota BoP Statute 151.37). Check with your state board of pharmacy for clarification about your state regulations.

Cylinders — Some EMSs will fill your “Medical E” style cylinders. The EMS is the drug manufacturer. They are responsible for assuring their compliance with CGMPs. However, if you are the owner of the cylinder, you could have liability if there is a problem with the cylinder (e.g. the cylinder is filled/damaged after the hydrotest date). Consult your counsel about your liability for the physical asset.

Labels — Some EMSs actually fill the cylinders with your labels and lot numbers. This is a violation of the regulations for them. But you have significant exposure as well. If a cylinder is incorrectly filled and is involved in an incident, the investigator will find your labels/lot numbers on the incident cylinder. This could place additional liability on you to prove that you were not the cause of the incident. We recommend that you not allow EMS organizations (or any firm) to fill cylinders using your labels.

Gases and Welding Distributors Association
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.badstubner@asterisk-inc.com.