EMS, i.e., fire departments, ambulance companies, rescue squads, etc. are defined as the following:
1) they are usually state government affiliated emergency services
2) they transfill Oxygen U.S.P. for their own use only. No other gases may be transfilled on site
3) they administer Oxygen U.S.P. to patients, victims, etc. in an emergency situation
4) they charge no specific fee for the administration of Oxygen U.S.P. nor do they receive any reimbursement from Medicare or Medicaid

At the current time, we believe the FDA is not requiring EMS to register or list with FDA as long as the following minimum requirements are implemented: a) establish written procedures covering all oxygen gas operations including distribution within the organization, recalls, labeling, training, etc.; and b) establish records documenting the above. For specific details, please refer to the sections of the CGMPs.

CAUTION: Any EMS failing to comply with (1) and (2) above, would be subject to the full CGMP requirements and would be required to register, list with the agency and will be inspected.

Go to www.fda.gov and search for "Guidance for Industry" and for "oxygen transfilling" to find additional information on transfilling.

(All EMS agencies are encouraged to read the complete current FDA regulation to
familarize themselves with all the requirements involved in the transfilling of medical grade oxygen. This exerpt from the CGMP may change from what is stated here. The reader should confirm that the above is still in effect.)