Representative Leonard Lance, R-NJ, introduced HR 2227, the Medical Gas Safety Act. The bill would allow any person to file a certification with the FDA that a medical gas (defined to include oxygen, nitrogen, nitrous oxide, carbon dioxide, helium, medical air, or any other medical gas deemed appropriate by the FDA) is a designated medical gas. The bill would prohibit the application of fees applicable to other drugs to be applied to medical gases, and would also require the FDA, within two years after enactment, to establish regulations for:
1. Appropriate current good manufacturing practice requirements for medical gases;
2. Separate labeling requirements for medical gases;
3. Separate wholesale distribution requirements for medical gases;
4. A streamlined electronic process for registration, and listing of medical gases, by medical gas manufacturers that are small business concerns (as defined in section 3 of the Small Business Act); and
5. Separate and proportionate product tracking and anti-counterfeiting rules for medical gases.
There are no hearings or other action scheduled for this bill, and there is no companion Senate bill as yet.
