U.S. Congress - H.R.2227 Medical Gas Safety Act
H.R.2227 - Medical Gas Safety Act
To amend the Federal Food, Drug, and Cosmetic Act to provide for the regulation of medical gases, taking into account the special characteristics of medical gases, the special techniques and processes required to produce medical gases, and the established history of safe and effective use of medical gases. view all titles (2)
All Bill Titles
- Official: To amend the Federal Food, Drug, and Cosmetic Act to provide for the regulation of medical gases, taking into account the special characteristics of medical gases, the special techniques and processes required to produce medical gases, and the established history of safe and effective use of medical gases. as introduced.
- Short: Medical Gas Safety Act as introduced.
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Official Summary
6/16/2011--Introduced.Medical Gas Safety Act - Amends the Federal Food, Drug, and Cosmetic Act to set forth provisions regarding the regulation of medical gases, including to establish a certification and approval process for medical gases. Lists designated medical gases, including oxygen,Official Summary
6/16/2011--Introduced.Medical Gas Safety Act - Amends the Federal Food, Drug, and Cosmetic Act to set forth provisions regarding the regulation of medical gases, including to establish a certification and approval process for medical gases. Lists designated medical gases, including oxygen, nitrous oxide, and medical air. Requires the Secretary to:(1) approve a certification for designated medical gases; and
(2) establish by rule appropriate procedures for the approval of medical gases that are not designated medical gases. Requires the Secretary to establish regulations for medical gases, including:
(1) appropriate current good manufacturing practice requirements,
(2) separate labeling requirements,
(3) separate wholesale distribution requirements,
(4) a streamlined electronic process for registration and listing of medical gases, and
(5) separate and proportionate product tracking and anti-counterfeiting rules for medical gases. Requires the Secretary to establish:
(1) a separate risk-based inspection regime specific to medical gas manufacturers that ensures coordination with state and local inspection activities, and
(2) the Medical Gas Advisory Committee to provide the Secretary with regular guidance and specific advice on medical gas regulatory activities. Directs the Secretary to assess and collect fees with respect to drugs that are non-designated medical gases, and establish the amount of fees to generate the total amount of costs of the Food and Drug Administration's (FDA's) regulation of non-designated medical gases. Exempts medical gases from new drug fees and new animal drug fees.
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