PlainBillCongress, translated.Legislation. Context. Public interest.Congressional Research Service
Version 00 · Introduced in House · Jun 16, 2011
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.
Showing the opening paragraphs of the official summary.
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.
People & committees
Rep. Lance, Leonard [R-NJ-7] · R–NJ
Legislative record
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Referred to the Subcommittee on Health.
Referred to the House Committee on Energy and Commerce.
Introduced in House
Introduced in House
Primary sources
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No related bills are listed in this snapshot. This does not establish whether the proposal has appeared in earlier Congresses.
Source last updated: Aug 14, 2025. Consult Congress.gov for the current record.
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