Title 21, Food and DrugsRelease 119-102

§360ddd–2 Inapplicability of Drug Fees to Designated Medical Gases

Title 21 › CHAPTER 9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT › SUBCHAPTER V — DRUGS AND DEVICES › Part G — Medical Gases › § 360ddd–2

Last updated Aug 21, 2026|Official source

Summary

Designated medical gases per 360ddd–1 treated as approved cannot be charged fees under 379h(a) or 379j–12(a).

Full Legal Text

Title 21, §360ddd–2

Food and Drugs, Source: USLM XML via OLRC

A designated medical gas, alone or in combination with another designated gas or gases (as medically appropriate) deemed under section 360ddd–1 of this title to have in effect an approved application shall not be assessed fees under section 379h(a) or 379j–12(a) of this title on the basis of such deemed approval.

Legislative History

Notes & Related Subsidiaries

Editorial Notes

Amendments

2016—Pub. L. 114–255 inserted “or 379j–12(a)” after “section 379h(a)”.

Reference

Citations & Metadata

Citation

21 U.S.C. § 360ddd–2

Title 21, Food and Drugs

Last Updated

Aug 21, 2026

Release point: 119-102