Title 21Food and DrugsRelease 119-73

§360ddd–2 Inapplicability of drug fees to designated medical gases

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

Last updated Apr 6, 2026|Official source

Summary

If a medical gas is treated by law as having an approval, it — by itself or mixed with other such gases when medically needed — must not be charged certain federal drug fees because of that treated approval.

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 21Food and Drugs

Last Updated

Apr 6, 2026

Release point: 119-73