The law › Title 21, Food and Drugs › Chapter 9

21 U.S.C. 379j-71: Definitions

Created in 2020 by the Coronavirus Aid, Relief, and Economic Security Act" or the "CARES Act (Public Law 116-136). Not changed since. 1 new law this Congress changed it.

How it got hereLaws that created or changed it, newest first

2020Coronavirus Aid, Relief, and Economic Security Act" or the "CARES Actadded it

21 U.S.C. 379j-71Definitions

(1)The term "affiliate" means a business entity that has a relationship with a…

(2)The term "contract manufacturing organization facility" means an OTC monograph…

(3)The term "costs of resources allocated for OTC monograph drug activities" means…

(4)The term "FDA establishment identifier" is the unique number automatically…

(5)The term "OTC monograph drug" means a nonprescription drug without an approved…

(6)The term "OTC monograph drug activities" means activities of the Secretary…

(7)The term "OTC monograph order request" means a request for an order submitted…

(8)The term "Tier 1 OTC monograph order request" means any OTC monograph order…

(9)(A) The term "Tier 2 OTC monograph order request" means, subject to…added to

(10)(A) The term "OTC monograph drug facility" means a foreign or domestic business…

(11)The term "OTC monograph drug meeting" means any meeting regarding the content…

(12)The term "person" includes an affiliate of a person.

(13)The terms "requestor" and "sponsor" have the meanings given such terms in…

(B)The Secretary may, based on program implementation experience or other factors…

(C)If a business or other entity would meet criteria specified in subparagraph…

This CongressBills that change it or would

H.R. 5371Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026law

past change
enacted this Congress
proposed

This Congress

H.R. 5371 Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 · became law · changed (9)

How it got here

Unchanged since the Coronavirus Aid, Relief, and Economic Security Act" or the "CARES Act, Public Law 116-136 (Mar 27, 2020).

Text, outline and history from the official U.S. Code (2024 edition) on GovInfo, published by the Office of the Law Revision Counsel. Changes made after that edition appear under This Congress.