21 U.S.C. 379g: Definitions

2022

• Pub. L. 117–180, §1002(a), substituted "does not include an application with respect to an allergenic extract product licensed before October 1, 2022, does not include an application with respect to a standardized allergenic extract product submitted pursuant to a notification to the appl… (Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023) Law text · (1)
• Pub. L. 117–180, §1002(b), substituted "(3)(A) The term" for "(3) The term", redesignated former subpars. (A) to (C) as cls. (i) to (iii), respectively, of subpar. (A), designated concluding provisions as subpar. (B) and substituted "an allergenic extract product licensed before October 1… (Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023) Law text · (3)
• Pub. L. 117–180, §1002(c), added par. (12). (Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023) Law text · (12)

2012

• Pub. L. 112–144, §407, struck out "or (k)" after "subsection (a)". (Food and Drug Administration Safety and Innovation Act) Law text · (1)
• Pub. L. 112–144, §102, substituted "expenses in connection with" for "expenses incurred in connection with". (Food and Drug Administration Safety and Innovation Act) Law text · (7)

2010

• Pub. L. 111–148 substituted "subsection (a) or (k) of section 262 of title 42" for "section 262 of title 42". (Patient Protection and Affordable Care Act) Law text · (1)

2007

• Pub. L. 110–85, §102(1), in introductory provisions, substituted "For purposes of this subpart" for "For purposes of this part". (Food and Drug Administration Amendments Act of 2007) Law text
• Pub. L. 110–85, §102(2)(D), substituted "subparagraph (B)" for "subparagraph (C)" in concluding provisions. (Food and Drug Administration Amendments Act of 2007) Law text · (1)
• Pub. L. 110–85, §102(2)(A), substituted "355(b) of this title, or" for "355(b)(1) of this title,". (Food and Drug Administration Amendments Act of 2007) Law text · (1)
• Pub. L. 110–85, §102(2)(B), (C), redesignated subpar. (C) as (B) and struck out former subpar. (B) which read as follows: "approval of a new drug submitted under section 355(b)(2) of this title after September 30, 1992, which requests approval of— (Food and Drug Administration Amendments Act of 2007) Law text · (1), (C)
• Pub. L. 110–85, §102(3), substituted "355(j)(7)(A) of this title (not including the discontinued section of such list)" for "355(j)(7)(A) of this title" and inserted "(not including the discontinued section of such list)" before period at end. (Food and Drug Administration Amendments Act of 2007) Law text · (3)
• Pub. L. 110–85, §102(4), inserted "(such as capsules, tablets, or lyophilized products before reconstitution)" before period at end. (Food and Drug Administration Amendments Act of 2007) Law text · (4)
• Pub. L. 110–85, §102(5), amended subpar. (F) generally. Prior to amendment, subpar. (F) read as follows: "In the case of drugs approved after October 1, 2002, under human drug applications or supplements: collecting, developing, and reviewing safety information on the drugs, including … (Food and Drug Administration Amendments Act of 2007) Law text · (6)
• Pub. L. 110–85, §102(6), substituted "October of the preceding fiscal year" for "April of the preceding fiscal year" and "October 1996" for "April 1997". (Food and Drug Administration Amendments Act of 2007) Law text · (8)
• Pub. L. 110–85, §102(7), (8), added pars. (9) and (10) and redesignated former par. (9) as (11). (Food and Drug Administration Amendments Act of 2007) Law text · (9), (10), (11)

2002

• Pub. L. 107–188, §503(1), substituted "licensure, as described in subparagraph (C)" for "licensure, as described in subparagraph (D)" in concluding provisions. (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (1)
• Pub. L. 107–188, §503(2)(D), which directed the amendment of concluding provisions of par. (3) by striking "section 262 of title 42" and all that follows through "biological product" and inserting "section 262 of title 42. Such term does not include a biological product", was executed by … (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (3)
• Pub. L. 107–188, §503(2)(A)–(C), added subpar. (C). (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (3)
• Pub. L. 107–188, §503(3), added subpar. (F). (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (6)
• Pub. L. 107–188, §503(4), struck out designations of subpars. (A) and (B) and text of subpar. (B) and concluding provisions, substituting definition of "adjustment factor" as the Consumer Price Index for definition of Index as the lower of the Consumer Price Index or the total of discreti… (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (8)

1997

• Pub. L. 105–115, §102(1), in closing provisions, struck out "and" before "does not include an application" and substituted "September 1, 1992, does not include an application for a licensure of a biological product for further manufacturing use only, and does not include an application or… (Food and Drug Administration Modernization Act of 1997) Law text · (1)
• Pub. L. 105–115, §125(b)(2)(M), inserted "or" at end of subpar. (B), redesignated subpar. (D) as (C), and struck out former subpar. (C) which read as follows: "initial certification or initial approval of an antibiotic drug under section 357 of this title, or". (Food and Drug Administration Modernization Act of 1997) Law text · (1)
• Pub. L. 105–115, §102(2), in closing provisions, struck out "and" before "does not include a large volume parenteral drug" and substituted "September 1, 1992, does not include a biological product that is licensed for further manufacturing use only, and does not include a drug that is not… (Food and Drug Administration Modernization Act of 1997) Law text · (3)
• Pub. L. 105–115, §102(3), substituted "without substantial further manufacturing" for "without further manufacturing". (Food and Drug Administration Modernization Act of 1997) Law text · (4)
• Pub. L. 105–115, §102(4), amended first sentence generally. Prior to amendment, first sentence read as follows: "The term 'prescription drug establishment' means a foreign or domestic place of business which is— (Food and Drug Administration Modernization Act of 1997) Law text · (5)
• Pub. L. 105–115, §102(5), substituted "contractors of the Food and Drug Administration," for "employees under contract with the Food and Drug Administration who work in facilities owned or leased for the Food and Drug Administration," and "and committees and to contracts with such cont… (Food and Drug Administration Modernization Act of 1997) Law text · (7)
• Pub. L. 105–115, §102(6)(A), substituted "April of the preceding fiscal year" for "August of the preceding fiscal year" and "April 1997" for "August 1992". (Food and Drug Administration Modernization Act of 1997) Law text · (8)
• Pub. L. 105–115, §102(6)(B), substituted "section 254(c)" for "section 254(d)", "fiscal year 1997" for "fiscal year 1992", and "105th Congress, 1st Session" for "102d Congress, 2d Session". (Food and Drug Administration Modernization Act of 1997) Law text · (8)
• Pub. L. 105–115, §102(7), added par. (9). (Food and Drug Administration Modernization Act of 1997) Law text · (9)