Page:United States Statutes at Large Volume 120.djvu/3500

 PUBLIC LAW 109–462—DEC. 22, 2006

120 STAT. 3469

Public Law 109–462 109th Congress An Act To amend the Federal Food, Drug, and Cosmetic Act with respect to serious adverse event reporting for dietary supplements and nonprescription drugs, and for other purposes.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 1. SHORT TITLE.

This Act may be cited as the ‘‘Dietary Supplement and Nonprescription Drug Consumer Protection Act’’.

Dec. 22, 2006 [S. 3546]

Dietary Supplement and Nonprescription Drug Consumer Protection Act. 21 USC 301 note.

SEC. 2. SERIOUS ADVERSE EVENT REPORTING FOR NONPRESCRIPTION DRUGS.

(a) IN GENERAL.—Chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) is amended by adding at the end the following: ‘‘Subchapter H—Serious Adverse Event Reports ‘‘SEC. 760. SERIOUS ADVERSE EVENT REPORTING FOR NONPRESCRIPTION DRUGS.

21 USC 379aa.

‘‘(a) DEFINITIONS.—In this section: ‘‘(1) ADVERSE EVENT.—The term ‘adverse event’ means any health-related event associated with the use of a nonprescription drug that is adverse, including— ‘‘(A) an event occurring from an overdose of the drug, whether accidental or intentional; ‘‘(B) an event occurring from abuse of the drug; ‘‘(C) an event occurring from withdrawal from the drug; and ‘‘(D) any failure of expected pharmacological action of the drug. ‘‘(2) NONPRESCRIPTION DRUG.—The term ‘nonprescription drug’ means a drug that is— ‘‘(A) not subject to section 503(b); and ‘‘(B) not subject to approval in an application submitted under section 505. ‘‘(3) SERIOUS ADVERSE EVENT.—The term ‘serious adverse event’ is an adverse event that— ‘‘(A) results in— ‘‘(i) death; ‘‘(ii) a life-threatening experience; ‘‘(iii) inpatient hospitalization; ‘‘(iv) a persistent or significant disability or incapacity; or

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