21 U.S.C. § 379aa Serious Adverse Event Reporting For Nonprescription Drugs

• Library: United States Statutes
• Edition: 2023 Edition
• Currency: Current through P.L. 118-19 (published on www.congress.gov on 10/06/2023)

(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 353(b) of this title; and

(B) not subject to approval in an application submitted under section 355 of this title.

(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

(v) a congenital anomaly or birth defect; or

(B) requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described under subparagraph (A).

(4) Serious adverse event report

The term "serious adverse event report" means a report that is required to be submitted to the Secretary under subsection (b).

(b) Reporting requirement

(1) In general

The manufacturer, packer, or distributor whose name (pursuant to section 352(b)(1) of this title) appears on the label of a nonprescription drug marketed in the United States (referred to in this section as the "responsible person") shall submit to the Secretary any report received of a serious adverse event associated with such drug when used in the United States, accompanied by a copy of the label on or within the retail package of such drug.

(2) Retailer

A retailer whose name appears on the label described in paragraph (1) as a distributor may, by agreement, authorize the manufacturer or packer of the nonprescription drug to submit the required reports for such drugs to the Secretary so long as the retailer directs to the manufacturer or packer all adverse events associated with such drug that are reported to the retailer through the address or telephone number described in section 352(x) of this title.

(c) Submission of reports

(1) Timing of reports

The responsible person shall submit to the Secretary a serious adverse event report no later than 15 business days after the report is received through the address or phone number described in section 352(x) of this title.