120 STAT. 3470
PUBLIC LAW 109–462—DEC. 22, 2006
‘‘(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 502(b)(1)) 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 502(x). ‘‘(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 502(x). ‘‘(2) NEW MEDICAL INFORMATION.—The responsible person shall submit to the Secretary any new medical information, related to a submitted serious adverse event report that is received by the responsible person within 1 year of the initial report, no later than 15 business days after the new information is received by the responsible person. ‘‘(3) CONSOLIDATION OF REPORTS.—The Secretary shall develop systems to ensure that duplicate reports of, and new medical information related to, a serious adverse event shall be consolidated into a single report. ‘‘(4) EXEMPTION.—The Secretary, after providing notice and an opportunity for comment from interested parties, may establish an exemption to the requirements under paragraphs (1) and (2) if the Secretary determines that such exemption would have no adverse effect on public health. ‘‘(d) CONTENTS OF REPORTS.—Each serious adverse event report under this section shall be submitted to the Secretary using the MedWatch form, which may be modified by the Secretary for nonprescription drugs, and may be accompanied by additional information. ‘‘(e) MAINTENANCE AND INSPECTION OF RECORDS.— ‘‘(1) MAINTENANCE.—The responsible person shall maintain records related to each report of an adverse event received by the responsible person for a period of 6 years. ‘‘(2) RECORDS INSPECTION.— ‘‘(A) IN GENERAL.—The responsible person shall permit an authorized person to have access to records required
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