H.R. 6168 · 109th Congress
Dietary Supplement and Nonprescription Drug Consumer Protection Act
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Never voted on. It didn't reach a floor vote before the 109th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
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CannonSponsor1 cosponsor · 1 D
0 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
Dietary Supplement and Nonprescription Drug Consumer Protection Act - Amends the Federal Food, Drug, and Cosmetic Act to require a manufacturer, packer, or distributor whose name appears on the label of a nonprescription drug or dietary supplement marketed in the United States to: (1) submit to the Secretary of Health and Human Services within 15 business…
What it does: CRS summary · Introduced in House · Sep 25, 2006
Dietary Supplement and Nonprescription Drug Consumer Protection Act - Amends the Federal Food, Drug, and Cosmetic Act to require a manufacturer, packer, or distributor whose name appears on the label of a nonprescription drug or dietary supplement marketed in the United States to: (1) submit to the Secretary of Health and Human Services within 15 business days any report received of a serious adverse event associated with such drug or supplement when used in the United States; (2) submit within 15 business days any related medical information that is received within one year of the initial report; (3) maintain records related to each report for six years; and (4) permit inspection of such records.
Requires the Secretary to develop systems to ensure that duplicate reports of a serious adverse event are consolidated into a single report.
Allows the Secretary to establish an exemption from such reporting that would have no adverse effect on public health.
Prohibits any state or local government from establishing or continuing any requirement related to a mandatory system for adverse event reports for nonprescription drugs or dietary supplements that is not identical to this Act.
Prohibits the responsible person from: (1) refusing to permit access to any required record; or (2) failing to establish or maintain any record, or make any report, required under this Act.
Deems a nonprescription drug or dietary supplement that is marketed in the United States to be misbranded, unless its label includes a domestic address or phone number for the reporting of a serious adverse event.
Prohibits the importation of such a drug or supplement if the Secretary has credible evidence or information indicating that the responsible person has not complied with the requirements of this Act or has not allowed access to its records.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Dietary Supplement and Nonprescription Drug Consumer Protection Act
Latest action (Oct 2, 2006): Referred to the Subcommittee on Health.
Policy area: Health · Origin: House · Introduced: Sep 25, 2006
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.