Requires drug labels to name the original manufacturer of each active ingredient and each company in the supply chain, and allows the FDA to assess civil penalties of up to 25 percent of a noncompliant drug lot's value.

• Requires labels for active pharmaceutical ingredients to name the original manufacturer, place of business, and unique facility identifier, or to link to a searchable electronic portal with that information.
• Requires finished drug products in package form to identify the original manufacturer of each active ingredient, the original manufacturer of the finished product, and any packer or distributor, printed on the label or available electronically.
• Sets civil monetary penalties of up to 25 percent of the affected lot's value for noncompliance, with the Secretary weighing business size, prior notice, and good-faith correction, and bars criminal penalties for these violations.
• Directs FDA to coordinate with U.S. Customs and Border Protection on overlap with country-of-origin marking rules, protects trade secrets, and applies to drugs manufactured and packaged on or after 5 years after enactment.

• Banking, Housing, and Urban Affairs Committee (Senate)
• Health, Education, Labor, and Pensions Committee (Senate)

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