The CLEAR LABELS Act amends federal drug labeling law to require that both active pharmaceutical ingredients (APIs) and finished drug products disclose the name and location of their "original manufacturer"—the facility that performed the majority of significant manufacturing steps—along with information about packers and distributors. This information can be printed directly on labels or made accessible through electronic means like a QR code or online portal, giving consumers, pharmacists, and healthcare providers more visibility into where their medications and drug ingredients actually come from, which is especially relevant given concerns about overseas manufacturing, particularly in countries like China and India. The bill affects drug manufacturers, packagers, and distributors, who would face civil monetary penalties of up to 25% of a drug lot's value for noncompliance, though the Secretary of Health and Human Services must consider factors like business size and good-faith correction efforts before assessing penalties, and violations cannot be treated as criminal offenses. The legislation also exempts compliant drug products from separate customs country-of-origin marking requirements to avoid duplicative rules, and directs the FDA to coordinate with Customs and Border Protection to prevent regulatory overlap. Trade secrets and confidential business information remain protected from disclosure, and the new requirements would take effect five years after the bill becomes law, giving the industry time to adjust supply chains and labeling practices.
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