HR 3162119th CongressIn Committee

Affordable and Safe Prescription Drug Importation Act of 2025

Introduced: May 1, 2025

Standard Summary

Comprehensive overview in 1-2 paragraphs

The Affordable and Safe Prescription Drug Importation Act of 2025 would amend the Federal Food, Drug, and Cosmetic Act to create a regulated pathway for the importation of certain prescription drugs into the United States. Under the act, the Secretary of Health and Human Services (HHS) would first permit importation by wholesale distributors, pharmacies, and individuals of “qualifying prescription drugs” from Canada, the United Kingdom, EU member states, Switzerland, and eventually other countries if safety criteria are met. The bill establishes a formal certification system for foreign sellers, requires labeling in English, imposes traceable supply chain practices, and allows for ongoing testing and oversight to protect public health. It also sets up enforcement tools to prevent online or cross-border misuse, requires reporting and recalls mechanisms, and provides waivers and discretion for individuals who import drugs for personal use. The overarching aim is to reduce US prescription drug costs by allowing safe, regulated importation while maintaining strong safeguards for drug quality, safety, and supply chain integrity. The bill includes protections against discriminatory practices by manufacturers, requires transparency and data collection, and preserves state remedies. It envisions a phased approach: initial regulations within a year, with broader importation possible from additional countries after demonstrated safety and effectiveness.

Key Points

1New pathway for importing safe, affordable drugs (Section 804). The Secretary must issue regulations within one year to authorize importation of qualifying prescription drugs by certified foreign sellers and importers, with personal importations allowed for individuals under defined limits and conditions (including a 90-day supply limit and a valid US prescription). Qualifying drugs must match US-approved active ingredients, routes, and strengths (or be a biosimilar), and labeling must meet English-language and other regulatory requirements.
2Certification system for foreign sellers (subsection (d)). Foreign sellers must be certified by the Secretary, pay a yearly fee, and meet strict criteria (location in permitted countries, proper licensing and compliance, quality assurance programs, recalls notification, grievance processes, and transparency about manufacturing and distribution). Certifications last two years and can be renewed.
3Public-facing list and supply chain controls (subsection (c) and (l)). The Secretary will publish a list of certified foreign sellers. The act imposes supply chain safeguards, requiring certified foreign sellers to purchase primarily from registered manufacturers or other certified foreign sellers, with limited exceptions coordinated through memoranda of understanding to ensure compliance and traceability.
4Expanded safety, testing, and oversight (multiple subsections). The Secretary may designate laboratories to test randomly for chemical authenticity. The labeling deeming provision ensures qualifying drugs are not misbranded if they meet labeling requirements. REMs (risk evaluation and mitigation strategies) and other safety structures apply to imported drugs with the same active ingredients as US-approved products. The act allows suspending importation for specific drugs or sellers if there are counterfeits, recalls, or other safety concerns.
5Enforcement, penalties, and case-by-case waivers for individuals (sections on enforcement and waivers). The bill adds penalties for online sellers that adulterate, counterfeit, or dispense without valid prescriptions. It grants enforcement discretion to focus on high-risk cases and authorizes the Secretary to grant waivers for individuals importing drugs for personal use under stated conditions, with published guidance to inform expectations.
6Reporting and oversight (section on reports). The Secretary must produce biannual reports on drug importation, and the GAO must deliver a separate implementation analysis within 18 months, covering safety, cost savings, and administrative costs.
7Protections against discrimination and preemption (sections on unfair practices and no preemption). The bill prohibits price discrimination against certified foreign sellers and other anti-competitive actions by manufacturers, while preserving state remedies and not preempting existing laws.
8Exclusions and limitations (definition highlights). Qualified drugs exclude certain categories (e.g., controlled substances, certain anesthetics, and compounded drugs). Some drugs (like insulin and certain therapies) are included for importation by individuals. The act requires that imported drugs have English labeling and that prescriptions come from a US-licensed practitioner with at least one in-person evaluation.

Impact Areas

Primary group/area affected- US patients and consumers: potential access to lower-cost prescription medications, especially for drugs that are expensive in the US, while maintaining safety standards.- Importers and wholesale distributors and pharmacies: new regulatory pathway, certification requirements, fees, and ongoing recordkeeping.Secondary group/area affected- International suppliers (certified foreign sellers) in Canada, the UK, EU member states, Switzerland, and other permitted countries: new export/import obligations, certification, and potential for expanded markets if safety criteria are met.- US Food and Drug Administration (FDA) and HHS: expanded regulatory framework, enforcement authority, laboratory testing, recalls, and reporting obligations.- Drug manufacturers: potential impact on pricing dynamics and distribution channels; protection against discrimination and certain competitive constraints provided by the bill.Additional impacts- State and local governments: continued ability to pursue remedies; potential changes in state laws related to drug importation and safety oversight.- Pharmacists and healthcare providers: must verify valid prescriptions, oversee compliance with import regulations, and respond to recalls or suspension orders.- Public safety and cost outcomes: potential reductions in patient out-of-pocket costs if imported drugs are cheaper, balanced against the need for robust oversight to prevent counterfeit or unsafe products.- Administrative and compliance costs: costs associated with certification, recordkeeping, labeling, and potential testing programs for import drugs.Qualifying prescription drug: a drug that matches an approved US version in active ingredient(s), route, and strength, with labeling compliant to certain foreign standards and English labeling required by the Secretary.Certified foreign seller: a foreign pharmacy or wholesale distributor that meets stringent qualifications and is listed by the Secretary as an approved source for US importation.Importer: a US-registered dispenser or wholesale distributor that imports qualifying drugs under this framework.Mutual Recognition Agreements (MRAs): FDA arrangements recognizing foreign regulatory inspections as equivalent to US inspections, cited in findings as a basis for confidence in imported drugs from certain countries.REMs: safety programs required for certain drugs to ensure safe use, applicable to imported drugs when there is an equivalent US-approved product.

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