US Export Plan - Sector Report - Pharmaceutical Services

Trade, policy and regulation considerations

International businesses exporting pharmaceutical services to the US must navigate a highly regulated environment shaped by the FDA, strict compliance standards, intellectual property protections, and complex healthcare delivery practices. Success depends on meeting regulatory requirements, aligning with US healthcare system dynamics, and building strong distribution and compliance partnerships.

In the United States, the Department of Health and Human Services (HHS) oversees public health and safety through a range of agencies and programs. Key divisions include the Food and Drug Administration (FDA), the Centers for Medicare & Medicaid Services (CMS), the Office of Inspector General, and the Office for Civil Rights (OCR), among others.

Pharmaceuticals are no longer exempted from US import tariffs, creating a complex picture for customs duties. However, there is a new UK-US agreement that gives duty free access for key parts of the sector. This may give a competitive advantage to some Scottish companies here global competitors are from geographies without such an arrangement. While there is a developing tariff picture around pharmaceutical goods and manufacturing, it has less of a bearing to pharma services that are not subject to customs duties. Where pharma services are provided alongside goods that are subject to duties, high-tech and branded products are more likely to be able to absorb any impact from tariffs due to the better margins for patented and innovative exports.^[22]

The regulatory environment for pharmaceutical supply chains is rapidly transforming. However most changes are nationwide and have a bearing on the US market as a whole rather than informing engagement with specific states. Many of the state level regulations are more focused on pharmaceutical distribution, which is of less relevance to Scottish exporters.

There is heightened emphasis on traceability and serialisation of prescription drugs, as mandated by laws like the US Drug Supply Chain Security Act, whose full enforcement began in November 2024. This is a major regulatory shift in how medicines are tracked, verified, and distributed across the US supply chain.^[23] Prescriptions are tightly regulated, with strong emphasis on evidence-based medicine. Marketing and service models must comply with FDA and FTC rules on promotion.

All foreign drug manufacturers whose products are imported into the US must register their facilities with the FDA and list all drugs distributed commercially in the country. They must also comply with the Foreign Supplier Verification Program to ensure FDA safety stands are met. To ensure proper notification, the importer or their representative must file an entry notice and bond with US Customs until the product’s admissibility is determined. FDA import inspections and enforcement rely on coordination with Customs, which alerts the FDA upon product entry. The FDA then decides whether the product can be admitted.^[24]

An FDA approved drug is one which is subject to an FDA approved application: New Drug Application (NDA), Abbreviated New Drug Application (ANDA) or Biologics License Application (BLA). After completing the necessary research and testing, researchers can apply for FDA approval. The FDA then evaluates the submitted data and determines whether the drug can be authorised for sale in the United States. These categories include:

a) New Drug Approval: Researchers prepare a New Drug Application (NDA) summarising all data from early testing through Phase 3 trials, along with safety details, labelling, and usage instructions. The FDA typically reviews the application within 6–10 months to decide on approval. If deemed safe and effective, the drug is authorised for patient use, though post-approval studies often continue in Phase 4 trials.

b) Accelerated Approval: A temporary approval by the FDA that is based on a less rigorous endpoint. This designation enables the drug to enter the market, allowing patients who need it to access the treatment more quickly if benefit to the patient is shown.

c) Label Expansions: Following the approval of a drug for one condition, researchers may explore additional uses. If they demonstrate safety and effectiveness for another disease, they can request a label expansion. Upon reviewing the data, the FDA may approve the expansion, allowing the drug to treat the new condition.^[25]

On top of these requirements, specific drugs such as cancer drugs, have various additional procedures and special FDA review programmes to be aware of.

Below are other US regulatory considerations for exporters of pharmaceutical services:

• Prior Notice & Entry filing: Key documents for importing pharmaceuticals include Packing Lists, Bills of Lading, Importer Security Filing (ISF), Commercial invoices, specific CBP forms, Arrival Notice, Customs Bonds and Commodity specific documentation. ^[26]
• OTC Drug Product: OTC drugs are marketed for consumer use without the intervention of a healthcare professional. They can be marketed under an NDA, ANDA, or by meeting OTC monograph standards, which allow non-prescription drugs without an NDA. Imports must comply with one of these pathways.
• Data privacy and HIPAA: Any pharmaceutical service involving patient data must comply with HIPAA regulations, ensuring secure handling of health information.
• Clinical trial standards: International companies offering trial services must meet FDA requirements for investigational new drugs (INDs) and clinical trial conduct.
• Cold Chain Express Shipping for Pharmaceuticals: Many drugs (biologics, vaccines, mRNA therapies) require precise temperature control from shipment to delivery under real-time monitoring and compliance with the Drug Supply Chain Security Act (DSCSA) as stated above. ^[27]

Strategies for addressing these considerations

On 1 December 2025, the United Kingdom and United States announced an agreement in principle under the Economic Prosperity Deal where for a three-year period all UK-origin pharmaceuticals, pharmaceutical ingredients, and medical technology exported to the US will enter duty-free, while the UK commits to increased investment in innovative medicines. For exporters from Scotland, this deal creates commercial opportunities, and may increase competitiveness, but demands precision in customs treatment, origin substantiation, and export declaration filing.^[28]