The Section 232 pharmaceutical tariff is sweeping in scope — but so are its exemptions. The White House proclamation carves out entire categories of drugs that pay 0% tariff regardless of manufacturer, country of origin, or patent status. If your drug falls into any of these categories, you are fully protected.
This is the complete list of every drug exemption category under the 2026 pharmaceutical tariff.
1. Generic Drugs (0% — Fully Exempt)
All FDA-approved generic drugs are completely exempt from the Section 232 tariff. A generic drug is a drug that is: bioequivalent to an approved brand-name drug, not subject to a valid unexpired US patent, and approved through the FDA's Abbreviated New Drug Application (ANDA) process.
Generics are listed in the FDA Orange Book. If a drug appears in the Orange Book as an approved generic, it pays 0% tariff — period.
Why this matters: Approximately 90% of all US prescriptions are filled with generic drugs. The vast majority of patients are insulated from the tariff by this single exemption.
2. Biosimilars (0% — Fully Exempt)
Biosimilar drugs are the biological equivalent of generics for complex protein-based medications (biologics). A biosimilar is FDA-approved as highly similar to a reference biologic product with no clinically meaningful differences in safety, purity, or potency.
Biosimilars are listed in the FDA Purple Book. All FDA-approved biosimilars are fully exempt — 0% tariff, regardless of country of manufacture.
Examples of fully exempt biosimilars:
- Adalimumab biosimilars (Hadlima, Hyrimoz, Cyltezo, Yusimry, Hulio) — biosimilars to Humira
- Trastuzumab biosimilars — biosimilars to Herceptin
- Bevacizumab biosimilars — biosimilars to Avastin
- Etanercept biosimilars (Erelzi, Eticovo) — biosimilars to Enbrel
- Ustekinumab biosimilars (Wezlana, Selarsdi) — biosimilars to Stelara
3. Orphan Drugs (0% — Fully Exempt)
An orphan drug is a drug approved by the FDA for treating a rare disease or condition affecting fewer than 200,000 people in the United States. Orphan drugs receive special regulatory designation under the Orphan Drug Act and are fully exempt from the Section 232 tariff.
This exemption covers hundreds of rare disease medications — from treatments for Duchenne muscular dystrophy to rare metabolic disorders. If your drug has FDA Orphan Drug Designation, it is exempt.
4. Nuclear Medicines and Radiopharmaceuticals (0% — Fully Exempt)
Radiopharmaceuticals — drugs that contain a radioactive component used for diagnosis or treatment — are fully exempt. This covers diagnostic imaging agents (PET scan tracers) and therapeutic radiopharmaceuticals used in cancer treatment.
Examples: Lutathera (lutetium dotatate, Novartis — also Annex III), Pluvicto (lutetium vipivotide, Novartis — also Annex III), and diagnostic tracers like Vizamyl and Amyvid.
5. Plasma-Derived Therapies (0% — Fully Exempt)
Plasma-derived therapies are products derived from human blood plasma. These include:
- Immunoglobulins (IVIG/SCIG) — Gammagard, Privigen, Hizentra, Cuvitru
- Albumin — Used in critical care and surgery
- Clotting factors — Factor VIII, Factor IX products for hemophilia
- Alpha-1 antitrypsin — Zemaira, Glassia
All plasma-derived therapies are fully exempt regardless of manufacturer or country of origin.
6. Fertility Treatments (0% — Fully Exempt)
Drugs used for fertility treatment — including injectable gonadotropins, GnRH agonists and antagonists, and related hormonal therapies — are fully exempt from the tariff.
Examples: Gonal-f (follitropin alfa), Follistim (follitropin beta), Menopur (menotropins), Lupron (leuprolide) when used for fertility, Ganirelix, Cetrotide.
7. Cell Therapies and Gene Therapies (0% — Fully Exempt)
Cell therapies (including CAR-T therapies) and gene therapies are fully exempt. These are among the most expensive drugs in medicine — often $300,000–$4.3 million per treatment — and the exemption is significant.
Examples: Kymriah (tisagenlecleucel, Novartis — also Annex III), Yescarta (axicabtagene, Gilead — also Annex III), Zynteglo (betibeglogene, bluebird bio), Hemgenix (etranacogene).
8. Antibody-Drug Conjugates (ADCs) (0% — Fully Exempt)
Antibody-drug conjugates are a specialized class of cancer drugs that combine an antibody with a cytotoxic payload. All ADCs are fully exempt regardless of manufacturer.
Examples: Kadcyla (ado-trastuzumab emtansine, Genentech — also Annex III), Padcev (enfortumab vedotin), Trodelvy (sacituzumab govitecan, Gilead — also Annex III), Enhertu (trastuzumab deruxtecan).
9. CBRN Countermeasures (0% — Fully Exempt)
Drugs designated as Chemical, Biological, Radiological, and Nuclear (CBRN) countermeasures — including drugs in the Strategic National Stockpile — are fully exempt.
How to Check Your Drug
Use the RxTariff drug search tool to instantly check whether your specific medication falls into any of these exempt categories. The tool cross-references real FDA and CMS data to give you an accurate tariff classification.