Classification conclusion and import answer
Conditional conclusion: a human medicament for therapeutic or prophylactic use, put up in measured doses or retail packaging, is generally classified in heading 3004. HTSUS 3004.90.9290 is a common residual candidate, often duty-free under Column 1 General, but the ten-digit line depends on active ingredient, dosage form and named breakouts. Bulk medicaments may fall in 3003, vaccines and many biologics in 3002, dressings in 3005, specified pharmaceutical goods in 3006, and pure APIs in Chapters 28 or 29. Customs entry does not authorize sale: most finished drugs require an approved NDA, ANDA or BLA, or compliance with an OTC monograph, plus establishment registration, drug listing, cGMP and lawful labeling.
| Imported article | Candidate provision | Decisive fact |
|---|---|---|
| Finished measured-dose medicine | 3004 | Active ingredient and dosage form |
| Bulk medicament | 3003 | Not in measured doses or retail packs |
| Vaccine/biologic | 3002 | Biological identity |
| Pure API | Chapter 28/29 | Chemical identity and purity |
| Medicated dressing | 3005 | Substrate and retail presentation |
Chapter 30 classification boundaries
Apply GRI 1, Chapter 30 notes and then GRI 6. Fix the complete qualitative and quantitative formula, salt form, strength, route, dosage form, therapeutic indication, packaging and approval status. Products merely labeled “supplement,” cosmetics with drug claims, combination products and veterinary drugs require separate jurisdiction and classification review. A foreign tariff code or an FDA product code does not determine HTSUS classification. Recurring high-value imports should be supported by a CBP ruling or a documented classification memorandum.
Duty, fees and origin
Many 3004 lines have a Free Column 1 General rate, but the current HTSUS and exact ten-digit suffix must be checked on the entry date. MPF applies to formal entries and HMF may apply to ocean cargo. Origin controls marking, preference, sanctions and Chapter 99; a drug's country of shipment is not necessarily its customs origin. Screen Section 301 only after the ten-digit line and origin are established, and screen AD/CVD by written scope rather than HTS alone. Customs value may include assists and royalties.
FDA approval pathway
Under the FD&C Act, a new prescription drug generally needs an effective NDA or ANDA, and a biological product generally needs a BLA, before commercial import. An OTC drug may be marketed under an approved application or a lawful OTC monograph. A foreign version of a U.S.-approved drug is still unapproved if it was not manufactured under the approved application. Investigational drugs require an effective IND and compliant consignee/labeling; limited import-for-export and personal-importation policies are not substitutes for commercial approval.
Registration, listing and import entry
Foreign establishments that manufacture, repack, relabel or salvage imported drugs must register with FDA, identify a U.S. agent and known importers, renew annually and list each commercially distributed drug. Entry data should match manufacturer, NDC/listing and application information; FDA may verify REG, DLS and DA Affirmations of Compliance. Registration and listing are not approval. Inaccurate identity, manufacturer, application or intended-use data can trigger manual review, detention or refusal under FD&C Act section 801.
cGMP and shipment admissibility
Imported drugs must comply with cGMP under 21 CFR Parts 210 and 211 and the approved application. FDA applies a risk-based admissibility review and may detain without physical examination under an Import Alert. Preserve batch records, COA, validated methods, stability, container-closure evidence, shipping temperatures and chain of custody. A product that appears adulterated, misbranded or unapproved may be refused even when HTS duty is zero. Confirm the foreign facility is not subject to an import alert before shipment.
DSCSA, labeling and distribution
Prescription drugs within DSCSA scope require authorized trading partners, package-level product identifiers, interoperable tracing, verification and suspect-product procedures. Labels must meet the applicable prescription, OTC, biologic or investigational requirements and correspond to the approved application/monograph. Importer of record, application holder, consignee, wholesale distributor and DSCSA trading partner are distinct roles. State wholesale-distribution and pharmacy licensing can apply after federal admissibility and should be mapped before commercial distribution.
Controlled drugs and special cases
Controlled substances require DEA registration, quota or import permit as applicable under the Controlled Substances Act; the precise schedule depends on substance, salt, isomer and concentration. Vaccines, blood products, radiopharmaceuticals, combination products, animal drugs and drug-device products may involve CBER, CDRH, CVM, NRC or other agencies. Emergency or shortage discretion is fact-specific and temporary. Do not convert a patient-use, IND or import-for-export exception into a general sales channel.
Entry file and customs description
Maintain the commercial invoice, packing list, transport record, value/origin support, complete formula, application and listing data, establishment registration, U.S. agent, label, COA, cGMP support, temperature log, DSCSA data and DEA documents where applicable. A useful description is “Human prescription drug, [dosage form], [active ingredient/salt] ... mg per unit, ... units per retail pack, NDA/ANDA/BLA ..., HTSUS candidate 3004.90.9290, origin ...”. Avoid “medicine” alone and never declare an FDA product code as the tariff number.
Official U.S. sources
Official sources checked 12 September 2026: USITC HTSUS, FDA Importing Human Drugs, FDA Shipment Admissibility, FDA Human Drug Imports, FDA DSCSA and eCFR Title 21. Recheck HTS revision, Import Alerts and application status on entry.
Limits of this guidance
This is conditional general guidance, not a CBP ruling or FDA admissibility/approval decision. A final opinion requires the active ingredient and salt, strength, complete formula, dosage form, route, indication, label, application/listing, manufacturer, origin, value and entry date. The importer remains responsible for classification, value, origin, FDA data, approval, cGMP, labeling, DSCSA, state licensing and controlled-substance compliance.
Official sources to verify
- WCO — HS Nomenclature 2022 and General Rules for Interpretation
- United States International Trade Commission — Harmonized Tariff Schedule
Editorial note
Prepared by the Global HS Code Checker Editorial Team for customs-classification, tariff and import-policy research. The correct code and applicable measures may change with the merchandise's actual characteristics, jurisdiction, entry date and supporting record. Verify the current tariff, governing measures and competent customs authority before filing an entry. A reviewer is identified only after a named expert has completed the review.