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Pharmaceuticals · FDA CDER · DEA

Importing pharmaceuticals into the United States

Every drug entry goes to FDA with the foreign site's registration, the NDC and the application number. Controlled substances also need DEA approval. Allied CHB, a licensed customs broker, files the entry and the agency data, and we apply the new Section 232 duty on patented drugs.

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Agencies

Which agencies regulate pharmaceuticals?

FDA decides if a drug may enter. DEA controls scheduled drugs. CBP collects the duty and enforces the decisions of the other agencies at the port.
  • FDA CDER

    Registration, listing and approval

    Each foreign site that makes, repacks or relabels the drug must register with FDA and list the drug (21 CFR 207.17 and 207.41). It must name a U.S. agent (21 CFR 207.69). A prescription drug needs an approved application. A nonprescription drug must meet an OTC monograph or have its own approval.
  • FDA CDER

    What FDA data does a drug entry need?

    FDA reviews drug lines under program code DRU in the FDA message set. A prescription drug for sale uses intended use code 080.012 (an approved NDA, ANDA or BLA). This code needs the application number (DA), the U.S. NDC (DLS) and the site registration number, a 9-digit DUNS (REG) (21 CFR 1.74). A drug with a Canadian label has a Health Canada DIN, not an NDC, so it has no NDC to report under code 080.012. Code 100.000 is personal use: FDA then decides each parcel under its personal importation policy. FDA drug lines carry no LPCO. Only DEA uses one: the permit from DEA Form 357 (document code 911) or the DEA Form 236 declaration (code 921).
  • DEA

    Controlled substances

    The importer must hold a DEA importer registration. Schedule I and II substances and narcotics in Schedules III to V need a DEA import permit (application on DEA Form 357). Most other Schedule III to V substances need an import declaration on DEA Form 236. File it at least 15 calendar days before release (21 CFR 1312.18).
  • CBP

    Duty, origin and release

    CBP collects the duty, including the Section 232 duty on patented drugs. It checks the Chapter 99 numbers, the country of origin and the value. CBP also holds the goods when FDA or DEA has not released them.

HTS and duties

Which HTS chapters and duties apply in 2026?

Most finished drugs are free of base duty. The 2026 changes are in Chapter 99. Patented drugs now pay a Section 232 duty, and drugs are exempt from the new Section 301 forced labor duty.
Main HTS headings for pharmaceuticals, base duty rates and Chapter 99 duties in effect on September 28, 2026
HTSGoodsBase dutyChapter 99 duties in effect (September 28, 2026)
3004Finished drugs in measured doses or retail packs: tablets, capsules, injectablesFreeSection 232 on patented drugs (9903.04.60 to 9903.04.70, see below). Exempt from the forced labor duty. Not on the Section 301 China lists.
3003Drugs not in measured doses or retail packsFreeSame as 3004.
3002Vaccines, blood fractions, immunological products, cell therapy productsFreeMany 3002 lines are on the Section 232 list. Exempt from the forced labor duty.
2936, 2937, 2939, 2941Vitamins, hormones, alkaloids and antibiotics in bulkMostly freeMost lines are exempt from the forced labor duty. Some 2937, 2939 and 2941 lines are on the Section 232 list and pay it when patented.
Other chapter 29Other active ingredients and intermediates (for example 2933, 2934)Often 6.5%. Free when listed in the Pharmaceutical Appendix (K)Forced labor duty applies unless the chemical is listed for pharmaceutical use (9903.05.89). Some lines are on the Section 232 list. Some lines of China: 25 percent (Section 301 List 3).

Base duty is the column 1 general rate in the Harmonized Tariff Schedule. A trade agreement can lower it. The rate for your goods depends on the full 10-digit number and the country of origin.

  • Since July 31, 2026, every entry of a covered chapter 29 or 30 HTS number must report a Chapter 99 number from 9903.04.60 to 9903.04.69. This applies even when the rate is 0 percent.
  • Patented drugs and their ingredients pay a 100 percent combined rate (base rate plus Section 232, 9903.04.60) under Proclamation 11020. Companies listed in Annex III pay since July 31, 2026. All other companies pay since September 29, 2026 (CBP CSMS 70054007). "Patented" means subject to a valid, unexpired U.S. patent and listed in FDA's Orange Book or Purple Book (U.S. note 40(c) to subchapter III of Chapter 99).
  • Goods of the EU, Japan, South Korea, Switzerland and Liechtenstein pay a 15 percent combined rate (9903.04.62). Goods of the United Kingdom pay 0 percent since July 31, 2026 (9903.04.63).
  • Canada has no reduced rate. A patented drug that is a product of Canada pays 100 percent (9903.04.60). USMCA does not remove the Section 232 duty: CBP collects it in addition to any free trade agreement rate.
  • 9903.04.66 (0 percent) covers specific uses: orphan drugs, nuclear medicines, plasma-derived therapies, fertility drugs, cell and gene therapy products, antibody drug conjugates, medical countermeasures and animal health products. Only products of listed jurisdictions can use it (91 FR 60360). The list: Argentina, Bangladesh, Cambodia, Ecuador, El Salvador, the European Union, Guatemala, India, Indonesia, Japan, Jordan, Malaysia, North Macedonia, South Korea, Switzerland and Liechtenstein, Taiwan, Thailand, the United Kingdom and Vietnam. Canada is not on the list.
  • 0 percent lines: generic drugs (9903.04.67), U.S.-origin products (9903.04.68), goods solely for clinical trials, research and development or other non-commercial use (9903.04.70), and companies with a Commerce onshoring and pricing agreement (9903.04.65). Drawback is available for the Section 232 pharmaceutical duties.
  • Drugs in 3002 to 3004 and listed vitamins, hormones and antibiotics are exempt from the Section 301 forced labor duty (9903.05.86). Other chemicals are exempt only if they are for pharmaceutical use and are listed in U.S. note 52(e) (9903.05.89).

Section 301 forced labor duty: 10 or 12.5 percent since July 24, 2026

USTR set an extra duty on goods of 60 economies (HTS 9903.05.20 to 9903.05.84). For example, goods of China, Hong Kong, Vietnam and Thailand pay 12.5 percent. Goods of India, Bangladesh, Indonesia and the United Kingdom pay 10 percent. Canada and Mexico pay 10 percent, except on goods that enter free under USMCA.

For the EU and Taiwan, the duty tops up the base rate to 10 percent. For Japan, South Korea and Switzerland, it tops up to 12.5 percent. Products listed in U.S. note 52 and goods properly entered under Chapter 98 do not pay it. CBP guidance, CSMS 69326983.

What else changed in 2026

IEEPA duties ended in February 2026. CBP refunds them with interest through CAPE declarations in the ACE Portal. IEEPA refunds.

The 10 percent Section 122 surcharge applied from February 24 to July 24, 2026. Section 301 duties on goods of China and Section 232 duties still apply where the actions say so. Section 301 China duties add to the forced labor duty. Goods under the Section 232 duties on metals, vehicles and parts, wood products and semiconductors do not pay the forced labor duty (9903.05.90).

Checklist

What documents do I need?

Send these before the goods ship. FDA reviews the data in the entry, often before the cargo arrives.

  • Commercial invoice and packing list

    Product name, strength, dosage form, quantity by package level, unit value, and the manufacturer's name and address.

  • Site registration number

    The unique facility identifier of each foreign site that made, repacked or relabeled the drug (21 CFR 1.74).

  • NDC and application number

    The National Drug Code from the drug listing, and the NDA, ANDA, BLA or IND number when one applies.

  • Section 232 facts

    The manufacturer, the country of origin, whether the drug is patented or generic, and any specific end use. We use them to pick the Chapter 99 number.

  • DEA documents

    For controlled substances: the importer's DEA registration and the permit, or the DEA Form 236 transaction number.

  • Power of attorney and bond

    A signed customs power of attorney and a customs bond. You can sign our power of attorney online.

Holds

What causes holds?

Most drug holds come from entry data that does not match FDA records, or from a product that FDA does not consider approved.

  • Registration or listing does not match

    The site did not renew its registration, or the NDC is not listed for that site. Drug sites renew each year from October 1 to December 31 (21 CFR 207.29).

  • Unapproved new drug

    A prescription drug without an approved application, or an OTC drug outside its monograph. FDA can refuse admission. FDA can destroy a refused drug valued at $2,500 or less (21 CFR 1.94).

  • FDA import alert

    Products of a firm on an import alert are detained without physical examination. The importer must show that the goods comply before FDA releases them.

  • Controlled substance without DEA approval

    CBP does not release a controlled substance without a valid permit or declaration for that shipment (21 CFR 1312.11).

  • Wrong Section 232 number

    A missing or wrong Chapter 99 number on a covered line gives the wrong duty. It leads to a correction, a duty bill or a penalty risk later.

  • Tableting and encapsulating machines

    These machines need DEA data in the entry. Since May 4, 2026, ACE rejects entries without it (DEA flag DE3).

  • Pharmacy parcels to U.S. patients

    From October 22, 2026, mail with FDA-regulated goods needs a formal entry or an entry type 13, with a customs bond. FDA decides each parcel under its personal importation policy. FDA can refuse a parcel and can destroy a refused drug valued at $2,500 or less.

  • Controlled drugs in the mail

    A foreign pharmacy cannot mail a controlled drug to a U.S. patient. Each import needs a DEA-registered importer and a DEA permit or declaration (21 U.S.C. 952 and 957). The personal exemption covers only a traveler who carries the drug (21 CFR 1301.26).

What to do when FDA holds a shipment

Process

How do we clear it?

We file the CBP entry and the FDA and DEA data together, so every agency sees one consistent record.
  1. YouBefore shipping

    Send the product details

    Send the invoice, the product list with NDCs, and the manufacturer and registration details. Tell us if a product is controlled or patented.

  2. Allied

    Check classification and duty

    We classify each line and pick the Section 232 and other Chapter 99 numbers. We check the site registration and the drug listing in FDA's public data.

  3. AlliedBefore arrival

    File the entry with FDA and DEA data

    We file the entry in ACE with the FDA product code, registration number, NDC and application number. For controlled substances we add the DEA data.

  4. AlliedOn arrival

    Follow the FDA review

    FDA screens each line. Most lines get a May Proceed. If FDA holds or samples a line, we tell you what FDA needs.

  5. You

    Send records on request

    If FDA or DEA asks for records, send them to us. We submit them and follow the line until release.

  6. AlliedAfter release

    Entry summary and duty

    We file the entry summary and pay the duty by ACH. We track liquidation and file corrections or protests when needed.

Request: Pharmaceutical import clearance

Quote on request

Do not send an EIN, a Social Security number or a password in this form. We ask for them securely later.

Or call (908) 291-8001 or email info@alliedchb.com.

Questions

Importing pharmaceuticals: common questions

Do I need FDA approval to import a drug for sale?

In most cases, yes. A prescription drug needs an approved NDA, ANDA or BLA. A nonprescription drug must meet an OTC monograph or have its own approval. The foreign site must also be registered, and the drug must be listed with FDA.

Can I import medicine for my own use?

FDA can allow a personal import under its personal importation policy. This is enforcement discretion, not a right. For an unapproved drug, FDA looks for a serious condition with no treatment available in the United States. There must be no promotion to U.S. residents, and generally not more than a 3-month supply. You must affirm in writing that the drug is for your own use. The policy does not cover goods for sale.

What is the Section 232 duty on pharmaceuticals?

It is a duty on patented drugs and their ingredients under Proclamation 11020. The combined rate is 100 percent for most countries and 15 percent for the EU, Japan, South Korea and Switzerland. The United Kingdom rate is 0 percent. Generic drugs are 0 percent. Annex III companies pay since July 31, 2026, and all other companies since September 29, 2026.

Do patented drugs from Canada pay the Section 232 duty?

Yes. Since September 29, 2026, a patented drug that is a product of Canada pays 100 percent (9903.04.60). Canada has no reduced rate, and USMCA does not remove the duty. Canada is not on the list for the 0 percent specific end use line (9903.04.66). Generic drugs pay 0 percent (9903.04.67).

Can a foreign pharmacy ship prescriptions to U.S. patients?

FDA states that personal imports of drugs are illegal in most circumstances, because foreign drugs are often not FDA-approved. From October 22, 2026, each parcel with drugs needs a formal entry or an entry type 13, a customs bond, and the owner, the purchaser or a licensed customs broker as filer. FDA decides each parcel under its personal importation policy: generally not more than a 3-month supply, for the patient's own use, and no commercialization or promotion to U.S. residents. FDA can refuse a parcel and can destroy a refused drug valued at $2,500 or less. Controlled drugs cannot be mailed. Section 804 importation programs need a State or Indian Tribe sponsor and FDA authorization (21 CFR part 251), so a pharmacy cannot use Section 804 on its own. Read our guide to pharmacy mail to U.S. patients.

Who can be the importer of record for a pharmacy parcel?

The owner or purchaser of the goods, or a licensed customs broker that the owner, purchaser or consignee designates (19 U.S.C. 1484(a)(2)(B)). So it matters who owns the drugs at import: the patient or the pharmacy. The importer of record is responsible for the duty and for accurate entry data.

Do drugs pay the Section 301 forced labor duty?

No. Drugs in headings 3002 to 3004 and many listed ingredients are exempt (9903.05.86). Other chemicals are exempt only if they are for pharmaceutical use and are listed in U.S. note 52(e) to Chapter 99 (9903.05.89).

How early must I file a DEA import declaration?

File DEA Form 236 at least 15 calendar days before the expected release date (21 CFR 1312.18). The declaration is valid only after DEA issues a transaction number. It becomes void 180 days after it is filed, and each shipment needs its own declaration.

What happens if FDA refuses my shipment?

FDA sends a notice and gives you a chance to present evidence (21 CFR 1.94). If the refusal stands, you must export or destroy the goods under CBP supervision, generally within 90 days. FDA can destroy a refused drug valued at $2,500 or less.

Do you clear active pharmaceutical ingredients?

Yes. APIs follow the same registration and listing rules. Many enter free under the Pharmaceutical Appendix to the HTS. Some need a Section 232 Chapter 99 number, and some from China pay Section 301 duties.

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Importing drugs or APIs? Send us the product list.

We check registration, listing, DEA needs and the Section 232 number before the goods ship. You get a written quote.

Call (908) 291-8001 or email info@alliedchb.com

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Last reviewed September 28, 2026. This page explains customs rules in general terms. It is not legal advice. Duty rates and CBP procedures change often, and we confirm the figures for your shipment in writing before you commit.

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