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.
Agencies
Which agencies regulate pharmaceuticals?
- 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 sees in the entry
The entry carries the FDA product code, the country of production, the intended use code and importer contact data (21 CFR 1.72). For a human drug it adds the site registration number, the NDC and the NDA, ANDA or IND number (21 CFR 1.74). In the FDA message set, these are the REG, DLS, DA and IND codes. - 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?
| HTS | Goods | Base duty | Chapter 99 duties in effect (September 26, 2026) |
|---|---|---|---|
| 3004 | Finished drugs in measured doses or retail packs: tablets, capsules, injectables | Free | Section 232 on patented drugs (9903.04.60 to 9903.04.69, see below). Exempt from the forced labor duty. Not on the Section 301 China lists. |
| 3003 | Drugs not in measured doses or retail packs | Free | Same as 3004. |
| 3002 | Vaccines, blood fractions, immunological products, cell therapy products | Free | Many 3002 lines are on the Section 232 list. Exempt from the forced labor duty. |
| 2936, 2937, 2939, 2941 | Vitamins, hormones, alkaloids and antibiotics in bulk | Mostly free | Most 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 29 | Other 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 from September 29, 2026.
- 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).
- 0 percent lines: generic drugs (9903.04.67), U.S.-origin products (9903.04.68) 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?
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, and whether the drug is patented or generic. 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?
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).
Process
How do we clear it?
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
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 from September 29, 2026.
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.
Importing drugs or APIs? Send us the product list.
Call (908) 291-8001 or email info@alliedchb.com
Last reviewed September 26, 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.