HS Code for Active Pharmaceutical Ingredient: Chapter 29 vs Chapter 30

The pharmaceutical supply chain has been one of the most disrupted by 2025 to 2026 trade policy. China supplies an estimated 70 to 80 percent of US API requirements across many high-volume generic categories. The Section 301 plus Section 122 stack at roughly 47 percent on Chinese APIs in 2026 has materially raised generic drug landed costs. The threatened 245 percent rate (not implemented as of June 2026 but periodically signaled) would render direct Chinese imports economically impossible.

This guide covers the chapter 29 vs chapter 30 classification, the worked tariff math by origin, the Indian and European alternatives that have absorbed substitution volume, and the documentation pharmaceutical importers need.

Chapter 29 vs chapter 30

Chapter 29 covers organic chemicals. Pharmaceutical APIs in their bulk drug substance form (active ingredient as a pure or near-pure chemical compound, in powder, crystalline, or solution form) classify into chapter 29 at the specific compound subheading.

Chapter 30 covers pharmaceutical products including:

• 3001: glands and other organs for organo-therapeutic uses.
• 3002: vaccines, blood derivatives, immunological products.
• 3003: medicaments with two or more constituents mixed (bulk).
• 3004: medicaments put up in measured doses or in retail packaging (tablets, capsules, injectables, retail packs).
• 3005: wadding, gauze, bandages, etc.
• 3006: pharmaceutical goods specified in note 4 to chapter 30.

The chapter 29 to chapter 30 transition happens at the compounding step that turns a bulk drug substance into a dosage form. Filling tablets into a bottle is HTS 3004. Synthesizing a tablet from bulk API is HTS 3004. Storing bulk API in drums is HTS 29xx.

Worked example: Chinese amoxicillin API

100,000 USD of HTS 2941.10 (penicillin in bulk) from a Chinese API producer.

Effective rate 134.0 percent. The AD layer is the binding cost on Chinese amoxicillin. Indian and European amoxicillin producers have absorbed essentially all the substituted volume since 2022.

Worked example: Indian metformin API

100,000 USD of HTS 2924.29 (other amides) including metformin from an Indian API producer.

Effective rate 25.9 percent. India is the largest non-Chinese API source globally. The 24 percent Section 122 layer is the biggest single cost.

Worked example: European API

100,000 USD of HTS 2918.29 (carboxylic acids, other) for an EU-sourced API.

Effective rate 11.1 percent. European APIs are the lowest-duty option for high-value low-volume specialty compounds. For high-volume generics, the European cost-of-production is too high for the price points; Indian or Chinese sources dominate despite the duty layers.

Worked example: Mexican-finished generic tablet

A Mexican pharmaceutical contract manufacturer imports Indian-sourced metformin API (HTS 2924.29), compounds into tablets, and ships finished HTS 3004.90 medicaments to the US.

Bottle of 100 metformin tablets, transaction value 28 USD per bottle.

USMCA RVC test: the Indian API value is non-originating. Assume API is 35 percent of finished product transaction value (typical for high-volume generics).

Non-originating: 9.80 USD (Indian API).

RVC (TV) = (28 minus 9.80) divided by 28 = 65 percent.

Qualifies under USMCA chapter 30 RVC rule (which requires 60 percent for most chapter 30 lines).

Effective rate 0.35 percent. Mexican-finished generic tablets are essentially duty-free. The Mexican contract manufacturing sector has expanded dramatically since 2022 to take advantage of this arithmetic for generics destined for US Medicare and Medicaid distribution.

Documentation pharma imports require

• Commercial invoice with HTS at 10-digit (US) or 8-digit (EU).
• Drug Master File (DMF) reference number (FDA-issued).
• Certificate of Analysis (CofA) from the producer for the specific batch.
• Certificate of GMP compliance.
• For chapter 30 finished products: NDC (National Drug Code) registration with FDA.
• For controlled substances (scheduled drugs): DEA Form 222 or equivalent.
• For biologics under chapter 30: BLA reference.
• USMCA certification if claiming preference.

CBP coordinates with FDA on most pharma imports. FDA Prior Notice is required at minimum 4 hours before arrival for ocean and 30 minutes before for air.

Run your pharma entry now

The LandedFees calculator handles chapter 29 and chapter 30 pharmaceutical imports with the active AD/CVD orders by specific compound, the Section 301 and Section 122 stack, the USMCA chapter 30 RVC test for Mexican-finished tablets, and the FDA Prior Notice timing flag.

Calculate a pharma entry

Section 122 status as of June 20 2026

The May 7 2026 Court of International Trade ruling in Oregon v. United States (consolidated with Burlap and Barrel v. United States) struck down the Section 122 proclamation. The Federal Circuit issued an administrative stay on May 12 2026, so CBP is still collecting the duty pending appeal. Importers paying now should preserve protest rights and refund claims in case the government loses on the merits. The underlying Section 122 authority sunsets July 24 2026 under the statutory 150-day ceiling, regardless of the appeal outcome, unless Congress extends or a fresh proclamation restarts the clock.

Citations

• USITC Harmonized Tariff Schedule chapter 29: https://hts.usitc.gov/?query=2924
• USITC Harmonized Tariff Schedule chapter 30: https://hts.usitc.gov/?query=3004
• Commerce ADCVD on Chinese amoxicillin (A-570-049): https://access.trade.gov
• USMCA chapter 30 rule of origin: USMCA Annex 4-B
• FDA Prior Notice requirement: https://www.fda.gov/food/importing-food-products-united-states/prior-notice-imported-foods
• USTR Section 301 List 1 pharma coverage: USTR