HS Code for Pharmaceutical Medicines
The HS Code for pharmaceutical medicines is 300490. The MFN duty rate for importing to the US is Free.
| HS Code (6-digit) | 300490 |
|---|---|
| US Duty Rate (MFN) | Free |
| EU Duty Rate (MFN) | 0% |
| Chapter | 30 |
| Heading | 3004 |
| Last Updated | 2026-05 |
Description
Other medicaments, put up in measured doses or for retail sale
HS Code 300490 covers other medicaments in measured doses or retail packages with a US MFN duty rate of Free.
Frequently Asked Questions
What additional costs, beyond the product price and standard duties, should I anticipate when importing pharmaceutical medicaments in measured doses (HTS 300490)?
Importers should budget for U.S. Food and Drug Administration (FDA) user fees, which are mandatory for each commercial import entry of human drugs. Additionally, goods under this HTS are often subject to FDA examination and possible laboratory analysis, which can incur detention and testing charges if the FDA requests samples.
What are the key regulatory compliance requirements for importing pharmaceutical medicines under HTS 300490 into the United States?
All shipments classified under HTS 300490 require prior approval from the U.S. Food and Drug Administration (FDA) and must be accompanied by a valid FDA Form 2877 for each entry. The importer of record must be registered with the FDA, and the foreign drug establishment where the product was manufactured must also be registered and listed. Strict labeling in English, demonstrating compliance with the Federal Food, Drug, and Cosmetic Act, is mandatory for retail sale.
What are the specific packaging and labeling requirements for shipping pharmaceutical medicines under HTS 300490 internationally?
Shipments under HTS 300490 must be in sealed retail or dose-ready packaging as per the tariff description. They require clear labeling with the drug name, dosage, batch number, and expiration date, and must be packed to prevent contamination and comply with the International Air Transport Association (IATA) Dangerous Goods Regulations if applicable.
Seasonal Import Patterns for Pharmaceutical Medicines
Imports under HTS 300490 (Medicines, Packed for Retail Sale) show a consistent, high-volume pattern year-round due to essential demand, but minor seasonal fluctuations are observable. Data often indicates a slight uptick in import declarations during the late third and fourth quarters (Q3/Q4) as suppliers build inventory for the Northern Hemisphere winter season and the annual flu season. Conversely, the first quarter may see a temporary dip following the holiday period, before activity stabilizes. This category is less subject to the dramatic peaks seen in consumer goods, with its trends primarily driven by healthcare system procurement cycles and anticipatory manufacturing for predictable seasonal illnesses.
Key Compliance Notes for Pharmaceutical Imports (3004.90)
Products classified under 3004.90 are subject to strict regulation by the U.S. Food and Drug Administration (FDA). An FDA entry number (e.g., for an approved NDA/ANDA or a Drug Listing Number) is typically required for customs clearance, and shipments may be held for examination. Ensure commercial invoices clearly state the product's proper name, dosage form, strength, and manufacturer details. Note that Section 321 de minimis entry for low-value shipments does not apply to FDA-regulated drugs, requiring full formal entry regardless of value.
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