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HSChapter 30
Penicillin-based medicaments — including ampicillin, amoxicillin, and other beta-lactam derivatives — are bulk pharmaceutical preparations not put up in measured doses for retail sale, used primarily as active pharmaceutical ingredients (APIs) or intermediate formulations in drug manufacturing. Austria and Italy are the leading US source countries, with China and India also significant suppliers — a supply chain that reflects both European finished-drug manufacturing and Asian API production. FDA's Center for Drug Evaluation and Research (CDER) governs admissibility, and all foreign manufacturing facilities must be registered with FDA and subject to inspection. Importers should note that penicillin-class APIs from certain origins have historically attracted FDA import alerts for cGMP non-compliance.
AI-written summary of the official U.S. Census Bureau trade figures on this page — verify before relying on it.
An FDA import alert authorizes FDA field offices to detain shipments from a specific manufacturer or country without physical examination, based on prior evidence of cGMP violations or adulteration. Penicillin API suppliers — particularly from Asian sources — have periodically appeared on import alerts. Importers should check FDA's import alert database before placing orders and request current cGMP compliance documentation from suppliers.
FDA distinguishes between APIs, intermediates, and finished drug products for regulatory purposes, but all require the foreign manufacturer to be registered with FDA under the Drug Supply Chain Security Act (DSCSA) framework. Partially formulated penicillin preparations may still require a drug master file (DMF) reference and cGMP compliance documentation. Customs classification and FDA regulatory status should both be confirmed before importation.
Monthly import values over time
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| Country | Imports | Exports | Balance |
|---|---|---|---|
| DOMINICAN REPUBLIC | -- | $47K | +$47K |
| HONG KONG | -- | $14K | +$14K |
| HAITI | -- | $12K | +$12K |
| MICRONESIA | -- | -- | -- |
| AUSTRIA | -- | -- | -- |
HS10 import codes under this HS6 parent. Source: U.S. Harmonized Tariff Schedule.
| Code | Description | Import Value | Effective Tariff % |
|---|---|---|---|
| 3003100000 | MEDICAMENTS CONT PENICILLINS OR DERIVATIVES ETC | $0 | -- |
MEDICAMENTS CONT PENICILLINS OR DERIVATIVES ETC
HS10 export codes under this HS6 parent. Source: U.S. Schedule B export classification.
| Code | Description | Export Value |
|---|---|---|
| 3003100000 | MEDICAMENTS CONT PENICILLINS OR DERIVATIVES ETC | $72K |
MEDICAMENTS CONT PENICILLINS OR DERIVATIVES ETC
79.3K kg
MEDICAMENTS NESOI, MEASURED DOSES, RETAIL PK NESOI
HS 300490
IMMUNOLOGICAL PRODUCTS, IN MEASURED DOESE/RTL SALE
HS 300215
VACCINES FOR HUMAN MEDICINE
HS 300241
HORMONES ETC. (NO ANTIBIOTICS CONTAINED) DOSAGE FM
HS 300439
ANTISERA AND OTHER BLOOD FRACTIONS
HS 300212
IMMUNOLOGICAL PRODUCTS, MIXED, NOT IN MSRED DOSES
HS 300214
| State | Imports | Exports | Balance |
|---|---|---|---|
| Texas | -- | $47K | +$47K |
| Massachusetts | -- | $14K | +$14K |
| Kentucky | -- | $12K | +$12K |
| Port | Imports | Exports | Balance |
|---|---|---|---|
| HOUSTON, TX | -- | $47K | +$47K |
| LOGAN AIRPORT, MA | -- | $14K | +$14K |
| MIAMI INTERNATIONAL AIRPORT, FL | -- | $12K | +$12K |