Compounded Pharmaceutical Imports

Compounded pharmaceutical imports face regulatory complexity beyond standard pharma. Section 503A (traditional compounding) and 503B (outsourcing facilities) under FDA Drug Quality and Security Act. Most compounded drugs are domestically produced; imported compounding ingredients face standard pharma classification.

This guide covers U.S. import tariff and compliance for compounded pharmaceuticals.

For SMB importers in this category, the practical questions are HTS classification, applicable Section 232/301/122 stacks, FTA opportunities, and regulatory overlay (FDA/USDA/EPA/CPSC where relevant).

HTS classification basics

Compounded drugs typically under HTS 3003 or 3004. Compounding ingredients under HTS 2941 (APIs). Specific subheadings by chemistry.

Tariff stack and rates

Base 0% + Section 122 (15% on non-USMCA). Section 232 pharma effective July 31 affects branded patented; generics excluded.

Country of origin considerations

Most active ingredients from India, China, EU. Some Mexican USMCA opportunities.

Regulatory overlay

FDA 503A or 503B compliance. State board of pharmacy licensing. DEA for controlled substances.

Mitigation opportunities

USMCA qualification on Mexican production. Section 232 pharma generic exclusion.

Frequently asked questions

What is the typical effective duty rate?

Depends on origin and HTS classification. China-origin: 22-42% effective when Section 301 + Section 122 stack. USMCA-qualifying Mexican production: often 0-3%. Vietnam, India, Korea: 15-17% with Section 122.

Can I qualify under USMCA?

Possible if production occurs in U.S., Mexico, or Canada and meets rules of origin (typically 60% RVC under transaction value or 50% net cost). USMCA-qualifying goods are exempt from Section 122.

Are IEEPA refunds available?

Yes – for entries between April 5, 2025 and February 24, 2026 that paid IEEPA duty. Filed through CBP’s CAPE portal. We file claims on contingency for filings above $50k.

What about Section 232 exposure?

Specific to product type. Steel and aluminum derivatives expansion brought some downstream products into scope. Component-level analysis identifies actual coverage.

How do you help with this category?

Tariff exposure assessment ($2,500-$7,500), classification audit, USMCA qualification, refund recovery, audit response. Independent of any customs brokerage.