HTS US: 3013.XX.XXXX
Description
This heading covers medicaments that consist of two or more constituents which have been mixed together. These products may be formulated for therapeutic or prophylactic purposes and generally include preparations in the form of powders, granules, tablets, capsules, ointments, gels, or other pharmaceutical forms containing multiple active or inactive ingredients blended into a single product.
These medicaments are distinguished from single-ingredient products and may include antibiotics combined with other agents, multi-vitamin preparations, or combination drugs intended for specific treatments.
Code Hierarchy
- Section VI: Products of the Chemical or Allied Industries (Chapters 28-38)
- Chapter 30: Pharmaceutical Products
- Heading 3013: Medicaments consisting of two or more constituents mixed together (including those consisting of two or more preparations).
- US HTS Code (10-digit):
3013.XX.XXXX– The last digits specify the exact formulation, presentation, or packaging.
Detailed Breakdown of Subheadings
According to the Harmonized Tariff Schedule and the Harmonized System nomenclature, the 4-digit heading 3013 encompasses various specific medicament forms distinguished at the 6-digit and 10-digit levels. These subheadings classify the medicaments based on their composition, pharmaceutical form, and intended use.
| HS/HTS Code | Description | Examples & Notes |
|---|---|---|
| 3013.10 | Medicaments containing penicillins or derivatives thereof with a beta-lactamase inhibitor | Combination antibiotic products designed to combat beta-lactamase producing bacteria. |
3013.10.0000 |
Penicillin-based combination medicaments | |
| 3013.20 | Medicaments containing other antibiotics | Preparations combining antibiotics other than penicillins, e.g., tetracycline-based combinations. |
3013.20.0000 |
Other antibiotic combination medicaments | |
| 3013.31 | Medicaments containing hormones or other products of heading 2937 or 2938 | Combination products with hormones or hormone derivatives, such as contraceptive pills with multiple hormones. |
3013.31.0000 |
Hormonal combination medicaments | |
| 3013.32 | Medicaments containing alkaloids or derivatives thereof | Preparations combining alkaloids like morphine with other constituents. |
3013.32.0000 |
Alkaloid-based combination medicaments | |
| 3013.39 | Other medicaments consisting of two or more constituents mixed together | Various other multi-constituent medicaments not classified elsewhere. |
3013.39.1000 |
Multi-ingredient vitamin and mineral preparations | |
3013.39.9000 |
Other mixed medicaments |
What is NOT Classified Here?
Important exclusions to avoid misclassification include:
- Single-ingredient medicaments: Products containing only one active ingredient fall under other headings, such as 3004 or 3003.
- Medicaments in bulk without mixing: Separate active ingredients shipped without being combined are classified individually.
- Medicaments consisting of goods of heading 3002 or 3005: These are classified in their respective headings.
- Non-medicinal products: Cosmetics, toiletries, and similar preparations are classified under Chapter 33.
Notes
- Regulatory Requirements: Importation of medicaments under HTS 3013 is subject to strict regulation by the U.S. Food and Drug Administration (FDA). Prior approval, labeling compliance, and documentation may be required.
- Duty Rates: Duty rates vary depending on the specific 10-digit subheading. Many combination medicaments benefit from low or zero tariffs under trade agreements.
- Packaging and Presentation: The classification can depend on the form (e.g., tablets, capsules, powders) and packaging (e.g., blister packs, bottles).
Declaration Example
Product: A shipment of combined antibiotic tablets containing penicillin and a beta-lactamase inhibitor.US HTS Code:
3013.10.0000(Medicaments containing penicillins or derivatives with beta-lactamase inhibitor)Unit of Quantity: Kilogram (kg)
General Duty Rate: Check current USHTS (Often duty-free or low tariff under trade agreements)
Additional Requirements: FDA approval and import documentation required.
Related HTS Codes
- HTS 3004: Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, not in heading 3013.
- HTS 3003: Medicaments consisting of two or more constituents but not mixed together (e.g., kits).
- HTS 3304: Beauty or make-up preparations and preparations for the care of the skin.
- HTS 2937 & 2938: Hormones, derivatives, and antibiotic substances relevant for classification of constituent ingredients.
