1. The regulatory position first
Most research peptides are not scheduled substances. "Not scheduled" is not the same as "unrestricted", and the enforcement risk in this trade sits in a specific place: the labelled end use of the material.
Importing research-grade peptide material for in-vitro laboratory use, with an RUO designation, from a licensed supplier, into a laboratory that documents its research purpose, is the pathway the industry works within. Importing the same material for human self-administration is a different activity with different legal exposure, and no commercial supplier should be facilitating it.
Our scope is research and in-vitro supply. We supply against a documented research or institutional application, and we are explicit about what the material is and is not for.
2. Your roles as importer
Two roles matter and they sit with you, not with us:
- Importer of record — the party that files the entry, pays duty and takes responsibility for the goods on entry. It must have a Customs bond in place.
- Possessor — whoever holds the material. In a university or hospital setting this is usually the institution, not the individual researcher.
Get these identified before the first shipment, not after the goods are on a plane. Most US consignments clear without difficulty when these two roles are documented and matched on the entry paperwork.
3. FDA prior notice
Under 21 CFR Part 127, an FDA prior notice must be filed for most shipments of food, drugs and biological products entering the United States. A prior notice is submitted by the manufacturer or shipper, carries the manufacturer identification details and the intended use, and is transmitted electronically to FDA's CFSAN system.
We include the data required for a prior-notice filing in our shipment documentation, and we will confirm the filing details with you or your freight forwarder before dispatch. Note that the filing is a regulatory transmission with a defined lead time — it cannot be done on the day the cargo is at the airport.
4. Customs classification and duty
Research peptides generally enter the United States under heading 2937 — polypeptide and protein hormones — with the specific subheading determined by the molecule. Classification affects the duty rate, so agree it with your broker before the commercial invoice is issued. Our HS code and import duty reference covers the equivalent Indian classification in detail, which is the same data your broker will use as a starting point.
Your invoice must carry the CAS number and a clear description of the material so the entry is not held for a query.
5. The documentation pack
For a US-bound research peptide consignment, we issue:
- Commercial invoice with CAS number and description
- Batch Certificate of Analysis with the HPLC chromatogram
- Mass spectrometry report
- MSDS
- Certificate of Origin
- Packing list and airway bill
- Declaration of conformity to your specification
We dispatch with the pack pre-reviewed by your broker wherever possible. That single step removes most of the clearance delay that US importers complain about.
6. State and institutional requirements
Federal rules are the floor. Your institution may impose its own: a biosafety committee registration, a chemical inventory entry, a controlled-substance determination for any analogue that falls within a scheduled definition, and an RUO acknowledgement signed by the receiving principal investigator.
For scheduled or partially scheduled analogues, the picture changes entirely and needs a US regulatory attorney, not a supplier. We will say so directly rather than quote on a shipment we cannot document.
7. Working with SPK Pharma
We ship to the United States with the documentation above and a full export pack. Tell us the SKU, quantity, grade and destination warehouse at RFQ stage, and we will confirm the prior-notice data, the classification and the incoterm in the quotation.
Related: export documentation · HS code and import duty · incoterms
B2B trade only — request a quote
All peptides are research-grade, for in-vitro use only, and supplied against a valid drug licence. Tell us your sequence, quantity and destination and the trade desk will respond within one business day.