RC

Regional review

United States

Buyers in the United States operate under a federal framework in which the FDA governs drug substances and drug products, the DEA governs controlled substances, and the EPA and TSCA framework governs industrial chemicals. The controlling question for any enquiry is which of those frameworks the material and its intended use fall under, because the evidence expected differs sharply between a research reagent, an industrial chemical, and a drug substance.

Sourcing considerations

Buyers commonly ask whether a drug substance is covered by a Drug Master File and whether the manufacturing site is registered and subject to inspection. For research-only material, purchasing organisations usually require written confirmation that the material is not intended for human or veterinary use and that the buyer is an institution capable of handling it.

Documentation requirements

Expect requests for a specification, a batch Certificate of Analysis with methods and acceptance criteria, a Safety Data Sheet in the 16-section GHS format used by OSHA HazCom, and a statement of the legal entity responsible for the material. Where a drug substance is involved, buyers may ask about DMF reference and site registration status.

Import considerations

Imports are screened by Customs and Border Protection with FDA import review for regulated articles, which can result in detention or refusal when labelling, intended use, or entity registration is inconsistent with the declared classification. Consistency between the invoice, the SDS, and the declared intended use matters more than any single document.

Shipping and transport

Domestic and inbound carriers apply IATA and DOT hazardous-material rules; temperature-sensitive material requires an agreed cold-chain method and a documented excursion tolerance before dispatch.

Questions buyers should ask

  • Which US framework applies to this material and use?
  • Is the material declared for research use only?
  • What analytical methods produced the COA results?
  • Which legal entity is named on the documentation?
  • Who is the importer of record?