Durbin

Durbin USA

Regulatory Affairs and Licenses

Regulatory Affairs and Licenses

Regulatory Affairs

Compliance is the best medicine.

It takes great diligence and dedication to ensure compliance with the widely varying laws and regulations concerning global distribution of named patient medicines. It is absolutely critical. Business depends on it. Lives depend on it.

Durbin USA's account application and qualification process ensures that importing facilities meet strict regulatory, legal and ethical standards. Additionally, our controlled export ensures that products are properly tracked and traced throughout the entire supply chain, in accordance with the guidelines of the DSCSA (Drug Supply Chain Security Act).

We work directly with the manufacturer to obtain documentation required by local authorities of the importing country, for example:

  • Product prescribing information.
  • Material Safety Data Sheets (MSDS).
  • Product stability data.
  • Certificates of Analysis (COA) or Certificates of Compliance (COC).
  • Technical inquiry data.
  • Product quality data.
  • Country-specific documentation, such as UK-required TSE statement

    (Transmissible Spongiform Encephalopathy).

Licenses

  • Mississippi Board of Pharmacy Wholesale of Human Prescriptions and/or Devices.
  • Mississippi Board of Pharmacy Wholesale of Controlled Substances.
  • US Drug Enforcement Administration (DEA) Registered Exporter, Controlled Substances Schedule 2, 2N, 3, 3N, 4, and 5.
  • US Drug Enforcement Administration (DEA) Registered Importer, Controlled Substances Schedule 3, 3N, 4 and 5.
  • US Drug Enforcement Administration (DEA) Registered Chemical Exporter, List 1 Chemicals.    

Certifications

Hazardous Materials (IATA, 49CFR)