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Exporting Control Drugs and List Chemicals
This is a brief summary of the process to Export Control Drugs from the U.S. The Importing party first requests an Import Certificate in English from their local governing body equivalent to the U.S. DEA. The Import Certificate contains the full and legal name and address of the Importer, full and legal name and address of Quantum:
Quantum Pharmaceutical Supply & Services, LLC
745 Atlanta Rd, Ste 111
Cumming, GA 30040
If required, each product name and description along with the quantity to import is listed. In some cases, products are calculated in the Gram quantity of the product base using a conversion factor. For example, Fentanyl Citrate injection would be calculated to the actual amount of Fentanyl base is being requested. Each country has a yearly quota per product based on INCB estimates (see INCB.org: Status of Estimates). If at any time assistance is needed with item descriptions and base calculations, please feel free to contact me. Please also check in advance to confirm that the particular drug requested is registered on our Export License.
After the Import Certificate is received and forwarded to us either by hard copy or scanned and e-mailed. The Certificates are submitted to the DEA Import/Export Unit and require a minimum of a 15 day approval and authorization period. Once Quantum receives the approval the product can be shipped as specified.
Please note that products in the U.S. may differ in presentation than elsewhere. At times the Import Certificate may require clarification and/or revision if there are significant differences. A few examples include when a product is available in multiple forms – tablets vs. capsules, ampules vs. vials, etc. It is best to inquiry with us before submitting the Import Certificate request. The U.S. DEA is requiring the Import Certificate to match as closely as possible to the products being shipped.
There are many more details involved and this is only a brief summary. Please reach out to me with any additional inquiries.
Andy Jaskowiak, M.S., RPh