Federal Tobacco Licensing

If your pharmacy exports drugs and biologics to foreign countries, you may be required to obtain an exporters license or certificate issued by the Food and Drug Administration (FDA), the Department of Commerce Bureau of Industry and Security (BIS), and/or the Drug Enforcement Agency (DEA).

Pursuant to FDA regulation, pharmacies are not required to obtain export certificates. However, many foreign governments do require verification of FDA approval from pharmaceutical exporters as an assurance that products being brought and sold in their countries are suitable to be marketed within the U.S. Thus, it is important that pharmaceutical exporters consult with the importing country to determine exactly what type of information is required. If the host country does require such verification, the FDA is legally mandated, upon official request, to issue an export certificate containing vital information about a product’s regulatory or marketing status within the United States.

To apply, pharmacy administrators must consult and complete form FDA 3613b. Exporters must keep in mind that each drug requires a separate application. However, if one drug is being exported to multiple countries, only one application must be used, with separate certificates to be issued for each distinct importing country. Fees include $175 per each certificate, with a reduced fee for each subsequent certificate for the same country in the same application. Certificates will expire 24 months from the date of notification, and thereupon require submission of a new application upon expiration.

According to the Department of Commerce Bureau of Industry and Security (BIS), only those pharmaceutical products classified with an ECCN require an export license. These products include but are not limited to: vaccines, immune-toxins, medical products, diagnostic and food testing kits as specifically listed in the Commerce Control List. To apply, pharmacies should consult form BIS-748P which may also be used to request classification of items/materials to be exported, or to request an advisory opinion as to whether a license is required for a particular item/ material for a given end-user and/ or destination. An export license issued by the BIS is valid for four years from the date issued.

Furthermore, under the DEA, a yearly exporter registration is required for all controlled substances. Pharmacies intending to export controlled substances must consult DEA Form 225 which, upon submission, involves a 4-6 week processing time and requires annual renewal and fees that range in excess of $1500.

CT Corporation will research complex license requirements, file and manage all pharmacy licenses. To get a free quote today, please contact CT Corporation to consult a licensing specialist.

If your company intends to store exported tobacco products within the United States, you may be required to obtain a federal permit. The Tobacco Export Warehouse Proprietor permit is required for all businesses that intend to warehouse tobacco products for export without payment of tax, or with drawback of tax. The license is issued through the Alcohol and Tobacco Tax and Trade Bureau (TTB). In order to apply for the permit, you must complete a detailed application, a personnel questionnaire for each officer, director, or stockholder of more than 10 percent, and obtain a surety bond.

U.S. Customs Service does not generally require an import/export license to trade goods internationally. However, specific products, such as plants, are listed as restricted items for purposes of international export. Therefore, obtaining an import/export license from the relevant government agency is essential for maintaining legal compliance only if you intend to export tobacco as a raw material.

It is recommended that tobacco exporters pre-emptively contact the embassy or consulate in the host country with which you intend to trade in order to understand the requisites of the receiving country. Many foreign governments do require verification of U.S. licensing as an assurance that products being brought and sold in their countries are suitable to be marketed within the U.S. and that the companies with whom they are doing business are legitimate. Thus, it is important that tobacco exporters consult with the importing country to determine exactly what type of information is required.

CT Corporation can help you obtain all necessary permits to ensure that your company is in compliance with federal, state, and local licensing laws. Our skilled account managers will identify any supplemental information needed, collecting and completing all paperwork and applications, and monitoring the process to ensure swift approval so that you can focus on growing your business. To get a free quote today, please contact CT Corporation to consult a licensing specialist.

If your company intends to import tobacco products within the United States, you may be required to obtain a federal permit through the Alcohol and Tobacco Tax and Trade Bureau (TTB) before engaging in such business. Additional wholesale or retail tobacco licenses may be required by state and local authorities depending on where the tobacco will be sold. Federal law requires all businesses that import tobacco products that are not for personal use or consumption to obtain an Importer of Tobacco Products permit. In order to apply for a permit, you must complete a detailed application, a personnel questionnaire for each officer, director, or stockholder of more than 10 percent, show proof of source of funds for the business, provide a copy of contact or letter of intent from foreign supplier, and obtain a surety bond. Failure to secure and maintain proper licensing could potentially incur civil fines, or the imposition of criminal penalties.

CT Corporation can help you obtain all necessary permits to ensure that your company is in compliance with federal, state, and local licensing laws. Our skilled account managers will identify any supplemental information needed, collecting and completing all paperwork and applications, and monitoring the process to ensure swift approval so that you can focus on growing your business. To get a free quote today, please contact CT Corporation to consult a licensing specialist.

If your company intends to manufacture tobacco products within the United States, you may be required to obtain a federal permit from the Alcohol and Tobacco Tax and Trade Bureau (TTB). Additional manufacturer or distributor of tobacco products licenses may be required by state and local authorities depending on where the tobacco will be sold. Federal law requires that all businesses who intend to manufacture tobacco products obtain a permit from TTB. To apply for a permit to manufacture tobacco products, you must complete a detailed application, a personnel questionnaire for each officer, director, or stockholder of more than 10 percent, provide a diagram of factory premises, and obtain a surety bond. Failure to secure and maintain proper licensing could potentially incur civil fines, or the imposition of criminal penalties.

CT Corporation can help you obtain all necessary permits to ensure that your company is in compliance with federal, state, and local licensing laws. Our skilled account managers will identify any supplemental information needed, collecting and completing all paperwork and applications, and monitoring the process to ensure swift approval so that you can focus on growing your business. To get a free quote today, please contact CT Corporation to consult a licensing specialist.