How to Obtain an FDA License to Sell Prescription Medicines

The U.S. Food and Drug Administration (FDA) administers product and manufacturing set-up licensing in the United States for a variety of products. The Center for Drug Evaluation and Research (CDER) is the division of FDA responsible for the evaluation and approval of new brand-name and generic prescription drugs. It is also responsible for licensing over-the-counter medications to protect consumers. You must take several steps to apply for a license to start selling a prescription drug in the U.S. or to get an export license to sell a product manufactured in the U.S. overseas.

Things You'll Need

• Appropriate FDA form for the type of submission to be made
• Supporting documentation for the license, including:
• A sample of the proposed label
• Chemistry, manufacturing and controls information
• A completed FDA methods validation package
• Clinical data to support the license application (optional)
• Statistical data to support the license application
• Case report forms
• Case report tabulations
• Photocopies of patent information on any patents associated with the drug
• Prescription Drug User Fee Act (PDUFA) Fee Cover Sheet
• Prescription Drug User Fee

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Instructions

• 1

  Go to the FDA website (see Resources). Download all of the relevant forms at the FDA website to apply for a Drug License for Human Use.

• 2

  Fill out all relevant sections of the form completely. Pay particular attention to the contact information section, putting in the name and phone number of anyone who will be able to answer detailed questions about the product prior to a license being awarded.

• 3

  Begin to assemble the supporting documentation in the order stated on the form, starting with the sample label, then the chemistry, manufacturing and controls information.

• 4

  Complete the FDA's methods validation package as thoroughly as possible.

• 5

  Review the clinical data and statistics and be sure there are no errors. Add to the application documentation.

• 6

  Organize all the case report forms. Include them in the case report tabulations. Add these to the application.

• 7

  Provide photocopies of any patents held with respect to the drug.

• 8

  Fill out the user fee cover sheet. Send a check or banker's draft for the application fee, which, as of 2011, is $1,405,500 if the application contains clinical data to be assessed, and $702,750 if no clinical data needs to be assessed.

• 9

  Create a summary of all the documents you have included, in the order in which you have included them, using the list of necessary items provided on your application form. Create an index of each submission.

• 10

  Photocopy the full submission package and application form. Keep them in a safe place for future reference. Submit the application to the FDA according to the instructions.