Key Elements of the Registration Process

The registration process includes:

• Submission of Completed Applications to SMA, FDA, and DEA
   
  • Contact the SMA for an application form and instructions and for information about applicable state regulations.
     
  • Contact FDA's Division of Scientific Investigations, Regulatory Management Branch, at 7520 Standish Place, Room 115, Rockville, MD 20855, Telephone number (301) 594-1029, for an application package for an NTP.
     
  • Contact the local DEA diversion field office to obtain the DEA application. (A copy of the DEA Form-363, "Application for Registration," is found in Appendix B. See Appendix D for a list of local DEA diversion field offices.)
     
• Review of Applications by the SMA, FDA, and DEA
   
• Pre-Registration Review and/or Inspection Conducted by the SMA, FDA, and DEA

The SMA, FDA, and DEA each conduct a separate pre-registration review and/or inspection. The personnel conducting the inspections review relevant requirements with the applicant.

• Approval

DEA may approve an application if the NTP has met all CSA recordkeeping and security requirements. However, a certificate of registration will not be issued until the SMA and FDA have licensed the applicant.

Registration Support  
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