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Drug Registration > Registration Categories and Fees

Registration Categories and Fees



Registration Requirements for Controlled Substance Handlers, Under Title 21, Code of Federal Regulations, Section 1301.13(e) (1)

IMPORTANT ISSUE: NEW FEE SCHEDULE AS NOVEMBER 1, 2006

 
Business Activity Controlled Substances DEA Application Forms Application Fee Registration Period Coincident Activities Allowed
Manufacturing Schedules I thru V New - 225
Renewal - 225a
$2,293 1 Year Schedule I through V: May distribute that substance or class for which registration was issued; may not distribute any substance or class for which not registered. Schedules II through V: May conduct chemical analysis and pre-clinical research (including quality control analysis) with those substances listed in schedules for which authorization as a manufacturer was issued.
 
Distributing Schedules I thru V New - 225
Renewal - 225a
$1,147 1 Year  
Dispensing or Instructing1

1- Includes Practitioner, Hospital/Clinic, Retail Pharmacy, Teaching Institution

Schedules II thru V New - 224
Renewal - 224a
$551 3 Years May conduct research and instructional activities with those substances for which registration was granted, except that a mid-level practitioner may conduct such research only to the extent expressly authorized under state statute. A pharmacist may manufacture an aqueous or oleaginous solution or solid dosage form containing a narcotic controlled substance in Schedule II through V in a proportion not exceeding 20 percent of the complete solution, compound or mixture.
 
Research Schedule I New - 225
Renewal - 225a
$184 1 Year A researcher may manufacture or import the basic class of substance or substances for which registration was issued, provided that such manufacture or import is set forth in the protocol required in Section 1301.18 and to distribute such class to persons registered or authorized to conduct research with such class of substance or registered or authorized to conduct chemical analysis with controlled substances.
 
Research Schedules II thru V New - 225
Renewal - 225a
$184 1 Year May conduct chemical analysis with controlled substances in those schedules for which registration was issued; manufacture such substances if and to the extent that such manufacture is set forth in a statement filed with the application for registration or re registration and provided that the manufacture is not for the purposes of dosage form development; import such substances for research purposes; distribute such substances to persons registered or authorized to conduct chemical analysis, instructional activities, or research with such substances, and to persons exempted from registration pursuant to Section 1301.24; and conduct instructional activities with controlled substances.
 
Narcotic Treatment Program (including compounder) Narcotic Drugs in Schedules II thru V New - 363
Renewal - 363a
$184 1 Year  
Importing Schedules I thru V New - 225
Renewal - 225a
$1,147 1 Year May distribute that substance or class for which registration was issued; may not distribute any substance or class for which not registered.
 
Exporting Schedules I thru V New - 225
Renewal - 225a
$1,147 1 Year  
Chemical Analysis Schedules I thru V New - 225
Renewal - 225a
$184 1 Year May manufacture and import controlled substances for analytical or instructional activities; may distribute such substances to persons registered or authorized to conduct chemical analysis, instructional activities, or research with such substances and to persons exempted from registration pursuant to Section 1301.24; may export such substances to persons in other countries performing chemical analysis or enforcing laws relating to controlled substances or drugs in those countries; and may conduct instructional activities with controlled substances.
 

 

 

 

 


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