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)

Select a Business Activity:

 

Business Activity Controlled Substances DEA Application Forms Application Fee Registration Period Coincident Activities Allowed
Manufacturing Schedules I thru V New - 225
Renewal - 225a
$3,047 1 Year Schedules I–V: May distribute that substance or class for which registration was issued; may not distribute or dispose of any substance or class for which not registered. Schedules II–V: Except a person registered to dispose of any controlled substance may conduct chemical analysis and preclinical research (including quality control analysis) with substances listed in those schedules for which authorization as a mfg. was issued.
Distributing Schedules I thru V New - 225
Renewal - 225a
$1,523 1 Year  
Reverse distributing Schedules I-V New--225,
Renewal--225a
$1,523 1 Year  
Dispensing or Instructing
- Includes Practitioner, Hospital/Clinic, Retail Pharmacy, Central fill pharmacy, Teaching Institution
Schedules II thru V New - 224
Renewal - 224a
$731 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–V in a proportion not exceeding 20% of the complete solution, compound or mixture. A retail pharmacy may perform central fill pharmacy activities.
Research Schedule I New - 225
Renewal - 225a
$244 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 § 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
$244 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 reregistration 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 § 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
$244 1 Year  
Importing Schedules I thru V New - 225
Renewal - 225a
$1,523 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
$1,523 1 Year  
Chemical Analysis Schedules I thru V New - 225
Renewal - 225a
$244 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 § 1301.24; may export such substances to persons in other countries performing chemical analysis or enforcing laws related to controlled substances or drugs in those countries; and may conduct instructional activities with controlled substances.

u:110106; 011912

DEA: Drug Enforcement Administration Home