21 CFR 1301.13 - Application for registration; time for application; expiration date; registration for independent activities; application forms, fees, contents and signature; coincident activities.
|Business activity||Controlled substances||DEA Application forms||Application fee($)||Registration period(years)||Coincident activities allowed|
|(i) Manufacturing||Schedules I-V||New-225 Renewal-225a||$3,047||1||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.|
|(ii) Distributing||Schedules I-V||New-225 Renewal-225a||1,523||1|
|(iii) Reverse distributing||Schedules I-V||New-225 Renewal-225a||1,523||1|
|(iv) Dispensing or instructing (includes Practitioner, Hospital/Clinic, Retail Pharmacy, Central fill pharmacy, Teaching Institution)||Schedules II-V||New-224 Renewal-224a||731||3||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.|
|(v) Research||Schedule I||New-225 Renewal-225a||244||1||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.|
|(vi) Research||Schedules II-V||New-225 Renewal-225a||244||1||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.|
|(vii) Narcotic Treatment Program (including compounder)||Narcotic Drugs in Schedules II-V||New-363 Renewal-363a||244||1|
|(viii) Importing||Schedules I-V||New-225 Renewal-225a||1,523||1||May distribute that substance or class for which registration was issued; may not distribute any substance or class for which not registered.|
|(ix) Exporting||Schedules I-V||New-225 Renewal-225a||1,523||1|
|(x) Chemical Analysis||Schedules I-V||New-225 Renewal-225a||244||1||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.|
Title 21 published on 2014-04-01.
The following are only the Rules published in the Federal Register after the published date of Title 21.
For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.
Title 21 published on 2014-04-01
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 1301 after this date.