21 CFR 1301.13 - Application for registration; time for application; expiration date; registration for independent activities; application forms, fees, contents and signature; coincident activities
Cite as | 21 CFR 1301.13 |
-
- This document is available in original version only for vLex customers
View this document and try vLex for 7 days - TRY VLEX
- This document is available in original version only for vLex customers
68 practice notes
-
Mark P. Koch, D.O.; Decision and Order
...engage in any activity for which registration is required until the application . . . is granted and a . . .registration is issued.'' 21 CFR 1301.13(a). Thus, in Wicks, the Agency held that notwithstanding its use of the words ``may apply to modify his/her registration,'' the regulation is ......
-
Top RX Pharmacy; Decision and Order
...Sec. 802(10). The Respondent's registration as a retail pharmacy authorizes the dispensing of controlled substances to ultimate users. 21 C.F.R. 1301.13(e). --------------------------------------------------------------------------- DEA has interpreted the ``legitimate medical purpose'' fea......
-
Disposal of Controlled Substances
...by their registration and in conformity with the CSA and its implementing regulations. 21 U.S.C. 822(b) and 958(g); See, e.g., 21 CFR 1301.13(e) and 1307.11. Manufacturers, distributors, importers, and practitioners are currently authorized to distribute their lawfully possessed controlled ......
-
Part II
...intend to dispense controlled substances by means of the Internet, you must first apply for registration as a pharmacy in accordance with 21 CFR 1301.13. Upon receipt of the Certificate of Registration as a pharmacy from Administrator, you may then apply for a modification to your registrat......
Request a trial to view additional results
6 cases
-
People v. Crouse, Court of Appeals No. 12CA2298
...for use ... under medical supervision." §§ 812(b)(1)(A)-(C). Physicians cannot prescribe marijuana as medicine under federal law, 21 C.F.R. § 1301.13 (2010). In other words, the CSA "designates marijuana as contraband for any purpose." Raich, 545 U.S. at 27, 125 S.Ct. 2195 (e......
-
U.S. v. Cannabis Cultivators Club, No. C 98-0085 CRB.
...conducted pursuant to a FDA approved protocol, and where the researcher has been registered with the DEA. See 21 U.S.C. § 823(f); 21 C.F.R. § 1301.13(e). 2. The Medical Necessity Defendants argue that even if the Controlled Substances Act prohibits their conduct, the injunction must neverth......
-
Beinor v. Indus. Claim Appeals Office of State , No. 10CA1685.
...for the prescription of controlled substances can only be obtained for Schedule II through V controlled substances. See [262 P.3d 974] 21 C.F.R. § 1301.13 (2010). Marijuana, in contrast, remains a Schedule I controlled substance under the applicable federal statute and consequently cannot b......
-
Green Collar Club v. State, No. 50437-5-II
...and a registration to prescribe controlled substances can be obtained only for substances on schedules II to IV. 21 C.F.R. § 1301.11 ; 21 C.F.R. § 1301.13. Pharmacies and pharmacists are required to distribute drugs approved by federal law for distribution by pharmacies, subject to narrow e......
Request a trial to view additional results
3 firm's commentaries
-
FDA Issues Draft Guidance on Cannabis Clinical Research and Sends CBD Enforcement Discretion Guidance to OMB for Review
...Schedule I material pursuant to a federal DEA Schedule I importer registration, and DEA has in the past issued such registrations. See 21 CFR 1301.13(e)(1)(viii). As FDA recognizes, primary authority for the regulation of controlled substances, including marijuana, lies with DEA. Therefore,......
-
FDA Issues Draft Guidance on Cannabis Clinical Research and Sends CBD Enforcement Discretion Guidance to OMB for Review
...Schedule I material pursuant to a federal DEA Schedule I importer registration, and DEA has in the past issued such registrations. See 21 CFR 1301.13(e)(1)(viii). As FDA recognizes, primary authority for the regulation of controlled substances, including marijuana, lies with DEA. Therefore,......
-
USDA Hemp Interim Rule: Crisis or Opportunity?
...is its requirement that Labs “must be registered by the DEA to conduct chemical analysis of controlled substances (in accordance with 21 CFR 1301.13).” The USDA’s basis for implementing this requirement is that Labs “could potentially handle cannabis that tests above the 0.3% concentration ......
58 provisions
-
Mark P. Koch, D.O.; Decision and Order
...engage in any activity for which registration is required until the application . . . is granted and a . . .registration is issued.'' 21 CFR 1301.13(a). Thus, in Wicks, the Agency held that notwithstanding its use of the words ``may apply to modify his/her registration,'' the regulation is ......
-
Top RX Pharmacy; Decision and Order
...Sec. 802(10). The Respondent's registration as a retail pharmacy authorizes the dispensing of controlled substances to ultimate users. 21 C.F.R. 1301.13(e). --------------------------------------------------------------------------- DEA has interpreted the ``legitimate medical purpose'' fea......
-
Disposal of Controlled Substances
...by their registration and in conformity with the CSA and its implementing regulations. 21 U.S.C. 822(b) and 958(g); See, e.g., 21 CFR 1301.13(e) and 1307.11. Manufacturers, distributors, importers, and practitioners are currently authorized to distribute their lawfully possessed controlled ......
-
Part II
...intend to dispense controlled substances by means of the Internet, you must first apply for registration as a pharmacy in accordance with 21 CFR 1301.13. Upon receipt of the Certificate of Registration as a pharmacy from Administrator, you may then apply for a modification to your registrat......
Request a trial to view additional results