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 |
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69 practice notes
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Revision of Import and Export Requirements for Controlled Substances, Listed Chemicals, and Tableting and Encapsulating Machines, Including Changes To Implement the International Trade Data System; Revision of Reporting Requirements for Domestic Transactions in Listed Chemicals and Tableting and Encapsulating Machines; and Technical Amendments
...importing or exporting activities as a coincident activity of their research or chemical analysis registration in accordance with 21 CFR 1301.13(e). --------------------------------------------------------------------------- In contrast, a ``regulated person'' means ``a person who manufactu......
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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......
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Moore Clinical Trials, L.L.C.; Decision and Order
...handling of controlled substances without a registration is a violation of DEA statutory and regulatory provisions.'' Id. at 29 (citing 21 CFR 1301.13(a)). The ALJ also found that ``the documents kept by Dr. Nichol,'' who was supervising the two clinical trials on behalf of Respondent, ``we......
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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 ......
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6 cases
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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......
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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 (emphasis in orig......
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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......
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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......
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3 firm's commentaries
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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,......
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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 ......
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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,......
1 provisions
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Act 220, SB 852 – Agriculture: industrial hemp; regulations for growing industrial hemp; create. Creates new act
...means a laboratory approved by this state and registered with the DEA to conduct chemical analysis of controlled substances pursuant to 21 CFR 1301.13 and that meets the requirements under section (z) "THC" means tetrahydrocannabinol. (aa) "Total delta-9-THC" means the total available tetra......