§885. Burden of proof; liabilities — Inbound Citations

Code of Federal Regulations Citations

Cited by 3 regulations in the Code of Federal Regulations.

• 21 C.F.R. § 1300.01(b)(2)(iii) — Definitions relating to controlled substances.

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  (iii) In accordance with 21 U.S.C. 885(a), any person claiming the benefit of an exemption or exception under paragraph (2)(ii) of this definition shall bear the burden of going forward with the evidence with respect to such exemption or exception.

  Automated dispensing system means a mechanical system that performs operations or activities, other than compounding or administration, relative to the storage, packaging, counting, labeling, and dispensing of medications, and which collects, controls, and maintains all transaction information.

  Basic class means, as to controlled substances listed in Schedules I and II:

• 21 C.F.R. § 1301.24(c) — Exemption of law enforcement officials.

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  (c) In order to enable law enforcement agency laboratories, including laboratories of the Administration, to obtain and transfer controlled substances for use as standards in chemical analysis, such laboratories shall obtain annually a registration to conduct chemical analysis. Such laboratories shall be exempted from payment of a fee for registration. Laboratory personnel, when acting in the scope of their official duties, are deemed to be officials exempted by this section and within the activity described in section 515(d) of the Act (21 U.S.C. 885(d)). For purposes of this paragraph, laboratory activities shall not include field or other preliminary chemical tests by officials exempted by this section.

• 21 C.F.R. § 1308.35(c) — Exemption of certain cannabis plant material, and products made therefrom, that contain tetrahydrocannabinols.

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  (c) In any proceeding arising under the Act or this chapter, the burden of going forward with the evidence that a material, compound, mixture, or preparation containing THC is exempt from control pursuant to this section shall be upon the person claiming such exemption, as set forth in section 515(a)(1) of the Act (21 U.S.C. 885(a)(1)). In order to meet this burden with respect to a product or plant material that has not been expressly exempted from control by the Administrator pursuant to § 1308.23, the person claiming the exemption must present rigorous scientific evidence, including well-documented scientific studies by experts trained and qualified to evaluate the effects of drugs on humans.

Citations to §885(a)

• 21 U.S.C. § 802(41)(C)(iii)

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  (iii) In accordance with section 885(a) of this title, any person claiming the benefit of an exemption or exception under clause (ii) shall bear the burden of going forward with the evidence with respect to such exemption or exception.