[Federal Register Volume 84, Number 247 (Thursday, December 26, 2019)]
[Notices]
[Page 71001]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27783]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-559]


Bulk Manufacturer of Controlled Substances Application: Bulk 
Manufacturers of Marihuana: Royal Emerald Pharmaceuticals Research and 
Development

ACTION: Notice of application.

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SUMMARY: The Drug Enforcement Administration (DEA) is providing notice 
of an application it has received from an entity applying to be 
registered to manufacture in bulk basic classes of controlled 
substances listed in schedule I. Prior to making decisions on this and 
other pending applications, DEA intends to promulgate regulations that 
govern the program of growing marihuana for scientific and medical 
research under DEA registration.

DATES: Registered bulk manufacturers of the affected basic classes, and 
applicants therefore, may file written comments on or objections to the 
issuance of the proposed registration on or before February 24, 2020.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DPW 8701 
Morrissette Drive, Springfield, Virginia 22152. To ensure proper 
handling of comments, please reference Docket No. DEA-559 in all 
correspondence, including attachments.

SUPPLEMENTARY INFORMATION: The Controlled Substances Act (CSA) 
prohibits the cultivation and distribution of marihuana except by 
persons who are registered under the CSA to do so for lawful purposes. 
In accordance with the purposes specified in 21 CFR 1301.33(a), DEA is 
providing notice that the entity identified below has applied for 
registration as a bulk manufacturer of schedule I controlled 
substances. In response, registered bulk manufacturers of the affected 
basic classes, and applicants therefore, may file written comments on 
or objections of the requested registration, as provided in this 
notice. This notice does not constitute any evaluation or determination 
of the merits of the application submitted.
    The applicant plans to manufacture bulk active pharmaceutical 
ingredients (APIs) for product development and distribution to DEA 
registered researchers. If its application for registration is granted, 
the registrant would not be authorized to conduct other activity under 
this registration aside from those coincident activities specifically 
authorized by DEA regulations. DEA will evaluate the application for 
registration as a bulk manufacturer for compliance with all applicable 
laws, treaties, and regulations and to ensure adequate safeguards 
against diversion are in place.
    As this applicant has applied to become registered as a Bulk 
Manufacturer of Marihuana, the application will be evaluated under the 
criteria of 21 U.S.C. 823(a) as described in 84 FR 44920, published on 
August 27, 2019.
    In accordance with 21 CFR 1301.33(a), DEA is providing notice that 
on September 24, 2019, Royal Emerald Pharmaceuticals Research and 
Development, 7220 Trade Street, Suite 340, San Diego, California 92121-
2324 applied to be registered as a bulk manufacturer of the following 
basic classes of controlled substances:

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              Controlled  substance                Drug code   Schedule
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Marihuana Extract...............................        7350           1
Marihuana.......................................        7360           I
Tetrahydrocannabinols...........................        7370           I
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    The applicant noticed above applied to become registered with DEA 
to grow marihuana as a bulk manufacturer subsequent to a 2016 DEA 
policy statement that provided information on how it intended to expand 
the number of registrations, and described in general terms the way it 
would oversee those additional growers. Before DEA completes the 
evaluation and registration process for applicants to grow marihuana, 
DEA intends to propose regulations in the near future that would 
supersede the 2016 policy statement and govern persons seeking to 
become registered with DEA to grow marihuana as bulk manufacturers, 
consistent with applicable law, as described in 84 FR 44920.

    Dated: December 6, 2019.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2019-27783 Filed 12-23-19; 8:45 am]
 BILLING CODE 4410-09-P