Notice2023-11132
Gary Gray d/b/a Complex; Decision and Order
Primary source
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Published
May 25, 2023
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Full Text
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<title>Federal Register, Volume 88 Issue 101 (Thursday, May 25, 2023)</title>
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[Federal Register Volume 88, Number 101 (Thursday, May 25, 2023)]
[Notices]
[Pages 33916-33917]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-11132]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 22-11]
Gary Gray d/b/a Complex; Decision and Order
On November 22, 2021, the Drug Enforcement Administration (DEA or
the Agency) issued an Order to Show Cause (OSC) to Gary Gray d/b/a
Complex (hereinafter, the Respondent) seeking to deny Respondent's
application for a DEA Certificate of Registration to manufacture
marihuana, Control No. W14063382E. OSC, at 1.
After a hearing, the Chief Administrative Law Judge (Chief ALJ)
issued his Recommended Rulings, Findings of Law, and Decision of the
Administrative Law Judge (Recommended Decision or RD), which
recommended Respondent's application for a manufacturing registration
be denied because ``the plain language of the controlling regulations
compels the denial of the present application as a matter of law.'' RD,
at 2, 11. The Agency agrees with the Chief ALJ's recommendation, and,
for the reasons explained below, denies Respondent's application as
inconsistent with the public interest under 21 U.S.C. 823(a).\1\
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\1\ Effective December 2, 2022, the Medical Marijuana and
Cannabidiol Research Expansion Act, Public Law 117-215, 136 Stat.
2257 (2022) (Marijuana Research Amendments or MRA), amended the
Controlled Substances Act (CSA) and other statutes; however, the
relevant provision here, 21 U.S.C. 823(a), remained the same.
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[[Page 33917]]
I. Findings of Fact
On July 30, 2014, Respondent filed an application with DEA to bulk
manufacture Schedule I controlled substances. Government Exhibit (GX)
1. According to Respondent, he is seeking to obtain DEA registration as
a bulk manufacturer of marihuana ``so that he may cultivate, harvest,
and package the particular strains of marihuana required for his
research and product development purposes.'' Resp Posthearing, at 4;
Tr. 30. Respondent hopes to ultimately produce products that will treat
Alzheimer's and other degenerative diseases. Tr. 30, 49.
Respondent is a pharmacist and has possessed, and operated under,
pharmacy controlled substance registrations, as well as having held
multiple state pharmacy licenses for over 50 years. Tr. 58-61. It is
undisputed, however, that Respondent does not currently hold any type
of DEA controlled substance registration, and at the onset of the
hearing, a certification of Respondent's lack of DEA registration as a
schedule 1 researcher was admitted into the record without objection.
Tr. 18; GX 1, at 2.
II. Discussion
The Controlled Substances Act (CSA) states that the Agency shall
register an applicant to manufacture controlled substances in schedule
I or II if such registration is determined to be ``consistent with the
public interest and with United States obligations under international
treaties, conventions, or protocols in effect on May 1, 1971.'' 21
U.S.C. 823(a). The CSA provides six factors DEA must consider in
determining the public interest. Id. 21 CFR 1318.05, which implements
the requirements of Sec. 823(a) for marihuana growers and
manufacturers, further provides that the Agency shall place
``particular emphasis'' on certain enumerated criteria in determining
the public interest.
In situations, such as here, where ``an applicant seeks
registration to grow cannabis for its own research or product
development'' one of the criteria of ``particular emphasis'' is that
``the applicant must possess registration as a schedule I researcher
with respect to marihuana under Sec. 1301.31 of this chapter.'' 21 CFR
1318.05(b)(3)(ii) (emphasis added). It is undisputed that Respondent
does not possess a DEA schedule I researcher registration under Sec.
1301.31. Tr. 19; Respondent's Exceptions, at 3. Accordingly, under the
plain language of the regulation, Respondent does not meet the criteria
to receive the manufacturer registration for which he has applied, and
the Agency finds that granting his application for a registration would
not be consistent with the public interest under Sec. 823(a).\2\
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\2\ Respondent filed Exceptions to the Chief ALJ's Recommended
Decision arguing that he is eligible for a manufacturer registration
because he applied for the requisite researcher registration in June
2022 and that application is pending with DEA. Respondent's
Exceptions, at 4. Respondent's argument is unpersuasive as the
regulations clearly state that an applicant must currently possess a
researcher registration, not just have submitted an application for
one. (Respondent's application for a researcher registration is also
not in the record under consideration for this matter as, based on a
declaration from Respondent's counsel, it was submitted after the
Chief ALJ had transferred the certified record for this matter to
the DEA Administrator). Respondent requests, in the alternative,
that any action on the instant application be stayed pending action
on his application for registration as a schedule 1 researcher. Id.
at 6-7. Respondent's request is denied. Respondent may submit a new
application for a manufacturer registration and that application
will be evaluated on its merits.
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Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 823(a), I hereby deny DEA registration application No.
W14063382E submitted by Gary Gray d/b/a/Complex. This Order is
effective June 26, 2023.
Signing Authority
This document of the Drug Enforcement Administration was signed on
May 16, 2023, by Administrator Anne Milgram. That document with the
original signature and date is maintained by DEA. For administrative
purposes only, and in compliance with requirements of the Office of the
Federal Register, the undersigned DEA Federal Register Liaison Officer
has been authorized to sign and submit the document in electronic
format for publication, as an official document of DEA. This
administrative process in no way alters the legal effect of this
document upon publication in the Federal Register.
Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2023-11132 Filed 5-24-23; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on May 25, 2023.
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