Applications To Become Registered Under the Controlled Substances Act To Manufacture Marijuana To Supply Researchers in the United States, 53846-53848 [2016-17955]
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Federal Register / Vol. 81, No. 156 / Friday, August 12, 2016 / Rules and Regulations
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1301
[Docket No. DEA–447]
Applications To Become Registered
Under the Controlled Substances Act
To Manufacture Marijuana To Supply
Researchers in the United States
Drug Enforcement
Administration, Department of Justice.
ACTION: Policy statement.
AGENCY:
To facilitate research
involving marijuana and its chemical
constituents, DEA is adopting a new
policy that is designed to increase the
number of entities registered under the
Controlled Substances Act (CSA) to
grow (manufacture) marijuana to supply
legitimate researchers in the United
States. This policy statement explains
how DEA will evaluate applications for
such registration consistent with the
CSA and the obligations of the United
States under the applicable
international drug control treaty.
DATES: August 12, 2016.
FOR FURTHER INFORMATION CONTACT:
Michael J. Lewis, Office of Diversion
Control, Drug Enforcement
Administration; Mailing Address: 8701
Morrissette Drive, Springfield, Virginia
22152; Telephone: (202) 598–6812.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Background
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Reasons for This Policy Statement
There is growing public interest in
exploring the possibility that marijuana
or its chemical constituents may be used
as potential treatments for certain
medical conditions. The Federal Food,
Drug and Cosmetic Act requires that
before a new drug is allowed to enter
the U.S. market, it must be
demonstrated through adequate and
well-controlled clinical trials to be both
safe and effective for its intended uses.
Congress long ago established this
process, recognizing that it was essential
to protect the health and welfare of the
American people.
Although no drug product made from
marijuana has yet been shown to be safe
and effective in such clinical trials,
DEA—along with the Food and Drug
Administration (FDA) and the National
Institutes of Health (NIH)—fully
supports expanding research into the
potential medical utility of marijuana
and its chemical constituents.1
1 There are two FDA-approved drugs that contain
a synthetic form of dronabinol, which is one of the
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21:03 Aug 11, 2016
Jkt 238001
There are a variety of factors that
influence whether and to what extent
such research takes place. Some of the
key factors—such as funding—are
beyond DEA’s control.2 However, one of
the ways DEA can help to facilitate
research involving marijuana is to take
steps, within the framework of the CSA
and U.S. treaty obligations, to increase
the lawful supply of marijuana available
to researchers.
For nearly 50 years, the United States
has relied on a single grower to produce
marijuana used in research. This grower
operates under a contract with the
National Institute on Drug Abuse
(NIDA). This longstanding arrangement
has historically been considered by the
U.S. Government to be the best way to
satisfy our nation’s obligations under
the applicable international drug control
treaty, as discussed in more detail
below. For most of the nearly 50 years
that this single marijuana grower
arrangement has been in existence, the
demand for research-grade marijuana in
the United States was relatively
limited—and the single grower was able
to meet such limited demand. However,
in recent years, there has been greater
public interest in expanding marijuanarelated research, particularly with
regard to certain chemical constituents
in the plant known as cannabinoids.
The term ‘‘cannabinoids’’ generally
refers to those chemicals unique to the
cannabis plant (marijuana).3 To date,
more than 100 different cannabinoids
have been found in the plant. One such
cannabinoid—known as cannabidiol or
CBD—has received increased attention
in recent years. Although the effects of
CBD are not yet fully understood by
chemicals found in marijuana. These drugs are
Marinol (which the FDA approved for the treatment
of nausea and vomiting associated with cancer
chemotherapy, and for the treatment of anorexia
associated with weight loss in patients with AIDS)
and Syndros (which was approved for the same
indications as Marinol).
2 Funding may actually be the most important
factor in whether research with marijuana (or any
other experimental drug) takes place. What appears
to have been the greatest spike in marijuana
research in the United States occurred shortly after
the State of California enacted legislation in 1999
to fund such research. Specifically, in 1999,
California enacted a law that established the
‘‘California Marijuana Research Program’’ to
develop and conduct studies on the potential
medical utility of marijuana. Cal. Health & Safety
Code § 11362.9. The state legislature appropriated
a total of $9 million for the marijuana research
studies. Over the next five years, DEA received
applications for registration in connection with at
least 17 State-sponsored pre-clinical or clinical
studies of marijuana (all of which DEA granted). 74
FR 2101, 2105 (2009). However, it appears that once
the State stopped funding the research, the studies
ended.
3 An acceptable and broader definition of
‘‘cannabinoids’’ includes not only those chemicals
unique to the cannabis plant but also their
derivatives and transformation products.
PO 00000
Frm 00001
Fmt 4701
Sfmt 4700
scientists, and research is ongoing in
this area, some studies suggest that CBD
may have uses in the treatment of
seizures and other neurological
disorders. A growing number of
researchers have expressed interest in
conducting research with extracts of
marijuana that have a particular
percentage of CBD and other
cannabinoids. DEA fully supports
research in this area. Based on
discussions with NIDA and FDA, DEA
has concluded that the best way to
satisfy the current researcher demand
for a variety of strains of marijuana and
cannabinoid extracts is to increase the
number of federally authorized
marijuana growers. To achieve this
result, DEA, in consultation with NIDA
and FDA, has developed a new
approach to allow additional marijuana
growers to apply to become registered
with DEA, while upholding U.S. treaty
obligations and the CSA. This policy
statement explains the new approach,
provides details about the process by
which potential growers may apply for
a DEA registration, and describes the
steps they must take to ensure their
activity will be carried out in
conformity with U.S. treaty obligations
and the CSA.
The historical system, under which
NIDA relied on one grower to supply
marijuana on a contract basis, was
designed primarily to supply marijuana
for use in federally funded research—
not for commercial product
development. Thus, under the historical
system, there was no clear legal
pathway for commercial enterprises to
produce marijuana for product
development. In contrast, under the new
approach explained in this policy
statement, persons may become
registered with DEA to grow marijuana
not only to supply federally funded or
other academic researchers, but also for
strictly commercial endeavors funded
by the private sector and aimed at drug
product development. Likewise, under
the new approach, should the state of
scientific knowledge advance in the
future such that a marijuana-derived
drug is shown to be safe and effective
for medical use, pharmaceutical firms
will have a legal means of producing
such drugs in the United States—
independent of the NIDA contract
process.
Legal Considerations
Applicable CSA Provisions
Under the CSA, all persons who seek
to manufacture or distribute a controlled
substance must apply for a DEA
registration. 21 U.S.C. 822(a)(1).
Applications by persons seeking to grow
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Federal Register / Vol. 81, No. 156 / Friday, August 12, 2016 / Rules and Regulations
marijuana to supply researchers are
governed by 21 U.S.C. 823(a); see
generally 76 FR 51403 (2011); 74 FR
2101 (2009). Under section 823(a), for
DEA to grant a registration, two
conditions must be satisfied: (1) The
registration must be consistent with the
public interest (based on the
enumerated criteria listed in section
823(a)) and (2) the registration must be
consistent with U.S. obligations under
the Single Convention on Narcotic
Drugs, 1961 (Single Convention). An
applicant seeking registration under
section 823(a) has ‘‘the burden of
proving that the requirements for such
registration pursuant to [this section] are
satisfied.’’ 21 CFR 1301.44(a). Although
each application for registration that
DEA receives will be evaluated
individually based on its own merit,
some general considerations warrant
mention here.
First, while it is DEA’s intention to
increase the number of registered
marijuana growers who will be
supplying U.S. researchers, the CSA
does not authorize DEA to register an
unlimited number of manufacturers. As
subsection 823(a)(1) provides, DEA is
obligated to register only the number of
bulk manufacturers of a given schedule
I or II controlled substance that is
necessary to ‘‘produce an adequate and
uninterrupted supply of these
substances under adequately
competitive conditions for legitimate
medical, scientific, research, and
industrial purposes.’’ See 74 FR at
2127–2130 (discussing meaning of
subsection 823(a)(1)). This provision is
based on the long-established principle
that having fewer registrants of a given
controlled substances tends to decrease
the likelihood of diversion.
Consistent with subsection 823(a)(1),
DEA will evaluate each application it
receives to determine whether adding
such applicant to the list of registered
growers is necessary to provide an
adequate and uninterrupted supply of
marijuana (including extracts and other
derivatives thereof) to researchers in the
United States.4
Second, as with any application
submitted pursuant to section 823(a), in
determining whether the proposed
registration would be consistent with
the public interest, among the factors to
be considered are whether the applicant
has previous experience handling
controlled substances in a lawful
manner and whether the applicant has
engaged in illegal activity involving
controlled substances. In this context,
illegal activity includes any activity in
4 In
making this determination, DEA will consult
with NIH and FDA, as warranted.
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Jkt 238001
violation of the CSA (regardless of
whether such activity is permissible
under State law) as well as activity in
violation of State or local law. While
past illegal conduct involving controlled
substances does not automatically
disqualify an applicant, it may weigh
heavily against granting the registration.
Third, given the in-depth nature of
the analysis that the CSA requires DEA
to conduct in evaluating these
applications, applicants should
anticipate that, in addition to the
information requested in the application
itself, they will be asked to submit other
information germane to the application
in accordance with 21 CFR 1301.15.
This will include, among other things,
detailed information regarding an
applicant’s past experience in the
manufacture of controlled substances. In
addition, applicants will be asked to
provide a written explanation of how
they believe they would be able to
augment the nation’s supply of researchgrade marijuana within the meaning of
subsection 823(a)(1). Applicants may be
asked to provide additional written
support for their application and other
information that DEA deems relevant in
evaluating the application under section
823(a).
Treaty Considerations
As stated above, DEA may only issue
a registration to grow marijuana to
supply researchers if the registration is
consistent with U.S. obligations under
the Single Convention. Although this
policy document will not list all of the
applicable requirements of the Single
Convention,5 the following is a
summary of some of the key
considerations.
Under articles 23 and 28 of the Single
Convention, a party (i.e., a country that
is a signatory to the treaty) that allows
the cultivation of cannabis for lawful
uses (e.g., FDA-authorized clinical
trials) must:
(a) Designate the areas in which, and
the plots of land on which, cultivation
of the cannabis plant for the purpose of
producing cannabis shall be permitted;
(b) License cultivators authorized to
cultivate cannabis;
(c) Specify through such licensing the
extent of the land on which the
cultivation is permitted;
(d) Purchase and take physical
possession of all cannabis crops from all
cultivators as soon as possible, but not
later than four months after the end of
the harvest; and
5 A detailed explanation of the relevant Single
Convention requirements can be found in 74 FR at
2114–2118.
PO 00000
Frm 00002
Fmt 4701
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53847
(e) Have the exclusive right of
importing, exporting, wholesale trading
and maintaining stocks of cannabis.
As DEA has stated in a prior
publication, DEA carries out those
functions of article 23, paragraph 2, that
are encompassed by the DEA
registration system (paragraphs (a)
through (c) above), and NIDA carries out
those functions relating to purchasing
the marijuana and maintaining a
monopoly over the wholesale
distribution (paragraphs (d) and (e)
above).6 76 FR at 51409.
As indicated, DEA’s historical
approach to ensuring compliance with
the foregoing treaty requirements was to
limit the registration of marijuana
growers who supply researchers to those
entities that operate under a contract
with NIDA. Under this historical
approach, the grower could be
considered an extension of NIDA and
thus all marijuana produced by the
grower was effectively owned by NIDA,
with NIDA controlling all distribution to
researchers.
However, as further indicated, DEA
has concluded, based on discussions
with NIDA and FDA, that it would be
beneficial for research to allow
additional marijuana growers outside
the NIDA-contract system, provided this
could be accomplished in a manner
consistent with the CSA and the treaty.
Toward this end, DEA took into account
the following statement contained in the
official commentary to the Single
Convention:
Countries . . . which produce . . .
cannabis . . . , [i]n so far as they permit
private farmers to cultivate the plants . . . ,
cannot establish with sufficient exactitude
the quantities harvested by individual
producers. If they allowed the sale of the
crops to private traders, they would not be
in a position to ascertain with reasonable
exactitude the amounts which enter their
controlled trade. The effectiveness of their
´
control regime would thus be considerably
weakened. In fact, experience has shown that
permitting licensed private traders to
purchase the crops results in diversion of
large quantities of drugs into illicit channels.
. . . [T]he acquisition of the crops and the
wholesale and international trade in these
agricultural products cannot be entrusted to
private traders, but must be undertaken by
governmental authorities in the producing
countries. Article 23 . . . and article 28 . . .
therefore require a government monopoly of
the wholesale and international trade in the
agricultural product in question in the
country which authorizes its production.
Commentary at 278
6 In accordance with the CSA, DEA carries out
functions that are indirectly related to those
specified in article 23, paragraph 2(e). For example,
DEA controls imports and exports of cannabis
through the CSA registration and permitting system.
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Federal Register / Vol. 81, No. 156 / Friday, August 12, 2016 / Rules and Regulations
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Given the foregoing considerations,
DEA believes it would be consistent
with the purposes of articles 23 and 28
of the Single Convention for DEA to
register marijuana growers outside of
the NIDA-contract system to supply
researchers, provided the growers agree
that they may only distribute marijuana
with prior, written approval from DEA.
In other words, in lieu of requiring the
growers to operate under a contract with
NIDA, a registered grower will be
permitted to operate independently,
provided the grower agrees (through a
written memorandum of agreement with
DEA) that it will only distribute
marijuana with prior, written approval
from DEA. DEA believes this new
approach will succeed in avoiding one
of the scenarios the treaty is designed to
prevent: Private parties trading in
marijuana outside the supervision or
direction of the federal government.
Also, consistent with the purposes
and structure of the CSA, persons who
become registered to grow marijuana to
supply researchers will only be
authorized to supply DEA-registered
researchers whose protocols have been
determined by the Department of Health
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Jkt 238001
and Human Services (HHS) to be
scientifically meritorious. See 21 U.S.C.
823(f). In 2015, HHS announced the
details of its current policy for
evaluating the merits of research
protocols involving marijuana. 80 FR
35960 (2015).
Finally, potential applicants should
note that any entity granted a
registration to manufacture marijuana to
supply researchers will be subject to all
applicable requirements of the CSA and
DEA regulations, including those
relating to quotas, record keeping, order
forms, security, and diversion control.
How To Apply for a Registration
Persons interested in applying for a
registration to become a bulk
manufacturer of marijuana to supply
legitimate researchers can find
instructions and the application form by
going to the DEA Office of Diversion
Control Web site registration page at
www.deadiversion.usdoj.gov/drugreg/
index.html#regapps. Applicants will
need to submit Form 225.
PO 00000
Note Regarding the Nature of This
Document
This document is a general statement
of DEA policy. While this document
reflects how DEA intends to implement
the relevant statutory and regulatory
provisions, it does not establish a rule
that is binding on any member of the
public. Any person who applies for a
registration to grow marijuana (as with
any other applicant for registration
under the CSA) is entitled to due
process in the consideration of the
application by the Agency. To ensure
such due process, the CSA provides
that, before taking action to deny an
application for registration, DEA must
serve upon the applicant an order to
show cause why the application should
not be denied, which shall provide the
applicant with an opportunity to request
a hearing on the application in
accordance with the Administrative
Procedure Act. 21 U.S.C. 824(c).
Dated: July 25, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016–17955 Filed 8–11–16; 8:45 am]
BILLING CODE 4410–09–P
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Agencies
[Federal Register Volume 81, Number 156 (Friday, August 12, 2016)]
[Rules and Regulations]
[Pages 53846-53848]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-17955]
Federal Register / Vol. 81 , No. 156 / Friday, August 12, 2016 /
Rules and Regulations
[[Page 53846]]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1301
[Docket No. DEA-447]
Applications To Become Registered Under the Controlled Substances
Act To Manufacture Marijuana To Supply Researchers in the United States
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Policy statement.
-----------------------------------------------------------------------
SUMMARY: To facilitate research involving marijuana and its chemical
constituents, DEA is adopting a new policy that is designed to increase
the number of entities registered under the Controlled Substances Act
(CSA) to grow (manufacture) marijuana to supply legitimate researchers
in the United States. This policy statement explains how DEA will
evaluate applications for such registration consistent with the CSA and
the obligations of the United States under the applicable international
drug control treaty.
DATES: August 12, 2016.
FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, Office of Diversion
Control, Drug Enforcement Administration; Mailing Address: 8701
Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-
6812.
SUPPLEMENTARY INFORMATION:
Background
Reasons for This Policy Statement
There is growing public interest in exploring the possibility that
marijuana or its chemical constituents may be used as potential
treatments for certain medical conditions. The Federal Food, Drug and
Cosmetic Act requires that before a new drug is allowed to enter the
U.S. market, it must be demonstrated through adequate and well-
controlled clinical trials to be both safe and effective for its
intended uses. Congress long ago established this process, recognizing
that it was essential to protect the health and welfare of the American
people.
Although no drug product made from marijuana has yet been shown to
be safe and effective in such clinical trials, DEA--along with the Food
and Drug Administration (FDA) and the National Institutes of Health
(NIH)--fully supports expanding research into the potential medical
utility of marijuana and its chemical constituents.\1\
---------------------------------------------------------------------------
\1\ There are two FDA-approved drugs that contain a synthetic
form of dronabinol, which is one of the chemicals found in
marijuana. These drugs are Marinol (which the FDA approved for the
treatment of nausea and vomiting associated with cancer
chemotherapy, and for the treatment of anorexia associated with
weight loss in patients with AIDS) and Syndros (which was approved
for the same indications as Marinol).
---------------------------------------------------------------------------
There are a variety of factors that influence whether and to what
extent such research takes place. Some of the key factors--such as
funding--are beyond DEA's control.\2\ However, one of the ways DEA can
help to facilitate research involving marijuana is to take steps,
within the framework of the CSA and U.S. treaty obligations, to
increase the lawful supply of marijuana available to researchers.
---------------------------------------------------------------------------
\2\ Funding may actually be the most important factor in whether
research with marijuana (or any other experimental drug) takes
place. What appears to have been the greatest spike in marijuana
research in the United States occurred shortly after the State of
California enacted legislation in 1999 to fund such research.
Specifically, in 1999, California enacted a law that established the
``California Marijuana Research Program'' to develop and conduct
studies on the potential medical utility of marijuana. Cal. Health &
Safety Code Sec. 11362.9. The state legislature appropriated a
total of $9 million for the marijuana research studies. Over the
next five years, DEA received applications for registration in
connection with at least 17 State-sponsored pre-clinical or clinical
studies of marijuana (all of which DEA granted). 74 FR 2101, 2105
(2009). However, it appears that once the State stopped funding the
research, the studies ended.
---------------------------------------------------------------------------
For nearly 50 years, the United States has relied on a single
grower to produce marijuana used in research. This grower operates
under a contract with the National Institute on Drug Abuse (NIDA). This
longstanding arrangement has historically been considered by the U.S.
Government to be the best way to satisfy our nation's obligations under
the applicable international drug control treaty, as discussed in more
detail below. For most of the nearly 50 years that this single
marijuana grower arrangement has been in existence, the demand for
research-grade marijuana in the United States was relatively limited--
and the single grower was able to meet such limited demand. However, in
recent years, there has been greater public interest in expanding
marijuana-related research, particularly with regard to certain
chemical constituents in the plant known as cannabinoids.
The term ``cannabinoids'' generally refers to those chemicals
unique to the cannabis plant (marijuana).\3\ To date, more than 100
different cannabinoids have been found in the plant. One such
cannabinoid--known as cannabidiol or CBD--has received increased
attention in recent years. Although the effects of CBD are not yet
fully understood by scientists, and research is ongoing in this area,
some studies suggest that CBD may have uses in the treatment of
seizures and other neurological disorders. A growing number of
researchers have expressed interest in conducting research with
extracts of marijuana that have a particular percentage of CBD and
other cannabinoids. DEA fully supports research in this area. Based on
discussions with NIDA and FDA, DEA has concluded that the best way to
satisfy the current researcher demand for a variety of strains of
marijuana and cannabinoid extracts is to increase the number of
federally authorized marijuana growers. To achieve this result, DEA, in
consultation with NIDA and FDA, has developed a new approach to allow
additional marijuana growers to apply to become registered with DEA,
while upholding U.S. treaty obligations and the CSA. This policy
statement explains the new approach, provides details about the process
by which potential growers may apply for a DEA registration, and
describes the steps they must take to ensure their activity will be
carried out in conformity with U.S. treaty obligations and the CSA.
---------------------------------------------------------------------------
\3\ An acceptable and broader definition of ``cannabinoids''
includes not only those chemicals unique to the cannabis plant but
also their derivatives and transformation products.
---------------------------------------------------------------------------
The historical system, under which NIDA relied on one grower to
supply marijuana on a contract basis, was designed primarily to supply
marijuana for use in federally funded research--not for commercial
product development. Thus, under the historical system, there was no
clear legal pathway for commercial enterprises to produce marijuana for
product development. In contrast, under the new approach explained in
this policy statement, persons may become registered with DEA to grow
marijuana not only to supply federally funded or other academic
researchers, but also for strictly commercial endeavors funded by the
private sector and aimed at drug product development. Likewise, under
the new approach, should the state of scientific knowledge advance in
the future such that a marijuana-derived drug is shown to be safe and
effective for medical use, pharmaceutical firms will have a legal means
of producing such drugs in the United States--independent of the NIDA
contract process.
Legal Considerations
Applicable CSA Provisions
Under the CSA, all persons who seek to manufacture or distribute a
controlled substance must apply for a DEA registration. 21 U.S.C.
822(a)(1). Applications by persons seeking to grow
[[Page 53847]]
marijuana to supply researchers are governed by 21 U.S.C. 823(a); see
generally 76 FR 51403 (2011); 74 FR 2101 (2009). Under section 823(a),
for DEA to grant a registration, two conditions must be satisfied: (1)
The registration must be consistent with the public interest (based on
the enumerated criteria listed in section 823(a)) and (2) the
registration must be consistent with U.S. obligations under the Single
Convention on Narcotic Drugs, 1961 (Single Convention). An applicant
seeking registration under section 823(a) has ``the burden of proving
that the requirements for such registration pursuant to [this section]
are satisfied.'' 21 CFR 1301.44(a). Although each application for
registration that DEA receives will be evaluated individually based on
its own merit, some general considerations warrant mention here.
First, while it is DEA's intention to increase the number of
registered marijuana growers who will be supplying U.S. researchers,
the CSA does not authorize DEA to register an unlimited number of
manufacturers. As subsection 823(a)(1) provides, DEA is obligated to
register only the number of bulk manufacturers of a given schedule I or
II controlled substance that is necessary to ``produce an adequate and
uninterrupted supply of these substances under adequately competitive
conditions for legitimate medical, scientific, research, and industrial
purposes.'' See 74 FR at 2127-2130 (discussing meaning of subsection
823(a)(1)). This provision is based on the long-established principle
that having fewer registrants of a given controlled substances tends to
decrease the likelihood of diversion.
Consistent with subsection 823(a)(1), DEA will evaluate each
application it receives to determine whether adding such applicant to
the list of registered growers is necessary to provide an adequate and
uninterrupted supply of marijuana (including extracts and other
derivatives thereof) to researchers in the United States.\4\
---------------------------------------------------------------------------
\4\ In making this determination, DEA will consult with NIH and
FDA, as warranted.
---------------------------------------------------------------------------
Second, as with any application submitted pursuant to section
823(a), in determining whether the proposed registration would be
consistent with the public interest, among the factors to be considered
are whether the applicant has previous experience handling controlled
substances in a lawful manner and whether the applicant has engaged in
illegal activity involving controlled substances. In this context,
illegal activity includes any activity in violation of the CSA
(regardless of whether such activity is permissible under State law) as
well as activity in violation of State or local law. While past illegal
conduct involving controlled substances does not automatically
disqualify an applicant, it may weigh heavily against granting the
registration.
Third, given the in-depth nature of the analysis that the CSA
requires DEA to conduct in evaluating these applications, applicants
should anticipate that, in addition to the information requested in the
application itself, they will be asked to submit other information
germane to the application in accordance with 21 CFR 1301.15. This will
include, among other things, detailed information regarding an
applicant's past experience in the manufacture of controlled
substances. In addition, applicants will be asked to provide a written
explanation of how they believe they would be able to augment the
nation's supply of research-grade marijuana within the meaning of
subsection 823(a)(1). Applicants may be asked to provide additional
written support for their application and other information that DEA
deems relevant in evaluating the application under section 823(a).
Treaty Considerations
As stated above, DEA may only issue a registration to grow
marijuana to supply researchers if the registration is consistent with
U.S. obligations under the Single Convention. Although this policy
document will not list all of the applicable requirements of the Single
Convention,\5\ the following is a summary of some of the key
considerations.
---------------------------------------------------------------------------
\5\ A detailed explanation of the relevant Single Convention
requirements can be found in 74 FR at 2114-2118.
---------------------------------------------------------------------------
Under articles 23 and 28 of the Single Convention, a party (i.e., a
country that is a signatory to the treaty) that allows the cultivation
of cannabis for lawful uses (e.g., FDA-authorized clinical trials)
must:
(a) Designate the areas in which, and the plots of land on which,
cultivation of the cannabis plant for the purpose of producing cannabis
shall be permitted;
(b) License cultivators authorized to cultivate cannabis;
(c) Specify through such licensing the extent of the land on which
the cultivation is permitted;
(d) Purchase and take physical possession of all cannabis crops
from all cultivators as soon as possible, but not later than four
months after the end of the harvest; and
(e) Have the exclusive right of importing, exporting, wholesale
trading and maintaining stocks of cannabis.
As DEA has stated in a prior publication, DEA carries out those
functions of article 23, paragraph 2, that are encompassed by the DEA
registration system (paragraphs (a) through (c) above), and NIDA
carries out those functions relating to purchasing the marijuana and
maintaining a monopoly over the wholesale distribution (paragraphs (d)
and (e) above).\6\ 76 FR at 51409.
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\6\ In accordance with the CSA, DEA carries out functions that
are indirectly related to those specified in article 23, paragraph
2(e). For example, DEA controls imports and exports of cannabis
through the CSA registration and permitting system.
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As indicated, DEA's historical approach to ensuring compliance with
the foregoing treaty requirements was to limit the registration of
marijuana growers who supply researchers to those entities that operate
under a contract with NIDA. Under this historical approach, the grower
could be considered an extension of NIDA and thus all marijuana
produced by the grower was effectively owned by NIDA, with NIDA
controlling all distribution to researchers.
However, as further indicated, DEA has concluded, based on
discussions with NIDA and FDA, that it would be beneficial for research
to allow additional marijuana growers outside the NIDA-contract system,
provided this could be accomplished in a manner consistent with the CSA
and the treaty. Toward this end, DEA took into account the following
statement contained in the official commentary to the Single
Convention:
Countries . . . which produce . . . cannabis . . . , [i]n so far
as they permit private farmers to cultivate the plants . . . ,
cannot establish with sufficient exactitude the quantities harvested
by individual producers. If they allowed the sale of the crops to
private traders, they would not be in a position to ascertain with
reasonable exactitude the amounts which enter their controlled
trade. The effectiveness of their control r[eacute]gime would thus
be considerably weakened. In fact, experience has shown that
permitting licensed private traders to purchase the crops results in
diversion of large quantities of drugs into illicit channels. . . .
[T]he acquisition of the crops and the wholesale and international
trade in these agricultural products cannot be entrusted to private
traders, but must be undertaken by governmental authorities in the
producing countries. Article 23 . . . and article 28 . . . therefore
require a government monopoly of the wholesale and international
trade in the agricultural product in question in the country which
authorizes its production.
Commentary at 278
[[Page 53848]]
Given the foregoing considerations, DEA believes it would be
consistent with the purposes of articles 23 and 28 of the Single
Convention for DEA to register marijuana growers outside of the NIDA-
contract system to supply researchers, provided the growers agree that
they may only distribute marijuana with prior, written approval from
DEA. In other words, in lieu of requiring the growers to operate under
a contract with NIDA, a registered grower will be permitted to operate
independently, provided the grower agrees (through a written memorandum
of agreement with DEA) that it will only distribute marijuana with
prior, written approval from DEA. DEA believes this new approach will
succeed in avoiding one of the scenarios the treaty is designed to
prevent: Private parties trading in marijuana outside the supervision
or direction of the federal government.
Also, consistent with the purposes and structure of the CSA,
persons who become registered to grow marijuana to supply researchers
will only be authorized to supply DEA-registered researchers whose
protocols have been determined by the Department of Health and Human
Services (HHS) to be scientifically meritorious. See 21 U.S.C. 823(f).
In 2015, HHS announced the details of its current policy for evaluating
the merits of research protocols involving marijuana. 80 FR 35960
(2015).
Finally, potential applicants should note that any entity granted a
registration to manufacture marijuana to supply researchers will be
subject to all applicable requirements of the CSA and DEA regulations,
including those relating to quotas, record keeping, order forms,
security, and diversion control.
How To Apply for a Registration
Persons interested in applying for a registration to become a bulk
manufacturer of marijuana to supply legitimate researchers can find
instructions and the application form by going to the DEA Office of
Diversion Control Web site registration page at
www.deadiversion.usdoj.gov/drugreg/index.html#regapps. Applicants will
need to submit Form 225.
Note Regarding the Nature of This Document
This document is a general statement of DEA policy. While this
document reflects how DEA intends to implement the relevant statutory
and regulatory provisions, it does not establish a rule that is binding
on any member of the public. Any person who applies for a registration
to grow marijuana (as with any other applicant for registration under
the CSA) is entitled to due process in the consideration of the
application by the Agency. To ensure such due process, the CSA provides
that, before taking action to deny an application for registration, DEA
must serve upon the applicant an order to show cause why the
application should not be denied, which shall provide the applicant
with an opportunity to request a hearing on the application in
accordance with the Administrative Procedure Act. 21 U.S.C. 824(c).
Dated: July 25, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016-17955 Filed 8-11-16; 8:45 am]
BILLING CODE 4410-09-P