Attorney General determines necessary to ensure that a 
registrant maintains effective controls against diversion.’’. 
(e) CONTINUATION OF RESEARCH ON SUBSTANCES 
NEWLY ADDED TO SCHEDULE I.—Section 302 of the 
Controlled Substances Act (21 U.S.C. 822) is amended 
by adding at the end the following: 
‘‘(h) CONTINUATION OF RESEARCH ON SUBSTANCES 
NEWLY ADDED TO SCHEDULE I.—If a person is con-
ducting research on a substance when the substance is 
added to schedule I, and the person is already registered 
to conduct research with a controlled substance in sched-
ule I— 
‘‘(1) not later than 90 days after the scheduling 
of the newly scheduled substance, the person shall 
submit a completed application for registration or 
modification of existing registration, to conduct re-
search on the substance, in accordance with regula-
tions issued by the Attorney General for purposes of 
this paragraph; 
‘‘(2) the person may, notwithstanding sub-
sections (a) and (b), continue to conduct the re-
search on the substance until— 
‘‘(A) the person withdraws the application 
described in paragraph (1) of this subsection; 
or 
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‘‘(B) the Attorney General serves on the 
person an order to show cause proposing the 
denial of the application under section 304(c); 
‘‘(3) if the Attorney General serves an order to 
show cause as described in paragraph (2)(B) and 
the person requests a hearing, the hearing shall be 
held on an expedited basis and not later than 45 
days after the request is made, except that the hear-
ing may be held at a later time if so requested by 
the person; and 
‘‘(4) if the person sends a copy of the applica-
tion described in paragraph (1) to a manufacturer or 
distributor of the substance, receipt of the copy by 
the manufacturer or distributor shall constitute suf-
ficient evidence that the person is authorized to re-
ceive the substance.’’. 
(f) TREATMENT OF CERTAIN MANUFACTURING AC-
TIVITIES AS COINCIDENT TO RESEARCH.—Section 302 of 
the Controlled Substances Act (21 U.S.C. 822), as amend-
ed by subsection (e), is amended by adding at the end 
the following: 
‘‘(i) TREATMENT OF CERTAIN MANUFACTURING AC-
TIVITIES AS COINCIDENT TO RESEARCH.— 
‘‘(1) IN GENERAL.—Except as provided in para-
graph (3), a person who is registered to perform re-
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search on a controlled substance may perform manu-
facturing activities with small quantities of that sub-
stance, including activities described in paragraph 
(2), without being required to obtain a manufac-
turing registration, if— 
‘‘(A) the activities are performed for the 
purpose of the research; and 
‘‘(B) the activities and the quantities of 
the substance involved in the activities are stat-
ed in— 
‘‘(i) a notification submitted to the 
Attorney General under section 303(l); 
‘‘(ii) a research protocol filed with an 
application for registration approval under 
section 303(f); or 
‘‘(iii) a notification to the Attorney 
General that includes— 
‘‘(I) the name of the registrant; 
and 
‘‘(II) an attestation that the re-
search to be conducted with the small 
quantities of manufactured substance 
is consistent with the scope of the re-
search that is the basis for the reg-
istration. 
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‘‘(2) ACTIVITIES
INCLUDED.—Activities per-
mitted under paragraph (1) include— 
‘‘(A) processing the substance to create ex-
tracts, tinctures, oils, solutions, derivatives, or 
other forms of the substance consistent with— 
‘‘(i) the information provided as part 
of a notification submitted to the Attorney 
General under section 303(l); or 
‘‘(ii) a research protocol filed with an 
application for registration approval under 
section 303(f); and 
‘‘(B) dosage form development studies per-
formed for the purpose of requesting an inves-
tigational new drug exemption under section 
505(i) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355(i)). 
‘‘(3) EXCEPTION
REGARDING
MARIHUANA.— 
The authority under paragraph (1) to manufacture 
substances does not include the authority to grow 
marihuana.’’. 
(g) TRANSPARENCY REGARDING SPECIAL PROCE-
DURES.—Section 303 of the Controlled Substances Act 
(21 U.S.C. 823), as amended by subsection (a), is amend-
ed by adding at the end the following: 
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‘‘(m) TRANSPARENCY REGARDING SPECIAL PROCE-
DURES.— 
‘‘(1) IN GENERAL.—If the Attorney General de-
termines, with respect to a controlled substance, that 
an application by a practitioner to conduct research 
with the substance should be considered under a 
process, or subject to criteria, different from the 
process or criteria applicable to applications to con-
duct research with other controlled substances in the 
same schedule, the Attorney General shall make 
public, including by posting on the website of the 
Drug Enforcement Administration— 
‘‘(A) the identities of all substances for 
which such determinations have been made; 
‘‘(B) the process and criteria that shall be 
applied to applications to conduct research with 
those substances; and 
‘‘(C) how the process and criteria described 
in subparagraph (B) differ from the process 
and criteria applicable to applications to con-
duct research with other controlled substances 
in the same schedule. 
‘‘(2) TIMING OF POSTING.—The Attorney Gen-
eral shall make information described in paragraph 
(1) public upon making a determination described in 
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that paragraph, regardless of whether a practitioner 
has submitted such an application at that time.’’. 
SEC. 4. RULEMAKING. 
(a) INTERIM FINAL RULES.—The Attorney Gen-
eral— 
(1) shall, not later than 1 year of the date of 
enactment of this Act, issue rules to implement this 
Act and the amendments made by this Act; and 
(2) may issue the rules under paragraph (1) as 
interim final rules. 
(b) PROCEDURE FOR FINAL RULE.— 
(1) 
EFFECTIVENESS
OF
INTERIM
FINAL 
RULES.—A rule issued by the Attorney General as 
an interim final rule under subsection (a) shall be-
come immediately effective as an interim final rule 
without requiring the Attorney General to dem-
onstrate good cause therefor, notwithstanding sub-
paragraph (B) of section 553(b) of title 5, United 
States Code. 
(2) OPPORTUNITY FOR COMMENT AND HEAR-
ING.—An interim final rule issued under subsection 
(a) shall give interested persons the opportunity to 
comment and to request a hearing. 
(3) FINAL RULE.—After the conclusion of such 
proceedings, the Attorney General shall issue a final 
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