(d) NEW INSPECTION NOT REQUIRED IN CERTAIN 
SITUATIONS.—Section 303(f) of the Controlled Sub-
stances Act (21 U.S.C. 823(f)) is amended— 
(1) by redesignating paragraphs (1) through 
(5) as subparagraphs (A) through (E), respectively, 
and by moving the margins of such subparagraphs 
two ems to the right; 
(2) by striking ‘‘(f) The’’ and inserting ‘‘(f)(1) 
The’’; and 
(3) by adding at the end, after the matter fol-
lowing subparagraph (E), as so redesignated, the 
following new paragraph: 
‘‘(2)(A) If a person is registered to conduct research 
with a controlled substance and applies for a registration, 
or a modification of a registration to conduct research 
with a second controlled substance that is in the same 
schedule or in a schedule with a higher numerical designa-
tion, a new inspection by the Attorney General of the reg-
istered location is not required. 
‘‘(B) Nothing in this paragraph shall prohibit the At-
torney General from conducting any inspection if the At-
torney General deems it necessary.’’. 
(e) CONTINUATION OF RESEARCH ON SUBSTANCES 
NEWLY ADDED TO SCHEDULE I; AUTHORITY TO CON-
DUCT RESEARCH WITH OTHER SUBSTANCES IN SCHED-
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ULE I.—Section 302 of the Controlled Substances Act (21 
U.S.C. 822) is amended by adding at the end the following 
new subsection: 
‘‘(h) CONTINUATION OF RESEARCH ON SUBSTANCES 
NEWLY ADDED TO SCHEDULE I; AUTHORITY TO CON-
DUCT RESEARCH WITH OTHER SUBSTANCES IN SCHED-
ULE I.— 
‘‘(1) If a person is conducting research on a 
substance at the time the substance is added to 
schedule I, and such person is already registered to 
conduct research with a controlled substance in 
schedule I or II then— 
‘‘(A) the person shall, within 30 days of 
the scheduling of the newly scheduled sub-
stance, submit a completed application for reg-
istration or modification of existing registration, 
to conduct research on such substance, in ac-
cordance with the regulations issued by the At-
torney General; 
‘‘(B) the person may, notwithstanding sub-
sections (a) and (b), continue to conduct the re-
search on such substance until the application 
referred to in subparagraph (A) is withdrawn 
by the applicant or until the Attorney General 
serves on the applicant an order to show cause 
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proposing the denial of the application pursuant 
to section 304(c); and 
‘‘(C) if the Attorney General serves such 
an order to show cause and the applicant re-
quests a hearing, such 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 applicant. 
‘‘(2)(A) A person who is registered to conduct 
research with a controlled substance in schedule I 
may, notwithstanding subsections (a) and (b), con-
duct research with another controlled substance in 
schedule I, provided the following conditions are 
met: 
‘‘(i) The person has applied for a modifica-
tion of the person’s registration to authorize re-
search with such other controlled substance in 
accordance with the regulations issued by the 
Attorney General. 
‘‘(ii) The Attorney General has obtained 
verification from the Secretary that the re-
search protocol submitted with the application 
is meritorious. 
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‘‘(iii) The Attorney General has deter-
mined that such activity is consistent with 
United States obligations under the Single Con-
vention on Narcotic Drugs, 1961. The Attorney 
General shall make such determination not 
later than 30 days after receiving the applica-
tion referred to in clause (i). 
‘‘(B) Nothing in this section shall be construed 
to alter the authority of the Attorney General to ini-
tiate proceedings to deny, suspend, or revoke any 
registration in accordance with sections 303 and 
304.’’. 
(f) TREATMENT OF CERTAIN ACTIVITIES AS COINCI-
DENT TO RESEARCH.—Section 302 of the Controlled Sub-
stances Act (21 U.S.C. 822), as amended by subsection 
(d), is further amended by adding at the end the following 
new subsection: 
‘‘(i) TREATMENT OF CERTAIN ACTIVITIES AS COIN-
CIDENT TO RESEARCH.— 
‘‘(1) IN
GENERAL.—Except as specified in 
paragraph (2), a person who is registered to perform 
research with a controlled substance may perform 
the following activities with small quantities of that 
substance, as set forth in the relevant statement or 
protocol filed with the application for registration 
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approved by the Attorney General without being re-
quired to obtain a manufacturing registration: 
‘‘(A) Processing the substance to create ex-
tracts, tinctures, oils, solutions, derivatives, or 
other forms of the substance consistent with the 
approved research protocol. 
‘‘(B) Dosage form development for the 
purpose of satisfying regulatory requirements 
implemented by the Food and Drug Adminis-
tration for submitting an investigational new 
drug application. 
‘‘(2) EXCEPTION
REGARDING
MARIHUANA.— 
The authority under paragraph (1) does not include 
authority to grow marihuana.’’. 
SEC. 3. REVIEW OF RESEARCH REGISTRATION PROCESS. 
(a) REVIEW.—Not later than one year after the date 
of the enactment of this section, the Attorney General and 
the Secretary of Health and Human Services shall conduct 
a review of the processes used to obtain or modify Federal 
authorization to conduct research with controlled sub-
stances, including— 
(1) an evaluation of the impacts of the amend-
ments made by section 2 on the risk of the diversion 
of controlled substances used in research and related 
public safety considerations; and 
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(2) identification of opportunities to reduce any 
unnecessary burden on persons seeking registration, 
potential redundancies, and inefficiencies in the 
process to obtain or modify Federal authorization to 
conduct research with controlled substances, includ-
ing the process for obtaining a registration under 
section 303 of the Controlled Substances Act (21 
U.S.C. 823) and the process by which the Secretary 
of Health and Human Services reviews research pro-
tocols. 
(b) GUIDANCE.—Following the review described in 
subsection (a), the Attorney General and the Secretary of 
Health and Human Services shall, as appropriate, jointly 
issue guidance to registrants and potential registrants 
clarifying the process for registration under section 303 
of the Controlled Substances Act (21 U.S.C. 823). 
Æ 
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