‘‘(b) A person shall not be subject to a criminal or 
civil penalty under this title or under any other Federal 
law solely for possession of a schedule A controlled sub-
stance.’’. 
(b) CONTROLLED SUBSTANCES IMPORT AND EXPORT 
ACT.—Section 1010(b) of the Controlled Substances Im-
port and Export Act (21 U.S.C. 960(b)) is amended by 
adding at the end the following: 
‘‘(8) In the case of a violation under subsection (a) 
involving a controlled substance in schedule A, the person 
committing such violation shall be sentenced to a term of 
imprisonment of not more than 20 years and if death or 
serious bodily injury results from the use of such sub-
stance shall be sentenced to a term of imprisonment of 
not less than 20 years and not more than life, a fine not 
to exceed the greater of that authorized in accordance with 
the provisions of title 18, United States Code, or 
$1,000,000 if the defendant is an individual or $5,000,000 
if the defendant is other than an individual, or both. If 
any person commits such a violation after a prior convic-
tion for a felony drug offense has become final, such per-
son shall be sentenced to a term of imprisonment of not 
more than 30 years and if death or serious bodily injury 
results from the use of such substance shall be sentenced 
to life imprisonment, a fine not to exceed the greater of 
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twice that authorized in accordance with the provisions of 
title 18, United States Code, or $2,000,000 if the defend-
ant is an individual or $10,000,000 if the defendant is 
other than an individual, or both. Notwithstanding section 
3583 of title 18, United States Code, any sentence impos-
ing a term of imprisonment under this paragraph shall, 
in the absence of such a prior conviction, impose a term 
of supervised release of not less than 3 years in addition 
to such term of imprisonment and shall, if there was such 
a prior conviction, impose a term of supervised release of 
not less than 6 years in addition to such term of imprison-
ment. Notwithstanding the prior sentence, and notwith-
standing any other provision of law, the court shall not 
place on probation or suspend the sentence of any person 
sentenced under the provisions of this paragraph which 
provide for a mandatory term of imprisonment if death 
or serious bodily injury results.’’. 
SEC. 5. FALSE LABELING OF SCHEDULE A CONTROLLED 
SUBSTANCES. 
(a) IN GENERAL.—Section 305 of the Controlled 
Substances Act (21 U.S.C. 825) is amended by adding at 
the end the following: 
‘‘(f) FALSE
LABELING
OF
SCHEDULE
A CON-
TROLLED SUBSTANCES.— 
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‘‘(1) It shall be unlawful to import, export, 
manufacture, distribute, dispense, or possess with 
intent to manufacture, distribute, or dispense, a 
schedule A substance or product containing a sched-
ule A substance, unless the substance or product 
bears a label clearly identifying a schedule A sub-
stance or product containing a schedule A substance 
by the nomenclature used by the International 
Union of Pure and Applied Chemistry (IUPAC). 
‘‘(2)(A) A product described in subparagraph 
(B) is exempt from the International Union of Pure 
and Applied Chemistry nomenclature requirement of 
this subsection if such product is labeled in the man-
ner required under the Federal Food, Drug, and 
Cosmetic Act. 
‘‘(B) A product is described in this subpara-
graph if the product— 
‘‘(i) is the subject of an approved applica-
tion as described in section 505(b) or (j) of the 
Federal Food, Drug, and Cosmetic Act; or 
‘‘(ii) is exempt from the provisions of sec-
tion 505 of such Act relating to new drugs be-
cause— 
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‘‘(I) it is intended solely for investiga-
tional use as described in section 505(i) of 
such Act; and 
‘‘(II) such product is being used ex-
clusively for purposes of a clinical trial 
that is the subject of an effective investiga-
tional new drug application.’’. 
(b) PENALTIES.—Section 402 of the Controlled Sub-
stances Act (21 U.S.C. 842) is amended— 
(1) in subsection (a)(16), by inserting ‘‘or sub-
section (f)’’ after ‘‘subsection (e)’’; and 
(2) in subsection (c)(1)(D), by inserting ‘‘or a 
schedule A substance’’ after ‘‘anabolic steroid’’. 
SEC. 6. REGISTRATION REQUIREMENTS FOR HANDLERS OF 
SCHEDULE A SUBSTANCES. 
(a) CONTROLLED SUBSTANCES ACT.—Section 303 of 
the Controlled Substances Act (21 U.S.C. 823) is amend-
ed— 
(1) in subsection (f), in the undesignated mat-
ter following paragraph (5)— 
(A) by inserting ‘‘or A’’ after ‘‘schedule I’’ 
each place it appears; and 
(B) by adding at the end the following: ‘‘A 
separate registration for engaging in research 
with a controlled substance in schedule A for 
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practitioners already registered under this part 
to engage in research with controlled substances 
in schedule I shall not be required. The Sec-
retary shall determine the merits of the re-
search protocol submitted by the practitioner 
registering to engage in research with a con-
trolled substance in schedule A, and the Attor-
ney General may deny or revoke the registra-
tion only on a ground specified in section 304.’’; 
and 
(2) by adding at the end the following: 
‘‘(k)(1) The Attorney General shall register an appli-
cant to manufacture schedule A substances if— 
‘‘(A) the applicant demonstrates that the sched-
ule A substances will be used for research, analyt-
ical, or industrial purposes approved by the Attorney 
General; and 
‘‘(B) the Attorney General determines that such 
registration is consistent with the public interest and 
with the United States obligations under inter-
national treaties, conventions, or protocols in effect 
on the date of enactment of this subsection. 
‘‘(2) In determining the public interest under para-
graph (1)(B), the Attorney General shall consider— 
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‘‘(A) maintenance of effective controls against 
diversion of particular controlled substances and any 
controlled substance in schedule A compounded 
therefrom into other than legitimate medical, sci-
entific, research, or industrial channels, by limiting 
the importation and bulk manufacture of such con-
trolled substances to a number of establishments 
which can produce an adequate and uninterrupted 
supply of these substances under adequately com-
petitive conditions for legitimate medical, scientific, 
research, and industrial purposes; 
‘‘(B) compliance with applicable State and local 
law; 
‘‘(C) promotion of technical advances in the art 
of manufacturing substances described in subpara-
graph (A) and the development of new substances; 
‘‘(D) prior conviction record of applicant under 
Federal and State laws relating to the manufacture, 
distribution, or dispensing of substances described in 
paragraph (A); 
‘‘(E) past experience in the manufacture of con-
trolled substances, and the existence in the establish-
ment of effective control against diversion; and 
‘‘(F) such other factors as may be relevant to 
and consistent with the public health and safety. 
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