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104th CONGRESS
1ST SESSION
H.R. 2618
IN THE HOUSE OF REPRESENTATIVES
MR. FRANK of Massachusetts, MR. JOHNSTON, MRS. PELOSI,
introduced the following bill; which was referred to the
Committee on
A BILL
To provide for the therapeutic use of marihuana in situations
involving life-threatening or sense-threatening illnesses
and to provide adequate supplies of marihuana for such
use.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. DEFINITIONS.
Section 102(16) of the Controlled Substances Act is
amended by adding at the end thereof the following new
sentence: "Such term also does not include
tetrahydrocannabinols not derived, extracted, or prepared
from plant Cannabis sativa L.".
SEC. 2. AUTHORIZING THE MEDICAL PRESCRIPTION OF
MARIHUANA.
(a) SCHEDULE I AMENDMENT. -- PARAGRAPH (C) OF
SCHEDULE I OF SECTION 202(C) OF THE CONTROLLED
SUBSTANCES ACT IS AMENDED --
(1) by striking out subparagraph (10);
(2) by redesignating subparagraphs (11)
through (17) as subparagraphs (10) through (16),
respectively; and
(3) by amending subparagraph (16) (as so re-
designated) to read as follows:
"(16) Tetrahydrocannabinols not derived, man-
ufactured, or prepared from the plant Cannabis
sativa L.".
(b) SCHEDULE II AMENDMENT. -- PARAGRAPH (A) OF
SCHEDULE II OF SECTION 202(C) OF THE CONTROLLED
SUBSTANCES ACT IS AMENDED BY ADDING AT THE END
THEREOF THE FOLLOWING NEW SUBPARAGRAPH:
"(5) Marihuana.".
SEC. 3. PRODUCTION AND DISTRIBUTION OF MEDICINAL
MARIHUANA.
(a) RULEMAKING. -- SECTION 301 OF THE CON-
TROLLED SUBSTANCES ACT IS AMENDED BY ADDING AT
THE END THEREOF THE FOLLOWING: ", EXCEPT THAT
RULES AND REGULATIONS SPECIFICALLY RELATING TO
THE REGULATION AND CONROL OF THE PRODUCTION,
DISTRIBUTION, AND DISPENSING OF MARIHUANA TO SEC-
TIONS 312 AND 313 SHALL BE PROMULGATED BY THE SEC-
RETARY.".
(b) PRODUCTION AND DISTRIBUTION. -- PART C OF
THE CONTROLLED SUBSTANCES ACT IS AMENDED BY
ADDING AT THE END THE FOLLOWING:
"OFFICE FOR THE SUPPLY OF INTERNATIONALLY
CONTROLLED DRUGS
"SEC. 311. (a) There is established in the Depart-
ment of Health and Human Services an office to be known
as the Office for the Supply of Internationally Controlled
Drugs (hereinafter referred to in this section and sections
312 and 313 as the 'Office'). The Office shall be respon-
sible for regulating, administering, and supervising the do-
mestic production of marihuana and, in accordance with
section 313, for the distribution of marihuana for medical,
scientific, and research purposes.
"(b) The Office shall be under the direction of a Chief
Officer who shall be appointed by the Secretary. The Sec-
retary is authorized to delegate his powers and responsibil-
ities under sections 312 and 313 to the Chief Officer.
"PRODUCTION OF MEDICINAL MARIHUANA
"SEC. 312. (a) The Secretary shall take all necessary
actions to secure and maintain a supply of marihuana ade-
quate for the legitimate medical, research, scientific, and
export needs of the United States. The Secretary shall de-
termine the total quantity of marihuana to be produced
each calendar year to provide for the estimated medical,
scientific, and research needs of the United States, for the
establishment of reserve stocks, and for any lawful export
requirements established by the Attorney General under
section 1003. Based on the determination under the pre-
ceding sentence, the Secretary shall recommend to the At-
torney General the aggregate production quotas that must
be established for marihuana under section 306(a). The
recommendation of the Secretary concerning the aggregate
production quotas for marihuana shall be binding on the
Attorney General.
"(b)(1) In order to maintain an adequate supply of
marihuana, the Secretary shall periodically publish notices
soliciting bids on a contract or contracts for the domestic
cultivation and delivery of marihuana. All bids submitted
must specify the areas in which, and the land on which,
cultivation of marihuana will be conducted. All bids sub-
mitted must be accompanied by an application for reg-
istration under section 302.
"(2) The Secretary shall forward a copy of the reg-
istration application to the Attorney General. The Sec-
retary, after consultation with the Attorney General, shall
recommend to the Attorney General that the application
for registration be granted or denied, taking into account
the factors set forth in section 303(a). The recommenda-
tions of the Secretary concerning the registration of appli-
cants to produce marihuana shall be binding on the Attor-
ney General.
"(3) The Secretary may accept of reject any bid that
is submitted by registered bidders, taking into consider-
ation (A) the factors set forth in section 303(a), and (B)
price. Marihuana may be produced only by accepted bid-
ders, solely on the land specified in the applicants' bids.
The Secretary shall provide persons whose bids have been
accepted with marihuana seeds capable of germination.
Such seeds shall be obtained by the Secretary from legiti-
mate commercial producers of marihuana or, if this is not
feasible, the National Institute on Drug Abuse, the Attor-
ney General through the Drug Enforcement Administra-
tion, or the Secretary of Agriculture shall provide the Sec-
retary with an adequate supply of seeds capable of germi-
nation.
"(c) Upon acceptance of a bid for the production of
marihuana, the Secretary shall establish an individual
quota for the production of marihuana for the bidder and
shall recommend to the Attorney General that this quota
be assigned to the bidder where required under section
306. The recommendations of the Secretary concerning in-
dividual quotas for the production of marihuana, including
recommendations that such a quota be decreased or in-
creased, shall be binding on the Attorney General.
"(d) The Secretary may revoke or suspend the ac-
ceptance of any bid for the production of marihuana prior
to the expiration of the contract executed on the basis of
the bid upon a finding by the Secretary (1) that the bidder
has materially breached the terms of the contract relating
to the maintenance of effective controls against diversion
of marihuana into other than legitimate medical, scientific,
and industrial channels; or (2) that any of the reasons
specified in section 304(a) are applicable. Upon such rev-
ocation or suspension, the Secretary shall recommend to
the Attorney General that the bidder's registration for the
production of marihuana be revoked or suspended pursu-
ant to section 304 and such recommendatios by the Sec-
retary shall be binding on the Attorney General.
"(e) Within four months of the end of the harvest
of marihuana grown by registered bidders pursuant to
contract with the Office, the Office or its delegate or dele-
gates shall take physical possession of the marihuana har-
vested.
"(f)(1) The Secretary may, at his discretion, periodi-
cally publish notices soliciting bids on a contract of con-
tracts for the physical collection, processing, and shipping
of marihuana crops produced under contracts entered into
under subsection (b) or of imported or forfeited stocks de-
scribed in subsections (g) and (h). All bids submitted must
be accompanied by an application for registration under
section 302.
"(2) The Secretary shall forward a copy of the reg-
istration application to the Attorney General. The Sec-
retary, after consultation with the Attorney General, shall
recommend to the Attorney General that the application
for registration be granted or denied, taking into account
the factors set forth in section 303(b) and such rec-
ommendatios of the Secretary shall be binding on the At-
ttorney General.
"(3) The Secretary may accept or reject any bids sub-
mitted by registered bidders, taking into consideration (A)
the factors set forth in section 303(b); (B) the provisions
in the bid for the processing of raw marihuana into medi-
cally usable forms, including the provisions for the mainte-
nance of controlled amounts of tetrahydrocannabinols in
each dosage unit; and (C) price.
"(g) If a supply of marihuana adequate to meet do-
mestic medical, scientific, and research needs is not ob-
tained through contractual arrangements with domestic
registered bidders, the Secretary shall declare that a state
of emergency exists. The declaration by the Secretary of
a state of emergency due to inadequate domestic supplies
of marihuana shall have the same effect as a finding by
the Attorney General of an emergency due to inadequate
domestic supplies under section 1002(a)(2)(A). If no ap-
plicants are registered to import marihuana under sections
1007 and 1008 within sixty days of the date of the dec-
laration by the Secretary that a state of emergency exists,
the Secretary shall make arrangements for the direct im-
portation by the Office of a supply of marihuana adequate
for domestic medical, scientific, and research needs.
"(h) If, while a state of emergency declared under
subsection (g) exists, the Secretary finds that a supply of
marihuana adequate for domestic medical, scientific, and
research needs cannot be obtained through importation,
then the Secretary may request that the Attorney General
forward to the Office forfeited stocks of marihuana that
are unadulterated with other substances, pursuant to sec-
tion 511(e).
"DISTRIBUTION OF MEDICINAL MARIHUANA
"SEC. 313. (a) Marihuana shall be distributed only
to hospitals and pharmacies that are --
"(1) registered under section 303(f) to dispense
drugs in schedule II of section 202; and
"(2) specified by (A) an eligible physician who
plans to use marihuana in the treatment of the nau-
sea of patients who are undergoing cancer chemo-
therapy or radiology or in the treatment of patients
who have glaucoma, AIDS wasting syndrome, or
muscle spasms from certain spastic disorders, in-
cluding multiple sclerosis, paraplegia, and quadriple-
gia; or (B) a person who has obtained approval by
the Secretary of an investigational new drug applica-
tion under section 505(i) of the Federal Food, Drug,
and Cosmetic Act for research involving the use of
marihuana.
"(b) In order to be certified as a physician eligible
for purposes of subsection (a)(2)(A), the physician must
file a written application with the Office seeking permis-
sion to use marihuana in his practice. Such an application
shall be approved or denied within thirty days of its receipt
by the Office, or, where possible, within such shorter time
as is deemed essential by the applicant in cases of medical
emergency. If an application is not acted upon within thir-
ty days of its receipt by the Office, it shall be deemed
approved. To be approved an application must affirma-
tively state (1) that the applicant is a physician registered
under section 303(f) to dispense controlled drugs in sched-
ule II of section 202; (2) the applicants's registration num-
ber; (3) that the applicant will use the requested mari-
huana solely for the treatment of glaucoma, AIDS wasting
syndrome, muscle spasms from certain spastic disorders,
including multiple sclerosis, paraplegia, and quadriplegia,
or the nausea associated with cancer chemotherapy or ra-
diology; (4) the name of all pharmacies or hospitals reg-
istered to dispense schedule II drugs that the applicant
is requesting that supplies of marihuana be sent to; (5)
that the applicant will inform the Office of any adverse
reactions by his patients to the use of marihuana; and (6)
that prior to administratio of marihuana to any patient,
he will obtain from the patient a signed consent form stat-
ing that informed patient consent has been obtained. Un-
less the Secretary determines that an application which
makes the statements required by the preceding sentence
contains a misstatement of fact, the application shall be
approved upon payment of a reasonable fee to cover the
costs of processing the application. Approval of the phys-
cian's application may be suspended or revoked by the
Secretary for good cause shown.
"(c)(1) Upon certification of a physician as eligible
under subsection (b), the Secretary shall issue serially
numbered marihuana oder forms to all registered phar-
macies or hospitals listed on the eligible physician's appli-
cation form. Whenever any such form is issued to a phar-
macy or hospital the Secretary shall, before delivery there-
of, insert therein the name of the pharmacy or hospital,
and it shall be unlawful for any other person (A) to use
such form for the purpose of obtaining controlled sub-
stances; or (B) to furnish such form to any person with
intent thereby to procure the distribution of such sun-
stances.
"(2) It shall be unlawful for any person to obtain by
means of order forms issued under this subsection con-
trolled substances for any purpose other than their use,
distribution, dispensing, or administration in the conduct
of a lawful business in such substances or in the course
or his professional practice or research.
"(3) Written orders made on marihuana order forms
issued under this subsection shall satisfy the requirements
of section 308(a).
"(4) The preservation and availability requirements
of section 308(c) apply to orders made on forms issued
under this subsection.
"(d) Hospitals and pharmacies may obtain supplies
of marihuana only by forwarding a written order to the
Secretary on the form issued in blank in accordance with
subsection (c). Upon receipt from a hospital or pharmacy
of a properly completed marihuana order form requesting
a supply of marihuana the Office or its delegate or dele-
gates shall forward a supply of marihuana to the phar-
macy or hospital within a reasonable time. If notified by
an eligible physician that there is a medical urgency for
immediate shipment, the Office or its delegate or delegates
shall forward a supply of marihuana within five days of
such notice, or sooner if feasible. Also, upon receipt by
the Secretary of a written request of a person who has
obtained approval of an investigational new drug applica-
tion under section 505(i) of the Federal Food, Drug, and
Cosmetic Act for research involving the use of marihuana,
the Office or its delegate or delegates shall forward a sup-
ply of marihuana to the specified pharmacy or hospital
licensed to dispense schedule II drugs within a reasonable
time.
"(e) The Secretary is directed to set a price for mari-
huana that will recoup, within a reasonable time, all of
the costs incurred by the Federal Government in produc-
ing, processing, and distributing marihuana.
"(f) Within six months from the date of the enact-
ment of this section, the Secretary, after consultation with
the Attorney General, shall promulgate regulations con-
sistent with public health and safety that are in accord
with the provisions of this title to ensure adequate sup-
ply of medically usable marihuana and to ensure proper
safeguards regarding the production, storage, processing,
distribution, and dispensing of marihuana so as to prevent
its diversion into other than legitimate medical, scientific,
or research channels.".
(c) Penalty. -- Section 402(a) of the Controlled Sub-
stances Act is amended (1) by striking out "or" at the
end of paragraph (9), (2) by stiking out the period at
the end of paragraph (10) and inserting in lieu thereof
"; or", and (3) by adding at the end the following new
paragraph:
"(11) to use an oder form issued under section
313(c) in a manner prohibited by such section or to
furnish such a form in violation of such section.".
SEC. 4. COMPLIANCE WITH THE FEDERAL FOOD, DRUG,
AND COSMETIC ACT.
The Federal Food, Drug, and Cosmetic Act is amend-
ed by inserting after section 505 the following:
"THERAPEUTIC USE OF MARIHUANA
"SEC. 505A. (a) Nothwithstanding section 505(a), the
approval of the Secretary shall not be required for the in-
troduction or delivery of marihuana into interstate com-
merce in compliance with the requirements of sections 312
and 313 of the Controlled Substances Act.
"(b) Marihuana is defined as a prescription drug for
purposes of section 503(b). Only physicians who are eligi-
ble to obtain marihuana under section 313(b) of the Con-
trolled Substances Act may issue written prescriptions au-
thorizing the dispensing or marihuana under section
503(b).".
SEC. 5. AUTHORIZATION OF APPROPRIATIONS.
There is authorized to be appropriated not to exceed
$5,000,000 for the fiscal year 1996, and $5,000,000 for
the fiscal year 1997, for the use of the Office for the Sup-
ply of Internationally Controlled Drugs in conducting,
contracting for, supervising, and administering the pro-
duction, testing, processing, distribution, and dispensing
of marihuana.
SEC. 6. INTERIM PROVISIONS.
The Secretary of Health and Human Services shall
procure a supply of marihuana adequate for the scientific,
medical, and research needs of the United States within
12 months after the date of the enactment of this Act.
The Secretary of Health and Human Services and the At-
torney General shall ensure that persons now receiving
marihuana pursuant to research projects approved by the
Secretary of Health and Human Services continue to re-
ceive uninterrupted supplies until the system for the proc-
essing and distribution of marihuana produced pursuant
to the Controlled Substances Act is fully operational.