[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2618 Introduced in House (IH)]







104th CONGRESS
  1st Session
                                H. R. 2618

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.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           November 10, 1995

 Mr. Frank of Massachusetts (for himself, Mr. Johnston of Florida, and 
 Ms. Pelosi) introduced the following bill; which was referred to the 
    Committee on Commerce, and in addition to the Committee on the 
 Judiciary, for a period to be subsequently determined by the Speaker, 
 in each case for consideration of such provisions as fall within the 
                jurisdiction of the committee concerned

_______________________________________________________________________

                                 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 Representatives 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 redesignated) to 
        read as follows:
            ``(16) Tetrahydrocannabinols not derived, manufactured, 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 Controlled Substances Act is 
amended by adding at the end thereof the following: ``, except that 
rules and regulations specifically relating to the regulation and 
control of the production, distribution, and dispensing of marihuana to 
sections 312 and 313 shall be promulgated by the Secretary.''.
    (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 Department 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 
responsible for regulating, administering, and supervising the domestic 
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 Secretary is authorized to 
delegate his powers and responsibilities 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 adequate for the legitimate 
medical, research, scientific, and export needs of the United States. 
The Secretary shall determine 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 preceding sentence, the Secretary shall 
recommend to the Attorney General the aggregate production quotas that 
must be established for marihuana under section 306(a). The 
recommendations of the Secretary concerning 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 
submitted must be accompanied by an application for registration under 
section 302.
    ``(2) The Secretary shall forward a copy of the registration 
application to the Attorney General. The Secretary, 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 recommendations of 
the Secretary concerning the registration of applicants to produce 
marihuana shall be binding on the Attorney General.
    ``(3) The Secretary may accept or reject any bid that is submitted 
by registered bidders, taking into consideration (A) the factors set 
forth in section 303(a), and (B) price. Marihuana may be produced only 
by accepted bidders, 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 legitimate commercial producers of 
marihuana or, if this is not feasible, the National Institute on Drug 
Abuse, the Attorney General through the Drug Enforcement 
Administration, or the Secretary of Agriculture shall provide the 
Secretary with an adequate supply of seeds capable of germination.
    ``(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 individual quotas 
for the production of marihuana, including recommendations that such a 
quota be decreased or increased, shall be binding on the Attorney 
General.
    ``(d) The Secretary may revoke or suspend the acceptance 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 revocation or suspension, the 
Secretary shall recommend to the Attorney General that the bidder's 
registration for the production of marihuana be revoked or suspended 
pursuant to section 304 and such recommendations by the Secretary 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 delegates shall take physical possession of 
the marihuana harvested.
    ``(f)(1) The Secretary may, at his discretion, periodically publish 
notices soliciting bids on a contract or contracts for the physical 
collection, processing, and shipping of marihuana crops produced under 
contracts entered into under subsection (b) or of imported or forfeited 
stocks described 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 registration 
application to the Attorney General. The Secretary, 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 
recommendations of the Secretary shall be binding on the Attorney 
General.
    ``(3) The Secretary may accept or reject any bids submitted 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 medically usable forms, including the provisions for 
the maintenance of controlled amounts of tetrahydrocannabinols in each 
dosage unit; and (C) price.
    ``(g) If a supply of marihuana adequate to meet domestic medical, 
scientific, and research needs is not obtained 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 applicants are registered to import 
marihuana under sections 1007 and 1008 within sixty days of the date of 
the declaration by the Secretary that a state of emergency exists, the 
Secretary shall make arrangements for the direct importation 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 section 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 nausea of patients 
                who are undergoing cancer chemotherapy or radiology or 
                in the treatment of patients who have glaucoma, AIDS 
                wasting syndrome, or muscle spasms from certain spastic 
                disorders, including multiple sclerosis, paraplegia, 
                and quadriplegia; or
                    ``(B) a person who has obtained approval by the 
                Secretary of an investigational new drug application 
                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 permission 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 thirty days of its receipt 
by the Office, it shall be deemed approved. To be approved an 
application must affirmatively state--
            ``(1) that the applicant is a physician registered under 
        section 303(f) to dispense controlled drugs in schedule II of 
        section 202;
            ``(2) the applicant's registration number;
            ``(3) that the applicant will use the requested marihuana 
        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 radiology;
            ``(4) the name of all pharmacies or hospitals registered 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 administration of marihuana to any 
        patient, he will obtain from the patient a signed consent form 
        stating that informed patient consent has been obtained.
Unless 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 a 
physician'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 
order forms to all registered pharmacies or hospitals listed on the 
eligible physician's application form. Whenever any such form is issued 
to a pharmacy or hospital the Secretary shall, before delivery thereof, 
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 substances; or (B) to furnish such form to any 
person with intent thereby to procure the distribution of such 
substances.
    ``(2) It shall be unlawful for any person to obtain by means of 
order forms issued under this subsection controlled 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 of 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 
delegates shall forward a supply of marihuana to the pharmacy 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 application 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 supply 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 marihuana that 
will recoup, within a reasonable time, all of the costs incurred by the 
Federal Government in producing, processing, and distributing 
marihuana.
    ``(f) Within six months from the date of the enactment of this 
section, the Secretary, after consultation with the Attorney General, 
shall promulgate regulations consistent with public health and safety 
that are in accord with the provisions of this title to ensure an 
adequate supply 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 Substances Act is 
amended (1) by striking out ``or'' at the end of paragraph (9), (2) by 
striking 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 order 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 amended by inserting 
after section 505 the following:

                     ``therapeutic use of marihuana

    ``Sec. 505A. (a) Notwithstanding section 505(a), the approval of 
the Secretary shall not be required for the introduction or delivery of 
marihuana into interstate commerce 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 eligible to obtain marihuana 
under section 313(b) of the Controlled Substances Act may issue written 
prescriptions authorizing the dispensing of 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 Supply of Internationally Controlled Drugs in 
conducting, contracting for, supervising, and administering the 
production, 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 
Attorney General shall ensure that persons now receiving marihuana 
pursuant to research projects approved by the Secretary of Health and 
Human Services continue to receive uninterrupted supplies until the 
system for the processing and distribution of marihuana produced 
pursuant to the Controlled Substances Act is fully operational.
                                 <all>