I

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.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. DEFINITIONS.

4 Section 102(16) of the Controlled Substances Act is

5 amended by adding at the end thereof the following new

6 sentence: ‘‘Such term also does not include
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1 tetrahydrocannabinols not derived, extracted, or prepared

2 from plant Cannabis sativa L.’’.

3 SEC. 2. AUTHORIZING THE MEDICAL PRESCRIPTION OF

4 MARIHUANA.

5 (a) SCHEDULE I AMENDMENT.—Paragraph (c) of

6 schedule I of section 202(c) of the Controlled Substances

7 Act is amended—

8 (1) by striking out subparagraph (10);

9 (2) by redesignating subparagraphs (11)

10 through (17) as subparagraphs (10) through (16),

11 respectively; and

12 (3) by amending subparagraph (16) (as so re13 designated) to read as follows:

14 ‘‘(16) Tetrahydrocannabinols not derived, man15 ufactured, or prepared from the plant Cannabis

16 sativa L.’’.

17 (b) SCHEDULE II AMENDMENT.—Paragraph (a) of

18 schedule II of section 202(c) of the Controlled Substances

19 Act is amended by adding at the end thereof the following

20 new subparagraph:

21 ‘‘(5) Marihuana.’’.

22 SEC. 3. PRODUCTION AND DISTRIBUTION OF MEDICINAL

23 MARIHUANA.

24 (a) RULEMAKING.—Section 301 of the Controlled

25 Substances Act is amended by adding at the end thereof
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1 the following: ‘‘, except that rules and regulations specifi2 cally relating to the regulation and control of the produc3 tion, distribution, and dispensing of marihuana to sections

4 312 and 313 shall be promulgated by the Secretary.’’.

5 (b) PRODUCTION AND DISTRIBUTION.—Part C of the

6 Controlled Substances Act is amended by adding at the

7 end the following:

8 ‘‘OFFICE FOR THE SUPPLY OF INTERNATIONALLY

9 CONTROLLED DRUGS

10 ‘‘SEC. 311. (a) There is established in the Depart11 ment of Health and Human Services an office to be known

12 as the Office for the Supply of Internationally Controlled

13 Drugs (hereinafter referred to in this section and sections

14 312 and 313 as the ‘Office’). The Office shall be respon15 sible for regulating, administering, and supervising the do16 mestic production of marihuana and, in accordance with

17 section 313, for the distribution of marihuana for medical,

18 scientific, and research purposes.

19 ‘‘(b) The Office shall be under the direction of a Chief

20 Officer who shall be appointed by the Secretary. The Sec21 retary is authorized to delegate his powers and responsibil22 ities under sections 312 and 313 to the Chief Officer.

23 ‘‘PRODUCTION OF MEDICINAL MARIHUANA

24 ‘‘SEC. 312. (a) The Secretary shall take all necessary

25 actions to secure and maintain a supply of marihuana ade26 quate for the legitimate medical, research, scientific, and
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1 export needs of the United States. The Secretary shall de2 termine the total quantity of marihuana to be produced

3 each calendar year to provide for the estimated medical,

4 scientific, and research needs of the United States, for the

5 establishment of reserve stocks, and for any lawful export

6 requirements established by the Attorney General under

7 section 1003. Based on the determination under the pre8 ceding sentence, the Secretary shall recommend to the At9 torney General the aggregate production quotas that must

10 be established for marihuana under section 306(a). The

11 recommendations of the Secretary concerning aggregate

12 production quotas for marihuana shall be binding on the

13 Attorney General.

14 ‘‘(b)(1) In order to maintain an adequate supply of

15 marihuana, the Secretary shall periodically publish notices

16 soliciting bids on a contract or contracts for the domestic

17 cultivation and delivery of marihuana. All bids submitted

18 must specify the areas in which, and the land on which,

19 cultivation of marihuana will be conducted. All bids sub20 mitted must be accompanied by an application for reg21 istration under section 302.

22 ‘‘(2) The Secretary shall forward a copy of the reg23 istration application to the Attorney General. The Sec24 retary, after consultation with the Attorney General, shall

25 recommend to the Attorney General that the application
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1 for registration be granted or denied, taking into account

2 the factors set forth in section 303(a). The recommenda3 tions of the Secretary concerning the registration of appli4 cants to produce marihuana shall be binding on the Attor5 ney General.

6 ‘‘(3) The Secretary may accept or reject any bid that

7 is submitted by registered bidders, taking into consider8 ation (A) the factors set forth in section 303(a), and (B)

9 price. Marihuana may be produced only by accepted bid10 ders, solely on the land specified in the applicants’ bids.

11 The Secretary shall provide persons whose bids have been

12 accepted with marihuana seeds capable of germination.

13 Such seeds shall be obtained by the Secretary from legiti14 mate commercial producers of marihuana or, if this is not

15 feasible, the National Institute on Drug Abuse, the Attor16 ney General through the Drug Enforcement Administra17 tion, or the Secretary of Agriculture shall provide the Sec18 retary with an adequate supply of seeds capable of germi19 nation.

20 ‘‘(c) Upon acceptance of a bid for the production of

21 marihuana, the Secretary shall establish an individual

22 quota for the production of marihuana for the bidder and

23 shall recommend to the Attorney General that this quota

24 be assigned to the bidder where required under section

25 306. The recommendations of the Secretary concerning in-
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1 dividual quotas for the production of marihuana, including

2 recommendations that such a quota be decreased or in3 creased, shall be binding on the Attorney General.

4 ‘‘(d) The Secretary may revoke or suspend the ac5 ceptance of any bid for the production of marihuana prior

6 to the expiration of the contract executed on the basis of

7 the bid upon a finding by the Secretary (1) that the bidder

8 has materially breached the terms of the contract relating

9 to the maintenance of effective controls against diversion

10 of marihuana into other than legitimate medical, scientific,

11 and industrial channels; or (2) that any of the reasons

12 specified in section 304(a) are applicable. Upon such rev13 ocation or suspension, the Secretary shall recommend to

14 the Attorney General that the bidder’s registration for the

15 production of marihuana be revoked or suspended pursu16 ant to section 304 and such recommendations by the Sec17 retary shall be binding on the Attorney General.

18 ‘‘(e) Within four months of the end of the harvest

19 of marihuana grown by registered bidders pursuant to

20 contract with the Office, the Office or its delegate or dele21 gates shall take physical possession of the marihuana har22 vested.

23 ‘‘(f)(1) The Secretary may, at his discretion, periodi24 cally publish notices soliciting bids on a contract or con25 tracts for the physical collection, processing, and shipping
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1 of marihuana crops produced under contracts entered into

2 under subsection (b) or of imported or forfeited stocks de3 scribed in subsections (g) and (h). All bids submitted must

4 be accompanied by an application for registration under

5 section 302.

6 ‘‘(2) The Secretary shall forward a copy of the reg7 istration application to the Attorney General. The Sec8 retary, after consultation with the Attorney General, shall

9 recommend to the Attorney General that the application

10 for registration be granted or denied, taking into account

11 the factors set forth in section 303(b) and such rec12 ommendations of the Secretary shall be binding on the At13 torney General.

14 ‘‘(3) The Secretary may accept or reject any bids sub15 mitted by registered bidders, taking into consideration (A)

16 the factors set forth in section 303(b); (B) the provisions

17 in the bid for the processing of raw marihuana into medi18 cally usable forms, including the provisions for the mainte19 nance of controlled amounts of tetrahydrocannabinols in

20 each dosage unit; and (C) price.

21 ‘‘(g) If a supply of marihuana adequate to meet do22 mestic medical, scientific, and research needs is not ob23 tained through contractual arrangements with domestic

24 registered bidders, the Secretary shall declare that a state

25 of emergency exists. The declaration by the Secretary of
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1 a state of emergency due to inadequate domestic supplies

2 of marihuana shall have the same effect as a finding by

3 the Attorney General of an emergency due to inadequate

4 domestic supplies under section 1002(a)(2)(A). If no ap5 plicants are registered to import marihuana under sections

6 1007 and 1008 within sixty days of the date of the dec7 laration by the Secretary that a state of emergency exists,

8 the Secretary shall make arrangements for the direct im9 portation by the Office of a supply of marihuana adequate

10 for domestic medical, scientific, and research needs.

11 ‘‘(h) If, while a state of emergency declared under

12 subsection (g) exists, the Secretary finds that a supply of

13 marihuana adequate for domestic medical, scientific, and

14 research needs cannot be obtained through importation,

15 then the Secretary may request that the Attorney General

16 forward to the Office forfeited stocks of marihuana that

17 are unadulterated with other substances, pursuant to sec18 tion 511(e).

19 ‘‘DISTRIBUTION OF MEDICINAL MARIHUANA

20 ‘‘SEC. 313. (a) Marihuana shall be distributed only

21 to hospitals and pharmacies that are—

22 ‘‘(1) registered under section 303(f) to dispense

23 drugs in schedule II of section 202; and

24 ‘‘(2) specified by

25 ‘‘(A) an eligible physician who plans to use

26 marihuana in the treatment of the nausea of
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1 patients who are undergoing cancer chemo2 therapy or radiology or in the treatment of pa3 tients who have glaucoma, AIDS wasting syn4 drome, or muscle spasms from certain spastic

5 disorders, including multiple sclerosis, paraple6 gia, and quadriplegia; or

7 ‘‘(B) a person who has obtained approval

8 by the Secretary of an investigational new drug

9 application under section 505(i) of the Federal

10 Food, Drug, and Cosmetic Act for research in11 volving the use of marihuana.

12 ‘‘(b) In order to be certified as a physician eligible

13 for purposes of subsection (a)(2)(A), the physician must

14 file a written application with the Office seeking permis15 sion to use marihuana in his practice. Such an application

16 shall be approved or denied within thirty days of its receipt

17 by the Office, or, where possible, within such shorter time

18 as is deemed essential by the applicant in cases of medical

19 emergency. If an application is not acted upon within thir20 ty days of its receipt by the Office, it shall be deemed

21 approved. To be approved an application must affirma22 tively state—

23 ‘‘(1) that the applicant is a physician registered

24 under section 303(f) to dispense controlled drugs in

25 schedule II of section 202;
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1 ‘‘(2) the applicant’s registration number;

2 ‘‘(3) that the applicant will use the requested

3 marihuana solely for the treatment of glaucoma,

4 AIDS wasting syndrome, muscle spasms from cer5 tain spastic disorders, including multiple sclerosis,

6 paraplegia, and quadriplegia, or the nausea associ7 ated with cancer chemotherapy or radiology;

8 ‘‘(4) the name of all pharmacies or hospitals

9 registered to dispense schedule II drugs that the ap10 plicant is requesting that supplies of marihuana be

11 sent to;

12 ‘‘(5) that the applicant will inform the Office of

13 any adverse reactions by his patients to the use of

14 marihuana; and

15 ‘‘(6) that prior to administration of marihuana

16 to any patient, he will obtain from the patient a

17 signed consent form stating that informed patient

18 consent has been obtained.

19 Unless the Secretary determines that an application which

20 makes the statements required by the preceding sentence

21 contains a misstatement of fact, the application shall be

22 approved upon payment of a reasonable fee to cover the

23 costs of processing the application. Approval of a physi24 cian’s application may be suspended or revoked by the

25 Secretary for good cause shown.
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1 ‘‘(c)(1) Upon certification of a physician as eligible

2 under subsection (b), the Secretary shall issue serially

3 numbered marihuana order forms to all registered phar4 macies or hospitals listed on the eligible physician’s appli5 cation form. Whenever any such form is issued to a phar6 macy or hospital the Secretary shall, before delivery there7 of, insert therein the name of the pharmacy or hospital,

8 and it shall be unlawful for any other person (A) to use

9 such form for the purpose of obtaining controlled sub10 stances; or (B) to furnish such form to any person with

11 intent thereby to procure the distribution of such sub12 stances.

13 ‘‘(2) It shall be unlawful for any person to obtain by

14 means of order forms issued under this subsection con15 trolled substances for any purpose other than their use,

16 distribution, dispensing, or administration in the conduct

17 of a lawful business in such substances or in the course

18 of his professional practice or research.

19 ‘‘(3) Written orders made on marihuana order forms

20 issued under this subsection shall satisfy the requirements

21 of section 308(a).

22 ‘‘(4) The preservation and availability requirements

23 of section 308(c) apply to orders made on forms issued

24 under this subsection.
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1 ‘‘(d) Hospitals and pharmacies may obtain supplies

2 of marihuana only by forwarding a written order to the

3 Secretary on the form issued in blank in accordance with

4 subsection (c). Upon receipt from a hospital or pharmacy

5 of a properly completed marihuana order form requesting

6 a supply of marihuana the Office or its delegate or dele7 gates shall forward a supply of marihuana to the phar8 macy or hospital within a reasonable time. If notified by

9 an eligible physician that there is a medical urgency for

10 immediate shipment, the Office or its delegate or delegates

11 shall forward a supply of marihuana within five days of

12 such notice, or sooner if feasible. Also, upon receipt by

13 the Secretary of a written request of a person who has

14 obtained approval of an investigational new drug applica15 tion under section 505(i) of the Federal Food, Drug, and

16 Cosmetic Act for research involving the use of marihuana,

17 the Office or its delegate or delegates shall forward a sup18 ply of marihuana to the specified pharmacy or hospital

19 licensed to dispense schedule II drugs within a reasonable

20 time.

21 ‘‘(e) The Secretary is directed to set a price for mari22 huana that will recoup, within a reasonable time, all of

23 the costs incurred by the Federal Government in produc24 ing, processing, and distributing marihuana.
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1 ‘‘(f) Within six months from the date of the enact2 ment of this section, the Secretary, after consultation with

3 the Attorney General, shall promulgate regulations con4 sistent with public health and safety that are in accord

5 with the provisions of this title to ensure an adequate sup6 ply of medically usable marihuana and to ensure proper

7 safeguards regarding the production, storage, processing,

8 distribution, and dispensing of marihuana so as to prevent

9 its diversion into other than legitimate medical, scientific,

10 or research channels.’’.

11 (c) PENALTY.—Section 402(a) of the Controlled Sub12 stances Act is amended (1) by striking out ‘‘or’’ at the

13 end of paragraph (9), (2) by striking out the period at

14 the end of paragraph (10) and inserting in lieu thereof

15 ‘‘; or’’, and (3) by adding at the end the following new

16 paragraph:

17 ‘‘(11) to use an order form issued under section

18 313(c) in a manner prohibited by such section or to

19 furnish such a form in violation of such section.’’.

20 SEC. 4. COMPLIANCE WITH THE FEDERAL FOOD, DRUG,

21 AND COSMETIC ACT.

22 The Federal Food, Drug, and Cosmetic Act is amend23 ed by inserting after section 505 the following:

24 ‘‘THERAPEUTIC USE OF MARIHUANA

25 ‘‘SEC. 505A. (a) Notwithstanding section 505(a), the

26 approval of the Secretary shall not be required for the in-
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1 troduction or delivery of marihuana into interstate com2 merce in compliance with the requirements of sections 312

3 and 313 of the Controlled Substances Act.

4 ‘‘(b) Marihuana is defined as a prescription drug for

5 purposes of section 503(b). Only physicians who are eligi6 ble to obtain marihuana under section 313(b) of the Con7 trolled Substances Act may issue written prescriptions au8 thorizing the dispensing of marihuana under section

9 503(b).’’.

10 SEC. 5. AUTHORIZATION OF APPROPRIATIONS.

11 There is authorized to be appropriated not to exceed

12 $5,000,000 for the fiscal year 1996, and $5,000,000 for

13 the fiscal year 1997, for the use of the Office for the Sup14 ply of Internationally Controlled Drugs in conducting,

15 contracting for, supervising, and administering the pro16 duction, testing, processing, distribution, and dispensing

17 of marihuana.

18 SEC. 6. INTERIM PROVISIONS.

19 The Secretary of Health and Human Services shall

20 procure a supply of marihuana adequate for the scientific,

21 medical, and research needs of the United States within

22 12 months after the date of the enactment of this Act.

23 The Secretary of Health and Human Services and the At24 torney General shall ensure that persons now receiving

25 marihuana pursuant to research projects approved by the
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1 Secretary of Health and Human Services continue to re2 ceive uninterrupted supplies until the system for the proc3 essing and distribution of marihuana produced pursuant

4 to the Controlled Substances Act is fully operational.

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