Marijuana Policy Project

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

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.'.

(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.'.

(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:

`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.

`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).

`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.'.

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

`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).'.

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.

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.