Robert Kowalski and I took a stab at drafting a Bill, and we would love to get your feedback.
As always, thank you for your continued support!
-Rico
118th CONGRESS
1st Session H.R. —-
(Projected Date) 1/13/2022
Short Title
This Act may be cited as the “ Lynn Pierson Compassionate Care Act”
A BILL
To provide for the therapeutic use of cannabis by Veterans of the United States Armed Forces suffering from service connected injuries, and to provide them adequate supplies of cannabis for such use.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
DEFINITIONS
Section 1. (a.) Section 102(15) 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 the plant Cannabis sativa L.”.
AUTHORIZING THE MEDICAL PRESCRIPTION OF CANNABIS
SEC. 2. (a.) Paragraph (c) of schedule I of section 202(c) of the Controlled Substances Act is amended –
By striking out subparagraph (10);
By redesignating subparagraphs (11) through (17) as subparagraphs (10) through (16), respectively; and
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) Paragraph (a) of schedule I of section 202(c) of the Controlled Substances Act is amended by adding at the end thereof the following new subparagraph:
“(5) Cannabis.”.
PRODUCTION AND DISTRIBUTION OF MEDICINAL CANNABIS
SEC. 3. (a) Section 301 of the Controlled Substances Act is amended 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 cannabis pursuant to sections 312 and 313 shall be promulgated by the Secretary.”.
(b) Part C of the Controlled Substances Act is amended by adding at the end thereof the following new sections:
“Office of Cannabis Regulation”
“SEC. 311. (a) There is established in the Department of Health and Human Services an office to be known as the Office of Cannabis Regulation (hereinafter referred to as the “Office”). The Office shall be responsible for the regulating, administering, and supervising the domestic production of cannabis and, in accordance with section 313, for the distribution of cannabis 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 their powers and responsibilities under sections 312 and 313 to the Chief Officer.
“PRODUCTION OF MEDICINAL CANNABIS
“SEC. 312. (a) The Secretary shall take all necessary actions to secure and maintain a supply of cannabis adequate for the legitimate medical, research, scientific, and export needs of the United States. The Secretary shall determine the total quantity of cannabis 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 the aggregate production of quotas that must be established for cannabis under section 306(a). The recommendations of the Secretary concerning aggregate production quotas for cannabis shall be binding on the Attorney General.
“(b)(1) In order to maintain an adequate supply of cannabis, the Secretary shall periodically publish notices soliciting bids on a contract or contracts for the domestic cultivation of cannabis 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 cannabis 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. Cannabis may be produced for federal use only by accepted bidders, solely on the land specified in the applicants’ bids. The Secretary shall provide persons whose bids have been accepted with cannabis, 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 cannabis, the Secretary shall establish an individual quota for the production of cannabis 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 cannabis, 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 cannabis prior to the expiration of the contract executed on the basis of the bid upon 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 cannabis grown for federal purposes, and 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 cannabis 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 cannabis grown by registered bidders pursuant to contract with the Office, the Office or its delegate or delegates shall take physical possession of the cannabis harvested.
“(f)(1) The Secretary may, at their discretion, periodically publish notices soliciting bids on a contract or contracts for the physical collection, processing, and shipping of cannabis 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 theAttorney 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 recommendation 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 cannabis into required forms for medical use, including the provisions for the maintenance of controlled amounts of tetrahydrocannabinols in each dosage unit; and (C) price.
“g) If a supply of cannabis 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 cannabis 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 cannabis 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 cannabis 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 cannabis 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 cannabis that are unadulterated with other substances, pursuant to section 511(e).
“DISTRIBUTION OF MEDICINAL CANNABIS
“SEC. 313. (a) Cannabis shall be distributed through the Veterans Health Administration, or other hospitals and pharmacies that are –
“(1) specified by (A) an eligible physician who plans to use cannabis in the treatment of their patient; 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 cannabis.
“(b) In order to be certified as a physician eligible for purposes of subsection (a)(2)(A), a physician must be authorized to practice medicine within the Veterans Health Administration; or a physician must file a written application with the Office seeking permission to use cannabis provided by the Office in their practice. Such an application shall be approved or denied within thirty days of its receipt by the Office, or, where possible, within such a 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 substances; (2) the applicant’s registration number; (3) that the applicant will use the requested cannabis solely for stated purposes in their application; (4) the name of all pharmacies or hospitals outside of the Veterans Health Administration registered to dispense controlled substances that the applicant is requesting that supplies of cannabis be sent to’ (5) that the applicant will inform the Office of any adverse reactions by their patients due to the quality of cannabis provided by the Office; (6) Unless the Secretary determines that an application 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 cannabis order forms to the Veterans Health Administration, and all other 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 the 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 their professional practice or research.
“(3) Written orders made on cannabis order forms issued under this subsection shall satisfy the requirements of section 308(c) apply to orders made on forms issued under this subsection.
“(4) The preservation and availability requirements of section 308(c) apply to orders made on forms issued under this subsection.
“(d) The Veterans Health Administration will be directed to identify strategic locations across the country which will serve as distribution points for veterans being prescribed medical cannabis, and to stock the pharmacies of other hospitals within their Veterans Integrated Services Networks. Other hospitals and pharmacies outside of the Veterans Health Administration may obtain supplies of cannabis 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 outside of the Veterans Health Administration of a properly completed cannabis order form requesting a supply of cannabis the Office or its delegate or delegates shall forward a supply of cannabis to the pharmacy or hospital that is outside of the Veterans Health Administration 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 cannabis within five days of such notice, or sooner if feasible. Also, upon receipt by the Secretary of a written request by 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 cannabis, the Office or its delegate or delegates shall forward a supply of cannabis to the specified pharmacy or hospital licensed to dispense medical cannabis within reasonable time. Veterans who are rated for service connected disabilities, and who have initiated care through a state run medical cannabis program may maintain their chosen treatment plan, and shall be provided a voucher of up to ten grams of cannabis per day, based upon their disability rating and need.
“(e) The Secretary is directed to set a price for cannabis that will recoup, within a reasonable time, all of the costs incurred by the Federal Government in producing, processing, and distributing cannabis outside of the Veterans Health Administration.
“(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 cannabis and to ensure proper safeguards regarding the production, storage, processing, distribution, and dispensing of cannabis so as to prevent its diversion into other than legitimate medical, scientific, or research channels.”.
(c) Section 402(a) of the Controlled Substances Act is amended (1) by striking out “or” at the end of paragraph (8), (2) by striking out the period at the end of paragraph (9) and inserting in lieu thereof; or”, and (3) by adding at the end the following new paragraph:
“(10) 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.”.
COSMETIC ACT
SEC. 4 The Federal Food, Drug, and Cosmetic Act is amended by inserting after section 505 the following new section:
“THERAPEUTIC USE OF CANNABIS
“SEC. 505A. (a) Notwithstanding the provisions of section 505(a), the approval of the Secretary shall not be required for the introduction or delivery of cannabis into interstate commerce in compliance with the requirements of sections 312 and 313 of the Controlled Substances Act.
“(b) Cannabis is a medicinal herb with an ancient history of use among humans across the world. As such the regulations and safeguards surrounding its use must be, by its very nature, unique when compared to regularly prescribed pharmaceutical drugs. Any qualified physician in good standing within the United States may issue written prescriptions authorizing the dispensing of cannabis.
AUTHORIZATION OF APPROPRIATIONS
SEC. 5. There is authorized to be appropriated not to exceed $22,000,000 for the fiscal year ending September 30, 2022, and $22,000,000 for the fiscal year ending September 30, 2023, for the use of the Office, and the Veterans Health Administration in conducting, contracting for, supervising, and administering the production, testing, processing, distribution, research and dispensing of cannabis.
INTERIM PROVISIONS
SEC. 6. The Secretary of Health and Human Services shall procure a supply of cannabis adequate for the scientific, medical, and research needs of the United States within twelve months of the date of the enactment of this Act. The Secretary of Health and Human Services, Secretary of the Veterans Health Administration, and the Attorney General shall ensure that persons now receiving cannabis pursuant to state medical cannabis programs approved by their respective state legislators continue to receive the care they are receiving until the system for the processing and distribution of cannabis produced pursuant to the Controlled Substances Act is fully operational.
ADDITIONAL GUIDANCE FOR VETERANS
SEC. 7. When signed into law by the President of the United States, H.R. —-:
Releases to the public data collected per VA directive 1315 and its predecessors, since 2011;
Releases to the public all relevant data from the federal compassionate IND program pertaining to the safety, and efficacy of cannabis being used by the participating federal patients who have passed away, since 1976;
Provides for training and continuing education uniformly across the Veterans Integrated Service Network (VISN) level including, but not limited to the history of cannabis medicine; the function of the endocannabinoid system; new discoveries as research is conducted; and federal/state policy in order to best uniformly integrate treatment into federal patient care;
Uniformly expands the federal Compassionate Investigational New Drug Program (IND) through the VA;
Recognizes veterans enrolled with, and receiving care from the VA as federal patients, requiring laws/policy being applied uniformly in all fifty states and territories of the U.S., reflecting the unique status of military (federal) personnel;
Provides an identifier on VA patient data cards identifying participating Veterans as federal cannabis patients; eliminating threat of prosecution/incarceration while traveling within the U.S. or on federal property with their medicine;
Provides for VA to grow cannabis for veterans participating in the expanded IND program, and occupational therapy programs. Uniformly promoting home cultivation, and medicinal access to a broad variety of cannabis products, and;
Provides for a cannabis voucher system within the VA for veterans to access cannabis under individual state medical cannabis programs/dispensaries.
Charters through Congress, new Veteran Service Organizations (VSOs) working in this field.