#aafth ,,congress #b;d ,session ,h4 ,r4 #cgig ,,an ,,act ,to amend the ,controlled ,substances ,act to make marijuana accessible for use by qualified marijuana researchers for medical purposes1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,medical ,marijuana ,research ,act4 #b4 ,facilitating marijuana research 7a7 ,production and supply ,the ,secretary of ,health and ,human ,services-- 7#a7 until the date on which the ,secretary determines that manufacturers and distributors 7other than the ,federal ,government7 can ensure a sufficient supply of marijuana 7as defined in section #ajb of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hjb71 as amended by section #h7 intended for research by qualified marijuana researchers registered pursuant to paragraph 7#c7 of section #cjc7;f7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbc7;f771 as added by section #c1 shall-- 7,a7 continue1 through grants1 contracts1 or cooperative agreements1 to produce marijuana through the ,national ,institute on ,drug ,abuse ,drug ,supply ,program2 7,b7 not later than one year after the date of enactment of this ,act1 act jointly with the ,attorney ,general of the ,united ,states to establish and implement a specialized process for manufacturers and distributors1 notwithstanding the registration requirements of section #cjc of such ,act 7#ba ,u4,s4,c4 #hbc71 to supply qualified marijuana researchers with marijuana products-- 7i7 available through ,state-authorized marijuana programs2 and 7ii7 consistent with the guidance issued under subsection 7c72 and 7,c7 not later than #fj days after the date of enactment of this ,act1 jointly convene with the ,attorney ,general a meeting to initiate the development of the specialized process described in subparagraph 7,b72 and 7#b7 beyond the date specified in paragraph 7#a71 may1 at the ,secretary's discretion1 continue-- 7,a7 through grants1 contracts1 or cooperative agreements1 to so produce marijuana2 and 7,b7 to implement such specialized process4 7b7 ,requirement to verify registration ,before supplying marijuana to any person through the ,national ,institute on ,drug ,abuse ,drug ,supply ,program or through implementation of the specialized process established under subsection 7a77#a77;,b71 the ,secretary of ,health and ,human ,services shall-- 7#a7 require the person to submit documentation demonstrating that the person is a qualified marijuana researcher seeking to conduct research pursuant to section #cjc7;f77#c7 of the ,controlled ,substances ,act1 as added by subsection 7d7 of this section1 or a manufacturer duly registered under section #cjc7l7 of the ,controlled ,substances ,act1 as added by section #c of this ,act2 and 7#b7 not later than #fj days after receipt of such documentation1 review such documentation and verify that the marijuana will be used for such research 7and for no other purpose authorized pursuant to this ,act or the amendments made by this ,act74 7c7 ,guidance on ,use of ,state-authorized marijuana programs ,not later than #ahj days after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services shall issue guidance related to marijuana from ,state-authorized marijuana programs for research4 7d7 ,research ,section #cjc7;f7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbc7;f77 is amended-- 7#a7 by redesignating paragraphs 7#a7 through 7#e7 as subparagraphs 7,a7 through 7,e71 respectively2 7#b7 by striking 7f7 ,the ,attorney ,general and inserting 7f77#a7 ,the ,attorney ,general2 7#c7 by striking ,registration applications and inserting the following3 7#b7 ,registration applications 2 7#d7 in paragraph 7#b71 as so designated1 by striking schedule ,i each place that term appears and inserting schedule ,i1 except marijuana12 7#e7 by striking ,article #g and inserting the following3 7#d7 ,article #g 2 and 7#f7 by inserting before paragraph 7#d71 as so designated1 the following3 7#c7 7,a7 ,the ,attorney ,general shall register the applicant to conduct research with marijuana if-- 7i7 the applicant is authorized to dispense1 or conduct research with respect to1 controlled substances in schedule ,i1 ,,ii1 ,,iii1 ,,iv1 or ,v2 7ii7 the applicant is compliant with1 and authorized to conduct the activities described in clause 7i7 under1 the laws of the ,state in which the applicant practices2 and 7iii7 in the case of an applicant pursuing clinical research1 the applicant's clinical research protocol has been reviewed and authorized to proceed by the ,secretary under section #eje7;i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act4 7,b7 ,an applicant registered under subparagraph 7,a7 shall be referred to in this section as a qualified marijuana researcher4 7,c7 7i7 ,not later than #fj days after the date on which the ,attorney ,general receives a complete application for registration under this paragraph1 the ,attorney ,general shall approve or deny the application4 7ii7 ,for purposes of clause 7i71 an application shall be deemed complete when the applicant has submitted documentation showing that the requirements under subparagraph 7,a7 are satisfied4 7iii7 ,in the case of a denial under clause 7i71 the ,attorney ,general shall provide a written explanation of the basis for the denial4 7,d7 ,the ,attorney ,general shall grant an application for registration under this paragraph unless the ,attorney ,general determines that the issuance of the registration would be inconsistent with the public interest4 ,in determining the public interest1 the following factors shall be considered3 7i7 ,the applicant's experience in dispensing1 or conducting research with respect to1 controlled substances4 7ii7 ,the applicant's conviction record under ,federal or ,state laws relating to the manufacture1 distribution1 or dispensing of controlled substances4 7iii7 ,compliance with applicable ,state or local laws relating to controlled substance misuse or diversion4 7iv7 ,such other conduct which may threaten the public health and safety4 7,e7 7i7 ,a qualified marijuana researcher shall store marijuana to be used in research in a securely locked1 substantially constructed cabinet4 7ii7 ,except as provided in clause 7i71 any security measures required by the ,attorney ,general for applicants conducting research with marijuana pursuant to a registration under this paragraph shall be consistent with the security measures for applicants conducting research on other controlled substances in schedule ,,ii that have a similar risk of diversion and abuse4 7,f7 7i7 ,if the ,attorney ,general grants an application for registration under this paragraph1 the applicant may amend or supplement the research protocol and proceed with the research under such amended or supplemented protocol1 without additional review or approval by the ,attorney ,general or the ,secretary of ,health and ,human ,services if the applicant does not change the type of marijuana1 the source of the marijuana1 or the conditions under which the marijuana is stored1 tracked1 or administered4 7ii7 ,if an applicant amends or supplements the research protocol or initiates research on a new research protocol under clause 7i71 the applicant shall1 in order to renew the registration under this paragraph1 provide notice to the ,attorney ,general of the amended or supplemented research protocol or any new research protocol in the applicant's renewal materials4 7iii7 7,i7 ,if an applicant amends or supplements a research protocol and the amendment or supplement involves a change to the type of marijuana1 the source of the marijuana1 or conditions under which the marijuana is stored1 tracked1 or administered1 the applicant shall provide notice to the ,attorney ,general not later than #cj days before proceeding on such amended or supplemental research or new research protocol1 as the case may be4 7,,ii7 ,if the ,attorney ,general does not object during the #cj-;day period following a notification under subclause 7,i71 the applicant may proceed with the amended or supplemental research or new research protocol4 7iv7 ,the ,attorney ,general may object to an amended or supplemental protocol or a new research protocol under clause 7i7 or 7iii7 only if additional security measures are needed to safeguard against diversion or abuse4 7,g7 ,if marijuana is listed on a schedule other than schedule ,i1 the provisions of paragraphs 7#a71 7#b71 and 7#d7 that apply to research with a controlled substance in the applicable schedule shall apply to research with marijuana or that compound1 as applicable1 in lieu of the provisions of subparagraphs 7,a7 through 7,f7 of this paragraph4 7,h7 ,nothing in this paragraph shall be construed as limiting the authority of the ,secretary under section #eje7;i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act or over requirements related to research protocols1 including changes in-- 7i7 the method of administration of marijuana2 7ii7 the dosing of marijuana2 and 7iii7 the number of individuals or patients involved in research4 4 #c4 ,manufacture and distribution of marijuana for use in legitimate research ,section #cjc of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbc71 as amended by section #b1 is further amended by adding at the end the following3 7l7 ,registration of persons to manufacture and distribute marijuana for use in legitimate research 7#a7 ,registration of manufacturers 7,a7 ,in general ,beginning not later than the day that is #a year after the date of enactment of the ,medical ,marijuana ,research ,act1 the ,attorney ,general1 pursuant to subsection 7f77#c7 and subject to subparagraph 7,b7 of this paragraph1 shall register an applicant to manufacture marijuana 7including any derivative1 extract1 preparation1 and compound thereof7 that is intended for-- 7i7 the ultimate and exclusive use by qualified marijuana researchers for research pursuant to subsection 7f77#c72 or 7ii7 subsequent downstream manufacture by a duly registered manufacturer for the ultimate and exclusive use by qualified marijuana researchers for research pursuant to subsection 7f77#c74 7,b7 ,public interest ,the ,attorney ,general shall register an applicant under subparagraph 7,a7 unless the ,attorney ,general determines that the issuance of such registration is inconsistent with the public interest4 ,in determining the public interest1 the ,attorney ,general shall take into consideration-- 7i7 maintenance of effective controls against diversion of marijuana and any controlled substance compounded therefrom into other than legitimate medical1 scientific1 or research channels2 7ii7 compliance with applicable ,state and local laws relating to controlled substance misuse and diversion2 7iii7 prior conviction record of the applicant under ,federal or ,state laws relating to the manufacture1 distribution1 or dispensing of such substances2 and 7iv7 such other conduct which may threaten the public health and safety4 7#b7 ,registration of distributors 7,a7 ,in general ,beginning not later than the day that is #a year after the date of enactment of the ,medical ,marijuana ,research ,act1 the ,attorney ,general shall register an applicant to distribute marijuana 7including any derivative1 extract1 preparation1 and compound thereof7 that is intended for the ultimate and exclusive use by qualified marijuana researchers for research pursuant to subsection 7f77#c7 or intended for subsequent downstream manufacture by a duly registered manufacturer for use by qualified marijuana researchers for research pursuant to such subsection1 unless the ,attorney ,general determines that the issuance of such registration is inconsistent with the public interest4 7,b7 ,public interest ,in determining the public interest under subparagraph 7,a71 the ,attorney ,general shall take into consideration-- 7i7 the factors specified in clauses 7i71 7ii71 7iii71 and 7iv7 of paragraph 7#a77;,b72 and 7ii7 past experience in the distribution of controlled substances1 and the existence of effective controls against diversion4 7#c7 ,no limit on number of manufacturers and distributors ,notwithstanding any other provision of law1 the ,attorney ,general shall not impose or implement any limit on the number of persons eligible to be registered to manufacture or distribute marijuana pursuant to paragraph 7#a7 or 7#b74 7#d7 ,requirement to verify use for legitimate research ,as a condition of registration under this section to manufacture or distribute marijuana1 the ,attorney ,general shall require the registrant-- 7,a7 to require any person to whom the marijuana will be supplied to submit documentation demonstrating that the marijuana 7including any derivative1 extract1 preparation1 and compound thereof7 will be ultimately used exclusively by qualified marijuana researchers for research pursuant to subsection 7f77#c7 or for subsequent downstream manufacture by a duly registered manufacturer for use by qualified marijuana researchers for research pursuant to such subsection2 7,b7 in the case of distribution1 to complete1 with respect to that distribution1 the appropriate order form in accordance with section #cjh and to upload such forms to the system used by the ,drug ,enforcement ,administration for such distribution2 7,c7 to include in the labeling of any marijuana so manufactured or distributed-- 7i7 the following statement3 ,this material is for biomedical and scientific research purposes only42 and 7ii7 the name of the requestor of the marijuana2 7,d7 to limit the transfer and sale of any marijuana under this subsection-- 7i7 to researchers who are registered under this ,act to conduct research with marijuana or to manufacturers duly registered under this subsection2 and 7ii7 for purposes of use in preclinical research or in a clinical investigation pursuant to an investigational new drug exemption under #eje7;i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act or for the purposes of further manufacturing of marijuana2 and 7,e7 to transfer or sell any marijuana manufactured under this subsection only with prior1 written consent for the transfer or sale by the ,attorney ,general4 7#e7 ,timing ,not later than #fj days after receipt of a request for registration under this subsection to manufacture or distribute marijuana1 the ,attorney ,general shall-- 7,a7 grant or deny the request2 and 7,b7 in the case of a denial1 provide a written explanation of the basis for the denial4 7#f7 ,deemed approval ,if the ,attorney ,general fails to grant or deny a request for registration under this subsection to manufacture or distribute marijuana within the #fj-;day period referred to in paragraph 7#e71 such request is deemed approved4 4 #d4 ,termination of interdisciplinary review process for non-,,nih-funded qualified marijuana researchers ,the ,secretary of ,health and ,human ,services may not-- 7#a7 reinstate the ,public ,health ,service interdisciplinary review process described in the guidance entitled ,guidance on ,procedures for the ,provision of ,marijuana for ,medical ,research 7issued on ,may #ba1 #aiii72 or 7#b7 create an additional review of scientific protocols that is only conducted for research on marijuana other than the review of research protocols performed at the request of a qualified marijuana researcher conducting nonhuman research that is not federally funded1 in accordance with section #cjc7;f77#c77;,a7 of the ,controlled ,substances ,act1 as added by section #b of this ,act4 #e4 ,consideration of results of research ,immediately upon the approval by the ,food and ,drug ,administration of an application for a drug that contains marijuana 7as defined in section #ajb of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hjb71 as amended by section #h of this ,act7 under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 and 7irrespective of whether any such approval is granted7 not later than the date that is #e years after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall-- 7#a7 conduct a review of existing medical and other research with respect to marijuana2 7#b7 submit a report to the ,congress on the results of such review2 and 7#c7 include in such report whether1 taking into consideration the factors listed in section #bja7;c7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #haa7;c771 as well as any potential for medical benefits1 any gaps in research1 and any impacts of ,federal restrictions and policy on research1 marijuana should be transferred to a schedule other than schedule ,i 7if marijuana has not been so transferred already74 #f4 ,production quotas for marijuana grown for legitimate1 scientific research ,section #cjf of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbf7 is amended by adding at the end the following3 7j7 ,the ,attorney ,general may only establish a quota for production of marijuana that is manufactured and distributed in accordance with the ,medical ,marijuana ,research ,act that meets the changing medical1 scientific1 and industrial needs for marijuana4 4 #g4 ,article #bh of the single convention on narcotic drugs ,article #bh of the ,single ,convention on ,narcotic ,drugs shall not be construed to prohibit1 or impose additional restrictions upon1 research involving marijuana1 or the manufacture1 distribution1 or dispensing of marijuana1 that is conducted in accordance with the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hja et seq471 this ,act1 and the amendments made by this ,act4 #h4 ,definitions 7a7 ,qualified marijuana researcher ,in this ,act1 the term qualified marijuana researcher has the meaning given the term in section #cjc7;f77#c7 of the ,controlled ,substances ,act1 as added by section #b7;d7 of this ,act4 7b7 ,updating term ,section #ajb7af7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hjb7af77 is amended-- 7#a7 in subparagraph 7,a71 by striking the term marihuana means and inserting the terms marihuana and marijuana mean2 and 7#b7 in subparagraph 7,b71 by striking ,the term marihuana does not and inserting ,the terms marihuana and marijuana do not4 #i4 ,determination of budgetary effects ,the budgetary effects of this ,act1 for the purpose of complying with the ,statutory ,pay-,as-,you-,go ,act of #bjaj1 shall be determined by reference to the latest statement titled ,budgetary ,effects of ,,paygo ,legislation for this ,act1 submitted for printing in the ,congressional ,record by the ,chairman of the ,house ,budget ,committee1 provided that such statement has been submitted prior to the vote on passage4 ,passed the ,house of ,representatives ,december #i1 #bjbj4;,clerk4