,,ii #aaeth ,,congress #ast ,session ,s4 #ahjc ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,september #ac1 #bjag,mr4 ,hatch 7for himself1 ,mr4 ,schatz1 ,mr4 ,gardner1 ,mr4 ,coons1 and ,mr4 ,tillis7 introduced the following bill2 which was read twice and referred to the ,committee on the ,judiciary ,a ,,bill ,to improve medical research on marijuana4 #a4 ,short title ,this ,act may be cited as the ,marijuana ,effective ,drug ,studies ,act of #bjag or the ,,meds ,act4 #b4 ,marijuana research 7a7 ,in general ,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 a practitioner to conduct research with marijuana if-- 7i7 the applicant is authorized to dispense1 or conduct research with respect to1 controlled substances in schedules ,,ii1 ,,iii1 ,,iv1 and ,v under the laws of the ,state in which the applicant practices2 7ii7 the applicant's research protocol-- 7,i7 has been reviewed and allowed by-- 7aa7 the ,secretary under section #eje7;i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;i772 or 7bb7 the ,national ,institutes of ,health or another ,federal agency that funds scientific research2 or 7,,ii7 in the case of nonhuman research that is not federally funded1 has been voluntarily submitted by the applicant to1 and approved by1 the ,national ,institutes of ,health2 and 7iii7 the applicant has demonstrated that there are effective procedures in place to adequately safeguard against diversion of the marijuana from legitimate medical or scientific use1 in accordance with subparagraph 7,e74 7,b7 ,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 ,state1 ,federal1 or local laws relating to controlled substances4 7iv7 ,such other conduct by the applicant that may threaten the public health and safety4 7,c7 ,not later than #ij days after the date of enactment of this paragraph1 for purposes of subparagraph 7,a77ii77,,ii71 the ,national ,institutes of ,health shall establish a process that-- 7i7 allows a researcher to voluntarily submit the research protocol of the researcher for review and approval2 and 7ii7 provides a researcher described in clause 7i7 with a decision not later than #cj days after the date on which the research protocol is submitted4 7,d7 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-- 7,i7 approve the application2 or 7,,ii7 serve an order to show cause upon the applicant in accordance with section #cjd7;c74 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 7,e7 7i7 ,a researcher registered under this paragraph shall store marijuana to be used in research in a securely locked1 substantially constructed cabinet4 7ii7 ,any other security measures required by the ,attorney ,general under this paragraph to safeguard against diversion shall be consistent with those required for practitioners conducting research on other controlled substances in schedules ,i and ,,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 without reapplying if the applicant does not-- 7,i7 change the type of drug1 the source of the drug1 or the conditions under which the drug is stored1 tracked1 or administered2 or 7,,ii7 otherwise increase the risk of diversion4 7ii7 ,if an applicant amends or supplements the 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 in the applicant's renewal materials4 7iii7 7,i7 ,if an applicant amends or supplements the research protocol in a manner that involves a change to the type of drug1 the source of the drug1 or conditions under which the drug is stored1 tracked1 or administered or otherwise increases the risk of diversion1 the applicant shall provide notice to the ,attorney ,general not later than #cj days before proceeding on such amended or supplemental research protocol4 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 protocol4 7iv7 ,the ,attorney ,general may object to an amended or supplemental research protocol under clause 7i7 or 7iii7 if additional security measures are needed to safeguard against diversion or abuse4 7,g7 ,article #bh of the ,single ,convention on ,narcotic ,drugs shall not be construed to prohibit1 or impose additional restrictions upon1 research involving marijuana that is conducted in accordance with this paragraph and other applicable provisions of this title4 7,h7 ,if marijuana or a compound of marijuana is listed on a schedule other than schedule ,i-- 7i7 the provisions of this subsection that apply to research with a controlled substance in the applicable schedule shall apply to research with marijuana or that compound1 as applicable2 and 7ii7 subparagraphs 7,a7 through 7,g7 of this paragraph shall not apply to research with marijuana or that compound1 as applicable4 4 7b7 ,conforming amendment ,section #ajb7af7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hjb7af77 is amended by inserting or marijuana after ,the term marihuana4 #c4 ,manufacturing of marijuana for clinical use ,section #cjc of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbc7 is amended by adding at the end the following3 7k7 ,registration of persons ,to manufacture and distribute marijuana 7#a7 ,manufacture and distribution for use in research ,the ,attorney ,general shall register an applicant to manufacture or distribute marijuana on behalf of the ,federal ,government to the extent that the marijuana is intended to be used exclusively for legitimate research and scientific uses1 in accordance with the applicable requirements under subsection 7a7 or 7b7 for registration of manufacturers or distributors of controlled substances in schedule ,i or ,,ii4 7#b7 ,manufacture and distribution for commercial production of ,,fda-approved drugs ,the ,attorney ,general shall register an applicant to manufacture or distribute marijuana on behalf of the ,federal ,government exclusively for the purpose of commercial production of a drug containing or derived from marijuana that is approved by the ,secretary under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 in accordance with the applicable requirements under subsection 7a7 or 7b7 of this section for registration of manufacturers or distributors of controlled substances in schedule ,i or ,,ii4 7#c7 ,no limit on number of manufacturers and distributors ,the ,attorney ,general shall not impose a limit on the number of applicants eligible to be registered under paragraph 7#a7 or 7#b74 7#d7 ,timing ,not later than #cj days after the date on which the ,attorney ,general receives an application for registration under paragraph 7#a7 or 7#b71 the ,attorney ,general shall-- 7,a7 grant the application2 or 7,b7 serve an order to show cause upon the applicant in accordance with section #cjd7;c74 7#e7 ,determination of supply ,in considering the factors under subsection 7a7 or 7b71 as applicable1 for the purposes of registering an applicant eligible under paragraph 7#a7 or 7#b7 of this subsection1 the ,attorney ,general shall consider the demand from researchers for an adequate and uninterrupted supply of specific strains of marijuana and for marijuana grown pursuant to specific manufacturing processes4 7#f7 ,relation to the ,single ,convention on ,narcotic ,drugs 7,a7 ,constructive possession and control ,the registration of manufacturers and distributors of marijuana under paragraphs 7#a7 and 7#b7 shall constitute constructive possession and control by the ,federal ,government for the purposes of the obligations under the ,single ,convention on ,narcotic ,drugs4 7,b7 ,article #bh ,article #bh of the ,single ,convention on ,narcotic ,drugs shall not be construed to prohibit1 or impose additional restrictions upon1 the manufacturing of marijuana that is conducted in accordance with paragraph 7#a7 or 7#b71 as applicable1 and other applicable provisions of this title4 4 #d4 ,good manufacturing practices ,not later than #ahj days after the date of enactment of this ,act1 the ,national ,institute for ,drug ,abuse shall develop and publish recommendations for good manufacturing practices for growing and producing marijuana 7as defined in section #ajb of the ,controlled ,substance ,act 7#ba ,u4,s4,c4 #hjb71 as amended by this ,act7 for research4 #e4 ,quotas ,section #cjf7;e7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbf7;e77 is amended in the third sentence by striking exceeds the aggregate of the quotas of all registrants under this section and inserting should be increased to meet the changing medical1 scientific1 and industrial needs for the controlled substance4 #f4 ,termination of interdisciplinary review process for non-,,nih-funded 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 conducted only for research on marijuana 7as defined in section #ajb of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hjb71 as amended by section #b7;b77 other than the review of research protocols performed at the request of a researcher conducting nonhuman research that is not federally funded1 in accordance with section #cjc7;f77#c77;,a77ii77,,ii7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbc7;f77#c77;,a77ii77,,ii771 as amended by section #b7;a74