,,ii #aaeth ,,congress #ast ,session ,s4 #abgf ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,may #be1 #bjag,mrs4 ,feinstein 7for herself1 ,mr4 ,grassley1 ,mr4 ,durbin1 ,mr4 ,tillis1 and ,mrs4 ,ernst7 introduced the following bill2 which was read twice and referred to the ,committee on the ,judiciary ,a ,,bill ,to require the ,attorney ,general to make a determination as to whether cannabidiol should be a controlled substance and listed in a schedule under the ,controlled ,substances ,act and to expand research on the potential medical benefits of cannabidiol and other marihuana components4 #a4 ,short title ,this ,act may be cited as the ,cannabidiol ,research ,expansion ,act4 #b4 ,definitions ,in this ,act-- 7#a7 the term authorized medical research means medical research that is-- 7,a7 a preclinical study or clinical investigation conducted in accordance with section #eje7;i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;i77 or otherwise permitted by the ,department of ,health and ,human ,services to determine the potential medical benefits of marihuana or cannabidiol as a drug2 and 7,b7 conducted by a covered institution of higher education1 practitioner1 or manufacturer that is appropriately registered under the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hja et seq472 7#b7 the term cannabidiol means the nonpsychoactive substance1 cannabidiol1 as derived from marihuana or the synthetic formulation2 7#c7 the terms controlled substance1 dispense1 distribute1 manufacture1 marihuana1 and practitioner have the meanings given such terms in section #ajb of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hjb72 7#d7 the term covered institution of higher education means an institution of higher education 7as defined in section #aja of the ,higher ,education ,act of #aife 7#bj ,u4,s4,c4 #ajja77 that-- 7,a7 7i7 has highest or higher research activity1 as defined by the ,carnegie ,classification of ,institutions of ,higher ,education2 or 7ii7 is an accredited medical school or an accredited school of osteopathic medicine2 and 7,b7 is appropriately registered under the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hja et seq472 7#e7 the term drug has the meaning given the term in section #bja7;g77#a7 of the ,federal ,food ,drug and ,cosmetics ,act 7#ba ,u4,s4,c4 #cba7;g77#a772 7#f7 the term registered manufacturer means an individual or entity who is appropriately registered to manufacture controlled substances under the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hja et seq471 including an individual or entity appropriately registered to manufacture controlled substances as part of research2 and 7#g7 the term ,state means any ,state of the ,united ,states1 the ,district of ,columbia1 and any territory of the ,united ,states4 #c4 ,proceedings for control1 transfer1 or removal of cannabidiol 7a7 ,scientific and medical evaluations ,not later than #a year after the date of enactment of this ,act1 the ,attorney ,general and the ,secretary of ,health and ,human ,services shall each complete the scientific and medical evaluation described in section #bja7;b7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #haa7;b77 as to cannabidiol1 which shall take into consideration the factors described in paragraphs 7#a7 through 7#h7 of subsection 7c7 of section #bja of that ,act 7#ba ,u4,s4,c4 #haa7;c774 7b7 ,proceedings ,to control1 transfer1 or remove cannabidiol ,after taking into consideration the evaluation described in subsection 7a71 if the ,attorney ,general determines that the evaluations1 recommendations1 and all other relevant data warrant control1 transfer1 or removal of cannabidiol1 the ,attorney ,general shall initiate proceedings for control1 transfer1 or removal under section #bja7;a7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #haa7;a774 #d4 ,research protocols ,the ,attorney ,general shall amend section #acja4ah of title #ba1 ,code of ,federal ,regulations 7as in effect on the date of enactment of this ,act71 by striking subsections 7c7 and 7d7 and inserting the following3 7c7 ,in the event that the registrant desires to increase the quantity of a controlled substance used for an approved research project1 he_/she shall submit a request to the ,registration ,unit1 ,drug ,enforcement ,administration1 by registered mail1 return receipt requested4 ,see the ,table of ,,dea ,mailing ,addresses in #acba4ja of this chapter for the current mailing address4 ,the request shall contain the following information3 ,,dea registration number2 name of the controlled substance or substances and the quantity of each authorized in the approved protocol2 and the additional quantity of each desired4 ,upon return of the receipt1 the registrant shall be authorized to purchase and use the additional quantity of the controlled substance or substances specified in the request4 7d7 ,in the event the registrant desires to conduct research beyond the variations provided in the registrant's approved protocol 7excluding any increase in the quantity of the controlled substance requested for his_/her research project as outlined in paragraph 7c7 of this section71 he_/she shall submit three copies by registered mail1 with a return receipt requested1 of a supplemental protocol in accordance with paragraph 7a7 of this section describing the new research and omitting information in the supplemental protocol which has been stated in the original protocol4 ,unless explicitly denied1 supplemental protocols shall be considered approved #cj days after the date on which the return receipt is returned4 4 #e4 ,medical research on cannabidiol 7a7 ,in general ,notwithstanding any provision of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hja et seq471 the ,safe and ,drug-,free ,schools and ,communities ,act 7#bj ,u4,s4,c4 #gaja et seq471 chapter #ha of title #da1 ,united ,states ,code1 or any other ,federal law1 an appropriately registered covered institution of higher education1 a practitioner1 or a manufacturer may manufacture1 distribute1 dispense1 or possess marihuana or cannabidiol if the marihuana or cannabidiol is manufactured1 distributed1 dispensed1 or possessed1 respectively1 for purposes of authorized medical research4 7b7 ,registration for research involving cannabidiol 7#a7 ,initial period ,during the period beginning on the date of enactment of this ,act and ending on the date on which the ,attorney ,general makes a determination regarding control of cannabidiol1 an individual or entity engaged in authorized medical research may distribute1 dispense1 or possess cannabidiol for purposes of the authorized medical research if the individual or entity is registered under the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hja et seq47 to engage in such activity with a controlled substance in schedule ,,ii in section #bjb7;c7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hab7;c774 7#b7 ,completion of ongoing research ,if1 as a result of the determination and proceedings described in section #c1 cannabidiol is a controlled substance in schedule ,i in section #bjb7;c7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hab7;c771 an individual or entity engaged in authorized medical research may continue to distribute1 dispense1 or possess cannabidiol for purposes of completing the authorized medical research if the individual or entity-- 7,a7 was engaged in the authorized medical research in accordance with paragraph 7#a7 on or before the date on which the proceedings are completed2 and 7,b7 is registered under the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hja et seq47 to engage in such activity with a controlled substance in schedule ,,ii in section #bjb7;c7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hab7;c774 7c7 ,registration for the commercial production and distribution of food and drug administration approved drugs ,the ,attorney ,general shall register an applicant to manufacture or distribute cannabidiol or marihuana for the purpose of commercial production of a drug containing or derived from marihuana that is approved by the ,secretary of ,health and ,human ,services 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 section #cjc of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbc74 7d7 ,timely processing of registration applications 7#a7 ,in general ,not later than #fj days after the ,attorney ,general receives an application for registration under the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hja et seq47 to manufacture1 distribute1 dispense1 or possess controlled substances1 the ,attorney ,general shall-- 7,a7 grant or deny the application2 or 7,b7 request supplemental information4 7#b7 ,additional information ,not later than #cj days after the ,attorney ,general receives supplemental information as described in paragraph 7#a77;,b7 in connection with an application described in paragraph 7#a71 the ,attorney ,general shall grant or deny the application4 7e7 ,information regarding denials ,if an application described in subsection 7d77#a7 is denied1 the ,attorney ,general shall provide a written explanation of the basis of denial to the applicant4 #f4 ,importation of cannabidiol for research purposes ,the ,controlled ,substances ,import and ,export ,act 7#ba ,u4,s4,c4 #iea et seq47 is amended-- 7#a7 in section #ajjb7;a7 7#ba ,u4,s4,c4 #ieb7;a77-- 7,a7 in paragraph 7#a71 by striking and at the end2 7,b7 in paragraph 7#b77;,c71 by inserting and after uses12 and 7,c7 inserting before the undesignated matter following paragraph 7#b77;,c7 the following3 7#c7 such amounts of marihuana or cannabidiol as are-- 7,a7 approved for authorized medical research 7as such terms are defined in section #b of the ,cannabidiol ,research ,expansion ,act71 or 7,b7 necessary for registered manufacturers to manufacture drugs containing marihuana or cannabidiol that have been approved for use by the ,commissioner of ,food and ,drugs under the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq471 2 and 7#b7 in section #ajjg 7#ba ,u4,s4,c4 #ieg71 by amending subsection 7a7 to read as follows3 7a7 7#a7 ,except as provided in paragraph 7#b71 no person may-- 7,a7 import into the customs territory of the ,united ,states from any place outside thereof 7but within the ,united ,states71 or import into the ,united ,states from any place outside thereof1 any controlled substance or list ,i chemical1 or 7,b7 export from the ,united ,states any controlled substance or list ,i chemical1 unless there is in effect with respect to such person a registration issued by the ,attorney ,general under section #ajjh1 or unless such person is exempt from registration under subsection 7b74 7#b7 ,paragraph 7#a7 shall not apply to the import or export of marihuana or cannabidiol that has been approved for-- 7,a7 authorized medical research authorized under section #e of the ,cannabidiol ,research ,expansion ,act2 or 7,b7 use by registered manufacturers to manufacture drugs containing marihuana or cannabidiol that have been approved for use by the ,commissioner of ,food and ,drugs under the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq474 4 #g4 ,safe harbor 7a7 ,definitions ,in this section-- 7#a7 the term adult means an individual who is not less than #ah years of age2 7#b7 the term child means an individual who is not more than #ag years of age2 7#c7 the term intractable epilepsy means an epileptic seizure disorder for which standard medical treatment-- 7,a7 does not prevent or significantly ameliorate recurring1 uncontrollable seizures2 or 7,b7 results in harmful side effects2 and 7#d7 the term neurologist means an allopathic or osteopathic physician board-certified in neurology in good standing and licensed in the ,state in which the physician practices neurology4 7b7 ,safe harbor ,notwithstanding the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hja et seq471 the ,controlled ,substances ,import and ,export ,act 7#ba ,u4,s4,c4 #iea et seq471 or any other ,federal law1 it shall not be unlawful for-- 7#a7 a legal guardian to possess or transport cannabidiol or any other nonpsychoactive component of marihuana for purposes of dispensing the cannabidiol or other nonpsychoactive component to a child of the legal guardian if-- 7,a7 the child has been treated by a neurologist for intractable epilepsy for not less than #f months2 7,b7 the child's neurologist attests that other treatment options have not resulted in significant clinical improvement2 7,c7 the child's neurologist attests that he or she has discussed the currently known potential harms and benefits of using cannabidiol or other nonpsychoactive components of marihuana as a treatment with the child's legal guardian2 7,d7 the child's neurologist attests that he or she will monitor the child for potential adverse reactions2 and 7,e7 the legal guardian provides documentation for the requirements under subparagraphs 7,a71 7,b71 7,c71 and 7,d72 7#b7 an adult to possess or transport cannabidiol or any other nonpsychoactive component of marihuana if-- 7,a7 the adult has been treated by a neurologist for intractable epilepsy for not less than #f months2 7,b7 the adult's neurologist attests that other treatment options have not resulted in significant clinical improvement2 7,c7 the adult's neurologist attests that he or she has discussed the currently known potential harms and benefits of using cannabidiol or other nonpsychoactive components of marihuana as a treatment with the adult2 7,d7 the adult's neurologist attests that he or she will monitor the adult for potential adverse reactions2 and 7,e7 the adult provides documentation for the requirements under subparagraphs 7,a71 7,b71 7,c71 and 7,d72 or 7#c7 a ,state-licensed physician to discuss the currently known potential harms and benefits of cannabidiol or any other nonpsychoactive component of marihuana as a treatment with a patient of the physician1 or the legal guardian of the patient if the patient is a child4 7c7 ,sunset ,this section shall cease to have force or effect on the date that is #d years after the date of enactment of this ,act4 #h4 ,federal research ,the ,secretary of ,health and ,human ,services1 either directly or through awarding grants1 contracts1 or cooperative agreements to covered institutions of higher education1 medical or osteopathic schools1 or practitioners1 or a consortia of covered institutions of higher education1 medical or osteopathic schools1 or practitioners1 shall expand1 intensify1 and coordinate the activities of the ,national ,institutes of ,health with respect to research on cannabidiol and other nonpsychoactive components of marihuana to better determine their potential therapeutic effects on serious medical conditions1 including intractable epilepsy4