,,ii #aaith ,,congress #ast ,session ,s4 #ccdf ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,december #d1 #bjbe,mr4 ,booker 7for himself and ,mr4 ,paul7 introduced the following bill2 which was read twice and referred to the ,committee on the ,judiciary ,a ,,bill ,to establish a special registration under the ,controlled ,substances ,act for schedule ,i eligible investigational drugs under the ,federal ,right to ,try law4 #a4 ,short title ,this ,act may be cited as the ,freedom to ,heal ,act of #bjbe4 #b4 ,special registration requirements related to right to try ,section #cjc of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbc7 is amended by adding at the end the following3 7p7 ,special registration for schedule ,i eligible investigational drugs under right to try 7#a7 ,definitions ,in this subsection1 the terms eligible investigational drug and eligible patient have the meanings given those terms in section #efa;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#j;a74 7#b7 ,special registration process ,the ,attorney ,general shall register physicians to directly administer eligible investigational drugs in schedule ,i to eligible patients under section #efa;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#j;a7 in accordance with paragraphs 7#c7 through 7#h7 of this subsection4 7#c7 ,requirements 7,a7 ,application ,a physician desiring a registration to directly administer an eligible investigational drug as described in paragraph 7#b7 shall submit to the ,attorney ,general an application containing-- 7i7 evidence of a valid registration to dispense or administer controlled substances in schedules ,,ii through ,v2 7ii7 evidence of compliance with section #efa;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#j;a71 including-- 7,i7 documentation from the manufacturer or sponsor verifying the investigational drug in schedule ,i is an eligible investigational drug2 7,,ii7 an agreement from the manufacturer or sponsor to supply the eligible investigational drug1 along with guidance on its administration1 to the requesting physician for the treatment of eligible patients2 and 7,,iii7 an affirmation that the physician will only directly administer the eligible investigational drug to treat eligible patients in a manner consistent with the guidance provided by the manufacturer or sponsor2 7iii7 the quantity of the eligible investigational drug to be supplied by the manufacturer or sponsor to the physician to treat eligible patients2 7iv7 evidence that the physician may treat eligible patients with eligible investigational drugs under the laws of the ,state in which the treatment will take place2 7v7 evidence of training1 credentials1 or experience relevant to treating patients with the eligible investigational drug2 7vi7 a description of the site at which the physician intends to store and administer the eligible investigational drug2 and 7vii7 any additional information the ,attorney ,general determines necessary to prevent diversion4 7,b7 ,approval ,not later than #de days after receiving an application containing the information required under subparagraph 7,a71 the ,attorney ,general shall-- 7i7 register the applicant2 or 7ii7 serve an order to show cause upon the applicant in accordance with section #cjd7;c74 7#d7 ,electronic submissions ,the ,attorney ,general shall provide a means for a physician to submit an application under paragraph 7#c77;,a7 electronically4 7#e7 ,limitation on amounts ,a physician treating eligible patients with an eligible investigational drug in schedule ,i under this subsection may only possess the amounts of the eligible investigational drug identified in-- 7,a7 the application submitted to the ,attorney ,general under paragraph 7#c77;,a72 or 7,b7 a supplemental notification that the physician may submit to the ,attorney ,general if the physician needs additional amounts of the eligible investigational drug for the treatment of eligible patients1 which supplemental notification-- 7i7 shall include-- 7,i7 the name of the physician2 7,,ii7 the additional quantity of the eligible investigational drug needed2 and 7,,iii7 an attestation that the treatment with the eligible investigational drug is consistent with the scope of treatment that was the subject of the application under paragraph 7#c77;,a72 and 7ii7 shall be deemed approved on the date that is #cj days after the date on which the physician submits the supplemental notification to the ,attorney ,general1 unless the ,attorney ,general serves an order to show cause upon the applicant in accordance with section #cjd7;c74 7#f7 ,single registration for related treatment sites ,a physician may treat eligible patients with an eligible investigational drug in schedule ,i under a single registration under this subsection if-- 7,a7 the treatment occurs exclusively on sites all of which are-- 7i7 within the same city or county2 and 7ii7 under the control of the same institution1 organization1 or agency2 and 7,b7 before commencing the treatment1 the physician notifies the ,attorney ,general of each site where the eligible investigational drug will be stored or administered in accordance with paragraph 7#c77;,a77vi74 7#g7 ,rulemaking ,notwithstanding the requirements of section #eec of title #e1 ,united ,states ,code1 not later than #bdj days after the date of enactment of this subsection1 the ,attorney ,general shall issue an interim final rule to implement this subsection1 including with respect to-- 7,a7 the manner in which an eligible investigational drug may be delivered to an approved registrant2 7,b7 the storage and security of an eligible investigational drug2 7,c7 the maintenance of records for an approved registrant2 7,d7 the process for renewal1 suspension1 or revocation of a registration2 and 7,e7 any other matters necessary to ensure effective controls against diversion4 7#h7 ,final rule ,not later than #b years after issuing an interim final rule under paragraph 7#g71 the ,attorney ,general shall issue a final rule to implement this subsection in accordance with section #eec of title #e1 ,united ,states ,code4 4