,i #aacth ,,congress #b;d ,session ,h4 ,r4 #djfi ,,in ,,the ,,house ,,of ,,representatives ,february #ah1 #bjad ,mr4 ,marino 7for himself and ,mrs4 ,blackburn7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce1 and in addition to the ,committee on the ,judiciary1 for a period to be subsequently determined by the ,speaker1 in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned ,a ,,bill ,to improve enforcement efforts related to prescription drug diversion and abuse1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,ensuring ,patient ,access and ,effective ,drug ,enforcement ,act of #bjac4 #b4 ,registration process under ,controlled ,substances ,act 7a7 ,definitions 7#a7 ,consistent with the public health and safety ,section #cjc of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbc7 is amended by adding at the end the following3 7j7 ,in this section1 the phrase consistent with the public health and safety means having a substantial relationship to this ,act's purpose of preventing diversion and abuse of controlled substances4 4 7#b7 ,imminent danger ,section #cjd7;d7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbd7;d77 is amended-- 7,a7 by striking 7d7 ,the ,attorney ,general and inserting 7d77#a7 ,the ,attorney ,general2 and 7,b7 by adding at the end the following3 7#b7 ,in this subsection1 the term imminent danger means a significant and present risk of death or serious bodily harm that is more likely than not to occur in the absence of an immediate suspension order4 4 7b7 ,criminal background checks and drug testing for employees with access to controlled substances 7#a7 ,requirements ,section #cjc of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbc7 is amended by inserting before subsection 7j7 7as added by subsection 7a77#a77 the following3 7i7 7#a7 ,the ,attorney ,general shall require all registrants under subsections 7a71 7b71 7d71 or 7e71 as a condition of such registration-- 7,a7 to obtain a criminal background check on each of the registrant's employees who has or will have access to facility areas where controlled substances under the registrant's possession or control are stored1 such as a cage1 vault1 or safe2 and 7,b7 to perform drug testing on each such employee in accordance with ,federal and ,state law4 7#b7 ,the criminal background checks required by paragraph 7#a7 shall be obtained-- 7,a7 periodically1 but not more frequently than every #b years1 for all employees of the registrant who are described in paragraph 7#a77;,a72 and 7,b7 at the time of hire1 for such employees who are hired after the date of enactment of the ,ensuring ,patient ,access and ,effective ,drug ,enforcement ,act of #bjac4 7#c7 ,the term drug testing means testing designed to detect the illegal use of a controlled substance4 4 7#b7 ,conforming change ,section #cjd7;a7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbc7;a77 is amended-- 7,a7 in paragraph 7#d71 by striking or at the end2 7,b7 in paragraph 7#e71 by striking the period at the end and inserting 2 or2 and 7,c7 by adding at the end the following3 7#f7 has failed to comply with the requirements under section #cjc7;i7 7relating to criminal background checks and drug testing74 4 7#c7 ,alternative civil penalty for failure ,to comply with criminal background check and drug testing requirements 7,a7 ,prohibited act ,section #djb7;a7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hdb7;a77 is amended-- 7i7 in paragraph 7#ad71 by striking or at the end2 7ii7 in paragraph 7#ae71 by striking the period at the end and inserting 2 or2 and 7iii7 by inserting after paragraph 7#ae7 the following3 7#af7 who is a registrant to fail to comply with the requirements under section #cjc7;i7 7relating to criminal background checks and drug testing72 4 7,b7 ,maximum civil penalty of #aj1jjj ,subsection 7c77#a77;,b7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hdb7;c77#a77;,b77 is amended by striking paragraph 7#e7 or 7#aj7 and inserting paragraph 7#e71 7#aj71 or 7#af74 7#d7 ,regulations1 guidance ,the ,attorney ,general of the ,united ,states shall finalize such regulations and guidance as the ,attorney ,general deems necessary to carry out the amendments made by this subsection4 7#e7 ,applicability ,the amendments made by this subsection shall apply beginning on the date that is #b years after the date of enactment of this ,act4 7c7 ,opportunity ,to submit corrective action plan prior to revocation or suspension ,section #cjd7;c7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbd7;c77 is amended-- 7#a7 by striking 7c7 ,before and inserting 7c77#a7 ,before2 and 7#b7 by adding at the end the following3 7#b7 ,before revoking or suspending a registration pursuant to section #cjc1 the ,attorney ,general shall-- 7,a7 provide-- 7i7 notice to the registrant of the grounds for revocation or suspension2 and 7ii7 in the case of any such grounds consisting of a violation of law1 a specific citation to such law2 7,b7 give the registrant an opportunity to submit a corrective action plan within a reasonable period of time to demonstrate how the registrant plans to correct the grounds for revocation or suspension2 and 7,c7 determine whether-- 7i7 in light of the plan1 revocation or suspension proceedings should be discontinued or deferred2 or 7ii7 additional changes need to be made in the corrective action plan4 4 #c4 ,combating ,prescription ,drug ,abuse ,working ,group 7a7 ,establishment ,there is established the ,combating ,prescription ,drug ,abuse ,working ,group 7referred to in this section as the ,working ,group74 7b7 ,membership 7#a7 ,appointment 7,a7 ,in general ,not later than #ahj days after the date of the enactment of this ,act1 the ,president shall appoint each member of the ,working ,group4 7,b7 ,composition ,the ,working ,group shall be composed of not more than #bj members and shall include at least #a and not more than #c of each of the following3 7i7 ,public policy experts4 7ii7 ,representatives of the ,drug ,enforcement ,administration4 7iii7 ,representatives of the ,food and ,drug ,administration4 7iv7 ,representatives of the ,office of ,national ,drug ,control ,policy4 7v7 ,representatives of patient groups4 7vi7 ,representatives of pharmacies4 7vii7 ,representatives of manufacturers of drugs4 7viii7 ,representatives of wholesale distributors of drugs4 7ix7 ,representatives of hospitals1 physicians1 and other health care providers4 7x7 ,representatives of ,state attorneys general4 7xi7 ,representatives of law enforcement officials1 including local law enforcement officials4 7xii7 ,representatives of health benefits plans and entities that provide pharmacy benefits management services on behalf of a health benefits plans4 7#b7 ,co-chairs ,the co-chairs shall be elected by the members of the ,working ,group4 ,the ,working ,group shall select for election from the members of the ,group two individuals1 of whom-- 7,a7 one shall be a representative of the ,federal ,government or a ,state government2 and 7,b7 one shall be a representative of a non-governmental entity4 7#c7 ,term2 vacancies ,each member shall be appointed for the life of the ,working ,group4 ,any vacancy in the ,working ,group shall not affect the powers of the ,working ,group and shall be filled in the same manner in which the original appointment was made4 7#d7 ,pay prohibited ,members of the ,working ,group shall serve without pay4 7c7 ,meetings ,the ,working ,group shall meet at the call of the co-chairs4 ,the ,working ,group shall conduct at least two public meetings1 at which the ,working ,group shall provide opportunity for public comment4 7d7 ,duties of the ,working ,group 7#a7 ,in general ,the ,working ,group shall-- 7,a7 review and report to ,congress on ,federal initiatives with respect to efforts to reduce prescription drug diversion and abuse2 7,b7 identify gaps and opportunities with respect to ensuring the safe use of prescription drugs with the potential for diversion and abuse2 7,c7 examine recommendations to transfer one or more controlled substances from schedule ,,iii to schedule ,,ii under the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hja et seq47 to evaluate-- 7i7 the effectiveness of such a transfer in reducing diversion and abuse2 and 7ii7 any effect of such a transfer on access to prescription drugs for legitimate medical purposes2 and 7,d7 make recommendations on specific ways to reduce the diversion and abuse of prescription drugs4 7#b7 ,report 7,a7 ,in general ,not later than one year after the date of the enactment of this ,act1 the ,working ,group shall issue a report to ,congress that describes the efforts of the ,working ,group to prevent or reduce prescription drug diversion and abuse to ensure that patients continue to have access to medications4 7,b7 ,recommendations ,the report described in subparagraph 7,a7 shall include specific recommendations for the ,drug ,enforcement ,administration1 the ,food and ,drug ,administration1 and other ,federal and ,state agencies1 as appropriate1 and shall address the following topics3 7i7 ,systems for prescription drug monitoring4 7ii7 ,illegal prescription drug ,internet sites and facilities that distribute and fill prescriptions indiscriminately4 7iii7 ,facilitating proper disposal of prescription drugs4 7iv7 ,identifying active geographic areas in which prescription drug abuse is prevalent4 7v7 ,ensuring access to prescription drugs for legitimate medical purposes4 7vi7 ,improving collaboration among ,federal agencies1 especially the ,drug ,enforcement ,administration and the ,food and ,drug ,administration1 for purposes of coordinating prevention and enforcement efforts to reduce prescription drug diversion and abuse4 7vii7 ,improving collaboration among ,federal agencies and ,state agencies for purposes of coordinating prevention and enforcement efforts to reduce prescription drug diversion and abuse4 7viii7 ,the resource needs for law enforcement with respect to prescription drug abuse4 7ix7 ,the need for education of providers1 patients1 parents1 and youth on prescription drug abuse4 7x7 ,development of abuse-resistant prescription drug products4 7xi7 ,recommendations for reducing robberies1 burglaries1 and cargo theft of prescription drugs4 7e7 ,powers of the ,working ,group 7#a7 ,hearings ,the ,working ,group may1 for the purpose of carrying out this section1 hold hearings1 sit and act at times and places1 take testimony1 and receive evidence as the ,working ,group considers necessary4 7#b7 ,information from ,federal agencies ,the ,working ,group may secure directly from any ,federal department or agency such information as the ,working ,group considers necessary to carry out this section4 ,upon the request of the co-chairs of the ,working ,group1 the head of such department or agency shall furnish such information to the ,working ,group in a timely manner4 7f7 ,termination of the ,working ,group ,the ,working ,group shall terminate two years after the date on which the members are appointed under subsection 7b74