,i #aaf? ,,congress #a/ ,session ,h4 ,r4 #hfc ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,janu>y #cj1 #bjai,ms4 ,matsui 7= h]self & ,mr4 ,johnson ( ,ohio7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,a ,,bill ,to am5d ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act to prev5t ! abuse ( dextrome?orphan1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,,dxm ,abuse ,prev5tion ,act ( #bjai4 #b4 ,sales ( ov]-!-c\nt] drugs conta9+ dextrome?orphan 7a7 ,prohibit$ acts 7#a7 ,v]ification sy/em ,section #cja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7 is am5d$ by add+ at ! end ! foll[+3 7fff7 ,! failure ( a retail] 7z def9$ 9 section #ejf;,h7 t (f]s = sale 9 int]/ate comm]ce cov]$ drugs 7z def9$ 9 section #ejf;,h7 to h a v]ification sy/em z requir$ by section #ejf;,h 7relat+ to sales ( ov]-!-c\nt] drugs conta9+ dextrome?orphan74 4 7#b7 ,id5tifi] = electronic po9t ( sale sy/em2 active +r$i5ts ,section #cja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cca71 z am5d$ by p>agraph 7#a71 is fur!r am5d$ by add+ at ! end ! foll[+3 7ggg7 ,! introduction or deliv]y = introduction into int]/ate comm]ce ( any cov]$ drug 7z def9$ 9 section #ejf;,h7 ^: label+ does n include-- 7#a7 a univ]sal product code1 univ]sal product numb]1 b> code1 or simil> id5tifi] to all[ an electronic po9t ( sale sy/em to recognize t ! sale ( ! cov]$ drug is prohibit$ to ^? "u ! age ( #ah2 & 7#b7 ! e/abli%$ "n ( ea* active +r$i5t ( ! cov]$ drug )9 ! fir/ panel ( ! drug facts label+ requir$ by section #bja4ff7;c7 ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations71 9 no small] ?an #f-po9t type4 4 7b7 ,v]ification sy/em ,! ,f$]al ,food1 ,drug1 & ,cosmetic ,act is am5d$ by ins]t+ aft] section #ejf;,g ( su* ,act 7#ba ,u4,s4,c4 #cef;g7 ! foll[+3 #ejf;,h4 ,sales ( ov]-!-c\nt] drugs conta9+ dextrome?orphan 7a7 ,v]ification sy/em ,any retail] sell+ or (f]+ = sale 9 int]/ate comm]ce a cov]$ drug %all h a v]ification sy/em 9 accordance ) ?is section t is int5d$ to ensure t no individual :o pur*ases a cov]$ drug f ! retail] is "u #ah ye>s ( age4 ,su* a sy/em %all be set up to prompt a retail] to exam9e a pur*as]'s id5tification c>d4 7b7 ,means us$ ,to ensure compliance ,a v]ification sy/em "u subsection 7a7 may ensure compliance ) ?is section by any (1 or any comb9ation (1 ! foll[+ means3 7#a7 ,an electronic po9t-(-sale sy/em t is cod$-- 7,a7 to prompt = v]ification ( ! age ( pur*as]s ( cov]$ drugs2 & 7,b7 to d5y sales ( cov]$ drugs to ^? "u ! age ( #ah4 7#b7 ,tra9+ manuals1 mat]ials1 or programs t in/ruct employees-- 7,a7 to v]ify ! age ( pur*as]s ( cov]$ drugs2 & 7,b7 to d5y sales ( cov]$ drugs to ^? "u ! age ( #ah4 7#c7 ,signage 9 & ar\nd ! sales c\nt] outl9+ ! age re/riction on sales ( cov]$ drugs4 7#d7 ,designat+ "o on-duty employee to approve sales ( cov]$ drugs4 7#e7 ,any o!r v]ification measure adopt$ by a retail] t is design$ to ensure t a pur*as] ( a cov]$ drug is n "u #ah ye>s ( age if1 bas$ on an exam9ation ( ! pur*as]'s id5tification c>d1 ! retail] reasonably concludes ! id5tification c>d is valid & indicates ! pur*as] is n "u #ah ye>s ( age4 7c7 ,exceptions 7#a7 ,individuals ov] #bf ,a v]ification sy/em "u subsection 7a7 ne$ n require v]ification ( ! age ( any individual ov] ! age ( #bf4 7#b7 ,valid prescription ,a v]ification sy/em "u subsection 7a7 ne$ n apply to any sale made by a retail] t is a ph>macy pursuant to a validly issu$ prescription4 7#c7 ,valid milit>y id5tification c>d ,a v]ification sy/em "u subsection 7a7 ne$ n apply to any sale to an individual :o supplies pro( at ! "t ( su* sale t su* individual is actively enroll$ 9 ! milit>y & pres5ts a valid milit>y id5tification c>d4 7d7 ,en=cem5t ,9 c>ry+ out ?is section1 ! ,secret>y %all coord9ate ) ,/ate entities t regulate retail]s1 z designat$ by ! ,/ate1 to p]=m activities to ensure compliance ) ?is section1 includ+ provid+ = appropriate inve/igation ( compla9ts relat$ to violations ( ?is section4 7e7 ,compliance ) ,/ate sy/em ,if a ,/ate has a law "u :i* a retail] 9 ! ,/ate is requir$ to h a sy/em t ensures t no individual :o pur*ases a cov]$ drug f ! retail] is "u #ah ye>s ( age1 ! ,secret>y %all treat any su* retail] 9 ! ,/ate t is 9 compliance ) su* law z hav+ a v]ification sy/em z requir$ by ?is section1 includ+ = purposes ( sections #cja7;fff7 & #cjc7;h74 7f7 ,def9itions ,9 ?is section3 7#a7 ,! t]m cov]$ drug-- 7,a7 means a drug t-- 7i7 conta9s dextrome?orphan2 & 7ii7 is n subject to section #ejc7;b77#a72 & 7,b7 excludes any drug t is packag$ 9 packets or p\*es & conta9s #b or few] maximum adult doses ( dextrome?orphan z all[able "u section #cda4gd ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations74 7#b7 ,! t]m id5tification c>d means an id5tification c>d t-- 7,a7 includes a photograph & ! date ( bir? ( ! individual2 & 7,b7 is issu$ by a ,/ate or ! ,f$]al ,gov]nm5t or is consid]$ acceptable = purposes ( sections #bgd;a4#b7;b77#a77v77,a7 & #bgd;a4#b7;b77#a77v77,b77#a7 ( title #h1 ,code ( ,f$]al ,regulations 7includ+ any successor regulations74 7#c7 ,! t]m retail] means-- 7,a7 a groc]y /ore1 g5]al m]*&ise /ore1 drug /ore1 ph>macy1 conv5i5ce /ore1 or o!r entity ^: activities z a sell] ( cov]$ drugs conta9+ dextrome?orphan are limit$ almo/ exclusively to sales = p]sonal use1 bo? 9 numb] & volume ( sales1 includ+ any sales made by ! ,int]net or o!r means2 & 7,b7 excludes any entity li/$ 9 subp>agraph 7,a7 t does n sell any cov]$ drug describ$ 9 p>agraph 7#a77;,a74 4 7c7 ,civil p5alties ,section #cjc ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #ccc7 is am5d$ by add+ at ! end ! foll[+3 7h7 ,a retail] t violates section #cja7;fff7 %all n be subject to subsection 7a7 or any civil monet>y p5alty "u ?is ,act = su* violation except z foll[s3 7#a7 ,if ! ,secret>y f9ds t a retail] fails to h a v]ification sy/em 9 violation ( section #cja7;fff7-- 7,a7 ^u ! fir/ su* f9d+1 ! ,secret>y %all issue a =mal notice ( violation & give ! retail] a p]iod ( at lea/ #cj days 7beg9n+ on ! receipt ( su* notice7 to correct ! violation2 7,b7 ^u ! second su* f9d+1 ! retail] %all be subject to a civil p5alty ( n m ?an #a1jjj2 7,c7 ^u ! ?ird su* f9d+1 ! retail] %all be subject to a civil p5alty ( n m ?an #b1jjj2 & 7,d7 ^u ! f\r? & any subsequ5t su* f9d+1 ! retail] %all be subject to a civil p5alty ( n m ?an #e1jjj4 7#b7 ,9 det]m9+ ! am\nt ( a civil p5alty "u ?is subsection = a retail]1 ! ,secret>y %all consid] :e!r ! retail] has tak5 appropriate /eps to prev5t subsequ5t violations1 su* z ! e/abli%m5t & adm9i/ration ( a docum5t$ employee tra9+ program to ensure all employees are famili> )1 & abid+ by1 ! retail]'s v]ification sy/em e/abli%$ pursuant to section #ejf;,h1 :]e su* program includes-- 7,a7 educat+ employees reg>d+ cov]$ drugs2 7,b7 in/ruction on ! correct me?od ( *eck+ a pur*as]'s id5tification c>d2 & 7,c7 notify+ employees ( ! civil p5alties "u ?is subsection4 7#c7 ,if a retail] transacts sales ( cov]$ drugs at m ?an "o physical location1 = purposes ( det]m9+ ! numb] ( violations by t retail] "u ?is subsection1 ea* individual physical location op]at$ by t retail] %all be consid]$ a sep>ate retail]4 7#d7 ,! ,secret>y %all notify retail]s f\nd to h violat$ section #cja7;fff7 z soon z practicable aft] ! ,secret>y discov]s su* violation4 ,su* notification %all include ! date & "t :5 ! failure to h a v]ification sy/em z requir$ by su* section 0 obs]v$ to occur4 7#e7 ,9 ?is subsection1 ! t]ms cov]$ drug & retail] h ! mean+s giv5 su* t]ms 9 section #ejf;,h4 4 7d7 ,applicability ,! am5dm5ts made by subsections 7a71 7b71 & 7c7 %all apply ) respect to drugs sold or (f]$ = sale on or aft] ! date t is "o ye> aft] ! date ( enactm5t ( ?is ,act4 7e7 ,s5se ( ,congress reg>d+ communication by organizations nom9at$ by manufactur]s ,x is ! s5se ( ,congress t organizations nom9at$ by manufactur]s ( cov]$ drugs 7z def9$ 9 section #ejf;,h ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by subsection 7c77 %\ld make reasonable ef=ts to communicate to retail]s 7z def9$ 9 su* section #ejf;,h7 ! requirem5ts ( su* section #ejf;,h1 includ+ by mak+ available ^u reque/ mat]ials 7:i* may include signage1 manuals1 mat]ials1 or programs7 to assi/ ) educat+ employees reg>d+ su* cov]$ drugs4 #c4 ,re/rictions on di/ribution ( bulk dextrome?orphan 7a7 ,9 g5]al ,! ,f$]al ,food1 ,drug1 & ,cosmetic ,act is am5d$-- 7#a7 9 section #cja 7#ba ,u4,s4,c4 #cca7 7z am5d$ by section #b7;a77 by add+ at ! end ! foll[+3 7hhh7 ,! possession1 receipt1 or di/ribution ( unf9i%$ dextrome?orphan 9 violation ( section #ejf;,i4 2 7#b7 by ins]t+ aft] section #ejf;,h 7z add$ by section #b7;b77 ! foll[+3 #ejf;,i4 ,re/rictions on ! di/ribution ( bulk dextrome?orphan 7a7 ,9 g5]al ,no p]son %all-- 7#a7 possess or receive unf9i%$ dextrome?orphan1 unless ! p]son is regi/]$ "u section #eaj or o!rwise regi/]$1 lic5s$1 or approv$ pursuant to ,f$]al or ,/ate law to engage 9-- 7,a7 ! practice ( ph>macy2 or 7,b7 drug or drug +r$i5t discov]y1 production1 manufacture1 or di/ribution2 or 7#b7 di/ribute unf9i%$ dextrome?orphan to any p]son o!r ?an a p]son describ$ 9 p>agraph 7#a74 7b7 ,exception = common c>ri]s ,?is section does n apply to a common c>ri] t possesses1 receives1 or di/ributes unf9i%$ dextrome?orphan = purposes ( di/ribut+ su* unf9i%$ dextrome?orphan betwe5 p]sons describ$ 9 subsection 7a74 7c7 ,def9itions ,9 ?is section3 7#a7 ,! t]m common c>ri] means any p]son t holds itself out to ! g5]al public z a provid] = hire ( ! transportation by wat]1 l&1 or air ( m]*&ise1 :e!r or n ! p]son actually op]ates ! vessel1 vehicle1 or aircraft by :i* ! transportation is provid$1 betwe5 a port or place & a port or place 9 ! ,unit$ ,/ates4 7#b7 ,! t]m unf9i%$ dextrome?orphan means dextrome?orphan t is n conta9$ 9 a drug t is 9 f9i%$ dosage =m4 2 & 7#c7 by am5d+ section #cjc1 z am5d$ by section #b7;c71 by add+ at ! end ! foll[+3 7i7 ,a p]son t violates section #cja7;hhh7 %all n be subject to subsection 7a7 or any civil monet>y p5alty "u ?is ,act = su* violation except su* p]son %all be subject to a civil p5alty 9 an am\nt ( n m ?an #ajj1jjj4 4 7b7 ,applicability ,! am5dm5ts made by ?is section apply beg9n+ on ! date ( enactm5t ( ?is ,act4