#aac? ,,congress #a/ ,session ,h4 ,r4 #aiai ,,an ,,act ,to am5d ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act ) respect to ! ph>maceutical di/ribution supply *a91 & = o!r purposes4 #a4 ,%ort title 7a7 ,%ort title ,?is ,act may be cit$ z ! ,safegu>d+ ,am]ica's ,ph>maceuticals ,act ( #bjac4 7b7 ,table ( cont5ts ,! table ( cont5ts ( ?is ,act is z foll[s3 ,sec4 #a4 ,%ort title4 ,sec4 #b4 ,ph>maceutical di/ribution supply *a94 ,sec4 #c4 ,enhanc$ drug di/ribution security4 ,sec4 #d4 ,national /&>ds = :olesale di/ributors4 ,sec4 #e4 ,national lic5sure /&>ds = ?ird-p>ty logi/ics provid]s4 ,sec4 #f4 ,p5alties4 ,sec4 #g4 ,uni=m national policy4 ,sec4 #h ,electronic label+4 #b4 ,ph>maceutical di/ribution supply *a9 ,*apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is am5d$ by add+ at ! end ! foll[+3 ,h ,ph>maceutical ,di/ribution ,supply ,*a9 #eha4 ,def9itions ,9 ?is sub*apt]3 7#a7 ,au?oriz$ ,! t]m au?oriz$ means-- 7,a7 9 ! case ( a manufactur] or repackag]1 hav+ a valid regi/ration 9 accordance ) section #eaj2 & 7,b7 9 ! case ( a :olesale di/ributor1 ?ird-p>ty logi/ics provid]1 or disp5s]1 lic5s$ 7z def9$ 9 ?is section74 7#b7 ,disp5s] ,! t]m disp5s]-- 7,a7 subject to subp>agraph 7,c71 means a retail ph>macy1 hospital ph>macy1 a gr\p ( *a9 ph>macies "u common own]%ip & control1 or any o!r p]son au?oriz$ by law to disp5se or adm9i/] prescription drugs1 to ! ext5t su* ph>macy1 gr\p1 or p]son does n act z a :olesale di/ributor2 7,b7 includes w>eh\ses & di/ribution c5t]s "u common own]%ip or control ( entities describ$ 9 subp>agraph 7,a7 t are memb]s ( an affiliat$ gr\p pursuant to section #aejd7;a7 ( ! ,int]nal ,rev5ue ,code ( #aihf1 to ! ext5t su* w>eh\ses & di/ribution c5t]s d n act z a :olesale di/ributor2 & 7,c7 does n include a p]son :o only disp5ses prescription drug product to be us$ 9 animals 9 accordance ) section #eab7;a77#e74 7#c7 ,disposition ,! t]m disposition1 ) respect to a prescription drug product )9 ! possession & control ( an entity-- 7,a7 means ! removal ( su* prescription drug product1 or tak+ measures to prev5t ! introduction ( su* prescription drug product1 f ! ph>maceutical di/ribution supply *a92 & 7,b7 may include disposal1 return ( ! prescription drug product = disposal1 or o!r appropriate h&l+ & o!r actions su* z reta9+ a sample ( ! prescription drug product = additional physical exam9ation or laboratory analysis by a manufactur] or regulatory or law en=cem5t ag5cy4 7#d7 ,di/ribute or di/ribution ,! t]ms di/ribute & di/ribution mean ! sale1 pur*ase1 trade1 deliv]y1 h&l+1 or /orage ( a prescription drug product4 7#e7 ,illegitimate prescription drug product ,! t]m illegitimate prescription drug product means a prescription drug product :i* a manufactur] has confirm$-- 7,a7 is c\nt]feit1 div]t$1 or /ol52 7,b7 is int5tionally adult]at$ su* t ! prescription drug product w\ld result 9 s]i\s adv]se heal? consequ5ces or dea? to humans2 or 7,c7 is o!rwise unfit = di/ribution su* t ! prescription drug product is reasonably likely to cause s]i\s adv]se human heal? consequ5ces or dea?4 7#f7 ,lic5s$ ,! t]m lic5s$ means-- 7,a7 9 ! case ( a :olesale di/ributor1 hav+ a valid lic5se to make :olesale di/ributions consi/5t ) ! /&>ds "u section #ehc2 7,b7 9 ! case ( a ?ird-p>ty logi/ics provid]1 hav+ a valid lic5se to engage 9 ! activities ( a ?ird-p>ty logi/ics provid] 9 accordance ) section #ehd2 & 7,c7 9 ! case ( a disp5s]1 hav+ a valid lic5se to disp5se prescription drugs "u ,/ate law4 7#g7 ,manufactur] ,! t]m manufactur] means1 ) respect to a prescription drug product-- 7,a7 a p]son t holds an application approv$ "u section #eje or a lic5se issu$ "u section #cea ( ! ,public ,heal? ,s]vice ,act = su* prescription drug product1 or if su* prescription drug product is n ! subject ( an approv$ application or lic5se1 ! p]son :o manufactur$ ! prescription drug product2 7,b7 a co-lic5s$ p>tn] ( ! p]son describ$ 9 subp>agraph 7,a7 t obta9s ! prescription drug product directly f ! p]son describ$ 9 su* subp>agraph2 or 7,c7 a p]son t-- 7i7 is a memb] ( an affiliat$ gr\p 7z def9$ 9 section #aejd7;a7 ( ! ,int]nal ,rev5ue ,code ( #aihf7 to :i* a p]son describ$ 9 subp>agraph 7,a7 or 7,b7 is also a memb]2 & 7ii7 receives ! prescription drug product directly f a p]son describ$ 9 subp>agraph 7,a7 or 7,b74 7#h7 ,package 7,a7 ,9 g5]al ,! t]m package means ! smalle/ individual saleable unit ( prescription drug product = di/ribution 9 int]/ate comm]ce by a manufactur] or repackag] t is int5d$ by ! manufactur] = ultimate sale to ! disp5s] ( su* prescription drug product4 7,b7 ,individual saleable unit ,! t]m individual saleable unit means ! smalle/ conta9] ( prescription drug product introduc$ into int]/ate comm]ce by ! manufactur] or repackag] t is int5d$ by ! manufactur] = individual sale to a disp5s]4 7#i7 ,prescription drug ,! t]m prescription drug means a drug = human use subject to section #ejc7;b77#a74 7#aj7 ,prescription drug product ,! t]m prescription drug product means a prescription drug 9 a f9i%$ dosage =m = adm9i/ration to a pati5t )\t sub/antial fur!r manufactur+ 7su* z capsules1 tablets1 & lyophiliz$ prescription drug products be=e recon/itution74 7#aa7 ,prescription drug product id5tifi] ,! t]m prescription drug product id5tifi] means a /&>diz$ graphic t-- 7,a7 includes ! /&>diz$ num]ical id5tifi]1 lot numb]1 & expiration date ( a prescription drug product2 & 7,b7 is 9 bo? human-readable =m & on a ma*9e-readable data c>ri] t con=ms to ! /&>ds develop$ by a widely recogniz$ int]national /&>ds developm5t organization4 7#ab7 ,qu>ant9e ,! t]m qu>ant9e means to /ore or id5tify a product1 = ! purpose ( prev5t+ di/ribution or transf] ( ! product1 9 a physically sep>ate area cle>ly id5tifi$ = su* use1 or ?r\gh use ( o!r proc$ures su* z automat$ designation4 7#ac7 ,repackag] ,! t]m repackag] means a p]son :o owns or op]ates an e/abli%m5t t repacks & relabels a prescription drug product or package = fur!r sale or di/ribution4 7#ad7 ,return ,! t]m return means provid+ prescription drug product to ! au?oriz$ trad+ p>tn] or trad+ p>tn]s f :i* su* prescription drug product 0 pur*as$ or receiv$1 or to a returns processor = h&l+ ( su* prescription drug product4 7#ae7 ,returns processor ,! t]ms returns processor mean a p]son :o owns or op]ates an e/abli%m5t t provides = ! disposition ( or o!rwise processes saleable & nonsaleable prescription drug product receiv$ f an au?oriz$ trad+ p>tn] su* t ! prescription drug product may be process$ = cr$it to ! pur*as]1 manufactur]1 sell]1 or dispos$ ( = no fur!r di/ribution4 7#af7 ,specific pati5t ne$ ,! t]m specific pati5t ne$-- 7,a7 means ) respect to ! transf] ( a prescription drug product f "o ph>macy to ano!r1 to fill a prescription = an id5tifi$ pati5t2 & 7,b7 does n include ! transf] ( a prescription drug product f "o ph>macy to ano!r = ! purpose ( increas+ or repl5i%+ /ock 9 anticipation ( a pot5tial ne$4 7#ag7 ,/&>diz$ num]ical id5tifi] ,! t]m /&>diz$ num]ical id5tifi] means a set ( numb]s or *>act]s t-- 7,a7 is us$ to uniquely id5tify ea* package or homog5\s case ( ! prescription drug product2 & 7,b7 is compos$ ( ! ,national ,drug ,code t corresponds to ! specific prescription drug product 7includ+ ! p>ticul> package configuration7 comb9$ ) a unique alphanum]ic s]ial numb] ( up to #bj *>act]s4 7#ah7 ,suspect prescription drug product ,! t]m suspect prescription drug product means a prescription drug product = :i* !re is reason to believe t su* prescription drug product-- 7,a7 is pot5tially c\nt]feit1 div]t$1 or /ol52 7,b7 is pot5tially int5tionally adult]at$ su* t ! prescription drug product w\ld result 9 s]i\s adv]se heal? consequ5ces or dea? to humans2 or 7,c7 appe>s o!rwise unfit = di/ribution su* t ! prescription drug product w\ld result 9 s]i\s adv]se heal? consequ5ces or dea? to humans4 7#ai7 ,?ird-p>ty logi/ics provid] ,! t]m ?ird-p>ty logi/ics provid] means an entity t provides or coord9ates w>eh\s+1 di/ribution1 or o!r logi/ics s]vices ( a prescription drug product 9 int]/ate comm]ce on behalf ( a manufactur]1 :olesale di/ributor1 or disp5s] ( a prescription drug product1 b does n take own]%ip ( ! prescription drug product1 nor h responsibility to direct ! sale or disposition (1 ! prescription drug product4 7#bj7 ,trad+ p>tn] ,! t]m trad+ p>tn] means-- 7,a7 a manufactur]1 repackag]1 :olesale di/ributor1 or disp5s] f :om a manufactur]1 repackag]1 :olesale di/ributor1 or disp5s] accepts own]%ip ( a prescription drug product or to :om a manufactur]1 repackag]1 :olesale di/ributor1 or disp5s] transf]s own]%ip ( a prescription drug product2 or 7,b7 a ?ird-p>ty logi/ics provid] f :om a manufactur]1 repackag]1 :olesale di/ributor1 or disp5s] accepts possession ( a prescription drug product or to :om a manufactur]1 repackag]1 :olesale di/ributor1 or disp5s] transf]s possession ( a prescription drug product4 7#ba7 ,transaction 7,a7 ,9 g5]al ,! t]m transaction means ! transf] 9 int]/ate comm]ce ( prescription drug product betwe5 p]sons 9 :i* a *ange ( own]%ip occurs4 7,b7 ,exemptions ,! t]m transaction does n include-- 7i7 intracompany di/ribution ( any prescription drug product1 includ+ betwe5 memb]s ( an affiliat$ gr\p 7z def9$ 9 section #aejd7;a7 ( ! ,int]nal ,rev5ue ,code ( #aihf72 7ii7 ! di/ribution ( a prescription drug product among hospitals or o!r heal? c>e entities t are "u common control2 7iii7 ! di/ribution ( a prescription drug product = em]g5cy m$ical reasons includ+ a public heal? em]g5cy decl>ation pursuant to section #cai ( ! ,public ,heal? ,s]vice ,act1 except t a drug %ortage n caus$ by a public heal? em]g5cy %all n con/itute an em]g5cy m$ical reason2 7iv7 ! disp5s+ ( a prescription drug product pursuant to a valid prescription execut$ 9 accordance ) section #ejc7;b77#a72 7v7 ! di/ribution ( prescription drug product samples by a manufactur] or a lic5s$ :olesale di/ributor 9 accordance ) section #ejc7;d72 7vi7 ! di/ribution ( blood or blood compon5ts int5d$ = transfusion2 7vii7 ! di/ribution ( m9imal quantities ( prescription drug product by a lic5s$ retail ph>macy to a lic5s$ practition] = (fice use2 7viii7 ! di/ribution ( a prescription drug product by a *>itable organization to a nonpr(it affiliate ( ! organization to ! ext5t o!rwise p]mitt$ by law2 7ix7 ! di/ribution ( a prescription drug product pursuant to ! sale or m]g] ( a ph>macy or ph>macies or a :olesale di/ributor or :olesale di/ributors1 except t any records requir$ to be ma9ta9$ = ! prescription drug product %all be transf]r$ to ! new own] ( ! ph>macy or ph>macies or :olesale di/ributor or :olesale di/ributors2 7x7 ! disp5s+ ( a prescription drug product approv$ "u section #eab7;b72 7xi7 ! transf] ( prescription drug products to or f any facility t is lic5s$ by ! ,nucle> ,regulatory ,commission or by a ,/ate pursuant to an agreem5t ) su* ,commission "u section #bgd ( ! ,atomic ,en]gy ,act ( #aied 7#db ,u4,s4,c4 #bjba72 7xii7 ! di/ribution ( a comb9ation product t consi/s (-- 7,i7 a product compris$ ( two or m compon5ts t are ea* a drug1 biological product1 or device & t are physically1 *emically1 or o!rwise comb9$ or mix$ & produc$ z a s+le entity2 7,,ii7 two or m sep>ate products packag$ toge!r 9 a s+le package or z a unit & compris$ ( a drug & device or a device & biological product2 or 7,,iii7 two or m f9i%$ devices plus "o or m drug or biological products :i* are packag$ toge!r 9 a m$ical conv5i5ce kit describ$ 9 clause 7xiii72 7xiii7 ! di/ribution ( a m$ical conv5i5ce kit :i* is a collection ( f9i%$ products 7consi/+ ( devices or drugs7 assembl$ 9 kit =m /rictly = ! conv5i5ce ( ! pur*as] or us] if-- 7,i7 ! m$ical conv5i5ce kit is assembl$ 9 an e/abli%m5t t is regi/]$ ) ! ,food & ,drug ,adm9i/ration z a m$ical device manufactur]2 7,,ii7 ! p]son :o manufactur]s ! m$ical conv5i5ce kit pur*as$ ! prescription drug product directly f ! manufactur] or f a :olesale di/ributor t pur*as$ ! prescription drug product directly f ! manufactur]2 7,,iii7 ! p]son :o manufactur]s ! m$ical conv5i5ce kit does n alt] ! prim>y conta9] or label ( ! prescription drug product z pur*as$ f ! manufactur] or :olesale di/ributor2 7,,iv7 ! m$ical conv5i5ce kit does n conta9 a controll$ sub/ance 7z def9$ 9 section #ajb ( ! ,controll$ ,sub/ances ,act72 & 7,v7 ! prescription drug products conta9$ 9 ! m$ical conv5i5ce kit are-- 7aa7 intrav5\s solutions int5d$ = ! repl5i%m5t ( fluids & electrolytes2 7bb7 drugs int5d$ to ma9ta9 ! equilibrium ( wat] & m9]als 9 ! body2 7cc7 drugs int5d$ = irrigation or recon/itution2 7dd7 ane/hetics2 7ee7 anticoagulants2 7ff7 vasopressors2 or 7gg7 sympa?icomimetics2 7xiv7 ! di/ribution ( an intrav5\s prescription drug product t1 by its =mulation1 is int5d$ = ! repl5i%m5t ( fluids & electrolytes 7su* z sodium1 *loride1 & potassium7 or calories 7su* z dextrose & am9o acids72 7xv7 ! di/ribution ( an intrav5\s prescription drug product us$ to ma9ta9 ! equilibrium ( wat] & m9]als 9 ! body1 su* z dialysis solutions2 7xvi7 ! di/ribution ( a prescription drug product t is int5d$ = irrigation or recon/itution1 or /]ile wat]1 :e!r int5d$ = su* purposes or = injection2 7xvii7 ! di/ribution ( compress$ m$ical gas2 or 7xviii7 7,i7 ! di/ribution ( a product by a disp5s]1 or a :olesale di/ributor act+ at ! direction ( ! disp5s]1 to a repackag] regi/]$ "u section #eaj = ! purpose ( repackag+ ! drug = use by t disp5s] or ano!r heal? c>e entity t is "u ! disp5s]'s own]%ip or control1 s long z ! disp5s] reta9s own]%ip ( ! prescription drug product2 & 7,,ii7 ! saleable or nonsaleable return by su* repackag] ( su* prescription drug product4 7,c7 ,compress$ m$ical gas ,= purposes ( subp>agraph 7,b77xvii71 ! t]m compress$ m$ical gas means any sub/ance 9 its gase\s or cryog5ic liquid =m t meets m$ical purity /&>ds & has application 9 a m$ical or homec>e environm5t1 includ+ oxyg5 & nitr\s oxide4 7#bb7 ,transaction hi/ory ,! t]m transaction hi/ory means a /atem5t t-- 7,a7 includes ! transaction in=mation = ea* transaction conduct$ ) respect to a prescription drug product beg9n+ ) ! manufactur] or initial pur*ase di/ributor2 & 7,b7 is 9 pap] or electronic =m4 7#bc7 ,transaction in=mation ,! t]m transaction in=mation means-- 7,a7 ! propriet>y or e/abli%$ "n or names ( ! prescription drug product2 7,b7 ! /r5g? & dosage =m ( ! prescription drug product2 7,c7 ! ,national ,drug ,code numb] ( ! prescription drug product2 7,d7 ! conta9] size2 7,e7 ! numb] ( conta9]s2 7,f7 ! lot numb] ( ! prescription drug product2 7,g7 ! date ( ! transaction2 7,h7 ! bus9ess "n & address ( ! p]son f :om own]%ip is be+ transf]r$2 & 7,i7 ! bus9ess "n & address ( ! p]son to :om own]%ip is be+ transf]r$4 7#bd7 ,transaction /atem5t ,! transaction /atem5t is a /atem5t1 :i* /ates t ! manufactur]1 repackag]1 :olesale di/ributor1 ?ird-p>ty logi/ics provid]1 or disp5s] transf]r+ own]%ip 9 a transaction-- 7,a7 is au?oriz$2 7,b7 receiv$ transaction in=mation & a transaction /atem5t z requir$ "u section #ehb f ! prior own] ( ! prescription drug product2 7,c7 did n kn[+ly & int5tionally %ip an illegitimate prescription drug product2 7,d7 did n kn[+ly & int5tionally provide false transaction in=mation2 & 7,e7 did n kn[+ly & int5tionally alt] ! transaction hi/ory4 7#be7 ,v]ification & v]ify ,! t]ms v]ification & v]ify-- 7,a7 mean det]m9+ :e!r ! prescription drug product id5tifi] affix$ to1 or impr9t$ ^u1 a package or homog5e\s case ( ! prescription drug product corresponds to ! /&>diz$ num]ical id5tifi] or lot numb]1 & expiration date assign$ to ! prescription drug product by ! manufactur] or ! repackag]1 z applicable2 & 7,b7 include mak+ ! det]m9ation "u subp>agraph 7,a7 us+ human-readable or ma*9e-readable me?ods4 7#bf7 ,:olesale di/ributor ,! t]m :olesale di/ributor-- 7,a7 means a p]son engag$ 9 :olesale di/ribution 7z def9$ 9 section #ehc72 & 7,b7 excludes-- 7i7 a manufactur]1 a co-lic5s$ p>tn] ( a manufactur]1 or a ?ird-p>ty logi/ics provid]1 or a disp5s] :o does n engage 9 su* :olesale di/ribution2 7ii7 a repackag] engag$ 9 su* :olesale di/ribution2 or 7iii7 ! di/ribution ( prescription drug product or an (f] to di/ribute prescription drug product by an au?oriz$ repackag] t has tak5 own]%ip or possession ( ! prescription drug product & repack$ ! prescription drug product 9 accordance ) ! requirem5ts ( section #ehb7;e74 #ehb4 ,requirem5ts 7a7 ,9 g5]al 7#a7 ,compliance requir$ ,an entity t is a manufactur]1 repackag]1 :olesale di/ributor1 ?ird-p>ty logi/ics provid]1 or disp5s] %all comply ) ! requirem5ts ( ?is section4 ,if an entity meets ! def9ition ( m ?an "o ( ! entities ref]r$ to 9 ! prec$+ s5t5ce1 su* entity %all comply ) all applicable requirem5ts ( ?is section1 b %all n be requir$ to comply ) duplicative requirem5ts4 7#b7 ,/&>ds ,! ,secret>y %all1 9 consultation ) o!r appropriate ,f$]al (ficials1 manufactur]s1 repackag]s1 :olesale di/ributors1 ?ird-p>ty logi/ics provid]s1 & disp5s]s1 e/abli%1 by regulation1 /&>ds = ! ex*ange ( transaction hi/ory & transaction /atem5t 79 pap] or electronic =m7 = purposes ( comply+ ) ?is section4 ,! /&>ds e/abli%$ "u ?is p>agraph %all be 9 accordance ) a =m develop$ by a widely recogniz$ int]national /&>ds developm5t organization4 ,9 e/abli%+ su* /&>ds1 ! ,secret>y %all consid] ! feasibility ( e/abli%+ /&>diz$ docum5tation to be us$ by all memb]s ( ! ph>maceutical di/ribution supply *a9 to convey ! transaction hi/ory & transaction /atem5t to ! subsequ5t own] ( a prescription drug product4 ,! ,secret>y %all publi% su* /&>ds n lat] ?an #ahj days aft] ! date ( ! enactm5t ( ! ,safegu>d+ ,am]ica's ,ph>maceuticals ,act ( #bjac4 7#c7 ,waiv]s1 exceptions1 & exemptions ,n lat] ?an "o ye> aft] ! date ( ! enactm5t ( ! ,safegu>d+ ,am]ica's ,ph>maceuticals ,act ( #bjac1 ! ,secret>y %all promulgate a regulation to-- 7,a7 e/abli% a process by :i* ! ,secret>y may grant1 at ! reque/ ( an au?oriz$ manufactur]1 repackag]1 :olesale di/ributor1 or disp5s]1 a waiv] f any ( ! requirem5ts ( ?is section-- 7i7 if ! ,secret>y det]m9es t su* requirem5ts w\ld result 9 an undue economic h>d%ip2 or 7ii7 = em]g5cy m$ical reasons1 includ+ a public heal? em]g5cy decl>ation pursuant to section #cai ( ! ,public ,heal? ,s]vice ,act2 7,b7 e/abli% a process1 ) respect to ! prescription drug product id5tifi] requirem5t "u p>agraph 7#b7 ( subsections 7b71 7c71 7d71 & 7e7 ?r\gh :i*-- 7i7 a manufactur] or repackag] may reque/ a waiv] ) respect to prescription drug products t are packag$ 9 a conta9] too small or o!rwise unable to accommodate a label ) suffici5t space to be> ! in=mation requir$ = compliance ) su* requirem5t2 & 7ii7 ! ,secret>y det]m9es :e!r to waive su* requirem5t2 & 7,c7 e/abli% a process by :i* ! ,secret>y may add ! prescription drug products or transactions t are exempt f ! requirem5ts ( ?is section4 7#d7 ,gr&fa!r$ p]sons & prescription drug products 7,a7 ,9 g5]al ,n lat] ?an "o ye> aft] ! date ( ! enactm5t ( ! ,safegu>d+ ,am]ica's ,ph>maceuticals ,act ( #bjac1 ! ,secret>y %all specify1 by regulation1 :e!r & "u :at circum/ances ! prescription drug product id5tifi] requirem5t "u p>agraph 7#b7 ( subsections 7b71 7c71 7d71 & 7e7 %all apply to a prescription drug product t is 9 ! supply *a9 or 9 a manufactur]'s inv5tory on ! date ( ! enactm5t ( ! ,safegu>d+ ,am]ica's ,ph>maceuticals ,act ( #bjac4 7,b7 ,?ird-p>ty logi/ics provid] lic5ses ,until ! date t is #a ye> aft] ! effective date ( ! ?ird-p>ty logi/ics provid] lic5s+ requirem5ts "u section #ehd1 a ?ird-p>ty logi/ics provid] %all be consid]$ lic5s$ "u section #eha7f77;,b7 unless ! ,secret>y has made a f9d+ t ! ?ird-p>ty logi/ics provid] does n utilize good h&l+ & di/ribution practices & publi%es notice !re(4 7,c7 ,label *anges ,*anges made to package labels solely to incorporate ! prescription drug product id5tifi] may be submitt$ to ! ,secret>y 9 ! annual report ( an e/abli%m5t1 9 accordance ) section #cad4gj7;d7 ( *apt] #ba1 ,code ( ,f$]al ,regulations 7or any successor regulation74 7b7 ,manufactur] requirem5ts 7#a7 ,prescription drug product trac+ 7,a7 ,9 g5]al ,beg9n+ n lat] ?an ,janu>y #a1 #bjae1 a manufactur] %all-- 7i7 prior to1 or at ! "t (1 ea* transaction 9 :i* su* manufactur] transf]s own]%ip ( a prescription drug product-- 7,i7 until ! date ?an is #e ye>s aft] ! date ( ! enactm5t ( ! ,safegu>d+ ,am]ica's ,ph>maceuticals ,act ( #bjac1 provide ! subsequ5t own] ) ! transaction hi/ory & a transaction /atem5t 9 a s+le docum5t 9 pap] or electronic =m2 & 7,,ii7 on or aft] su* date1 provide ! subsequ5t own] ) ! transaction hi/ory & a transaction /atem5t 9 electronic =m2 & 7ii7 ma9ta9 ! transaction in=mation = ea* su* transaction = n less ?an #c ye>s aft] ! date ( ! transaction4 7,b7 ,reque/s = in=mation ,^u a reque/ by ! ,secret>y or o!r appropriate ,f$]al or ,/ate (ficial1 9 ! ev5t ( a recall or = ! purpose ( inve/igat+ a suspect prescription drug product or an illegitimate prescription drug product1 a manufactur] %all1 n lat] ?an #b bus9ess days aft] receiv+ ! reque/ or 9 su* reasonable "t z det]m9$ by ! ,secret>y1 provide to ! ,secret>y or o!r (ficial1 ! applicable transaction hi/ory & transaction /atem5t = ! prescription drug product4 7#b7 ,prescription drug product id5tifi] ,beg9n+ n lat] ?an #e ye>s aft] ! date ( ! enactm5t ( ! ,safegu>d+ ,am]ica's ,ph>maceuticals ,act ( #bjac1 a manufactur] %all affix or impr9t a prescription drug product id5tifi] on ea* package & homog5\s case ( a prescription drug product int5d$ to be introduc$ 9 a transaction4 ,su* manufactur] %all ma9ta9 ! in=mation 9 ! prescription drug product id5tifi] = su* prescription drug product = n less ?an #c ye>s aft] ! date ( ! transaction4 7#c7 ,au?oriz$ trad+ p>tn]s ,beg9n+ n lat] ?an ,janu>y #a1 #bjae1 a manufactur] %all ensure t ea* ( its trad+ p>tn]s is au?oriz$4 7#d7 ,li/ ( au?oriz$ di/ributors ( record ,beg9n+ n lat] ?an ,janu>y #a1 #bjae1 ea* manufactur] ( a prescription drug %all-- 7,a7 ma9ta9 a li/ ( ! au?oriz$ di/ributors ( record ( su* drug at ! corporate (fices ( su* manufactur]2 7,b7 make su* li/ publicly available1 includ+ placem5t on ! ,int]net ,website ( su* manufactur]2 & 7,c7 update su* li/ n less ?an once p] qu>t]4 7#e7 ,v]ification ,beg9n+ n lat] ?an ,janu>y #a1 #bjae1 a manufactur] %all implem5t sy/ems & processes to enable ! manufactur] to comply ) ! foll[+ requirem5ts3 7,a7 ,suspect prescription drug product 7i7 ,9 g5]al ,^u mak+ a det]m9ation t a prescription drug product 9 ! possession or control ( ! manufactur] is a suspect prescription drug product1 or ^u receiv+ a reque/ = v]ification f ! ,secret>y t a prescription drug product )9 ! possession or control ( a manufactur] is a suspect prescription drug product1 a manufactur] %all promptly conduct an inve/igation 9 coord9ation ) trad+ p>tn]s1 z applicable1 to det]m9e :e!r ! prescription drug product is an illegitimate prescription drug product4 ,beg9n+ n lat] ?an #e ye>s aft] ! date ( ! enactm5t ( ! ,safegu>d+ ,am]ica's ,ph>maceuticals ,act ( #bjac1 su* inve/igation %all include-- 7,i7 v]ify+ ! prescription drug product at ! package level2 7,,ii7 validat+ any applicable transaction hi/ory 9 ! possession ( ! manufactur]2 & 7,,iii7 o!rwise inve/igat+ to det]m9e :e!r ! prescription drug product is an illegitimate prescription drug product4 7ii7 ,cle>$ prescription drug product ,if ! manufactur] det]m9es t a suspect prescription drug product is n an illegitimate prescription drug product1 ! manufactur] %all promptly notify ! ,secret>y ( su* det]m9ation & su* prescription drug product may be fur!r di/ribut$4 7iii7 ,records ,a manufactur] %all keep records ( its inve/igation ( a suspect prescription drug product = n less ?an #c ye>s aft] ! conclusion ( ! inve/igation4 7,b7 ,illegitimate prescription drug product 7i7 ,9 g5]al ,^u det]m9+ t a prescription drug product 9 ! possession or control ( a manufactur] is an illegitimate prescription drug product1 ! manufactur] %all-- 7,i7 qu>ant9e su* prescription drug product f prescription drug product int5d$ = di/ribution2 & 7,,ii7 provide = ! disposition ( ! illegitimate prescription drug product4 7ii7 ,trad+ p>tn] ,^u det]m9+ t a prescription drug product 9 ! possession or control ( a trad+ p>tn] is an illegitimate prescription drug product1 ! manufactur] %all take reasonable /eps to assi/ a trad+ p>tn] to provide = ! disposition ( ! illegitimate prescription drug product4 7iii7 ,mak+ a notification ,^u det]m9+ t a prescription drug product 9 ! possession or control ( ! manufactur] is an illegitimate prescription drug product1 ! manufactur] %all notify ! ,secret>y ( su* det]m9ation n lat] ?an #bd h\rs aft] mak+ su* det]m9ation4 ,! ,secret>y %all det]m9e :e!r additional trad+ p>tn] notification is appropriate4 7iv7 ,respond+ to a notification ,^u ! receipt ( a notification f ! ,secret>y t a det]m9ation has be5 made t a prescription drug product is an illegitimate prescription drug product1 a manufactur] %all-- 7,i7 id5tify all illegitimate prescription drug products t are subject to su* notification & 9 ! possession or control ( ! manufactur]1 includ+ any prescription drug product t is subsequ5tly receiv$2 & 7,,ii7 p]=m ! activities describ$ 9 clause 7i74 7v7 ,records ,a manufactur] %all keep records ( ! disposition ( an illegitimate prescription drug product = n less ?an #c ye>s aft] ! conclusion ( ! disposition4 7,c7 ,electronic database ,a manufactur] may satisfy ! requirem5ts ( ?is p>agraph ?r\gh ! use ( a secure electronic database develop$ & op]at$ by ! manufactur] or ano!r entity4 ,! own] ( su* database %all e/abli% ! requirem5ts & processes to respond to reque/s & may provide = data access to o!r memb]s ( ! ph>maceutical di/ribution supply *a91 z appropriate4 ,! developm5t & op]ation ( su* a database %all n relieve a manufactur] ( ! requirem5t "u ?is p>agraph to respond to a v]ification reque/ submitt$ by means o!r ?an a secure electronic database4 7,d7 ,return$ prescription drug product ,beg9n+ n lat] ?an #e ye>s aft] ! date ( ! enactm5t ( ! ,safegu>d+ ,am]ica's ,ph>maceuticals ,act ( #bjac1 ^u receipt ( a return$ prescription drug product t ! manufactur] int5ds to fur!r di/ribute1 be=e fur!r di/ribut+ su* prescription drug product1 ! manufactur] %all-- 7i7 v]ify ! prescription drug product id5tifi] = ea* seal$ homog5e\s case ( su* prescription drug product2 or 7ii7 if su* prescription drug product is n 9 a seal$ homog5e\s case1 v]ify ! prescription drug product id5tifi] on ea* package4 7c7 ,:olesale di/ributor requirem5ts 7#a7 ,prescription drug product trac+ 7,a7 ,9 g5]al ,beg9n+ n lat] ?an ,april #a1 #bjae1 a :olesale di/ributor %all-- 7i7 n accept own]%ip ( a prescription drug product unless ! previ\s own] prior to1 or at ! "t (1 ! transaction provides ! applicable transaction hi/ory & a transaction /atem5t = ! prescription drug product2 7ii7 subject to clause 7iv71 prior to1 or at ! "t (1 ea* transaction 9 :i* ! :olesale di/ributor transf]s own]%ip ( a prescription drug product-- 7,i7 9 ! case t ! :olesale di/ributor pur*as$ ! prescription drug product directly f ! manufactur]1 ! exclusive di/ributor ( ! manufactur]1 or a repackag] t pur*as$ directly f ! manufactur]1 provide ! subsequ5t own] ) transaction hi/ory & a transaction /atem5t = ! prescription drug product-- 7aa7 if ! subsequ5t own] is a disp5s]1 on a s+le docum5t 9 pap] or electronic =m2 or 7bb7 if ! subsequ5t own] is a :olesale di/ributor1 ?r\gh any comb9ation ( self-g5]at$ pap]1 electronic data1 or manufactur]-provid$ in=mation on ! product package2 7,,ii7 9 ! case t ! :olesale di/ributor did n pur*ase ! prescription drug product z describ$ 9 subclause 7,i7-- 7aa7 provide ! subsequ5t own] ) ! transaction hi/ory & a transaction /atem5t beg9n+ ) ! :olesale di/ributor t did s pur*ase ! prescription drug product 9 pap] or electronic =m2 or 7bb7 pursuant to a writt5 agreem5t betwe5 ! :olesale di/ributor & a disp5s]1 ma9ta9 ! transaction hi/ory & transaction /atem5t on behalf ( ! disp5s] & if reque/$ by ! disp5s]1 provide ! transaction hi/ory & transaction /atem5t to ! disp5s] 9 pap] or electronic =m 9 a timely mann] s z to p]mit ! disp5s] to comply ) reque/s pursuant to subsection 7d77#a77;,d72 7iii7 ma9ta9 ! transaction in=mation = ea* transaction describ$ 9 clauses 7i7 & 7ii7 = n less ?an #c ye>s aft] ! transaction2 & 7iv7 on or aft] ! date t is #e ye>s aft] ! date ( ! enactm5t ( ! ,safegu>d+ ,am]ica's ,ph>maceuticals ,act ( #bjac1 provide ! transaction hi/ory & transaction /atem5t 9 electronic =m4 7,b7 ,inclusion ( lot numb] 9 transaction hi/ory ,until ! date t is #e ye>s aft] ! date ( ! enactm5t ( ! ,safegu>d+ ,am]ica's ,ph>maceuticals ,act ( #bjac1 ! transaction hi/ory provid$ by a :olesale di/ribut] "u ?is p>agraph %all n be requir$ to include ! lot numb] ( ! product or ! initial date ( ! transaction f ! manufactur] 7z su* t]ms are us$ 9 subp>agraphs 7,f7 & 7,g7 ( section #eha7bc774 7,c7 ,returns exception 7i7 ,saleable returns ,not)/&+ subp>agraph 7,a71 a :olesale di/ributor may-- 7,i7 accept return$ prescription drug product )\t a transaction hi/ory f a disp5s] or repackag]2 & 7,,ii7 di/ribute su* return$ prescription drug product ) a transaction hi/ory t beg9s ) ! :olesale di/ributor t s accept$ ! return$ product4 7ii7 ,nonsaleable returns ,a :olesale di/ributor may return a nonsaleable prescription drug to ! manufactur] or repackag]1 to ! :olesale di/ributor f :om su* prescription drug 0 pur*as$1 or to a p]son act+ on behalf ( su* a p]son1 includ+ a returns processor1 )\t provid+ ! in=mation requir$ "u subp>agraph 7,a74 7,d7 ,reque/s = in=mation ,^u a reque/ by ! ,secret>y or o!r appropriate ,f$]al or ,/ate (ficial1 9 ! ev5t ( a recall or = ! purpose ( inve/igat+ a suspect prescription drug product or an illegitimate prescription drug product a :olesale di/ributor %all1 n lat] ?an #b bus9ess days aft] receiv+ ! reque/ or 9 su* o!r reasonable "t z det]m9$ by ! ,secret>y1 provide ! applicable transaction hi/ory & transaction /atem5ts = ! prescription drug product4 7#b7 ,prescription drug product id5tifi] ,beg9n+ n lat] ?an #g ye>s aft] ! date ( ! enactm5t ( ! ,safegu>d+ ,am]ica's ,ph>maceuticals ,act ( #bjac1 a :olesale di/ributor may engage 9 transactions involv+ a prescription drug product only if su* prescription drug product is encod$ ) a prescription drug product id5tifi]1 except z provid$ 9 subsection 7a77#d74 7#c7 ,au?oriz$ trad+ p>tn]s ,beg9n+ n lat] ?an ,janu>y #a1 #bjae1 a :olesale di/ributor %all ensure t ea* ( its trad+ p>tn]s is au?oriz$4 7#d7 ,v]ification ,beg9n+ n lat] ?an ,april #a1 #bjae1 a :olesale di/ributor %all implem5t sy/ems to enable ! :olesale di/ributor to comply ) ! foll[+ requirem5ts3 7,a7 ,suspect prescription drug product 7i7 ,9 g5]al ,^u mak+ a det]m9ation t a prescription drug product 9 ! possession or control ( ! :olesale di/ributor is a suspect prescription drug product1 or ^u receiv+ a reque/ = v]ification f ! ,secret>y t a prescription drug product )9 ! possession or control ( a :olesale di/ributor is a suspect prescription drug product1 a :olesale di/ributor %all promptly conduct an inve/igation to det]m9e :e!r ! prescription drug product is an illegitimate prescription drug product4 ,beg9n+ n lat] ?an #g ye>s aft] ! date ( ! enactm5t ( ! ,safegu>d+ ,am]ica's ,ph>maceuticals ,act ( #bjac1 su* inve/igation %all include-- 7,i7 v]ify+ a package ( ! prescription drug product2 7,,ii7 validat+ any applicable transaction hi/ory 9 ! possession ( ! :olesale di/ributor2 & 7,,iii7 o!rwise inve/igat+ to det]m9e :e!r ! prescription drug product is an illegitimate prescription drug product4 7ii7 ,cle>$ prescription drug product ,if ! :olesale di/ributor det]m9es t a suspect prescription drug product is n an illegitimate prescription drug product1 ! :olesale di/ributor %all promptly notify ! ,secret>y ( su* det]m9ation & su* prescription drug product may be fur!r di/ribut$4 7iii7 ,records ,a :olesale di/ributor %all keep records ( its inve/igation ( a suspect prescription drug product = n less ?an #c ye>s aft] ! conclusion ( ! inve/igation4 7,b7 ,illegitimate prescription drug product 7i7 ,9 g5]al ,^u receiv+ notice t a manufactur] ( a prescription drug product has det]m9$ t a prescription drug product 9 ! possession or control ( a :olesale di/ributor is an illegitimate prescription drug product1 ! :olesale di/ributor %all-- 7,i7 qu>ant9e su* prescription drug product )9 ! possession or control ( ! :olesale di/ributor f prescription drug product int5d$ = di/ribution2 & 7,,ii7 provide = ! disposition ( ! illegitimate prescription drug product )9 ! possession or control ( ! :olesale di/ributor4 7ii7 ,trad+ p>tn] ,^u det]m9+ t a prescription drug product 9 ! possession or control ( a trad+ p>tn] is an illegitimate prescription drug product1 ! :olesale di/ributor %all take reasonable /eps to assi/ a trad+ p>tn] to provide = ! disposition ( ! illegitimate prescription drug product4 7iii7 ,mak+ a notification ,^u det]m9+ t a prescription drug product 9 ! possession or control ( ! :olesale di/ributor is an illegitimate prescription drug product1 ! :olesale di/ributor %all notify ! ,secret>y ( su* det]m9ation n lat] ?an #bd h\rs aft] mak+ su* det]m9ation4 ,! ,secret>y %all det]m9e :e!r additional trad+ p>tn] notification is appropriate4 7iv7 ,respond+ to a notification ,^u ! receipt ( a notification f ! ,secret>y t a det]m9ation has be5 made t a prescription drug product is an illegitimate prescription drug product1 a :olesale di/ributor %all-- 7,i7 id5tify all illegitimate prescription drug products subject to su* notification t are 9 ! possession or control ( ! :olesale di/ributor1 includ+ any su* prescription drug product t is subsequ5tly receiv$2 & 7,,ii7 p]=m ! activities describ$ 9 clause 7i74 7v7 ,records ,a :olesale di/ributor %all keep records ( ! disposition ( an illegitimate prescription drug product = n less ?an #c ye>s aft] ! conclusion ( ! disposition4 7,c7 ,electronic database ,a :olesale di/ributor may satisfy ! requirem5ts ( ?is p>agraph ?r\gh ! use ( a secure electronic database develop$ & op]at$ by ! manufactur] or ano!r entity4 ,! own] ( su* database %all e/abli% ! requirem5ts & processes to respond to reque/s & may provide = data access to o!r memb]s ( ! ph>maceutical di/ribution supply *a91 z appropriate4 ,! developm5t & op]ation ( su* a database %all n relieve a :olesale di/ributor ( ! requirem5t "u ?is p>agraph to respond to a v]ification reque/ submitt$ by means o!r ?an a secure electronic database4 7,d7 ,return$ prescription drug product ,beg9n+ n lat] ?an #g ye>s aft] ! date ( ! enactm5t ( ! ,safegu>d+ ,am]ica's ,ph>maceuticals ,act ( #bjac1 ^u receipt ( a return$ prescription drug product t ! :olesale di/ributor int5ds to fur!r di/ribute1 be=e fur!r di/ribut+ su* prescription drug product1 ! :olesale di/ributor %all-- 7i7 v]ify ! prescription drug product id5tifi] = ea* seal$ homog5e\s case ( su* prescription drug product2 or 7ii7 if su* prescription drug product is n 9 a seal$ homog5e\s case1 v]ify ! prescription drug product id5tifi] on ea* package4 7d7 ,disp5s] requirem5ts 7#a7 ,prescription drug product trac+ 7,a7 ,9 g5]al ,beg9n+ n lat] ?an ,july #a1 #bjae1 a disp5s]-- 7i7 %all n accept own]%ip ( a prescription drug product1 unless ! previ\s own] prior to1 or at ! "t (1 ! transaction1 provides transaction hi/ory & a transaction /atem5t2 7ii7 prior to1 or at ! "t (1 ea* transaction 9 :i* ! disp5s] transf]s own]%ip ( a prescription drug product 7b n includ+ disp5s+ to a pati5t or returns7 %all provide ! subsequ5t own] ) transaction hi/ory & a transaction /atem5t = ! prescription drug product1 except t ! requirem5ts ( ?is clause %all n apply to sales by a disp5s] to ano!r disp5s] to fulfill a specific pati5t ne$2 & 7iii7 %all ma9ta9 transaction in=mation = a p]iod ( n less ?an #c ye>s aft] ! date ( ! transaction4 7,b7 ,agreem5ts ) ?ird p>ties ,a disp5s] may ent] into a writt5 agreem5t ) a ?ird p>ty1 includ+ an au?oriz$ :olesale di/ributor1 "u :i* ! ?ird p>ty confid5tially ma9ta9s ! transaction in=mation requir$ to be ma9ta9$ "u ?is subsection on behalf ( ! disp5s]4 ,if a disp5s] ent]s into su* an agreem5t1 ! disp5s] %all ma9ta9 a copy ( ! writt5 agreem5t4 7,c7 ,returns exception 7i7 ,saleable returns ,not)/&+ subp>agraph 7,a77ii71 a disp5s] may return prescription drug product to ! trad+ p>tn] f :i* ! disp5s] obta9$ ! prescription drug product )\t provid+ ! in=mation requir$ "u su* subp>agraph4 7ii7 ,nonsaleable returns ,not)/&+ subp>agraph 7,a77ii71 a disp5s] may return a nonsaleable prescription drug to ! manufactur] or repackag]1 to ! :olesale di/ributor f :om su* prescription drug 0 pur*as$1 to a returns processor1 or to a p]son act+ on behalf ( su* p]sons )\t provid+ ! in=mation requir$ "u su* subp>agraph4 7,d7 ,reque/s = in=mation ,^u a reque/ by ! ,secret>y or o!r appropriate ,f$]al or ,/ate (ficial1 9 ! ev5t ( a recall or = ! purpose ( inve/igat+ a suspect prescription drug product or an illegitimate prescription drug product-- 7i7 a disp5s] %all n lat] ?an #b bus9ess days aft] receiv+ ! reque/ or 9 ano!r su* reasonable "t z det]m9$ by ! ,secret>y1 provide ! applicable transaction hi/ory & transaction /atem5t :i* ! disp5s] receiv$ f ! previ\s own]2 7ii7 ! in=mation provid$ by ! disp5s] "u clause 7i7 is n requir$ to include ! lot numb] ( ! product1 ! initial date ( ! transaction1 or ! initial date ( ! %ipm5t f ! manufactur] unless su* in=mation 0 provid$ electronically by ! previ\s own]1 manufactur]1 or :olesale di/ributor to ! disp5s]2 & 7iii7 a disp5s] may respond to ! reque/ by provid+ ! pap] docum5tation receiv$ f ! previ\s own] or by provid+ electronic in=mation4 7#b7 ,prescription drug product id5tifi] ,beg9n+ n lat] ?an #h ye>s aft] ! date ( ! enactm5t ( ! ,safegu>d+ ,am]ica's ,ph>maceuticals ,act ( #bjac1 a disp5s] may engage 9 transactions involv+ a prescription drug product only if su* prescription drug product is encod$ ) a prescription drug product id5tifi]1 except z provid$ 9 subsection 7a77#d74 7#c7 ,au?oriz$ trad+ p>tn]s ,beg9n+ n lat] ?an ,janu>y #a1 #bjae1 a disp5s] %all ensure t ea* ( its trad+ p>tn]s is au?oriz$4 7#d7 ,v]ification ,beg9n+ n lat] ?an ,janu>y #a1 #bjae1 a disp5s] %all implem5t sy/ems to enable ! disp5s] to comply ) ! foll[+ requirem5ts3 7,a7 ,suspect prescription drug product 7i7 ,9 g5]al ,^u mak+ a det]m9ation t a prescription drug product 9 ! possession or control ( ! disp5s] is a suspect prescription drug product1 or ^u receiv+ a reque/ = v]ification f ! ,secret>y t a prescription drug product )9 ! possession or control ( a disp5s] is a suspect prescription drug product1 a disp5s] %all promptly conduct an inve/igation to det]m9e :e!r ! prescription drug product is an illegitimate prescription drug product4 ,su* inve/igation %all include-- 7,i7 v]ify+ :e!r ! lot numb] ( a suspect prescription drug product corresponds ) ! lot numb] = su* prescription drug product2 7,,ii7 beg9n+ #h ye>s aft] ! date ( ! enactm5t ( ! ,safegu>d+ ,am]ica's ,ph>maceuticals ,act ( #bjac1 v]ify+ t ! product id5tifi] ( at lea/ #c packages or #aj p]c5t ( su* suspect prescription drug product1 :i*ev] is great]1 or all packages1 if !re are few] ?an #c1 corresponds ) ! prescription drug product id5tifi] = su* product2 7,,iii7 validat+ any applicable transaction hi/ory 9 ! possession ( ! disp5s]2 & 7,,iv7 o!rwise inve/igat+ to det]m9e :e!r ! prescription drug product is an illegitimate prescription drug product4 7ii7 ,cle>$ prescription drug product ,if ! disp5s] makes ! det]m9ation t a suspect prescription drug product is n an illegitimate prescription drug product1 ! disp5s] %all promptly notify ! ,secret>y ( su* det]m9ation & su* prescription drug product may be fur!r disp5s$4 7iii7 ,records ,a disp5s] %all keep records ( its inve/igation ( a suspect prescription drug product = n less ?an #c ye>s aft] ! conclusion ( ! inve/igation4 7,b7 ,illegitimate prescription drug product 7i7 ,9 g5]al ,^u receiv+ notice t a manufactur] ( a prescription drug product has det]m9$ t a prescription drug product 9 ! possession or control ( a disp5s] is an illegitimate prescription drug product1 ! disp5s] %all-- 7,i7 qu>ant9e su* prescription drug product )9 ! possession or control ( ! disp5s] f prescription drug product int5d$ = di/ribution2 & 7,,ii7 provide = ! disposition ( ! illegitimate prescription drug product )9 ! possession or control ( ! disp5s]4 7ii7 ,trad+ p>tn]s ,^u det]m9+ t a prescription drug product 9 ! possession or control ( a trad+ p>tn] is an illegitimate prescription drug product1 ! disp5s] %all take reasonable /eps to assi/ a trad+ p>tn] to provide = ! disposition ( ! illegitimate prescription drug product4 7iii7 ,mak+ a notification ,^u det]m9+ t a prescription drug product 9 ! possession or control ( ! disp5s] is an illegitimate prescription drug product1 ! disp5s] %all notify ! ,secret>y ( su* det]m9ation n lat] ?an #bd h\rs aft] mak+ su* det]m9ation4 ,! ,secret>y %all det]m9e :e!r additional trad+ p>tn] notification is appropriate4 7iv7 ,respond+ to a notification ,^u ! receipt ( a notification f ! ,secret>y t a det]m9ation has be5 made t a prescription drug product is an illegitimate prescription drug product1 a disp5s] %all-- 7,i7 id5tify all illegitimate prescription drug products t are subject to su* notification & 9 ! possession or control ( ! disp5s]1 includ+ any su* prescription drug product t is subsequ5tly receiv$2 & 7,,ii7 p]=m ! activities describ$ 9 clause 7i74 7v7 ,records ,a disp5s] %all keep records ( ! disposition ( an illegitimate prescription drug product = n less ?an #c ye>s aft] ! conclusion ( ! disposition4 7,c7 ,electronic database ,a disp5s] may satisfy ! requirem5ts ( ?is p>agraph ?r\gh ! use ( a secure electronic database develop$ & op]at$ by ! manufactur] or ano!r entity4 ,! own] ( su* database %all e/abli% ! requirem5ts & processes to enable respond+ to reque/s & may provide = data access to o!r memb]s ( ! ph>maceutical di/ribution supply *a91 z appropriate4 ,! developm5t & op]ation ( su* a database %all n relieve a disp5s] ( ! requirem5t "u ?is p>agraph to respond to a v]ification reque/ submitt$ by means o!r ?an a secure electronic database4 7e7 ,repackag] requirem5ts 7#a7 ,prescription drug product trac+ 7,a7 ,9 g5]al ,beg9n+ n lat] ?an ,april #a1 #bjae1 ) respect to a prescription drug product receiv$ by a repackag] f a :olesale di/ributor1 & beg9n+ n lat] ?an ,janu>y #a1 #bjae1 ) respect to any o!r prescription drug product1 a repackag] %all-- 7i7 n accept own]%ip ( a prescription drug product unless ! previ\s own]1 prior to1 or at ! "t (1 ! transaction1 provides transaction hi/ory & a transaction /atem5t = ! prescription drug product2 7ii7 prior to1 or at ! "t (1 ea* transaction 9 :i* ! repackag] transf]s own]%ip ( a prescription drug product1 provide ! subsequ5t own] ) transaction hi/ory & a transaction /atem5t2 7iii7 ma9ta9 ! transaction in=mation = ea* transaction describ$ 9 clause 7i7 or 7ii7 = n less ?an #c ye>s aft] ! transaction2 & 7iv7 ma9ta9 records t all[ ! repackag] to associate ! prescription drug product id5tifi] ! repackag] affixes or impr9ts ) ! prescription drug product id5tifi] assign$ by ! orig9al manufactur] ( ! prescription drug product4 7,b7 ,returns exception ,not)/&+ subp>agraph 7,a77ii71 a repackag] may return prescription drug product to ! trad+ p>tn] f :om ! repackag] obta9$ ! prescription drug product )\t provid+ ! in=mation requir$ "u su* subp>agraph4 7,c7 ,reque/s = in=mation ,^u a reque/ by ! ,secret>y or o!r appropriate ,f$]al or ,/ate (ficial1 9 ! ev5t ( a recall or = ! purpose ( inve/igat+ a suspect prescription drug product or an illegitimate prescription drug product1 a repackag] %all1 n lat] ?an #b bus9ess days aft] receiv+ ! reque/ or 9 su* o!r reasonable "t z det]m9$ by ! ,secret>y1 provide ! applicable transaction hi/ory & transaction /atem5t = ! prescription drug product4 7#b7 ,prescription drug product id5tifi] ,beg9n+ n lat] ?an #f ye>s aft] ! date ( ! enactm5t ( ! ,safegu>d+ ,am]ica's ,ph>maceuticals ,act ( #bjac1 a repackag]-- 7,a7 %all affix or impr9t a prescription drug product id5tifi] to ea* package & homog5\s case ( prescription drug product int5d$ to be introduc$ 9 a transaction2 7,b7 %all ma9ta9 ! prescription drug product id5tifi] = su* prescription drug product = n less ?an #c ye>s aft] ! date ( ! transaction2 & 7,c7 may engage 9 transactions involv+ a prescription drug product only if su* prescription drug product is encod$ ) a prescription drug product id5tifi] except z provid$ 9 subsection 7a77#d74 7#c7 ,au?oriz$ trad+ p>tn]s ,beg9n+ on ,janu>y #a1 #bjae1 a repackag] %all ensure t ea* ( its trad+ p>tn]s is au?oriz$4 7#d7 ,v]ification ,beg9n+ n lat] ?an ,janu>y #a1 #bjae1 a repackag] %all implem5t sy/ems to enable ! repackag] to comply ) ! foll[+ requirem5ts3 7,a7 ,suspect prescription drug product 7i7 ,9 g5]al ,^u mak+ a det]m9ation t a prescription drug product 9 ! possession or control ( ! repackag] is a suspect prescription drug product1 or ^u receiv+ a reque/ = v]ification f ! ,secret>y t a prescription drug product )9 ! possession or control ( a repackag] is a suspect prescription drug product1 a repackag] %all promptly conduct an inve/igation to det]m9e :e!r ! prescription drug product is an illegitimate prescription drug product1 includ+-- 7,i7 beg9n+ n lat] ?an #f ye>s aft] ! date ( ! enactm5t ( ! ,safegu>d+ ,am]ica's ,ph>maceuticals ,act ( #bjac1 v]ify+ ! prescription drug product at ! package level2 7,,ii7 validat+ any applicable transaction in=mation 9 ! possession ( ! repackag]2 & 7,,iii7 o!rwise inve/igat+ to det]m9e :e!r ! prescription drug product is an illegitimate prescription drug product4 7ii7 ,cle>$ prescription drug product ,if ! repackag] det]m9es t a suspect prescription drug product is n an illegitimate prescription drug product1 ! repackag] %all promptly notify ! ,secret>y ( su* det]m9ation & su* prescription drug product may be fur!r di/ribut$4 7iii7 ,records ,a repackag] %all keep records ( its inve/igation ( a suspect prescription drug product = n less ?an #c ye>s aft] ! conclusion ( ! inve/igation4 7,b7 ,illegitimate prescription drug product 7i7 ,9 g5]al ,^u receiv+ notice t a manufactur] ( a prescription drug product has det]m9$ t a prescription drug product 9 ! possession or control ( a repackag] is an illegitimate prescription drug product1 ! repackag] %all-- 7,i7 qu>ant9e su* prescription drug product )9 ! possession or control ( ! repackag] f prescription drug product int5d$ = di/ribution2 & 7,,ii7 provide = ! disposition ( ! illegitimate prescription drug product )9 ! possession or control ( ! repackag]4 7ii7 ,trad+ p>tn] ,^u det]m9+ t a prescription drug product 9 ! possession or control ( a trad+ p>tn] is an illegitimate prescription drug product1 ! repackag]s %all take reasonable /eps to assi/ ! trad+ p>tn] to provide = ! disposition ( ! illegitimate prescription drug product4 7iii7 ,mak+ a notification ,^u det]m9+ t a prescription drug product 9 ! possession or control ( ! repackag] is an illegitimate prescription drug product1 ! repackag] %all notify ! ,secret>y ( su* det]m9ation n lat] ?an #bd h\rs aft] mak+ su* det]m9ation4 ,! ,secret>y %all det]m9e :e!r additional trad+ p>tn] notification is appropriate4 7iv7 ,respond+ to a notification ,^u ! receipt ( a notification f ! ,secret>y t a det]m9ation has be5 made t a prescription drug product is an illegitimate prescription drug product1 a repackag] %all-- 7,i7 id5tify all illegitimate prescription drug products t are subject to su* notification & 9 ! possession or control ( ! repackag]1 includ+ any su* prescription drug product t is subsequ5tly receiv$2 & 7,,ii7 p]=m ! activities describ$ 9 clause 7i74 7v7 ,records ,a repackag] %all keep records ( ! disposition ( an illegitimate prescription drug product = n less ?an #c ye>s aft] ! conclusion ( ! disposition4 7,c7 ,electronic database ,a repackag] may satisfy ! requirem5ts ( ?is p>agraph ?r\gh ! use ( a secure electronic database develop$ & op]at$ by ! manufactur] or ano!r entity4 ,! own] ( su* database %all e/abli% ! requirem5ts & processes to respond to reque/s & may provide = data access to o!r memb]s ( ! ph>maceutical di/ribution supply *a91 z appropriate4 ,! developm5t & op]ation ( su* a database %all n relieve a repackag] ( ! requirem5t "u ?is p>agraph to respond to a v]ification reque/ submitt$ by means o!r ?an a secure electronic database4 7,d7 ,return$ prescription drug product ,beg9n+ n lat] ?an #f ye>s aft] ! date ( ! enactm5t ( ! ,safegu>d+ ,am]ica's ,ph>maceuticals ,act ( #bjac1 ^u receipt ( a return$ prescription drug product t ! repackag] int5ds to fur!r di/ribute1 be=e fur!r di/ribut+ su* prescription drug product1 ! repackag] %all-- 7i7 v]ify ! prescription drug product id5tifi] = ea* seal$ homog5e\s case ( su* prescription drug product2 or 7ii7 if su* prescription drug product is n 9 a seal$ homog5e\s case1 v]ify ! prescription drug product id5tifi] on ea* package4 7f7 ,?ird-,p>ty logi/ics provid] requirem5ts 7#a7 ,au?oriz$ trad+ p>tn]s ,beg9n+ on ,janu>y #a1 #bjae1 a ?ird-p>ty logi/ics provid] %all ensure t ea* ( its trad+ p>tn]s is au?oriz$4 7#b7 ,v]ification ,beg9n+ n lat] ?an ,janu>y #a1 #bjae1 a ?ird-p>ty logi/ics provid] %all implem5t sy/ems to enable ! ?ird-p>ty logi/ics provid] to comply ) ! foll[+ requirem5ts3 7,a7 ,suspect prescription drug product 7i7 ,9 g5]al ,^u mak+ a det]m9ation t a prescription drug product 9 ! possession or control ( a ?ird-p>ty logi/ics provid] is a suspect prescription drug product1 a ?ird-p>ty logi/ics provid] %all promptly notify ! own] ( su* prescription drug product ( ! ne$ to conduct an inve/igation to det]m9e :e!r ! prescription drug product is an illegitimate prescription drug product4 7ii7 ,cle>$ prescription drug product ,if ! own] ( ! prescription drug product notifies ! ?ird-p>ty logi/ics provid] ( ! det]m9ation t a suspect prescription drug product is n an illegitimate prescription drug product1 su* prescription drug product may be fur!r di/ribut$4 7iii7 ,records ,a ?ird-p>ty logi/ics provid] %all keep records ( ! activities describ$ 9 clauses 7i7 & 7ii7 ) respect to a suspect prescription drug product = n less ?an #c ye>s aft] ! conclusion ( ! inve/igation4 7,b7 ,illegitimate prescription drug product 7i7 ,9 g5]al ,^u receiv+ notice t a manufactur] ( a prescription drug product has det]m9$ t a prescription drug product 9 ! possession or control ( a ?ird-p>ty logi/ics provid] is an illegitimate prescription drug product1 ! ?ird-p>ty logi/ics provid] %all-- 7,i7 qu>ant9e su* prescription drug product )9 ! possession or control ( ! ?ird-p>ty logi/ics provid] f prescription drug product int5d$ = di/ribution2 7,,ii7 promptly notify ! own] ( su* prescription drug product ( ! ne$ to provide = ! disposition ( su* prescription drug product2 & 7,,iii7 promptly transf] possession ( ! prescription drug product to ! own] ( su* prescription drug product to provide = ! disposition ( ! prescription drug product4 7ii7 ,mak+ a notification ,^u det]m9+ t a prescription drug product 9 ! possession or control ( ! ?ird-p>ty logi/ics provid] is an illegitimate prescription drug product1 ! ?ird-p>ty logi/ics provid] %all notify ! ,secret>y n lat] ?an #bd h\rs aft] mak+ su* det]m9ation4 ,! ,secret>y %all det]m9e :e!r additional trad+ p>tn] notification is appropriate4 7iii7 ,respond+ to a notification ,^u ! receipt ( a notification f ! ,secret>y1 a ?ird-p>ty logi/ics provid] %all-- 7,i7 id5tify all illegitimate prescription drug products subject to su* notification t are 9 ! possession or control ( ! ?ird-p>ty logi/ics provid]1 includ+ any su* prescription drug product t is subsequ5tly receiv$2 & 7,,ii7 p]=m ! activities describ$ 9 clause 7i74 7iv7 ,records ,a ?ird-p>ty logi/ics provid] %all keep records ( ! activities describ$ 9 clauses 7i7 & 7ii7 ) respect to an illegitimate prescription drug product = n less ?an #c ye>s aft] ! conclusion ( ! disposition4 7g7 ,drop %ipm5ts ,?is section does n apply to any entity1 not)/&+ its /atus z a :olesale di/ributor or repackag]1 or o!r /atus t is n involv$ 9 ! physical h&l+1 di/ribution1 or /orage ( a prescription drug product4 ,= purposes ( ?is subsection1 facilitat+ ! di/ribution ( a prescription drug product by provid+ v>i\s adm9i/rative s]vices1 includ+ process+ ( ord]s & paym5ts1 %all n1 by itself1 be con/ru$ z be+ involv$ 9 ! h&l+1 di/ribution1 or /orage ( a prescription drug product4 4 #c4 ,enhanc$ drug di/ribution security 7a7 ,pilot projects 7#a7 ,9 g5]al ,n lat] ?an #b ye>s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y %all e/abli% "o or m pilot projects 9 coord9ation ) manufactur]s1 repackag]s1 :olesale di/ributors1 ?ird-p>ty logi/ics provid]s1 & disp5s]s to explore & evaluate me?ods to enhance ! safety & security ( ! ph>maceutical di/ribution supply *a94 7#b7 ,cont5t 7,a7 ,9 g5]al ,! ,secret>y %all ensure t ! pilot projects "u p>agraph 7#a7 collectively-- 7i7 reflect ! div]sity ( ! ph>maceutical di/ribution supply *a92 & 7ii7 include p>ticipants repres5tative ( e sector )9 ! ph>maceutical di/ribution supply *a91 includ+ p>ticipants repres5tative ( small bus9esses4 7,b7 ,project design ,! pilot projects %all be design$ to-- 7i7 utilize ! prescription drug product id5tifi] = trac+ ( a prescription drug product1 :i* utilization may include-- 7,i7 v]ification ( ! prescription drug product id5tifi] ( a prescription drug product2 & 7,,ii7 ! use ( aggregation & inf]5ce2 7ii7 improve ! te*nical capabilities ( ea* sector )9 ! ph>maceutical supply *a9 to comply ) sy/ems & processes ne$$ to utilize ! prescription drug product id5tifi]s to enhance trac+ ( a prescription drug product2 & 7iii7 conduct su* o!r activities z ! ,secret>y det]m9es appropriate to explore & evaluate me?ods to enhance ! safety & security ( ! ph>maceutical di/ribution supply *a94 7b7 ,public meet+s 7#a7 ,9 g5]al ,n lat] ?an #f mon?s aft] ! date ( ! enactm5t ( ?is ,act1 & at lea/ e #f mon?s !reaft] until ! submission ( ! report requir$ by subsection 7e77#b71 ! ,secret>y %all hold a public meet+ to enhance ! safety & security ( ! ph>maceutical di/ribution supply *a94 ,9 conduct+ su* meet+s1 ! ,secret>y %all take all measures reasonable & practicable to ensure ! protection ( confid5tial comm]cial in=mation & trade secrets4 7#b7 ,cont5t ,9 conduct+ meet+s "u ?is subsection1 ! ,secret>y %all seek to address1 9 at lea/ "o su* meet+1 ea* ( ! foll[+ topics3 7,a7 ,be/ practices 9 ea* ( ! sectors )9 ! ph>maceutical di/ribution supply *a9 to implem5t ! requirem5ts ( section #ehb ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #b4 7,b7 ,! co/s & b5efits ( implem5tation ( su* section #ehb1 includ+ ! impact on ea* ph>maceutical di/ribution supply *a9 sector & on public heal?4 7,c7 ,:e!r additional electronic traceability requirem5ts1 includ+ trac+ ( prescription drug product at ! package level1 are feasible1 co/ effective1 ov]ly burd5some on small bus9esses1 & ne$$ to protect public heal?4 7,d7 ,! sy/ems & processes ne$$ to utilize ! prescription drug product id5tifi]s to enhance trac+ ( prescription drug product at ! package level1 includ+ all[+ = v]ification1 aggregation1 & inf]5ce by ea* sector )9 ! ph>maceutical di/ribution supply *a9 = cases1 pallets1 totes1 & o!r conta9]s ( aggregat$ prescription drug product z necess>y4 7,e7 ,! te*nical capabilities & legal au?orities1 if any1 ne$$ to e/abli% an electronic sy/em t provides = enhanc$ trac+ ( prescription drug product at ! package level4 7,f7 ,! impact t ! requirem5ts1 sy/ems1 processes1 capabilities1 & legal au?orities ref]r$ to 9 subp>agraphs 7,c71 7,d71 & 7,e7 w\ld h on pati5t safety1 ! drug supply1 co/ & regulatory burd51 ! timel9ess ( pati5t access to prescription drugs1 & small bus9esses4 7c7 ,/udy ( ! ph>maceutical di/ribution supply *a9 7#a7 ,9 g5]al ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a /udy to exam9e implem5tation ( ! requirem5ts e/abli%$ "u sub*apt] ,h ( *apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #b1 9 ord] to in=m ! regulations promulgat$ "u ?is section4 7#b7 ,consid]ation ,9 conduct+ ! /udy "u ?is subsection1 ! ,comptroll] ,g5]al %all provide = /akehold] input & %all consid] ! foll[+3 7,a7 ,! implem5tation ( ! requirem5ts e/abli%$ "u su* sub*apt] ,h ) respect to-- 7i7 ! ability ( ! heal? c>e sy/em collectively to ma9ta9 pati5t access to m$ic9es2 7ii7 ! scalability ( su* requirem5ts1 includ+ ) respect to prescription drug product l9es2 & 7iii7 ! capability ( diff]5t sectors )9 ! ph>maceutical di/ribution supply *a91 includ+ small bus9esses1 to affix & utilize ! prescription drug product id5tifi]4 7,b7 ,! ne$ = additional legal au?orities & activities to address additional gaps 9 ! ph>maceutical di/ribution supply *a91 if any1 aft] ! implem5tation ( ! requirem5ts e/abli%$ "u su* sub*apt] ,h ) respect to-- 7i7 ! sy/ems & processes ne$$ to enhance trac+ ( prescription drug product at ! package level1 includ+ ! use & evaluation ( v]ification1 aggregation1 & inf]5ce by ea* sector )9 ! ph>maceutical di/ribution supply *a9 z necess>y2 7ii7 ! impact1 feasibility1 & co/ effectiv5ess t additional requirem5ts pursuant to ?is section w\ld h on ea* ph>maceutical di/ribution supply *a9 sector & ! public heal?2 & 7iii7 ! sy/ems & processes ne$$ to enhance int]op]ability among trad+ p>tn]s4 7,c7 ,risks to ! security & privacy ( data collect$1 ma9ta9$1 or ex*ang$ pursuant to ! requirem5ts e/abli%$ "u su* sub*apt] ,h4 7d7 ,small disp5s]s 7#a7 ,9 g5]al ,n lat] ?an #aj ye>s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y %all ent] into a contract ) a private1 indep5d5t consult+ firm ) relevant exp]tise to conduct a te*nology & s(tw>e /udy on ! feasibility ( disp5s]s t h #be or few] full-"t employees conduct+ int]op]able1 electronic trac+ ( prescription drug products at ! package level4 7#b7 ,condition ,z a condition ( ! aw>d ( a contract "u p>agraph 7#a71 ! private indep5d5t consult+ firm aw>d$ su* contract %all agree to consult ) disp5s]s t h #be or few] full-"t employees :5 conduct+ ! /udy "u su* subp>agraph4 7#c7 ,/udy cont5t ,! /udy conduct$ "u p>agraph 7#a7 %all assess :e!r1 ) respect to conduct+ int]op]able1 electronic trac+ ( prescription drug products at ! package level1 ! necess>y h>dw>e & s(tw>e-- 7,a7 is readily accessible to su* disp5s]s2 7,b7 is n prohibitively exp5sive to obta91 in/all1 & ma9ta9 = su* disp5s]s2 & 7,c7 c be integrat$ into bus9ess practices1 su* z int]op]ability ) :olesale di/ributors1 = su* disp5s]s4 7#d7 ,publication ,! ,secret>y %all publi%-- 7,a7 ! /atem5t ( "w = ! /udy conduct$ "u p>agraph 7#a7 = public comm5t n lat] ?an #cj days be=e comm5c+ ! /udy2 & 7,b7 ! f9al v]sion ( su* /udy = public comm5t n lat] ?an #cj days aft] su* /udy is complet$4 7#e7 ,report to ,congress ,n lat] ?an #cj days aft] ! date on :i* ! /udy conduct$ "u p>agraph 7#a7 is complet$1 ! ,secret>y %all submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate1 a report on ! f9d+s ( ! /udy & any recomm5dations to improve ! te*nology & s(tw>e available to small disp5s]s = purposes ( conduct+ electronic1 int]op]able trac+ ( prescription drug products at ! package level4 7#f7 ,public meet+ ,n lat] ?an #ahj days aft] ! date on :i* ! /udy conduct$ "u p>agraph 7#a7 is complet$1 ! ,secret>y %all hold a public meet+ at :i* memb]s ( ! public1 includ+ /akehold]s1 may pres5t _! views on ! /udy4 7e7 ,reports 7#a7 ,,gao report ,n lat] ?an #ab ye>s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al %all submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate a report on ! results ( ! /udy conduct$ "u subsection 7c74 7#b7 ,,fda report ,n lat] ?an #ab ye>s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y %all submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate a report on ! results ( ! pilot program conduct$ "u subsection 7a71 tak+ into consid]ation-- 7,a7 ! comm5ts receiv$ dur+ ! public meet+s conduct$ "u subsection 7b72 & 7,b7 ! results ( ! /udy conduct$1 & ! public comm5ts receiv$ dur+ ! public meet+ held1 "u subsection 7d74 7f7 ,e/abli%m5t ( additional requirem5ts 7#a7 ,9 g5]al ,not)/&+ any o!r provision ( ?is ,act1 includ+ ! am5dm5ts made by ?is ,act1 n e>li] ?an ,janu>y #a1 #bjbg1 & n lat] ?an ,m>* #a1 #bjbg1 ! ,secret>y %all issue propos$ regulations t e/abli% additional requirem5ts to prev5t a suspect product1 illegitimate product1 or a product t is c\nt]feit1 /ol51 div]t$1 or o!rwise unfit = di/ribution f ent]+ into or be+ fur!r di/ribut$ 9 ! supply *a91 includ+-- 7,a7 requirem5ts relat$ to ! use ( int]op]able electronic sy/ems & te*nologies = enhanc$ trac+ ( prescription drug product at ! package level1 :i* may include v]ification ( ! prescription drug product id5tifi] ( a package ( prescription drug product & enhanc$ v]ification ( saleable returns2 7,b7 requirem5ts relat$ to ! use ( additional prescription drug product id5tifi]s or prescription drug product id5tifi] te*nology t meet ! /&>ds develop$ "u section #ehb7;a77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #b2 7,c7 requirem5ts relat$ to ! use ( aggregation1 inf]5ce1 & o!r me?ods1 :i* %all p]mit ! use ( aggregation & inf]5ce = cases1 pallets1 totes1 & o!r conta9]s ( aggregat$ prescription drug products by ea* sector ( ! ph>maceutical di/ribution supply *a91 if det]m9$ to be necess>y compon5ts ( ! sy/ems & te*nologies ref]r$ to 9 subp>agraph 7,a72 & 7,d7 o!r data transmission & ma9t5ance requirem5ts & int]op]ability /&>ds4 7#b7 ,flexibility ,! requirem5ts describ$ 9 p>agraph 7#a7 %all provide = flexibility = a memb] ( ! ph>maceutical supply *a91 by-- 7,a7 ) respect to disp5s]s1 all[+ a disp5s] to ent] into a writt5 agreem5t ) a ?ird p>ty1 includ+ an au?oriz$ :olesale di/ributor1 "u :i*-- 7i7 ! ?ird p>ty confid5tially ma9ta9s any in=mation requir$ to be ma9ta9$ "u su* requirem5ts = ! disp5s]2 & 7ii7 ! disp5s] ma9ta9s a copy ( ! writt5 agreem5t & is n reliev$ ( ! o!r obligations ( ! disp5s] "u su* requirem5ts2 7,b7 e/abli%+ a process by :i* an au?oriz$ manufactur]1 repackag]1 :olesale di/ributor1 or disp5s] may reque/ a waiv] f any su* requirem5ts if ! ,secret>y det]m9es t su* requirem5ts w\ld result 9 an undue economic h>d%ip on ! manufactur]1 :olesale di/ributor1 or disp5s]2 7,c7 n requir+ ! adoption ( specific bus9ess sy/ems by a memb] ( ! ph>maceutical supply *a9 = ! ma9t5ance & transmission ( prescription drug product trac+ data2 & 7,d7 prescrib+ alt]native me?ods ( compliance = small bus9esses1 z specifi$ 9 p>agraph 7#d74 7#c7 ,consid]ations ,9 issu+ propos$ regulations "u p>agraph 7#a71 ! ,secret>y %all consid]-- 7,a7 ! results (1 & public comm5ts result+ f1 ! pilot project conduct$ "u subsection 7a72 7,b7 ! public meet+s held "u subsection 7b7 & public comm5ts f su* meet+s2 7,c7 ! /udies conduct$ "u subsections 7c7 & 7d72 7,d7 ! reports submitt$ "u subsection 7e72 7,e7 ! public heal? b5efits ( su* regulations comp>$ ) ! co/ ( compliance ) ! requirem5ts conta9$ 9 su* regulations1 includ+ ) respect to entities ( v>y+ sizes & capabilities2 & 7,f7 ! div]sity ( ! ph>maceutical di/ribution supply *a9 by provid+ appropriate flexibility = ea* sector 9 ! supply *a91 includ+ small bus9esses4 7#d7 ,small bus9ess protection ,! ,secret>y1 tak+ into consid]ation ! /udy conduct$ "u p>agraph 7d71 %all1 if ! ,secret>y det]m9es t ! requirem5ts e/abli%$ pursuant to p>agraph 7#a7 w\ld result 9 an undue economic h>d%ip on small bus9esses1 provide = alt]native me?ods ( compliance ) any su* requirem5t by small bus9esses1 includ+-- 7,a7 e/abli%+ timel9es = su* compliance 7includ+ compliance by disp5s]s ) #be or few] full-"t employees7 t d n impose undue economic h>d%ip = small bus9esses1 includ+ disp5s]s ) respect to :i* ! /udy conclud$ has insuffici5t h>dw>e & s(tw>e to conduct int]op]able1 electronic trac+ ( prescription drug products at ! package level2 & 7,b7 e/abli%+ a process by :i* a disp5s] may reque/ a waiv] f any su* requirem5t4 7#e7 ,regulations ,9 issu+ regulations to c>ry out ?is subsection1 ! ,secret>y %all-- 7,a7 issue a notice ( propos$ rulemak+ t includes a copy ( ! propos$ rule2 7,b7 provide = a p]iod ( n less ?an #fj days = comm5ts on ! propos$ rule2 & 7,c7 provide = an effective date ( ! f9al rule t is #b ye>s aft] ! date on :i* su* f9al rule is publi%$4 7#f7 ,sunset ,! requirem5ts reg>d+ ! provision & receipt ( transaction hi/ory & transaction /atem5ts "u section #ehb ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #b1 %all cease to be effective on ! date on :i* ! regulations issu$ "u ?is section are fully implem5t$4 7g7 ,def9itions ,9 ?is section3 7#a7 ,! t]ms def9$ 9 section #eha ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #b1 %all h ! same mean+s 9 ?is section z su* t]ms are giv5 9 su* section #eha4 7#b7 ,! t]m ,secret>y means ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs4 #d4 ,national /&>ds = :olesale di/ributors 7a7 ,/&>ds ,*apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is am5d$-- 7#a7 9 section #ejc 7#ba ,u4,s4,c4 #cec71 by /rik+ 7e77#a77;,a7 & all t foll[s ?r\gh 7#c7 ,= ! purposes ( ?is subsection & subsection 7d7-- & ins]t+ ! foll[+3 7e7 ,= purposes ( subsection 7d7-- 2 7#b7 9 section #ejc7;e7 7#ba ,u4,s4,c4 #cec7;e771 by r$esignat+ subp>agraphs 7,a7 & 7,b7 z p>agraphs 7#a7 & 7#b71 respectively2 & 7#c7 9 sub*apt] ,h1 z add$ by section #b1 by add+ at ! end ! foll[+3 #ehc4 ,national /&>ds = :olesale di/ributors 7a7 ,/&>ds 7#a7 ,9 g5]al ,! ,secret>y %all e/abli%1 by regulation1 /&>ds = ! lic5s+ ( p]sons t make :olesale di/ributions4 7#b7 ,requirem5ts ,! /&>ds "u p>agraph 7#a7 %all1 ) respect to :olesale di/ributions1 include requirem5ts =-- 7,a7 ! /orage & h&l+ ( drugs subject to section #ejc7;b77#a71 includ+ facility requirem5ts2 7,b7 ! e/abli%m5t & ma9t5ance ( records ( ! di/ributions ( su* drugs2 7,c7 ! furni%+ ( a bond or o!r equival5t means ( security 9 accordance ) p>agraph 7#c72 7,d7 m&atory backgr\nd *ecks & f+]pr9t+ ( facility manag]s or designat$ repres5tatives2 7,e7 ! e/abli%m5t & implem5tation ( qualifications = key p]sonnel2 7,f7 ! m&atory physical inspection ( any facility to be us$ 9 :olesale di/ribution )9 a reasonable timeframe f ! initial application = lic5sure ( ! :olesale di/ributor2 & 7,g7 9 accordance ) p>agraph 7#e71 ! prohibition ( c]ta9 p]sons f engag+ 9 :olesale di/ribution4 7#c7 ,bond or o!r security ,! requirem5ts "u p>agraph 7#b77;,c7 %all provide = ! foll[+3 7,a7 ,an applicant t is n a gov]nm5t-own$-&-op]at$ :olesale di/ributor1 = ! issuance or r5ewal ( a :olesale di/ributor lic5se1 %all submit a surety bond ( #ajj1jjj or o!r equival5t means ( security acceptable to ! applicable lic5s+ au?ority4 7,b7 ,= purposes ( subp>agraph 7,a71 ! applicable lic5s+ au?ority may accept a surety bond ( less ?an #ajj1jjj if ! annual gross receipts ( ! previ\s tax ye> = ! :olesale di/ributor is #aj1jjj1jjj or less1 9 :i* case ! surety bond may n be less ?an #be1jjj4 7,c7 ,if a :olesale di/ributor c provide evid5ce t x possesses ! requir$ bond 9 a ,/ate1 ! requirem5t = a bond 9 ano!r ,/ate is waiv$4 7#d7 ,inspections ,to satisfy ! inspection requirem5t "u p>agraph 7#b77;,f71 ! ,secret>y may conduct ! inspection1 or may accept an inspection by-- 7,a7 ! gov]nm5t ( ! ,/ate 9 :i* ! facility is locat$2 or 7,b7 a ?ird-p>ty accr$itation or inspection s]vice approv$ by ! ,secret>y4 7#e7 ,prohibit$ p]sons ,! requirem5ts "u p>agraph 7#b7 %all include requirem5ts to prohibit a p]son f receiv+ or ma9ta9+ lic5sure = :olesale di/ribution if ! p]son-- 7,a7 has be5 convict$ (-- 7i7 any felony = conduct relat+ to :olesale di/ribution2 7ii7 any felony violation ( section #cja7;i7 or #cja7k72 or 7iii7 any felony violation ( section #acfe ( title #ah1 ,unit$ ,/ates ,code1 relat+ to prescription drug product tamp]+2 or 7,b7 has engag$ 9 a patt]n ( violat+ ! requirem5ts ( ?is section t pres5ts a ?reat ( s]i\s adv]se heal? consequ5ces or dea? to humans4 7b7 ,report+ by lic5s$ :olesale di/ributors 7#a7 ,annual report ,beg9n+ n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is section1 ea* p]son engag$ 9 :olesale di/ribution 9 int]/ate comm]ce %all submit on an annual basis1 & update z necess>y1 a report to ! ,secret>y includ+-- 7,a7 ! :olesale di/ributor's "n2 7,b7 ! :olesale di/ributor's address2 7,c7 a li/+ ( ea* ,/ate 9 :i* ! :olesale di/ributor is lic5s$ = :olesale di/ribution2 & 7,d7 any discipl9>y actions tak5 by a ,/ate1 ! ,f$]al ,gov]nm5t1 or a =eign gov]nm5t dur+ ! report+ p]iod aga9/ ! :olesale di/ributor4 7#b7 ,po/+ on ,int]net ,! ,secret>y %all po/ on ! public ,int]net ,website ( ! ,food & ,drug ,adm9i/ration ! "n ( ea* :olesale di/ributor1 & ! ,/ate 9 :i* ea* su* di/ributor is lic5s$1 bas$ on reports "u p>agraph 7#a74 7c7 ,pres]vation ( ,/ate au?ority ,?is sub*apt] does n prohibit a ,/ate f-- 7#a7 lic5s+ :olesale di/ributors = ! conduct ( :olesale di/ribution activities 9 ! ,/ate 9 accordance ) ?is sub*apt]2 & 7#b7 collect+ fees f :olesale di/ributors 9 connection ) su* lic5s+1 s long z ! ,/ate does n require su* lic5sure to ! ext5t to :i* an entity is engag$ 9 ?ird-p>ty logi/ics provid] activities4 7d7 ,def9ition ,9 ?is section1 ! t]m :olesale di/ribution means ! di/ribution ( a drug subject to section #ejc7;b77#a7 to a p]son o!r ?an a consum] or pati5t1 b does n include-- 7#a7 intracompany di/ribution ( any drug betwe5 memb]s ( an affiliat$ gr\p 7z def9$ 9 section #aejd7;a7 ( ! ,int]nal ,rev5ue ,code ( #aihf72 7#b7 ! di/ribution ( a drug1 or an (f] to di/ribute a drug among hospitals or o!r heal? c>e entities :i* are "u common control2 7#c7 ! di/ribution ( a drug or an (f] to di/ribute a drug = em]g5cy m$ical reasons1 includ+ a public heal? em]g5cy decl>ation pursuant to section #cai ( ! ,public ,heal? ,s]vice ,act1 except t a drug %ortage n caus$ by a public heal? em]g5cy %all n con/itute su* an em]g5cy m$ical reason2 7#d7 disp5s+ ( a drug pursuant to a valid prescription execut$ 9 accordance ) subsection #ejc7;b77#a72 7#e7 ! di/ribution ( m9imal quantities ( drug by a lic5s$ retail ph>macy to a lic5s$ practition] = (fice use2 7#f7 ! di/ribution ( a drug or an (f] to di/ribute a drug by a *>itable organization to a nonpr(it affiliate ( ! organization to ! ext5t o!rwise p]mitt$ by law2 7#g7 ! pur*ase or o!r acquisition by a disp5s]1 hospital1 or o!r heal? c>e entity ( a drug = use by su* disp5s]1 hospital1 or o!r heal? c>e entity2 7#h7 ! di/ribution ( a drug by ! manufactur] ( su* drug2 7#i7 ! receipt or transf] ( a drug by an au?oriz$ ?ird-p>ty logi/ics provid] provid$ t su* ?ird-p>ty logi/ics provid] does n take own]%ip ( ! drug2 7#aj7 ! transport ( a drug by a common c>ri]1 provid$ t ! common c>ri] does n take own]%ip ( ! drug2 7#aa7 ! di/ribution ( a drug1 or an (f] to di/ribute a drug1 by an au?oriz$ repackag] t has tak5 own]%ip ( ! drug & repack$ x 9 accordance ) section #ehb7;e72 7#ab7 saleable drug returns :5 conduct$ by a disp5s] 9 accordance ) section #bjc4bc ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulation72 7#ac7 ! di/ribution ( a comb9ation prescription drug product describ$ 9 section #eha7bj77;,b77xii72 7#ad7 ! di/ribution ( a m$ical conv5i5ce kit describ$ 9 section #eha7ba77;,b77xiii72 7#ae7 ! di/ribution ( an intrav5\s drug t1 by its =mulation1 is int5d$ = ! repl5i%m5t ( fluids & electrolytes 7su* z sodium1 *loride1 & potassium7 or calories 7su* z dextrose & am9o acids72 7#af7 ! di/ribution ( an intrav5\s drug us$ to ma9ta9 ! equilibrium ( wat] & m9]als 9 ! body1 su* z dialysis solutions2 7#ag7 ! di/ribution ( a drug t is int5d$ = irrigation or recon/itution1 or /]ile wat]1 :e!r int5d$ = su* purposes or = injection2 7#ah7 ! di/ribution ( compress$ m$ical gas 7z def9$ 9 section #eha7ba77;,c772 7#ai7 facilitat+ ! di/ribution ( a prescription drug product by provid+ adm9i/rative s]vices1 su* z process+ ( ord]s & paym5ts1 )\t physical h&l+1 di/ribution1 or /orage ( a prescription drug product2 or 7#bj7 7,a7 ! di/ribution ( a product by a disp5s]1 or a :olesale di/ributor act+ at ! direction ( ! disp5s]1 to a repackag] regi/]$ "u section #eaj = ! purpose ( repackag+ ! drug = use by t disp5s] or ano!r heal? c>e entity t is "u ! disp5s]'s own]%ip or control1 s long z ! disp5s] reta9s own]%ip ( ! prescription drug product2 & 7,b7 ! saleable or nonsaleable return by su* repackag] ( su* prescription drug product4 7e7 ,effective date ,! /&>ds requir$ by subsection 7a7 %all take effect n lat] ?an #b ye>s aft] ! date ( ! enactm5t ( ?is section4 ,! ,secret>y %all issue ! regulations requir$ by subsection 7a7 n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act4 4 7b7 ,con=m+ am5dm5t ,section #hjd7;a77#e77;,a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #chd7;a77#e77;,a77 is am5d$ by /rik+ #ejc7;e77#b77;,a7 & ins]t+ #ehc7;a74 #e4 ,national lic5sure /&>ds = ?ird-p>ty logi/ics provid]s ,sub*apt] ,h ( *apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z am5d$ by section #d1 is fur!r am5d$ by add+ at ! end ! foll[+3 #ehd4 ,national lic5sure /&>ds = ?ird-p>ty logi/ics provid]s 7a7 ,lic5se requirem5t ,no facility may engage 9 ! activities ( a ?ird-p>ty logi/ics provid] 9 any ,/ate unless-- 7#a7 ! facility is lic5s$-- 7,a7 by ! ,/ate f :i* ! drug is di/ribut$ by ! ?ird-p>ty logi/ics provid] 9 accordance ) a qualifi$ lic5s+ program1 if ! ,/ate has su* a program2 or 7,b7 by ! ,secret>y "u ?is section1 if ! ,/ate f :i* ! drug is di/ribut$ does n h su* a program2 & 7#b7 if ! drug is di/ribut$ int]/ate & ! facility is n lic5s$ by ! ,secret>y "u p>agraph 7#a77;,b71 regi/]s ) ! ,/ate into :i* ! drug is di/ribut$ if su* ,/ate requires su* regi/ration4 7b7 ,report+ by lic5s$ ?ird-,p>ty logi/ics provid]s 7#a7 ,annual report ,beg9n+ n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is section1 ea* facility engag$ 9 ! activities ( a ?ird-p>ty logi/ics provid] %all submit on an annual basis1 & update z necess>y1 a report to ! ,secret>y includ+-- 7,a7 ! facility's "n2 7,b7 ! facility's address2 7,c7 a li/+ ( ea* jurisdiction 7:e!r ,/ate or ,f$]al7 9 :i* ! facility is lic5s$ = ?ird-p>ty logi/ics provid] activities2 & 7,d7 any discipl9>y actions tak5 by a ,/ate or ,f$]al lic5s+ au?ority dur+ ! report+ p]iod aga9/ ! facility4 7#b7 ,po/+ on ,int]net ,! ,secret>y %all po/ on ! public ,int]net ,website ( ! ,food & ,drug ,adm9i/ration ! "n ( ea* ?ird-p>ty logi/ics provid]1 & ea* jurisdiction 7:e!r ,/ate or ,f$]al7 9 :i* ! provid] is lic5s$1 bas$ on reports "u p>agraph 7#a74 7c7 ,pres]vation ( ,/ate au?ority ,?is sub*apt] does n prohibit a ,/ate f-- 7#a7 lic5s+ ?ird-p>ty logi/ic provid]s = ! conduct ( ?ird-p>ty logi/ics provid] activities 9 ! ,/ate 9 accordance ) ?is sub*apt]2 & 7#b7 collect+ fees f ?ird-p>ty logi/ics provid]s 9 connection ) su* lic5s+1 s long z ! ,/ate does n require su* lic5sure to ! ext5t to :i* an entity is engag$ 9 :olesale di/ribution4 7d7 ,co/s 7#a7 ,au?oriz$ lic5sure fees ,9 ! case ( a facility engag+ 9 ! activities ( a ?ird-p>ty logi/ics provid] lic5s$ by ! ,secret>y "u ?is section1 ! ,secret>y may assess & collect a reasonable fee 9 an am\nt equal to ! co/s to ! ,f$]al ,gov]nm5t ( e/abli%+ & adm9i/]+ ! lic5sure program e/abli%$1 & conduct+ p]iod inspections1 "u ?is section4 7#b7 ,adju/m5t ,! ,secret>y %all adju/ ! am\nt ( ! fee "u p>agraph 7#a7 on an annual basis1 if necess>y1 to g5]ate an am\nt ( rev5ue equal to ! co/s ref]r$ to 9 su* p>agraph4 7#c7 ,availability ,fees assess$ & collect$ "u ?is subsection %all be available = obligation only to ! ext5t & 9 ! am\nt provid$ 9 advance 9 appropriations ,acts4 ,su* fees %all rema9 available until exp5d$4 7e7 ,lic5se regulations 7#a7 ,9 g5]al ,! ,secret>y %all e/abli%1 by regulation1 /&>ds1 t]ms1 & conditions = lic5s+ p]sons to engage 9 ?ird-p>ty logi/ics provid] activities4 7#b7 ,cont5t ,! regulations "u p>agraph 7#a7 %all-- 7,a7 include /&>ds relat+ to eligibility =1 & revocation & reissuance (1 lic5ses2 7,b7 e/abli% a process by :i* ! applicable lic5s+ au?ority w1 ^u reque/ by a ?ird-p>ty logi/ics provid] t is accr$it$ by a ?ird-p>ty accr$itation program approv$ by ! ,secret>y1 issue a lic5se to ! provid]2 7,c7 e/abli% a process by :i* ! ,secret>y %all issue a lic5se to a ?ird-p>ty logi/ics provid] if ! ,secret>y is n able to approve a ?ird-p>ty accr$itation program because no su* program meets ! ,secret>y's requirem5ts necess>y = approval ( su* a ?ird-p>ty accr$itation program2 7,d7 require t ! ?ird-p>ty logi/ics provid] comply ) /orage practices1 z det]m9$ by ! ,secret>y1 at ! provid]'s facilities1 includ+-- 7i7 ma9ta9+ access to w>eh\se space ( suitable size to facilitate safe op]ations1 includ+ a suitable area to qu>ant9e suspect prescription drug product2 7ii7 ma9ta9+ adequate security2 & 7iii7 hav+ writt5 policies & proc$ures to-- 7,i7 address receipt1 security1 /orage1 inv5tory1 %ipm5t1 & di/ribution ( a prescription drug product2 7,,ii7 id5tify1 record1 & report confirm$ losses or !fts 9 ! ,unit$ ,/ates2 7,,iii7 correct errors & inaccuracies 9 inv5tories2 7,,iv7 provide support = manufactur] recalls2 7,v7 prep>e =1 protect aga9/1 & address any reasonably =eseeable crisis t affects security or op]ation at ! facility1 su* z a /rike1 fire1 or flood2 7,,vi7 ensure t any expir$ prescription drug product is segregat$ f o!r prescription drug products & return$ to ! manufactur] or repackag] or de/roy$2 7,,vii7 ma9ta9 ! capability to electronically trace ! receipt & outb\nd di/ribution ( a prescription drug product1 & supplies & records ( inv5tory2 & 7,,viii7 qu>ant9e or de/roy a suspect prescription drug product if direct$ to d s by ! respective manufactur]1 :olesale di/ributor1 disp5s]1 or an au?oriz$ gov]nm5t ag5cy2 7,e7 provide = p]iodic inspection1 z det]m9$ by ! ,secret>y1 ( su* facility w>eh\se space to ensure compliance ) ?is section2 7,f7 prohibit a facility f hav+ z a manag] or designat$ repres5tative anyone convict$ ( any felony violation ( section #cja7;i7 or #cja7k7 or any felony violation ( section #acfe ( title #ah1 ,unit$ ,/ates ,code1 relat+ to prescription drug product tamp]+2 7,g7 p]=m m&atory backgr\nd *ecks ( ! provid]'s facility manag]s or designat$ repres5tatives ( su* manag]s2 7,h7 require a ?ird-p>ty logi/ics provid] to provide to ! applicable lic5s+ au?ority1 ^u ! au?ority's reque/1 a li/ ( all prescription drug product manufactur]s1 :olesale di/ributors1 & disp5s]s = :om ! ?ird-p>ty logi/ics provid] provides s]vices at ! provid]'s facilities2 & 7,i7 include proc$ures "u :i* any ?ird-p>ty logi/ics provid] lic5se-- 7i7 w expire on ! date t is #c ye>s aft] issuance ( ! lic5se2 & 7ii7 may be r5ew$ = additional #c-ye> p]iods4 7f7 ,validity ( lic5se ,a lic5se issu$ "u ?is section %all rema9 valid z long z su* ?ird-p>ty logi/ics provid] rema9s accr$it$ by ! ,secret>y1 subject to r5ewal "u subsection 7d74 ,if ! ,secret>y f9ds t ! ?ird-p>ty accr$itation program demon/rates t all applicable requirem5ts = lic5sure "u ?is section are met1 ! ,secret>y %all issue a lic5se "u ?is section to a ?ird-p>ty logi/ics provid] receiv+ accr$itation4 7g7 ,qualifi$ lic5s+ program def9$ ,9 ?is section1 ! t]m qualifi$ lic5s+ program means a program meet+ ! requirem5ts ( ?is section & ! regulations !reund]4 7h7 ,effective date ,! requirem5ts ( ?is section %all take effect n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is section4 ,! ,secret>y %all issue ! regulations requir$ by subsection 7d7 n lat] ?an #ahj days aft] ! date ( ! enactm5t ( ?is section4 4 #f4 ,p5alties 7a7 ,prohibit$ acts ,section #cja7t7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7t77 is am5d$ by /rik+ or ! di/ribution ( drugs 9 violation ( section #ejc7;e7 or ! failure to o!rwise comply ) ! requirem5ts ( section #ejc7;e7 & ins]t+ ! failure to comply ) any requirem5t ( section #ehb1 engag+ 9 ! :olesale di/ribution ( a drug 9 violation ( section #ehc or ! failure to o!rwise comply ) ! requirem5ts ( section #ehc1 or engag+ 9 ! activities ( a ?ird-p>ty logi/ics provid] 9 violation ( section #ehd or ! failure to o!rwise comply ) ! requirem5ts ( section #ehd4 7b7 ,enhanc$ p5alty = kn[+ unlic5s$ activities ,section #cjc7;b77#a77;,d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #ccc7;b77#a77;,d77 is am5d$ by /rik+ #ejc7;e77#b77;,a7 & ins]t+ #ehc or #ehd4 7c7 ,misbr&+ ,section #ejb ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #ceb7 is am5d$ by add+ at ! end ! foll[+3 7bb7 ,if x is a drug & x fails to be> a prescription drug product id5tifi] z requir$ by section #ehb4 4 #g4 ,uni=m national policy ,sub*apt] ,h ( *apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z am5d$ by section #e1 is fur!r am5d$ by add+ at ! end ! foll[+3 #ehe4 ,uni=m national policy 7a7 ,preemption ( ,/ate prescription drug product trac+ & o!r requirem5ts ,beg9n+ on ! date ( ! enactm5t ( ! ,safegu>d+ ,am]ica's ,ph>maceuticals ,act ( #bjac1 no ,/ate or political subdivision ( a ,/ate may e/abli% or cont9ue 9 effect any requirem5ts = trac+ drugs ?r\gh ! di/ribution sy/em 7includ+ any requirem5ts ) respect to pap] or electronic p$igrees1 track & trace1 /atem5ts ( di/ribution hi/ory1 transaction hi/ory1 or transaction /atem5ts1 or v]ification1 inve/igation1 disposition1 al]ts1 or recordkeep+ relat+ to ! ph>maceutical di/ribution supply *a9 sy/em7 t-- 7#a7 are inconsi/5t )1 m /r+5t ?an1 or 9 addition to any requirem5ts applicable "u ?is ,act2 or 7#b7 are inconsi/5t ) any applicable waiv]1 exception1 or exemption issu$ by ! ,secret>y "u section #ehb7;a74 7b7 ,/&>ds or lic5sure 7#a7 ,9 g5]al ,beg9n+ on ! date ( ! enactm5t ( ,safegu>d+ ,am]ica's ,ph>maceuticals ,act ( #bjac1 no ,/ate or political subdivision ( a ,/ate may e/abli% or cont9ue any /&>ds1 requirem5ts1 or regulations ) respect to :olesale drug di/ributor or ?ird-p>ty logi/ics provid] lic5sure :i* are inconsi/5t )1 less /r+5t ?an1 9 addition to1 or m /r+5t ?an1 ! /&>ds & requirem5ts "u ?is ,act4 7#b7 ,lic5s+ fees ,p>agraph 7#a7 does n affect ! au?ority ( a ,/ate to collect fees f :olesale drug di/ributors or ?ird-p>ty logi/ics provid]s 9 connection ) ,/ate lic5s+ "u section #ehc or #ehd pursuant to a lic5s+ program meet+ ! requirem5ts ( su* sections4 7#c7 ,en=cem5t1 susp5sion1 & revocation ( lic5ses ,not)/&+ p>agraph 7#a71 a ,/ate-- 7,a7 may take adm9i/rative action1 includ+ f9es1 to en=ce a lic5sure requirem5t promulgat$ by ! ,/ate 9 accordance ) ?is ,act2 7,b7 may provide = ! susp5sion or revocation ( lic5ses issu$ by ! ,/ate = violations ( ! laws ( su* ,/ate2 7,c7 ^u conviction ( a p]son = a violation ( ,f$]al1 ,/ate1 or local controll$ sub/ance laws or regulations1 may provide = f9es1 imprisonm5t1 or civil p5alties2 & 7,d7 may regulate activities ( entities lic5s$ pursuant to section #ehc or #ehd 9 a mann] t is consi/5t ) ! provisions ( ?is sub*apt]4 4 #h4 ,electronic label+ 7a7 ,9 g5]al ,section #ejb7;f7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #ceb7;f77 is am5d$ by add+ at ! end ! foll[+ new s5t5ce3 ,requir$ label+ 7o!r ?an imm$iate conta9] or c>ton labels7 t is int5d$ = use by a physician1 a ph>maci/1 or ano!r heal? c>e pr(essional1 & t provides directions = human use ( a drug subject to section #ejc7;b77#a71 may 7except z necess>y to mitigate a safety risk1 z specifi$ by ! ,secret>y 9 regulation7 be made available by electronic means in/ead ( pap] =m1 provid$ t su* label+ complies ) all applicable requirem5ts ( law1 ! manufactur] or di/ributor1 z applicable1 af=ds heal? c>e pr(essionals & au?oriz$ disp5s]s 7z def9$ 9 section #eha7 ! opportunity to reque/ ! label+ 9 pap] =m1 & aft] su* a reque/ ! manufactur] or di/ributor promptly provides ! reque/$ in=mation )\t additional co/44 7b7 ,regulations ,! ,secret>y ( ,heal? & ,human ,s]vices %all promulgate regulations implem5t+ ! am5dm5t made by subsection 7a74 7c7 ,application ,! la/ s5t5ce ( section #ejb7;f7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #ceb7;f771 z add$ by subsection 7a71 %all apply beg9n+ on ! e>li] (-- 7#a7 ! effective date ( f9al regulations promulgat$ "u subsection 7b72 or 7#b7 ! day t is #ahj days aft] ! date ( enactm5t ( ?is ,act4 ,pass$ ! ,h\se ( ,repres5tatives ,june #c1 #bjac4;,cl]k4