,,ii #aac? ,,congress #a/ ,session ,s4 #ieg ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,may #ae1 #bjac ,mr4 ,b5net 7= himself1 ,mr4 ,burr1 ,mr4 ,h>k91 ,mr4 ,alex&]1 & ,mr4 ,isakson7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,a ,,bill ,to am5d ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act ) respect to ! ph>maceutical di/ribution supply *a94 #a4 ,%ort title ,?is ,act may be cit$ z ! ,drug ,supply ,*a9 ,security ,act4 #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 hav+ a valid lic5se "u ,/ate law or section #ehc1 9 accordance ) section #ehb7;a77#f7 & comply+ ) ! lic5sure report+ requirem5ts "u section #ejc7;e71 z am5d$ by ! ,drug ,supply ,*a9 ,security ,act2 7,c7 9 ! case ( a ?ird-p>ty logi/ics provid]1 hav+ a valid lic5se "u ,/ate law or section #ehd7;a77#a71 9 accordance ) section #ehb7;a77#g7 & comply+ ) ! lic5sure report+ requirem5ts "u section #ehd7;b72 & 7,d7 9 ! case ( a disp5s]1 hav+ a valid lic5se "u ,/ate law4 7#b7 ,compress$ m$ical gas ,! t]m compress$ 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$ical or homec>e environm5t1 includ+ oxyg5 & nitr\s oxide4 7#c7 ,disp5s] ,! t]m disp5s]-- 7,a7 means a retail ph>macy1 hospital ph>macy1 a gr\p ( *a9 ph>macies "u common own]%ip & control t d n act z a :olesale di/ributor1 or any o!r p]son au?oriz$ by law to disp5se or adm9i/] prescription drugs1 & ! affiliat$ w>eh\ses or di/ribution c5t]s ( su* entities "u common own]%ip & control t d n act z a :olesale di/ributor2 & 7,b7 does n include a p]son :o only disp5ses products to be us$ 9 animals 9 accordance ) section #eab7;a77#e74 7#d7 ,disposition ,! t]m disposition1 ) respect to a product )9 ! possession or control ( an entity1 means ! removal ( su* product f ! ph>maceutical di/ribution supply *a91 :i* may include disposal or return ( ! product = disposal or o!r appropriate h&l+ & o!r actions su* z reta9+ a sample ( ! product = fur!r additional physical exam9ation or laboratory analysis ( ! product by a manufactur] or regulatory or law en=cem5t ag5cy4 7#e7 ,di/ribute or di/ribution ,! t]m di/ribute or di/ribution means ! sale1 pur*ase1 trade1 deliv]y1 h&l+1 /orage1 or receipt ( a product4 7#f7 ,exclusive di/ributor ,! t]m exclusive di/ributor means ! :olesale di/ributor t directly pur*as$ product f ! manufactur] & is ! sole di/ributor ( t manufactur]'s product to a subsequ5t :olesale di/ributor or disp5s]4 7#g7 ,homog5e\s case ,! t]m homog5e\s case means a seal$ case conta9+ only product t has a s+le ,national ,drug ,code numb] belong+ to a s+le lot4 7#h7 ,illegitimate product ,! t]m illegitimate product means a product = :i* cr$ible evid5ce %[s t ! product-- 7,a7 is c\nt]feit1 div]t$1 or /ol52 7,b7 is int5tionally adult]at$ su* t ! product w\ld result 9 s]i\s adv]se heal? consequ5ces or dea? to humans2 7,c7 is ! subject ( a fraudul5t transaction2 or 7,d7 appe>s o!rwise unfit = di/ribution su* t ! product c\ld result 9 s]i\s adv]se heal? consequ5ce or dea? to humans4 7#i7 ,lic5s$ ,! t]m lic5s$ means-- 7,a7 9 ! case ( a :olesale di/ributor1 hav+ a valid lic5se "u ,/ate law or section #ehc1 9 accordance ) section #ehb7;a77#f72 7,b7 9 ! case ( a ?ird-p>ty logi/ics provid]1 hav+ a valid lic5se "u ,/ate law or section #ehd7;a77#a71 9 accordance ) section #ehb7;a77#g72 & 7,c7 9 ! case ( a disp5s]1 hav+ a valid lic5se "u ,/ate law4 7#aj7 ,manufactur] 7,a7 ,9 g5]al ,! t]m manufactur] means1 ) respect to a product-- 7i7 a p]son t holds an application approv$ "u section #eje or a lic5se issu$ "u section #cea ( ! ,public ,heal? ,s]vice ,act = su* product1 or if su* product is n ! subject ( an approv$ application or lic5se1 ! p]son :o manufactur$ ! product2 7ii7 a co-lic5s$ p>tn] ( ! p]son describ$ 9 clause 7i7 t obta9s ! product directly f ! p]son describ$ 9 clause 7i7 or 7ii72 or 7iii7 an affiliate ( a p]son describ$ 9 clause 7i7 or 7iii7 t receives ! product directly f a p]son describ$ 9 clause 7i71 7ii71 or 7iii74 7,b7 ,affiliate ,= purposes ( ?is p>agraph1 ! t]m affiliate means a memb] ( an affiliat$ gr\p1 z t t]m is def9$ 9 section #aejd7;a7 ( ! ,int]nal ,rev5ue ,code4 7#aa7 ,package 7,a7 ,9 g5]al ,! t]m package means ! smalle/ individual saleable unit ( product = di/ribution by a manufactur] or repackag] t is int5d$ by ! manufactur] = ultimate sale to ! disp5s] ( su* product4 7,b7 ,individual saleable unit ,= purposes ( ?is p>agraph1 an individual saleable unit is ! smalle/ conta9] ( product introduc$ into comm]ce by ! manufactur] or repackag] t is int5d$ by ! manufactur] or repackag] = individual sale to a disp5s]4 7#ab7 ,prescription drug ,! t]m prescription drug means a drug = human use subject to section #ejc7;b77#a74 7#ac7 ,product ,! t]m 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$ products be=e recon/itution71 b does n include blood or blood compon5ts int5d$ = transfusion1 radioactive drugs or radioactive biological products 7z def9$ 9 section #fjj4c7;ee7 ( title #ba1 ,code ( ,f$]al ,regulations7 t are regulat$ 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 #bjba71 or any compress$ m$ical gas4 7#ad7 ,product id5tifi] ,! t]m product id5tifi] means a /&>diz$ graphic t includes1 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 organization1 ! /&>diz$ num]ical id5tifi]1 lot numb]1 & expiration date ( ! product4 7#ae7 ,qu>ant9e ,! t]m qu>ant9e means ! /orage or id5tification ( a product1 to prev5t di/ribution or transf] ( ! product1 9 a physically sep>ate area cle>ly id5tifi$ = su* use or ?r\gh o!r proc$ures su* z automat$ designation4 7#af7 ,repackag] ,! t]m repackag] means a p]son :o owns or op]ates an e/abli%m5t t repacks & relabels a product or package = fur!r sale4 7#ag7 ,return ,! t]m return means provid+ product to ! au?oriz$ imm$iate trad+ p>tn] f :i* su* product 0 pur*as$1 or to a returns processor or rev]se logi/ics provid] = h&l+ ( su* product4 7#ah7 ,returns processor or rev]se logi/ics provid] ,! t]m returns processor or rev]se logi/ics provid] means a p]son :o owns or op]ates an e/abli%m5t t dispositions or o!rwise processes saleable or nonsaleable product receiv$ f an au?oriz$ trad+ p>tn] su* t ! product may be process$ = cr$it to ! pur*as]1 manufactur]1 or sell] or dispos$ ( = no fur!r di/ribution4 7#ai7 ,specific pati5t ne$ ,! t]m specific pati5t ne$ ref]s to ! transf] ( a product f "o ph>macy to ano!r to fill a prescription = an id5tifi$ pati5t4 ,su* t]m does n include ! transf] ( a product f "o ph>macy to ano!r = ! purpose ( increas+ or repl5i%+ /ock 9 anticipation ( a pot5tial ne$4 7#bj7 ,/&>diz$ num]ical id5tifi] or ,,sni ,! t]m /&>diz$ num]ical id5tifi] or ,,sni means a set ( numb]s or *>act]s us$ to uniquely id5tify ea* package or homog5\s case t is compos$ ( ! ,national ,drug ,code t corresponds to ! specific product 7includ+ ! p>ticul> package configuration7 comb9$ ) a unique alphanum]ic s]ial numb] ( up to #bj *>act]s4 7#ba7 ,suspect product ,! t]m suspect product means a product = :i* !re is reason to believe t su* product-- 7,a7 is pot5tially c\nt]feit1 div]t$1 or /ol52 7,b7 is pot5tially int5tionally adult]at$ su* t ! product w\ld result 9 s]i\s adv]se heal? consequ5ces or dea? to humans2 7,c7 is pot5tially ! subject ( a fraudul5t transaction2 or 7,d7 appe>s o!rwise unfit = di/ribution su* t ! product w\ld result 9 s]i\s adv]se heal? consequ5ces or dea? to humans4 7#bb7 ,?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 or o!r logi/ics s]vices ( a product 9 int]/ate comm]ce on behalf ( a manufactur]1 :olesale di/ributor1 or disp5s] ( a product1 b does n take own]%ip ( ! product1 nor h responsibility to direct ! sale or disposition ( ! product4 7#bc7 ,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 direct own]%ip ( a product or to :om a manufactur]1 repackag]1 :olesale di/ributor1 or disp5s] transf]s direct own]%ip ( a product2 or 7,b7 a ?ird-p>ty logi/ics provid] f :om a manufactur]1 repackag]1 :olesale di/ributor1 or disp5s] accepts direct possession ( a product or to :om a manufactur]1 repackag]1 :olesale di/ributor1 or disp5s] transf]s direct possession ( a product4 7#bd7 ,transaction 7,a7 ,9 g5]al ,! t]m transaction means ! transf] ( 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 product betwe5 memb]s ( an affiliat$ gr\p 7z def9$ 9 section #aejd7;a7 ( ! ,int]nal ,rev5ue ,code ( #aihf72 7ii7 ! di/ribution ( a product among hospitals or o!r heal? c>e entities t are "u common control2 7iii7 ! di/ribution ( a 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$ical reason2 7iv7 ! disp5s+ ( a product pursuant to a valid prescription execut$ 9 accordance ) section #ejc7;b77#a72 7v7 ! di/ribution ( 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 ( product by a lic5s$ retail ph>macy to a lic5s$ practition] = (fice use2 7viii7 ! sale1 pur*ase1 or trade ( a drug or an (f] to sell1 pur*ase1 or trade a drug by a *>itable organization describ$ 9 section #eja7;c77#c7 ( ! ,int]nal ,rev5ue ,code ( #aied to a nonpr(it affiliate ( ! organization to ! ext5t o!rwise p]mitt$ by law2 7ix7 ! di/ribution ( a 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$ = ! product %all be transf]r$ to ! new own] ( ! ph>macy or ph>macies or :olesale di/ributor or :olesale di/ributors2 7x7 ! disp5s+ ( a product approv$ "u section #eab7;b72 7xi7 products transf]r$ 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 a comb9ation product t is-- 7,i7 a product compris$ ( a device & #a or m o!r regulat$ compon5ts 7su* z a drug_/device1 biologic_/device1 or drug_/device_/biologic7 t are physically1 *emically1 or o!rwise comb9$ or mix$ & produc$ z a s+le entity2 7,,ii7 #b or m sep>ate products packag$ toge!r 9 a s+le package or z a unit & compris$ ( a drug & device products or device & biological product2 or 7,,iii7 #b or m f9i%$ m$ical devices plus "o or m drug or biological products :i* are packag$ toge!r 9 :at is ref]r$ to z a m$ical conv5i5ce kit z describ$ 9 clause 7xiii72 7xiii7 ! di/ribution ( a collection ( f9i%$ m$ical devices or a collection ( f9i%$ drug or biological products assembl$ 9 kit =m /rictly = ! conv5i5ce ( ! pur*as] or us] 7to be kn[n z a m$ical conv5i5ce kit7 if-- 7,i7 ! m$ical conv5i5ce kit is assembl$ 9 an e/abli%m5t t is regi/]$ ) ! ,food & ,drug ,adm9i/ration z a device manufactur] 9 accordance ) section #eaj7;b77#b72 7,,ii7 ! p]son :o manufactures a m$ical conv5i5ce kit pur*as$ ! product conta9$ 9 ! m$ical conv5i5ce kit directly f ! ph>maceutical manufactur] or f a :olesale di/ributor t pur*as$ ! product directly f ! ph>maceutical manufactur]2 7,,iii7 ! p]son :o manufactures a m$ical conv5i5ce kit does n alt] ! prim>y conta9] or label ( ! product z pur*as$ f ! manufactur] or :olesale di/ributor2 7,,iv7 ! m$ical conv5i5ce kit does n conta9 a controll$ sub/ance t appe>s 9 a s*$ule conta9$ 9 ! ,compreh5sive ,drug ,abuse ,prev5tion & ,control ,act ( #aigj2 & 7,v7 ! products conta9$ 9 ! m$ical conv5i5ce kit are-- 7aa7 intrav5\s solutions int5d$ = ! repl5i%m5t ( fluids & electrolytes2 7bb7 products int5d$ to ma9ta9 ! equilibrium ( wat] & m9]als 9 ! body2 7cc7 products int5d$ = irrigation or recon/itution2 7dd7 ane/hetics2 7ee7 anticoagulants2 7ff7 vasopressors2 or 7gg7 sympa?icomimetics2 7xiv7 ! di/ribution ( an intrav5\s 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 product us$ to ma9ta9 ! equilibrium ( wat] & m9]als 9 ! body1 su* z dialysis solutions2 7xvi7 ! di/ribution ( a product t is int5d$ = irrigation or recon/itution1 or /]ile wat]1 :e!r int5d$ = su* purposes or = injection2 7xvii7 ! di/ribution ( compress$ m$ical gas2 or 7xviii7 ! di/ribution or sale ( any lic5s$ product "u section #cea ( ! ,public ,heal? ,s]vice ,act t meets ! def9ition ( a device "u section #bja7;h74 7#be7 ,transaction hi/ory ,! t]m transaction hi/ory means a /atem5t 9 pap] or electronic =m1 includ+ ! transaction in=mation = ea* prior transaction go+ back to ! manufactur] ( ! product4 7#bf7 ,transaction in=mation ,! t]m transaction in=mation means-- 7,a7 ! propriet>y or e/abli%$ "n or names ( ! product2 7,b7 ! /r5g? & dosage =m ( ! product2 7,c7 ! ,national ,drug ,code numb] ( ! product2 7,d7 ! conta9] size2 7,e7 ! numb] ( conta9]s2 7,f7 ! lot numb] ( ! product2 7,g7 ! date ( ! transaction2 7,h7 ! date ( ! %ipm5t1 if diff]5t f ! date ( ! transaction2 7,i7 ! bus9ess "n & address ( ! p]son f :om own]%ip is be+ transf]r$2 & 7,j7 ! bus9ess "n & address ( ! p]son to :om own]%ip is be+ transf]r$4 7#bg7 ,transaction /atem5t ,! transaction /atem5t is a /atem5t1 9 pap] or electronic =m1 t ! entity transf]r+ own]%ip 9 a transaction-- 7,a7 is au?oriz$ z requir$ "u ! ,drug ,supply ,*a9 ,security ,act2 7,b7 receiv$ ! product f a p]son t is au?oriz$ z requir$ "u ! ,drug ,supply ,*a9 ,security ,act2 7,c7 receiv$ transaction in=mation & a transaction /atem5t f ! prior own] ( ! product1 z requir$ "u section #ehb2 7,d7 did n kn[+ly %ip a suspect or illegitimate product2 7,e7 _h sy/ems & processes 9 place to comply ) v]ification requirem5ts "u section #ehb2 7,f7 did n kn[+ly provide false transaction in=mation2 & 7,g7 did n kn[+ly alt] ! transaction hi/ory4 7#bh7 ,v]ification or v]ify ,! t]m v]ification or v]ify means det]m9+ :e!r ! product id5tifi] affix$ to1 or impr9t$ ^u1 a package or homog5e\s case corresponds to ! /&>diz$ num]ical id5tifi] or lot numb]1 & expiration date assign$ to ! product by ! manufactur] or ! repackag]1 z applicable 9 accordance ) section #ehb4 7#bi7 ,:olesale di/ributor ,! t]m :olesale di/ributor means a p]son 7o!r ?an a manufactur]1 a manufactur]'s co-lic5s$ p>tn]1 a ?ird-p>ty logi/ics provid]1 or repackag]7 engag$ 9 :olesale di/ribution 7z def9$ 9 section #ejc7;e77#d71 z am5d$ by ! ,drug ,supply ,*a9 ,security ,act74 #ehb4 ,requirem5ts 7a7 ,9 g5]al 7#a7 ,o!r activities ,ea* manufactur]1 repackag]1 :olesale di/ributor1 ?ird-p>ty logi/ics provid]1 & disp5s] %all comply ) ! requirem5ts set =? 9 ?is section ) respect to ! role ( su* manufactur]1 repackag]1 :olesale di/ributor1 ?ird-p>ty logi/ics provid]1 or disp5s] 9 a transaction involv+ product4 ,if an entity meets ! def9ition ( m ?an "o ( ! entities li/$ 9 ! prec$+ s5t5ce1 su* entity %all comply ) all applicable requirem5ts 9 ?is section1 b %all n be requir$ to duplicate requirem5ts4 7#b7 ,initial /&>ds 7,a7 ,9 g5]al ,! ,secret>y %all1 9 consultation ) o!r appropriate ,f$]al (ficials1 manufactur]s1 repackag]s1 :olesale di/ributors1 ?ird-p>ty logi/ics provid]s1 disp5s]s1 & o!r ph>maceutical di/ribution supply *a9 /akehold]s1 issue a draft guidance docum5t t e/abli%es /&>ds = ! int]op]able ex*ange ( transaction in=mation = compliance ) subsections 7a71 7b71 7c71 7d71 7e71 & 7f74 ,! /&>ds e/abli%$ "u ?is p>agraph %all take into consid]ation ! /&>ds e/abli%$ "u section #eje;,d & %all comply ) a =m & =mat develop$ by a widely recogniz$ int]national /&>ds developm5t organization4 7,b7 ,public input ,prior to issu+ ! draft guidance "u subp>agraph 7,a71 ! ,secret>y %all ga!r comm5ts & in=mation f /akehold]s & ma9ta9 su* comm5ts & in=mation 9 a public docket = at lea/ #fj days prior to issu+ su* guidance4 7,c7 ,publication ,! ,secret>y %all publi% ! /&>ds e/abli%$ "u subp>agraph 7,a7 n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,drug ,supply ,*a9 ,security ,act4 7#c7 ,waiv]s1 exceptions1 & exemptions 7,a7 ,9 g5]al ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,drug ,supply ,*a9 ,security ,act1 ! ,secret>y %all1 by guidance-- 7i7 e/abli% a process by :i* an au?oriz$ manufactur]1 repackag]1 :olesale di/ributor1 or disp5s] may reque/ a waiv] f any ( ! requirem5ts set =? 9 ?is section if ! ,secret>y det]m9es t su* requirem5ts w\ld result 9 an undue economic h>d%ip or = em]g5cy m$ical reasons1 includ+ a public heal? em]g5cy decl>ation pursuant to section #cai ( ! ,public ,heal? ,s]vice ,act2 7ii7 e/abli% a process by :i* ! ,secret>y det]m9es exceptions1 & a process ?r\gh :i* a manufactur] or repackag] may reque/ su* an exception1 to ! requirem5ts relat+ to product id5tifi]s if a product is packag$ 9 a conta9] too small or o!rwise unable to accommodate a label ) suffici5t space to be> ! in=mation requir$ = compliance ) ?is section2 & 7iii7 e/abli% a process by :i* ! ,secret>y may det]m9e o!r products or transactions t %all be exempt f ! requirem5ts ( ?is section4 7,b7 ,cont5t ,! guidance issu$ "u subp>agraph 7,a7 %all include a process = ! bi5nial review & r5ewal ( su* waiv]s1 exceptions1 & exemptions1 z applicable4 7,c7 ,process ,9 issu+ ! guidance "u ?is section1 ! ,secret>y %all provide an effective date t is n lat] ?an #ahj days prior to ! date on :i* manufactur]s are requir$ to affix or impr9t a product id5tifi] to ea* package & homog5\s case ( product int5d$ to be introduc$ 9 a transaction into comm]ce consi/5t ) ?is section4 7#d7 ,self-execut+ requirem5ts ,except :]e o!rwise specifi$1 ! requirem5ts ( ?is section may be en=c$ )\t fur!r regulations or guidance f ! ,secret>y4 7#e7 ,gr&fa!r+ product 7,a7 ,product id5tifi] ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,drug ,supply ,*a9 ,security ,act1 ! ,secret>y %all f9alize guidance specify+ :e!r & "u :at circum/ances product t is n label$ ) a product id5tifi] & t is 9 ! ph>maceutical di/ribution supply *a9 at ! "t ( ! effective date ( ! requirem5ts ( ?is section %all be exempt$ f ! requirem5ts ( ?is section4 7,b7 ,trac+ ,= a product t ent]$ ! ph>maceutical di/ribution supply *a9 prior to ! date t is #a ye> aft] ! date ( enactm5t ( ! ,drug ,supply ,*a9 ,security ,act-- 7i7 au?oriz$ trad+ p>tn]s %all be exempt f provid+ transaction in=mation z requir$ "u subsections 7b77#a77;,a77i71 7c77#a77;,a77ii71 7d77#a77;,a77ii71 & 7e77#a77;,a77ii7 ( ?is section2 7ii7 transaction hi/ory requir$ "u ?is section %all beg9 ) ! own] ( su* product on su* date2 & 7iii7 ! own]s ( su* product on su* date %all be exempt f ass]t+ receipt ( transaction in=mation & transaction /atem5t f ! prior own] z requir$ "u ?is section4 7#f7 ,:olesale di/ributor lic5ses ,not)/&+ section #eha7i77;,a71 until ! effective date ( ! :olesale di/ributor lic5s+ regulations "u section #ehc1 ! t]m lic5s$ or au?oriz$1 z x relates to a :olesale di/ributor ) respect to prescription drugs1 %all mean a :olesale di/ributor ) a valid lic5se "u ,/ate law4 7#g7 ,?ird-p>ty logi/ics provid] lic5ses ,until ! effective date ( ! ?ird-p>ty logi/ics provid] lic5s+ regulations "u section #ehd1 a ?ird-p>ty logi/ics provid] %all be consid]$ lic5s$ "u section #eha7i77;,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#h7 ,label *anges ,*anges made to package labels solely to incorporate ! product id5tifi] may be submitt$ to ! ,secret>y 9 ! annual report ( an e/abli%m5t1 9 accordance ) section #cad4gj7;d7 ( *apt] #ba1 ,code ( ,f$]al ,regulations 7or any successor regulation74 7#i7 ,product id5tifi]s ,) respect to any requirem5t relat+ to product id5tifi]s "u ?is sub*apt]-- 7,a7 unless ! ,secret>y all[s1 ?r\gh guidance1 ! use ( o!r te*nologies = data in/ead ( or 9 addition to ! te*nologies describ$ 9 clauses 7i7 & 7ii71 ! applicable data-- 7i7 %all be includ$ 9 a #b-;dim5sional data matrix b>code :5 affix$ to1 or impr9t$ ^u1 a package2 or 7ii7 %all be includ$ 9 a l9e> or #b-;dim5sional data matrix b>code :5 affix$ to1 or impr9t$ ^u1 a homog5e\s case2 & 7,b7 v]ification ( ! product id5tifi] may occur by us+ human-readable or ma*9e-readable me?ods4 7b7 ,manufactur] requirem5ts 7#a7 ,product trac+ 7,a7 ,9 g5]al ,beg9n+ n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,drug ,supply ,*a9 ,security ,act1 a manufactur] %all-- 7i7 prior to1 or at ! "t (1 ea* transaction 9 :i* su* manufactur] transf]s-- 7,i7 own]%ip ( a product1 provide ! subsequ5t recipi5t ) transaction hi/ory1 transaction in=mation1 & a transaction /atem5t2 or 7,,ii7 possession ( a product to a ?ird-p>ty logi/ics provid] = ! purpose ( transf]r+ own]%ip z "p ( a transaction to a subsequ5t recipi5t1 provide to ! ?ird-p>ty logi/ics provid] ! transaction hi/ory1 transaction in=mation1 & a transaction /atem5t = su* transaction to a subsequ5t recipi5t2 & 7ii7 ma9ta9 ! transaction in=mation1 transaction hi/ory1 & transaction /atem5t = ea* transaction = n less ?an #f ye>s aft] ! date ( ! transaction4 7,b7 ,reque/s = in=mation ,^u a reque/ by ! ,secret>y or o!r appropriate ,f$]al or ,/ate (ficial1 9 ! ev5t ( a recall or = ! purpose ( inve/igat+ a suspect product or an illegitimate product1 a manufactur] %all1 n lat] ?an #bd h\rs aft] receiv+ ! reque/ or 9 o!r su* reasonable "t z det]m9$ by ! ,secret>y1 bas$ on ! circum/ances ( ! reque/1 provide ! applicable transaction in=mation1 transaction hi/ory1 & transaction /atem5t = ! product4 7#b7 ,product id5tifi] ,beg9n+ n lat] ?an #d ye>s aft] ! date ( enactm5t ( ! ,drug ,supply ,*a9 ,security ,act1 a manufactur] %all affix or impr9t a product id5tifi] to ea* package & homog5\s case ( a product int5d$ to be introduc$ 9 a transaction into comm]ce4 ,su* manufactur] %all ma9ta9 ! product id5tifi] in=mation = su* product = n less ?an #f ye>s aft] ! date ( ! transaction4 7#c7 ,au?oriz$ trad+ p>tn]s ,beg9n+ n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,drug ,supply ,*a9 ,security ,act1 ! trad+ p>tn]s ( a manufactur] may be only au?oriz$ trad+ p>tn]s4 7#d7 ,v]ification ,beg9n+ n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,drug ,supply ,*a9 ,security ,act1 a manufactur] %all h sy/ems 9 place to enable ! manufactur] to comply ) ! foll[+ requirem5ts3 7,a7 ,suspect product 7i7 ,9 g5]al ,^u mak+ a det]m9ation t a product 9 ! possession or control ( ! manufactur] is a suspect product1 or ^u receiv+ a reque/ = v]ification f ! ,secret>y t has made a det]m9ation t a product )9 ! possession or control ( a manufactur] is a suspect product1 a manufactur] %all-- 7,i7 qu>ant9e su* product )9 ! possession or control ( ! manufactur] f product int5d$ = di/ribution until su* product is cle>$ or disposition$2 & 7,,ii7 promptly conduct an inve/igation 9 coord9ation ) trad+ p>tn]s1 z applicable1 to det]m9e :e!r ! product is an illegitimate product1 :i* %all include validat+ any applicable transaction hi/ory & transaction in=mation 9 ! possession ( ! manufactur] & o!rwise inve/igat+ to det]m9e :e!r ! product is an illegitimate product1 &1 beg9n+ #d ye>s aft] ! date ( enactm5t ( ! ,drug ,supply ,*a9 ,security ,act1 v]ify+ ! product at ! package level4 7ii7 ,cle>$ product ,if ! manufactur] makes ! det]m9ation t a suspect product is n an illegitimate product1 ! manufactur] %all promptly notify ! ,secret>y1 if applicable1 ( su* det]m9ation & su* product may be fur!r di/ribut$4 7iii7 ,records ,a manufactur] %all keep records ( ! inve/igation ( a suspect product = n less ?an #f ye>s aft] ! conclusion ( ! inve/igation4 7,b7 ,illegitimate product 7i7 ,9 g5]al ,^u det]m9+ t a product 9 ! possession or control ( a manufactur] is an illegitimate product1 ! manufactur] %all1 9 a mann] consi/5t ) ! sy/ems & processes ( su* manufactur]-- 7,i7 qu>ant9e su* product )9 ! possession or control ( ! manufactur] f product int5d$ = di/ribution until su* product is disposition$2 7,,ii7 disposition ! illegitimate product )9 ! possession or control ( ! manufactur]2 7,,iii7 take reasonable & appropriate /eps to assi/ a trad+ p>tn] to disposition an illegitimate product n 9 ! possession or control ( ! manufactur]2 & 7,,iv7 reta9 a sample ( ! product = fur!r physical exam9ation or laboratory analysis ( ! product by ! manufactur] or ,secret>y 7or o!r appropriate ,f$]al or ,/ate (ficial7 ^u reque/ by ! ,secret>y 7or o!r appropriate ,f$]al or ,/ate (ficial71 z necess>y & appropriate4 7ii7 ,mak+ a notification 7,i7 ,illegitimate product ,^u det]m9+ t a product 9 ! possession or control ( ! manufactur] is an illegitimate product1 ! manufactur] %all notify ! ,secret>y & all imm$iate trad+ p>tn]s t ! manufactur] has reason to believe may h receiv$ su* illegitimate product ( su* det]m9ation n lat] ?an #bd h\rs aft] mak+ su* det]m9ation4 7,,ii7 ,high risk ( illegitimacy ,a manufactur] %all notify ! ,secret>y & imm$iate trad+ p>tn]s t ! manufactur] has reason to believe may h 9 ! trad+ p>tn]'s possession a product manufactur$ by1 or purport$ to be a product manufactur$ by1 ! manufactur] n lat] ?an #bd h\rs aft] det]m9+ or be+ notifi$ by ! ,secret>y or a trad+ p>tn] t !re is a high risk t su* product is an illegitimate product4 ,= purposes ( ?is subclause1 a high risk may include a specific high-risk t c\ld increase ! likelihood t illegitimate product w ent] ! ph>maceutical di/ribution supply *a9 & o!r high risks z det]m9$ by ! ,secret>y 9 guidance pursuant to subsection 7i74 7iii7 ,respond+ to a notification ,^u ! receipt ( a notification f ! ,secret>y or a trad+ p>tn] t a det]m9ation has be5 made t a product is an illegitimate product1 a manufactur] %all id5tify all illegitimate product subject to su* notification t is 9 ! possession or control ( ! manufactur]1 includ+ any product t is subsequ5tly receiv$1 & %all p]=m ! activities describ$ 9 subp>agraph 7,a74 7iv7 ,t]m9at+ a notification ,^u mak+ a det]m9ation1 9 consultation ) ! ,secret>y1 t a notification is no long] necess>y1 a manufactur] %all promptly notify imm$iate trad+ p>tn]s t ! manufactur] notifi$ pursuant to clause 7ii7 t su* notification has be5 t]m9at$4 7v7 ,records ,a manufactur] %all keep records ( ! disposition ( an illegitimate product = n less ?an #f ye>s aft] ! conclusion ( ! disposition4 7,c7 ,reque/s = v]ification ,beg9n+ #d ye>s aft] ! date ( enactm5t ( ! ,drug ,supply ,*a9 ,security ,act1 ^u receiv+ a reque/ = v]ification f an au?oriz$ repackag]1 :olesale di/ributor1 or disp5s] t is 9 possession or control ( a product !y believe to be manufactur$ by su* manufactur]1 a manufactur] %all1 n lat] ?an #bd h\rs aft] receiv+ ! v]ification reque/ or 9 o!r su* reasonable "t z det]m9$ by ! ,secret>y1 bas$ on ! circum/ances ( ! reque/1 notify ! p]son mak+ ! reque/ :e!r ! product id5tifi]1 includ+ ! /&>d num]ic id5tifi]1 t is ! subject ( ! reque/ corresponds to ! product id5tifi] affix$ or impr9t$ by ! manufactur]4 ,if a manufactur] respond+ to a v]ification reque/ id5tifies a product id5tifi] t does n correspond to t affix$ or impr9t$ by ! manufactur]1 ! manufactur] %all treat su* product z suspect product & conduct an inve/igation z describ$ 9 subp>agraph 7,a74 ,if ! manufactur] has reason to believe ! product is an illegitimate product1 ! manufactur] %all advise ! p]son mak+ ! reque/ ( su* belief at ! "t su* manufactur] responds to ! v]ification reque/4 7,d7 ,electronic database ,a manufactur] may satisfy ! requirem5ts ( ?is p>agraph by develop+ a secure electronic database or utiliz+ a secure electronic database develop$ or op]at$ by 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,e7 ,saleable return$ product ,beg9n+ #d ye>s aft] ! date ( enactm5t ( ! ,drug ,supply ,*a9 ,security ,act 7except z provid$ pursuant to subsection 7a77#e771 ^u receipt ( a return$ product t ! manufactur] int5ds to fur!r di/ribute1 be=e fur!r di/ribut+ su* product1 ! manufactur] %all v]ify ! product id5tifi] = ea* seal$ homog5e\s case ( su* product or1 if su* product is n 9 a seal$ homog5e\s case1 v]ify ! product id5tifi] on ea* package4 7,f7 ,nonsaleable return$ product ,a manufactur] may return a nonsaleable product to ! manufactur] or repackag]1 to ! :olesale di/ributor f :om su* product 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 p>agraph 7#a77;,a77i74 7c7 ,:olesale di/ributor requirem5ts 7#a7 ,product trac+ 7,a7 ,9 g5]al ,beg9n+ n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,drug ,supply ,*a9 ,security ,act1 ! foll[+ requirem5ts %all apply to :olesale di/ributors3 7i7 ,a :olesale di/ributor %all n accept own]%ip ( a product unless ! previ\s own] prior to1 or at ! "t (1 ! transaction provides ! transaction hi/ory1 transaction in=mation1 & a transaction /atem5t = ! product1 z applicable "u ?is subp>agraph4 7ii7 7,i7 7aa7 ,if ! :olesale di/ributor pur*as$ a product directly f ! manufactur]1 ! exclusive di/ributor ( ! manufactur]1 or a repackag] t pur*as$ directly f ! manufactur]1 !n prior to1 or at ! "t (1 ea* transaction 9 :i* ! :olesale di/ributor transf]s own]%ip ( a product1 ! :olesale di/ributor %all provide to ! subsequ5t pur*as]-- 7,,aa7 a transaction /atem5t1 :i* %all /ate t su* :olesale di/ributor1 or a memb] ( ! affiliat$ gr\p ( su* :olesale di/ributor1 pur*as$ ! product directly f ! manufactur]1 exclusive di/ributor ( ! manufactur]1 or repackag] t pur*as$ directly f ! manufactur]2 & 7,,bb7 subject to subclause 7,,ii71 ! transaction hi/ory & transaction in=mation4 7bb7 ,! :olesale di/ributor %all provide ! transaction hi/ory1 transaction in=mation1 & transaction /atem5t "u item 7aa7-- 7,,aa7 if provid$ to a disp5s]1 on a s+le docum5t 9 an electronic or pap] =mat2 & 7,,bb7 if provid$ to a :olesale di/ributor1 ?r\gh any comb9ation ( self-g5]at$ pap]1 electronic data1 or manufactur]-provid$ in=mation on ! product package4 7,,ii7 ,= purposes ( transactions describ$ 9 subclause 7,i71 transaction hi/ory & transaction in=mation %all n be requir$ to include ! lot numb] ( ! product1 ! initial transaction date1 or ! initial %ipm5t date f ! manufactur] 7z def9$ 9 subp>agraphs 7,f71 7,g71 & 7,h7 ( section #eha7bf774 7iii7 ,if ! :olesale di/ributor did n pur*ase a product directly f ! manufactur]1 ! exclusive di/ributor ( ! manufactur]1 or a repackag] t pur*as$ directly f ! manufactur]1 z describ$ 9 clause 7ii71 !n prior to1 or at ! "t (1 ea* transaction or subsequ5t transaction1 ! :olesale di/ributor-- 7,i7 %all provide to ! subsequ5t pur*as] a transaction /atem5t1 transaction hi/ory1 & transaction in=mation2 & 7,,ii7 may provide ! in=mation describ$ 9 subclause 7,i7 to a subsequ5t pur*as] on a s+le docum5t 9 an electronic or pap] =mat or ?r\gh any comb9ation ( self-g5]at$ pap]1 electronic data1 or manufactur] provid$ in=mation on ! product package4 7iv7 ,= ! purposes ( clause 7iii77,i71 ! transaction hi/ory suppli$ %all beg9 only ) ! :olesale di/ributor describ$ 9 clause 7ii77,i71 b ! :olesale di/ributor describ$ 9 clause 7iii7 %all in=m ! subsequ5t pur*as] t su* :olesale di/ributor receiv$ a direct pur*ase /atem5t f ! manufactur]1 ! exclusive di/ributor ( ! manufactur]1 or a repackag] t pur*as$ directly f ! manufactur]1 & %all id5tify ! manufactur]1 exclusive di/ributor ( ! manufactur]1 or repackag] t pur*as$ directly f ! manufactur] f :i* ! direct pur*ase /atem5t 0 receiv$4 7v7 ,a :olesale di/ributor %all ma9ta9 ! transaction in=mation1 transaction hi/ory1 & transaction /atem5t = ea* transaction describ$ 9 clauses 7i71 7ii71 & 7iii7 = n less ?an #f ye>s aft] ! date ( ! transaction4 7,b7 ,returns 7i7 ,saleable returns ,not)/&+ subp>agraph 7,a77i71 ! foll[+ %all apply3 7,i7 ,requirem5ts ,until ! date t is #f ye>s aft] ! date ( enactm5t ( ! ,drug ,supply ,*a9 ,security ,act 7except z provid$ pursuant to subsection 7a77#e771 a :olesale di/ributor may accept return$ product f a disp5s] pursuant to ! t]ms & conditions ( any agreem5t betwe5 ! p>ties1 &1 not)/&+ subp>agraph 7,a77ii71 may di/ribute su* return$ product )\t provid+ ! transaction hi/ory4 ,= transactions subsequ5t to ! return1 ! transaction hi/ory ( su* product %all beg9 ) ! :olesale di/ributor t accept$ ! return$ product1 consi/5t ) ! requirem5ts ( ?is subsection4 7,,ii7 ,enhanc$ requirem5ts ,beg9n+ #f ye>s aft] ! date ( enactm5t ( ! ,drug ,supply ,*a9 ,security ,act 7except z provid$ pursuant to subsection 7a77#e771 a :olesale di/ributor may accept return$ product f a disp5s] only if ! :olesale di/ributor c associate return$ product ) ! transaction in=mation & transaction /atem5t associat$ ) t product4 ,= all transactions aft] su* date1 ! transaction hi/ory1 z applicable1 ( su* product %all beg9 ) ! :olesale di/ributor t accept$ & v]ifi$ ! return$ product4 ,= purposes ( ?is subp>agraph1 ! transaction in=mation & transaction hi/ory1 z applicable1 ne$ n include transaction dates if x is n reasonably practicable to obta9 su* dates4 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,a77i74 7,c7 ,reque/s = in=mation ,^u a reque/ by ! ,secret>y or o!r appropriate ,f$]al or ,/ate (ficial1 9 ! ev5t ( a recall or = ! purpose ( inve/igat+ a suspect product or an illegitimate product a :olesale di/ributor %all1 n lat] ?an #bd h\rs aft] receiv+ ! reque/ or 9 o!r su* reasonable "t z det]m9$ by ! ,secret>y1 bas$ on ! circum/ances ( ! reque/1 provide ! applicable transaction in=mation1 transaction hi/ory1 & transaction /atem5t = ! product4 7#b7 ,product id5tifi] ,beg9n+ #f ye>s aft] ! date ( enactm5t ( ! ,drug ,supply ,*a9 ,security ,act1 a :olesale di/ributor may engage 9 transactions involv+ a product only if su* product is encod$ ) a product id5tifi] 7except z provid$ pursuant to subsection 7a77#e774 7#c7 ,au?oriz$ trad+ p>tn]s ,beg9n+ n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,drug ,supply ,*a9 ,security ,act1 ! trad+ p>tn]s ( a :olesale di/ributor may be only au?oriz$ trad+ p>tn]s4 7#d7 ,v]ification ,beg9n+ n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,drug ,supply ,*a9 ,security ,act1 a :olesale di/ributor %all h sy/ems 9 place to enable ! :olesale di/ributor to comply ) ! foll[+ requirem5ts3 7,a7 ,suspect product 7i7 ,9 g5]al ,^u mak+ a det]m9ation t a product 9 ! possession or control ( ! :olesale di/ributor is a suspect product1 or ^u receiv+ a reque/ = v]ification f ! ,secret>y t has made a det]m9ation t a product )9 ! possession or control ( a :olesale di/ributor is a suspect product1 a :olesale di/ributor %all-- 7,i7 qu>ant9e su* product )9 ! possession or control ( ! :olesale di/ributor f product int5d$ = di/ribution until su* product is cle>$ or disposition$2 & 7,,ii7 promptly conduct an inve/igation 9 coord9ation ) trad+ p>tn]s1 z applicable1 to det]m9e :e!r ! product is an illegitimate product1 :i* %all include validat+ any applicable transaction hi/ory & transaction in=mation 9 ! possession ( ! :olesale di/ributor & o!rwise inve/igat+ to det]m9e :e!r ! product is an illegitimate product1 &1 beg9n+ #f ye>s aft] ! date ( enactm5t ( ! ,drug ,supply ,*a9 ,security ,act 7except z provid$ pursuant to subsection 7a77#e771 v]ify+ ! product at ! package level4 7ii7 ,cle>$ product ,if ! :olesale di/ributor det]m9es t a suspect product is n an illegitimate product1 ! :olesale di/ributor %all promptly notify ! ,secret>y1 if applicable1 ( su* det]m9ation & su* product may be fur!r di/ribut$4 7iii7 ,records ,a :olesale di/ributor %all keep records ( ! inve/igation ( a suspect product = n less ?an #f ye>s aft] ! conclusion ( ! inve/igation4 7,b7 ,illegitimate product 7i7 ,9 g5]al ,^u det]m9+1 9 coord9ation ) ! manufactur]1 t a product 9 ! possession or control ( a :olesale di/ributor is an illegitimate product1 ! :olesale di/ributor %all1 9 a mann] t is consi/5t ) ! sy/ems & processes ( su* :olesale di/ributor-- 7,i7 qu>ant9e su* product )9 ! possession or control ( ! :olesale di/ributor f product int5d$ = di/ribution until su* product is disposition$2 7,,ii7 disposition ! illegitimate product )9 ! possession or control ( ! :olesale di/ributor2 7,,iii7 take reasonable & appropriate /eps to assi/ a trad+ p>tn] to disposition an illegitimate product n 9 ! possession or control ( ! :olesale di/ributor2 & 7,,iv7 reta9 a sample ( ! product = fur!r physical exam9ation or laboratory analysis ( ! product by ! manufactur] or ,secret>y 7or o!r appropriate ,f$]al or ,/ate (ficial7 ^u reque/ by ! manufactur] or ,secret>y 7or o!r appropriate ,f$]al or ,/ate (ficial71 z necess>y & appropriate4 7ii7 ,mak+ a notification ,^u det]m9+ t a product 9 ! possession or control ( ! :olesale di/ributor is an illegitimate product1 ! :olesale di/ributor %all notify ! ,secret>y & all imm$iate trad+ p>tn]s t ! :olesale di/ributor has reason to believe may h receiv$ su* illegitimate product ( su* det]m9ation n lat] ?an #bd h\rs aft] mak+ su* det]m9ation4 7iii7 ,respond+ to a notification ,^u ! receipt ( a notification f ! ,secret>y or a trad+ p>tn] t a det]m9ation has be5 made t a product is an illegitimate product1 a :olesale di/ributor %all id5tify all illegitimate product subject to su* notification t is 9 ! possession or control ( ! :olesale di/ributor1 includ+ any product t is subsequ5tly receiv$1 & %all p]=m ! activities describ$ 9 subp>agraph 7,a74 7iv7 ,t]m9at+ a notification ,^u a det]m9ation1 9 consultation ) ! ,secret>y1 t a notification is no long] necess>y1 a :olesale di/ributor %all promptly notify imm$iate trad+ p>tn]s t ! :olesale di/ributor notifi$ pursuant to clause 7ii7 t su* notification has be5 t]m9at$4 7v7 ,records ,a :olesale di/ributor %all keep records ( ! disposition ( an illegitimate product = n less ?an #f ye>s aft] ! conclusion ( ! disposition4 7,c7 ,electronic database ,a :olesale di/ributor may satisfy ! requirem5ts ( ?is p>agraph by develop+ a secure electronic database or utiliz+ a secure electronic database develop$ or op]at$ by 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 ,v]ification ( saleable return$ product ,beg9n+ #f ye>s aft] ! date ( enactm5t ( ! ,drug ,supply ,*a9 ,security ,act1 ^u receipt ( a return$ product t ! :olesale di/ributor int5ds to fur!r di/ribute1 be=e fur!r di/ribut+ su* product1 ! :olesale di/ributor %all v]ify ! product id5tifi] = ea* seal$ homog5e\s case ( su* product or1 if su* product is n 9 a seal$ homog5e\s case1 v]ify ! product id5tifi] on ea* package4 7d7 ,disp5s] requirem5ts 7#a7 ,product trac+ 7,a7 ,9 g5]al ,beg9n+ #a ye> aft] ! date ( enactm5t ( ! ,drug ,supply ,*a9 ,security ,act1 a disp5s]-- 7i7 %all n accept own]%ip ( a product1 unless ! previ\s own] prior to1 or at ! "t (1 ! transaction1 provides transaction hi/ory1 transaction in=mation1 & a transaction /atem5t2 7ii7 prior to1 or at ! "t (1 ea* transaction 9 :i* ! disp5s] transf]s own]%ip ( a product 7b n includ+ disp5s+ to a pati5t or returns7 %all provide ! subsequ5t own] ) transaction hi/ory1 transaction in=mation1 & a transaction /atem5t = ! product1 except t ! requirem5ts ( ?is clause %all n apply to sales by a disp5s] to ano!r disp5s] to fulfill a specific pati5t ne$2 & 7iii7 %all ma9ta9 transaction in=mation1 transaction hi/ory1 & transaction /atem5ts1 z necess>y to inve/igate a suspect product1 = n less ?an #f ye>s aft] ! transaction4 7,b7 ,agreem5ts ) ?ird p>ties ,a disp5s] may ent] into a writt5 agreem5t ) a ?ird p>ty1 includ+ an au?oriz$ :olesale di/ributor1 "u :i* ! ?ird p>ty confid5tially ma9ta9s ! transaction in=mation1 transaction hi/ory1 & transaction /atem5ts 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 agreem5t & %all n be reliev$ ( ! obligations ( ! disp5s] "u ?is subsection4 7,c7 ,returns 7i7 ,saleable returns ,a disp5s] may return product to ! trad+ p>tn] f :i* ! disp5s] obta9$ ! product )\t provid+ ! in=mation requir$ "u subp>agraph 7,b74 7ii7 ,nonsaleable returns ,a disp5s] may return a nonsaleable product to ! manufactur] or repackag]1 to ! :olesale di/ributor f :om su* product 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 subp>agraph 7,a77i74 7,d7 ,reque/s = in=mation ,^u a reque/ by ! ,secret>y or o!r appropriate ,f$]al or ,/ate (ficial1 9 ! ev5t ( a recall or = ! purpose ( inve/igat+ a suspect or an illegitimate product1 a disp5s] %all1 n lat] ?an #b bus9ess days aft] receiv+ ! reque/ or 9 ano!r su* reasonable "t z det]m9$ by ! ,secret>y1 bas$ on ! circum/ances ( ! reque/1 provide ! applicable transaction in=mation1 transaction /atem5t1 & transaction hi/ory :i* ! disp5s] receiv$ f ! previ\s own]1 :i* %all n include ! lot numb] ( ! product1 ! initial transaction date1 or ! initial %ipm5t date f ! manufactur] unless su* in=mation 0 includ$ 9 ! transaction in=mation1 transaction /atem5t1 & transaction hi/ory provid$ by ! manufactur] or :olesale di/ributor to ! disp5s]4 7#b7 ,product id5tifi] ,beg9n+ n lat] ?an #g ye>s aft] ! date ( enactm5t ( ! ,drug ,supply ,*a9 ,security ,act1 a disp5s] may engage 9 transactions involv+ a product only if su* product is encod$ ) a product id5tifi] 7except z provid$ pursuant to subsection 7a77#e774 7#c7 ,au?oriz$ trad+ p>tn]s ,beg9n+ n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,drug ,supply ,*a9 ,security ,act1 ! trad+ p>tn]s ( a disp5s] may be only au?oriz$ trad+ p>tn]s4 7#d7 ,v]ification ,beg9n+ n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,drug ,supply ,*a9 ,security ,act1 a disp5s] %all h sy/ems 9 place to enable ! disp5s] to comply ) ! foll[+ requirem5ts3 7,a7 ,suspect product 7i7 ,9 g5]al ,^u mak+ a det]m9ation t a product 9 ! possession or control ( ! disp5s] is a suspect product1 or ^u receiv+ a reque/ = v]ification f ! ,secret>y t has made a det]m9ation t a product )9 ! possession or control ( a disp5s] is a suspect product1 a disp5s] %all-- 7,i7 qu>ant9e su* product )9 ! possession or control ( ! disp5s] f product int5d$ = di/ribution until su* product is cle>$ or disposition$2 & 7,,ii7 promptly conduct an inve/igation 9 coord9ation ) trad+ p>tn]s1 z applicable1 to det]m9e :e!r ! product is an illegitimate product4 7ii7 ,inve/igation ,an inve/igation conduct$ "u clause 7i77,,ii7 %all include-- 7,i7 beg9n+ #g ye>s aft] ! date ( enactm5t ( ! ,drug ,supply ,*a9 ,security ,act1 v]ify+ :e!r ! lot numb] ( a suspect product corresponds ) ! lot numb] = su* product2 7,,ii7 beg9n+ #g ye>s aft] ! date ( enactm5t ( su* ,act1 v]ify+ t ! product id5tifi] ( at lea/ #c packages or #aj p]c5t ( su* suspect product1 :i*ev] is great]1 or all packages1 if !re are few] ?an #c1 corresponds ) ! product id5tifi] = su* product2 7,,iii7 validat+ any applicable transaction hi/ory & transaction in=mation 9 ! possession ( ! disp5s]2 & 7,,iv7 o!rwise inve/igat+ to det]m9e :e!r ! product is an illegitimate product4 7iii7 ,cle>$ product ,if ! disp5s] makes ! det]m9ation t a suspect product is n an illegitimate product1 ! disp5s] %all promptly notify ! ,secret>y1 if applicable1 ( su* det]m9ation & su* product may be fur!r di/ribut$ or disp5s$4 7iv7 ,records ,a disp5s] %all keep records ( ! inve/igation ( a suspect product = n less ?an #f ye>s aft] ! conclusion ( ! inve/igation4 7,b7 ,illegitimate product 7i7 ,9 g5]al ,^u det]m9+1 9 coord9ation ) ! manufactur]1 t a product 9 ! possession or control ( a disp5s] is an illegitimate product1 ! disp5s] %all-- 7,i7 disposition ! illegitimate product )9 ! possession or control ( ! disp5s]2 7,,ii7 take reasonable & appropriate /eps to assi/ a trad+ p>tn] to disposition an illegitimate product n 9 ! possession or control ( ! disp5s]2 & 7,,iii7 reta9 a sample ( ! product = fur!r physical exam9ation or laboratory analysis ( ! product by ! manufactur] or ,secret>y 7or o!r appropriate ,f$]al or ,/ate (ficial7 ^u reque/ by ! manufactur] or ,secret>y 7or o!r appropriate ,f$]al or ,/ate (ficial71 z necess>y & appropriate4 7ii7 ,mak+ a notification ,^u det]m9+ t a product 9 ! possession or control ( ! disp5s] is an illegitimate product1 ! disp5s] %all notify ! ,secret>y & all imm$iate trad+ p>tn]s t ! disp5s] has reason to believe may h receiv$ su* illegitimate product ( su* det]m9ation n lat] ?an #bd h\rs aft] mak+ su* det]m9ation4 7iii7 ,respond+ to a notification ,^u ! receipt ( a notification f ! ,secret>y or a trad+ p>tn] t a det]m9ation has be5 made t a product is an illegitimate product1 a disp5s] %all id5tify all illegitimate product subject to su* notification t is 9 ! possession or control ( ! disp5s]1 includ+ any product t is subsequ5tly receiv$1 & %all p]=m ! activities describ$ 9 subp>agraph 7,a74 7iv7 ,t]m9at+ a notification ,^u mak+ a det]m9ation1 9 consultation ) ! ,secret>y1 t a notification is no long] necess>y1 a disp5s] %all promptly notify imm$iate trad+ p>tn]s t ! disp5s] notifi$ pursuant to clause 7ii7 t su* notification has be5 t]m9at$4 7v7 ,records ,a disp5s] %all keep records ( ! disposition ( an illegitimate product = n less ?an #f ye>s aft] ! conclusion ( ! disposition4 7,c7 ,electronic database ,a disp5s] may satisfy ! requirem5ts ( ?is p>agraph by develop+ a secure electronic database or utiliz+ a secure electronic database develop$ or op]at$ by ano!r entity4 7e7 ,repackag] requirem5ts 7#a7 ,product trac+ 7,a7 ,9 g5]al ,beg9n+ n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,drug ,supply ,*a9 ,security ,act1 a repackag] %all-- 7i7 n accept own]%ip ( a product unless ! previ\s own]1 prior to1 or at ! "t (1 ! transaction1 provides transaction hi/ory1 transaction in=mation1 & a transaction /atem5t = ! product2 7ii7 prior to1 or at ! "t (1 ea* transaction 9 :i* ! repackag] transf]s own]%ip ( a product1 or transf]s possession ( a product to a ?ird-p>ty logi/ics provid]1 provide ! subsequ5t own] ) transaction hi/ory1 transaction in=mation1 & a transaction /atem5t2 & 7iii7 ma9ta9 ! transaction in=mation1 transaction hi/ory1 & transaction /atem5t = ea* transaction describ$ 9 clauses 7i7 & 7ii7 = n less ?an #f ye>s aft] ! transaction4 7,b7 ,nonsaleable returns ,a repackag] may return a nonsaleable product to ! manufactur] or repackag]1 or to ! :olesale di/ributor f :om su* product 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,a77ii74 7,c7 ,reque/s = in=mation ,^u a reque/ by ! ,secret>y or o!r appropriate ,f$]al or ,/ate (ficial1 9 ! ev5t ( a recall or = ! purpose ( inve/igat+ a suspect product or an illegitimate product1 a repackag] %all1 n lat] ?an #bd h\rs aft] receiv+ ! reque/ or 9 o!r su* reasonable "t z det]m9$ by ! ,secret>y1 bas$ on ! circum/ances ( ! reque/1 provide ! applicable transaction in=mation1 transaction hi/ory & transaction /atem5t = ! product4 7#b7 ,product id5tifi] ,beg9n+ n lat] ?an #e ye>s aft] enactm5t ( ! ,drug ,supply ,*a9 ,security ,act1 a repackag]-- 7,a7 %all a fix or impr9t a product id5tifi] to ea* package & homog5\s case ( product int5d$ to be introduc$ 9 a transaction 9 comm]ce2 7,b7 %all ma9ta9 ! product id5tifi] in=mation = su* product = n less ?an #f ye>s aft] ! date ( ! transaction2 7,c7 may engage 9 transactions involv+ a product only if su* product is encod$ ) a product id5tifi] 7except z provid$ pursuant to subsection 7a77#e772 & 7,d7 ma9ta9 records = n less ?an #f ye>s to all[ ! repackag] to associate ! product id5tifi] ! repackag] affixes or impr9ts ) ! product id5tifi] assign$ by ! orig9al manufactur] ( ! product4 7#c7 ,au?oriz$ trad+ p>tn]s ,beg9n+ #a ye> aft] ! date ( enactm5t ( ! ,drug ,supply ,*a9 ,security ,act1 ! trad+ p>tn]s ( a repackag] may be only au?oriz$ trad+ p>tn]s4 7#d7 ,v]ification ,beg9n+ n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,drug ,supply ,*a9 ,security ,act1 a repackag] %all h sy/ems 9 place to enable ! repackag] to comply ) ! foll[+ requirem5ts3 7,a7 ,suspect product 7i7 ,9 g5]al ,^u mak+ a det]m9ation t a product 9 ! possession or control ( ! repackag] is a suspect product1 or ^u receiv+ a reque/ = v]ification f ! ,secret>y t has made a det]m9ation t a product )9 ! possession or control ( a repackag] is a suspect product1 a repackag] %all-- 7,i7 qu>ant9e su* product )9 ! possession or control ( ! repackag] f product int5d$ = di/ribution until su* product is cle>$ or disposition$2 & 7,,ii7 promptly conduct an inve/igation 9 coord9ation ) trad+ p>tn]s1 z applicable1 to det]m9e :e!r ! product is an illegitimate product1 :i* %all include validat+ any applicable transaction hi/ory & transaction in=mation 9 ! possession ( ! repackag] & o!rwise inve/igat+ to det]m9e :e!r ! product is an illegitimate product1 &1 beg9n+ #e ye>s aft] ! date ( enactm5t ( ! ,drug ,supply ,*a9 ,security ,act 7except z provid$ pursuant to subsection 7a77#e771 v]ify+ ! product at ! package level4 7ii7 ,cle>$ product ,if ! repackag] makes ! det]m9ation t a suspect product is n an illegitimate product1 ! repackag] %all promptly notify ! ,secret>y1 if applicable1 ( su* det]m9ation & su* product may be fur!r di/ribut$4 7iii7 ,records ,a repackag] %all keep records ( ! inve/igation ( a suspect product = n less ?an #f ye>s aft] ! conclusion ( ! inve/igation4 7,b7 ,illegitimate product 7i7 ,9 g5]al ,^u det]m9+1 9 coord9ation ) ! manufactur]1 t a product 9 ! possession or control ( a repackag] is an illegitimate product1 ! repackag] %all1 9 a mann] t is consi/5t ) ! sy/ems & processes ( su* repackag]-- 7,i7 qu>ant9e su* product )9 ! possession or control ( ! repackag] f product int5d$ = di/ribution until su* product is disposition$2 7,,ii7 disposition ! illegitimate product )9 ! possession or control ( ! repackag]2 7,,iii7 take reasonable & appropriate /eps to assi/ a trad+ p>tn] to disposition an illegitimate product n 9 ! possession or control ( ! repackag]2 & 7,,iv7 reta9 a sample ( ! product = fur!r physical exam9ation or laboratory analysis ( ! product by ! manufactur] or ,secret>y 7or o!r appropriate ,f$]al or ,/ate (ficial7 ^u reque/ by ! manufactur] or ,secret>y 7or o!r appropriate ,f$]al or ,/ate (ficial71 z necess>y & appropriate4 7ii7 ,mak+ a notification ,^u det]m9+ t a product 9 ! possession or control ( ! repackag] is an illegitimate product1 ! repackag] %all notify ! ,secret>y & all imm$iate trad+ p>tn]s t ! repackag] has reason to believe may h receiv$ ! illegitimate product ( su* det]m9ation n lat] ?an #bd h\rs aft] mak+ su* det]m9ation4 7iii7 ,respond+ to a notification ,^u ! receipt ( a notification f ! ,secret>y or a trad+ p>tn]1 a repackag] %all id5tify all illegitimate product subject to su* notification t is 9 ! possession or control ( ! repackag]1 includ+ any product t is subsequ5tly receiv$1 & %all p]=m ! activities describ$ 9 subp>agraph 7,a74 7iv7 ,t]m9at+ a notification ,^u a det]m9ation1 9 consultation ) ! ,secret>y1 t a notification is no long] necess>y1 a repackag] %all promptly notify imm$iate trad+ p>tn]s t ! repackag] notifi$ pursuant to clause 7ii7 t su* notification has be5 t]m9at$4 7v7 ,records ,a repackag] %all keep records ( ! disposition ( an illegitimate product = n less ?an #f ye>s aft] ! conclusion ( ! disposition4 7,c7 ,reque/s = v]ification ,beg9n+ #e ye>s aft] enactm5t ( ! ,drug ,supply ,*a9 ,security ,act1 ^u receiv+ a reque/ = v]ification f an au?oriz$ manufactur]1 :olesale di/ributor1 or disp5s] t is 9 possession or control ( a product !y believe to be repackag$ by su* repackag]1 a repackag] %all1 n lat] ?an #bd h\rs aft] receiv+ ! v]ification reque/ or 9 o!r su* reasonable "t z det]m9$ by ! ,secret>y1 bas$ on ! circum/ances ( ! reque/1 notify ! p]son mak+ ! reque/ :e!r ! product id5tifi]1 includ+ ! /&>d num]ic id5tifi]1 t is ! subject ( ! reque/ corresponds to ! product id5tifi] affix$ or impr9t$ by ! repackag]4 ,if a repackag] respond+ to a v]ification reque/ id5tifies a product id5tifi] t does n correspond to t affix$ or impr9t$ by ! repackag]1 ! repackag] %all treat su* product z suspect product & conduct an inve/igation z describ$ 9 subp>agraph 7,a74 ,if ! repackag] has reason to believe ! product is an illegitimate product1 ! repackag] %all advise ! p]son mak+ ! reque/ ( su* belief at ! "t su* manufactur] responds to ! v]ification reque/4 7,d7 ,electronic database ,a repackag] may satisfy ! requirem5ts ( p>agraph 7#d7 by develop+ a secure electronic database or utiliz+ a secure electronic database develop$ or op]at$ by 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 p>agraph 7#d7 to respond to a v]ification reque/ submitt$ by means o!r ?an a secure electronic database4 7,e7 ,v]ification ( saleable return$ product ,beg9n+ #e ye>s aft] ! date ( enactm5t ( ! ,drug ,supply ,*a9 ,security ,act1 ^u receipt ( a return$ product t ! repackag] int5ds to fur!r di/ribute1 be=e fur!r di/ribut+ su* product1 ! repackag] %all v]ify ! product id5tifi] = ea* seal$ homog5e\s case ( su* product or1 if su* product is n 9 a seal$ homog5e\s case1 v]ify ! product id5tifi] on ea* package4 7f7 ,?ird-,p>ty logi/ics provid] requirem5ts 7#a7 ,9 g5]al ,beg9n+ n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,drug ,supply ,*a9 ,security ,act1 a ?ird-p>ty logi/ics provid] %all-- 7,a7 n accept possession ( a product unless ! own] ( ! product provides ! transaction hi/ory1 transaction in=mation1 & a transaction /atem5t = ! product2 7,b7 ma9ta9 a copy ( ! in=mation describ$ 9 subp>agraph 7,a7 = n less ?an #f ye>s aft] ! transf] ( possession2 & 7,c7 ^u a reque/ by ! ,secret>y or o!r appropriate ,f$]al or ,/ate (ficial1 9 ! ev5t ( a recall or = ! purpose ( inve/igat+ a suspect product or an illegitimate product1 n lat] ?an #bd h\rs aft] receiv+ ! reque/ or 9 o!r su* reasonable "t z det]m9$ by ! ,secret>y bas$ on ! circum/ances ( ! reque/1 provide ! applicable transaction in=mation1 transaction hi/ory1 & transaction /atem5t = ! product4 7#b7 ,product trac+ ,beg9n+ n lat] ?an #f ye>s aft] ! date ( enactm5t ( ! ,drug ,supply ,*a9 ,security ,act1 a ?ird-p>ty logi/ics provid] may accept possession ( product only if su* product is encod$ ) a product id5tifi] 7except z provid$ pursuant to subsection 7a77#e774 7#c7 ,au?oriz$ trad+ p>tn]s ,beg9n+ #a ye> aft] ! date ( enactm5t ( ! ,drug ,supply ,*a9 ,security ,act1 ! trad+ p>tn]s ( a ?ird-p>ty logi/ics provid] may be only au?oriz$ trad+ p>tn]s4 7#d7 ,v]ification ,beg9n+ n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,drug ,supply ,*a9 ,security ,act1 a ?ird-p>ty logi/ics provid] %all h sy/ems 9 place to enable ! ?ird-p>ty logi/ics provid] to comply ) ! foll[+ requirem5ts3 7,a7 ,suspect product 7i7 ,9 g5]al ,^u mak+ a det]m9ation t a product 9 ! possession or control ( a ?ird-p>ty logi/ics provid] is a suspect product1 a ?ird-p>ty logi/ics provid] %all-- 7,i7 qu>ant9e su* product )9 ! possession or control ( ! ?ird-p>ty logi/ics provid] f product int5d$ = di/ribution until su* product is cle>$ or transf]r$ to ! own] ( su* product = disposition ( ! product2 & 7,,ii7 promptly notify ! own] ( su* product ( ! ne$ to conduct an inve/igation to det]m9e :e!r ! product is an illegitimate product4 7ii7 ,cle>$ product ,if ! own] ( ! product notifies ! ?ird-p>ty logi/ics provid] ( ! det]m9ation t a suspect product is n an illegitimate product1 su* product may be fur!r di/ribut$4 7iii7 ,records ,a ?ird-p>ty logi/ics provid] %all keep records ( ! activities describ$ 9 subclauses 7,i7 & 7,,ii7 ( clause 7i71 z su* subclauses relate to a suspect product1 = n less ?an #f ye>s aft] ! conclusion ( ! inve/igation4 7,b7 ,illegitimate product 7i7 ,9 g5]al ,^u det]m9+1 9 coord9ation ) ! manufactur]1 t a product 9 ! possession or control ( a ?ird-p>ty logi/ics provid] is an illegitimate product1 ! ?ird-p>ty logi/ics provid] %all-- 7,i7 promptly notify ! own] ( su* product ( ! ne$ to disposition su* product2 & 7,,ii7 promptly transf] possession ( ! product to ! own] ( su* product to disposition ! product4 7ii7 ,mak+ a notification ,^u det]m9+ t a product 9 ! possession or control ( ! ?ird-p>ty logi/ics provid] is an illegitimate product1 ! ?ird-p>ty logi/ics provid] %all notify ! ,secret>y n lat] ?an #bd h\rs aft] mak+ su* det]m9ation4 7iii7 ,respond+ to a notification ,^u ! receipt ( a notification f ! ,secret>y1 a ?ird-p>ty logi/ics provid] %all id5tify all illegitimate product subject to su* notification t is 9 ! possession or control ( ! ?ird-p>ty logi/ics provid]1 includ+ any product t is subsequ5tly receiv$1 & %all p]=m ! activities describ$ 9 subp>agraph 7,a74 7iv7 ,t]m9at+ a notification ,^u mak+ a det]m9ation1 9 consultation ) ! ,secret>y & ! own] ( su* product1 t a notification is no long] necess>y1 a ?ird-p>ty logi/ics provid] %all promptly t]m9ate su* notification4 7v7 ,records ,a ?ird-p>ty logi/ics provid] %all keep records ( ! activities describ$ 9 subclauses 7,i7 & 7,,ii7 ( clause 7i7 z su* subclauses relate to an illegitimate product = n less ?an #f ye>s aft] ! conclusion ( ! disposition4 7g7 ,drop %ipm5ts ,?is section %all n apply to any entity t does n physically h&le1 di/ribute1 or /ore product4 ,= purposes ( ?is section1 provid+ v>i\s adm9i/rative s]vices1 includ+ process+ ( ord]s & paym5ts1 %all n by itself1 be con/ru$ z be+ involv$ 9 ! h&l+1 di/ribution1 or /orage ( a product4 ,= purposes ( ?is section1 ! t]m entity means a :olesale di/ributor1 relabel]1 repackag]1 or any o!r /atus4 4 #c4 ,enhanc$ drug di/ribution security 7a7 ,9 g5]al ,section #ehb ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #b1 is am5d$ by add+ at ! end ! foll[+3 7h7 ,enhanc$ drug di/ribution security 7#a7 ,9 g5]al ,on ! date t is #aj ye>s aft] ! date ( enactm5t ( ! ,drug ,supply ,*a9 ,security ,act1 ! foll[+ int]op]able1 electronic trac+ ( product at ! package level requirem5ts %all g into effect3 7,a7 ,! transaction in=mation & ! transaction /atem5ts z requir$ "u ?is section %all be ex*ang$ 9 a secure1 int]op]able1 electronic mann] 9 accordance ) ! /&>ds e/abli%$ "u ! guidance issu$ pursuant to p>agraphs 7#c7 & 7#d7 ( subsection 7i71 includ+ any revision ( su* guidance issu$ 9 accordance ) p>agraph 7#e7 ( su* subsection4 7,b7 ,! transaction in=mation requir$ "u ?is section %all include ! product id5tifi] at ! package level = ea* package includ$ 9 ! transaction4 7,c7 ,sy/ems & processes = v]ification ( product at ! package level %all be requir$ 9 accordance ) ! /&>ds e/abli%$ "u ! guidance issu$ pursuant to subsection 7a77#b7 & ! guidances issu$ pursuant to p>agraphs 7#b71 7#c71 & 7#d7 ( subsection 7i71 includ+ any revision ( su* guidances issu$ 9 accordance ) p>agraph 7#e7 ( su* subsection1 :i* may include ! use ( aggregation & inf]5ce z necess>y4 7,d7 ,! sy/ems & processes necess>y to promptly respond ) ! transaction in=mation & transaction /atem5t = a product ^u a reque/ by ! ,secret>y 7or o!r appropriate ,f$]al or ,/ate (ficial7 9 ! ev5t ( a recall or = ! purposes ( inve/igat+ a suspect product or an illegitimate product %all be requir$4 7,e7 ,! sy/ems & processes necess>y to promptly facilitate ga!r+ ! in=mation necess>y to produce ! transaction in=mation = ea* transaction go+ back to ! manufactur]1 z applicable %all be requir$-- 7i7 9 ! ev5t ( a reque/ by ! ,secret>y 7or o!r appropriate ,f$]al or ,/ate (ficial71 on acc\nt ( a recall or = ! purposes ( inve/igat+ a suspect product or an illegitimate product2 or 7ii7 9 ! ev5t ( a reque/ by an au?oriz$ trad+ p>tn]1 9 a secure mann] t ensures ! protection ( confid5tial comm]cial in=mation & trade secrets1 = purposes ( inve/igat+ a suspect product or assi/+ ! ,secret>y 7or o!r appropriate ,f$]al or ,/ate (ficial7 ) a reque/ describ$ 9 clause 7i74 7,f7 ,ea* p]son accept+ a saleable return %all h sy/ems & processes 9 place to all[ acceptance ( su* product & may accept saleable returns only if su* p]son c associate ! saleable return product ) ! transaction in=mation & transaction /atem5t associat$ ) t product4 7#b7 ,compliance 7,a7 ,in=mation ma9t5ance agreem5t ,a disp5s] %all be p]mitt$ to ent] into a writt5 agreem5t ) a ?ird p>ty1 includ+ an au?oriz$ :olesale di/ributor1 "u :i* ! ?ird p>ty %all confid5tially ma9ta9 any in=mation & /atem5ts requir$ to be ma9ta9$ "u ?is section4 ,if a disp5s] ent]s into su* an agreem5t1 ! disp5s] %all ma9ta9 a copy ( ! writt5 agreem5t & %all n be reliev$ ( ! obligations ( ! disp5s] "u ?is subsection4 7,b7 ,alt]native me?ods ,! ,secret>y1 tak+ into consid]ation ! assessm5t conduct$ "u p>agraph 7#c71 %all provide = alt]native me?ods ( compliance ) any ( ! requirem5ts set =? 9 p>agraph 7#a71 includ+-- 7i7 e/abli%+ timel9es = compliance by small bus9esses 7includ+ small bus9ess disp5s]s ) #be or few] full-"t employees7 ) su* requirem5ts1 9 ord] to ensure t su* requirem5ts d n impose undue economic h>d%ip = small bus9esses1 includ+ small bus9ess disp5s]s = :om ! crit]ia set =? 9 ! assessm5t "u p>agraph 7#c7 is n met1 if ! ,secret>y det]m9es t su* requirem5ts "u p>agraph 7#a7 w\ld result 9 undue economic h>d%ip2 & 7ii7 e/abli%+ a process by :i* a disp5s] may reque/ a waiv] f any ( ! requirem5ts set =? 9 p>agraph 7#a7 if ! ,secret>y det]m9es t su* requirem5ts w\ld result 9 an undue economic h>d%ip1 :i* %all include a process = ! bi5nial review & r5ewal ( any su* waiv]4 7#c7 ,assessm5t 7,a7 ,9 g5]al ,n lat] ?an ! date t is #ah mon?s aft] ! ,secret>y issues ! f9al guidance requir$ "u subsection 7i71 ! ,secret>y %all ent] into contract ) a private1 indep5d5t consult+ firm ) exp]tise to conduct a te*nology & s(tw>e assessm5t t looks at ! feasibility ( disp5s]s ) #be or few] full-"t employees conduct+ int]op]able1 electronic trac+ ( products at ! package level4 ,9 no case may su* assessm5t comm5ce lat] ?an #g4e ye>s aft] ! date ( enactm5t ( ! ,drug ,supply ,*a9 ,security ,act4 7,b7 ,condition ,z a condition ( ! aw>d ( ! contract "u subp>agraph 7,a71 ! private1 indep5d5t consult+ firm %all agree to consult ) disp5s]s ) #be or few] full-"t employees :5 conduct+ ! assessm5t "u su* subp>agraph4 7,c7 ,cont5t ,! assessm5t conduct$ "u subp>agraph 7,a7 %all assess :e!r-- 7i7 ! necess>y s(tw>e & h>dw>e is readily accessible to su* disp5s]s2 7ii7 ! necess>y s(tw>e & h>dw>e is n prohibitively exp5sive to obta91 in/all1 & ma9ta9 = su* disp5s]s2 & 7iii7 ! necess>y h>dw>e & s(tw>e c be integrat$ into bus9ess practices1 su* z int]op]ability ) :olesale di/ributors1 = su* disp5s]s4 7,d7 ,publication ,! ,secret>y %all-- 7i7 publi% ! /atem5t ( "w = ! assessm5t conduct$ "u subp>agraph 7,a7 = public comm5t prior to beg9n+ ! assessm5t2 7ii7 publi% ! f9al assessm5t = public comm5t n lat] ?an #cj cal5d> days aft] receiv+ su* assessm5t2 & 7iii7 hold a public meet+ n lat] ?an #ahj cal5d> days aft] receiv+ ! f9al assessm5t at :i* public /akehold]s may pres5t _! views on ! assessm5t4 7#d7 ,proc$ure ,not)/&+ section #eec ( title #e1 ,unit$ ,/ates ,code1 ! ,secret>y1 9 promulgat+ any regulation pursuant to ?is section1 %all-- 7,a7 provide appropriate flexibility by-- 7i7 n requir+ ! adoption ( specific bus9ess sy/ems = ! ma9t5ance & transmission ( data2 7ii7 prescrib+ alt]native me?ods ( compliance = any ( ! requirem5ts set =? 9 p>agraph 7#a7 or set =? 9 regulations implem5t+ su* requirem5ts1 includ+ timel9es-- 7,i7 = small bus9esses to comply ) ! requirem5ts set =? 9 ! regulations 9 ord] to ensure t su* requirem5ts d n impose undue economic h>d%ip = small bus9esses 7includ+ small bus9ess disp5s]s = :om ! crit]ia set =? 9 ! assessm5t "u p>agraph 7#c7 is n met71 if ! ,secret>y det]m9es t su* requirem5ts w\ld result 9 undue economic h>d%ip2 & 7,,ii7 :i* %all include e/abli%+ a process by :i* a disp5s] may reque/ a waiv] f any ( ! requirem5ts set =? 9 su* regulations if ! ,secret>y det]m9es t su* requirem5ts w\ld result 9 an undue economic h>d%ip2 & 7iii7 tak+ into consid]ation-- 7,i7 ! results ( pilot projects1 includ+ pilot projects pursuant to ?is section2 7,,ii7 ! public meet+s held & relat$ guidance docum5ts issu$ "u ?is section2 7,,iii7 ! public heal? b5efits ( any additional regulations 9 comp>ison to ! co/ ( compliance ) su* requirem5ts1 includ+ on entities ( v>y+ sizes & capabilities2 7,,iv7 ! div]sity ( ! ph>maceutical di/ribution supply *a9 by provid+ appropriate flexibility = ea* sector1 includ+ bo? l>ge & small bus9esses2 & 7,v7 ! assessm5t pursuant to p>agraph 7#c7 ) respect to small bus9ess disp5s]s1 includ+ relat$ public comm5t & ! public meet+1 & requirem5ts "u ?is section2 7,b7 issue a notice ( propos$ rulemak+ t includes a copy ( ! propos$ regulation2 7,c7 provide a p]iod ( n less ?an #fj days = comm5ts on ! propos$ regulation2 & 7,d7 publi% ! f9al regulation n less ?an #b ye>s prior to ! effective date ( ! regulation4 7i7 ,guidance docum5ts 7#a7 ,9 g5]al ,= ! purposes ( facilitat+ ! successful & effici5t adoption ( secure1 int]op]able product trac+ at ! package level 9 ord] to enhance drug di/ribution security & fur!r protect ! public heal?1 ! ,secret>y %all issue ! guidance docum5ts z provid$ = 9 ?is subsection4 7#b7 ,suspect & illegitimate product 7,a7 ,9 g5]al ,n lat] ?an #ahj days aft] enactm5t ( ! ,drug ,supply ,*a9 ,security ,act1 ! ,secret>y %all issue a guidance docum5t to aid trad+ p>tn]s 9 ! id5tification ( a suspect product & notification t]m9ation4 ,su* guidance docum5t %all-- 7i7 id5tify specific sc5>ios t c\ld significantly increase ! risk ( a suspect product ent]+ ! ph>maceutical di/ribution supply *a92 7ii7 provide recomm5dation on h[ trad+ p>tn]s may id5tify su* product & make a det]m9ation if ! product is a suspect product z soon z practicable2 & 7iii7 set =? ! process by :i* manufactur]s1 repackag]s1 :olesale di/ributors1 disp5s]s1 & ?ird-p>ty logi/ics provid]s %all t]m9ate notifications 9 consultation ) ! ,secret>y reg>d+ illegitimate product pursuant to subsections 7b77#d77;,b71 7c77#d77;,b71 7d77#d77;,b71 7e77#d77;,b71 & 7f77,b74 7,b7 ,revis$ guidance ,if ! ,secret>y revises ! guidance issu$ "u subp>agraph 7,a71 ! ,secret>y %all foll[ ! proc$ure set =? 9 p>agraph 7#e74 7#c7 ,unit level trac+ 7,a7 ,9 g5]al ,9 ord] to enhance drug di/ribution security at ! package level1 n lat] ?an #ah mon?s aft] conduct+ a public meet+ on ! sy/em attributes necess>y to enable secure trac+ ( product at ! package level1 ! ,secret>y %all issue a f9al guidance docum5t t outl9es & makes recomm5dations ) respect to ! sy/em attributes necess>y to enable secure trac+ at ! package level z requir$ "u ! requirem5ts e/abli%$ "u subsection 7h74 ,su* guidance docum5t %all-- 7i7 def9e ! circum/ances "u :i* ! sectors )9 ! ph>maceutical di/ribution supply *a9 may1 9 ! mo/ effici5t mann] practicable1 inf] ! cont5ts ( a case1 pallet1 tote1 or o!r aggregate ( individual packages or conta9]s ( product1 f a product id5tifi] associat$ ) ! case1 pallet1 tote1 or o!r aggregate1 )\t op5+ ea* case1 pallet1 tote1 or o!r aggregate or o!rwise individually scann+ ea* package2 7ii7 id5tify me?ods & processes to enhance secure trac+ ( product at ! package level1 su* z enhanc$ v]ification activities1 ! use ( aggregation & inf]5ce1 processes t utilize ! product id5tifi]s to enhance trac+ ( product at ! package level1 or package security features2 & 7iii7 ensure ! protection ( confid5tial comm]cial in=mation & trade secrets4 7,b7 ,proc$ure ,9 issu+ ! guidance "u subp>agraph 7,a71 & 9 revis+ su* guidance1 if applicable1 ! ,secret>y %all foll[ ! proc$ure set =? 9 p>agraph 7#e74 7#d7 ,/&>ds = int]op]able data ex*ange 7,a7 ,9 g5]al ,9 ord] to enhance secure trac+ ( a product at ! package level1 ! ,secret>y1 n lat] ?an #ah mon?s aft] conduct+ a public meet+ on ! int]op]able /&>ds necess>y to enhance ! security ( ! ph>maceutical di/ribution supply *a91 %all update ! guidance issu$ pursuant to subsection 7a77#b71 z necess>y & appropriate1 & f9alize su* guidance docum5t s t ! guidance docum5t-- 7i7 id5tifies & makes recomm5dation ) respect to ! /&>ds necess>y = adoption 9 ord] to support ! secure1 int]op]able electronic data ex*ange among ! ph>maceutical di/ribution supply *a9 t comply ) a =m & =mat develop$ by a widely recogniz$ int]national /&>ds developm5t organization2 7ii7 takes into consid]ation /&>ds e/abli%$ pursuant to subsection 7a77#b7 & section #eje;,d2 7iii7 facilitates ! creation ( a uni=m process or me?odology = product trac+2 & 7iv7 ensures ! protection ( confid5tial comm]cial in=mation & trade secrets4 7,b7 ,proc$ure ,9 issu+ ! guidance "u subp>agraph 7,a71 & 9 revis+ su* guidance1 if applicable1 ! ,secret>y %all foll[ ! proc$ure set =? 9 p>agraph 7#e74 7#e7 ,proc$ure ,9 issu+ or revis+ any guidance issu$ pursuant to ?is subsection or subsection 7h71 except ! initial guidance issu$ "u p>agraph 7#b77;,a71 ! ,secret>y %all-- 7,a7 publi% a notice 9 ! ,f$]al ,regi/] = a p]iod n less ?an #cj days ann\nc+ t ! draft or revis$ draft guidance is available2 7,b7 po/ ! draft guidance docum5t on ! ,int]net ,web site ( ! ,food & ,drug ,adm9i/ration & make su* draft guidance docum5t available 9 h>d copy2 7,c7 provide an opportunity = comm5t & review & take into consid]ation any comm5ts receiv$2 7,d7 revise ! draft guidance1 z appropriate2 7,e7 publi% a notice 9 ! ,f$]al ,regi/] = a p]iod n less ?an #cj days ann\nc+ t ! f9al guidance or f9al revis$ guidance is available2 7,f7 po/ ! f9al guidance docum5t on ! ,int]net ,web site ( ! ,food & ,drug ,adm9i/ration & make su* f9al guidance docum5t available 9 h>d copy2 & 7,g7 provide = an effective date ( n e>li] ?an #a ye> aft] su* guidance becomes f9al4 7j7 ,public meet+s 7#a7 ,9 g5]al ,! ,secret>y %all hold n less ?an #c public meet+s to enhance ! safety & security ( ! ph>maceutical di/ribution supply *a9 & provide = comm5t4 ,! ,secret>y may hold ! fir/ su* public meet+ n e>li] ?an #a ye> aft] ! date ( enactm5t ( ! ,drug ,supply ,*a9 ,security ,act4 ,9 c>ry+ out ! public meet+s describ$ 9 ?is p>agraph1 ! ,secret>y %all-- 7,a7 prioritize topics necess>y to in=m ! issuance ( ! guidance describ$ 9 p>agraphs 7#c7 & 7#d7 ( subsection 7i72 & 7,b7 take all measures reasonable & practicable to ensure ! protection ( confid5tial comm]cial in=mation & trade secrets4 7#b7 ,cont5t ,ea* ( ! foll[+ topics %all be address$ 9 at lea/ "o ( ! public meet+s describ$ 9 p>agraph 7#a73 7,a7 ,an assessm5t ( ! /eps tak5 "u subsections 7b7 ?r\gh 7f7 to build capacity = a unit-level sy/em1 includ+ ! impact ( ! requirem5ts ( su* subsections on-- 7i7 ! ability ( ! heal? c>e sy/em collectively to ma9ta9 pati5t access to m$ic9es2 7ii7 ! scalability ( su* requirem5ts1 includ+ z x relates to product l9es2 & 7iii7 ! capability ( diff]5t sectors & subsectors1 includ+ bo? l>ge & small bus9esses1 to affix & utilize ! product id5tifi]4 7,b7 ,! sy/em attributes necess>y to support ! requirem5ts set =? "u subsection 7h71 includ+ ! /&>ds necess>y = adoption 9 ord] to support ! secure1 int]op]able electronic data ex*ange among sectors )9 ! ph>maceutical di/ribution supply *a94 7,c7 ,be/ practices 9 ea* ( ! diff]5t sectors )9 ! ph>maceutical di/ribution supply *a9 to implem5t ! requirem5ts ( ?is section4 7,d7 ,! co/s & b5efits ( ! implem5tation ( ?is section1 includ+ ! impact on ea* ph>maceutical di/ribution supply *a9 sector & on public heal?4 7,e7 ,:e!r electronic trac+ requirem5ts1 includ+ trac+ ( product at ! package level are feasible1 co/-effective & ne$$ to protect public heal?4 7,f7 ,! sy/ems & processes ne$$ to utilize ! product id5tifi]s to enhance trac+ ( product at ! package level4 7,g7 ,! te*nical capabilities & legal au?orities1 if any1 ne$$ to e/abli% an int]op]able1 electronic sy/em t provides = trac+ ( product at ! package level4 7,h7 ,! impact t su* additional requirem5ts w\ld h on pati5t safety1 ! drug supply1 co/ & regulatory burd51 & timely pati5t access to prescription drugs4 7,i7 ,o!r topics1 z det]m9$ appropriate by ! ,secret>y4 7k7 ,pilot projects 7#a7 ,9 g5]al ,! ,secret>y %all e/abli% #a or m pilot projects1 9 coord9ation ) au?oriz$ manufactur]s1 repackag]s1 :olesale di/ributors1 ?ird-p>ty logi/ics provid]s1 & disp5s]s1 to explore & evaluate me?ods to enhance ! safety & security ( ! ph>maceutical di/ribution supply *a94 ,su* projects %all build ^u ef=ts1 9 exi/5ce z ( ! date ( enactm5t ( ! ,drug ,supply ,*a9 ,security ,act1 to enhance ! safety & security ( ! ph>maceutical di/ribution supply *a91 take into consid]ation any pilot projects conduct$ prior to su* date ( enactm5t1 & in=m ! draft & f9al guidance "u p>agraphs 7#c7 & 7#d7 ( subsection 7i74 7#b7 ,cont5t 7,a7 ,9 g5]al ,! ,secret>y %all ensure t ! pilot projects "u p>agraph 7#a7 reflect ! div]sity ( ! ph>maceutical di/ribution supply *a9 & t ! pilot projects1 :5 tak5 z a :ole1 include p>ticipants repres5tative ( e sector1 includ+ bo? l>ge & small bus9esses4 7,b7 ,project design ,! pilot projects "u p>agraph 7#a7 %all be design$ to-- 7i7 utilize ! product id5tifi] = trac+ ( a product1 :i* may include v]ification ( ! product id5tifi] ( a product1 includ+ ! use ( aggregation & inf]5ce2 7ii7 improve ! te*nical capabilities ( ea* sector & subsector to comply ) sy/ems & processes ne$$ to utilize ! product id5tifi]s to enhance trac+ ( a product2 7iii7 id5tify sy/em attributes t are necess>y to implem5t ! requirem5ts e/abli%$ "u ?is section2 & 7iv7 complete o!r activities z det]m9$ by ! ,secret>y4 7l7 ,sunset ,! foll[+ requirem5ts %all h no =ce or effect beg9n+ on ! date t is #aj ye>s aft] ! date ( enactm5t ( ! ,drug ,supply ,*a9 ,security ,act3 7#a7 ,! provision & receipt ( transaction hi/ory "u ?is section4 7#b7 ,! requirem5ts set =? = returns "u subsection 7c77#a77;,b77i74 7m7 ,rule ( con/ruction ,! requirem5ts set =? 9 subsections 7h77#d71 7j71 & 7k7 %all n be con/ru$ z a condition1 prohibition1 or prec$5t = preclud+ or delay+ ! provisions becom+ effective pursuant to subsection 7h74 4 #d4 ,national lic5sure /&>ds = :olesale di/ributors 7a7 ,am5dm5ts 7#a7 ,lic5se requirem5t ,section #ejc7;e7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cec7;e77 is am5d$ by /rik+ p>agraphs 7#a71 7#b71 & 7#c7 & ins]t+ ! foll[+3 7#a7 ,lic5se requirem5t ,subject to section #ehc3 7,a7 ,9 g5]al ,no p]son may engage 9 :olesale di/ribution ( a drug subject to subsection 7b77#a7 9 any ,/ate unless su* p]son-- 7i7 7,i7 is lic5s$ by ! ,/ate f :i* ! drug is di/ribut$2 or 7,,ii7 if ! ,/ate f :i* ! drug di/ribut$ has n e/abli%$ a lic5sure requirem5t1 is lic5s$ by ! ,secret>y2 & 7ii7 if ! drug is di/ribut$ int]/ate1 is lic5s$ by ! ,/ate into :i* ! drug is di/ribut$ if ! ,/ate into :i* ! drug is di/ribut$ requires ! lic5sure ( a p]son t di/ributes drugs into ! ,/ate4 7,b7 ,lic5se /&>ds ,ea* ,f$]al & ,/ate lic5se describ$ 9 subp>agraph 7,a7 %all meet ! /&>ds1 t]ms1 & conditions e/abli%$ by ! ,secret>y "u section #ehc4 7#b7 ,lic5sure report+ & database 7,a7 ,lic5sure report+ ,beg9n+ #a ye> aft] ! date ( enactm5t ( ! ,drug ,supply ,*a9 ,security ,act1 any p]son :o owns or op]ates an e/abli%m5t t engages 9 :olesale di/ribution %all report to ! ,secret>y1 on an annual basis pursuant to a s*$ule det]m9$ by ! ,secret>y-- 7i7 ea* ,/ate by :i* ! p]son is lic5s$ & ! appropriate id5tification numb] ( ea* su* lic5se2 & 7ii7 ! "n & address ( ea* facility at :i*1 & all trade names "u :i*1 ! p]son conducts bus9ess4 7,b7 ,database ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,drug ,supply ,*a9 ,security ,act1 ! ,secret>y %all e/abli% a database ( lic5s$ :olesale di/ributors4 ,su* database %all-- 7i7 id5tify ea* :olesale di/ributor by "n1 contact in=mation1 & ea* ,/ate :]e su* :olesale di/ributor is appropriately lic5s$ to engage 9 :olesale di/ribution2 7ii7 be available to ! public on ! ,int]net ,web site ( ! ,food & ,drug ,adm9i/ration2 & 7iii7 be regul>ly updat$ on a s*$ule det]m9$ by ! ,secret>y4 7#c7 ,co/s 7,a7 ,au?oriz$ lic5sure fees ( secret>y ,if a ,/ate does n e/abli% a lic5s+ program = p]sons engag$ 9 ! :olesale di/ribution ( a drug subject to subsection 7b71 ! ,secret>y %all lic5se a p]son engag$ 9 :olesale di/ribution locat$ 9 su* ,/ate & may collect a reasonable fee 9 su* am\nt necess>y to reimburse ! ,secret>y = co/s associat$ ) e/abli%+ & adm9i/]+ ! lic5sure program & conduct+ p]iodic inspections "u ?is section4 ,! ,secret>y %all adju/ fee rates z ne$$ on an annual basis to g5]ate only ! am\nt ( rev5ue ne$$ to p]=m ?is s]vice4 ,fees au?oriz$ "u ?is p>agraph %all be collect$ & available = obligation only to ! ext5t & 9 ! am\nt provid$ 9 advance 9 appropriations ,acts4 ,su* fees are au?oriz$ to rema9 available until exp5d$4 7,b7 ,/ate lic5s+ fees ,no?+ 9 ?is ,act %all prohibit ,/ates f collect+ fees f :olesale di/ributors 9 connection ) ,/ate lic5s+ ( su* di/ributors4 4 7#b7 ,:olesale di/ribution ,section #ejc7;e7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cec7;e771 z am5d$ by subsection 7a71 is fur!r am5d$ by add+ at ! end ! foll[+3 7#d7 ,= ! purposes ( ?is subsection & subsection 7d71 ! t]m :olesale di/ribution means ! di/ribution ( a drug subject to subsection 7b7 to a p]son o!r ?an a consum] or pati5t1 or receipt ( a drug subject to subsection 7b7 by a p]son o!r ?an ! 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 an em]g5cy m$ical reason2 7,d7 ! disp5s+ ( a drug pursuant to a valid prescription execut$ 9 accordance ) section #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,j7 a common c>ri] t transports a drug1 provid$ t ! common c>ri] does n take own]%ip ( ! drug2 7,k7 ! di/ribution ( a drug1 or an (f] to di/ribute a drug by an au?oriz$ repackag] t has tak5 own]%ip or possession ( ! drug & repacks x 9 accordance ) section #ehb7;e72 7,l7 saleable drug returns :5 conduct$ by a disp5s]2 7,m7 ! di/ribution ( a m$ical conv5i5ce kit :i* is a collection ( f9i%$ drug or biologic products assembl$ 9 kit =m /rictly = ! conv5i5ce ( ! pur*as] or us] if-- 7i7 ! m$ical conv5i5ce kit is assembl$ 9 an e/abli%m5t t is regi/]$ ) ! ,food & ,drug ,adm9i/ration z a device manufactur] 9 accordance ) section #eaj7;b77#b72 7ii7 ! p]son :o manufactures ! m$ical conv5i5ce kit pur*as$ ! f9i%$ drug or biologic product conta9$ 9 ! m$ical conv5i5ce kit directly f ! ph>maceutical manufactur] or f a :olesale di/ributor t pur*as$ ! product directly f ! ph>maceutical manufactur]2 7iii7 ! p]son :o manufactures a m$ical conv5i5ce kit does n alt] ! prim>y conta9] or label ( ! product z pur*as$ f ! manufactur] or :olesale di/ributor2 7iv7 ! m$ical conv5i5ce kit does n conta9 a controll$ sub/ance t appe>s 9 a s*$ule conta9$ 9 ! ,compreh5sive ,drug ,abuse ,prev5tion & ,control ,act ( #aigj 7#ba ,u4,s4,c4 #hja1 et seq472 & 7v7 ! products conta9$ 9 ! m$ical conv5i5ce kit are-- 7,i7 intrav5\s solutions int5d$ = ! repl5i%m5t ( fluids & electrolytes2 7,,ii7 drugs int5d$ to ma9ta9 ! equilibrium ( wat] & m9]als 9 ! body2 7,,iii7 drugs int5d$ = irrigation or recon/itution2 7,,iv7 ane/hetics2 7,v7 anticoagulants2 7,,vi7 vasopressors2 or 7,,vii7 sympa?icomimetics2 7,n7 ! 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,o7 ! di/ribution ( an intrav5\s drug us$ to ma9ta9 ! equilibrium ( wat] & m9]als 9 ! body1 su* z dialysis solutions2 7,p7 ! di/ribution ( a drug t is int5d$ = irrigation or recon/itution1 or /]ile wat]1 :e!r int5d$ = su* purposes or = injection2 7,q7 ! di/ribution ( compress$ m$ical gas1 def9$ z 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 oxide2 7,r7 facilitat+ ! di/ribution ( a product by provid+ solely adm9i/rative s]vices1 includ+ process+ ( ord]s & paym5ts2 or 7,s7 ! transf] ( a product by a hospital or o!r heal? c>e entity to a repackag] regi/]$ "u section #eaj = ! purpose ( repackag+ ! drug = use by t hospital1 or o!r heal? c>e entity & o!r heal? c>e entities t are "u common control1 if own]%ip ( ! drug rema9s ) ! hospital or o!r heal? c>e entity at all times4 4 7#c7 ,?ird-p>ty logi/ics provid]s ,section #ejc7;e7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cec7;e771 z am5d$ by subsection 7a71 is fur!r am5d$ by add+ at ! end ! foll[+3 7#e7 ,?ird-p>ty logi/ics provid]s ,not)/&+ p>agraphs 7#a7 ?r\gh 7#d71 ea* entity t meets ! def9ition ( a ?ird-p>ty logi/ics provid] "u section #eha7bb7 %all obta9 a lic5se z a ?ird-p>ty logi/ics provid] z describ$ 9 section #ehd7;a7 & is n requir$ to obta9 a lic5se z a :olesale di/ributor if ! entity nev] assumes an own]%ip int]e/ 9 ! product x h&les4 4 7#d7 ,lic5sure /&>ds ,sub*apt] ,h ( *apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #b1 is am5d$ by add+ at ! end ! foll[+3 #ehc4 ,national lic5sure /&>ds = :olesale di/ributors 7a7 ,9 g5]al ,! ,secret>y %all1 n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,drug ,supply ,*a9 ,security ,act1 by regulation e/abli% m9imum /&>ds1 t]ms1 & conditions = ! lic5s+ ( p]sons "u section #ejc7;e77#a7 7z am5d$ by ! ,drug ,supply ,*a9 ,security ,act71 includ+ ! revocation1 reissuance1 & r5ewal ( su* lic5se4 7b7 ,cont5t ,! /&>ds e/abli%$ "u subsection 7a7 %all apply to all ,/ate & ,f$]al lic5ses describ$ "u section #ejc7;e77#a7 7z am5d$ by ! ,drug ,supply ,*a9 ,security ,act7 & %all prescribe m9imum requirem5ts =-- 7#a7 ! /orage & h&l+ ( su* drugs1 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 if-- 7,a7 an applicant t is n a gov]nm5t own$ & op]at$ :olesale di/ributor1 = ! issuance or r5ewal ( a :olesale di/ributor lic5se %all submit a surety bond ( "o hundr$ ?\s& doll>s or o!r equival5t means ( security acceptable to ! ,/ate2 7,b7 = purposes ( subp>agraph 7,a71 ! ,/ate or o!r applicable au?ority may accept a surety bond less ?an #ajj1jjj if ! annual gross receipts ( ! previ\s tax ye> = ! :olesal] is #aj1jjj1jjj or less1 9 :i* case ! surety bond %all be #be1jjj2 & 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$2 7#d7 m&atory backgr\nd *ecks & f+]pr9t+ ( facility manag]s or designat$ 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 "t frame f ! initial application ( ! facility & to be conduct$ by ! lic5s+ au?ority or by ! ,/ate1 consi/5t ) subsection 7c72 & 7#g7 9 accordance ) subsection 7d71 ! prohibition ( c]ta9 p]sons f receiv+ or ma9ta9+ lic5sure = :olesale di/ribution4 7c7 ,inspections ,to satisfy ! inspection requirem5t ! ,f$]al or ,/ate lic5s+ au?ority may conduct ! inspection1 or may accept an inspection by ! ,/ate 9 :i* ! facility is locat$1 or by a ?ird-p>ty accr$itation or inspection s]vice approv$ by ! ,secret>y or ! ,/ate lic5s+ su* :olesale di/ributor4 7d7 ,prohibit$ p]sons ,! /&>ds e/abli%$ "u subsection 7a7 %all include requirem5ts to prohibit a p]son f receiv+ or ma9ta9+ lic5sure = :olesale di/ribution if ! p]son-- 7#a7 has be5 convict$ ( any felony = conduct relat+ to :olesale di/ribution1 any felony violation ( subsection 7i7 or 7k7 ( section #cja1 or any felony violation ( section #acfe ( title #ah1 ,unit$ ,/ates ,code1 relat+ to product tamp]+2 or 7#b7 has engag$ 9 a patt]n ( violat+ ! requirem5ts ( ?is section1 or ,/ate requirem5ts = lic5sure1 t pres5ts a ?reat ( s]i\s adv]se heal? consequ5ces or dea? to humans4 7e7 ,requirem5ts ,! ,secret>y1 9 promulgat+ any regulation pursuant to ?is section1 %all1 not)/&+ section #eec ( title #e1 ,unit$ ,/ates ,code-- 7#a7 issue a notice ( propos$ rulemak+ t includes a copy ( ! propos$ regulation2 7#b7 provide a p]iod ( n less ?an #fj days = comm5ts on ! propos$ regulation2 & 7#c7 provide t ! f9al regulation take effect on ! date t is #b ye>s aft] ! date su* f9al regulation is publi%$4 4 7b7 ,con=m+ am5dm5ts ,section #ejc7;d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cec7;d77 is am5d$-- 7#a7 by /rik+ au?oriz$ di/ributor ( record ea* place su* t]m appe>s & ins]t+ :olesale di/ributor2 & 7#b7 by /rik+ au?oriz$ di/ributors ( record ea* place su* t]m appe>s & ins]t+ :olesale di/ributors4 7c7 ,effective date ,! am5dm5ts made by subsections 7a7 & 7b7 %all take effect on ! day t is #a ye> aft] ! date ( enactm5t ( ?is ,act4 #e4 ,national lic5sure /&>ds = ?ird-p>ty logi/ics provid]s2 uni=m national policy ,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 requirem5ts ,no ?ird-p>ty logi/ics provid] 9 any ,/ate may conduct activities 9 any ,/ate unless ea* facility ( su* ?ird-p>ty logi/ics provid]-- 7#a7 7,a7 is lic5s$ by ! ,/ate f :i* ! drug is di/ribut$ by ! ?ird-p>ty logi/ics provid]1 9 accordance ) ! regulations promulgat$ "u subsection 7d72 or 7,b7 if ! ,/ate f :i* ! drug di/ribut$ by ! ?ird-p>ty logi/ics provid] has n e/abli%$ a lic5sure requirem5t1 is lic5s$ by ! ,secret>y1 9 accordance ) ! regulations promulgat$ "u subsection 7d72 & 7#b7 if ! drug is di/ribut$ int]/ate1 is lic5s$ by ! ,/ate into :i* ! drug is di/ribut$ by ! ?ird-p>ty logi/ics provid] if su* ,/ate lic5ses ?ird-p>ty logi/ics provid]s t di/ribute drugs into ! ,/ate & ! ?ird-p>ty logi/ics provid] is n lic5s$ by ! ,secret>y z describ$ 9 subp>agraph 7,a77ii74 7b7 ,lic5sure report+ ,beg9n+ #a ye> aft] ! date ( enactm5t ( ! ,drug ,supply ,*a9 ,security ,act1 a facility ( a ?ird-p>ty logi/ics provid] %all report to ! ,secret>y1 on an annual basis pursuant to a s*$ule det]m9$ by ! ,secret>y-- 7#a7 ! ,/ate by :i* ! facility is lic5s$ & ! appropriate id5tification numb] ( su* lic5se2 & 7#b7 ! "n & address ( ! facility1 & all trade names "u :i*1 su* facility conducts bus9ess4 7c7 ,co/s 7#a7 ,au?oriz$ lic5sure fees ( secret>y ,if a ,/ate does n e/abli% a lic5s+ program = a ?ird-p>ty logi/ics provid]1 ! ,secret>y %all lic5se ! ?ird-p>ty logi/ics provid] locat$ 9 su* ,/ate & may collect a reasonable fee 9 su* am\nt necess>y to reimburse ! ,secret>y = co/s associat$ ) e/abli%+ & adm9i/]+ ! lic5sure program & conduct+ p]iodic inspections "u ?is section4 ,! ,secret>y %all adju/ fee rates z ne$$ on an annual basis to g5]ate only ! am\nt ( rev5ue ne$$ to p]=m ?is s]vice4 ,fees au?oriz$ "u ?is p>agraph %all be collect$ & available = obligation only to ! ext5t & 9 ! am\nt provid$ 9 advance 9 appropriations ,acts4 ,su* fees are au?oriz$ to rema9 available until exp5d$4 7#b7 ,/ate lic5s+ fees 7,a7 ,/ate e/abli%$ program ,no?+ 9 ?is ,act %all prohibit a ,/ate t has e/abli%$ a program to lic5se a ?ird-p>ty logi/ics provid] f collect+ fees f a ?ird-p>ty logi/ics provid] = su* a lic5se4 7,b7 ,no ,/ate e/abli%$ program ,a ,/ate t does n e/abli% a program to lic5se a ?ird-p>ty logi/ics provid] 9 accordance ) ?is section %all be prohibit$ f collect+ a ,/ate lic5s+ fee f a ?ird-p>ty logi/ics provid]4 7d7 ,lic5se regulations 7#a7 ,9 g5]al ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,drug ,supply ,*a9 ,security ,act1 ! ,secret>y %all issue regulations reg>d+ ! m9imum issuance & eligibility requirem5ts = lic5s+ "u subsection 7a71 includ+ ! revocation & reissuance ( su* lic5se1 to ?ird-p>ty logi/ics provid]s "u ?is section4 7#b7 ,cont5t ,su* regulations %all-- 7,a7 e/abli% a process by :i* a ?ird-p>ty accr$itation program approv$ by ! ,secret>y %all1 ^u reque/ by a ?ird-p>ty logi/ics provid]1 issue a lic5se to ea* ?ird-p>ty logi/ics provid] t meets ! m9imum requirem5ts set =? 9 ?is section2 7,b7 e/abli% a process by :i* ! ,secret>y %all issue a lic5se to ea* ?ird-p>ty logi/ics provid] t meets ! m9imum requirem5ts set =? 9 ?is section 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,c7 require t ! entity complies ) /orage practices1 z det]m9$ by ! ,secret>y = su* facility1 includ+-- 7i7 ma9ta9+ access to w>eh\se space ( suitable size to facilitate safe op]ations1 includ+ a suitable area to qu>ant9e suspect product2 7ii7 ma9ta9+ adequate security2 & 7iii7 hav+ writt5 policies & proc$ures to-- 7,i7 address receipt1 security1 /orage1 inv5tory1 %ipm5t1 & di/ribution ( a product2 7,,ii7 id5tify1 record1 & report confirm$ 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$ product is segregat$ f o!r products & return$ to ! manufactur] or re-packag] or de/roy$2 7,,vii7 ma9ta9 ! capability to electronically trace ! receipt & outb\nd di/ribution ( a product1 & supplies & records ( inv5tory2 & 7,,viii7 qu>ant9e or de/roy a suspect product if direct$ to d s by ! respective manufactur]1 :olesale di/ributor1 disp5s] or an au?oriz$ gov]nm5t ag5cy2 7,d7 provide = p]iodic inspection by ! lic5s+ au?ority1 z det]m9$ by ! ,secret>y1 ( su* facility w>eh\se space to ensure compliance ) ?is section2 7,e7 prohibit a facility f hav+ z a manag] or designat$ repres5tative anyone convict$ ( any felony violation ( subsection 7i7 or 7k7 ( section #cja or any violation ( section #acfe ( title #ah1 ,unit$ ,/ates ,code relat+ to product tamp]+2 7,f7 provide = m&atory backgr\nd *ecks ( a facility manag] or a designat$ repres5tative ( su* manag]2 & 7,g7 require a ?ird-p>ty logi/ics provid] to provide ! ,secret>y1 ^u a reque/ by ! ,secret>y1 a li/ ( all product manufactur]s1 :olesale di/ributors1 & disp5s]s = :om ! ?ird-p>ty logi/ics provid] provides s]vices at su* facility4 7#c7 ,proc$ure ,9 promulgat+ ! regulations "u ?is subsection1 ! ,secret>y %all1 not)/&+ section #eec ( title #e1 ,unit$ ,/ates ,code-- 7,a7 issue a notice ( propos$ rulemak+ t includes a copy ( ! propos$ regulation2 7,b7 provide a p]iod ( n less ?an #fj days = comm5ts on ! propos$ regulation2 & 7,c7 provide t ! f9al regulation takes effect ^u ! expiration ( #a ye> aft] ! date t su* f9al regulation is issu$4 7e7 ,r5ewal ( lic5ses ,! ,secret>y %all develop proc$ures = lic5se r5ewal4 ,lic5ses issu$ "u ?is section %all expire on ! date t is #c ye>s aft] issuance ( ! lic5se4 ,su* an expir$ lic5se may be r5ew$ = additional #c-ye> p]iods accord+ to proc$ures develop$ by ! ,secret>y4 #ehe4 ,uni=m national policy 7a7 ,product trac+ & o!r requirem5ts ,beg9n+ on ! date ( enactm5t ( ! ,drug ,supply ,*a9 ,security ,act1 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 /atem5ts ( di/ribution hi/ory1 transaction hi/ory1 transaction in=mation1 or transaction /atem5t ( a ph>maceutical product z su* product *anges own]%ip 9 ! supply *a91 or v]ification1 inve/igation1 disposition1 notification1 or record-keep+ relat+ to su* sy/ems1 includ+ pap] or electronic p$igree sy/ems or = track+ & trac+ drugs ?r\gh\t ! di/ribution sy/em7 :i* are inconsi/5t )1 m /r+5t ?an1 or 9 addition to1 any requirem5ts applicable "u section #ejc7;e7 7z am5d$ by su* ,act7 or ?is sub*apt] 7or regulations issu$ !reund]71 or :i* are inconsi/5t )-- 7#a7 any waiv]1 exception1 or exemption issu$ by ! ,secret>y "u section #eha or #ehb2 or 7#b7 any re/rictions specifi$ 9 section #ehb4 7b7 ,di/ribution & lic5s+ /&>ds 7#a7 ,9 g5]al ,beg9n+ on ! date ( enactm5t ( ! ,drug ,supply ,*a9 ,security ,act1 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 t are less /r+5t ?an ! /&>ds & requirem5ts applicable "u section #ejc7;e7 7z am5d$ by su* ,act71 9 ! case ( a :olesale di/ributor1 or section #ehd1 9 ! case ( a ?ird-p>ty logi/ics provid]4 7#b7 ,/ate regulation ( ?ird-p>ty logi/ics provid]s ,no ,/ate %all regulate ?ird-p>ty logi/ics provid]s z :olesale di/ributors4 7#c7 ,adm9i/ration fees ,not)/&+ p>agraph 7#a71 a ,/ate may adm9i/] fee collections = effectuat+ ! :olesale drug di/ributor & ?ird-p>ty logi/ics provid] lic5sure requirem5ts "u sections #ejc7;e7 7z am5d$ by ! ,drug ,supply ,*a9 ,security ,act71 #ehc1 & #ehd4 7#d7 ,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 ) section #ejc7;e7 7z am5d$ by ! ,drug ,supply ,*a9 ,security ,act7 or ?is sub*apt]2 7,b7 may provide = ! susp5sion or revocation ( lic5ses issu$ by ! ,/ate = violations ( ! laws ( su* ,/ate2 7,c7 ^u conviction ( violations ( ,f$]al1 ,/ate1 or local drug laws or regulations1 may provide = f9es1 imprisonm5t1 or civil p5alties2 & 7,d7 may regulate activities ( lic5s$ entities 9 a mann] t is consi/5t ) product trac+ requirem5ts "u section #ehb4 7c7 ,exception ,no?+ 9 subsection 7a7 or 7b7 %all be con/ru$ to preempt ,/ate requirem5ts relat$ to ! di/ribution ( prescription drugs if su* requirem5ts are n relat$ to product trac+ z describ$ 9 subsection 7a71 includ+ any requirem5ts applicable "u section #ejc7;e7 7z am5d$ by ! ,drug ,supply ,*a9 ,security ,act7 or ?is sub*apt] 7or regulations issu$ !reund]74 4 #f4 ,p5alties 7a7 ,prohibit$ act ,section #cja7t7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7t771 is am5d$-- 7#a7 by /rik+ or aft] ! requirem5ts ( section #ejc7;d712 & 7#b7 by ins]t+ 1 failure to comply ) ! requirem5ts "u section #ehb1 ! failure to comply ) ! requirem5ts "u section #ehd1 z applicable1 aft] 9 violation ( section #ejc7;e74 7b7 ,misbr&+ ,section #ejb ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #ceb71 is am5d$ by add+ at ! end ! foll[+3 7bb7 ,if x is a drug & x fails to be> ! product id5tifi] z requir$ by section #ehb4 4 #g4 ,con=m+ am5dm5ts ,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+ #ejc7;e77#a74 #h4 ,sav+s clause ,except z provid$ 9 ! am5dm5ts made by p>agraphs 7#a71 7#b71 & 7#c7 ( section #d7;a7 & by section #f7;a71 no?+ 9 ?is ,act 7includ+ ! am5dm5ts made by ?is ,act7 %all be con/ru$ z alt]+ any au?ority ( ! ,secret>y ( ,heal? & ,human ,s]vices ) respect to a drug subject to section #ejc7;b77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cec7;b77#a77 "u any o!r provision ( su* ,act or ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bja et seq474