,,ii #aaf? ,,congress #a/ ,session ,s4 #cjgb ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,decemb] #ag1 #bjai,mrs4 ,hyde-,smi? 7= h]self1 ,mr4 ,cram]1 ,mr4 ,wick]1 ,mr4 ,inh(e1 ,mr4 ,scott ( ,florida1 ,mr4 ,da9es1 ,mr4 ,cotton1 ,mr4 ,sasse1 ,mr4 ,lank=d1 ,mr4 ,r\nds1 & ,mr4 ,moran7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,a ,,bill ,to am5d ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act to prohibit ! approval ( new abortion drugs1 to prohibit inve/igational use exemptions = abortion drugs1 & to impose additional regulatory requirem5ts ) respect to previ\sly approv$ abortion drugs1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,support ,& ,value ,expectant ,moms & ,babies ,act ( #bjai or ! ,,save ,moms & ,babies ,act ( #bjai4 #b4 ,abortion drugs prohibit$ 7a7 ,9 g5]al ,section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 is am5d$ by add+ at ! end ! foll[+3 7z7 ,abortion drugs 7#a7 ,prohibitions ,! ,secret>y %all n approve-- 7,a7 any application submitt$ "u subsection 7b7 or 7j7 = m>ket+ an abortion drug2 or 7,b7 grant an inve/igational use exemption "u subsection 7i7 =-- 7i7 an abortion drug2 or 7ii7 any inve/igation 9 :i* ! human embryo or human fetus ( a woman kn[n to be pregnant is kn[+ly de/roy$4 7#b7 ,previ\sly approv$ abortion drugs ,if an approval describ$ 9 p>agraph 7#a7 is 9 effect = an abortion drug z ( ! date ( enactm5t ( ! ,support ,& ,value ,expectant ,moms & ,babies ,act ( #bjai1 ! ,secret>y %all-- 7,a7 n approve any label+ *ange-- 7i7 to approve ! use ( su* abortion drug aft] #gj days ge/ation2 or 7ii7 to approve ! disp5s+ ( su* abortion drug by any means o!r ?an 9-p]son adm9i/ration by ! prescrib+ heal? c>e practition]2 7,b7 treat su* abortion drug z subject to section #ejc7;b77#a72 & 7,c7 require su* abortion drug to be subject to a risk evaluation & mitigation /rategy "u section #eje-a t at a m9imum-- 7i7 requires heal? c>e practition]s :o prescribe su* abortion drug-- 7,i7 to be c]tifi$ 9 accordance ) ! /rategy2 & 7,,ii7 to n be act+ 9 _! capacity z a ph>maci/2 7ii7 z "p ( ! c]tification process ref]r$ to 9 clause 7i71 requires su* practition]s-- 7,i7 to h ! ability to assess ! duration ( pregnancy accurately2 7,,ii7 to h ! ability to diagnose ectopic pregnancies2 7,,iii7 to h ! ability to provide surgical int]v5tion 9 cases ( incomplete abortion or sev]e ble$+2 7,,iv7 to h ! ability to ensure pati5t access to m$ical facilities equipp$ to provide blood transfusions & resuscitation1 if necess>y2 & 7,v7 to report any dea?s or o!r adv]se ev5ts associat$ ) ! use ( su* abortion drug to ! ,food & ,drug ,adm9i/ration & to ! manufactur] ( su* abortion drug1 id5tify+ ! pati5t by a non-id5tifiable ref]5ce & ! s]ial numb] f ea* package ( su* abortion drug2 7iii7 limits ! disp5s+ ( su* abortion drug to pati5ts-- 7,i7 9 a cl9ic1 m$ical (fice1 or hospital by means ( 9-p]son adm9i/ration by ! prescrib+ heal? c>e practition]2 & 7,,ii7 n 9 ph>macies or any sett+ o!r ?an ! heal? c>e sett+s describ$ 9 subclause 7,i72 7iv7 requires ! prescrib+ heal? c>e practition] to give to ! pati5t docum5tation on any risk ( s]i\s complications associat$ ) use ( su* abortion drug & receive ackn[l$gm5t ( su* receipt f ! pati5t2 7v7 requires all kn[n adv]se ev5ts associat$ ) su* abortion drug to be report$1 exclud+ any individually id5tifiable pati5t in=mation1 to ! ,food & ,drug ,adm9i/ration by !-- 7,i7 manufactur]s ( su* abortion drug2 & 7,,ii7 prescrib]s ( su* abortion drug2 & 7vi7 requires report+ ( adm9i/ration ( ! abortion drug z requir$ by ,/ate law1 or 9 ! abs5ce ( a ,/ate law reg>d+ su* report+1 9 ! same mann] z a surgical abortion4 7#c7 ,report+ on adv]se ev5ts by o!r heal? c>e practition]s ,! ,secret>y %all require all o!r heal? c>e practition]s to report to ! ,food & ,drug ,adm9i/ration any adv]se ev5ts exp]i5c$ by _! pati5ts t are connect$ to use ( an abortion drug1 exclud+ any individually id5tifiable pati5t in=mation4 7#d7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to re/rict ! au?ority ( ! ,secret>y1 or ( a ,/ate1 to e/abli%1 implem5t1 & en=ce requirem5ts & re/rictions ) respect to abortion drugs "u provisions ( law o!r ?an ?is section t are 9 addition to ! requirem5ts & re/rictions "u ?is section4 7#e7 ,def9itions ,9 ?is section3 7,a7 ,! t]m abortion drug means any drug1 sub/ance1 or comb9ation ( drugs or sub/ances t is int5d$ = use or t is 9 fact us$ 7irrespective ( h[ ! product is label$7-- 7i7 to int5tionally kill ! unborn *ild ( a woman kn[n to be pregnant2 or 7ii7 to int5tionally t]m9ate ! pregnancy ( a woman kn[n to be pregnant1 ) an int5tion o!r ?an-- 7,i7 to produce a live bir?2 or 7,,ii7 to remove a dead unborn *ild4 7,b7 ,! t]m adv]se ev5t includes ea* ( ! foll[+3 7i7 ,a fatality4 7ii7 ,an ectopic pregnancy4 7iii7 ,a hospitalization4 7iv7 ,a blood loss requir+ a transfusion4 7v7 ,an infection1 includ+ endometritis1 pelvic inflammatory disease1 & pelvic infections ) sepsis4 7vi7 ,a sev]e infection4 7,c7 ,! t]m ge/ation means ! p]iod ( days beg9n+ on ! fir/ day ( ! la/ m5/rual p]iod4 7,d7 ,! t]m heal? c>e practition] means any individual :o is lic5s$1 regi/]$1 or o!rwise p]mitt$1 by ! ,unit$ ,/ates or ! jurisdiction 9 :i* ! individual practices1 to prescribe drugs subject to section #ejc7;b77#a74 7,e7 ,! t]m unborn *ild means an individual organism ( ! species homo sapi5s1 beg9n+ at f]tilization1 until ! po9t ( be+ born alive z def9$ 9 section #h7;b7 ( title #a1 ,unit$ ,/ates ,code4 4 7b7 ,ongo+ inve/igational use ,9 ! case ( any inve/igational use ( a drug pursuant to an inve/igational use exemption "u section #eje7;i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;i77 t 0 grant$ be=e ! date ( enactm5t ( ?is ,act1 su* exemption is deem$ to be resc9d$ z ( ! day t is #c ye>s aft] ! date ( enactm5t ( ?is ,act if ! ,secret>y w\ld be prohibit$ by section #eje7z77#a77;,b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by subsection 7a71 f grant+ su* exemption z ( su* day4