Case Information
*1 OFFICE OF THE A-ITORNEY GENERAL OF TEXAS
AUSTIN
Honorable Walter Coualn~, Jr., Soarotary
Texan Board of Phsrmaay
gll bouthlard Llf4 Annox Bulwng
D8lla81,!hxam
opinion loi o-'138l ) r4quosting an opinion fra fall above mbjoat F48d8UfOllOV instruatloas of
aoval of the orlgina1 of a phy8laisn do68 not 18 our bollof Vhllo 8 r4krlotod to pbamaists tll4 Phamaay Lav." 18lon8 of
Introduatory to an lnterpretatlan of the above altod SeatMn 8 it 18 noted tlmt tbi8 uatlon 18 one of aOX&8iUg ha014 45h?8 and that arttale 8W8&4m iU ~OZTLOIi’8 Annotated civil btstUt48 iXlOldsd (L8 %haptor Bight -Pharmna " in the Publlo Eealth title mm- box@ 71. Thla Artiols ocmpMhon8ite regarding T *2 and v48 mind th4 tio4 of Piam80~ th8 zwgulaflou ttl zyi8~tUPO in 1943. It 18
4adr4-4n44t4dbJth4 8ilpatfl4Ubt -t t&4 -OS07 4hU84 Of th419')3 4Ot l’44it48 th8 NIwn) fOP th4 mi814lt t4 b4 thd “th4 pFb84nt mr I&S i8 iE8d4QWk rod 4YUt4-4P8 th4 publie hWlth l 82 th e 110 W41fbP4 Of thi8 8td4.” &WOif’iUuJ, 48 VU Uti4d a48tlon ill 1943 P4448 48 f411W8:
“&a. 8. It 8Wll bo unlawiul for ay mP8OQ old0 th4 m- rho 18 UOt 4 P4gi8kP4d @IAmi8t Of %ht8 bt t0 Om, Vi8fOW lix WWfUtUM, OC&B~~, p?4p4~4, l&41, 8411 ordl8&ibut44t~4t4ll 4P Vh414443.4 WJ -8 OP I#bi4b48, in 4X4@
w-448. ?PWidOd fb*t ti Q4P84W ZlW phnuoi8t8 ia tbl8 8trt4 rhrllhV4 r&P&r4 th4 Pt&ht8 6FUtOd t4 pbmwi8t8 tbi8 lWi4P in Uli8 Abt A4t. ?X’OVidOd, ttOWWP, IbOw tb8t 8h mll l p pl7 to o r id4 rf4~4 with l ny lio8w4d ma at%- tiolur Of YdiOipr), d4Ilti8tl7 OF OhiPO~, Who 18 U mah by Bi8 Bawd dw M&8t4Wd I’48mtiW 8trt. Of bui-8 Of tht8 8ti&4, rho 8-1 rupPlr hi8 OP dOlrtri8t Ol! OhiPO)KIdi8t, l eriOi4SL, b4P mti4Zd8, U rpab, With 8-h -48 2t3tT8~%7it rod Vho do88 not ke.p l Phrumy, -8h494l’m8ton 8dVW’t%84dWOth4l’Vi8O, fOP th4 FOtrilw Of =&Oh48 OP lBO18OlU5 alkd prO- VidOd, -, Gbrt Wthb& OOn- in thi8 &t 8u b4 OOWtPWd t4 -4&kt th4 POPUbSRl4d5i.d8- tP8tiOn Of -8 W 84&iOiru8 UPPiOd br &Bly w- 8%OiUL, 8UP#OOU, dOUti8t, 4t&4-8t O? Wkrinrr~tl Of lh4lW4d br hi8 l’48mfiW = Of kYilirP8 R44d8 Of hi8 8kt4, in -P to 8w4 th. -t4 filU8, pltiOnt8j WP t0 mV4nt 84l.4 by -8488, th, jotit 8bok O-l&48, ~tl#P8hi~8 OF OOP'&W~tiOU8, Of *tOlit 0% PO- 4thW thrn P4&8t@ti phU’WMi8t8, WP in844tiOSd48 OP ftUl@CridU W dXVd Oh tbt OW,QOWdd fOr mlr 4&PiO\rltlU'4l -848." i8 L 014W U2dWUbim -28143% bwadlr Vho not (L r4#8kP4d zgbY..n&yono ph+mWi8t t OF VhO 18 Wt 8pcWi t34uT ~XaO&4# thOP4br fPW MiwV%thdnyl8 4l&M&iOiil48. 'Ru~~iXlint4Tlt Of th4 Aat, th3.8 8UtiQZh, V411 88 Ott&W pro*i81Oli8 Of t&t th8 ~&Wbl%O 8h4ll b. ~POt48tOd irar 3.@4l’WU34, iX’F48~tb%l%tJ, 0%’ fiU’4~488Ik488 iI& th4 pw?ohUL4 Of dxygo 8tPi6t P4@8tiwOn. Wd m4diOilt48 tiWOU& By t4m8 *3 Eon. vllt4r 0arUh8, Jr. - P-4 Qfbrry8rppdHdlOh48 &W4V1814M, th4m
Ofth4S4 (iorhEt'~OOU8~tl4U)18 t4dCbd~tiOP thP48 alow roqairaont8 n4aoly; (1) th4 parson badling th4 list RU8t b4 a N$8&4lWBd mi8t (2) tm W&OF the pw8on h@adllvq tha met bo a ~loiro, don ti 8t, ObiPOpodP8t, 4t4. liO4M4d to mOtiO4 by hi8 P48~OtiYO Bawd lbsria4rs: (3) or or medlaln48 maut b4 8old or dl8tribut4d in th4i.P OPigm Vhlah bear v a gwlntsd label giving lnrtmOthn8 for ttm % U84. B4448- UPllJ, th4pP4giuwlOa,p4Ok8gln&,4lldl4b4llngof th4 A di8OU88iCBll Of 8lMh UP8 ati ~tiOkl8, wtiOlX8. i8 aOt h4P4 W448w.
hWWOP,
ITi th4 UH 8pbrittOd, 8 ~l’8Oa VhO rUith4P i8 ~lirorr~by4ofrifrtinrrud~pluuitul#ra
-lOti' diP48tiOE8 fW it8 884. A ~PtiUOllt hot, ia &ddltlOn to t&484 in th4 8bOV4 lOttOP, ti88 ti80 boon 8T%fl14& PHl~, 18 E4t tbt th4 ph)riOiU2 -84Ut Vh4n tk&8hb4~4PX'4-lrkliry 444UP8. Iti8*l8oOl44P irorJorrlOttOP8 tbrt~tb4?8-hb4~4dP44~84P4~t ldldOPd3.8tPlbUt4d to ttb4 to th4dOd4rbatUO POt\awd o-r* ~8~&2801~4inrio~~iaaOf~~-
+9,8iOll8 Of b4tiOa U it 18 O*t4UdOd 8 8Piprr, tie88 bT the di8tZ%bUt4P, it I8 wllptod &htwefra by th e l sOUp- .8 OOIlllard ia tioaportudngtooriglml J, ti488 thi8 4XOOp- fiPltmti44P,BOP8 48 l pgli48 t4 th4 lab4 tl6aut4orlglaalp8o +43&88t4tb484llilI# Of M,~ di8tWthUy P&OT&t~ 4XOO~tiO~ Wf4P8 d t4 th4 HdiOh48. and "mll OP di8 lbuteat,MtiailoPuholo Jo’, panr4 to JlOXWit pZ’84Ii8 Op?4t48 aOt &!4&$8t+P4d t0 84U. dFU#8 0bT1OIW4, th8 4X44PtiOa iU th4iP OPi&illEl m-48., prohib1t.d oPdfUt 0th~ Ut8 oomolwbljmadify oouldaot 88 it VOldd bo illl$488ibblO “to oapound, mlx,mntu8atw4, ocmbla4,pn~aro, dPI&8vltb4%It breakIngthe OPi&nd
lt4lth4r our POf4P to t?m P4melnlaglt4m iROlrd4d iZ"thi8
"bb41" iI& thi8 -P io. Ji8Pt at lU8t, to "lN'4j34F4." Thi8 aam be re~%o~ilOd Vith th4 dofbltiona &VW iR Se&ion 20 of Artialo 4928 rhoro & ~~ph8z!m.(3?.8t' 18 mid t0 b4 on4 Vi&O "O-8. H-8, OP di8~448" Vhi14 *4 Hon. Walter Coualn~, Jr. - P8g4 4
a "muiaoturerr*18 ormvh4,8m other thiQJ8, p4ak4g48 or mlanufaotur48*. P8r4n "&a otlaall~, it nOted thrt Wtlon 17 of Art&o14 45428 r4qulr48 a munafsm- tPnr,to~w&penritf~~hibto~r~tor~8~r
th4 -4 Of th4 phmwi8t OF "phiraroOUtiO4l oh4&8t" 8mPlO~ at 8uoh f4Otorj.
That the oxoeptlon Psde of orl.glm.1 pealcage doe8 not apply to the prohlbltod aat of aan bo f'urthor r44onall4d (and a14PlfL4dd, if with other pBWilliOn8 Of the %OtiOn. In the &bow quoted beotion tkrzrlded tbrt tbm prohibition 8hll not prevent
. of p8tont or pmprl4tary m4dioln48, or raedle8&d'm8dla8mont8 germr4llylnuwatxlvhlohm if Used Mo$Fding to the ia8~~iOn8 OOn~iMd mul8 th4 “0*igln81 pnalag48” ax-
084 aontalnlng dlreatlow vbiah ar4 hmmlere if wad in aaaord8nao with "the pri.nted label", and the tV0 4xaOptiOU8 4F4 OOMi8tcmt. m lab41 18 u) 4884XltiIBl partofth4origin4lp4ak4g4.
The ten "ori(llirulp4&4go"b8b44nu84din wrlou8 8tatut484ndh8 boon g4n4r814d4fln4dby in th4 light the oontaxt in vhlah it 18 authorltl48 UMd (840 30 uOX'd8 k PhM848, Pp. 309-316). In OomM4ra4 the tam 18 84id to moan not the lndlvldu81 box or bottle but the 14rgor aont8lnor in vhlah thsro 8ro paok4d uvl 8hipp4d,4nd th%8mmingh48b44n4pplL4d tom4dioinein bottl48 (Stste t8. Pm8on8, 27 SW 1102). But appll8d to tholrut8atam0, 8u4hrm4alngv4uld4xalud4 wona "prop4rly 18bol4d" bottle fmm the 4xa4ptlon, mad la a8 mmh 88 th4 pmvl814n (Se&ion 8) 8p4alfloally lnoludor ret811 saler, the doflnltlon glvon in a later aa8o appear8 to be mom applla4blo. In Kentuaky Bo8rd of Ph8rm3oy ~8. th88idy (74 m 730) the OOUl't, in OOn4tlWing 8 Silli- prov1814n prohlbltlng a por8on not a r4gl8t4r4d phrrnsolst fPO8l 84lliw Or di8pOn8hg drUg8 OF lMdiOin48 %XOO~t PrO- prletuy or patout medlolno8 in original paakxgos', de- fined the tenII "Origiml p44hg48" 88 fOllOVII$
"Zh4 term lorigina]. p4ak4g4,' a8 applicable to the Sole of patent end pmprletary medlalnes, mMn8--ati 18 80 UIkdOr8tOOd by 011 p4rSOl38--the mmll ladlvldasl plakage or bottle as
r4tall and not the large box Or thellsr peak8gea nmy hme been rhipped by the man faaturor and ii 80 used la St. 1899 o. # auth&%r;lng the ~18 petont midlolne~ in original peakages." (lIpqphs814 mided) *5 - P8g4 ma. l<or oou8la8. Jr. 4a8d8 pd*t “‘Anyp4r84anotk
lfb8bru,O~,dX, 01 8411 8t POtril w -8, m&43X&48, k'18W8 0%' phama44&i4al upen a p4814iur'8 pP4$aPNtloa8 pluMPiptiOa, W Oth4FUl84, @ VhOOWP, b4iw tb4 maa8gor or 4lInoP of th4 8t4%Wrm4P fMtO~, OF 4th4P$t.M4 Of 6"$ U8h480, 8h4ti.- tUW, OF p cmrit m UOt lihi84d U l PbRlMOi8t tOOorpa\md,RlS,bl~, di8lW84uy.~8,leQi- OfIWl,P4%8~ OP~h4=404U~44l~P='ati~,Orr *6 @+a. Waltor 0QU8iM, Jr. - Pbgo
'ghlriOirnti.~484Plpti41i%;' OOlltPU7 t0 4Qy Of the 3@4ti81a8 Of thi# tit6 8b4l1 b4 rubjoot to mI@ti48 Of tbi8hOt.
Tht8 PPti8101r,.~4V4WPc,18B~ti~4d Oldt to furthor lllwbak th4 rnifo8f robning end intent of 84ation 8Wp4, of vhloh th4 MQuort pro84nnted 88k8 for snlnterpretWon,anda dlwa8814nofvbeth4r th4 ln8tant ea.114 vould oonlrtltuto b violation of the psnal ~0~1~10~~ 18 unlbvful for euyono not
8411 8t rOfr%l" -8, rrdz- p48Orlptlon b pQvlolen~8 fOP end ~04hX-48 &UUPlii~ the P884diU ~vlolbtlon, 1% 18 aOt8d U18t th0 B0Ud Of Phbmbo7 18 given the pomP (APtlol4 45428, 844tlon 5) to "la8tltut4 .a eatlon in it8 4va ~884 to 4ajoln ary of riol4tUn Of fhi8'&t," bd tbt8twhWtim -8i4tt8 8brnb4 to q other aut?zoMretd by Irv. ln,eddltlon
It 18 lbQt n48uMry to olbbei=eto an tb4 PPOPO-~ 8itiOll tb.t VitUiM in th4 iMtUt -84 Is4 'WS OF m~Oi~8"+ithia~~~~Offhrr,8~~~. Th4P44P4 mboJ~~pl'OpU%tih8, and4l'b breed ~enerlo dofinltlon Of th8 t bo OlA88itl4d 48 IWh, eti in .m4 in8tbM48 ion VOU%d dopead On oh0 8&3441tio U#4 Of ttl4 ~tiOU. ffOll4X-l~, Vit8dl8 U’O OF ~4&%OiEl48, brd SIN th4 in8tSat -84 th4 VW OOn- -8 .t4atiOIl U to th4iP ill OPi&ibl RlbOw48 rdnit8 thi8 Oh88ifiO8tiOb
fho fO?~oiry OOMid4Md it OOtAOlWbd that eny 8830 Of bug8 bf%OF the -p&d Irbol h48 beea ~418Owd not th4 0414 O$ orl@ubl pro]ag48 sXOOpt4d in th4 8trtUt4 end tkmt.th4 Oonkvntibn tb4di8tPlbUt4P in the iC rlithout m42it. Oa84 ~484’&4& that in the OplniOn Aooordlngl~, $0~ 4r4 8dvl88d
of thl$ QffiO4, th4 fMt8 8ubnitt4d Wollld OOli8titUt4 of the I)eotion alted. yio&t;on of ti4 porlsion tmilJ
TOUP8 t4rf APPROVthXI OCT 24,1946 01 ,!i’X@a A%‘¶QXXXY-U-
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