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 

4 instruatloas of 

aoval of the orlgina1 

of a phy8laisn do68 not 

Vhllo it 18 our bollof 

8 r4krlotod to pbamaists 

18lon8 of tll4 Phamaay Lav." 

Introduatory to an lnterpretatlan of the above 

altod SeatMn 8 it 18 noted tlmt tbi8 uatlon 18 one of 

8W8&4m aOX&8iUg ha014 45h?8 and that thi8 arttale 

18 iXlOldsd iU ~OZTLOIi’8 Annotated civil btstUt48 (L8 

%haptor Bight -Pharmna 

T 

" in the Publlo Eealth title mmbox@ 71. Thla Artiols 5424 18 ocmpMhon8ite regarding 
th8 zwgulaflou of th4 tio4 of Piam80~ and v48 mind 

4adr4-4n44t4dbJth4 ttl zyi8~tUPO in 1943. It 18 

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 the 110 W41fbP4 Of thi8 8td4.” &WOif’iUuJ, 

a48tlon 48 it VU Uti4d ill 1943 P4448 48 f411W8: 

“&a. 8. It 8Wll bo unlawiul for ay mP8OQ 

rho 18 UOt 4 P4gi8kP4d @IAmi8t old0 th4 mVi8fOW Of %ht8 bt t0 Om, lix WWfUtUM, 

OC&B~~, p?4p4~4, l&41, 8411 ordl8&ibut44t~4t4ll 

4P Vh414443.4 WJ -8 OP I#bi4b48, 4X4@ in 

w-448. ?PWidOd fb*t ti Q4P84W ZlW 

r&P&r4 phnuoi8t8 ia tbl8 8trt4 rhrllhV4 

th4 Pt&ht8 6FUtOd t4 pbmwi8t8 lWi4P tbi8 

A4t. ?X’OVidOd, ttOWWP, tb8t IbOw in Uli8 Abt 

8hml ll p p l7 to or id4 r f4 ~w4 ith l ny lio 8w4 d ma a t%- 

tiolur Of YdiOipr), d4Ilti8tl7 OF OhiPO~, Who 18 

dw M&8t4Wd U mah by Bi8 I’48mtiW 8trt. Bawd 

Of bui-8 Of tht8 8ti&4, rho 8-1 rupPlr hi8 OP 

b4P mti4Zd8, 88 l eriOi4SL, dOlrtri8t Ol! OhiPO)KIdi8t, 

2t3tT8~%7it 

U rpab, With 8-h -48 48 

rod Vho do88 not ke.p l Phrumy, 

-8h494l’m8ton 8dVW’t%84dWOth4l’Vi8O, 

fOP th4 FOtrilw Of =&Oh48 OP lBO18OlU5 alkd prOVidOd, -, Gbrt Wthb& OOn- in thi8 &t 

8u b4 OOWtPWd t4 -4&kt th4 POPUbSRl4d5i.d8- 

tP8tiOn Of -8 W 84&iOiru8 UPPiOd br &Bly w8%OiUL, 8UP#OOU, dOUti8t, 4t&4-8t O? Wkrinrr~tl 

lh4lW4d br hi8 l’48mfiW = Of kYilirP8 Of thi8 

8kt4, in -P to 8w4 th. -t4 R44d8 Of hi8 

pltiOnt8j WP t0 mV4nt th, 84l.4 by -8488, filU8, 

jotit 8bok O-l&48, ~tl#P8hi~8 OF OOP'&W~tiOU8, 

4thW thrn P4&8t@ti phU’WMi8t8, Of *tOlit 0% POWP in844tiOSd48 OP ftUl@CridU tbt W dXVd Oh 

OW,QOWdd fOr mlr 4&PiO\rltlU'4l -848." 

-8 i8 L 014W U2dWUbim -28143% bwadlr 

zgbY..n&yono Vho 18 not (L r4#8kP4d ph+mWi8t 

t OF VhO 18 Wt 8pcWi t34uT ~XaO&4# thOP4br 

fPW MiwV%thdnyl8 4l&M&iOiil48. 'Ru~~iXlint4Tlt 

Of th3.8 8UtiQZh, 44 V411 88 Ott&W pro*i81Oli8 Of th4 Aat, 

28 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 

Wd m4diOilt48 tiWOU& 8tPi6t P4@8tiwOn. By th8 t4m8 
Eon. vllt4r 0arUh8, Jr. - P-4 3 

Ofth4S4 &W4V1814M, th4m 

(iorhEt'~OOU8~tl4U)18 

Qfbrry8rppdHdlOh48 

t4dCbd~tiOP thP48 

alow roqairaont8 n4aoly; (1) th4 parson badling 

tm RU8t b4 a N$8&4lWBd mi8t W&OF th4 list 

the pw8on h@adllvq tha met bo a ~loiro, don ti 

(2) 

8t, 

ObiPOpodP8t, 4t4. liO4M4d to mOtiO4 by hi8 P48~OtiYO 

Bawd of lbsria4rs: or (3) the -8 or medlaln48 maut b4 

8old or dl8tribut4d in th4i.P OPigm v 08 Vhlah bear 

a gwlntsd label giving lnrtmOthn8 for ttm % U84. B4448- 

UPllJ, th4pP4giuwlOa,p4Ok8gln&,4lldl4b4llngof th4 

wtiOlX8. A di8OU88iCBll Of 8lMh UP8 ati ~tiOkl8, 

hWWOP, i8 aOt h4P4 W448w. 

ITi th4 UH 8pbrittOd, 8 ~l’8Oa VhO i8 rUith4P 8 

~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~, tbt th4 ph)riOiU2 18 E4t -84Ut Vh4n 

tk&8hb4~4PX'4-lrkliry 444UP8. Iti8*l8oOl44P 

irorJorrlOttOP8 tbrt~tb4?8-hb4~4dP44~84P4~t 

POt\awd to th4dOd4rbatUO ldldOPd3.8tPlbUt4d to ttb4 

o-r* 

~8~&2801~4inrio~~iaaOf~~- 

+9,8iOll8 Of b4tiOa 8 8Piprr, tie88 U it 18 O*t4UdOd 

bT the di8tZ%bUt4P, it I8 wllptod &htwefra by the l sOUptioaportudngtooriglml .8 OOIlllard ia th4 

fiPltmti44P,BOP8 J, ti488 thi8 4XOOptl6aut4orlglaalp8o 48 l p g lit4 4 8 th4 lab4 

+43&88t4tb484llilI# di8tWthUy Of M,~ 

HdiOh48. P&OT&t~ 

panr4 "mll OP di8 

thi8 4XOO~tiO~ Wf4P8 d t4 th4 

lbuteat,MtiailoPuholo Jo’, and 

Op?4t48 to JlOXWit pZ’84Ii8 aOt &!4&$8t+P4d t0 84U. dFU#8 

iU th4iP OPi&illEl m-48., 0bT1OIW4, th8 4X44PtiOa 

oouldaot oomolwbljmadify oPdfUt 0th~ Ut8 prohib1t.d 

88 it VOldd bo illl$488ibblO “to oapound, mlx,mntu8atw4, 

ocmbla4,pn~aro, dPI&8vltb4%It breakIngthe OPi&nd 

lt4lth4r our it POf4P to t?m P4melnlaglt4m 

iROlrd4d iZ"thi8 

"bb41" iI& thi8 -P 18, 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 
Hon. Walter Coualn~, Jr. - P8g4 4 

a "muiaoturerr*18 ormvh4,8m 

p4ak4g48 or mlanufaotur48*. P8r4n "&a 

other thiQJ8, 

otlaall~, it 

nOted thrt Wtlon 17 of Art&o14 45428 r4qulr48 a munafsmtPnr,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 8 

tkrzrlded tbrt tbm prohibition 8hll not prevent 

. of p8tont or pmprl4tary m4dioln48, or 

raedle8&d'm8dla8mont8 germr4llylnuwatxlvhlohm 

-488 if Used Mo$Fding to the ia8~~iOn8 OOn~iMd 

mul8 th4 “0*igln81 pnalag48” ax084 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 the 

authorltl48 in th4 light of the oontaxt in vhlah it 18 

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 Silliprov1814n prohlbltlng a por8on not a r4gl8t4r4d phrrnsolst 

fPO8l 84lliw Or di8pOn8hg drUg8 OF lMdiOin48 %XOO~t PrOprletuy or patout medlolno8 in original paakxgos', defined 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. 85 

# 231, auth&%r;lng the ~18 of petont midlolne~ 

in original peakages." (lIpqphs814 mided) 
ma. l<or oou8la8. Jr. - P8g4 5 

“‘Anyp4r84anotk 

lfb8bru,O~,dX, 

4a8d8 pd*t 

01 8411 8t POtril w -8, m&43X&48, k'18W8 0%' 

phama44&i4al pP4$aPNtloa8 upen a p4814iur'8 

pluMPiptiOa, W Oth4FUl84, @ VhOOWP, b4iw tb4 

maa8gor or 4lInoP of th4 

fMtO~, OF 4th4P$t.M4 6"$ Of 

8t4%Wrm4P 

U8h480, 8h4ti.- 

tUW, OF p c mr it m UOt lih i84 d U l P b R lM Oi8t 

tOOorpa\md,RlS,bl~, di8lW84uy.~8,leQiOfIWl,P4%8~ OP~h4=404U~44l~P='ati~,Orr 
@+a. Waltor 0QU8iM, Jr. - Pbgo 6 

'ghlriOirnti.~484Plpti41i%;' OOlltPU7 t0 4Qy Of the 

3@4ti81a8 Of thi# tit6 8b4l1 b4 rubjoot to the 

mI@ti48 Of tbi8hOt. 

Tht8 PPti8101r,.~4V4WPc,18B~ti~4d Oldt to 

furthor lllwbak th4 rnifo8f robning end intent of 

84ation 8, 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~~ 

it 18 unlbvful for euyono not 

8411 8t rOfr%l" -8, rrdzb pQvlolen~8 p48Orlptlon 

&UUPlii~ the P884diU end ~04hX-48 fOP 

~vlolbtlon, 1% 18 aOt8d U18t th0 B0Ud Of 

the pomP (APtlol4 45428, 844tlon 5) to 

Phbmbo7 18 given 

"la8tltut4 .a 

eatlon in it8 4va ~884 to 4ajoln riol4tUn of ary of th4 

-8i4tt8 Of fhi8'&t," bd tbt8twhWtim 8brnb4 

ln,eddltlon to q other aut?zoMretd by Irv. 

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 

-8 OF ~4&%OiEl48, brd SIN th4 in8tSat -84 th4 VW OOn- 

.t4atiOIl U to th4iP -4 ill OPi&ibl RlbOw48 rdnit8 thi8 

Oh88ifiO8tiOb 

fho fO?~oiry OOMid4Md it 18 OOtAOlWbd that 

eny 8830 Of bug8 bf%OF the -p&d Irbol h48 beea ~418Owd 

18 not th4 0414 O$ orl@ubl pro]ag48 sXOOpt4d in th4 

8trtUt4 end tkmt.th4 Oonkvntibn of tb4di8tPlbUt4P in the 

Oa84 ~484’&4& iC rlithout m42it. 

Aooordlngl~, $0~ 4r4 8dvl88d that in the OplniOn 

of thl$ QffiO4, th4 fMt8 8ubnitt4d Wollld OOli8titUt4 4 

yio&t;on of ti4 porlsion of the I)eotion 8 alted. 

TOUP8 t4rf tmilJ 

APPROVthXI OCT 24,1946 A%‘¶QXXXY-U- 01 ,!i’X@a 

JLrjt