Untitled Texas Attorney General Opinion ( 1946 )

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 " in the Publlo Eealth title mm-
box@ 71. Thla Artiols T5424 18 ocmpMhon8ite regarding
th8 zwgulaflou of th4 tio4 of Piam80~ and v48 mind
4adr4-4n44t4dbJth4 ttlzyi8~tUPO in 1943. It 18
8ilpatfl4Ubt -t t&4 -OS07 4hU84 Of th419')3 4Ot
l’44it48th8 NIwn) fOP th4 mi814lt t4 b4 thd “th4 pFb84nt
mr I&S i8 iE8d4QWk rod 4YUt4-4P8 th4 publie hWlth
l82 th e 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 m-
Vi8fOW 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
8h ml
ll
p p l7
to o r id4 r f4 ~w
4ithlny 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, dOlrtri8tOl! OhiPO)KIdi8t,
U rpab, With 8-h -48 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
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% PO-
WP 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 Qfbrry8rppdHdlOh48
(iorhEt'~OOU8~tl4U)18 t4dCbd~tiOP thP48
alow roqairaont8 n4aoly; (1) th4 parson badling
tm RU8t b4 a N$8&4lWBd mi8t W&OF th4 list (2)
the pw8on h@adllvq tha met bo a ~loiro, donti 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 di8OU88iCBllOf 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``-
+9,8iOll8Of b4tiOa 8 8Piprr, tie88 U it 18 O*t4UdOd
bT the di8tZ%bUt4P, it I8 wllptod &htwefra by th elsOUp-
tioaportudngtooriglml .8OOIlllard ia th4
fiPltmti44P,BOP8 J, ti488 thi8 4XOOp-
tl6aut4orlglaalp8o 48 l p g li4t4 8
th4 lab4
+43&88t4tb484llilI# di8tWthUy Of M,~
HdiOh48. P&OT&t~thi8 4XOO~tiO~ Wf4P8 d t4 th4
panr4 "mll OP di8 lbuteat,MtiailoPuholo Jo’, and
Op?4t48 to JlOXWitpZ’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$488ibblO “to oapound, mlx,mntu8atw4,
ocmbla4,pn~aro, dPI&8vltb4%It breakIngthe OPi&nd
lt4lth4r our it POf4P to t?m P4melnlaglt4m
iROlrd4d iZ"thi8
"bb41" iI& thi8 -P 18, io. Ji8Pt at lU8t, to "lN'4j34F4."
Thi8 aam be re~%o~ilOd Vith th4 dofbltiona &VW iR
Se&ion 20 of Artialo 4928 rhoro & ``ph8z!m.(3?.8t'18 mid
t0 b4 on4 Vi&O "O-8. H-8, OP di8~448" Vhi14
Hon. Walter Coualn~, Jr. - P8g4 4
a "muiaoturerr*18 ormvh4,8m other thiQJ8,
"&a otlaall~, it
p4ak4g48 or mlanufaotur48*. P8r4n
nOted thrt Wtlon 17 of Art&o14 45428 r4qulr48 a munafsm-
tPnr,to~w&penritf``hibto~r~tor~8~r
th4 -4 Of th4 phmwi8t OF "phiraroOUtiO4l oh4&8t"
8mPlO~ at 8uoh f4Otorj.
That the oxoeptlon Psde of orl.glm.1 pealcage
doe8 not apply to the prohlbltod aat of aan bo
f'urthor r44onall4d (and a14PlfL4dd, if with other
pBWilliOn8 Of the %OtiOn. In the &bow quoted beotion 8
tkrzrlded tbrt tbm prohibition 8hll not prevent
. of p8tont or pmprl4tary m4dioln48, or
raedle8&d'm8dla8mont8 germr4llylnuwatxlvhlohm
-488 if Used Mo$Fding to the ia8``iOn8 OOn~iMd
mul8 th4 “0*igln81 pnalag48” ax-
084 aontalnlng dlreatlow vbiah ar4 hmmlere
if wad in aaaord8nao with "the pri.ntedlabel", 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 S.W. 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. 85
# 231, auth&%r;lng the ~18 of petont midlolne~
in original peakages." (lIpqphs814
mided)
ma. l<or oou8la8. Jr. - P8g4 5
“‘Anyp4r84anotk 4a8d8 pd*t
lfb8bru,O~,dX,
01 8411 8t POtril w -8, m&43X&48, k'18W8 0%'
phama44&i4al pP4$aPNtloa8 upen a p4814iur'8
pluMPiptiOa, W Oth4FUl84, @ VhOOWP, b4iw tb4
maa8gor or 4lInoP of th4 8t4%Wrm4P
fMtO~, OF 4th4P$t.M4 Of U8h480, 8h4ti.-
6"$
tUW, OF p c mr it m UOt lih i84 d U l P b R lM Oi8t
tOOorpa\md,RlS,bl~, di8lW84uy.~8,leQi-
OfIWl,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 pro84nnted88k8 for
snlnterpretWon,anda dlwa8814nofvbeth4r th4 ln8tant
vould oonlrtltuto
ea.114 b violationof the psnal ~0~1~10``
it 18 unlbvful for euyono not
8411 8t rOfr%l" -8, rrdz-
b pQvlolen~8 p48Orlptlon
&UUPlii~ the P884diU end ~04hX-48 fOP
~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 riol4tUn of ary of th4
-8i4tt8 Of fhi8'&t," bd tbt8twhWtim 8brnb4
ln,eddltlon to q otheraut?zoMretdby Irv.
It 18 lbQtn48uMry to olbbei=etoan tb4 PPOPO-~
8itiOlltb.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-
.t4atiOIlU to th4iP -4 illOPi&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 rlithoutm42it.
Aooordlngl~, $0~ 4r4 8dvl88d that in the OplniOn
of thl$ QffiO4, th4 fMt8 8ubnitt4d WollldOOli8titUt4 4
yio&t;on of ti4 porlsion of the I)eotion8 alted.
TOUP8 t4rf tmilJ
APPROVthXI OCT 24,1946
A%‘¶QXXXY-U- 01 ,!i’X@a
JLrjt