      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 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. 85
     # 231, auth&%r;lng the ~18 of petont midlolne~
     in original peakages."    (lIpqphs814
                                         mided)
ma. l&ltor 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




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