0776 Registration of Outsourcing Facilities under 503B GFI

ÿ
ÿ

2345678975
ÿ
ÿ
9ÿ84ÿ


54ÿ76
854ÿ9557536ÿ


3
8
ÿ

3

7
5

ÿ



ÿ

ÿ
7

3
ÿ

ÿ

7
ÿ
ÿ
ÿ
!593ÿ
ÿ 8ÿ"678#ÿ
ÿ
ÿ
ÿ
ÿ
ÿ
ÿ
ÿ
ÿ
ÿ
ÿ
ÿ
ÿ
ÿ
ÿ
ÿ
ÿ
ÿ
ÿ
ÿ
$%&%ÿ()*+,-.)/-ÿ01ÿ2)+3-4ÿ+/5ÿ26.+/ÿ&),789):ÿ
;005ÿ+/5ÿ(,6<ÿ=5.8/8:-,+-80/ÿ
>)/-),ÿ10,ÿ(,6<ÿ?7+36+-80/ÿ+/5ÿ@):)+,94ÿA>(?@Bÿ
ÿ
C,09)56,+3ÿ
D07).E),ÿFGHIÿ
ÿ
ÿ

ÿ
ÿ

01234526ÿ812952
52ÿ
1
2
435126ÿ
ÿ

ÿÿÿÿ
!"ÿ#$ÿ%$&ÿ
'
"


ÿ
(

$




ÿ
)
*
+
,ÿ


ÿ


ÿ
%
.
ÿ
/$

ÿ
ÿ
ÿ
0"$ÿÿ1"2ÿ

ÿ
ÿ

455678ÿ95ÿ:9;;<=67>?69=@AÿB6C6@69=ÿ95ÿBD?69=ÿÿ
:8=?8Dÿ59DÿBDH<>?69=ÿ>=IÿJ8@8>D7Kÿ
L99Iÿ>=IÿBD?69=ÿ
NOOONÿP8QÿR>;S@K6D8ÿMC8TAÿR6HH>=I>H8ÿUHIETAÿV?KÿLH99Dÿÿ
W6HC8DÿWSD6=EAÿXBÿYOZZ[ÿÿ
\K9=8]ÿ^__`_V[`[a^Vÿ9Dÿ[ON`aZb`[VOOcÿL>d]ÿ[ON`V[N`b[_[ÿ
G;>6H]ÿIDTKK@TE9Cÿÿ
K??S]ffQQQT5I>TE9CfBD=78:9;SH6>=78J8E?9DhF=59D;>?69=fg<6I>=78@fI85>=IÿBD?69=ÿ
NOZO[ÿP8QÿR>;S@K6D8ÿMC8Tÿ
W6HC8DÿWSD6=EAÿXBÿYOZZ[ÿ
\K9=8]ÿ[ON`aZb`V^[Oÿ
ÿ

ÿ
ÿ
ÿ
ÿ
ÿ
ÿ
ÿ
ÿ
ÿ
jklkÿmnopqrsntrÿuvÿwnpxryÿptzÿw{sptÿlnq|}~nÿ
€uuzÿptzÿmq{ÿ‚zs}t}rqpr}utÿ
ƒntrnqÿvuqÿmq{ÿ„|px{pr}utÿptzÿ…nnpq~yÿ†ƒm„…‡ÿ
ÿ
ˆqu~nz{qpxÿ
‰u|nsŠnqÿ‹ŒŽÿ

01234526ÿ812952
52ÿ
1
2
435126ÿ
ÿ
ÿÿÿ
ÿ
ÿ
ÿ  !ÿ"ÿ
ÿ #$! ÿÿ"ÿ

ÿ %&'ÿ(&)*+,-ÿ)./ÿ01&%+,-ÿ1,ÿÿ"ÿ
ÿ 1230ÿ24ÿ,5+6ÿ$&+/).10ÿ7ÿ
ÿ $$ÿ89ÿ ÿÿÿ!!$ÿ:ÿÿ;ÿ
ÿ852ÿ52&*/ÿ0'+6,0%ÿÿ;ÿ
ÿ 92<ÿ,2ÿ0'+6,0%ÿÿ;ÿ
=>ÿ?@ABCDÿFCGÿHIAJCIGKLMNÿOPKLQLARÿS@NLJAGPALCMÿ>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>ÿTÿ
U>ÿ?@ABCDÿFCGÿHIAJCIGKLMNÿOPKLQLARÿV@WS@NLJAGPALCMÿ>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>ÿTÿ
T>ÿXCJALMNÿCFÿS@NLJAGPALCMÿYMFCGZPALCMÿ>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>ÿ[ÿ
ÿ*01,%2.+1ÿ0'+6,%),+2.ÿ8)+\0%6ÿÿ]ÿ
ÿ0'+6,%),+2.ÿ006ÿÿ]ÿ

ÿ
ÿ
ÿ
ÿ

2345678975
ÿ

ÿ9ÿ84ÿ

54ÿ76
854ÿ9557536ÿ
38ÿ375
ÿÿ

ÿ73ÿ ÿ!7ÿ
ÿ
"593ÿ
8ÿ#678$%ÿ
ÿ
ÿ
ÿ

ÿ
&'()ÿ*+(,-./0ÿ10210)0.3)ÿ3'0ÿ455,ÿ-.,ÿ61+*ÿ7,8(.()31-3(5.9)ÿ:4679)ÿ51ÿ7*0./;9)<ÿ/+110.3ÿ3'(.=(.*ÿ5.ÿ
3'()ÿ352(/>ÿÿ?3ÿ,50)ÿ.53ÿ/10-30ÿ51ÿ/5.@01ÿ-.;ÿ1(*'3)ÿ@51ÿ51ÿ5.ÿ-.;ÿ201)5.ÿ-.,ÿ,50)ÿ.53ÿ5201-30ÿ35ÿA(.,ÿ467ÿ
51ÿ3'0ÿ2+AB(/>ÿÿC5+ÿ/-.ÿ+)0ÿ-.ÿ-B301.-3(D0ÿ-2215-/'ÿ(@ÿ3'0ÿ-2215-/'ÿ)-3()@(0)ÿ3'0ÿ10E+(1080.3)ÿ5@ÿ3'0ÿ
-22B(/-AB0ÿ)3-3+30)ÿ-.,ÿ10*+B-3(5.)>ÿ?@ÿ;5+ÿF-.3ÿ35ÿ,()/+))ÿ-.ÿ-B301.-3(D0ÿ-2215-/'Gÿ/5.3-/3ÿ3'0ÿ467ÿ)3-@@ÿ
10)25.)(AB0ÿ@51ÿ(82B080.3(.*ÿ3'()ÿ*+(,-./0>ÿÿ?@ÿ;5+ÿ/-..53ÿ(,0.3(@;ÿ3'0ÿ-221521(-30ÿ467ÿ)3-@@Gÿ/-BBÿ3'0ÿ
-221521(-30ÿ.+8A01ÿB()30,ÿ5.ÿ3'0ÿ3(3B0ÿ2-*0ÿ5@ÿ3'()ÿ*+(,-./0>ÿÿ
ÿ

ÿ
ÿ
#Hÿ #JK2K#Jÿ
ÿ
&'()ÿ*+(,-./0ÿ()ÿ(.30.,0,ÿ@51ÿ@-/(B(3(0)ÿ2B-..(.*ÿ35ÿ10*()301ÿ51ÿ10.0Fÿ10*()31-3(5.ÿ-)ÿ'+8-.ÿ,1+*ÿ
/5825+.,(.*ÿ5+3)5+1/(.*ÿ@-/(B(3(0)ÿ:5+3)5+1/(.*ÿ@-/(B(3(0)<>ÿÿ7ÿ/5825+.,01ÿ/-.ÿ0B0/3ÿ35ÿ10*()301ÿ
F(3'ÿ467ÿ-)ÿ-.ÿ5+3)5+1/(.*ÿ@-/(B(3;ÿ+.,01ÿ)0/3(5.ÿMNOPÿ5@ÿ3'0ÿ40,01-Bÿ455,Gÿ61+*Gÿ-.,ÿ
Q5)803(/ÿ7/3ÿ:46RQÿ7/3<ÿ:S0ÿT>U>Q>ÿOMOAÿX-FÿY5>ÿ00OZM[ÿ:Y5D08A01ÿS\GÿSN0O<>ÿÿ&'()ÿ*+(,-./0ÿ,0)/1(A0)ÿ3'0ÿ215/0))ÿ@51ÿ
0B0/315.(/ÿ)+A8())(5.ÿ5@ÿ0)3-AB()'80.3ÿ10*()31-3(5.ÿ(.@518-3(5.ÿ@51ÿ5+3)5+1/(.*ÿ@-/(B(3(0)>ÿ?.ÿ
/013-(.ÿ1-10ÿ/-)0)Gÿ467ÿ8-;ÿ*1-.3ÿ-.ÿ0.3(3;ÿ-ÿF-(D01ÿ@158ÿ)+A8(33(.*ÿ10*()31-3(5.ÿ(.@518-3(5.ÿ
0B0/315.(/-BB;>ÿÿ&'()ÿ*+(,-./0ÿ-B)5ÿ215D(,0)ÿ(.@518-3(5.ÿ5.ÿ'5Fÿ35ÿ5A3-(.ÿ)+/'ÿ-ÿF-(D01>ÿ
ÿ
4679)ÿ*+(,-./0ÿ,5/+80.3)Gÿ(./B+,(.*ÿ3'()ÿ*+(,-./0Gÿ,5ÿ.53ÿ0)3-AB()'ÿB0*-BB;ÿ0.@51/0-AB0ÿ1(*'3)ÿ
51ÿ10)25.)(A(B(3(0)>ÿÿ?.)30-,Gÿ*+(,-./0)ÿ,0)/1(A0ÿ3'0ÿ7*0./;9)ÿ/+110.3ÿ3'(.=(.*ÿ5.ÿ-ÿ352(/ÿ-.,ÿ
)'5+B,ÿA0ÿD(0F0,ÿ5.B;ÿ-)ÿ10/5880.,-3(5.)Gÿ+.B0))ÿ)20/(@(/ÿ10*+B-351;ÿ51ÿ)3-3+351;ÿ10E+(1080.3)ÿ
-10ÿ/(30,>ÿÿ&'0ÿ+)0ÿ5@ÿ3'0ÿF51,ÿ^_`abcÿ(.ÿ7*0./;ÿ*+(,-./0)ÿ80-.)ÿ3'-3ÿ)5803'(.*ÿ()ÿ)+**0)30,ÿ51ÿ
10/5880.,0,GÿA+3ÿ.53ÿ10E+(10,>ÿÿ
ÿ
##Hÿ !d"2Jÿ
ÿ
!Hÿ 84ÿe957$ÿ9ÿ3857$ÿ!7ÿ
ÿ
ÿ
&'0ÿ6VU7ÿ-,,)ÿ.0Fÿ)0/3(5.ÿMNOPÿ35ÿ3'0ÿ46RQÿ7/3>ÿÿT.,01ÿ)0/3(5.ÿMNOP:A<ÿ5@ÿ3'0ÿ46RQÿ7/3Gÿ
-ÿ/5825+.,01ÿ/-.ÿ0B0/3ÿ35ÿA0/580ÿ-.ÿ5+3)5+1/(.*ÿ@-/(B(3;ÿ-.,ÿ10*()301ÿF(3'ÿ467>ÿÿf-/'ÿ
5+3)5+1/(.*ÿ@-/(B(3;ÿ8+)3ÿ102513ÿ35ÿ467ÿ/013-(.ÿ(.@518-3(5.ÿ-A5+3ÿ3'0ÿ,1+*ÿ215,+/3)ÿ(3ÿ
ÿ0ÿÿ&'
ÿÿÿÿ(ÿ)ÿÿÿ*ÿÿ+ÿ(ÿ,ÿÿ-ÿÿ.ÿ/ÿÿ0ÿÿÿFÿÿÿÿ)ÿÿÿ2ÿÿ1ÿ0ÿ2ÿÿ-ÿ1ÿÿ0ÿ,ÿÿÿÿAÿ;ÿÿÿÿ3ÿ'ÿ0ÿÿÿg@@(/0ÿ5@ÿQ582B(-./0GÿQ0.301ÿ@51ÿ61+*ÿfD-B+-3(5.ÿ-.,ÿh0)0-1/'Gÿ-3ÿ3'0ÿ455,ÿ
-.,ÿ61+*ÿ7,8(.()31-3(5.>ÿ

ÿ

0ÿ

01234526ÿ812952
52ÿ
1
2
435126ÿ
ÿ
ÿÿÿÿ!"#! ÿ#ÿ#ÿ$%&'ÿ(!ÿ )ÿ!*ÿ!ÿÿ#ÿ(ÿ
!#*ÿ(#+#,ÿ(ÿ"(+#,ÿ!ÿ-#ÿ!ÿÿ./0ÿ(!1(+ÿ!"#! ÿ#ÿ#ÿ
$%$ÿÿÿ./23ÿ0ÿ45ÿ673&$$8ÿ(ÿÿ!"#! ÿÿ+(9+ÿ!ÿ:#ÿ("(ÿ
#!#ÿ!ÿÿ!ÿ#ÿ$%48458ÿÿÿ./23ÿ0ÿ45ÿ673ÿ&$484588ÿÿ;!#*ÿ
(#+##ÿ:#++ÿ9ÿ#ÿ9,ÿ./0ÿ(ÿÿ+,ÿ:#ÿ!ÿ!1##ÿÿÿ./23ÿ0)ÿ
ÿ(ÿ!!ÿ*ÿ((!#*ÿ!(#ÿ43<=>8ÿ!"#! ÿÿÿ
ÿ
0!ÿÿ###(+ÿ!*#!(#)ÿ!ÿ#ÿ$%&'498ÿÿÿ./23ÿ0)ÿ(ÿ(#+#,ÿ(ÿ+ÿÿ
!*#!ÿ:#ÿ./0ÿ(ÿ(ÿ!#*ÿ(#+#,ÿÿ(+ÿÿÿ((++,ÿ!ÿ(ÿ,(!ÿ!(!ÿ
(ÿ#ÿ:#ÿÿ!(#ÿ(ÿ!#*ÿ(#+#,)ÿ!#*ÿÿ!*#!(#ÿ!#ÿ9: ÿ;9!ÿ5ÿ
(ÿ/ 9!ÿ&5?ÿ!*#!ÿ(ÿ(ÿ!#*ÿ(#+#,ÿ(ÿ!ÿÿ!1#ÿ#ÿ( )ÿ
+(ÿÿ9#)ÿ(ÿ#"ÿ(#+#,ÿ###!&)ÿ(ÿ(ÿ#ÿÿ(ÿ(#+ÿ(!ÿ4#ÿ
$%&'4984584084#88ÿÿ?ÿ(#+#,ÿÿ(+ÿ##(ÿ:!ÿ#ÿ#ÿÿ)ÿ:##ÿÿ
-ÿ(+(!ÿ,(!)ÿ(ÿ!*ÿ(ÿ((!ÿÿ./0@ÿ!*ÿ!(*ÿ+#ÿ#ÿÿ!ÿ#ÿ$%ABÿ
ÿÿ./23ÿ0ÿ45ÿ673ÿ&$A8ÿ4#ÿ$%&'4984584084##88)ÿ(ÿ:!ÿ#ÿÿ!ÿ
9+Cÿ!*ÿ9(D)ÿ()ÿ#ÿ)ÿ:!ÿ#ÿÿ!#+ÿ!ÿ!#+ÿ!*ÿ!ÿÿ9+Cÿ
!*ÿ9(ÿ
ÿ
EFÿ HIJKLÿJMÿNOPQÿRSPTUVILÿ
ÿ
?#ÿ*#(ÿ ÿ!#9ÿÿ!ÿ!ÿ!*#!#*ÿ(ÿ(ÿ!#*ÿ(#+#,ÿ!ÿ
#ÿ$%&'ÿÿÿ./23ÿ0ÿ7(!(ÿ*#(ÿ!1#ÿ#!#ÿÿ(, ÿÿ
!*#!(#$ÿ ÿ(ÿ:ÿ!#*ÿ(#+##ÿ+ÿ!!ÿÿ./0ÿÿ!*ÿ!ÿ,ÿ
ÿÿ?#ÿ*#(ÿ!+ÿ./0@ÿ!!ÿ#C#*ÿ#ÿ+#*ÿÿ-##*ÿ((ÿ((!)ÿ
#!(#ÿ+*,)ÿ(ÿ#!(#ÿ((* ÿ!!ÿÿ0ÿÿ1(!#(9+ÿ(*ÿ1!ÿ
# )ÿ./0ÿ(,ÿ!1##ÿ#ÿ*#(ÿ(ÿÿ##(#ÿ!#9ÿ#ÿ#ÿÿÿ#ÿ
*#(ÿ
ÿ
ÿÿÿ.ÿÿ/0ÿ
ÿÿÿÿÿÿÿÿ(ÿÿÿÿ#ÿÿÿÿÿÿÿÿÿÿ(ÿÿÿÿÿ!ÿ(ÿÿÿÿÿÿ*ÿÿÿ#ÿÿÿ(ÿÿÿÿÿÿÿÿÿÿÿ#ÿ#ÿ4WXYYZ[\ÿ]^^_ÿ`a[Xbac\XYd[eÿfYac\dcZÿgÿh[\ZYdiÿ]Xd_a[cZÿb^Yÿ

jXia[ÿkYXeÿW^il^X[_d[eÿmX\n^XYcd[eÿoacdpd\dZnÿq[_ZYÿrZc\d^[ÿstuv^bÿ\wZÿokxWÿyc\zÿÿ;ÿ#(+#{)ÿ(ÿ
*#(ÿ:#++ÿ!!ÿÿ0*,@ÿ#C#*ÿÿ#ÿ#ÿÿ
./0@ÿ*#(ÿ(!ÿ(1(#+(9+ÿÿ#ÿ*#(ÿ: 9#ÿÿ./0ÿ(ÿ*#(ÿ!*+(!+,ÿ?ÿ(Cÿ!ÿ,ÿ(1ÿ
ÿÿ!ÿ1!#ÿÿ(ÿ*#()ÿ1##ÿÿ*#(ÿ: 9#ÿ(ÿ
|}}:::(*1}/!*}<#(3+#(~ *+(!,!(#}<#(}(+ÿÿ
&ÿ
7 ÿÿ*#(ÿ!ÿ#!,ÿrlZcdbdca\d^[ÿ^bÿ\wZÿq[dXZÿoacdpd\€ÿh_Z[\dbdZYÿqohzÿr€n\Ziÿb^YÿkYXeÿ‚n\aƒpdnwiZ[\ÿ
„Zedn\Ya\d^[ÿÿ0+*ÿ#ÿ*#(ÿ#ÿ#ÿÿ(!ÿ!1##ÿÿ!ÿ#ÿ#ÿ$5%ÿÿÿ./23ÿ0)ÿ
./0@ÿ##(#ÿÿÿ6.ÿ,ÿ#ÿ#ÿ*#(ÿ(+ÿ(+#ÿÿ(#+##ÿ(ÿ!*#!ÿ(ÿ!#*ÿ(#+##ÿ
!ÿ#ÿ$%&'ÿÿÿ./23ÿ0ÿÿÿ
Dÿ
0+*ÿ#ÿ$%&'498458408ÿÿÿ##(++,ÿ##,ÿ#ÿ#!(#ÿ!*(!#*ÿ9+Cÿ!*ÿ9()ÿ
#ÿ$%&'4984584'84##8ÿ!"#!ÿ./0ÿÿ9+#ÿ#ÿ#!(#ÿÿÿ!ÿ4 ÿ#ÿ'&ÿ9+:8ÿ
?!!)ÿ./0ÿ#ÿ!"#!#*ÿ(ÿ#ÿ#!(#ÿ9ÿ+#ÿ(ÿ(!ÿÿÿ!*#!(#ÿ9##ÿ
$ÿ
7 ÿ*#(ÿ!ÿ#!,ÿoZZnÿb^YÿjXia[ÿkYXeÿW^il^X[_d[eÿmX\n^XYcd[eÿoacdpd\dZnÿq[_ZYÿrZc\d^[nÿstuvÿa[_ÿ
…††‡ÿ^bÿ\wZÿokxWÿyc\ÿ(ÿ‚pZc\Y^[dcÿfY^_Xc\ÿ„Zl^Y\d[eÿb^YÿjXia[ÿkYXeÿW^il^X[_d[eÿmX\n^XYcd[eÿoacdpd\dZnÿ
q[_ZYÿrZc\d^[ÿstuvÿ^bÿ\wZÿoZ_ZYapÿo^^_ˆÿkYXeˆÿa[_ÿW^niZ\dcÿyc\ÿÿÿÿÿÿ

ÿÿ

ÿ ÿ ÿ

01234526ÿ812952
52ÿ
1
2
435126ÿ
ÿ
ÿ ÿÿ ÿÿÿ!"!"#ÿ #$%ÿ
ÿ
ÿ &'ÿ&'()*ÿ+,-./+0ÿ
ÿ
1ÿ234536789:ÿ2;7ÿ9<92=ÿ=3ÿ:9>?@=9:ÿA?=BÿCD1ÿ;@ÿ;7ÿ36=@36:2?7>ÿE;2?ÿE;2?;>9@ÿ?7ÿ=B9ÿ23453678?7>ÿ3Eÿ@=9:?<9ÿ8:6>@GÿÿH;2Bÿ36=@36:2?7>ÿE;2?93>:;5B?2ÿ
<32;=?37ÿ3:ÿ;88:9@@ÿ46@=ÿ:9>?@=9:ÿ@95;:;=9ÿE;2?Bÿ?=ÿ4;FÿPK9ÿ;ÿ?@=9:ÿA?=BÿCD1ÿ;@ÿ36=@36:2?7>ÿE;2??@=:;=?37ÿ
?7E3:4;=?37ÿ6@?7>ÿ=B9ÿ9i?@=?7>ÿ@=:62=6:98ÿ5:3862=ÿ<;K9ÿLjklMÿE3:4;=GÿÿC3:ÿ89=;?<98ÿ
?7@=:62=?37@ÿ37ÿB3Aÿ=3ÿ@6K4?=ÿ?7E3:4;=?37ÿ6@?7>ÿjklNÿ36=@36:2?7>ÿE;2?6?8;729ÿE3:ÿ?786@=:Fÿo\YpaZabcÿhVc^feWY\gÿq^rsa__aYb_ÿabÿtfV`W\Yba`ÿdY\seWÿ
uÿv\^cÿt_Werfa_XsVbWÿhVca_W\eWaYbÿebZÿv\^cÿwa_WabcGÿÿCD1ÿ;<@3ÿ3EE9:@ÿ=33<@ÿ;78ÿ?7E3:4;=?37ÿE3:ÿ
2ÿ:9;=?7>ÿ;78ÿ@6K4?==?7>ÿjklÿE?<9@Gÿ188?=?37;<ÿ?7E3:4;=?37ÿ2;7ÿK9ÿE3678ÿ;=ÿAAAGE8;G>3Ox98:<@Gÿ
1E=9:ÿ?7?=?;<ÿ:9>?@=:;=?37NÿE;2??@=9:ÿ;776;<?@=9:98ÿ36=@36:2?7>ÿE;2?3:Fÿ3EÿK6@?79@@ÿ359:;=?37ÿE3:ÿ36=@36:2?7>ÿE;2?ÿE;2??@=:;=?37ÿ?7E3:4;=?37ÿ6@?7>ÿ=B9ÿK6@?79@@ÿ359:;=?37ÿ{|64;7ÿD:6>ÿ}3453678?7>ÿ
y6=@36:2?7>ÿC;2??@=9:ÿ;@ÿ;7ÿ36=@36:2?7>ÿE;2?ÿ?7E3:4;=?37ƒÿ
„ÿ†;49ÿ3Eÿ=B9ÿE;2?ÿ
@B3:=;>9ÿÿ@6K@=;729@‹Nÿ;78ÿ?Eÿ@3Nÿ
AB9=B9:ÿ?=ÿ23453678@ÿ@=9:?<9ÿ3:ÿ737@=9:?<9ÿ8:6>@ÿE:34ÿK6<Šÿ8:6>ÿ@6K@=;729@ÿ
ÿ
ŒTÿ UVWXYZÿ[Y\ÿ]^W_Y^\`abcÿde`afaWgÿvVhVca_W\eWaYbÿ
ÿ
C;2??@=9:98ÿA?=BÿCD1ÿ;@ÿ36=@36:2?7>ÿE;2??@=:;=?37ÿKFÿ
@6K4?==?7>ÿ?7E3:4;=?37ÿ=3ÿ89Ž:9>?@=9:ÿ6@?7>ÿ=B9ÿjklÿE3:4;=GÿÿC3:ÿ89=;?<98ÿ?7@=:62=?37@ÿ37ÿB3Aÿ=3ÿ
ÿÿjÿÿ9ÿÿ2ÿ=ÿ?ÿ3ÿÿ7ÿÿÿÿÿ€ÿÿÿL
ÿÿÿÿ8ÿMÿLÿÿÿMÿÿÿ3ÿÿEÿÿÿ=ÿBÿ9ÿÿÿÿCÿD‚}ÿ
ÿÿÿÿÿÿÿÿ12
ÿÿ=ÿ
Pÿ

ˆÿ
j92=?37ÿ€LKMLzML1Mÿ37?@=:;7=@ÿ=3ÿ?72<689ÿ;ÿ53?7=ÿ3Eÿ237=;2=ÿ94;?<ÿ;88:9@@Gÿÿ|3A9O9:NÿA9ÿ
:‹92344978ÿ=B;=ÿ:9>?@=:;7=@ÿ;<@3ÿ@655?@ABÿC=?DÿE<@FFile Typeapplication/pdfFile TitleRegistration of Human Drug Compounding ...ies Under Section 503B of the FD&C ActAuthorDHCFile Modified2020-11-27File Created2020-11-27