Compounding Update: A Focus on USP Review ... Fall 2013...Review noncompliance and infractions that...
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Compounding Update: A Focus on USP <797> This Talk Will Cover… Review noncompliance and infractions that get pharmacies in trouble Review the differences between compounding and manufacturing Review USP Standards
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Transcript of Compounding Update: A Focus on USP Review ... Fall 2013...Review noncompliance and infractions that...
Co
mp
ou
nd
ing
Up
date
:
A F
ocu
s o
n U
SP
<7
97
>
Th
is T
alk
Will
Co
ver…
lR
evie
w n
oncom
plia
nce a
nd infr
actio
ns tha
t ge
t p
ha
rma
cie
s in
tro
ub
le
lR
evie
w t
he
diffe
rences b
etw
een
co
mpo
un
din
g a
nd m
anu
factu
rin
g
lR
evie
w U
SP
Sta
nda
rds
His
tory
of
Ph
arm
acy
Co
mp
ou
nd
ing
in
th
e U
.S.
lIn
the
pa
st,
Com
pou
nd
ing w
as P
ha
rma
cy
l19
00
s g
ave
way t
o c
om
me
rcia
lly p
rep
are
d
ph
arm
aceu
ticals
lM
an
y s
tre
ng
ths/d
osa
ge
fo
rms a
vaila
ble
lE
con
om
ics c
han
ge
d a
ll th
at
lLim
ite
d s
tre
ng
ths/d
osa
ge
form
s
l“O
ne
Siz
e F
its A
ll” a
ppro
ach
Exte
nt
of
Co
mp
ou
nd
ing
in
th
e U
.S.
lM
ore
tha
n 7
0%
of
pha
rma
cie
s r
epo
rt t
he
y d
o
so
me c
om
pou
nd
ing (
NC
PA
20
06
)
lV
irtu
ally
all
hospitals
do c
om
pou
ndin
g
lE
stim
ate
d 1
0%
of
all
pre
scrip
tio
ns a
nd
med
ication
ord
ers
are
com
pou
nd
ed
l$
22
-25
bill
ion
do
llars
pe
r ye
ar
Ho
w D
id W
e G
et
Here
?
lLo
ss o
f m
an
ufa
ctu
red
dru
g p
rod
ucts
lG
row
th o
f co
mpo
un
din
g
lO
ffic
e u
se
lD
rug
sh
ort
ag
es
lO
ther
NE
CC
In
fracti
on
s
lN
on p
atient-
specific
lN
o p
atient
his
tories,
DU
Rs,
as r
equired b
y t
he
Massachusett
s B
OP
lD
istr
ibution p
rior
to r
eceiv
ing s
terilit
y t
esting lots
lF
inal ste
riliz
ation d
id n
ot fo
llow
pro
per
sta
ndard
s
lA
uto
cla
ves n
ot
valid
ate
d
lP
ow
der
hoods in c
lean r
oom
s?
lT
acky m
ats
vis
ibly
soile
d
lLeakin
g b
oile
r adja
cent
to the c
lean r
oom
NE
CC
In
fracti
on
s
lLa
ck o
f S
tan
da
rd O
pe
ratin
g P
roced
ure
s
lLa
ck o
f tr
ain
ing o
f pha
rma
cis
ts
lLa
ck o
f tr
ain
ing o
f te
ch
nic
ian
s
lP
harm
acis
ts o
vers
igh
t in
ade
qu
ate
NE
CC
In
fracti
on
s i
n
Asep
tic C
om
po
un
din
g
lD
eficie
nt
enviro
nm
enta
l m
on
ito
rin
g in
asep
tic
pro
ce
ssin
g a
rea
s
lE
quip
ment
not
main
tain
ed
app
rop
ria
tely
to
pre
ven
t con
tam
ina
tio
n
lC
onta
min
ation
pre
ven
tio
n p
roce
du
res f
or
ste
rile
pre
para
tion
s d
o n
ot
inclu
de
ad
eq
ua
te
va
lidation
of
the s
teriliz
ation
pro
cess
lF
ilte
red a
ir s
up
ply
is d
eficie
nt
in a
sep
tic
pro
ce
ssin
g a
rea
s
NE
CC
In
fracti
on
s i
n
Asep
tic C
om
po
un
din
g
lN
o w
ritt
en
sta
nda
rds o
r m
eth
od
s f
or
ste
riliz
atio
n o
r te
stin
g f
or
pyro
ge
nic
pro
pert
ies
lC
loth
ing
is in
ap
pro
pria
te f
or
du
tie
s p
erf
orm
ed
lP
rep
ara
tion
testin
g d
oe
s n
ot
dete
rmin
e
co
nfo
rma
nce t
o s
pecific
atio
ns a
nd ing
redie
nt
str
eng
th
lN
o w
ritt
en
te
st to
asse
ss s
tab
ility
ch
ara
cte
ristics o
f dru
g p
rep
ara
tion
s
NE
CC
In
fracti
on
s i
n
Asep
tic C
om
po
un
din
g
lR
outin
e c
alib
ratio
n n
ot
pe
rfo
rme
d o
n
mecha
nic
al an
d e
lectr
onic
eq
uip
me
nt
lP
repa
ration
s n
ot sto
red
in
re
co
mm
ende
d
tem
pera
ture
or
ligh
t
lQ
C p
ers
on
ne
l la
ck a
uth
ority
to f
ully
in
ve
stig
ate
err
ors
lB
uild
ing c
onstr
uctio
n d
oe
s n
ot
facili
tate
cle
anin
g,
ma
inte
nan
ce
an
d p
rope
r op
era
tion
s
Th
e F
all
ou
t
lC
ong
ress
–R
epre
senta
tives m
akin
g n
ois
e
–In
troduction o
f pro
posed b
ills
lS
tate
Board
s
–Id
aho B
oard
of
Pharm
acy
lA
gencie
s
–P
CA
B
Co
ng
ressio
nal
Acti
vit
ies
lM
ark
ey B
ill
–In
troduced b
y E
d M
ark
ey
(D-M
A)
on N
ov.
2,
201
2
–V
erify
ing A
uth
ority
and L
egalit
y in
Dru
g (
VA
LID
) C
om
pound
ing A
ct of
20
12
–cites a
“re
gula
tory
gap”
and t
he n
eed t
o “
str
ength
en F
DA
’s o
vers
ight.”
lD
ela
uro
an
d L
ow
ery
, H
.R.
6638
–In
troduced b
y U
.S. R
eps. R
osa D
eLauro
(D
-Conn)
and N
ita L
ow
ery
(D
-N.Y
.)
–S
upp
ort
ing A
ccess to F
orm
ula
ted a
nd E
ffectiveness (
SA
FE
) C
om
pounded D
rugs A
ct
–T
he p
roposed legis
lation w
ould
am
end the F
ood,
Dru
g, and
Cosm
etic
Act to
require n
otification t
o p
atients
that
a c
om
pounded d
rug h
as
been p
rescribed,
pro
duct
labelin
g a
s a
“non
-FD
A a
ppro
ved
com
pounded d
rug p
roduct,”
regis
tration f
or
dru
g c
om
pounders
,
train
ing,
the e
sta
blis
hm
ent of
advis
ory
com
mitte
es,
and r
eport
ing
Co
ng
ressio
nal
Acti
vit
ies (
co
nt’
d)
lB
ill S
.959:
Ph
arm
aceu
tical Q
uality
, S
ecu
rity
, an
d
Ac
co
un
tab
ilit
y A
ct
–A
bill
to
am
en
d th
e F
ed
era
l Fo
od
, D
rug
an
d C
osm
etic A
ct w
ith
re
sp
ect to
co
mpo
un
din
g d
rug
s
–S
ub
jects
ind
ep
en
de
nt co
mm
un
ity
ph
arm
acis
ts to
bro
ad
ly e
xpa
nd
ed
FD
A
au
tho
rity
th
at co
uld
jeo
pa
rdiz
e p
atie
nt a
cce
ss to
me
dic
atio
ns
–It
wo
uld
re
qu
ire
co
mm
un
ity
ph
arm
acis
ts to
no
tify
FD
A e
very
tim
e th
ey
co
mp
ou
nd
a m
ed
ica
tio
n th
at is
in s
ho
rta
ge
lH
.R. 3089, T
he C
om
po
un
din
g C
lari
ty A
ct
–S
po
nso
red
by
U.S
Rep
s. M
org
an
Griff
ith
(R
-Va
.), G
en
e G
ree
n (
D-T
exa
s)
&
Dia
na
DeG
ett
e (
D-C
olo
.)
–P
rese
rve
s s
tate
bo
ard
of p
ha
rma
cy
ove
rsig
ht o
f th
e m
ajo
rity
of in
de
pe
nd
en
t co
mm
un
ity
ph
arm
acie
s th
at co
mp
ou
nd
–If
a p
ha
rma
cy
pre
pa
res s
teri
le m
ed
ica
tio
ns fo
r o
ffic
e u
se
, sh
ips th
ose
m
ed
ica
tio
ns a
cro
ss s
tate
lin
es, a
nd
su
ch
me
dic
atio
ns a
cco
un
t fo
r >
5%
of d
rug
s
it p
rod
uce
s, th
en
th
e c
om
po
un
din
g p
rovid
e w
ou
ld f
all
un
de
r th
e le
gis
latio
n’s
ne
wly
esta
blis
he
d c
ate
go
ry o
f “o
uts
ou
rcin
g fa
cili
tie
s”
su
bje
ct to
FD
A r
eg
ula
tio
n
Wh
at
is
Co
mp
ou
nd
ing
?
US
P C
om
po
un
din
g D
efi
nit
ion
l“T
he
pre
para
tion
, m
ixin
g,
asse
mblin
g,
alteri
ng,
pa
ckag
ing,
an
d lab
elin
g o
f a d
rug o
r devic
e o
r oth
er
art
icle
, a
s t
he r
esult o
f a
pra
ctitio
ne
r’s o
rde
r o
r in
anticip
atio
n o
f such
an
ord
er
based
on
ro
utine
, re
gula
rly
ob
se
rve
d p
rescri
bin
g p
att
ern
s.”
Ph
arm
ace
uti
cal C
om
po
un
der
lA
ph
arm
ac
eu
tica
l co
mp
ou
nd
er
is in
vo
lved
in
oth
er
activitie
s c
oncern
ed w
ith
th
e
pre
pa
ratio
n o
f d
rug
s a
s p
revio
usly
de
fin
ed
an
d is r
egu
late
d b
y t
he ind
ivid
ua
l sta
te
bo
ard
s o
f ph
arm
acy
lF
DA
-Com
pou
ndin
g involv
es a
physic
ian
-pa
tie
nt-
ph
arm
acis
t re
latio
nship
for
ea
ch
pre
scri
ptio
n
US
P M
an
ufa
ctu
rin
g D
efi
nit
ion
l“T
he
pro
ductio
n,
pro
pag
ation
, con
ve
rsio
n,
or
pro
ce
ssin
g o
f a
dru
g o
r d
evic
e, e
ith
er
dire
ctly
or
ind
ire
ctly,
by e
xtr
actio
n o
f th
e d
rug
fro
m
su
bsta
nce
s o
f natu
ral ori
gin
or
by m
ea
ns o
f ch
em
ical or
bio
log
ical synth
esis
.”
Ph
arm
ace
uti
cal M
an
ufa
ctu
rer
lA
ph
arm
ac
eu
tical
ma
nu
factu
rer
is a
n e
ntity
tha
t pro
duces a
dru
g o
r dru
g p
rod
uct
for
hum
an
or
vete
rinary
use
that
–H
as b
een a
pp
roved b
y t
he
FD
A t
hro
ugh
the
ND
A,
AN
DA
or
oth
er
app
rop
ria
te r
eg
ula
tory
ch
ann
els
, or
–Is
allo
wed b
y t
he F
DA
to p
roduce a
pro
duct
tha
t is
not
FD
A a
ppro
ved,
as in t
he c
ase
of
pre
-1938
dru
gs,
vete
rinary
, and
over-
the
-co
unte
r dru
gs,
etc
.
lA
ph
arm
aceutical m
anufa
ctu
rer
is r
eg
iste
red w
ith
an
d
reg
ula
ted b
y t
he F
DA
Ho
w d
oes c
om
po
un
din
g d
iffe
r fr
om
man
ufa
ctu
rin
g?
Ph
arm
acis
t
Practi
tio
ner
Pa
tien
t
TH
E T
RIA
D
Co
mp
ou
nd
ing
vs.
Man
ufa
ctu
rin
g
lM
anufa
ctu
ring
•N
o s
pecific
patient
in m
ind w
hen d
rug is p
roduced
•H
as p
rescribers
matc
hin
g p
atients
to the p
roduct
availa
ble
•E
conom
ic c
onsid
era
tions lim
it c
hoic
es in d
rug
dosages a
nd d
osage f
orm
s
lC
om
poundin
g
•M
akin
g t
he form
ula
matc
h the p
atient’s n
eeds
•A
dm
inis
tering t
he d
rug t
o the s
ight
of
action in t
he
most
eff
ective d
osage f
orm
availa
ble
GM
Ps,
GC
Ps,
Sta
nd
ard
s a
nd
R
eg
ula
tory
Issu
es
lG
ood
Man
ufa
ctu
rin
g P
ractices (
GM
Ps)
lG
ood
Com
pou
nd
ing P
ractices (
GC
Ps)
lU
SP
Sta
nda
rds
lS
tate
Board
s o
f P
harm
acy
–Law
s
–R
egula
tions
lC
ong
ressio
na
l A
ctivitie
s
Th
e U
nit
ed
Sta
tes
Ph
arm
aco
pe
ia a
nd
Na
tio
nal
Fo
rmu
lary
(U
SP
-NF
)
l3 v
olu
me c
olle
ction
–
Dru
g in
form
ation for
the h
ealthcare
pro
fessio
nal
–A
dvic
e for
the p
atient
–A
ppro
ved d
rug p
roducts
and le
gal re
quire
ments
lU
SP
’s g
oal is
to h
ave m
onogra
phs in U
SP
-NF
for
all
FD
A-a
ppro
ved d
rugs
lU
SP
als
o d
evelo
ps m
onogra
phs f
or
thera
peutic
pro
ducts
not
appro
ved b
y F
DA
–
Pre
-1938
dru
gs
–D
ieta
ry s
upp
lem
ents
–C
om
pound
ed p
repara
tions
Th
e U
SP
on
Co
mp
ou
nd
ing
G
en
era
l C
hap
ters
US
P
Ch
ap
ters
Co
nte
nt
<797>
P
harm
aceutical C
om
poundin
g –
Ste
rile
Pre
para
tions
<795>
P
harm
aceutical C
om
poundin
g –
Nonste
rile
Pre
para
tions
<11
60>
P
harm
aceutical C
alc
ula
tions in P
rescription
Com
poundin
g
<11
63>
Q
ualit
y A
ssura
nce in P
harm
aceutical C
om
poundin
g
<11
76>
P
rescription B
ala
nces a
nd V
olu
metr
ic A
ppara
tus
<11
91>
S
tabili
ty C
onsid
era
tions in a
Dis
pensin
g P
ractice
<11
51>
P
harm
aceutical D
osage F
orm
s
<51>
A
ntim
icro
bia
l E
ffectiveness T
esting
<71>
S
terilit
y Tests
<85>
B
acte
rial E
ndoto
xins T
est
Go
od
Co
mp
ou
nd
ing
Pra
cti
ces
l<
10
75
> G
ood
Com
po
un
din
g P
ractices
–G
uid
ance f
or
apply
ing G
CP
s f
or
com
pounded
form
ula
tions
–N
ow
incorp
ora
ted into
l
<7
95>
and <
797>
–In
put als
o p
rovid
ed b
y o
ther
chapte
rs
US
P-N
F C
hap
ters
in
Dev
elo
pm
en
t
lC
om
po
un
din
g w
ith
Hazard
ous D
rug
s
–R
educe t
he p
ote
ntial harm
ful eff
ects
on
healthcare
work
ers
lC
om
po
un
din
g f
or
Clin
ical D
rug
Stu
die
s
–M
ate
rials
managem
ent,
qualit
y a
ssura
nce
pro
gra
m, assig
nin
g B
UD
, packagin
g,
labelin
g
Wh
at
is U
SP
<797>
?
lA
ch
ap
ter
of
the
United
Sta
tes P
harm
acop
eia
–
Nation
al F
orm
ula
ry (
US
P-N
F)
lE
sta
blis
hed
be
st
pra
ctice
s a
nd r
eg
ula
tio
ns
for
the
pro
ductio
n o
f com
pou
nd
ed
ste
rile
p
rep
ara
tio
ns
lU
SP
<7
97>
was d
esig
ned s
pecific
ally
to b
e
an
en
forc
ea
ble
se
t of
sta
nda
rds
Wh
o W
rote
US
P <
797>
lU
nited
Sta
tes P
harm
aco
pe
ia C
om
po
un
din
g
Com
mitte
e
lC
ente
r fo
r D
isea
se
Contr
ol
l F
ood
an
d D
rug
Adm
inis
tra
tio
n
lD
raft
revie
wed b
y m
em
bers
of
the
US
P a
nd
indu
str
y
Wh
ere
Do
es U
SP
<797>
Ap
ply
?
lA
ny f
acili
ty p
rod
ucin
g C
SP
s a
nd a
ny
pe
rso
nn
el w
ho
pe
rfo
rm c
om
po
un
din
g a
re
su
bje
ct
to r
egu
lation
by U
SP
<7
97>
–H
ospitals
, com
munity p
harm
acie
s,
hom
e infu
sio
n
serv
ices,
am
bula
tory
care
serv
ices,
nurs
ing
hom
es,
pra
ctitioner’s o
ffic
es, etc
.
lM
an
y s
tate
s h
ave r
eg
ula
tion
s
–E
ach s
tate
varies
Wh
at
is a
Co
mp
ou
nd
ed
Ste
rile
P
rep
ara
tio
n (
CS
P)?
l“C
om
pounded b
iolo
gic
s,
dia
gnostics,
dru
gs,
nutr
ients
, and r
adio
-pharm
aceuticals
…th
at
must
be
ste
rile
when t
hey a
re a
dm
inis
tere
d t
o p
atients
, “a
nd
“manufa
ctu
red s
terile
pro
ducts
that
are
either
pre
pare
d s
tric
tly a
ccord
ing t
o t
he in
str
uctions
appearing in t
he m
anufa
ctu
rers
’ appro
ved
labelin
g…
or
pre
pare
d d
iffe
rently t
han p
ublis
hed in
such labelin
g”
<797>
Ph
arm
aceu
tical
Co
mp
ou
nd
ing
– S
teri
le
En
vir
on
men
tal
Qu
ali
ty a
nd
Co
ntr
ol
lF
acili
ty d
esig
n,
enviro
nm
enta
l an
d
en
gin
eeri
ng c
ontr
ols
; en
vir
onm
enta
l te
stin
g
and
cle
an
ing
pro
ce
dure
s;
an
d p
ers
onn
el
ga
rbin
g,
tra
inin
g a
nd t
estin
g r
eq
uir
em
en
ts.
Are
a
ISO
Cla
ss
Work
bench
ISO
Cla
ss 5
Buffer
Are
a
ISO
Cla
ss 7
Ante
Room
IS
O C
lass 8
<797>
Ph
arm
aceu
tical
Co
mp
ou
nd
ing
– S
teri
le
Th
ree M
ost
Imp
ort
an
t F
acto
rs G
uara
nte
ein
g S
teri
lity
lP
rop
er
han
d h
yg
ien
e a
nd
garb
ing
–S
hoe
covers
, hea
d/f
acia
l hair
co
ver,
facia
l m
ask/e
ye
shie
lds,
perf
orm
hand
cle
ansin
g p
rocedure
s,
gow
n,
wate
rle
ss a
lco
hol-
based s
urg
ica
l scru
b,
ste
rile
po
wder
free
-glo
ves
lP
rop
er
asep
tic t
ech
niq
ue b
y c
om
po
un
din
g
pers
on
nel
lA
bsen
ce o
f su
rface c
on
tam
inati
on
–C
lea
nin
g h
oo
d a
t beg
innin
g o
f sh
ift,
befo
re e
very
new
batc
h,
every
30 m
in d
uri
ng c
om
pound
ing
, spill
s, or
obvio
us c
onta
min
atio
n
<797>
Ph
arm
aceu
tical
Co
mp
ou
nd
ing
– S
teri
le
Mic
rob
ial
Co
nta
min
ati
on
Ris
k L
evels
Ris
k L
evel
Defi
nit
ion
Imm
edia
te-
Use
ISO
Cla
ss 5
environm
ent
is N
OT
required.
Pre
para
tions a
re
for
em
erg
ency
us o
r im
media
te p
atient
adm
inis
tration.
Must
use w
ithin
1 h
our.
Low
-Ris
k
ISO
Cla
ss 5
air q
ualit
y environm
ent
or
bett
er,
fro
m s
terile
in
gre
die
nts
, pro
ducts
, com
ponents
, and d
evic
es.
No m
ore
th
an 3
packages o
f ste
rile
pro
duct
can b
e u
sed,
and n
ot
more
th
an 2
entr
ies into
any
one o
f th
e s
terile
conta
iners
.
Mediu
m-R
isk
Multip
le indiv
idual or
sm
all
doses o
f ste
rile
pro
ducts
are
com
bin
ed,
adm
inis
tere
d t
o m
ultip
le p
atients
or
to o
ne p
atient
on m
ultip
le o
ccasio
ns.
Hig
h-R
isk
Non-s
terile
pro
duct
is u
sed,
final pre
p h
as t
o b
e s
teriliz
ed.
<797>
Ph
arm
aceu
tical
Co
mp
ou
nd
ing
– S
teri
le
Veri
ficati
on
of
Co
mp
ou
nd
ing
Accu
racy
an
d S
teri
lity
lQ
ualit
y o
f C
SP
is d
irectly r
ela
ted t
o a
chie
vin
g t
he
goal of
purity
, pote
ncy,
and s
terilit
y
lU
SP
Chapte
rs <
71>
, <
1035>
, <
731>
, <
1160>
and
<1211>
are
used f
or
guid
ance o
n m
eth
ods o
f ste
riliz
ation a
nd c
om
poundin
g a
ccura
cy a
nd
valid
ation
lF
ilters
used m
ust underg
o inte
grity
testing p
er
manufa
ctu
rer
lP
roof
that th
e e
nd-p
roducts
are
accura
te a
nd s
teri
le
is r
equired
<797>
Ph
arm
aceu
tical
Co
mp
ou
nd
ing
– S
teri
le
Beyo
nd
-Use D
ate
s
Ris
k L
evel
Defi
nit
ion
Low
-Ris
k
Room
Tem
p:
48 h
ours
R
efr
igera
ted:
14 d
ays
F
rozen:
45 d
ays
Mediu
m-R
isk
Room
Tem
p:
30 h
ours
R
efr
igera
ted:
9 d
ays
F
rozen:
4
5 d
ays
Hig
h-R
isk
Room
Tem
p:
24 h
ours
R
efr
igera
ted:
3 d
ays
F
rozen:
4
5 d
ays
Mu
lti-
do
se v
ials
is 2
8 d
ays
after
ente
ring w
ith a
needle
, or
pun
ctu
ring t
he
sto
pper, u
nle
ss s
pecifie
d b
y th
e m
anufa
ctu
rer.
Sin
gle
use c
on
tain
ers
is 6
hours
after
the f
irst entr
y in
to t
he v
ial o
r 1 h
our
is n
ot
in a
n I
SO
Cla
ss 5
envir
onm
ent.
<797>
Ph
arm
aceu
tical
Co
mp
ou
nd
ing
– S
teri
le
En
vir
on
men
tal
Sam
plin
g -
Typ
es
lE
nvironm
enta
l Sam
plin
g
–N
on
-via
ble
s
–V
iab
les
lA
ir
lS
urf
ace
lG
loved f
inger
tip
lM
edia
fill
test
<797>
Ph
arm
aceu
tical
Co
mp
ou
nd
ing
– S
teri
le
No
n-V
iab
le P
art
icle
Air
Sam
plin
g
lO
nce
eve
ry 6
mon
ths o
r w
he
n P
rim
ary
E
ng
inee
ring C
ontr
ols
(P
EC
) are
mo
ved
or
alte
red
lIn
respo
nse t
o m
ajo
r serv
icin
g o
f th
e a
rea
aro
un
d
the
PE
C
lE
ach
IS
O 5
are
a,
ISO
7 b
uff
er
are
a a
nd I
SO
8
ante
are
a.
All
separa
te a
rea
s m
ust
be t
este
d.
ISO
1
46
44
lD
ocum
en
t lo
ca
tion
, co
llection
meth
od,
frequ
en
cy
of
sam
plin
g,
vo
lum
e,
an
d t
ime o
f da
y r
ela
tive
to
com
po
un
din
g a
ctivitie
s
<797>
Ph
arm
aceu
tical
Co
mp
ou
nd
ing
– S
teri
le
Via
ble
Pa
rtic
le A
ir S
am
pli
ng
lO
nce
every
6 m
onth
s o
r w
he
n P
rim
ary
E
ngin
eeri
ng C
ontr
ols
are
mo
ve
d o
r altere
d o
r se
rvic
ed
lT
SA
or
soybe
an
casein
dig
est
aga
r fo
r ba
cte
ria
lM
alt E
xtr
act
Agar
(ME
A)
or
Sabou
rau
d
Dextr
ose
Aga
r fo
r fu
ng
i; o
nly
re
qu
ire
d f
or
hig
h r
isk c
om
po
un
din
g
<797>
Ph
arm
aceu
tical
Co
mp
ou
nd
ing
– S
teri
le
Via
ble
Pa
rtic
le S
urf
ace S
am
pli
ng
lN
o m
an
da
tory
sa
mplin
g p
erio
d,
on
ce
every
six
month
s is r
eco
mm
en
de
d
lC
onta
ct
pla
tes a
re t
he
pre
ferr
ed m
eth
od,
sw
ab s
am
plin
g is p
erm
itte
d
lT
SA
(M
EA
for
fun
gi)
with lecith
in o
r po
lyso
rbate
80
lF
un
gi
sa
mp
lin
g o
nly
fo
r h
igh
ris
k
co
mp
ou
nd
ing
<797>
Ph
arm
aceu
tical
Co
mp
ou
nd
ing
– S
teri
le
Glo
ved
Fin
gert
ip S
am
pli
ng
lU
se
d t
o e
va
luate
work
er
garb
ing
techn
ique
lO
nce
a y
ear
for
low
an
d m
ediu
m r
isk
co
mpo
un
din
g,
every
6 m
onth
s f
or
hig
h r
isk
co
mpo
un
din
g
lA
ll n
ew
work
ers
must
perf
orm
3 s
ucce
ssfu
l glo
ve t
ests
pri
or
to b
egin
nin
g c
om
po
un
din
g
work
lU
su
ally
pe
rfo
rme
d b
y the
on
site
su
pe
rvis
or
<797>
Ph
arm
aceu
tical
Co
mp
ou
nd
ing
– S
teri
le
Med
ia F
ill
Test
lD
esig
ne
d to t
est
abili
ty o
f w
ork
er,
pro
ced
ure
an
d
eq
uip
men
t to
pro
duce s
terile
pro
duct
lR
ep
licate
s e
ntire
com
pou
ndin
g p
roce
ss u
sin
g
so
yb
ea
n c
ase
in d
ige
st m
ed
ia in
pla
ce o
f dru
gs
lA
nn
ua
l testing
for
low
an
d m
ed
ium
ris
k
com
pou
ndin
g, once e
ve
ry 6
month
s for
hig
h r
isk
co
mpo
un
din
g
lN
ew
em
plo
yee
s r
equ
ired to c
om
ple
te o
ne t
est
prior
to b
egin
nin
g c
om
po
und
ing
<797>
Ph
arm
aceu
tical
Co
mp
ou
nd
ing
– S
teri
le
Acti
on
Levels
lA
ny a
irborn
e c
fu f
ound in I
SO
5,
7,
or
8 m
ust be
identified t
o t
he g
enus level (s
pecie
s r
ecom
mended)
* C
FU
– C
olo
ny
Form
ing U
nits
** c
onta
ct
pla
te a
reas v
ary
fro
m 2
4-3
0 c
m2. w
hen s
wabbin
g is u
sed in
sam
plin
g,
the a
rea c
overe
d s
hould
be a
t le
ast
24 c
m2 b
ut
no larg
er
than 3
0 c
m2
ISO
Cla
ss
> 0
.5 m
No
nvia
ble
part
icle
s/m
3
Via
ble
Air
bo
rne
(cfu
*/m
3)
Via
ble
Su
rface *
*
(cfu
/co
nta
ct
pla
te)
5
3,5
20
>1
>3
7
352,0
00
>10
>5
8
3,5
20,0
00
>100
>100
<797>
Ph
arm
aceu
tical
Co
mp
ou
nd
ing
– S
teri
le
Wh
y I
den
tify
?
lS
om
e o
rganis
ms a
re p
ath
ogenic
enough t
hat
they
cannot
be t
ole
rate
d in a
clin
ical envirom
ent
at
any
concenta
tion (
MR
SA
, A
cin
eto
bacte
r)
lG
enus identification is u
sefu
l, b
ut
cannot
dis
tinguis
h
betw
een h
arm
ful and b
enig
n s
pecie
s w
ithin
the
sam
e g
enus g
roup
lW
ithout
know
ing t
he s
pecie
s o
f an o
rganis
m,
all
cfu
fr
om
a g
enus t
hat conta
ins k
now
n p
ath
ogens h
ave t
o
be t
reate
d a
s if
they a
re p
ath
ogens
<797>
Ph
arm
aceu
tical
Co
mp
ou
nd
ing
– S
teri
le
Ph
ysic
al
Facto
rs
lB
uild
ing C
han
ge
s o
r C
on
str
uctio
n
lP
rim
ary
Engin
eeri
ng C
ontr
ols
–
Are
they w
ork
ing p
rop
erly?
–H
ave
they b
ee
n p
rop
erly m
ain
tain
ed?
lP
rop
er
Cle
anin
g
–C
heck r
ecord
s
–C
lean
ing a
ge
nt ty
pes?
–R
ota
tion?
–P
roper
cle
an
ing tools
?
–A
re m
ate
rials
in la
b c
apa
ble
of bein
g c
leaned?
<797>
Ph
arm
aceu
tical
Co
mp
ou
nd
ing
– S
teri
le
Ph
ysic
al
Facto
rs
lE
nvir
onm
enta
l C
ond
itio
ns
–T
em
pera
ture
, hum
idity,
seasons,
weath
er,
etc
.
lB
uild
ing C
hang
es o
r C
onstr
uction
lLa
bo
rato
ry W
ork
flo
w
–T
raff
ic a
reas
–H
igh r
isk a
reas (
win
dow
s,
doors
, vents
, equip
ment
lP
rocess a
nd
Mate
ria
ls
–A
re m
ate
rials
moved into
and o
ut
aseptically
?
–A
re s
upplie
s c
leaned a
s they a
re b
rought
into
the
<797>
Ph
arm
aceu
tical
Co
mp
ou
nd
ing
– S
teri
le
Rem
ed
iati
on
- C
lean
ing
lIs
the
pro
per
cle
anin
g a
gen
t b
ein
g u
sed
fo
r th
e t
ask? N
ot
all
age
nts
are
eff
ective a
ga
inst
all
via
ble
part
icle
s.
lIs
the
cle
anin
g a
gen
t b
ein
g u
sed
pro
perl
y?
lIs
the
cle
anin
g a
gen
t b
ein
g s
tore
d u
nde
r pro
per
tem
pera
ture
an
d lig
ht
co
nd
itio
ns?
lH
as t
he c
lean
ing a
ge
nt
expir
ed?
lA
re c
lean
ing a
gen
ts b
ein
g r
ota
ted
?
<797>
Ph
arm
aceu
tical
Co
mp
ou
nd
ing
– S
teri
le
Rem
ed
iati
on
– C
lean
ing
(c
on
t’d
)
lA
re c
lean
ing t
ools
non
-she
dd
ing a
nd d
edic
ate
d for
the
cle
an r
oo
m o
nly
?
lB
e a
ware
th
at
cle
anin
g a
ctivitie
s c
an im
pact
the
work
en
vironm
en
t
lC
lean
ing s
che
du
les
–IS
O 5
: sta
rt o
f e
ach s
hift,
prior
to c
om
poun
din
g e
ach b
atc
h o
r every
30 m
in,
when o
bvio
us s
pill
s o
r conta
min
ation a
re
suspecte
d
–IS
O 7
and
8:
floo
rs a
nd w
ork
surf
aces d
aily
–A
reas a
round
hood
s a
nd isola
tors
daily
–S
tora
ge s
helv
es,
walls
and c
eili
ngs m
onth
ly
–S
tora
ge s
ites a
s n
eeded
<797>
Ph
arm
aceu
tical
Co
mp
ou
nd
ing
– S
teri
le
Do
cu
men
tati
on
lP
rim
ary
Eng
inee
ring C
ontr
ols
–C
alib
ration c
ert
ific
ate
s
–M
ain
tenance r
ecord
s
lIn
ve
stiga
tion r
eco
rds (
if invo
lve
d)
–D
ocum
ent
investigation p
rocess
–R
esults o
f in
vestigation
–A
ctions t
o c
orr
ect
issue
–R
esults o
f corr
ective a
ction
lT
rain
ing/T
esting r
ecord
s (
fingert
ip a
nd m
edia
fill
)
<797>
Ph
arm
aceu
tical
Co
mp
ou
nd
ing
– S
teri
le
Fir
st
Ste
ps T
ow
ard
Co
mp
lian
ce
lD
ete
rmin
e r
isk level of
the
co
mpo
un
din
g
lP
erf
orm
ga
p a
naly
sis
–C
om
pare
curr
ent pharm
acy c
om
poundin
g
opera
tions w
ith U
SP
797
lD
eve
lop a
n a
ction
pla
n
lE
va
luate
the u
se
of
altern
ative p
roducts
lR
easse
ss w
ork
loa
d o
f com
po
un
din
g p
ers
on
ne
l
lD
ocu
men
t pe
rform
ance a
nd q
ualit
y
impro
vem
ents
Su
rveyin
g P
harm
acie
s f
or
Co
mp
lian
ce
wit
h U
SP
Ch
ap
ters
<795>
an
d <
797>
lV
isit the
ba
thro
om
lLo
ok in
th
e r
efr
igera
tor
lLo
ok a
rou
nd
the
sin
k a
rea
an
d w
ork
are
a
lIs
the
re f
unctio
na
l lin
ear
work
surf
aces to
ade
qua
tely
perf
orm
work
?
lW
aste
an
d S
harp
dis
posal
lD
oes a
ny e
quip
me
nt
ha
ve
an
y e
xpir
ed
ce
rtific
ation s
ticke
rs
Su
rveyin
g P
harm
acie
s f
or
Co
mp
lian
ce
wit
h U
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Ch
ap
ters
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d <
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lS
urv
eyin
g f
or
Com
plia
nce
–W
ho r
uns the p
harm
acy?
–W
ho o
vers
ees t
he o
pera
tions?
–W
ho h
as f
inal auth
ority
and a
ppro
val pow
er?
lA
sk t
he
ph
arm
acis
t:
–W
hat
do y
ou d
o?
–H
ow
do y
ou d
o t
he w
ork
?
–S
how
me h
ow
you d
o it.
Co
nclu
sio
n
lF
DA
is c
urr
ently m
onitori
ng p
harm
acy’s
co
mplia
nce
with
cha
pte
r 7
97
lA
dditio
na
l re
gula
tory
pro
mu
lga
tio
ns c
ould
be
m
ad
e t
o r
estr
ict
the p
ractice o
f com
pou
nd
ing
lT
he r
estr
ictio
n o
f com
pou
nd
ing u
ltim
ate
ly
impa
cts
pati
en
t ca
re a
nd o
ur
pro
fessio
n o
f ph
arm
acy
Qu
esti
on
s?
