Innovations-Magazine-June-2023 - 13

ASSOCIATION NEWS
NABP's Updated Universal Inspection Form and Training
Program Enhance Pharmacy Inspections
In 2016, NABP's Multistate Pharmacy
Inspection Blueprint Program was launched
in response to requests from member boards
for more uniform, current, and robust
inspections of pharmacies that ship sterile
compounded preparations across state lines.
The program was developed to ensure that
pharmacies meet minimum standards for
sterile compounding, and a key component
of that program is the Universal Inspection
Form. The form incorporates the current
standards of United States Pharmacopeia
(USP) Chapters <797> and <795>.
In addition, the Blueprint Program
emphasizes the importance of training state
inspectors to current national standards for
sterile compounding of drug products. In
support of these goals, NABP has engaged
with several organizations to provide
training to state inspectors on the newly
revised USP chapters. NABP staff has
also taken steps to update the Universal
Inspection Form as well as the forms used
by the NABP Verified Pharmacy Program®
to conform to these standards. These
updates will be completed and ready for
use this summer.
The Multistate Pharmacy Inspection
Blueprint Program supports states that have
the resources to perform resident inspections
by providing the Inspection Blueprint, a
living document that includes a minimum
set of criteria for pharmacy inspections.
By utilizing the current USP standards,
along with field operations' best practices
States wishing to join the
Blueprint Program must
agree to a set of processes
for inspecting in-state sterile
compounding pharmacies
that ship to other states.
WA
NH
MT
OR
ID
WY
NV
UT
CO
CA
AZ
KS
NM
TX
LA
AK
FL
HI
OK
AR
AL
MS
GA
SC
MO
TN
KY
MD
NC
DC
SD
NE
IA
IL
IN
OH
WV
VA
DE
ND
MN
WI
NY
MI
PA
NJ
CT
VT
ME
MA
RI
Twenty states are currently participating in the Multistate Pharmacy Inspection Blueprint Program.
developed in partnership with participating
boards of pharmacy, the Inspection Blueprint
provides the various tools needed to confirm
pharmacies are fulfilling minimum sterile
compounding standards.
States wishing to join the Blueprint
Program must agree to a set of processes
for inspecting in-state sterile compounding
pharmacies that ship to other states.
This includes using either the Universal
Inspection Form or the state's sterile
compounding inspection form, which is
reviewed by NABP staff to ensure that it
meets the Inspection Blueprint standards.
If a state chooses the Universal Inspection
Form, it agrees to use it when inspecting
pharmacies that ship sterile compounded
products to other states. In the future,
participation may expand to include general
pharmacy and nonsterile compounding.
NABP also provides training for inspectors
and compliance officers who conduct these
inspections, with no cost to boards.
Becoming a Blueprint state has many
benefits, including the ability to establish
minimum standards for pharmacies that
engage in sterile compounding, consistency
across participating states, and the
opportunity to receive training at no cost.
By joining the Blueprint Program, states can
help safeguard the compounded sterile drug
products that come into their state.
The NABP Multistate Pharmacy
Inspection Blueprint Program is an
important initiative that supports states
in enforcing common standards for sterile
compounding in pharmacies. The Universal
Inspection Form, along with the training
provided to inspectors and compliance
officers, helps to achieve uniformity across
participating states. States that wish to join
the program can benefit from the many
advantages it provides, including access to
training at no cost and the ability to ensure
that pharmacies are meeting the necessary
standards for sterile compounding. NABP
encourages participation in the Blueprint
Program to help safeguard compounded
sterile drug products and ensure the
safety of patients.
JUNE 2023 | 11

https://nabp.pharmacy/members/programs-services/inspections/#blueprint

Innovations-Magazine-June-2023

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