Innovations-Magazine-March-2023 - 13

ASSOCIATION NEWS
NABP Now Offers Preoperational Inspections for
Pharmacies and Distributors
Pharmacies and distributors that need a
facility inspection to obtain a resident license
but are located in a state whose board of
pharmacy is unable to perform inspections
can now apply for a Preoperational
Inspection from NABP. The service is
intended to address the inspection needs
of all types of pharmacies (community,
compounding, mail order, etc) and
distributors (prescription drugs, prescription
devices, third-party logistics provider)
seeking a resident license but that are not yet
operational or are undergoing operational
changes, such as moving to a new location,
a change in ownership, or significant
construction.
Inspections typically take place within
30 calendar days and are unannounced.
If an applicant is required to submit
missing information or documentation,
the review and scheduling process may
take longer, as an inspection is scheduled
only after an application is complete.
Since the facility being inspected is not
yet operational, some key areas NABP will
inspect include, but are not limited to:
* Construction - Is the facility fully
constructed? Does it have operational
refrigerators, secure drug storage,
HVAC, proper lighting and ventilation,
NABP does not issue a certificate of inspection or make any
determination of " passed " or " compliant " with regard to specific
state regulations. A state determines a facility's compliance based
on the findings of the inspection, and completion of the inspection
does not imply the Association's endorsement or approval.
restrooms with hot and cold running
water, a generator, and internet and
telephone access?
* Facility size - The facility should
be appropriately sized for the type
of business.
* Security - Are there secure locations
for storing controlled substances and
patient records?
* Personnel - Are there appropriate
staff on site (ie, a pharmacist to oversee
a pharmacy)?
Within 10 business days of completion
of the inspection, NABP will email a
Preoperational Inspection report to the
applicant as well as upload it to the applicant's
business NABP e-Profile®. The report,
which resembles the Association's Verified
Pharmacy Program® and Supply Chain
Inspection reports, can be viewed, along
with additional application information
and documentation, by the state boards
of pharmacy and state regulators via
NABP's Information Sharing Network.
NABP does not issue a certificate of
inspection or make any determination of
" passed " or " compliant " with regard to
specific state regulations. A state determines
a facility's compliance based on the
findings of the inspection, and completion
of the inspection does not imply the
Association's endorsement or approval.
More information about this new
program and NABP's other inspection
services is available on the NABP website.
Visit the Members menu, select Programs
and Services for Boards, and click on
Inspection Services to learn more.
MARCH 2023 | 11
https://nabp.pharmacy/members/programs-services/inspections/
Innovations-Magazine-March-2023

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