Supporting state board of pharmacy efforts to enforce compounding
regulations, NABP is implementing a four-part action plan centered
around inspection of nonresident compounding pharmacies and creating
an information-sharing network of regulatory details on such pharmacies.
Focusing on inspections of nonresident compounding pharmacies and
sharing this data among boards of pharmacy nationwide was determined
by NABP and its member state boards of pharmacy to be key to preventing
future tragedies like the current meningitis outbreak.
NABP developed the action plan at a November 2012 meeting of board
of pharmacy executive directors where the attendees expressed a strong
commitment to correcting system failures that allowed the meningitis
outbreak to occur, and implementation began quickly thereafter. The Iowa
Board of Pharmacy recently requested NABP to develop an inspection
program for entities that are licensed by the state as nonresident pharmacies
and dispensing compounded drugs in Iowa. Those in attendance expressed
their support of this inspection initiative, which became a cornerstone of
the four-part action plan.
In the first part of its action plan, NABP shared the list of nonresident
compounding pharmacies provided by the Iowa Board with other NABP
member boards of pharmacy and began coordinating the collection of
information on these pharmacies. The boards’ collaboration on this data
helped NABP identify the initial pharmacies to inspect. NABP believes that
the list provided by Iowa represents a significant number of nonresident
pharmacies dispensing compounded drugs across the country.
Implementing the inspection program is the second part of the action
plan and is currently underway. Initial results will reveal whether the selected pharmacies are compounding pursuant to a prescription in compliance
with state regulations, or instead are engaging in manufacturing. Entities
that refuse inspection may be subject to disciplinary action by the Iowa
Board and such actions will be shared with all of NABP’s member boards.
The third part of the action plan includes NABP collecting and maintaining data on the compounding pharmacies identified by the Iowa Board
and by other boards of pharmacy. Initial data collected from the boards
and the inspection reports will be stored in an NABP Pharmacy e-Profile,
allowing the Association to disseminate pertinent public information
among state boards. Ultimately, states will be able to submit inspection
reports and other related information to NABP for inclusion in pharmacies’
e-Profiles. The network will be made available at no cost to boards for use
in making licensure and registration determinations for pharmacies, and
may also help to identify pharmacies whose operations are more akin to
manufacturing than compounding.
As the final part of the action plan, NABP plans to schedule immediate
and ongoing training of board of pharmacy inspectors and compliance officers via Webinar and field training opportunities. NABP will also continue
cooperative efforts with Food and Drug Administration and legislators to
address the regulatory quagmire that exists when traditional compounding
is exceeded and manufacturing may be occurring.
Source found here
regulations, NABP is implementing a four-part action plan centered
around inspection of nonresident compounding pharmacies and creating
an information-sharing network of regulatory details on such pharmacies.
Focusing on inspections of nonresident compounding pharmacies and
sharing this data among boards of pharmacy nationwide was determined
by NABP and its member state boards of pharmacy to be key to preventing
future tragedies like the current meningitis outbreak.
NABP developed the action plan at a November 2012 meeting of board
of pharmacy executive directors where the attendees expressed a strong
commitment to correcting system failures that allowed the meningitis
outbreak to occur, and implementation began quickly thereafter. The Iowa
Board of Pharmacy recently requested NABP to develop an inspection
program for entities that are licensed by the state as nonresident pharmacies
and dispensing compounded drugs in Iowa. Those in attendance expressed
their support of this inspection initiative, which became a cornerstone of
the four-part action plan.
In the first part of its action plan, NABP shared the list of nonresident
compounding pharmacies provided by the Iowa Board with other NABP
member boards of pharmacy and began coordinating the collection of
information on these pharmacies. The boards’ collaboration on this data
helped NABP identify the initial pharmacies to inspect. NABP believes that
the list provided by Iowa represents a significant number of nonresident
pharmacies dispensing compounded drugs across the country.
Implementing the inspection program is the second part of the action
plan and is currently underway. Initial results will reveal whether the selected pharmacies are compounding pursuant to a prescription in compliance
with state regulations, or instead are engaging in manufacturing. Entities
that refuse inspection may be subject to disciplinary action by the Iowa
Board and such actions will be shared with all of NABP’s member boards.
The third part of the action plan includes NABP collecting and maintaining data on the compounding pharmacies identified by the Iowa Board
and by other boards of pharmacy. Initial data collected from the boards
and the inspection reports will be stored in an NABP Pharmacy e-Profile,
allowing the Association to disseminate pertinent public information
among state boards. Ultimately, states will be able to submit inspection
reports and other related information to NABP for inclusion in pharmacies’
e-Profiles. The network will be made available at no cost to boards for use
in making licensure and registration determinations for pharmacies, and
may also help to identify pharmacies whose operations are more akin to
manufacturing than compounding.
As the final part of the action plan, NABP plans to schedule immediate
and ongoing training of board of pharmacy inspectors and compliance officers via Webinar and field training opportunities. NABP will also continue
cooperative efforts with Food and Drug Administration and legislators to
address the regulatory quagmire that exists when traditional compounding
is exceeded and manufacturing may be occurring.
Source found here
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