Sterile Product Pharmacies
It is not news to any pharmacist, or to most of the public, that
there have been issues with some products compounded by
pharmacies that prepare sterile products. Though the vast majority
of pharmacies prepare products that serve the well-being of the
patient, a small number of pharmacies have bypassed standards
and prepared contaminated sterile products. The damage caused
by these products has touched people in numerous states and
related stories have headlined the national news.
While the federal legislature, pharmacy activists, and Food
and Drug Administration debate appropriate oversight for compounding
pharmacies, the states maintain the responsibility for
inspection and licensing of all pharmacies within their states.
Alabama has approximately 200 pharmacies that are registered
as sterile compounding businesses. This includes institutional
and retail settings, pharmacies that prepare one or two sterile
products per day, plus pharmacies that service 1,000-plus bed
hospitals, and pharmacies that ship to purchasers in multiple
states. Compounding ranges from low-risk to high-risk and
hazardous products. In Alabama, the Board wants to be sure
that all of these pharmacies in all categories are complying with
standards written by the United States Pharmacopeial Convention and a
dopted by the state of Alabama.
To assist in implementation of this monitoring, the Board
hired Dr Susan Alverson in May of this year to commit to inspection of
all registered sterile product pharmacies. Dr Alverson
obtained her pharmacy degree from the University of Wisconsin
and did graduate work at the Medical College of Virginia and
at the University of Southern California. She has worked in
sterile compounding in the hospital setting and in private home
health. She has taught sterile compounding at the McWhorter
School of Pharmacy, Samford University since 1993. She and
the Board inspectors have been reviewing inspection standards
for Alabama pharmacies and have recently begun inspections.
If you are a sterile compounding pharmacy, you will likely see
Dr Alverson within the next few months.
There will be a topic heading added to the Board Web site at
www.albop.com. You will be able to view the inspection form
and the list of documents that will be required for those inspections.
Now would be the time to collect those in one place.
quoted from Alabama Board of Pharmacy August 2013 Newsletter
It is not news to any pharmacist, or to most of the public, that
there have been issues with some products compounded by
pharmacies that prepare sterile products. Though the vast majority
of pharmacies prepare products that serve the well-being of the
patient, a small number of pharmacies have bypassed standards
and prepared contaminated sterile products. The damage caused
by these products has touched people in numerous states and
related stories have headlined the national news.
While the federal legislature, pharmacy activists, and Food
and Drug Administration debate appropriate oversight for compounding
pharmacies, the states maintain the responsibility for
inspection and licensing of all pharmacies within their states.
Alabama has approximately 200 pharmacies that are registered
as sterile compounding businesses. This includes institutional
and retail settings, pharmacies that prepare one or two sterile
products per day, plus pharmacies that service 1,000-plus bed
hospitals, and pharmacies that ship to purchasers in multiple
states. Compounding ranges from low-risk to high-risk and
hazardous products. In Alabama, the Board wants to be sure
that all of these pharmacies in all categories are complying with
standards written by the United States Pharmacopeial Convention and a
dopted by the state of Alabama.
To assist in implementation of this monitoring, the Board
hired Dr Susan Alverson in May of this year to commit to inspection of
all registered sterile product pharmacies. Dr Alverson
obtained her pharmacy degree from the University of Wisconsin
and did graduate work at the Medical College of Virginia and
at the University of Southern California. She has worked in
sterile compounding in the hospital setting and in private home
health. She has taught sterile compounding at the McWhorter
School of Pharmacy, Samford University since 1993. She and
the Board inspectors have been reviewing inspection standards
for Alabama pharmacies and have recently begun inspections.
If you are a sterile compounding pharmacy, you will likely see
Dr Alverson within the next few months.
There will be a topic heading added to the Board Web site at
www.albop.com. You will be able to view the inspection form
and the list of documents that will be required for those inspections.
Now would be the time to collect those in one place.
quoted from Alabama Board of Pharmacy August 2013 Newsletter
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