Iowa/NABP Pharmacy Inspection Project
Results
The Board recently completed a special project in which nearly
80% of nonresident (out-of-state) pharmacies licensed to do business
in Iowa were inspected. Between December 1, 2012 and December
31, 2013, a total of 538 nonresident pharmacies were surveyed with
the assistance of the field services division of the National Association
of Boards of Pharmacy® (NABP®).
The pharmacies that were inspected were located in 42 states.
The top 10 states were:
♦♦ Florida: 69 pharmacies
♦♦ Illinois: 45 pharmacies
♦♦ Nebraska: 41 pharmacies
♦♦ California: 31 pharmacies
♦♦ Pennsylvania: 30 pharmacies
♦♦ Minnesota: 26 pharmacies
♦♦ Missouri: 22 pharmacies
♦♦ Tennessee: 21 pharmacies
♦♦ Texas: 20 pharmacies
♦♦ Ohio: 20 pharmacies
A total of 263 pharmacies (49%) were found to be engaged in some
form of compounding. One hundred thirteen pharmacies (21%) were
found to be doing both sterile and nonsterile compounding. Eighty five
pharmacies (16%) were doing only nonsterile compounding,
while 65 pharmacies (12%) were doing only sterile compounding.
Of those pharmacies that were engaging in sterile compounding,
the following was observed:
♦♦ High-risk preparations by prescription: 93 pharmacies
♦♦ High-risk preparations without a prescription: 40 pharmacies
♦♦ Medium-risk preparations by prescription: 121 pharmacies
♦♦ Medium-risk preparations without a prescription: 24 pharmacies
♦♦ Low-risk preparations by prescription: 134 pharmacies
♦♦ Low-risk preparations without a prescription: 23 pharmacies
In addition, 158 pharmacies (29%) were found to be performing
bulk compounding without a prescription in anticipation of receiving
prescriptions. There were 14 pharmacies that were also licensed as
a distributor, with internal movement of compounded product from
the pharmacy to the distributor.
These pharmacies ranged in size from 65 square feet to 163,000
square feet. The size of their compounding areas ranged from two
square feet to 1,000 square feet.
The number of pharmacists per facility ranged from one to 258,
while the number of pharmacy technicians ranged from one to 668.
Some facilities dispensed up to 90,000 prescriptions per day. The
number of prescriptions dispensed to Iowa patients ranged from
one to 1,285 per day.
Interestingly, 47 of these same pharmacies (8.7%) were also
inspected by Food and Drug Administration (FDA) during the
same time period. Twenty-six of those pharmacies (4.8%) received
a warning letter from FDA.
One hundred nine pharmacies (20%) were found to be operating
under a waiver granted by their home state board of pharmacy. The
types of pharmacies inspected included the following:
♦♦ Traditional retail/Community
♦♦ Health Maintenance Organization/Pharmacy Benefit Management
only
♦♦ Institutional (hospital or long-term care)
♦♦ Mail order
♦♦ Central fill/Central processing
♦♦ Internet pharmacy
♦♦ Telepharmacy
The results of these inspections have been reviewed by the Board.
In some cases, nonresident pharmacies have been issued letters of
education or administrative warnings. In other cases, nonresident
pharmacies have been issued a Statement of Charges and Notice
of Hearing, which initiates the formal disciplinary process. More
information will be released as it becomes available.
As of April 22, 2014, Iowa has 685 nonresident pharmacies actively
licensed to do business in Iowa.
quoted from here
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