Wednesday, October 23, 2013

Iowa and NABP Inspections Are Finding The Following Violations At Compounding Pharmacies: Is Your Pharmacy Guilty of Any of These?

Iowa Inspection Program
NABP Began conducting pharmacy inspections on behalf of the Iowa Board of Pharmacy in December 2012
. As of press time, NABP surveyors have conducted inspections of 384 nonresident pharmacies dispensing drugs to patients in Iowa.
Inspections are ongoing across the nation and as such
are not consigned to any one state. Aggregate data reports with relevant survey findings are submitted directly to the Iowa Board. Trends from the reports were shared by Lloyd K. Jessen, JD, RPh, executive
director/drug control program administrator, Iowa Board of Pharmacy, during a continuing pharmacy education session at the NABP 109 Annual Meeting, May 18-21, 2013. (See the 2013 Special Issue of
the NABP Newsletter for details.) Additional Observations from Iowa inspections include the following:
Compounded products being shipped to states where the pharmacy did not hold a pharmacy license.
Products being shipped “for office use” to entities that did not hold a pharmacy license in that state.
Sterile products being improperly labeled.
Facilities with improperly labeled or expired compounded drugs that were “returned to stock.”
A facility where a cleanroom was identified as ISO class 7 certified, though it failed to meet the criteria for that designation.
Air changes per hour did not meet the standards at some facilities were significantly below the average observed at other pharmacies.
(Cover articles in the May 2013 NABP
Newsletter and the June-July 2013 NABP Newsletter
provide additional background and updates on the Iowa compounding inspection program.)
 

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