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MQA Q4 2015 - 2016
This measure calculates the inspection end date and the inspection deficiency data. The number
of sterile compounding pharmacy inspections completed without serious deficiencies is divided
by the number of sterile compounding pharmacy inspections completed during a specified
timeframe. It is important to make sure sterile compounding pharmacies are in compliance
with Florida Statutes and administrative rules and do not pose a threat to the health, safety and
welfare of the public.
MEASURE:
Percent of sterile compounding pharmacy inspections with no serious deficiencies.
INITIATIVE:
Due to the implementation of U.S. Pharmacopoeia 797 (USP 797), standards for sterile
compounding pharmacies were raised. The Board of Pharmacy adopted the standards into Florida
Administrative Code Rule 64B16-27.797, and the Bureau of Enforcement adopted the standards
into their inspection forms. To ensure compounded sterile drugs entering and leaving the state
are safe and adhere to USP 797 requirements, the following action steps will be carried out.
Monthly conference calls will be conducted with MQA inspectors to monitor how new standards
are affecting pharmacy passage rates, and all new senior pharmacists will undergo “boot camp”
training. Annual “boot camp” refresher training will also be mandatory for all senior pharmacists.
The Bureau of Enforcement will also continue to facilitate USP 797 workshops to educate
pharmacies and pharmacists on common sterile compounding deficiencies. Pharmacies that
have substantive deficiencies during an inspection must provide a corrective action plan that is
reviewed for compliance and a follow-up inspection will be conducted. Three Senior Pharmacists
attended Food and Drug Administration (FDA) sponsored training on current Good Manufacturing
Practices in July and September of 2015 as well as March and May of 2016. So far, Senior
Pharmacists conducted five sterile compounding, pharmacy inspections in conjunction with our
FDA partners.
TARGET:
95%
DEFINITION:
Data source:
MQA Licensing and Enforcement Information Database System (LEIDS).
STERILE
COMPOUNDING
PHARMACY
INSPECTION
BALANCED SCORECARD MEASURES
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