g. Outcomes of Recent Sterile Compounding Inspections
Dr. Ratcliff provided the committee with a summary of outcomes from recent board inspections
of sterile compounding pharmacies. Between January 1, 2013 and mid-May 2013, staff
completed 87 inspections. The meeting materials included more specific information.
Discussion
There was no comments from the board or from the public.
h. Recalls of Compounded Drugs Throughout the United States
Background
Between April 11, 2013 and May 20, 2013, the board posted seven subscriber alerts related to
compounding drug recalls and two subscriber alerts related to cease and desist orders issued.
A summary of the alerts are listed below.
• Green Valley Drugs in Henderson, Nevada, voluntarily recalled all lots of sterile products
compounded, repackaged, and distributed by the pharmacy due to lack of sterility
assurance and concerns associated with the quality control processes.
• ApotheCure, Inc. recalled all lots of sterile products compounded by the pharmacy that are
not expired to the user. The recall was initiated due to lack of sterility assurance and
concerns associated with the quality control processes.
• NuVision Pharmacy recalled all unexpired lots of lyophilized compounds of HcG 5000IU
5ml and Sermorelin/GHRH6-5ml to the user. The recall was initiated due to the lack of
sterility assurance and concerns associated with the quality control processes identified
during a FDA inspection.
• Balances Solutions Compounding Pharmacy, LLC recalled all lots of sterile products
compounded by the pharmacy that were not expired. The recall was initiated due to
concerns associated with quality control processes, which present a lack of sterility
assurance.
• Nora Apothecary & Alternative Therapies recalled a multi-state recall of all sterile drug
products compounded by the pharmacy that have not reached the expiration date listed
Minutes of July 30-31, 2013 Public Board Meeting
on the product. The compounded products that are subject to the recall were products
within their expiration date that were compounded and dispensed by the pharmacy on or
before Friday, April 19, 2013. The recall was initiated due to concerns associated with
quality control processes that present a lack of sterility assurance and were observed
during a recent FDA inspection.
• The U.S. Food and Drug Administration alerted health care providers, hospital supply
managers, and pharmacists that the FDA’s preliminary findings of practices at The
Compounding Shop of St. Petersburg, Florida, raised concerns about a lack of sterility
assurance for sterile drugs produced at and distributed from this site.
• Pentec Health, Inc. initiated a limited recall of in-date nutritional prescriptions for renal
patients due to lack of sterility assurance associated with one of its laminar flow hoods
used in compounding.
• Southern California Compounding Pharmacy, LLC was issued a cease and desist order on
April 19, 2013, for any and all non-sterile compounding.
• Advance Outcome Management Pharmacy Services was issued a cease and desist order on
April 29, 2013, from furnishing sterile injectable compounded products.
Discussion
No comments from the board or from the public
quoted from here
Dr. Ratcliff provided the committee with a summary of outcomes from recent board inspections
of sterile compounding pharmacies. Between January 1, 2013 and mid-May 2013, staff
completed 87 inspections. The meeting materials included more specific information.
Discussion
There was no comments from the board or from the public.
h. Recalls of Compounded Drugs Throughout the United States
Background
Between April 11, 2013 and May 20, 2013, the board posted seven subscriber alerts related to
compounding drug recalls and two subscriber alerts related to cease and desist orders issued.
A summary of the alerts are listed below.
• Green Valley Drugs in Henderson, Nevada, voluntarily recalled all lots of sterile products
compounded, repackaged, and distributed by the pharmacy due to lack of sterility
assurance and concerns associated with the quality control processes.
• ApotheCure, Inc. recalled all lots of sterile products compounded by the pharmacy that are
not expired to the user. The recall was initiated due to lack of sterility assurance and
concerns associated with the quality control processes.
• NuVision Pharmacy recalled all unexpired lots of lyophilized compounds of HcG 5000IU
5ml and Sermorelin/GHRH6-5ml to the user. The recall was initiated due to the lack of
sterility assurance and concerns associated with the quality control processes identified
during a FDA inspection.
• Balances Solutions Compounding Pharmacy, LLC recalled all lots of sterile products
compounded by the pharmacy that were not expired. The recall was initiated due to
concerns associated with quality control processes, which present a lack of sterility
assurance.
• Nora Apothecary & Alternative Therapies recalled a multi-state recall of all sterile drug
products compounded by the pharmacy that have not reached the expiration date listed
Minutes of July 30-31, 2013 Public Board Meeting
on the product. The compounded products that are subject to the recall were products
within their expiration date that were compounded and dispensed by the pharmacy on or
before Friday, April 19, 2013. The recall was initiated due to concerns associated with
quality control processes that present a lack of sterility assurance and were observed
during a recent FDA inspection.
• The U.S. Food and Drug Administration alerted health care providers, hospital supply
managers, and pharmacists that the FDA’s preliminary findings of practices at The
Compounding Shop of St. Petersburg, Florida, raised concerns about a lack of sterility
assurance for sterile drugs produced at and distributed from this site.
• Pentec Health, Inc. initiated a limited recall of in-date nutritional prescriptions for renal
patients due to lack of sterility assurance associated with one of its laminar flow hoods
used in compounding.
• Southern California Compounding Pharmacy, LLC was issued a cease and desist order on
April 19, 2013, for any and all non-sterile compounding.
• Advance Outcome Management Pharmacy Services was issued a cease and desist order on
April 29, 2013, from furnishing sterile injectable compounded products.
Discussion
No comments from the board or from the public
quoted from here
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