FDA Response
FDA Response
26AUG
NuVision Pharmacy is a specialty compounding pharmacy committed to patient safety. We adhere to the USP <797>, which is the professional and legal standard for all sterile compounding pharmacies. We follow all state and federal pharmacy laws and our pharmacy license is in good standing with the Texas State Board of Pharmacy.
In response to the warning letter issued by the FDA about our sterile products, we would like to take this opportunity to set the record straight and address their accusations.
There is no evidence to support the FDA’s claim that our products lack sterility assurance. We have sterility tests performed on every lot of sterile products we dispense. We maintain test results documenting a passing sterility test for every product sold by our pharmacy and there is no evidence of any sterile product dispensed by our pharmacy being contaminated.
The FDA did not receive reports about fever, flu-like symptoms, and soreness at the injection site associated with the methylcobalamin injection product. This is information we voluntarily provided to the FDA. The FDA inspectors had no knowledge of this incident prior to our disclosure. The symptoms were experienced by three individuals and were related to the use of one vial.
Before the FDA was even aware of this issue, NuVision Pharmacy had already proactively recalled the lot in question and contacted everyone who had received it. No one else reported any adverse effects from the use of the product. The vial in question was also used by the same doctor to inject other patients who experienced no adverse effects. The vial associated with these adverse effects was returned to our pharmacy for testing and it passed pyrogen and sterility testing at a third party lab. Neither the FDA nor our pharmacy uncovered any evidence that the symptoms were caused by our product and were not due to an unknown alternative source.
There is currently a debate on which standards should be applied to compounding pharmacies. The FDA has been inspecting compounding pharmacies around the nation and they inspected our pharmacy from March to April 2013. During these inspections the FDA has been inappropriately using the FDA 210 and 211 Manufacturing Guidelines as a basis for their inspections despite the fact sterile compounding pharmacies are not manufacturers and should be instead be judged according to USP <797> regulations.
While we disagree with the FDA’s approach, we do recognize the necessity for continuous quality improvement. Our highest priority is patient safety and we are continuing to make improvements in order to uphold the highest standards for pharmacy compounding.
NuVision Pharmacy continues to improve our facility and incorporate safety measures that would surpass the requirements of current regulation, including changes based on the FDA’s recommendations.
Any of our patients and customers with concerns should contact us . We will be happy to discuss this issue with you and provide you with further information as necessary.
Sincerely,
Thank you,
Dr. Kristi Kubosh, PharmD, RPh
President
Pharmacist in Charge
quoted from here
26AUG
NuVision Pharmacy is a specialty compounding pharmacy committed to patient safety. We adhere to the USP <797>, which is the professional and legal standard for all sterile compounding pharmacies. We follow all state and federal pharmacy laws and our pharmacy license is in good standing with the Texas State Board of Pharmacy.
In response to the warning letter issued by the FDA about our sterile products, we would like to take this opportunity to set the record straight and address their accusations.
There is no evidence to support the FDA’s claim that our products lack sterility assurance. We have sterility tests performed on every lot of sterile products we dispense. We maintain test results documenting a passing sterility test for every product sold by our pharmacy and there is no evidence of any sterile product dispensed by our pharmacy being contaminated.
The FDA did not receive reports about fever, flu-like symptoms, and soreness at the injection site associated with the methylcobalamin injection product. This is information we voluntarily provided to the FDA. The FDA inspectors had no knowledge of this incident prior to our disclosure. The symptoms were experienced by three individuals and were related to the use of one vial.
Before the FDA was even aware of this issue, NuVision Pharmacy had already proactively recalled the lot in question and contacted everyone who had received it. No one else reported any adverse effects from the use of the product. The vial in question was also used by the same doctor to inject other patients who experienced no adverse effects. The vial associated with these adverse effects was returned to our pharmacy for testing and it passed pyrogen and sterility testing at a third party lab. Neither the FDA nor our pharmacy uncovered any evidence that the symptoms were caused by our product and were not due to an unknown alternative source.
There is currently a debate on which standards should be applied to compounding pharmacies. The FDA has been inspecting compounding pharmacies around the nation and they inspected our pharmacy from March to April 2013. During these inspections the FDA has been inappropriately using the FDA 210 and 211 Manufacturing Guidelines as a basis for their inspections despite the fact sterile compounding pharmacies are not manufacturers and should be instead be judged according to USP <797> regulations.
While we disagree with the FDA’s approach, we do recognize the necessity for continuous quality improvement. Our highest priority is patient safety and we are continuing to make improvements in order to uphold the highest standards for pharmacy compounding.
NuVision Pharmacy continues to improve our facility and incorporate safety measures that would surpass the requirements of current regulation, including changes based on the FDA’s recommendations.
Any of our patients and customers with concerns should contact us . We will be happy to discuss this issue with you and provide you with further information as necessary.
Sincerely,
Thank you,
Dr. Kristi Kubosh, PharmD, RPh
President
Pharmacist in Charge
President
Pharmacist in Charge
quoted from here
26AUG
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