Important Must Read Comments From Readers Regrading Pharmacy Creation Recall
Anonymous said...
This pharmacy was acquired by Imprimis Pharmaceuticals in early 2014--the website describes what appears to be an unapproved new drug development "pathway" for patent- pending products that rely on 503A exemptions to certain provisions of the food drug and cosmetic act. But, if the products don't meet conditions for exemptions, they will be paddling uphill and into a strong current (i.e., the traditional drug development pathway for marketing an approved therapy). Even if an affiliated pharmacy meets conditions for exemptions, other provisions of the FDCA may apply, according to the finalized guidance, which can be viewed here: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM377052.pdf.
I would read this recall in conjunction with the FORM FDA 483 issued to Front Range, which included information on the passing purportedly sterile samples where positive controls tested negative.
The 483 can be viewed here: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicREadingRoom/ucm340853.htm
It would be interesting in this regard to see the response to this letter: http://democrats.energycommerce.house.gov/sites/default/files/documents/Karolchyk-Compounding-Centers-2012-12-7.pdf
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