Compounding pharmacy College Pharmacy's manufacture and distribution of some products without valid prescriptions for individually identified patients drew an FDA citation under two Food, Drug and Cosmetic Act provisions for continued objectionable conditions in its aseptic processing operations, the agency said in an Aug. 15 warning letter.
FDA cited the Colorado Springs, Colo., pharmacy for adulteration of purportedly sterile drugs under section 501(a)(2)(A) of the act, but then also cited it under the act's section 201 and...
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