The FDA told three compounding pharmacies in California, Kentucky and Vermont that it found serious deficiencies in their practices for producing sterile drugs, according to warning letters posted Jan. 12 on the FDA’s website.
The Food and Drug Administration said that based on inspections, the pharmacies appear to be producing drugs that violate the Federal Food, Drug, and Cosmetic Act (FDCA).
The pharmacies include one outsourcing facility: Edge Pharmacy Services LLC in Colchester, Vt. The other compounding pharmacies are Ionia Pharmacy LLC in Tustin, Calif., and Spoonamore Drug Co. in Louisville, Ky.
The Drug Quality and Security Act of 2013 ...
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