Thursday, March 6, 2014

Wedgewood: Exclusive: Absent prescriptions, bad manufacturing processes alleged at South Jersey pharmacy

Senior Reporter- Philadelphia Business Journal
Inspectors from the Food and Drug Administration have issued a warning letter to a South Jersey compounding pharmacy that alleges numerous violations of federal regulations governing the manufacturing of pharmaceutical products. But the company, Wedgewood Village Pharmacy in Swedesboro, N.J., is arguing that they are being penalized for violating laws that weren't in place at the time their business was investigated.
Wedgewood is among the largest compounding pharmacies in the country. It serves more than 25,000 prescribers across the United States, and has a formulary of more than 14,000 custom-compounded preparations. Compounding pharmacies are those that make drugs for specific patients who have needs that can’t be met by commercially available drugs. A patient, for example, may have an allergy to an ingredient in the commercial version of a desired medicine.
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