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The US Food and Drug Administration sent Med-South Pharmacy a Warning Letter for producing large volumes of betamethasone acetate?betamethasone sodium phosphate without following current good manufacturing practices (CGMPs).
Rockville, MD (Oct. 9)-The US Food and Drug Administration sent Med-South Pharmacy (Pelham, AL) a Warning Letter for producing large volumes of betamethasone acetate–betamethasone sodium phosphate without following current good manufacturing practices (CGMPs). The agency conducted two inspections of Med-South’s Pelham facility, which operates under the name Partners in Care. Among the 24 CGMP violations FDA cited were:
FDA began investigating Med-South after receiving an adverse-event report relating to the betamethasone acetate–betamethasone sodium phosphate product. The investigation revealed that more than 70 patients had filed complaints with Med-South about the drug. The complaints described symptoms such as redness, bruising, swelling, rash, fever, and cellulitis, a potentially serious skin infection.
During the inspections, FDA found that, although Med-South calls itself a compounding pharmacy, it produces drugs in volumes that exceed the scope of traditional pharmacy practice. For this reason, the agency concluded that the company should be regulated as a pharmaceutical manufacturer.
Betamethasone acetate–betamethasone sodium phosphate is an injectable corticosteroid. The product is manufactured by Schering-Plough and sold under the name “Celestone Soluspan.” The drug is used to treat conditions such as rheumatic disorders, dermatologic diseases, endocrine disorders, respiratory diseases, hematologic disorders, and neoplastic disorders.
FDA’s warning letter was sent on Sept. 28, 2007 and posted on the agency’s website on Oct. 9. Click here for the full text of the Warning Letter.