FDA Censures Med-South Pharmacy for CGMP Violations

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:

• Failure to establish and follow written procedures to prevent microbiological contamination of injectable drug products purporting to be sterile

• Failure to establish and follow written procedures for production and process controls to ensure injectable drug products have the identity, strength, quality, and purity they are purported to have

• Failure to establish a quality-control unit that approves or rejects all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products

• Failure to investigate instances when drug products do not meet their specifications

• Failure to establish a written stability-testing program

• Failure to ensure drug products held in unlabeled conditions are sufficiently identified to preclude mislabeling

• Failure to establish written procedures for the cleaning and maintenance of manufacturing, processing, packing, or holding equipment

• Failure to reject components that do not meet required specifications. Specifically, FDA discovered Med-South used a component labeled “Sterile Water for Irrigation USP” and “Not for Injection” to manufacture sterile injectable drug products, although the company’s formula worksheets require sterile water for injection.

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.