Compounding pharmacies rarely get tough punishments; Another firm recalls drugs

Nov 2 2012

USA Today examines how officials have dealt with charges of misconduct at the pharmacies in the past. Meanwhile, a compounding pharmacy, which is owned by the same company that owned the plant linked to the meningitis outbreak, is recalling its products after an FDA review.

USA Today: Harsh Punishments Rare For Drug Compounding Mistakes
The legal landscape is littered with charges of negligence and misconduct by compounding pharmacies such as the one implicated in the nation's ongoing meningitis outbreak, but they rarely result in tough punishments, an examination of legal records shows (Eisler, 10/31).

Medpage Today: Meningitis: New Drug Recall, 29 Dead
A sister company of the compounding pharmacy at the heart of the fungal meningitis outbreak that has now claimed 29 lives is voluntarily recalling all its products. The move is an "expansion of our cooperation" with the FDA and the Massachusetts Board of Registration in Pharmacy, Ameridose, of Westborough, Mass., said in a statement today. The company, which shares ownership with the New England Compounding Center, said it does not know of any adverse reactions from its products and there has been no evidence of impurities. Instead, the company said, the move is being undertaken out of an "abundance of caution." Meanwhile, the CDC has reported an additional 14 cases and one death related to the preservative-free methylprednisolone acetate made and distributed by the New England Compounding Center (Smith, 10/31).

The Associated Press: Mass. Firm With Ties To Outbreak-Linked Pharmacy Issues Voluntary Recall Of All Products
A company with the same founders as the specialty pharmacy linked to deadly meningitis outbreak said Wednesday that it's recalling all its products after federal inspectors said it must improve its sterility testing process. Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration, said she could not be specific about the problem at Ameridose (10/31).

CNN: Concerns Over Drug Shortages With Mass. Company Recall
However, federal officials said the recall may contribute to a shortage of products. "The FDA has identified some Ameridose products that currently appear on the critical shortage list," the agency said in a statement. "These products were in shortage before the Ameridose recall, but supplies may be further affected as a result. ... The FDA is working with alternative manufacturers to maintain supplies of these life-saving drugs" (10/31).