An FDA News Release reports of a nationwide voluntary recall of all non-expired sterile drugs distributed by Abrams Royal Compounding Pharmacy. The Dallas company is recalling all intravenous injections, injectable medication, eye drops, nasal sprays, pellet implants, inhalation solutions, and eye ointments made between June 17th and December 17th 2013.
The FDA is alerting all health care professionals to stop using affected products as they may cause serious ...
continue reading...
According to a USA Today story about an ongoing fungal meningitis outbreak, the specialty pharmacy responsible has been flagrantly violating both sanitation standards and the terms of the federal laws permitting it to operate.
But the story characterizes the problem not simply as the practices of a single irresponsible business, but a systemic failing that’s permitted “compounding pharmacies” to operate on a large scale under relatively lax regulatory standards.
And patients ...
continue reading...
A U.S. Senate committee has approved a bill designed to impose tighter restrictions on compounding pharmacies, such as the one blamed for a deadly meningitis outbreak. The legislation is now headed for the full Senate.
But according to a story in the Washington Post, consumer health and public advocacy groups are criticizing the proposed legislation for not going far enough.
Compounding pharmacies are specialty pharmacies that prepare medications from ingredients provided ...
continue reading...
A deadly fungal meningitis outbreak apparently caused by tainted medication may present yet another hazard for patients, according to a NBC News story.
Officials with the U.S. Centers for Disease Control and Prevention report a relapse in an 80-year-old man who developed meningitis last year.
The CDC officials wrote of that case in a recent edition of the New England Journal of Medicine.
According to the CDC, the outbreak has read more.... --> continue reading...
Following an inspection by the U.S. Food and Drug Administration, a Florida specialty pharmacy called The Compounding Shop is recalling all of its sterile products, ABC News reports.
According to the story, FDA inspectors were concerned about sterility problems with company drugs that could lead to bacterial contamination. The agency advised health care professionals to keep drugs produced at the company away from patients.
The FDA investigation was part of a ...
continue reading...Food and Drug Administration Commissioner Dr. Margaret A. Hamburg has admitted that her agency wasn’t aggressive enough in investigating compounding pharmacies, such as the one responsible for a deadly, nationwide meningitis outbreak.
But in a hearing before a House Energy and Commerce subcommittee, Hamburg also said the agency needs stronger legal authority if it’s going to make such pharmacies conform to stricter safety standards, the New ...
continue reading...
