Showing posts with label Blanchard. Show all posts
Showing posts with label Blanchard. Show all posts

Monday, April 8, 2013

After meningitis outbreak, FDA cracks down on compounding pharmacies By Jaclyn Cosgrove | Published: April 7,

 A few months after a nationwide fungal meningitis outbreak linked to contaminated drugs, the U.S. Food and Drug Administration launched an investigation into several compounding pharmacies, including one in Oklahoma.


Lowlyn Pharmacies, a Blanchard pharmacy that operates under the name Red Cross Drug, is one of about 30 pharmacies across the U.S. that were cited in an FDA investigation of facilities that the federal regulatory agency says are operating outside the realm of traditional compounding pharmacies.
“The recent tragic fungal meningitis outbreak linked to a contaminated compounded drug has shed a harsh but important light on an area that state and federal regulatory authorities have struggled to effectively oversee for years,” FDA spokesman Christopher Kelly said in a statement. “In light of the outbreak and other past events involving compounders, the FDA will continue to use its existing authorities we have to protect consumers.”
Kelly could not comment specifically on Lowlyn Pharmacies, for the FDA's investigation is still pending. Employees at the pharmacy declined to comment.
Compounding pharmacies provide specialized drugs for patients, who among other reasons, might have an allergy to a certain ingredient in a drug or need a drug that's unavailable because of a drug shortage.
Kelly said the FDA does not want to limit traditional compounding pharmacies but rather “nontraditional” compounding pharmacies that produce large amounts of drugs that aren't created for a specific patient.
This was the case in the compounding pharmacy behind the outbreak.
In September, the New England Compounding Center began its recall of steroid injections that were determined contaminated and causing patients to develop fungal meningitis. The compounding center was producing large amounts of compounded drugs and shipping them out of state.
The first lot of contaminated steroid injections was produced from the New England Compounding Center in May, according to the Centers for Disease Control and Prevention. Nineteen Oklahoma medical facilities were customers of the New England Compounding Center, according to FDA records.
The outbreak has sickened at least 720 people and killed 48. No one in Oklahoma has been reported sick or to have died because of the outbreak.
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