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After meningitis outbreak, FDA cracks down on compounding pharmacies

by Jaclyn Cosgrove Published: April 7, 2013

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.

Earlier this year, the FDA investigated about 30 pharmacies nationwide in what Kelly said is the first round of this type of investigation. Depending on the result of these investigations, the FDA could expand its list of pharmacies to check into.

Red Cross Drug's compounding practice was founded by Harvey Ahl, who was a pharmacist for several years, and is now owned and operated by his son, Jeff Ahl, according to the company's website.

In their report on the Blanchard pharmacy, FDA investigators made 12 observations, noting the pharmacy's staff lacked proper training, did not wear proper gowning while at work and did not use proper sterilization techniques, according to the report.

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by Jaclyn Cosgrove
Medical and Health Reporter
Jaclyn Cosgrove writes about health, public policy and medicine in Oklahoma, among other topics. She is an Oklahoma State University graduate. Jaclyn grew up in the southeast region of the state and enjoys writing about rural Oklahoma. She is...
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