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After meningitis outbreak, FDA cracks down on compounding pharmacies

by Jaclyn Cosgrove Published: April 7, 2013

Cindy Hamilton, at the state Board of Pharmacy, said Lowlyn Pharmacy has not come before the board and is not scheduled to be disciplined on Thursday at the board's April meeting.

Larry Kirkpatrick is listed in the state Board of Pharmacy's online database as the pharmacist in charge at Red Cross Drug. He is in good standing with the board and has no disciplinary actions listed against him, according to the database.

Lowell J. Ahl is listed in the FDA's report as the president of Lowlyn Pharmacy. He is a pharmacy technician and in good standing with no prior disciplinary actions, according to the state Board of Pharmacy's database.

In 2004, the FDA investigated the pharmacy and cited “significant violations of the Federal Food, Drug and Cosmetic Act.” The FDA's letter to Lowlyn Pharmacies cites concern over veterinary drugs compounded without an animal identified to receive treatment and drugs compounded that duplicate drugs available on the market.

Kelly said the pharmacy was operating outside the realm of services a compounding pharmacy is supposed to provide.

“What we view as nontraditional compounding occurs when a compounded product is intended to be sterile and the compounding is done in advance or without receiving a prescription and when (the pharmacy) ships compounded product across state lines,” he said.

Motives questioned

A debate currently exists among pharmacists about whether the FDA investigated these pharmacies to be more comprehensive in their approach or because the agency needs to show the public it's doing something in light of the fungal meningitis outbreak.

Loyd Allen, the editor of the International Journal of Pharmaceutical Compounding, said he believes a large part of it is the latter.

One of the important services that compounding pharmacies provide is producing drugs that are not available because of a drug shortage, he said.

“What has really complicated the system of health care is the drug shortage issue, and so you've got hospitals all over the U.S. trying to buy medications for their patients, and they're not available,” Allen said.

In 2011, there were about 270 drugs facing shortages. Whenever there's a drug shortage, a compounding pharmacy is allowed to make that drug to help increase access.

But a gray area exists around what a compounding pharmacy can and cannot do when there's a shortage for a drug, he said.

“Pharmacies have tried to fill the void, and most of them are doing a great job, no question, but what we hear mostly about is those that don't, and for those that don't, there are some issues because they're either not properly trained or not abiding by the standards that are set,” he said.

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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