Ohio to inspect more pharmacies this fall Meningitis outbreak leads to scrutiny

DAYTON — Ohio is cracking down on pharmacies that custom-mix individualized prescriptions after a deadly fungal meningitis outbreak linked to a Massachusetts compounding company.

Jesse Wimberly, pharmacy inspector for the Ohio State Board of Pharmacy, said there are 17 specially designated compounding pharmacies statewide. They’re usually inspected at least once every three years, though inspectors will go more often if there are complaints or reported violations.

“Now we’re going to every one of these pharmacies that are designated for compounding,” Mr. Wimberly told the Dayton Daily News.

He said the state now requires pharmacies to specify how much of their business is strictly retail sales and how much is mixing custom preparations. They must demonstrate that they meet cleanliness standards and show that their products are being prepared for specific patients — not mixed up in advance and set aside to fill future orders.

Not being able to link prescriptions to specific patients is one of the issues that officials are finding in the investigation of the New England Compounding Center in Framingham, Mass., he said.

The U.S. Centers for Disease Control and Prevention reports that more than two dozen people have died and more than 300 have been sickened across the country in the outbreak, which has been linked to steroid shots for back pain.

Eleven people have been sickened in Ohio, but no one has died.

To continue reading click here

Markey says need for new pharmacy regulations

To read this article click here

CDC: Cases of a rare fungal meningitis rise to 363; deaths at 28

Dr. Allen, Expert on Compounding, Points Out Misrepresentations by the Press

Here is part of Dr. Allen's Editorial that appears in the Compounding Today Newletter:

Editorial: Misrepresentations by the Press

Those keeping up with the events in Massachusetts have no doubt read many accounts of the events and the answers to questions posed to pharmacy leadership by the press. Most reporters have very little, if any, knowledge of pharmacy compounding and are either unaware or seemingly don't care if they are not accurate and complete in their reporting.

A specific comment I would like to address is that some reports have misquoted statements that say that compounders want lower standards. This is absolutely false! Pharmacists, pharmacy compounding leadership, and company CEOs involved in providing support to compounding pharmacies want strong quality standards, and they work hard for strong quality standards.

What many reporters do not understand is that there is a difference in Good Manufacturing Practices (GMPs) that are required for FDA-registered manufacturers and the legal standards for compounding developed by the United States Pharmacopeia (USP) and the state boards of pharmacy. USP standards are enforceable by both the FDA and the state boards of pharmacy.

To continue reading this editorial click here