Compounding pharmacy that recalled drugs had customers in states where it’s not licensed

Posted: Published on April 9th, 2013

This post was added by Dr P. Richardson

A Woburn compounding pharmacy that recalled two dozen drugs this week has said it distributed directly to patients and doctors in up to 21 states, but a Globe review found the company lacked the required license to operate as a pharmacy in at least a third of those states.

The California pharmacy board on Wednesday ordered Pallimed Solutions Inc. to stop shipping prescription drugs into that state because it had no license. Texas will consider taking similar action, the pharmacy board director said. State officials in Illinois, Maine, Wisconsin, Vermont, and Virginia all listed on the distribution list in Pallimeds recall notice said the company was not properly licensed to operate within their borders.

The possibility that the pharmacy was operating in states where it is not licensed points to continued gaps in the oversight of compounding pharmacies exposed last year when tainted steroids produced at New England Compounding Center caused a national crisis.

The Framingham pharmacys drugs sickened hundreds of people and have been linked to 51 deaths. Regulators have said New England Compounding was acting more like a drug manufacturer, shipping products in bulk to providers nationwide though it didnt have a federal license.

While manufacturers are overseen by the Food and Drug Administration, it is the responsibility of compounding pharmacies to secure proper licenses for the states in which they do business.

Its easy to see how, given the regulatory structure, these companies can go undetected, particularly if they are shipping drugs directly to patients homes, said Dr. Michael Carome, deputy director of the Health Research Group at Public Citizen, a consumer advocacy group.

Compounders are supposed to custom make drugs for individual patients who need doses or preparations that arent available off the shelf. Some compounders, including Pallimed and New England Compounding, specialized in mixing sterile products, which can include injections, intravenous solutions, and eye drops.

Pallimed announced on Tuesday that it is working with the FDA to recall all sterile compounded products it has dispensed since Jan. 1, after inspectors found still-unidentified contaminants in five vials of drugs at the companys Woburn pharmacy.

Many of the recalled products are injections used to treat erectile dysfunction or other conditions. No patient injuries or illnesses have been reported as a result of the recall. Pallimed has said it will continue to make products that dont require a sterile compounding process.

The company would not comment this week on how many patients might have received recalled items, where exactly it shipped its drugs, or where the pharmacy is licensed.

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Compounding pharmacy that recalled drugs had customers in states where it’s not licensed

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