Massachusetts Compounding Pharmacy Recalls All 2013 Products

An unannounced inspection at a Massachusetts compounding pharmacy recently uncovered suspicious material on medication containers, leading the operation to order a voluntarily recall for all its 2013 products.

Pallimed Soluitions, Inc. of Woburn issued the recall after the visit from the Food and Drug Administration (FDA) and the Massachusetts Board of Registration in Pharmacy. The agencies found an unknown substance on sterile compounding products. Five affected vials were discovered and no illness has been reported. The recalled drugs include those used for erectile dysfunction treatment, testosterone replacement therapy, vitamin injections and ophthalmic preparations.

The Board of Registration has ordered the pharmacy to halt sterile compounding activities. In December, the compounding pharmacy was among three cited by the state pharmacy board during unannounced inspections. Pallimed was ordered to stop production of sildenafil citrate, which is sold as Viagra. The inspection found the medication was being prepared with improper components.

Medication involved in the recall was shipped to patients and medical offices in Massachusetts, New Hampshire, Rhode Island, Maine, Connecticut, Vermont and 15 other states. Recipients are advised to discontinue use of medications and return to Pallimed Solutions.

The FDA and Massachusetts Board of Registration in Pharmacy share regulation of compounding pharmacies in Massachusetts, which in contrast to large manufacturers, are allowed to dispense medications for individuals with prescriptions, often with conditions which cannot be met in regular pharmacies.

Both agencies are still responding to the aftermath of 2012, when the New England Compounding Center in Framingham was linked to a deadly fungal meningitis outbreak, which sickened over 650 people in 19 states and killed at least 39 others.

In January, Gov. Deval Patrick proposed new licensing requirements for compounding pharmacies, including to let the state assess fines for violating regulations, to protect whistleblowers and reorganize the state pharmacy board.

Along with federal regulations, compounding pharmacies in Massachusetts operate under 247 CMR. Under M.G.L. 94C, section 21 and 105 CMR 721.000, pharmacies and pharmacists must have a prescription for a specific patient before they dispense a medication.

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Meningitis Outbreak Prompts Federal and State Action on Compounding Pharmacies

A Massachusetts congressmen is proposing legislation that would give the Food and Drug Administration (FDA) greater authority over compounding pharmacies in the wake of a 19-state meningitis outbreak that has killed 29 people.

Rep. Edward Markey, (D., Mass.) last week announced the legislation, which would allow the FDA to inspect and regulate pharmacies partly based on their product volume.

Currently, states hold most of the authority over compounding pharmacies and the FDA is limited to inspections. It cannot require a compounding pharmacy to follow any operating standard.

Markey’s proposal aims to add oversight for compounding pharmacies which produce larger quantities. It does not target the traditional compounding pharmacy, which makes drugs for individual patients with a prescription.

The meningitis outbreak is being blamed on tainted steroid shots made by New England Compounding Center (NECC) of Framingham. As of Nov. 2, 395 people had contracted fungal meningitis, including the 29 deaths. Nine patients have fungal joint infections from steroid injections to the knee, hip, shoulder and elbow.

Officials say the defective drugs were shipped to 23 states and up to 14,000 patients may have been exposed. None of the contaminated product was distributed to Massachusetts healthcare providers or hospitals.

Markey’s proposal follows other attempts for regulation. In 1997, Congress passed a law giving the FDA authority to regulate large compounding pharmacies which advertised their products. But the U.S. Supreme Court struck down the law in 2002.

In Massachusetts, the Board of Registration in Pharmacy also moved to tighten controls last week, unanimously approving rules which allow the state to track drugs made by compounding pharmacies. The state’s goal is to determine whether a compounding pharmacy is violating its license and producing bulk quantities like a manufacturing facility. State officials say NECC was in violation of its license.

NECC has been shut down by the state and all of its products have been recalled. Another compounding pharmacy under the same ownership, Ameridose of Westborough, also recalled all of its drugs last week. On Oct. 10, Ameridose agreed to a temporary shutdown, which has been extended until Nov. 19.

State officials are seeking permanent surrender of NECC’s pharmacy license and permanent license revocation for NECC’s three pharmacists. The state has also started inspecting other compounding pharmacies, one of which has agreed to surrender its license after violations were found.

The Federal Bureau of Investigation (FBI) has launched a criminal investigation and at least three people have also filed personal injury lawsuits, reports USA Today.

Insight: How compounding pharmacies rallied patients to fight regulation, Reuters.

Harsh punishments rare for drug compounding mistakes, USA Today.

Pharmacy board adopts new rules, The Boston Globe.

Meningitis outbreak nears 400 infected as lawmakers push for tougher regulation, Associated Press/CBS News.
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