States: More federal help needed in compounding pharmacy oversight

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PharMerica agrees with FTC lawsuit blocking Omnicare takeover
PharMerica agrees with FTC lawsuit blocking Omnicare takeover

Brought together by the recent outbreak of fungal meningitis, state regulators sought action from the U.S. Food and Drug Administration to regulate compounding pharmacies. The requests came in a Dec. 19 meeting convened by the FDA with representatives from all 50 states.

Traditional compounding pharmacies make custom medications for patients in response to a prescription. In the meningitis outbreak, New England Compounding Center reportedly produced large amounts of medication without individual prescriptions. So far 39 people have died, with 620 overall being affected by the outbreak.

“The federal government should establish a federal definition of manufacturer and compounding pharmacy,” said Mark Johnston, executive director of the Idaho State Board of Pharmacy. “The most important task is defining the exceptions.”

In addition, the states asked the FDA for better communication and training, and pointed to the legislature for stronger and clearer laws and standards for nontraditional pharmacies. State boards of pharmacy oversee compounding pharmacies.

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