Sunday, January 6, 2013

State Regulation of Compounding Pharmacies Is Inadequate

Over the past several weeks, 36 people have died and more than 500 others have been infected with fungal meningitis from tainted steroids obtained from a compounding pharmacy in Massachusetts. This industry prefers state regulation of its practices and has been fighting Food and Drug Administration (FDA) oversight for more than a decade. Some, including Rep. Ed Markey (D-MA) and FDA Commissioner Margaret Hamburg, are now calling for clear FDA oversight authority over compounding pharmacies.

Traditionally, compounding pharmacies mixed medicines specifically for individual patients, following the instructions in a health care provider's prescription. For example, they would eliminate an allergen from a medicine or put cherry flavoring in foul-tasting medicine based on an individual patient’s needs. States oversee these compounding practices. But 42 states permit a practice known as “compounding for office use” where a pharmacist prepares multiple doses of a medicine without a prescription for a specific patient and sells those doses to providers. At some point, a compounding pharmacy produces so many doses of a medicine that its practices begin to look like manufacturing rather than compounding.
Generally, states have regulated pharmacy practices, and the compounding industry prefers to leave it that way. Markey's recent report on the industry suggests the reason why. Only six states have a record of taking enforcement action against compounding pharmacies since 2001. As Markey's report notes, “State regulators are not, or cannot, perform the same sort of safety related oversight of compounding pharmacy practices that FDA has historically undertaken.” In other words, effective FDA standards might have safeguarded the public from the meningitis outbreak.

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