Black holes and gray areas: State, federal authorities take a closer look at pharmacy compounding

Retailers moving into sterile compounding could encounter more complex legal, regulatory environment

Authorities in Massachusetts are looking to tighten regulations on compounding pharmacies as the state health department announced some changes to the makeup of the Massachusetts Board of Pharmacy and sent cease-and-desist notices to three compounding pharmacies for alleged violations.

Retail pharmacies looking to get into sterile compounding and exercise greater control over that supply chain — as Walgreens did last month when it bought an independent specialty compounding pharmacy in Indiana — should take note because it seems there will be increased scrutiny on the practice following a nationwide outbreak of meningitis linked to alleged unsanitary conditions at the Framingham, Mass.-based New England Compounding Center.

At the same time, federal authorities are looking to crack down on an industry whose regulatory environment the Massachusetts health department characterized as a "gray area." In November, Food and Drug Administration commissioner Margaret Hamburg testified before the House Committee on Energy and Commerce, detailing the FDA's response to the meningitis outbreak and requesting greater oversight for the agency over pharmacy compounding.

In her testimony, Hamburg herself said that the FDA's ability to scrutinize and take action against compounding pharmacies that may be endangering public health has been held back by unclear and incomplete laws, some of which have led to legal challenges to the agency's regulatory authority. Earlier that month, in response to the outbreak, Rep. Edward Markey, D-Mass., proposed legislation to strengthen the federal government's ability to regulate compounding by ending the "regulatory black hole."

There are two basic forms of compounding: traditional or nonsterile compounding, which is done in the pharmacy and involves making products like creams and ointments, mouthwashes and suppositories; and sterile compounding, which refers to industrial scale compounding of injected drugs and requires specialized facilities and attention to sanitation and cleanliness.

Many pharmacy retailers, particularly independents, already do the former. With more and more retailers moving into specialty, the latter makes good business sense as well. But as state and federal authorities start taking a closer look at the practice, pharmacy retailers should pay close attention because things could start getting complicated.

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