Bill could force many compounding pharmacies to give up practice, survey finds

HOUSTON — A bill under consideration by the Senate could force more than 40% of compounding pharmacies to abandon compounding, according to a new survey.

PCCA, a company that supplies ingredients, equipment, education and training to independent compounding pharmacies, announced the results of a survey of nearly 800 pharmacists regarding S. 959, the Pharmaceutical Quality, Security and Accountability Act. Slightly more than 41% of respondents also said that the bill would force them to change current business practices in order to remain as a "traditional" compounding pharmacy; about 29% either would not have to change or didn't know if they would.

S. 959 requires pharmacies engaging in three common practices regulated under state law to register as "compounding manufacturers." Pharmacies included under the bill include those that prepare sterile preparations for human use, prepare them in advance of receiving a legal prescription order or dispense them outside the state in which they're located.

PCCA said that the bill, despite being proposed to improve the safety of compounded drugs, would force many pharmacies to make choices that it said would decrease the safety of compounded medications and reduce patients' access to compounded drugs.

The bill was proposed by Sen. Tom Harkin, D-Iowa, in response to last year's contamination scandal centered on the New England Compounding Center, which resulted in a nationwide outbreak of fungal meningitis that sickened hundreds and killed dozens. The outbreak led to calls for stricter regulations of compounding pharmacies, particularly those that engage in sterile compounding of injected drugs. Sterile compounding differs from non-sterile compounding in that the latter typically involves the making of suppositories, ointments and other simple preparations by a pharmacist for a single patient under orders from a physician. Sterile compounding typically involves specialty drugs.

"The sponsors of S. 959 claim that this legislation will not affect community pharmacies," PCCA president Jim Smith said. "In fact, 41% of the respondents to this survey meet the bill's criteria for 'manufacturing.' The survey showed that pharmacies would be either forced to give up their pharmacy business or make painful changes to their business that would greatly reduce access to compounded preparations."