S. 959 passage would close 40% of compounding pharmacies, survey says

September 26, 2013

A new poll sent to independent compounding pharmacies by the Professional Compounding Centers of America (PCCA) found that approximately 40% of pharmacies surveyed would close their businesses under the requirements of Senate Bill 959, The Pharmaceutical Quality, Security, and Accountability Act.

 

A new poll sent to independent compounding pharmacies by the Professional Compounding Centers of America (PCCA) found that approximately 40% of pharmacies surveyed would close their businesses under the requirements of Senate Bill 959, The Pharmaceutical Quality, Security, and Accountability Act.

S. 959 requires that pharmacies register as “compounding manufacturers” if they compound sterile preparations for human use, compound sterile preparations in advance of receiving a prescription, and dispense the preparations outside of the state. Pharmacies must chose to be a “traditional” compounding pharmacy or register as a “compounding manufacturer”. The pharmacies may not operate in both categories from the same facility.

In addition, compounding manufacturers are only permitted to sell their preparations to hospitals, clinics, and prescribers with a purchase order. They would be limited to an FDA list for non-sterile compounding.

Traditional compounders could still fill prescribers’ order for office use, but would have to keep the names of all patients to whom a physician has administered the compound from the office order. Reconciliation of the patients receiving the compound would be required within 14 days of administration. In addition, there would be a limit of no more than 10% of total compounded drugs in a 30-day period for office-use compounds.

“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, increase costs, and/or eliminate local jobs,” said PCCA President Jim Smith in a press statement.

“If this rate is typical, of 7,500 compounding pharmacies nationwide, 3,075 pharmacies would be forced to give up their pharmacy business or change them in ways detrimental to them, the economy, their patients, and prescribers – while doing nothing to improve the safety of compounded medications.”

Smith said that PCCA disagrees that S. 959 will enhance patient safety by giving the FDA more federal authority over this state-regulated profession.

Both Senate and House committee leaders who oversee health policy reached an agreement September 25 on the compounding legislation and legislation to improve drug safety in the pharmaceutical supply chain with the Drug Quality and Security Act. Senate HELP Committee Chairman Tom Harkin (D-IA) had introduced S. 959 in May, a bill designed to help ensure compounding safety following last year’s deadly meningitis outbreak that was linked to the New England Compounding Center, Framingham, Mass.