Rx compounding is a state issue,

Sunday, August 31, 2003

WASHINGTON – Despite documented problems with drug compounding at the pharmacy level, the federal government should leave oversight of the process to the states, say HME providers who handle medications.

Federal interest in the compounding procedure escalated in late June when Sens. Kit Bond (R-Mo.) and Pat Roberts (R-Kan.) announced intentions to investigate the safety of drug compounding at the pharmacy level. Recent incidents of cancer drug dilution and bacteria contamination that resulted in patient deaths prompted the senators to create an advisory committee to study the safety and necessity of compounded drugs.

The inclusion of the advisory committee in national Medicare reform has raised provider questions about whether the federal government has the right to claim jurisdiction over the states on pharmacy regulation.

“The state boards of pharmacy and the federal government have always been separate,” said Marcus Kruk, vice president of Cincinnati-based HME Services. “The feds have historically taken a back seat even when they wanted to be involved.”

Likewise, Jeff Reagan, owner of Reagan Home Care Pharmacy in Conyers, Ga., believes the feds should back off.

“This should be done on a state level, not a federal level,” said Reagan, a registered pharmacist.

“I am licensed by the state for pharmacy and by the feds only for distribution of narcotics. I believe each state has the right and responsibility to take care of its residents.”

Moreover, HME providers wonder whether federal law would supersede state law and what measures the federal government would take to enforce any new regulations it creates.

Imposing the same compounding standards on independent pharmacies as pharmaceutical manufacturers could cripple the industry, one provider said.

“In many ways it would elevate the corner pharmacy to the level of a manufacturer, and that could definitely have an impact on the marketplace,” the provider said. “It will probably drive certain people out of the compounding business altogether because of the cost involved.”

Ironically, pharmacy started out as a compounding profession, Reagan said. Equating a pharmacist’s compounding procedures with manufacturing is regulatory overkill, he said.

“If a pharmacy is making mass quantities of product and putting it on a shelf anticipating prescriptions for it, that is manufacturing,” Reagan said.

“If I’m presented with a prescription with a specific dosage for an individual patient, that is not manufacturing, that is compounding. As an independent pharmacy, I am not mass producing and stockpiling product.”

Done properly in a sanitary environment, drug compounding poses no danger to patients, Reagan added.

“We have a clean room set up for IV therapy mixing and it’s no different than mixing in a hospital. We use sterile products and sanitary techniques. We are inspected by the state to make sure we are following procedures,” Reagan said. HME