Pharmacy accused of illegal compounding

NORTH KINGSTOWN, R.I. (WPRI) -- The Rhode Island Department of Health has ordered a Saunderstown pharmacy, it said was illegally compounding and distributing medication, to immediately stop the practice. However, the owner insists it's nothing more than a paperwork issue.

HEALTH officials announced Tuesday it issued sanctions against Bayview Pharmacy, located on Tower Hill Rd. in North Kingstown, citing illegal compounding operations and health violations found during a Sept. 7 inspection and a subsequent Nov. 13 follow-up.

The agency said the pharmacy is only licensed to compound, or combine, medications prescribed by licensed prescribers for specific patients. However, inspectors said records show Bayview had been operating as an unlicensed manufacturer and distributor of sterile injectable medications to both Rhode Island residents and out-of-state customers, located as far away as Illinois.

Other violations cited include:

• Use of expired powders.
• Use of compounding powders obtained by unlicensed manufacturers and distributors.
• Failure follow mandatory maintenance and cleaning procedures in its sterile compounding room.
• Failure to perform weekly environmental monitoring for microorganism, as required for high-risk sterile compounding.
• Pet bedding, food and dish located in a cubicle next to the compounding area.

While it must immediately stop compounding sterile injectables in its clean room, Bayview Pharmacy will be permitted to continue operations covered by its retail pharmacy license.

Pharmacy owner Ryan Dyer told Eyewitness News he believes the Health Department is blowing things out of proportion, saying it boils down to missing paperwork.

"Their allegations sound much larger than they are," Dyer said. "I expect the next visit that they come in to be very good and to have no issues whatsoever."

Dyer said local compounding pharmacies are being scrutinized as a result of the recent nationwide fungal meningitis outbreak. In that case, dozens of people across the country died and hundreds more became ill, including three people in Rhode Island, after receiving a steroid injection manufactured at a Massachusetts compounding facility.

"[Inspectors] found we do run a very good pharmacy," Dyer said. "I think it's a win win. The more inspections, the better."

In order for sanctions to be lifted, health officials say Bayview Pharmacy and its staff must, among other things, provide proof it followed proper testing procedures and has hired an independent company to conduct environmental testing.

Dyer said he expects by Wednesday all requirements will be met and that the compounding clean room, in which Bayview staff makes injectable medication, will be allowed to reopen.