Sensing that the time has come for the profession to take responsibility for policing what many view as a pharmacist"s cherished prerogative—compounding—Kenneth Baker has accepted the job of implementing a way for compounding pharmacies to earn a stamp of approval from the Pharmacy Compounding Accreditation Board (PCAB).
Sensing that the time has come for the profession to take responsibility for policing what many view as a pharmacist's cherished prerogative-compounding-Kenneth Baker has accepted the job of implementing a way for compounding pharmacies to earn a stamp of approval from the Pharmacy Compounding Accreditation Board (PCAB).
A longtime Pharmacists Mutual Insurance Co. executive, Baker is a pharmacist-lawyer who was hired last month to be PCAB's first executive director. Announced last April at the annual meeting of the American Pharmacists Association, the board is being underwritten by 10 national pharmacy groups as a way to recognize compounding pharmacies that measure up to official standards of practice. Although the organizations have pledged money for three years, ultimately PCAB will be funded by fees paid by pharmacies seeking accreditation. The amount of the fee has not been set.
"What I see us doing right now is putting together the organization and a budget," Baker told Drug Topics. "A lot of time will be spent going out to compounding pharmacies across the country to make sure we understand what it is they need for us to do. The bottom line is that this has got to be something they support. They can't run it because it's got to be independent, but we need their input. My goal in the next year and a half is to sign up 300 pharmacies to be accredited."
Under a contract with PCAB, the National Association of Boards of Pharmacy will be vetting compounding pharmacies that apply for accreditation. NABP is ready to begin accrediting pharmacies and has trained five surveyors who will inspect the pharmacies, said executive director Carmen Catizone, who is a member of PCAB's board. Several pharmacies have already applied for accreditation, and if the number of applications goes up, NABP will train more surveyors.
At present, NABP is conducting a beta test. "We're going to pharmacies and seeing how the standards actually apply and tweaking those standards," said Catizone. "As soon as that's done, we will be going through the applications that we have received."
Any compounding R.Ph.s who think the PCAB process will be a walk in the park are in for a big surprise, said Catizone. "NABP is not going to attach its name to anything that's less than credible," he said. "If it's not credible, NABP will withdraw. So if people think this is going to be a rubber stamp, they better understand that's not going to happen. It's going to be a very rigorous and credible process, and if it's not, it's just going to create more problems for the profession."
Compounding pharmacy has come under fire in recent months for some high-profile cases that have captured media attention. And the sector has been fighting off attempts by the Food & Drug Administration to bring compounding under its jurisdiction.
"We need standards set up by the industry, standards that are attainable and yet protect the public," said Baker. That's how we have to look at ourselves: protecting the public."