March 12, 2014
Chuck Leiter, CEO & President of Leiter's Compounding, was featured in Retinal Physician's recent article titled "Drug Quality and Security Act Addresses Compounding Pharmacies". You can read his feature below and the full article on Retialn Physician's Website here: http://www.retinalphysician.com/articleviewer.aspx?articleID=109882
Charles Leiter, PharmD, president and secretary-treasurer of Leiter’s Compounding Pharmacy in San Jose, CA, is not taking any chances. When news about the fungal meningitis outbreak first broke, Dr. Leiter was already in the process of building a new pharmacy. When he heard the news, he says, he “stopped and re-geared as a cGMP pharmacy.”
He hopes his new facility will be something of a gold standard in the industry. “We were able to design the layout” to comply with cGMP standards, he says. “When drugs come in, according to cGMP, they have to come through a separate entrance than the ones going out. And the ones coming in have to be certified as to what they are, so we have two separate rooms: one for quarantine of raw materials and one for certification.”
The facility also has a separate storage area for compounded drugs. “Our clean room is state-of-the-art,” Dr. Leiter says. “My entire staff is in ‘bunny suits’ ” — industry vernacular for protective clothing.
Quality and efficacy are paramount to Dr. Leiter, and he also seeks to achieve them through a rigorous drug testing process. “A lot of people think you test the drugs and that’s it, but you have to test 17% of the drugs to get a 95% accuracy rate on the fact that it’s a sterile product,” he says. “Those odds still aren’t great, so we’re also going through and doing procedures on everything and validations on all our procedures. That’s expensive and time consuming, but it’s what the manufacturers do.”
An independent laboratory conducts testing for Leiter’s and meets the good manufacturing practice standards, Dr. Leiter says. “And it’s very expensive,” he adds. “If you make 10 items a day, you’re doing 10 sets of plates a day, and then you’re sending them in to be incubated. That department’s probably going to cost me $1 million a year. The refreshing thing is, I raised my prices around 15% to cover all this and I’ve had no complaints.”
“My personal opinion is that anybody shipping outside of the state, sterile or nonsterile, should be under the auspices of the FDA. That way, there’s one law for everybody. I firmly believe one law for the whole country would save a lot of money and make things a lot simpler,” Dr. Leiter says.
“I have three friends who do a lot of nonsterile compounding but quit sterile compounding altogether because they don’t want the FDA coming into their facility, and they don’t want to be under the FDA’s jurisdiction,” he adds.
Stories like these show the FDA is aiming to heal an industry marred by tragedy. Is the FDA’s intention to limit the ability of small-time operations like Franck’s?
“Probably, but that’s a good thing,” says Dr. Leiter. “The little mom-and-pop stores, nothing against them, but sterile compounding has left typical compounding in the dust, and it’s gone up to a whole new level. Hospitals aren’t going to be buying from them. I’ve already had many hospitals call to ask if I planned to register for the FDA.”
quoted from here
Chuck Leiter, CEO & President of Leiter's Compounding, was featured in Retinal Physician's recent article titled "Drug Quality and Security Act Addresses Compounding Pharmacies". You can read his feature below and the full article on Retialn Physician's Website here: http://www.retinalphysician.com/articleviewer.aspx?articleID=109882
Charles Leiter, PharmD, president and secretary-treasurer of Leiter’s Compounding Pharmacy in San Jose, CA, is not taking any chances. When news about the fungal meningitis outbreak first broke, Dr. Leiter was already in the process of building a new pharmacy. When he heard the news, he says, he “stopped and re-geared as a cGMP pharmacy.”
He hopes his new facility will be something of a gold standard in the industry. “We were able to design the layout” to comply with cGMP standards, he says. “When drugs come in, according to cGMP, they have to come through a separate entrance than the ones going out. And the ones coming in have to be certified as to what they are, so we have two separate rooms: one for quarantine of raw materials and one for certification.”
The facility also has a separate storage area for compounded drugs. “Our clean room is state-of-the-art,” Dr. Leiter says. “My entire staff is in ‘bunny suits’ ” — industry vernacular for protective clothing.
Quality and efficacy are paramount to Dr. Leiter, and he also seeks to achieve them through a rigorous drug testing process. “A lot of people think you test the drugs and that’s it, but you have to test 17% of the drugs to get a 95% accuracy rate on the fact that it’s a sterile product,” he says. “Those odds still aren’t great, so we’re also going through and doing procedures on everything and validations on all our procedures. That’s expensive and time consuming, but it’s what the manufacturers do.”
An independent laboratory conducts testing for Leiter’s and meets the good manufacturing practice standards, Dr. Leiter says. “And it’s very expensive,” he adds. “If you make 10 items a day, you’re doing 10 sets of plates a day, and then you’re sending them in to be incubated. That department’s probably going to cost me $1 million a year. The refreshing thing is, I raised my prices around 15% to cover all this and I’ve had no complaints.”
“My personal opinion is that anybody shipping outside of the state, sterile or nonsterile, should be under the auspices of the FDA. That way, there’s one law for everybody. I firmly believe one law for the whole country would save a lot of money and make things a lot simpler,” Dr. Leiter says.
“I have three friends who do a lot of nonsterile compounding but quit sterile compounding altogether because they don’t want the FDA coming into their facility, and they don’t want to be under the FDA’s jurisdiction,” he adds.
Stories like these show the FDA is aiming to heal an industry marred by tragedy. Is the FDA’s intention to limit the ability of small-time operations like Franck’s?
“Probably, but that’s a good thing,” says Dr. Leiter. “The little mom-and-pop stores, nothing against them, but sterile compounding has left typical compounding in the dust, and it’s gone up to a whole new level. Hospitals aren’t going to be buying from them. I’ve already had many hospitals call to ask if I planned to register for the FDA.”
quoted from here
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