Federal regulators say they observed unsanitary practices at two Tampa Bay-area compounding pharmacies during inspections in response to the national fungal meningitis outbreak.
Tainted drugs made by the New England Compounding Center were linked with the deaths of 53 people — five in Florida — and blamed for sickening hundreds of patients.
AnazaoHealth Corporation in Tampa and the Compounding Shop in St. Petersburg were among 31 facilities inspected by the U.S. Food and Drug Administration, which is seeking more authority to regulate compounding pharmacies. Neither was implicated in any reports of illness.
FDA Commissioner Dr. Margaret A. Hamburg said in some facilities, inspectors saw "unidentified black particles floating in vials of supposedly sterile medicine; rust and mold in 'clean rooms' where sterile injectable medications were produced; technicians handling supposedly sterile products with bare hands; and employees wearing non-sterile lab coats."
Compounding pharmacies have long customized drugs for patients with special needs, like a liquid form of a medicine for someone who cannot swallow a pill. But in recent years, as their numbers multiplied, some have become essentially mass manufacturers. The FDA says it has limited authority to oversee their operations, which are regulated by state boards of pharmacy. The issue is to be discussed next week in congressional hearings on the meningitis outbreak.
Officials at the Florida Department of Health said they were aware of the FDA concerns identified at four compounding pharmacies — the two in Tampa Bay plus Axium Healthcare Pharmacy's Balanced Solutions Compounding Pharmacy in Lake Mary and Lowlite Investments' Olympia Pharmacy in Orlando.
Black particles weren't reported in the Tampa Bay region. But FDA inspectors did find "exposed rust" and "numerous splattered brownish stains" on equipment used to prepare injectable drugs and eye medications at the Compounding Shop, which declined to comment for this article.
Inspectors also cited concerns about the sterility of the clothing worn by those preparing drugs at the Compounding Shop and AnazaoHealth.
AnazaoHealth officials said Friday they follow national guidelines and state laws, but the FDA is using different standards.
"We believe the FDA purposely used inflammatory language to make the point to their superiors, and perhaps to the Congress, that they needed to give them (additional regulatory) powers," said David Joseph, AnazaoHealth's director of pharmacy, quality and regulatory compliance.
For example, FDA inspectors noted that after disinfecting some containers and equipment, AnazaoHealth employees wiped them off with "a dirty rag."
Company officials said that was a blue cloth, used with an antifungal spray, that was recommended by the equipment's manufacturer. Still, the company has switched to disposable cloths recommended by the FDA.
"We would have happily (met the FDA standards) if required by our licensing board," AnazaoHealth attorney Natarsha Nesbitt said.
She noted that the FDA is publicizing the problems its inspectors found, but not the company's responses explaining industry practices and, in some cases, voluntarily agreeing to changes.
Both the Compounding Shop and AnazaoHealth have been disciplined in the past by state officials, although not for the concerns raised by the FDA. AnazaoHealth, which in its sterile compounding unit mostly makes custom medications for people with implanted pain pumps, agreed to a $3,000 fine and to pay $70,000 in state expenses after problems were found with a medication it made for use during eye surgery. It had received an incorrect formula for compounding the medication from an outside company, officials said, noting that the sterility of their operations has never been an issue.
Information from the New York Times was used in this report. Letitia Stein can be reached at [email protected] or (727) 893-8330.