Axium Healthcare Pharmacy was inspected by the FDA back in March as part of an enforcement blitz prompted by an outbreak of meningitis linked to a compounder in Massachusetts. Outbreaks of infections tied to compounding concerns have since occurred in Tennessee and Texas.
Agency investigators said many of the products that Axium “manufactures and distributes” are unapproved and misbranded drugs because they aren’t backed by a valid prescription for individually identified patients. Many of those same products, intended for conditions that are not amenable to self-diagnosis and treatments by individuals who are not health practitioners, also lack adequate directions for use, the warning letter states.
The letter, posted Aug. 27, also notes FDA concern with Axium’s sterile drug production processes, which the agency said took place under unsanitary conditions. The letter chides Axium for poor gowning practices, namely that employees wore non-sterile gowns that exposed bare skin and allowed for extending arms over sterile, uncovered vials.
Employees also failed to move in a “slow, deliberative manner in the aseptic processing area,” the agency said.
A Form 483 issued after the March inspection stated that one lot of triamcinolone acetonide injectable solution, 60 mg/ml contained black particles. “One of the vials appeared to contain more than one of these particles,” the form reads. The agency also found a vial in one lot of chromium chloride injectable solution, 4 mcg/ml contained a cloth-like filament.
Axium recalled two lots of contaminated products due to the observations, the FDA said.
The Florida pharmacy now says it plans to leave the compounding business, which it says makes up less than one percent of its total revenue.
“Compounding is not part of Axium’s core strategy to grow in the specialty pharmacy business, so we made a business decision to close that operation,” the company said, adding that all of its sterile compounding practices were brought to a halt back in April.
Pharmacies that compound products without a prescription have drawn particular scrutiny from the FDA, especially after a meningitis outbreak last year was tied to drugs mixed at the New England Compounding Center. The agency believes that regulating traditional compounders, which make products based on valid prescriptions, should be left to the states. However, it has asked Congress for additional authority to go after the larger compounders that make products without a prescription and ship them to other states.
The Government Accountability Office agreed with the agency in a recent report outlining the need for clearer authority.
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