The US Food and Drug Administration (FDA) has announced that yet another compounding pharmacy has initiated a national recall for all products manufactured at a Florida facility, explaining that an inspection of the facility last month found deficient practices that might have exposed its sterile products to microbial contamination.
Compounding pharmacies enjoy a relatively unusual regulatory exemption in the US whereby they can compound products without having received regulatory approval so long as they create the products specifically for a single patient with a valid prescription. Historically, these compounding pharmacies have largely been overseen by state-not federal-regulatory officials, and most commonly state boards of pharmacy.
The industry, once small, has expanded rapidly in recent years as the Internet has allowed pharmacies to take orders from all across the US, and drug shortages have placed an increased reliance on compounders to make up for the quality failures of federally regulated pharmaceutical manufacturers.
But that expansion has come with problems. FDA, which in the past had been hesitant to inspect compounding pharmacies due to its questionable authority over the industry, has recently started to crack down heavily on the industry, and its findings have been alarming to many.
Black Particles and Filaments
The 21 April 2013 recall notice for Balanced Solutions Compounding Pharmacy (BSCP), a subsidiary of Axium Healthcare Pharmacy, is in many ways typical of the findings at many other compounding pharmacies.
A 12-15 March 2013 inspection on BSCP's by FDA resulted in a Form 483-a form used to report deficient findings-to the company, which stated that investigators had observed a number of quality control problems.
In one notable instance, an FDA inspector looked at a sample of already-released triamcinolone acetonide injectable solution, and found seven vials to contain "black particles of un-known origin in the product." At least one of the vials had more than one particle present.
Another alarming observation noted FDA's finding of a vial of chromium chloride injectable solution that had a "cloth-like filament of un-known origin." Subsequent testing by FDA determined this to be Sphingobacterium thalpophilum, a gram-negative bacteria that luckily does not often cause infection in humans.
Similar sterility concerns have been behind more than 30 Form 483s to compounding pharmacies, and a proposed FDA framework would seek to prevent any compounding pharmacy from making sterile products in light of regulators' numerous concerns.
Problems May Stem From Quality Deficiencies
Those sterility problems may have had their roots in un-sterile manufacturing areas, FDA implied. One supposedly sterile compounding area was observed to have "spills and splatters of amber and clear droplets and residue" around a heating plate and sitter. Another area had a splatter of "white residue" around a transparent air guard close to where another product was prepared.
FDA inspectors also said they observed improper employee practices, like failing to sanitize gloves before compounding a product, using methods that could have contaminated the sample, not wearing proper equipment at all times, and moving about the facility too quickly.
Other troubling observations include: Some compounding areas did not have validated air flow studies conducted; surface sampling plates were observed to have microbial contamination present, a lack of monitoring for non-viable particulates, non-validated sterilization processes for some drug products, improper clothing for some personnel, and expiration dates having not been determined for the products.
FDA said all facilities that have received products from the company should quarantine them and prepare to return them to BSCP.