Two other compounding pharmacies have recalled products after federal regulators encountered problems with sterility testing by a contractor that serves more than 100 compounders across the country. Reportedly, both recalls involved specialty drugs tested by Colorado-based Front Range Laboratories Inc. The U.S. Food and Drug Administration (FDA) says this company is used by compounders in 32 states to verify purity and quality. While no reports of patient harm have emerged, the FDA said it couldn’t rule out the prospect of microbial contamination in the recalled products. This recurring theme has led to numerous recalls since last year’s deadly fungal meningitis outbreak linked to New England Compounding Center (NECC).
The FDA said it had concerns that results obtained from Front Range are not reliable. The agency had recommended that pharmacies not use this firm for sterility and other quality attributes testing. One of the recalls was by Alabama-based Wellness Pharmacy Inc., involving six lots of drugs. The other recall was by Kansas-based JCB Laboratories, which pulled four products from the market. Both recalls were “voluntary.” As we have reported previously, the FDA lacks authority over compounders to order recalls.
Congress appears to be in agreement about the need to clarify the respective oversight roles of the FDA and state boards of pharmacy, but nothing has been done even though legislation is now in the works. Hopefully, something of substance will pass and become law. Much of the controversy surrounding compounders has centered on the question of whether they have evolved beyond their original purpose of tailoring discrete products for consumers with special needs into full-blown manufacturers operating in a legal gray area.
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