Another Compounding Pharmacy Recall Issued, As Proposed Regulatory Legislation Criticized

Another compounding pharmacy has recalled all of its drugs amid safety concerns, as legislation designed to address industry-wide problems has faced harsh criticism from consumer groups.  

On May 18, the FDA announced a recall for all sterile drug products made by NuVision Pharmacy, a Dallas, Texas-based compounding pharmacy. The FDA said it was warning healthcare professionals not to give the company’s drugs to any patients. The NuVision Pharmacy sterile drug recall came following a recent inspection that revealed poor sterile production practices, the agency reported.

The recall is an expansion of one issued by the pharmacy in April for methylcobalamin injection and lyophilized injection products due to a lack of sterility assurance.

In recent months, the federal and state health officials have been cracking down on compounding pharmacies nationwide in the wake of a fungal meningitis outbreak that killed more than 50 people and sickened more than 700; many of whom will require treatment for months.

That outbreak was linked to the New England Compounding Center (NECC), which not only had bad sterility practices, the FDA has reported, but was also operating as a stealth drug manufacturer, shipping massive amounts of unapproved FDA drugs nationwide. The pharmacy was shut down, has declared bankruptcy, and faces a number of fungal meningitis lawsuits as a result.

“Compounding Manufacturer” Bill Draws Fire

Compounding pharmacies are traditionally pharmacies that create custom-made drugs on a per-prescription basis for local patients who require drugs that cannot be obtained from a drug manufacturer. However, the outbreak investigation revealed that many are mass-producing drugs that have never undergone FDA inspection.

NECC shipped more than 17,000 potentially tainted epidural steroid injections that were believed to be the source of the fungal meningitis outbreak. An estimated 14,000 patients in the U.S. received the injections.

Late last month, new legislation was proposed that would create a new class of drug maker called compounding manufacturers. The bill would give the FDA more power to regulate these compounding manufacturers. However, the proposal has drawn sharp criticism.

The consumer watchdog group Public Citizen has indicated that the proposed legislation is nonsensical and a bad idea, indicating that it would create a class of drug manufacturers that would not have to meet current federal drug requirements.

“They could mass-produce new drugs without testing for safety and efficacy and would undergo inspections only after a drug is on the market,” the group warned in a statement issued on May 16. “This scheme represents an unacceptable step backward from the strict standards currently required for all drug manufacturers in the United States, and would result in the further growth of substandard – and what is currently illegal – drug manufacturing that has been allowed to thrive under the guise of pharmacy compounding.”

Instead, Public Citizen called for legislation that would clearly define drug manufacturers and compounding pharmacies and give the FDA the funding and authority it needs to enforce existing laws.