Monday, August 19, 2013

FDA reissues alert after compounding pharmacy refuses recall request

The U.S. Food and Drug Administration today repeated its warning about sterile products made by a Texas compounding pharmacy because the business is refusing to abide by the agency’s request for a recall.

The business is Dallas-based NuVision Pharmacy, which is licensed to sell products in this state, according to the Tennessee Department of Health website. The FDA previously issued an alert about the company’s products on May 18.

“NuVision Pharmacy has repeatedly declined to recall its sterile products,” the FDA said in today’s announcement. “The FDA most recently issued a letter to NuVision on July 26, 2013, requesting an immediate recall of all lots of sterile products that have not passed their expiration dates produced at NuVision. In the letter, the FDA outlined poor sterile production practices observed by FDA investigators during an April 2013 inspection of NuVision’s Dallas facility. The FDA explained that those practices raised concerns about a lack of sterility assurance of NuVision’s sterile drug products. The FDA noted that if a drug product marketed as sterile contains microbial contamination, patients could be at risk for serious, potentially life-threatening infections.”
NuVision has this statement on its web site:

“NuVision pharmacy is a compounding pharmacy committed to patient safety. We are not a manufacturer. We are in compliance with (U.S. Pharmacopia rules 795 and 797) which are the standards of law for compounding pharmacy. The FDA has been inspecting compounding pharmacies based on a different set of standards for manufacturers called FDA 210 and 211. The FDA manufacturing law is different than USP. The current state laws do not require compounding pharmacies to follow the standards for manufacturing. NuVision Pharmacy is not recalling all sterile injectables. All of our sterile injectables are tested by a third party lab for sterility prior to dispensing. For anyone with questions or concerns about the sterility of our products, NuVision Pharmacy will send you the results proving that our products are sterile.”

FDA Commissioner Margaret Hamburg testified to key committees of Congress that her agency needed greater legislative authority to enforce safety practices at compounding pharmacies last year in the wake of the fungal meningitis outbreak. Fungal infections associated with that outbreak have sickened 749 people in the United States with 63 deaths.

Tennessee has been one of the hardest hit states in that outbreak, which federal investigators linked to medicine made by Massachusetts-based New England Compounding Center.

This week, U.S. Sen. Lamar Alexander, R-Tenn., called on the Senate to pass legislation “as soon as possible” sent forward by the health police committee on which he is the ranking member. Legislation has yet to emerge from a House committee on measures to better regulate compounding pharmacies.

The FDA reported that patients in two hospitals who received injections of drugs from Specialty Compounding from Cedar Park, Texas, developed bacterial bloodstream infections thought to be related to the drug infusions.

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