As we are seeing there are issues on the front end of compounding with the bulk powders, issues with the actual compounding (sterility and potency) and now with the testing laboratories with blurred or no lines as to who oversees what it. Compounding pharmacists who feared what federal regulation would do to their business now have far greater concerns-lack of trust by the public, liability issues, etc. with potential federal regulation being the least of the worries and potentially a blessing to the good compounders doing it right. With these overwhelming and out-of-control issues in the compounding world, Congress would be doing a grave injustice to the American people if it does not pass some form of federal legislation.
Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Wednesday, August 28, 2013
Question of the Day August 28, 2013 In light of the issues at Front Range Laboratories Inc. and the estimate that it tested compounds for 100 compounding pharmacies in 32 states will Congress act quickly in September to help give the FDA the much needed resources to get this enormous problem with compounding preparations under control?
We’re All at Risk While Drug Compounders Fight Regulation; One Person Doesn't Like the Odds
on August 27, 2013
The expected backlash to attempts by the FDA to crackdown on compounding pharmacies has begun, threatening public safety.
Dallas, TX compounder NuVision is refusing to voluntarily recall its sterile products, thumbing its nose at FDA requests following safety concerns stemming from a federal inspection of its production facilities this spring. In response, the FDA has issued two public alerts to health care providers not to use any sterile NuVision products and to “quarantine” any supplies in stock.
Shockingly, the FDA has no authority to require a compounding pharmacy to recall any products, even if inspectors have observed lax procedures that could endanger patients. Currently, compounding pharmacies, many of which began as small family-owned operations, are not considered “manufacturers.” But as compounders have flourished, many have become national, high-volume producers. A lapse in sterile procedures at one of these companies has the potential to endanger hundreds, if not thousands, of patients.
continue to read here
Dallas, TX compounder NuVision is refusing to voluntarily recall its sterile products, thumbing its nose at FDA requests following safety concerns stemming from a federal inspection of its production facilities this spring. In response, the FDA has issued two public alerts to health care providers not to use any sterile NuVision products and to “quarantine” any supplies in stock.
Shockingly, the FDA has no authority to require a compounding pharmacy to recall any products, even if inspectors have observed lax procedures that could endanger patients. Currently, compounding pharmacies, many of which began as small family-owned operations, are not considered “manufacturers.” But as compounders have flourished, many have become national, high-volume producers. A lapse in sterile procedures at one of these companies has the potential to endanger hundreds, if not thousands, of patients.
continue to read here
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