News tagged contamination
USP Prescription Container Labeling Chapter is Now the Official Standard
The United States Pharmacopeia (USP) General Chapter <17> Prescription Container Labeling, published in the USP 36–NF 31, became an official standard on May 1, 2013.
Congressional Committee Holds Hearing to Investigate Causes of Fungal Meningitis Outbreak
The United States House of Representatives Committee on Energy and Commerce’s Subcommittee on Oversight and Investigations held a hearing today, November 14, 2012, to hear testimony regarding the multi-state outbreak of fungal meningitis that has been linked to contaminated methylprednisolone...
Read More →ASHP Offers Provider Resources on Safe Compounding and Outsourcing
The American Society of Health-System Pharmacists (ASHP) provides several resources to help pharmacists and other providers address the new responsibilities and demands resulting from the fungal meningitis outbreak caused by contaminated methylprednisolone acetate injection compounded by NECC. The ASHP Sterile...
Read More →Legislation to Strengthen Compounding Regulations Introduced to Congress
Legislation that would give Food and Drug Administration (FDA) clear, new authority to oversee compounding pharmacy practices throughout the country was introduced to Congress on November 2, 2012, by Representative Edward J. Markey (D-MA). The Verifying Authority and Legality In...
Read More →MA Board of Pharmacy Approves Emergency Regulations for Compounding Pharmacies
The Massachusetts Board of Registration in Pharmacy has approved emergency regulations to enhance oversight of compounding pharmacies. The emergency regulations (PDF) will allow the state to track volume and distribution at compounding pharmacies in order to determine if a pharmacy...
Read More →Additional NECC Products Test Positive for Bacterial Contamination, FDA Reports
FDA and Centers for Disease Control and Prevention (CDC) report that samples of two additional recalled New England Compounding Center (NECC) products, preservative-free injectable betamethasone and cardioplegia solution, have tested positive for bacteria. Previously, the fungus Exserohilum rostratum was identified...
Read More →All Ameridose Drug Products Recalled, FDA Reports
FDA announced that Ameridose, LLC, voluntarily recalled all of its unexpired drug products on October 31, 2012. Ameridose, based in Westborough, MA, initiated the recall in response to findings from an FDA inspection that raised concerns about lack of sterility...
Read More →CDC and FDA Continue Investigation as Number of Fungal Meningitis Cases Climbs
As the investigation continues into the multistate outbreak of meningitis due to contaminated methylprednisolone injections compounded by the New England Compounding Center (NECC), Centers for Disease Control and Prevention (CDC) reports that at least 363 individuals have been affected. Further,...
Read More →CDC and FDA Provide Updates on Meningitis Outbreak and Related Investigation
Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) have confirmed that the contaminated intrathecal methylprednisolone injections compounded by the New England Compounding Center (NECC) are linked to the multistate outbreak of fungal meningitis and joint...
Read More →Outbreak of Meningitis Associated With Contaminated Intrathecal Steroid Injection
At least 231 cases of fungal meningitis, including 15 deaths, have been reported to be caused by intrathecal methylprednisolone injections compounded by the New England Compounding Center (NECC). Of the 231 cases reported as of October 16, 2012, a total...
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