Month: March 2016

FDA Inspection Results in Compounding Pharmacy Recall

Reliable Drug Pharmacy is voluntarily recalling all unexpired lots of compounded products due to a concern of lack of quality assurance and potential mislabeling after a series of inspections by the FDA. SUPER-POTENT MORPHINE RECALLED All recalled products were distributed to patients and veterinarians within California. A few products were shipped to Hawaii, New Mexico and …

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Two Pharmacy Rules to Prevent Drug Contamination in 2016

Since the passage of the Affordable Care Act, the healthcare industry has introduced a number of regulatory changes to improve patient care. In the past year, following a string of deadly compounding errors, such as a New England meningitis outbreak that resulted in 64 patient deaths, many such changes have focused on standardized guidelines for …

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Safe handling of hazardous drugs: USP publishes new chapter

A new general chapter from the U.S. Pharmacopeial Convention (USP) will do more to ensure hazardous drugs are handled properly. General Chapter <800>, Hazardous Drugs—Handling in Healthcare Settings, published in February 2016, was developed to protect health care workers, including pharmacists, from residual exposure in health care settings. The mandatory rule applies to every site …

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FDA Moves Forward With Plans To Release GM Mosquitoes in the U.S. To ‘Fight Zika Virus’

The FDA announced plans this week to move forward with a trial release of genetically modified mosquitoes in the U.S. as a strategy to fight the Zika virus. The announcement details the release of the GM male mosquitoes into the environment somewhere near Key West, Florida. The male mosquitoes have been modified to contain a gene that kills the …

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FDA approves an expanded cancer treatment

The Food and Drug Administration expanded approval of a Pfizer drug to treat a small subset of lung cancer patients with a rare mutation. The agency says Xalkori capsules are now approved for patients with the ROS-1 gene mutation, who make up about 1 percent of U.S. patients with non-small cell lung cancer, the most …

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Pharmacy Recalling Narcotic Painkiller After Three Newborns Sickened

(NOBLESVILLE) – A central Indiana compounding pharmacy is recalling a narcotic painkiller after three newborns were sickened by a “super-potent” intravenous form of the drug the company distributed. The Indianapolis Star reports that Pharmakon Pharmaceuticals issued a voluntary recall for an intravenous form of morphine sulfate on February 11 after lab results showed that it …

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FDA Approves Zika Virus Diagnostic for Emergency Use

The U.S. Food and Drug Administration (FDA) last week approved the first diagnostic to detect the Zika virus under its emergency use authorization pathway, reports the Regulatory Affairs Professionals Society (RADS). This allows the FDA to authorize unapproved products during a public health emergency. There are currently no other approved diagnostics available to detect Zika, a …

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IV clinic investigation extended to chemist who supplied potentially deadly vitamins

NSW Health authorities have widened their investigation of an  IV “hydration” clinic to include the pharmacist who manufactured a cocktail of injectable vitamins that  put a Sydney woman in hospital. Dr Michael Serafin, of Complementary Compounding Services in Ballina, confirmed on Wednesday he had been dragged into an expanded inquiry surrounding the iv.me clinic in Darlinghurst, alleging to Fairfax Media that he would not have supplied the product …

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New, Stronger FDA Warning for Essure Birth Control Implant

Federal health regulators plan to warn consumers more strongly about Essure, a contraceptive implant that has drawn thousands of complaints from women reporting chronic pain, bleeding and other health problems. The Food and Drug Administration announced Monday it would add a boxed warning — its most serious type — to alert doctors and patients to …

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