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Regulatory and Washington

  • USPLabs agrees to recall and destroy dietary supplement following FDA actions

    SILVER SPRING, Md. — Following actions by the Food and Drug Administration, USPLabs has agreed to recall and destroy the dietary supplement OxyElite Pro, as it has been linked to dozens of cases of acute liver failure and hepatitis, including one death and illnesses so severe that several patients required liver transplants, the agency noted Wednesday. 

  • W.Va. Retailers Association lauds efforts to prevent diversion of OTC drugs for meth

    CHARLESTON, W.Va. — Through mid-November, a national registry of over-the-counter drugs considered chemical precursors to methamphetamine prevented more than 16,700 boxes of the drugs from being sold illegally.

  • Perrigo seeks approval for generic version of Acanya

    ALLEGAN, Mich. — Drug maker Perrigo has filed with the Food and Drug Administration for approval of a generic topical ointment for treating acne in adolescents and adults, the company said Wednesday.

    Perrigo said it filed for approval of clindamycin phosphate and benzoyl peroxide gel in the 1.2%/2.5% strengths. The drug is used to treat acne in patients 12 years and older.

  • Bitcoin payment service chief executive touts e-currency as federal authorities signal openness to it

    WASHINGTON — The electronic currency known as bitcoin allows small- and medium-sized companies to reach more customers by opening new markets that were previously unreachable, the co-founder of a company that allows businesses to use bitcoins said in testimony Tuesday before two Senate subcommittees. And it appears that federal authorities are open to its development.

  • Pair of Congress leaders advocate on behalf of community pharmacy

    ALEXANDRIA, Va. — Reps. Doug Collins, R-Ga., and Martha Roby, R-Ala., on Tuesday advocated for community pharmacy with letters addressed to the leaders of the House Energy and Commerce Committee and Ways and Means Committee. 

    In serving Medicare seniors, community pharmacies should be subject to the same three-year audit review period as hospitals, and not forced to document 10-year-old claims, the Representatives suggested.  

  • FDA seizes $2 million in DMAA product

    SILVER SPRING, Md. — At the request of the Food and Drug Administration, U.S. Marshals seized dietary supplements manufactured and held by Hi-Tech Pharmaceuticals, located in Norcross, Ga., after FDA investigators found the products contained 1, 3-Dimethylamylamine HCl (DMAA) or its chemical equivalent, the agency announced Monday.  

  • N.J. specialty pharmacy wins URAC accreditation

    NEW YORK — URAC has granted accreditation to Parkway Pharmacy, a specialty pharmacy based in New Jersey.

    The pharmacy said Monday that it had received URAC's full Specialty Pharmacy Accreditation. Parkway was established in 2010.

  • Senate passes Drug Quality and Security Act

    NEW YORK — A bill that would implement federal tracking and tracing of drugs and strengthen federal regulations on pharmacy compounding has passed in the Senate and will go to President Barack Obama for his signature.

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