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Regulatory and Washington

  • FDA investigation finds widespread problems at compounding pharmacies

    SILVER SPRING, Md. — An inspection of more than two-dozen compounding pharmacies by Food and Drug Administration officials has found widespread problems with sanitation and sterilization practices, FDA commissioner Margaret Hamburg wrote in a blog post on the agency's website Thursday.

  • Celgene head elected as PhRMA chairman

    SAN DIEGO — Celgene Corp. chairman and CEO Robert Hugin has been elected as chairman of a pharmaceutical industry trade group.

    The Pharmaceutical Research and Manufacturers of America announced the election of Hugin, as well as Pfizer president and CEO Ian Read as chairman-elect of the PhRMA board of directors and Merck chairman, president and CEO as board treasurer.

    Hugin succeeds Eli Lilly president, chairman and CEO John Lechleiter as chairman, PhRMA said.

     

  • Reports: Alberta government to give pharmacists allowance in preparation for generic pricing changes

    NEW YORK — The government of Canada's Alberta province will pay pharmacists C$1 for each prescription filled as part of a one-year transition program for which it will spend $24 million, according to published reports.

  • QS/1 introduces 'first of its kind' Medicare Part B documentation system

    SPARTANBURG, S.C. — QS/1 has released Medicare Part B compliance documentation, which it said would be the first of its type on the market to help pharmacies that want to serve Part B customers while remaining compliant, the company said.

    QS/1 said its Medicare Part B Compliance Documentation software system was the first of its kind, allowing pharmacies using NRx or PrimeCare Pharmacy Management Systems to serve Medicare Part B customer needs while keeping necessary documents in the event of an audit.

  • Congress leaders call out energy drink marketers to list caffeine content in investigative report

    WASHINGTON — Three Democratic lawmakers on Wednesday released a report that found inconsistencies in the labeling and classification of energy drinks, extensive marketing to adolescents and young adults through social media and events, and high caffeine levels that exceed what is considered safe in soda by the Food and Drug Administration. The report was compiled using responses from 14 energy drink companies received by Rep. Ed Markey, D-Mass., and Sens. Richard Durbin, D-Ill., and Richard Blumenthal, D-Conn., from their investigation into the industry.

  • Pharmavite: SoyJoy earns gluten-free certification from Gluten-Free Certification Organization

    NORTHRIDGE, Calif. — Pharmavite on Wednesday announced receipt of the brand's official gluten-free certification across its SoyJoy line from the Gluten-Free Certification Organization. 

    With this certification, SoyJoy's packaging will feature the official "GF" logo starting this summer. The logo symbolizes standards that the GFCO calls all of its certified brands and restaurants to uphold, specifically the requirement that there be less that 10 ppm of gluten in all raw and finished goods, as well as a required audit of all facilities used in manufacturing

  • Maryland state legislature shelves biosimilars legislation

    WASHINGTON — Legislation designed to limit the use of biosimilars has met defeat in Maryland.

  • Obama budget proposes increasing tobacco taxes

    WASHINGTON — President Barack Obama has proposed increasing federal taxes on cigarettes, drawing criticism from tobacco companies and praise from anti-smoking groups.

    As part of his proposed budget, Obama proposed raising the tax on cigarettes by 94 cents per pack, with similar increases on other tobacco products. The current tax is $1.01 per pack.

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