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Regulatory and Washington

  • CRN’s Supplement OWL goes live

    One year after the project was formally announced, the Council for Responsible Nutrition’s Supplement OWL initiative became a reality this spring when the online product registry went live. A resource for regulators, retailers and the industry, the OWL is an industry-wide, self-regulatory initiative that will help create a rich and more complete picture of the marketplace, and can be accessed by anyone.

  • Looking beyond influenza immunizations

    In the roughly 20 years since pharmacists began providing vaccinations in some states, pharmacy is growing as a preferred site for patients to receive their immunizations. In PrescribeWellness’ 2017 Vaccination and Preventive Care Study, 55% of survey respondents said they prefer their pharmacy to their physician’s office as the place to get vaccinated.

  • NACDS urges Congress to pass provider status legislation

    WASHINGTON — The National Association of Chain Drug Stores this week shared with the House Ways and Means Committee the important role pharmacy plays in the nation’s healthcare system in an effort to encourage passage of legislaton giving pharmacists provider status under Medicare Part B.

    The Pharmacy and Medically Underserved Areas Enhancement Act has been introduced in both the House and Senate, and NACDS’ statement looked to drum up support by outlining the work pharmacists do for patients, particularly in medically underserved areas.

  • Teva gets FDA approval for first generic of Truvada

    SILVER SPRING, Md. — The Food and Drug Administration on Friday announced its approval of Teva’s abbreviated new drug application the first generic of Gilead’s Truvada (emtricitabine and tenofovir disoproxil).

    The drug is indicated both as a treatment for HIV-1 in combination with other antiretroviral drugs and for pre-exposure prophylaxis to prevent sexually acquired HIV infection in combination with safer sex practices. 

  • House Energy and Commerce Committee helps pave way toward OTC hearing aids

    WASHINGTON — The House Energy and Commerce Committee on Wednesday helped pave the way forward toward a non-prescription hearing aid category by incorporating amendments specifically addresssing the new OTC category to the FDA Reauthorization Act (FDARA) of 2017, which will re-up FDA's user fee programs.

  • New Nevada law looks to help visually impaired pharmacy patients

    CARSON CITY, Nev. — A bill that aims to protect blind and visually impaired people from taking the wrong medications has been signed into law in Nevada.

  • NACDS, APhA caution Trump administration on drug importation

    WASHINGTON — The National Association of Chain Drug Stores and the American Pharmacists Association this week urged the Trump administration to steer clear of legislation that would clear the way for the importation of prescription drugs from other countries.

    The two penned a letter calling on Pres. Trump and administration officials to “refrain from endorsing pending legislative proposals that would allow for broad personal and commercial importation of non-[Food and Drug Administration (FDA)] approved prescription drugs.”

  • NCPA weighs in on proposed CMS DIR fee guidance

    WASHINGTON — In mid-May, the Centers for Medicare and Medicaid Services released a proposed guidance on Medicare Part D reporting requirements for direct and indirect remuneration fees. The National Community Pharmacists Association on Thursday submitted to CMS a letter with comments about the proposed guidance. The organization notes that there is some promise in the guidance. 
     
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