Legislative News

  1. Compounding Drugs Active Ingredient List

    The FDA is developing a list of bulk drug substances (active ingredients) that can be used to compound drug products in accordance with the FD&C Act. The FDA previously solicited nominations for the list, but some of the nominated substances were not supported by sufficient information for the FDA to evaluate them. The FDA is establishing a public docket where these substances can be renominated with sufficient supporting information or to receive nominations of bulk drug substances that were not previously nominated for consideration for inclusion on the 503B bulks list. Comments can be submitted at any time.

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  2. GAO Report on EHRs

    A new U.S. Government Accountability Office (GAO) report outlines five key obstacles to achieving interoperability. GAO  interviewed representatives from 18 selected unidentified, nonfederal initiatives aimed at advancing interoperability, and their approaches to achieving interoperability. Read the full report

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  3. ONC Publishes Health IT Strategic Plan 2015-2020

    The Office of the National Coordinator (ONC) released the revamped version of the Health IT Strategic Plan 2015-2020. According to the ONC, this is a blueprint to improve the health IT infrastructure to help transform healthcare delivery, improve individual and community health and support a responsive, evolving health IT ecosystem that puts individuals at the center of care.

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  4. FDA Biosimilar Naming Guidance and Proposed Rule

    The Food & Drug Administration (FDA) released draft guidance and a related proposed rule on the naming of biologic drugs and biosimilars. The draft guidance proposes that reference products and biosimilars have nonproprietary names (also called proper names in the guidance) that share a core drug substance name and, in order to better identify each product, an FDA-designated suffix that is unique for each product. This suffix would be composed of four lowercase letters that won't carry any meaning.

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  5. 340B Omnibus Guidance Proposed

    The Department of Health & Human Services (HHS) published its much anticipated draft omnibus guidance on the 340B program.  The draft guidance is intended for covered entities, such as hospitals and certain clinics, enrolled in the 340B program and the drug manufacturers that are required to provide discounts on outpatient drugs.

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