Application for Permit as a Restricted Prescription Drug Distributor – Institutional Research  

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    DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

    Drugs, Devices and Cosmetics

    RULE NO.:RULE TITLE:

    61N-2.023Application for Permit as a Restricted Prescription Drug Distributor – Institutional Research

    NOTICE OF CHANGE

    Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol. 45 No. 225, November 19, 2019 issue of the Florida Administrative Register.

    Summaries of Substantive Changes to Amended Form DBPR-DDC-212 are as follows:

    61N-2.023 – Amended Form DBPR-DDC-212:

    The effective date of the Form was amended from “TBA” to “September 2019” to properly reflect the date contained within the rule text and displayed on the form are consistent.

    Page 8, Section VII, “Prescription Drug Distribution Activity”:  The rule text provides that this permit is required for a licensed pharmacy of a university to transfer prescription drugs to practitioner or non-practitioner researchers for university sponsored research conducted in accordance with Section 1004.22, F.S., as set forth in rule 61N-1.023(6), F.A.C.  The application form for a permit as a Restricted Prescription Drug Distributor-Institutional Research is amended to delete all options for intended customers except practitioner researchers for university sponsored research and non-practitioner researchers for university sponsored research.

     

    61N-2.023 Application for Permit as a Restricted Prescription Drug Distributor – Institutional Research.

    No change.