Special Sterile Compounding Permits for Pharmacies and Outsourcing Facilities  

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    DEPARTMENT OF HEALTH

    Board of Pharmacy

    RULE NO.:RULE TITLE:

    64B16-28.802Special Sterile Compounding Permits for Pharmacies and Outsourcing Facilities

    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. 43 No. 93, May 12, 2017 issue of the Florida Administrative Register.

    The change is in response to written comments submitted by the staff of the Joint Administrative Procedures Committee and discussion and subsequent vote by the board at the public meeting held August 15, 2017. The rule shall now read as follows:

    64B16-28.802 Special Sterile Compounding Permits for Pharmacies and Outsourcing Facilities.

    (1) through (5) No change.

    (6) The SSCP is not required for a Type B Modified Class II an Iinstitutional Modified II B Pharmacy under the following conditions:

    (a) The pharmacy only compounds low-risk level compounded sterile products; and

    (b) The pharmacy only compounds those low-risk level compounded sterile preparations products for immediate use pursuant to the provisions the United States Pharmacopeia adopted and incorporated in rule 64B16-27.797, F.A.C.

    Rulemaking Authority 465.005, 465.022 FS. Law Implemented 465.0196 FS. History–New 6-18-13, Amended 10-20-13, 5-8-16, 12-18-16,           .

     

    THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: C. Erica White, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3254.