64B13-18.003. Procedures Regarding Topical Ocular Pharmaceutical Agents

Effective on Monday, September 2, 2019
  • 1(1) Requests for the addition, deletion or modification of the formulary of topical ocular pharmaceutical agents shall be filed with the Board.

    23(2) 24The request shall be in writing and shall contain the following information:

    36(a) The name, address, and telephone number of the individual or entity filing the request;

    51(b) The chemical name of the agent;

    58(c) The brand name(s) of the agent;

    65(d) The concentration of the agent;

    71(e) The United States FDA approved information sheet for the agent;

    82(f) The date the FDA released the agent for sale; and,

    93(g) An explanation why the requested addition, deletion or modification is consistent with the provisions of section 110463.0055, F.S. 112and should be made.

    116Rulemaking Authority 118463.0055(2)(a) FS. 120Law Implemented 122463.0055 FS. 124History–New 5-15-97, Formerly 59V-18.003, Amended 3-13-14, 9-2-19.