Fla. Admin. Code R. 64B13-18.003

Current through Reg. 50, No. 235-239, December 10, 2024

Section 64B13-18.003 - Procedures Regarding Topical Ocular Pharmaceutical Agents

(1) Requests for the addition, deletion or modification of the formulary of topical ocular pharmaceutical agents shall be filed with the Board.

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

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

(b) The chemical name of the agent;

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

(d) The concentration of the agent;

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

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

(g) An explanation why the requested addition, deletion or modification is consistent with the provisions of section 463.0055, F.S. and should be made.

Fla. Admin. Code Ann. R. 64B13-18.003

Rulemaking Authority 463.0055(2)(a) FS. Law Implemented 463.0055 FS.

New 5-15-97, Formerly 59V-18.003, Amended 3-13-14, Amended by Florida Register Volume 45, Number 162, August 20, 2019 effective 9/2/2019.

New 5-15-97, Formerly 59V-18.003, Amended 3-13-14, 9-2-19.