Florida Regulations 64B13-18.003: Procedures Regarding Topical Ocular Pharmaceutical Agents
Current as of: 2024 | Check for updates
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(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 Florida Statutes § 463.0055 and should be made.
Rulemaking Authority 463.0055(2)(a) FS. Law Implemented Florida Statutes § 463.0055. History-New 5-15-97, Formerly 59V-18.003, Amended 3-13-14, 9-2-19.
(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 Florida Statutes § 463.0055 and should be made.
Rulemaking Authority 463.0055(2)(a) FS. Law Implemented Florida Statutes § 463.0055. History-New 5-15-97, Formerly 59V-18.003, Amended 3-13-14, 9-2-19.