All Permits - Labels and Labeling of Medicinal Drugs

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO.:RULE TITLE:

64B16-28.108All Permits - Labels and Labeling of Medicinal Drugs

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. 47 No. 177, September 13, 2021 issue of the Florida Administrative Register.

The Notice of Change is in response to a vote by the Board to amend the rule, at a duly-noticed public Board meeting held August 25, 2021, in Tampa, Florida. The rule shall now read as follows:

64B16-28.108 All Permits – Labels and Labeling of Medicinal Drugs.

Each container of medicinal drugs dispensed shall have a label or shall be accompanied by labeling.

system.

(1) through (9) No change.

(10) The labeling affixed to patient specific medications compounded intravenous compounds (this does not include plain IV solutions or floor stock) dispensed from an Institutional Class II, Modified Class II Type B, or Class III permit shall include:

(a) through (d) No change.

(e) Identification of responsible compounding personnel and/or dispensing pharmacist;

(f) No change.

(g) Labels for patient specific medications patient individualized intravenous preparations must also include:

1. through 3. No change.

Rulemaking Authority 465.005, 465.022 FS. Law Implemented 465.022(1), 465.0255 FS. History–Amended 5-19-72, Repromulgated 12-18-74, Amended 10-10-78, 9-18-84, 1-20-85, Formerly 21S-1.13, Amended 10-2-88, Formerly 21S-1.013, Amended 7-31-91, 10-1-92, 4-19-93, 7-12-93, Formerly 21S-28.108, 61F10-28.108, 59X-28.108, Amended 3-31-05, 4-22-13, 6-24-21,                            .

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Jessica Sapp, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3254. [e-mail].