The Board proposes the rule amendment to incorporate new labeling requirements in certain settings.

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO.:RULE TITLE:

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

PURPOSE AND EFFECT: The Board proposes the rule amendment to incorporate new labeling requirements in certain settings.

SUMMARY: Language regarding all permits – labels and labeling of medicinal drugs will be updated.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: During discussion of the economic impact of this rule at its Committee meetings and Board meetings, the Board, based upon the expertise and experience of its members, determined that a Statement of Estimated Regulatory Costs (SERC) was not necessary and that the rule will not require ratification by the Legislature. No person or interested party submitted additional information regarding the economic impact at that time.

Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

RULEMAKING AUTHORITY: 465.005, 465.022 FS.

LAW IMPLEMENTED: 465.022(1), 465.0255 FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

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].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

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 compounded intravenous compounds (this does not include plain IV solutions or floor stock) shall include:

(a) Names of active ingredients;

(b) Amounts or concentrations of active ingredients;

(c) Beyond use date and time;

(d) Storage requirements (if applicable);

(e) Identification of responsible compounding personnel;

(f) Labels for batch-prepared CSPs must also include:

1. Control or lot number;

2. Auxiliary labeling (including precautions); and

3. Device-specific instructions;

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

1. Patient’s name;

2. Location the medication is to be delivered to; and

3. Directions for use and applicable accessory and cautionary instructions.

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,                            .

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Board of Pharmacy

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Board of Pharmacy

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: June 10, 2021

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: August 17, 2021