The Board proposes the rule amendment to update language regarding all permits – labels and labeling of medicinal drugs.

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO. RULE TITLE:

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

PURPOSE AND EFFECT: The Board proposes the rule amendment to update language regarding all permits – labels and labeling of medicinal drugs.

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.

(1) through (5) No change.

(6) A customized patient medication package may be utilized if:

(a) No change.

(b) The label includes:

1. through 8. No change.

9. A beyond use date that is not more than 120 60 days from the date of preparation of the customized patient medication package but shall not be later than any appropriate beyond use date for any medicinal drug included in the customized patient medication package. A pharmacy utilizing customized patient medication packages shall have policies and procedures that specifically address change to patient medicatoin regimens.

(c) The customized patient medication package can be separated into individual medicinal drug containers, then each container shall identify the medicinal drug product contained.

(7) through (9) 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,    .

 

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: February 4, 2021

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: October 27, 2020