The Board proposes the rule amendment to update label requirements.

 

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 label requirements.
SUMMARY: Label requirements 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 Board meeting, 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) 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: Mark Whitten, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin C04, Tallahassee, Florida 32399-3254

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) No change.

(2) The label affixed to each container dispensed to a patient shall include:

(a) through (g) No change.

(h) Discard after Expiration date.

(i) No change.

(3) The label on the immediate container of a repackaged product or a multiple unit prepackaged drug product shall include:

(a) through (d) No change.

(e) Discard after Expiration date

(f) No change.

(4) through (9) No change.

Rulemaking Specific Authority 465.005, 465.022 FS. Law Implemented 465.022(1) 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,                   .

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: August 10, 2012
DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: June 1, 2012