The Board proposes the rule amendment to clarify the existing rule requirement that the 3:1 ratio only applies to activities related to sterile compounding and does not limit the ratios for other non-sterile compounding related activities.

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO.:RULE TITLE:

64B16-27.410Registered Pharmacy Technician to Pharmacist Ratio

PURPOSE AND EFFECT: The Board proposes the rule amendment to clarify the existing rule requirement that the 3:1 ratio only applies to activities related to sterile compounding and does not limit the ratios for other non-sterile compounding related activities.

SUMMARY: Language will be clarified regarding the 3:1 ratio regarding sterile compounding and non-sterile compounding related activities.

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: 456.069(1), 465.005, 465.014, 465.017, 465.022 FS.

LAW IMPLEMENTED: 465.014, 465.022 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: C. Erica White, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin C04, Tallahassee, Florida 32399-3254.

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64B16-27.410 Registered Pharmacy Technician to Pharmacist Ratio.

(1) through (3) No change.

(4) Three to One (3:1) Ratio: Any pharmacy or any pharmacist engaged in sterile compounding shall not exceed a ratio of up to three (3) registered pharmacy technicians to one (1) pharmacist (3:1). The 3:1 ratio only applies to pharmacists and technicians engaged in sterile compounding, and does not affect the technician ratios for other activities not involving sterile compounding in areas of the pharmacy physically separated from the area in which sterile compounding activities take place.

(5) Six to One (6:1) Ratio: Any pharmacy or any pharmacist may allow a supervision ratio of up to six (6) registered pharmacy technicians to one (1) pharmacist (6:1), as long as the pharmacist or registered pharmacy technicians are or pharmacy is not engaged in sterile compounding.

(6) Eight to One (8:1) Ratio:

(a) Non-dispensing pharmacies. Any pharmacy which does not dispense medicinal drugs, and the pharmacist(s) employed by such pharmacy, may allow a supervision ratio of up to eight (8) registered pharmacy technicians to one (1) pharmacist (8:1), as long as the pharmacy or pharmacist or registered pharmacy technicians are is not engaged in sterile compounding.

(b) No change.

(7) No change.

Rulemaking Authority 465.005, 456.069(1), 465.014, 465.017, 465.022 FS. Law Implemented 465.014, 465.022 FS. History–New 2-14-77, Amended 3-31-81, Formerly 21S-4.02, Amended 8-31-87, Formerly 21S-4.002, Amended 9-9-92, Formerly 21S-27.410, 61F10-27.410, Amended 1-30-96, Formerly 59X-27.410, Amended 2-23-98, 10-15-01, 1-1-10, 1-7-15, 7-6-15, 5-8-18,  .

 

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: October 3, 2018

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: October 29, 2018