The Board proposes the rule amendment to update the definitions contained in the rule and revise language, including expanding the use of technology.

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO.: RULE TITLE:

64B16-27.4001Delegation to and Supervision of Pharmacy Technicians; Responsibility of Supervising Pharmacist

PURPOSE AND EFFECT: The Board proposes the rule amendment to update the definitions contained in the rule and revise language, including expanding the use of technology.

SUMMARY: The language will be updated and revised, including expanding the use of technology.

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, 465.0155, 465.022 FS.

LAW IMPLEMENTED: 465.014 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:

64B16-27.4001 Delegation to and Supervision of Pharmacy Technicians; Responsibility of Supervising Pharmacist.

(1) Delegation: A pharmacist shall not delegate more tasks than he or she can personally supervise and ensure compliance with this rule. A pharmacist may delegate those non-discretionary delegable tasks enumerated in Rule 64B16-27.420, F.A.C., to the following types of pharmacy technicians:

(a) No change.

(b) Pharmacy Technicians in Training (PTT): are those technicians who are receiving practical (non-didactic) training in delegable tasks as part of employer-sponsored based or non-employer sponsored based board-approved pharmacy technician training programs who are not required to be duly registered with the board as pharmacy technicians.

(2) Supervision: Delegated tasks must be performed under the direct supervision of a pharmacist and pursuant to the following definitions and requirements:

(a) Direct Supervision: means supervision by a pharmacist who is readily and immediately available on the premises at all times the delegated tasks are being performed; who is aware of delegated tasks being performed; and who is readily available to provides personal assistance, direction and approval throughout the time the delegated tasks are being performed. “Readily and immediately available” means the pharmacist and technician(s) are on the same physical premises, or if not, technology is used to enable real time, two-way communications between the pharmacist and technician(s).

(b) Use of Technology: A pharmacist, as an adjunct to assist in the direct supervision of the pharmacy technician, may employ technological means to communicate with or observe the pharmacy technician. A pharmacist shall make certain all applicable state and federal laws, including, but not limited to confidentiality, are fully observed when employing technological means of communication and observation. If technology is being used to provide direct supervision of pharmacy technician(s), such technology shall be sufficient to provide the personal assistance, direction and approval required to meet the standard of practice for the delegated tasks.

Rulemaking Authority 465.005, 465.0155, 465.022 FS. Law Implemented 465.014 FS. History–New 12-31-14, Amended____.

 

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 7, 2018

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: September 24, 2018