The Board proposes the rule amendment to specify minimum responsibilities of the Prescription Department Manager.

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO.:RULE TITLE:

64B16-27.104Conduct Governing Pharmacists and Pharmacy Permittees

PURPOSE AND EFFECT: The Board proposes the rule amendment to specify minimum responsibilities of the Prescription Department Manager.

SUMMARY: Minimum responsibilities of the Prescription Department Manager will be identified in the rule.

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, 465.018, 465.022 FS.

LAW IMPLEMENTED: 465.018, 465.022, 465.024 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: Allison Dudley, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin C04, Tallahassee, Florida 32399-3254

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64B16-27.104 Conduct Governing Pharmacists and Pharmacy Permittees; Prescription Department Managers.

(1) through (4) No change.

(5) Prescription Department Managers.  Pursuant to Section 465.018, F.S., a permit for a community pharmacy may not be issued unless a licensed pharmacist is designated as the prescription department manager.

(a) Registration as prescription department manager. responsible for maintaining all drug records, providing for the security of the prescription department and following such other rules as relate to the practice of the profession of pharmacy. The Board shall not register a prescription department manager as the manager of more than one pharmacy. The Board shall grant an exception to this requirement upon application by the permittee and the prescription department manager showing circumstances such as proximity of permits and limited pharmacist workload that would allow the manager to carry out all duties and responsibilities required of a prescription department manager.

(b)  Responsibilities of the prescription department manager.  Prescription department managers are responsible for ensuring the pharmacy permittee's compliance with all statutes and rules governing the practice of the profession of pharmacy, including maintenance of all drug records and ensuring the security of the prescription department, and shall competently and diligently exercise their responsibilities as a prescription department manager.  Prescription department managers shall spend such time in the prescription department as is necessary to exercise these responsibilities by, at a minimum:

1.  Within fourteen (14) days of being designated as the prescription department manager of a pharmacy, the pharmacist so designated shall conduct an on-site visit of the pharmacy.  During this on-site visit, the prescription department manager shall verify that the pharmacy is in compliance with all statutes and rules, and shall also perform the tasks identified in subparagraph (b)2., below.

2.  Following the initial on-site visit, the prescription department manager shall, no less than semi-annually, perform the following tasks:

a. Review the prescription department's records and documentation, including

i. drug records, inventory logs and CQI committee minutes;

ii. employee training (including training materials, policies and procedures manuals, and documentation of compliance with training requirements);

iii. compliance with Board rules regarding pharmacist to technician ratios;

iv. other documentation required by state and federal laws and rules.

b. Review the pharmacy's drug stocks and inventory for compliance with Rule 64B16-28.110, F.A.C.;

3. Prescription department managers shall document compliance with paragraph (5)(b), above, and shall provide such documentation to the Board or Department upon request. 

Rulemaking Specific Authority 465.005, 465.0155, 465.018, 465.022 FS. Law Implemented 465.018, 465.022, 465.024 FS. History–New 10-20-81, Formerly 21S-1.20, 21S-1.020, Amended 7-30-91, Formerly 21S-27.104, 61F10-27.104, 59X-27.104, Amended 11-18-07,               .

 

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: April 5, 2016

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: May 3, 2016