The Board proposes the rule amendment to update requirements regarding original prescriptions not in written form.

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO.:RULE TITLE:

64B16-28.140Record Maintenance Systems for All Pharmacy Permits

PURPOSE AND EFFECT: The Board proposes the rule amendment to update requirements regarding original prescriptions not in written form.

SUMMARY: The rule amendment updates requirements regarding original prescriptions not in written form.

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: 465.003(14), 465.022, 465.026, 465.035, 893.07 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:

 

64B16-28.140 Record Maintenance Systems for All Pharmacy Permits.

(1) Requirements for records maintained in a data processing system.

(a) through (c) No change.

(d) Original prescriptions, not received in written form including prescriptions received as provided for in Rule 64B16-28.1003, F.A.C., Transmission of Prescription Orders, shall be reduced to writing or recorded electronically if permitted by federal law a hard copy if not received in written form. All original prescriptions shall be retained for a period of not less than four (4) years from date of last filling. To the extent authorized by 21 C.F.R. §1304.04, a pharmacy may, in lieu of retaining the actual original prescriptions, use an electronic imaging recordkeeping system, provided such system is capable of capturing, storing, and reproducing the exact image of the prescription, including the reverse side of the prescription if necessary, and that such image be retained for a period of no less than four (4) years from the date of last filling.

(e) through (h) No change.

(2) through (6) No change.

Rulemaking Authority 465.005, 465.022 FS. Law Implemented 465.003(14), 465.022, 465.026, 465.035, 893.07 FS. History–New 3-16-94, Formerly 61F10-28.140, Amended 3-12-97, 6-4-97, Formerly 59X-28.140, Amended 10-29-97, 6-15-98, 11-11-98, 10-15-01, 3-24-14,                   .

 

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: June 16, 2022

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: September 28, 2022