The Board proposes the rule amendments to require consistent periods of record retention. Four years is compatible with the biennial inspection period by the Department of Health. Consistent periods of record retention increase efficiency.

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO.:RULE TITLE:

64B16-28.450Centralized Prescription Filling, Delivering and Returning

PURPOSE AND EFFECT: The Board proposes the rule amendments to require consistent periods of record retention. Four years is compatible with the biennial inspection period by the Department of Health. Consistent periods of record retention increase efficiency.

SUMMARY: Period of time for record retention will be changed.

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 proposed rule at its Board meeting, the Board, with input from the public, determined that record maintenance for 4 years would not have an adverse effect on small business, and that there would not be a regulatory cost of $200,000 in the aggregate to any entity. Change of ownership documentation and quality assurance program reports and analyses are not high volume records and would not pose a burden to maintain an additional two years. The 4 year maintenance of prescription records is required by Section 465.022(12)(b), F.S.

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, 465.0265 FS.

LAW IMPLEMENTED: 465.003(16), 465.019, 465.0265 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: Patrick Kennedy, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin C04, Tallahassee, Florida 32399-3254

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64B16-28.450 Centralized Prescription Filling, Delivering and Returning.

(1) through (3) No change.

(4) The central fill and originating pharmacy shall each be identified on the prescription container label. The originating pharmacy shall be identified with pharmacy name and address. The central fill pharmacy may be identified by a code available at the originating pharmacy. Prescription and labeling requirements for pharmacies participating in central prescription filling, delivering and returning:

(a) Prescriptions may be transmitted electronically from an originating pharmacy to a central fill pharmacy including via facsimile. The originating pharmacy transmitting the prescription information must:

1. through 3. No change.

4. Maintain the original prescription for a period of four (4) two years from the date the prescription was last refilled.

5. No change.

(b) The central fill pharmacy receiving the transmitted prescription must:

1. through 4. No change.

(5) through (7) No change.

Rulemaking Authority 465.005, 465.0155, 465.0265 FS. Law Implemented 465.003(16), 465.019, 465.022, 465.0265 FS. History–New 9-23-03, Amended 7-27-04, 4-28-08, 2-5-14,____________.

 

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: February 12, 2014

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: March 5, 2014