To provide for zero activity reports and to amend the filing schedule for renewal of Notification of Exemption from Reporting to coincide with biennial license renewal cycle.

DEPARTMENT OF HEALTH

Prescription Drug Monitoring Program

RULE NO.:RULE TITLE:

64K-1.004Management and Operation of Database.

PURPOSE AND EFFECT:  To provide for zero activity reports and to amend the filing schedule for renewal of Notification of Exemption from Reporting to coincide with biennial license renewal cycle. 

SUMMARY: Amendment to provide for zero activity reports for dispensers with no dispensing transactions for preceding 7 days and to amend the filing schedule for renewal of notifications of Exemption from Reporting to coincide with biennial license renewal cycle. 

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION: The agency has determined this amendment 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: Based on the SERC checklist, this rulemaking will not have an adverse impact or regulatory costs in excess of $1 million within five years as established in s. 120.541(2)(a), F.S.

Any person who wishes to provide information regarding the statement of estimated regulatory costs, or to provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

RULEMAKING AUTHORITY:  893.055, FS.

LAW IMPLEMENTED:  893.055, FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FLORIDA ADMINISTRATIVE REGISTER.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS:  Rebecca R. Poston, Program Manager, 4052 Bald Cypress way, Bin #C-16, Tallahassee, FL 32399-3250, [phone] or [e-mail].

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64K-1.004 Management and Operation of Database.

(1) through (2) No change.

(3) All dispensers shall electronically report dispensing information to the program’s database as soon as possible, but not more than 7 days after the controlled substance is dispensed. Extensions of time to report the dispensing of a controlled substance may be granted for no more than 30 days upon request to the program by any dispenser unable to submit data by electronic means if the dispenser provides evidence of having suffered a mechanical or electronic failure or cannot report for reasons beyond the control of the dispenser or if the database is unable to receive submissions. A dispenser that has no dispensing transactions to report for the preceding seven-day period must submit a zero activity report as described in the “Dispenser’s Implementation Guide.”

(4) through (5) No change.

(6) Pharmacies that do not dispense controlled substances in or into this state must submit a “Notification of Exemption From Reporting,” DH8016-PDMP, (effective 7/2015), incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-06461. Exemptions must be renewed on or before February 28 in odd years by making the appropriate election on the biennial pharmacy permit renewal form or September 30 in even years on “Renewal of Notification of Exemption from Reporting Form,” DH8018-PDMP, (effective 7/2015), incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-06463. Pharmacies seeking to begin dispensing controlled substances must notify the program electronically and be removed from the exempt list prior to registering to report to the program database.

(7) through (8) No change.

(9) Information submitted to the database by dispensers directly dispensing a controlled substance shall include the telephone number of the person for whom the prescription was written. 

Rulemaking Authority 893.055 FS. Law Implemented 893.055 FS. History–New 11-24-11, Amended 2-17-16,              .

NAME OF PERSON ORIGINATING PROPOSED RULE:  Rebecca R. Poston

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Celeste Philip, MD, MPH, Surgeon General and Secretary

DATE PROPOSED RULE APPROVED BY AGENCY HEAD:  November 7, 2016

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: May 18, 2016