Notice of Proposed Rule

DEPARTMENT OF HEALTH
Prescription Drug Monitoring Program
RULE NO.: RULE TITLE:
64K-1.002: American Society of Automation in Pharmacy Standards and Formats
PURPOSE AND EFFECT: To establish data reporting standards designed to capture controlled substance dispensing data from dispensing practitioners and pharmacies. To encourage responsible prescribing by implementing provisions to help establish a limited access comprehensive electronic database system for controlled substances.
SUMMARY: This rule describes the format for submissions to the Prescription Drug Monitoring Program database as ASAP 2007 version 4.1, specifies the Zero Report standard for no controlled substances dispensed, and provides where the standards may be obtained.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: 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.
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: 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 FAW.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Rebecca R. Poston, Program Manager, 4052 Bald Cypress Way, Bin #C16, Tallahassee, Florida 32399-3250, (850)245-4797 or Rebecca_Poston@doh.state.fl.us

THE FULL TEXT OF THE PROPOSED RULE IS:

64K-1.002 American Society of Automation in Pharmacy Standards and Formats.

The format for submission to the database shall be in accordance with the Electronic Reporting Standard for Prescription Monitoring Programs of the American Society for Automation in Pharmacy (ASAP), ASAP 2007 version 4.1. The format for submission to the database if no controlled substances dispensed shall be in accordance with the ASAP Zero Report standard. A copy of the Electronic Reporting Standard for Prescription Monitoring Programs may be obtained from the American Society for Automation in Pharmacy, 492 Norristown Road, Suite 160, Blue Bell, Pennsylvania 19422, Telephone: (610)825-7783, Website: www.asapnet.org.

Rulemaking Authority 893.055 FS. Law Implemented 893.055 FS. History–New________.


NAME OF PERSON ORIGINATING PROPOSED RULE: Rebecca Poston
NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: H. Frank Farmer, M.D., Ph.D, FACP
DATE PROPOSED RULE APPROVED BY AGENCY HEAD: April 20, 2011
DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: March 12, 2010