Fla. Admin. Code R. 64K-1.004

Current through Reg. 50, No. 222; November 13, 2024

Section 64K-1.004 - Management and Operation of Database

(1) All non-exempt entities that dispense controlled substances as defined in Section 893.055(1)(c), F.S., are required to register and report to the program database. Orders for administration are exempt from reporting.

(2) Dispensers must register electronically at https://pmpclearinghouse.net/registrations/new. Prior to registration, a dispenser must review the "PMP AWARxE^® Data Submission Guide for Dispensers, Version 3.0, DH8013-PDMP, effective 7/2022, incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-15674, before registration can be completed.

(3) All dispensers shall electronically report dispensing information to E-FORCSE^® as soon as possible, but no later than the close of the next business day after the day 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 E-FORCSE^® is unable to receive submissions. A dispenser that has no dispensing transactions to report for the preceding business day must submit a zero activity report as described in the "PMP AWARxE^® Data Submission Guide for Dispensers."

(4) Dispensing information with errors or omissions shall be corrected and resubmitted to E-FORCSE^® by the reporting dispenser within seven business days of receiving electronic or written notice from the program manager or support staff of the error or omission.

(5) The program will file a complaint with the Department and refer to law enforcement any failure to report the dispensing of controlled substances as defined in Section 893.055(1)(c), F.S.

(6)

(a) Pharmacies and registered dispensing practitioners that do not dispense controlled substances in or into this state and meet one of the exemptions in Section 893.055(3)(b), F.S., must submit a "Notification of Exemption From Reporting, " DH8016-PDMP, effective 7/2018, incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-11372 or https://controlled-substance-reporting-waiver.pmpaware.net/florida/waiver/index.

(b) Exemption requests must be renewed on a biennial basis or before February 28 in odd years on "Renewal of Notification of Exemption from Reporting Form, " DH8018-PDMP, effective 7/2018, incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-11373 or https://controlled-substance-reporting-waiver.pmpaware.net/florida/waiver/index.

(c) Pharmacies and registered dispensing practitioners seeking to begin dispensing controlled substances must notify the program electronically at e-forcse@flhealth.gov, requesting to be removed from the exempt list.

(7)

(a) A patient, health care provider, prescriber, or dispenser may submit an electronic request to the program manager for the correction of erroneous information in E-FORCSE^®. The request shall include:

1. A statement explaining in detail the error and the basis for the requested correction,

2. The precise change requested,

3. Documentation establishing the correct information,

4. The requester's name, address, telephone number, and license number if licensed as a health care provider in Florida.

(b) The program manager or support staff will review all requests to correct information and will request the reporting dispenser to correct identified errors. No correction will be made if no error is found. The program will notify the entity or person requesting the correction of the results of the review.

(8) Information reported to E-FORCSE^® will be available for access for a period of 2 years from the date the prescription was dispensed.

Fla. Admin. Code Ann. R. 64K-1.004

Rulemaking Authority 893.055 FS. Law Implemented 893.055 FS.

New 11-24-11, Amended by Florida Register Volume 42, Number 021, February 02, 2016 effective 2/17/2016, Amended by Florida Register Volume 42, Number 250, December 28, 2016 effective 1/12/2017, Amended by Florida Register Volume 45, Number 230, November 26, 2019 effective 12/11/2019, Amended by Florida Register Volume 49, Number 143, July 25, 2023 effective 8/8/2023.

New 11-24-11, Amended 2-17-16, 1-12-17, 12-11-19, 8-8-23.