Florida Regulations 64-4.009: Compassionate Use Registry
Current as of: 2024 | Check for updates
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(1) Ordering physicians licensed under Chapter 458 or 459, F.S., meeting the educational requirements of Florida Statutes § 381.986(4), may access the Compassionate Use Registry using their existing MQA Services credentials.
(2) Other persons may request access to the Compassionate Use Registry by completing form DH8009-OCU-2/2015, “”Request for Access to the Compassionate Use Registry,”” herein incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-05459. Those requesting access must meet one of the following criteria:
(a) Authorized employee of a Dispensing Organization;
(b) Law enforcement official, or
(c) Authorized employee of the department.
(3) Persons seeking to access to the registry shall have successfully completed a department-approved course in their responsibilities related to patient confidentiality and shall make documentation of completion available to the department upon request.
(4) Before dispensing any Derivative Product to a qualified registered patient or the patient’s legal representative, the Dispensing Organization must verify that the patient has an active registration, the order presented matches the order contents as recorded by the physician in the registry, and the order has not already been dispensed.
(5) The Dispensing Organization shall enter a dispensing action into the registry immediately upon dispensing the Derivative Product to the qualified registered patient or the patient’s legal representative.
Rulemaking Authority 381.986(5)(d) FS. Law Implemented 381.986(5)(a), 837.06 FS. History-New 6-17-15.
(2) Other persons may request access to the Compassionate Use Registry by completing form DH8009-OCU-2/2015, “”Request for Access to the Compassionate Use Registry,”” herein incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-05459. Those requesting access must meet one of the following criteria:
(a) Authorized employee of a Dispensing Organization;
(b) Law enforcement official, or
(c) Authorized employee of the department.
(3) Persons seeking to access to the registry shall have successfully completed a department-approved course in their responsibilities related to patient confidentiality and shall make documentation of completion available to the department upon request.
(4) Before dispensing any Derivative Product to a qualified registered patient or the patient’s legal representative, the Dispensing Organization must verify that the patient has an active registration, the order presented matches the order contents as recorded by the physician in the registry, and the order has not already been dispensed.
(5) The Dispensing Organization shall enter a dispensing action into the registry immediately upon dispensing the Derivative Product to the qualified registered patient or the patient’s legal representative.
Rulemaking Authority 381.986(5)(d) FS. Law Implemented 381.986(5)(a), 837.06 FS. History-New 6-17-15.