DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION
RULE NO.:RULE TITLE:
61N-2.022Application for Permit as a Restricted Prescription Drug Distributor – Health Care Entity
NOTICE OF CHANGE
Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol. 45 No. 225, November 19, 2019 issue of the Florida Administrative Register.
Summaries of Substantive Changes to Amended Form DBPR-DDC-207 are as follows:
61N-2.022 – Amended Form DBPR-DDC-207:
The effective date of the Form was amended from “TBA” to “September 2019” to properly reflect the date contained within the rule text and displayed on the form are consistent.
Page 8, Section VII, “Prescription Drug Distribution Activity”: The rule text provides that this permit is required for a hospital or a health care entity as defined in s. 499.003(15), F.S., for the limited purpose of transferring prescription drugs among hospitals or other health care entities that are: (1) under “common control” as provided in Section 499.012(1)(a)3., F.S. or (2) members of a group purchasing organization as provided for in Section 499.012(1)(a)1., F.S. Transfers are limited to a facility under common control or a group purchasing organization, either of which must be licensed with a pharmacy permit that authorizes the acquisition and possession of prescription drugs.
The application form for a permit as a Restricted Prescription Drug Distributor-Health Care Entity is amended to delete all current options for intended customers and to replace that list with the following: (1) hospitals that have a pharmacy license and that are under common control as provided for in s. 499.012(1)(a)3., F.S., with the permitted entity; (2) health care entities that have a pharmacy permit and that are under common control as provided for in s. 499.012(1)(a)3., F.S., with the permitted entity; (3) hospitals that are members of a group purchasing organization as provided for in s.499.012(1)(a)1., F.S.; and (4) health care entities that are members of a group purchasing organization as provided for in s.499.012(1)(a)1., F.S.
61N-2.022 Application for Permit as a Restricted Prescription Drug Distributor – Health Care Entity
No change.
