Application for Out-of-State Prescription Drug Wholesale Distributor Permit

 

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Drugs, Devices and Cosmetics

RULE NO.:RULE TITLE:

61N-2.012Application for Out-of-State Prescription Drug Wholesale Distributor Permit

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. 43 No. 68, April 7, 2017 issue of the Florida Administrative Register.

The changes are in response to written comments submitted by the staff of the Joint Administrative Procedures Committee. The changes are as follows:

The Department will revise the rulemaking authority to include section 499.041(2)(b).

The Department will remove section 499.001 from the laws implemented by this section.

Section III- Ownership Information

Page 7, Number 1-8:

The Division will revise the form incorporated by reference DBPR-DDC-214, Application for Out-of-State Prescription Drug Wholesale Distributor Permit, effective March 2017, to comply with section 499.012(8) and request information on persons who own 5 percent or more of the outstanding stock or equity interest in the entity instead of 10 percent.

The Division will revise the form incorporated by reference DBPR-DDC-214, Application for Permit as an Out-of-State Prescription Drug Wholesale Distributor to include the Personal Information Statement as required by 499.012(9)(a)1. through 12. and the Personal Information Statement to be signed under oath in compliance with section 499.012(9)(b).

 

THE PERSON TO BE CONTACTED REGARDING THIS CHANGE IS: Dinah Greene, Operations Review Specialist, Division of Drugs, Devices and Cosmetics, Department of Business and Professional Regulation, 2601 Blair Stone Road, Tallahassee, Florida 32399-1047; [phone]; [e-mail].