Application for Prescription Drug Manufacturer Permit

 

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Drugs, Devices and Cosmetics

RULE NO.:RULE TITLE:

61N-2.014Application for Prescription Drug Manufacturer 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. 42 No. 53, March 17, 2016 issue of the Florida Administrative Register.

61N-2.014Application for Prescription Drug Manufacturer Permit.

Section 499.041(1)(a), F.S., has been added to the rulemaking authority.

Sections 499.051(1), 499.005(6), 499.0051(13), and 559.79, F.S., have been added to the law implemented.

 

The following changes have been made to incorporated form DBPR-DDC-201, Application for Permit as a Prescription Drug Manufacturer, effective April 2016:

The “DRAFT” watermark has been removed from the application.

On page 1, the word “biennial” has been inserted between “$1,500” and “application fee” to denote that the fee is biennial.

On page 4, the text:

“List Operating Hours – minimum 10 total per week (M-F) between 8:00 a.m. and 5:00 p.m., Eastern Standard Time, and at least 2 consecutive hours on at least 1 day. REMEMBER to circle “a.m.” or “p.m.” for each time indicated below.“

has been replaced with:

“List the establishment’s daily hours of operation in terms of Eastern Time. REMEMBER to circle “a.m.” or “p.m.” for each time indicated below.”

On page 7, the text:

“The term “affiliated party” includes all of the following that may apply:  (i) the applicant’s directors, officers, trustees, partners, or committee members; (ii) any person who manages, controls, or oversees the applicant’s operations (does not have to be an employee), including the establishment manager and the next four (4) highest ranking employees responsible for prescription drug wholesale operations; and (iii) the five (5) individuals (natural persons) who own at least 5% of the applicant’s stock ownership interest.”

has been replaced with the text:

“The term “affiliated party” means:  (a) a director, officer, trustee, partner, or committee member of a permittee or applicant or a subsidiary or service corporation of the permittee or applicant; (b) a person who, directly or indirectly, manages, controls, or oversees the operation of a permittee or applicant, regardless of whether such person is a partner, shareholder, manager, member, officer, director, independent contractor, or employee of the permittee or applicant; (c) a person who has filed or is required to file a personal information statement pursuant to s. 499.012(9) or is required to be identified in an application for a permit or to renew a permit pursuant to s. 499.012(8); or (d) the five largest natural shareholders that own at least 5 percent of the permittee or applicant.”

 

 

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, 1940 North Monroe Street Suite 26A, Tallahassee, Florida 32399-1047; [phone]; [e-mail].