The purpose of development is create a new rule establishing exemptions from establishment, security and storage requirements under s. 499.0121, F.S., for prescription drug manufacturer- virtual, non-resident prescription drug manufacturer-virtual, ...

 

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Drugs, Devices and Cosmetics

RULE NO.:RULE TITLE:

61N-1.0155Establishment, Security, Storage Exemptions for Virtual Manufacturers and Broker-Only Distributors

PURPOSE AND EFFECT: The purpose of development is create a new rule establishing exemptions from establishment, security and storage requirements under s. 499.0121, F.S., for prescription drug manufacturer- virtual, non-resident prescription drug manufacturer-virtual, and prescription drug wholesale distributor-broker only permit holders pursuant to s. 499.01(2)(a),(c), and (e), F.S.

SUBJECT AREA TO BE ADDRESSED: The subject area to be addressed in this rule is exemptions from establishment, security and storage requirements under s. 499.0121, F.S., for prescription drug manufacturer – virtual, non-resident prescription drug manufacturer - virtual, and prescription drug wholesale distributor-broker only permit holders pursuant to s. 499.01(2)(a),(c), and (e), F.S.

RULEMAKING AUTHORITY: 499.003, 499.01, 499.0121, 499.05(1)(a) FS.

LAW IMPLEMENTED: 499.002, 499.003, 499.01, 499.012, 499.0121, 499.03, 499.05, 499.052 FS.

A RULE DEVELOPMENT WORKSHOP WILL BE HELD AT THE DATE, TIME AND PLACE SHOWN BELOW:

DATE AND TIME: May 10, 2018 at 1:00 p.m.

PLACE: Floridays Resort, 12562 International Drive, Orlando, FL 32821 – [phone]

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE DEVELOPMENT AND A COPY OF THE PRELIMINARY DRAFT, IF AVAILABLE, IS: Dinah Greene, Division of Drugs, Devices and Cosmetics, Department of Business and Professional Regulation, 2601 Blair Stone Road, Tallahassee, Florida 32399-1047; [e-mail]; [phone].

THE PRELIMINARY TEXT OF THE PROPOSED RULE DEVELOPMENT IS NOT AVAILABLE.