20263705, 61N-1.0155 - Florida Administrative Rules, Law, Code, Register

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Florida Department of State and Division of Library and Information Services

Notice: 20263705

Notice of Development of Rulemaking

Department:

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Division:

Drugs, Devices and Cosmetics

Chapter:

REGULATIONS FOR DRUGS, DEVICES AND COSMETICS

Overview

RULE:

61N-1.0155

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

PURPOSE:

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:

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) F.S.

LAW:

499.002, 499.003, 499.01, 499.012, 499.0121, 499.03, 499.05, 499.052 F.S.

PRINT PUBLISH DATE:

4/5/2018 Vol. 44/67

RELATED STATUTES
AND LAWS:

499.003, 499.01, 499.0121, 499.05(1)(a) F.S., 499.002, 499.003, 499.01, 499.012, 499.0121, 499.03, 499.05, 499.052 F.S.

OVERSIGHT COMMITTEE:

Joint Administrative Procedures Committee
Florida Administrative Law Central Online Network (F.A.L.C.O.N.)

RELATED COURT CASES:

Division of Administrative Hearings

FEDERAL eRULEMAKING
WEB PORTAL:

Regulations.gov

HOW TO LINK TO
THIS NOTICE:

http://www.flrules.org/gateway/ruleno.asp?id=61N-1.0155&PDate=4/5/2018&Section=1

REFERENCE MATERIALS:

No reference(s).

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