24558768, 61N-2.037 - Florida Administrative Rules, Law, Code, Register

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Florida Department of State and Division of Library and Information Services

Notice: 24558768

Notice of Development of Rulemaking

Department:

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Division:

Drugs, Devices and Cosmetics

Chapter:

Applications, Forms and Regulations

Overview

RULE:

61N-2.037

Application for Registration as a Non-Resident Prescription drug Manufacturer in the International Prescription drug Importation program

PURPOSE:

This rule development will consider rules necessary to adopt the form used to apply for participation as a Non-Resident Prescription Drug Manufacturer in the International Prescription Drug Importation Program as authorized by 499.0285, F.S., 21 U.S.C.§384 and 21 C.F.R.  Part 251.

SUBJECT:

International Prescription Drug Importation Program

RULEMAKING AUTHORITY:

499.0285

LAW:

499.0285, 499.02851

PRINT PUBLISH DATE:

5/19/2021 Vol. 47/97

RELATED STATUTES
AND LAWS:

499.0285, 499.0285, 499.02851

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-2.037&PDate=5/19/2021&Section=1

REFERENCE MATERIALS:

No reference(s).

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