21194711, 2-40.007 - Florida Administrative Rules, Law, Code, Register

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Florida Department of State and Division of Library and Information Services

Notice: 21194711

Notice of Development of Rulemaking

Department:

DEPARTMENT OF LEGAL AFFAIRS

Chapter:

SCHEDULING AND RESCHEDULING OF CONTROLLED SUBSTANCES

Overview

RULE:

2-40.007

Rescheduling of a Drug Product in Finished Dosage Formulation That Has Been Approved by the U.S. Food and Drug Administration That Contains Cannabidiol (2-[1R-3-methyl-6R-(1-methylethenyl)-2-cyclohexen-1-yl]-5-pentyl-1,3-benzenediol) Derived from Cannabis and No More Than 0.1 Percent (w/w) Residual Tetrahydrocannabinols

PURPOSE:

The proposed rule development is intended to reschedule a drug product in finished dosage formulation that has been approved by the Food and Drug Administration that contains cannabidiol (2-[1R-3-methyl-6R-(1-methylethenyl)-2-cyclohexen-1-yl]-5-pentyl-1, 3-benzenediol) derived from cannabis and no more than 0.1 percent (w/w) residual tetrahydrocannabinols, from a Schedule I to a Schedule V controlled substance.

SUBJECT:

The rescheduling of the above drug product from a Schedule I to a Schedule V controlled substance.

RULEMAKING AUTHORITY:

893.0355, F.S.

LAW:

893.0355, F.S.

PRINT PUBLISH DATE:

11/27/2018 Vol. 44/229

RELATED STATUTES
AND LAWS:

893.0355, F.S., 893.0355, 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=2-40.007&PDate=11/27/2018&Section=1

REFERENCE MATERIALS:

No reference(s).

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