21109642, 2ER18-1 - Florida Administrative Rules, Law, Code, Register

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Notice: 21109642

Notice of Emergency Rule

Department:

DEPARTMENT OF LEGAL AFFAIRS

Overview

RULE:

2ER18-1

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

SPECIFIC REASONS FOR FINDING AN IMMEDIATE DANGER TO THE PUBLIC HEALTH, SAFETY OR WELFARE:

There are currently approximately 64 patients in the state of Florida who are legally using a FDA approved cannabidiol product for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome pursuant to clinical trial programs that have either ended or will end soon.  Any delay caused by the rescheduling of this FDA approved cannabidiol product through the regular rulemaking process or by waiting for legislative action during the 2019 legislative session will likely cause a disruption in the supply of this product that will result in serious bodily harm to seriously ill Floridians.  Attorney General Bondi recognizes that such circumstances constitute an immediate danger to the health, safety and welfare of a limited but extremely vulnerable population of Floridians, and therefore, concludes that such circumstances justify the promulgation of emergency rule 2ER18-1 pursuant to Section 893.0355 and Section 120.54(4), Florida Statutes.

REASON FOR CONCLUDING THAT THE PROCEDURE IS FAIR UNDER THE CIRCUMSTANCES:

Failure to reschedule the above-mentioned compound will result in an immediate and imminent hazard to the public health, safety, and welfare which requires emergency action.   The Attorney General will continue to promulgate a rule through the regular rulemaking process and will ask the Florida Legislature to memorialize this action through legislation in its 2019 legislative session.  A copy of the Attorney General’s findings in support of this emergency rule may be obtained by contacting the Office of the Attorney General, PL-01, The Capitol, Tallahassee, Florida 32399-1050; (850) 245-0145.

SUMMARY:

The proposed emergency rule reschedules 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.

THE PERSON TO BE CONTACTED REGARDING THE EMERGENCY RULE IS:

Andrew Benard, Assistant Deputy Attorney General and Special Counsel, PL-01, The Capitol, Tallahassee, Florida 32399-1050.

PRINT PUBLISH DATE:

11/1/2018 Vol. 44/214

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=2ER18-1&PDate=11/1/2018&Section=4

REFERENCE MATERIALS:

No reference(s).

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