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-...

 

DEPARTMENT OF LEGAL AFFAIRS

RULE NO.:RULE TITLE:

2-40.007Rescheduling 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 AND EFFECT: 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 AREA TO BE ADDRESSED: The rescheduling of the above drug product from a Schedule I to a Schedule V controlled substance.

RULEMAKING AUTHORITY: 893.0355, FS.

LAW IMPLEMENTED: 893.0355, FS.

IF REQUESTED IN WRITING AND NOT DEEMED UNNECESSARY BY THE AGENCY HEAD, A RULE DEVELOPMENT WORKSHOP WILL BE NOTICED IN THE NEXT AVAILABLE FLORIDA ADMINISTRATIVE REGISTER.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE DEVELOPMENT AND A COPY OF THE PRELIMINARY DRAFT, IF AVAILABLE, IS: Edward A. Tellechea, Chief Assistant Attorney General, PL-01, The Capitol, Tallahassee, Florida 32399-1050.

THE PRELIMINARY TEXT OF THE PROPOSED RULE DEVELOPMENT IS AVAILABLE AT NO CHARGE FROM THE CONTACT PERSON LISTED ABOVE.