The proposed rule 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-...

 

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 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.

SUMMARY: The above substance is being rescheduled from a Schedule I to a Schedule V controlled substance.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: the agency has concluded that the rule will not increase any fees, business costs, personnel costs, will not decrease profit opportunities, and will not require any specialized knowledge to comply. This change will not increase any direct or indirect regulatory costs. Hence, the agency determined that a Statement of Estimated Regulatory Costs (SERC) was not necessary and that the rule will not require ratification by the Legislature.

Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

RULEMAKING AUTHORITY: 893.0355, FS.

LAW IMPLEMENTED: 893.0355, FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Edward A. Tellechea, Chief Assistant Attorney General, PL-01, The Capitol, Tallahassee, Florida 32399-1050.

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

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. Under the authority of Section 893.0355, Florida Statutes, 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, is hereby rescheduled from a Schedule I to a Schedule V controlled substance.

Rulemaking Authority: 893.0355 FS.  Law Implemented: 893.0355 FS. History–New___.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Pam Bondi, Attorney General

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Pam Bondi, Attorney General

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: October 31, 2018

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: November 27, 2018