ARC 4240C

ARC 4240C

PUBLIC HEALTH DEPARTMENT[641]

Notice of Intended Action

Proposing rule making related to vaporizable forms of medical cannabidiol

and providing an opportunity for public comment

The Public Health Department hereby proposes to amend Chapter 154, "Medical Cannabidiol Program," Iowa Administrative Code.

Legal Authority for Rule Making

This rule making is proposed under the authority provided in Iowa Code section 124E.11.

State or Federal Law Implemented

This rule making implements, in whole or in part, Iowa Code section 124E.11(2)"c."

Purpose and Summary

The Medical Cannabidiol Board asked the Board of Medicine to reconsider vaporizable forms of medical cannabidiol as allowable forms. The vaporizable forms allow for the administration of medical cannabidiol by a different route that avoids the digestive system and does not require the ability to swallow. The Board of Medicine approved the proposed amendment at its December 14, 2018, meeting. This proposed amendment adds the vaporizable form of inhaled medical cannabidiol to the allowable forms.

Fiscal Impact

This rule making has no fiscal impact to the State of Iowa.

Jobs Impact

After analysis and review of this rule making, no impact on jobs has been found.

Waivers

Any person who believes that the application of the discretionary provisions of this rule making would result in hardship or injustice to that person may petition the Department for a waiver of the discretionary provisions, if any, pursuant to the Department's variance and waiver provisions contained in 641—Chapter 178.

Public Comment

Any interested person may submit written comments concerning this proposed rule making. Written comments in response to this rule making must be received by the Department no later than 4:30 p.m. on February 5, 2019. Comments should be directed to:

Public Hearing

A public hearing at which persons may present their views orally or in writing will be held as follows:

Persons who wish to make oral comments at the public hearing may be asked to state their names for the record and to confine their remarks to the subject of this proposed rule making.

Any persons who intend to attend the public hearing and have special requirements, such as those related to hearing or mobility impairments, should contact the Department and advise of specific needs.

Review by Administrative Rules Review Committee

The Administrative Rules Review Committee, a bipartisan legislative committee which oversees rule making by executive branch agencies, may, on its own motion or on written request by any individual or group, review this rule making at its regular monthly meeting or at a special meeting. The Committee's meetings are open to the public, and interested persons may be heard as provided in Iowa Code section 17A.8(6).

The following rule-making action is proposed:

Amend rule 641—154.14(124E) as follows:

641—154.14(124E) Form and quantity of medical cannabidiol. The form and quantity of medical cannabidiol authorized in this rule may be modified pursuant to recommendations by the medical cannabidiol board, subsequent approval of the recommendations by the board of medicine and adoption of the recommendations by the department by rule.

154.14(1) Quantity. A 90-day supply is the maximum amount of each product that shall be dispensed by a dispensary at one time.

154.14(2) Form.

a. A manufacturer may only manufacture medical cannabidiol in the following forms:

(1)Oral forms, including but not limited to:

1.Tablet.

2.Capsule.

3.Liquid.

4.Tincture.

5.Sublingual.

(2)Topical forms, including but not limited to:

1.Gel.

2.Ointment, cream or lotion.

3.Transdermal patch.

(3)Nebulizable inhaled forms. Inhaled forms, limited to:

1.Nebulizable.

2.Vaporizable.

(4)Rectal/vaginal forms, including but not limited to suppository.

b. A manufacturer may not produce medical cannabidiol in any form that may be smoked.

c. A manufacturer may not produce medical cannabidiol in an edible form as defined in rule 641—154.1(124E).