ARC 4399C

ARC 4399C

PUBLIC HEALTH DEPARTMENT[641]

Adopted and Filed

Rule making related to vaporizable forms of medical cannabidiol

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

Legal Authority for Rule Making

This rule making is adopted 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 amendment at its December 14, 2018, meeting. This amendment adds the vaporizable form of inhaled medical cannabidiol to the allowable forms.

Public Comment and Changes to Rule Making

Notice of Intended Action for this rule making was published in the Iowa Administrative Bulletin on January 16, 2019, as ARC 4240C. A public hearing was held on February 6, 2019, at 11 a.m.in Room 518, Lucas State Office Building, Des Moines, Iowa. No one attended the public hearing. No public comments were received. No changes from the Notice have been made.

Adoption of Rule Making

This rule making was adopted by the State Board of Health on March 13, 2019.

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.

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).

Effective Date

This rule making will become effective on May 15, 2019.

The following rule-making action is adopted:

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).

[Filed 3/13/19, effective 5/15/19]

[Published 4/10/19]

Editor's Note: For replacement pages for IAC, see IAC Supplement 4/10/19.