Kan. Admin. Regs. § 100-22-7

Current through Register Vol. 43, No. 49, December 5, 2024

Section 100-22-7 - Orders to dispense prescription-only medical devices

(a) For the purpose of this regulation, "prescription-only medical device" shall mean an apparatus that meets the following conditions:

(1) May be sold or distributed only upon the authorization of a person licensed by state law to administer or use the device; and

(2) is intended either to use in diagnosing or treating a disease, injury, or deformity or to affect the structure, action, or physiologic property of any part of the human body.

(b) Each licensee who issues an order that authorizes the sale, lease, or other method of distribution of a prescription-only medical device to another person for other than self-treatment shall create a written record of the order, signed by the licensee, and shall maintain that record for at least 10 years following the date of the order. The written record shall include, at a minimum, all of the following statements:

(1) The licensee knows or has reason to know that the person to whom the medical device is to be dispensed is professionally competent and legally authorized to use the device for other than self-treatment.

(2) The licensee acknowledges that the device is approved for acts and functions that are within the normal and customary specialty, competence, and lawful practice of the licensee.

(3) The licensee will supervise the use of the device.

(c) Each violation of this regulation shall constitute prima facie evidence of dishonorable conduct.

Kan. Admin. Regs. § 100-22-7

Authorized by K.S.A. 65-2865 and K.S.A. 2006 Supp. 65-28,127; implementing K.S.A. 65-2836 and K.S.A. 2006 Supp. 65-28,127; effective July 6, 2007.