ARC 2288C
PHARMACY BOARD[657]
Notice of Intended Action
Twenty-five interested persons, a governmental subdivision, an agency or association of 25 or more persons may demand an oral presentation hereon as provided in Iowa Code section 17A.4(1)“b.”
Notice is also given to the public that the Administrative Rules Review Committee may, on its own motion or on written request by any individual or group, review this proposed action under section 17A.8(6) at a regular or special meeting where the public or interested persons may be heard.
Pursuant to the authority of Iowa Code section 147.76, the Board of Pharmacy hereby gives Notice of Intended Action to amend Chapter 6, “General Pharmacy Practice,” and Chapter 8, “Universal Practice Standards,” Iowa Administrative Code.
The amendments were approved at the August 31, 2015, regular meeting of the Board of Pharmacy.
The proposed amendments are intended to implement 2015 Iowa Acts, Senate File 462, which authorizes the prescribing of epinephrine auto-injectors in the name of a facility as defined in Iowa Code subsection 135.185(1), a school district, or an accredited nonpublic school. The proposed amendments exclude such a prescription from the requirement for a preexisting patient-prescriber relationship and establish the unique prescription label and record-keeping requirements for a prescription issued to a facility, school district, or accredited nonpublic school as authorized by 2015 Iowa Acts, Senate File 462.
Requests for waiver or variance of the discretionary provisions of Board rules will be considered pursuant to 657—Chapter 34.
Any interested person may present written comments, data, views, and arguments on the proposed amendments not later than 4:30 p.m.	on December 29, 2015. Such written materials may be sent to Terry Witkowski, Executive Officer, Board of Pharmacy, 400 S.W. Eighth Street, Suite E, Des Moines, Iowa 50309-4688; or by e-mail to terry.witkowski@iowa.gov.
After analysis and review of this rule making, no impact on jobs has been found.
These amendments are intended to implement Iowa Code section 155A.27 and 2015 Iowa Acts, Senate File 462.
The following amendments are proposed.
	Item 1. Amend subrule 6.10(1) as follows:
	6.10(1) Required information. The label affixed to or on the dispensing container of any prescription drug or device dispensed by a pharmacy pursuant to a prescription drug order shall bear the following:
	a.  and b.  No change.
	c. 	The Except as provided in 657—subrule 8.19(7) for epinephrine auto-injectors, the name of the patient or, if such drug is prescribed for an animal, the species of the animal and the name of its owner;
	d.  to h.  No change.
	Item 2. Amend subrule 8.19(1) as follows:
	8.19(1) Requirements for a prescription. A valid prescription drug order shall be based on a valid patient-prescriber relationship except as provided in subrule 8.19(7) for epinephrine auto-injectors.
	a. 	Written, electronic, or facsimile prescription. In addition to the electronic prescription application and pharmacy prescription application requirements of this rule, a written, electronic, or facsimile prescription shall include:
	(1)	The date issued.
	(2)	The name and address of the patient except as provided in subrule 8.19(7) for epinephrine auto-injectors.
	(3)	The name, strength, and quantity of the drug or device prescribed.
	(4)	The name and address of the prescriber and, if the prescription is for a controlled substance, the prescriber’s DEA registration number.
	(5)	The written or electronic signature of the prescriber.
	b.  to d.  No change.
	Item 3. Amend subrule 8.19(5) as follows:
	8.19(5) Legitimate purpose. The pharmacist shall ensure that the prescription drug or medication order, regardless of the means of transmission, has been issued for a legitimate medical purpose by an authorized practitioner acting in the usual course of the practitioner’s professional practice. A pharmacist shall not dispense a prescription drug if the pharmacist knows or should have known that the prescription was issued solely on the basis of an Internet-based questionnaire, an Internet-based consultation, or a telephonic consultation and without a valid preexisting patient-practitioner relationship except as provided in subrule 8.19(7) for epinephrine auto-injectors.
	Item 4. Adopt the following new subrule 8.19(7):
	8.19(7) Epinephrine auto-injector prescription issued to school or facility. A physician, advanced registered nurse practitioner, or a physician assistant may issue a prescription for one or more epinephrine auto-injectors in the name of a facility as defined in Iowa Code subsection 135.185(1), a school district, or an accredited nonpublic school. The prescription shall comply with all requirements of subrule 8.19(1) as applicable to the form of the prescription except that the prescription shall be issued in the name and address of the facility, the school district, or the accredited nonpublic school in lieu of the name and address of a patient. Provisions requiring a preexisting patient-prescriber relationship shall not apply to a prescription issued pursuant to this subrule.
	a. 	The pharmacy’s patient profile and record of dispensing of a prescription issued pursuant to this subrule shall be maintained in the name of the facility, school district, or accredited nonpublic school to which the prescription was issued and the drug was dispensed.
	b. 	The label affixed to an epinephrine auto-injector dispensed pursuant to this subrule shall identify the name and address of the facility, school district, or accredited nonpublic school to which the prescription is dispensed.