Repackaging of VA medications, 22.6
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 22, "Unit Dose, Alternative Packaging, and Emergency Boxes," Iowa Administrative Code.
This amendment was approved at the November 1, 2017, regular meeting of the Board of Pharmacy.
Patients within the Veterans Administration (VA) health care system are limited in where they may obtain their prescriptions drugs under the VA benefit, and VA pharmacies do not provide prescription drugs in unit dose drug distribution systems, which are usually required in care facilities. This amendment proposes to adopt a new rule that would allow pharmacies to repackage prescription drugs originally dispensed by a VA pharmacy for a patient residing in a care facility. In the care facility, drug security and accountability are better provided when drugs are packaged in unit dose drug distribution systems. This proposed rule identifies the minimum standard for such repackaging activities.
Any interested person may present written comments, data, views, and arguments on the proposed amendment not later than 4:30 p.m.on January 19, 2018. Such written materials may be sent to Terry Witkowski, Executive Officer, Iowa Board of Pharmacy, 400 S.W. Eighth Street, Suite E, Des Moines, Iowa 50309-4688; or by email at email@example.com.
Requests for waiver or variance of the discretionary provisions of Board rules will be considered pursuant to 657—Chapter 34.
After analysis and review of this rule making, no impact on jobs is anticipated.
This amendment is intended to implement Iowa Code sections 124.301, 126.11, 155A.13, 155A.28, 155A.35, and 155A.36.
The following amendment is proposed.
Adopt the following new rule 657—22.6(124,126,155A):
657—22.6(124,126,155A) Repackaging of VA medications. A pharmacy may repackage, for a specific patient residing in a care facility as defined in 657—Chapter 23, a supply of medications originally dispensed by a Veterans Administration (VA) pharmacy. A pharmacy that repackages VA medications for a patient residing in a care facility assumes liability for such service unless liability is waived by the patient or the patient's caregiver.
22.6(1) Labeling. In addition to the labeling requirements of 657—subrule 6.10(1), rule 657—22.1(155A), or rule 657—22.5(126,155A), the labeling of medication pursuant to this rule shall include an appropriate beyond-use date.
22.6(2) Record. In addition to the record-keeping requirements of 657—subrule 8.3(7) or rule 657—22.5(126,155A), the pharmacy shall create and maintain a record that includes at a minimum:
a. Name, address, and telephone number of the VA pharmacy which dispensed the medication; and
b. The prescription number or unique identification assigned to the medication dispensed by the VA pharmacy.