Kan. Admin. Regs. § 68-7-15 - Packaging of drugs or devices in advance of immediate need
All drugs or devices, whether in a unit-dose container or multiple-dose container, packaged in advance of immediate need shall meet the requirements of this regulation.
(a)
Packaging shall be done by a pharmacist or under the pharmacist's direct
supervision. The pharmacist shall verify and document verification of the
packaged drugs or devices before the packaged drugs or devices are released
from a facility registered with the board.
(b) Packaging shall be limited to the drugs
or devices dispensed from or supplied by the facility registered with the board
or in accordance with a shared services agreement.
(c) All containers used for packaging shall
preserve the stability and integrity of the drug or device. The storage
conditions of each packaged drug or device shall be maintained according to the
manufacturer's recommendations to preserve the stability and integrity of the
drug. The beyond-use date assigned to each packaged drug or device shall be the
manufacturer's expiration date, the maximum allowable beyond-use date for the
type of packaging material used, or not more than 12 months from the date of
packaging, whichever is earlier.
(d) An electronic or a written record shall
be established for lot numbers for recall purposes and shall be kept readily
retrievable in the facility registered with the board.
(e) If an area apart or separated from the
prescription drug area is used for packaging, the area shall be enclosed and
locked when a pharmacist is not in attendance in that area.
(f) In lieu of separately dispensing a drug
and an ingestible event marker approved by the food and drug administration to
monitor whether a patient is taking the drug as prescribed, any pharmacist may
use an ingestible event medication adherence package pursuant to a valid
prescription order or after obtaining the consent of the practitioner,
caregiver, or patient.
(g) For
purposes of this regulation, "ingestible event medication adherence package"
shall mean an ingestible unit-dose package designed to ensure medication
adherence that contains drugs from a manufacturer's original container and an
ingestible event marker, as defined by
21 C.F.R.
880.6305, effective February 1, 2022 and
hereby adopted by reference.
(h) In
addition to meeting the requirements of this regulation, all packaging of
sterile preparations shall meet the requirements of
K.A.R.
68-13-4.
Notes
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