Current through Register Vol. 63, No. 3, March 1, 2024
(1) A
charitable pharmacy may not accept:
(a) Any
controlled substance or any kit, package or blister pack that contains any
controlled substance;
(b) A
non-prescription drug;
(c) A drug
in a container or package that does not contain a product identification label
(PIL), except that a drug in a manufacturer's original container or a
manufacturer's blister pack does not need to bear a PIL;
(d) An FDA REMS (Risk Evaluation and
Mitigation Strategy) drug;
(e) A
drug donated from another state.
(2) A charitable pharmacy may accept:
(a) A prescription drug received in original,
sealed, tamper-evident packaging that displays the lot number and expiration
date of the drug; and
(b) Sealed
single unit dose packages received in opened packages containing multiple
single unit doses.
(3)
The following are examples of acceptable packaging:
(a) Manufacturer's original
container;
(b) Single-dose blister
packs in sealed outer package;
(c)
Single-dose blister packs in opened outer package;
(d) Tamper-evident hospice kit containing
manufacturer's original containers.
(4) Donated drugs that do not meet the above
criteria or are judged by the pharmacist to be unsafe for re-dispensing must be
stored separately from the drug supply until they can be destroyed.
(5) A charitable pharmacy may accept a drug
from:
(a) An individual;
(b) A long-term care facility;
(c) A pharmacy;
(d) A practitioner who has been given
dispensing privileges by their licensing board and is acting within their scope
of practice;
(e) Another registered
charitable pharmacy;
(f) A medical
clinic;
(g) A drug manufacturer or
wholesaler;
(h) A Medication
Assistance Program (MAP) such as those supported by drug
manufacturers.
(6) The
donor must certify on a Donor Form provided by the Board that the donated drug
has been properly stored, in accordance with manufacturer's recommendations,
and has never been opened, used, adulterated or misbranded.
(7) Upon written request, the Board may waive
any of the requirements of this rule if a waiver will further public health and
safety. A waiver granted under this section shall only be effective when it is
issued in writing.
Stat. Auth.: ORS
689.205
Stats. Implemented: ORS
689.772 &
689.774
