Or. Admin. Code § 855-044-0030

Current through Register Vol. 63, No. 12, December 1, 2024

Section 855-044-0030 - Drug Donation

(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.

Or. Admin. Code § 855-044-0030

BP 6-2010, f. & cert. ef. 6-29-10; BP 1-2017, f. & cert. ef. 2/23/2017

Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 689.772 & 689.774