1. (1) A charitable pharmacy may not distribute a donated prescription drug that:

   1. (a) Fails to meet the requirements of the program;
   2. (b) Has not been stored in accordance with manufacturer’s recommendations;
   3. (c) Has been repackaged, except that a drug that has been repackaged for a long-term care pharmacy may be distributed;
   4. (d) Bears an expiration date that is less than nine months from the date the drug is donated;
   5. (e) Is adulterated or misbranded;
   6. (f) Is a controlled substance;
   7. (g) Is a drug that requires a special registration for dispensing;
   8. (h) Is an over-the-counter drug;
   9. (i) Requires specialty storage or handling;
   10. (j) Requires refrigeration;

   11. (k) Is a compounded drug; or

       1. (L) In the pharmacist’s professional judgment, may be unfit for dispensing.

2. (2) A charitable pharmacy may only dispense a drug to a person who:

   1. (a) Has a valid prescription for the drug; and
   2. (b) Is a resident of Oregon; and
   3. (c) Is underinsured or does not have adequate health insurance coverage for the prescription drug requested; or
   4. (d) Is enrolled in a program of public assistance as defined in ORS 411.010;

3. (3) A drug may only be dispensed by a pharmacist or by a practitioner who has been given dispensing privileges by their licensing board and is acting within their scope of practice, or by a registered nurse subject to the following:

   1. (a) A registered nurse who is an employee of a charitable pharmacy may dispense a drug to a client of the charitable pharmacy; and
   2. (b) Such dispensing by a registered nurse shall be pursuant to the order of a person authorized to prescribe the drug.
4. (4) The dispensing practitioner must provide the patient with appropriate counseling on the use of the drug and any potential side effects, and may provide written drug information;

5. (5) A recipient of a drug under this program must sign a Recipient Form, provided by the Board, that attests that the recipient has been notified that:

   1. (a) The prescription drug was donated to the program;
   2. (b) A visual inspection was conducted by a pharmacist to ensure that the drug has not expired, been adulterated or misbranded, and is in its original, sealed packaging;
   3. (c) A pharmacist has determined that the drug is safe to distribute based on the accuracy of the Donor’s Form and the visual inspection by the pharmacist;
   4. (d) Participants in the program are immune from liability as provided in ORS 689.780; and
   5. (e) That they are qualified to receive the drug as specified in section (2) of this rule.
6. (6) 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.

Statutory/Other Authority

ORS 689.205

Statutes/Other Implemented

ORS 689.772 & 689.774

History

BP 6-2010, f. & cert. ef. 6-29-10