1. (1) A charitable pharmacy must maintain a donation record of all drugs received that includes:

   1. (a) Donor’s name and address;
   2. (b) Drug manufacturer, lot number, name and strength;
   3. (c) Drug quantity;
   4. (d) Expiration date of the drug;
   5. (e) Date donated; and
   6. (f) The unique identifier.

2. (2) A charitable pharmacy must maintain a distribution and dispensing record that includes:

   1. (a) Drug name and strength;
   2. (b) Quantity distributed;
   3. (c) Name of manufacturer;
   4. (d) Lot number and expiration date;
   5. (e) Date of distribution or dispensing;
   6. (f) Name and address of recipient.
3. (3) A charitable pharmacy must maintain a record of all drugs that are destroyed.
4. (4) In addition to the above records, a charitable pharmacy must cross-reference the donation record and the distribution and dispensing record with the appropriate donor and recipient forms.
5. (5) A charitable pharmacy must make an annual report to the Board by completing a form provided by the Board and submitting it with their application for renewal of registration.
6. (6) All records required by these rules must be retained for three years and made available to the Board upon request.
7. (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.

Statutory/Other Authority

ORS 689.205

Statutes/Other Implemented

ORS 689.774

History

BP 9-2014, f. & cert. ef. 12-4-14
BP 6-2010, f. & cert. ef. 6-29-10