1. (1) A PPK must maintain proper storage of all drugs. This includes, but is not limited to the following:

   1. (a) All drugs must be stored according to manufacturer’s published or USP guidelines.
   2. (b) All drugs must be stored in appropriate conditions of temperature, light, humidity, sanitation, ventilation, and space.
   3. (c) Appropriate storage conditions must be provided for, including during transfers between facilities and to patients.
   4. (d) A PPK must quarantine drugs which are outdated, adulterated, misbranded or suspect.

2. (2) A PPK must store all drugs at the proper temperature according to manufacturer’s published guidelines (pursuant to FDA package insert or USP guidelines).

   1. (a) All drug refrigeration systems must:

      1. (A) Maintain refrigerated products between 2 to 8 °C (35.6 to 46.4°F); frozen products between -25 to -10 °C (-13 to 14 °F); or as specified by the manufacturer.
      2. (B) Utilize a centrally placed, accurate, and calibrated thermometer;
      3. (C) Be dedicated to pharmaceuticals only;
      4. (D) Be measured continuously and documented either manually twice daily to include minimum, maximum and current temperatures; or with an automated system capable of creating a producible history of temperature readings.

   2. (b) A PPK must adhere to a monitoring plan, which includes, but is not limited to:

      1. (A) Documentation of training of all personnel;
      2. (B) Maintenance of manufacturer recommended calibration of thermometers;
      3. (C) Maintenance of records of temperature logs for a minimum of three years;
      4. (D) Documentation of excursion detail, including, but not limited to, event date and name of persons(s) involved in excursion responses;
      5. (E) Documentation of action(s) taken, including decision to quarantine product for destruction, or determination by a Pharmacist that it is safe for continued use. This documentation must include details of the information source;
      6. (F) A written emergency action plan;
      7. (G) Routine preventative maintenance and evaluation of refrigeration equipment and monitoring equipment; and
      8. (H) Documentation and review of temperature recordings at least once every 28 days by the Pharmacist at the time of in person physical inspection.

Statutory/Other Authority

ORS 689.205 & ORS 689.325

Statutes/Other Implemented

ORS 689.155 & ORS 689.527

History

BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023