Or. Admin. Code § 855-139-0125

Current through Register Vol. 63, No. 11, November 1, 2024

Section 855-139-0125 - Drug: Storage

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

(a) All drugs must be stored according to manufacturer's published or USP guidelines.

(b) All drugs must be stored in appropriate conditions of temperature, light, humidity, sanitation, ventilation, and space.

(c) Appropriate storage conditions must be provided for, including during transfers between facilities and to patients.

(d) A RDSP must quarantine drugs which are outdated, adulterated, misbranded or suspect. Cold Storage and Monitoring.

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

(a) All drug refrigeration systems must:

(A) Maintain refrigerated products between 2 to 8 °C (35 to 46 °F); frozen products between -25 to -10 °C (-13 to 14 °F); or as specified by the manufacturer.

(B) Utilize a centrally placed, accurate, and calibrated thermometer;

(C) Be dedicated to pharmaceuticals only;

(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.

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

(A) Documentation of training of all personnel;

(B) Maintenance of manufacturer recommended calibration of thermometers;

(C) Maintenance of records of temperature logs for a minimum of three years;

(D) Documentation of excursion detail, including, but not limited to, event date and name of persons(s) involved in excursion responses;

(E) Documentation of action(s) taken, including decision to quarantine product for destruction, or determination by an Oregon licensed Pharmacist that it is safe for continued use. This documentation must include details of the information source;

(F) A written emergency action plan;

(G) Routine preventative maintenance and evaluation of refrigeration equipment and monitoring equipment; and

(H) Documentation and review of temperature recordings at least once every 28 days by the Oregon licensed Pharmacist at the time of in person physical inspection.

(3) Vaccine Drug Storage:

(a) A RDSP that stores vaccines must comply with section two of this rule and the following:

(A) Vaccines must be stored in the temperature stable sections of the refrigerator;

(B) A centrally placed and accurate buffered probe thermometer, such as glycol or glass beads, calibrated within a plus or minus 0.5 °C variance must be utilized;

(C) Each freezer and refrigerator compartment must have its own exterior door and independent thermostat control;

(D) A system of continuous temperature monitoring with automated data logging and physical confirmation must be utilized. Documentation of the temperature of each active storage unit must be logged at least twice daily, data must be downloaded weekly, and system validations must be conducted quarterly; and

(E) Must adhere to a written quality assurance process to avoid temperature excursions.

(4) A retail drug outlet may store drugs in another location that is registered as a Drug Room and meets all Pharmacy drug storage and security requirements.

Or. Admin. Code § 855-139-0125

BP 43-2021, adopt filed 12/16/2021, effective 1/1/2022

Statutory/Other Authority: ORS 689.205 & ORS 689.325

Statutes/Other Implemented: ORS 689.155