Oregon Administrative Rules
Chapter 855 - BOARD OF PHARMACY
Division 139 - REMOTE DISPENSING SITE PHARMACY
Section 855-139-0125 - Drug: Storage
Universal Citation: OR Admin Rules 855-139-0125
Current through Register Vol. 63, No. 3, March 1, 2024
(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quarantine drugs which are outdated, adulterated, misbranded or suspect.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.
Statutory/Other Authority: ORS 689.205 & ORS 689.325
Statutes/Other Implemented: ORS 689.155
Disclaimer: These regulations may not be the most recent version. Oregon may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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