OAR 855-041-1036
Proper Storage of Drugs

(1)

A pharmacy 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A pharmacy must quarantine drugs which are outdated, adulterated, misbranded or suspect. Cold Storage and Monitoring.

(2)

A pharmacy 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; and

(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 pharmacy 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 that it is safe for continued use. This documentation must include details of the information source;

(F)

A written emergency action plan; and

(G)

Routine preventative maintenance and evaluation of refrigeration equipment and monitoring equipment.

(3)

Vaccine Drug Storage:

(a)

A pharmacy 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.

Source: Rule 855-041-1036 — Proper Storage of Drugs, https://secure.­sos.­state.­or.­us/oard/view.­action?ruleNumber=855-041-1036.

855–041–1001
Definitions 855–041–1010
Personnel (Both Retail and Institutional Drug Outlets) 855–041–1015
Operation of Pharmacy (Both Retail and Institutional Drug Outlets) 855–041–1020
Security of Prescription Area 855–041–1025
Disposal of Drugs 855–041–1030
Reporting Drug Loss 855–041–1035
Minimum Equipment Requirements (Both Retail and Institutional Drug Outlets) 855–041–1036
Proper Storage of Drugs 855–041–1040
Drug Outlet Procedures 855–041–1045
Returned Drugs and Devices 855–041–1046
Secure and Responsible Drug Disposal 855–041–1050
Pharmacy Depots 855–041–1055
Confidentiality 855–041–1060
Non-Resident Pharmacies 855–041–1080
Pharmacy Registration (Both Retail and Institutional Drug Outlets) 855–041–1085
Change of Location of a Pharmacy (Both Retail and Institutional Drug Outlets) 855–041–1090
Change of Business Name, Closure (Both Retail and Institutional Drug Outlets) 855–041–1095
Pharmacy Advertising 855–041–1105
Requirements for Prescriptions 855–041–1110
Tamper-resistant Prescription 855–041–1115
Verification of Prescription Authenticity 855–041–1120
Prescription Refills 855–041–1125
Prescription Expiration 855–041–1130
Prescription Labeling 855–041–1131
Prescription Reader Accessibility 855–041–1132
Limited English Proficiency and Accessibility 855–041–1135
Defines Labeling and Container Requirements for Repackage Drugs 855–041–1140
Customized Patient Medication Packages 855–041–1145
New Containers 855–041–1160
Prescription Records and Retention 855–041–1165
Patient Medical Record 855–041–1170
Grounds for Discipline 855–041–2100
Operation of a Double Set-Up Pharmacy in a Retail Drug Outlet 855–041–2115
Transfer of Prescription Information Between Pharmacies 855–041–2310
Definitions 855–041–2320
Epinephrine 855–041–2340
Naloxone 855–041–3000
Central Fill and Remote Processing Outlet Designations and Consulting/Drugless Pharmacy Outlets - Purpose and Scope 855–041–3005
Central Fill - Purpose and Scope 855–041–3010
Central Fill - Definitions 855–041–3015
Central Fill - General Requirements 855–041–3020
Central Fill - Policies and Procedures 855–041–3025
Central Fill - Labeling 855–041–3030
Central Fill - Records 855–041–3035
Central Fill - Delivery of Medications 855–041–3040
Central Fill - Filled Prescriptions 855–041–3045
Central Fill - Prohibited Practices 855–041–3100
Remote Processing - Purpose and Scope 855–041–3105
Remote Processing - Definitions 855–041–3110
Remote Processing - General Requirements 855–041–3115
Remote Processing - Policies and Procedures 855–041–3120
Remote Processing - Records 855–041–3125
Remote Processing - Prescription or Drug Order Processing 855–041–3130
Remote Processing - Prohibited Practices 855–041–3300
Consulting/Drugless Pharmacy - Purpose and Scope 855–041–3305
Consulting/Drugless Pharmacy - Definitions 855–041–3310
Consulting/Drugless Pharmacy - Registration 855–041–3315
Consulting/Drugless Pharmacy - Personnel 855–041–3320
Consulting/Drugless Pharmacy - Confidentiality 855–041–3325
Consulting/Drugless Pharmacy - General Provisions and Minimum Standards 855–041–3330
Consulting/Drugless Pharmacy - Security Requirements 855–041–3335
Consulting/Drugless Pharmacy - Policies and Procedures 855–041–3340
Consulting/Drugless Pharmacy - Records 855–041–4000
Purpose - Expedited Partner Therapy (EPT) 855–041–4005
Expedited Partner Therapy (EPT) - Procedures 855–041–4025
Purpose and Scope - Home Dialysis 855–041–4035
Home Dialysis - Definitions 855–041–4045
Home Dialysis - Drug Delivery and Control 855–041–4055
Home Dialysis - Duties of the Pharmacist 855–041–4100
Definitions - Automated Pharmacy System 855–041–4110
Remote Dispensing Machine (RDM) - Duties and Responsibilities of the Pharmacist-in-Charge 855–041–4120
Remote Dispensing Machine (RDM) - Drug Delivery and Control 855–041–5005
Definitions - Institutional and Residential Pharmacy Drug Outlets 855–041–5015
Registration 855–041–5050
Remote Distribution Facility (RDF) - Definitions 855–041–5055
Remote Distribution Facility (RDF) 855–041–5100
Definitions - Technician Checking Validation Program (TCVP) 855–041–5120
Technician Checking Validation Program (TCVP) - Hospital and Pharmacist in Charge Requirements 855–041–5130
Technician Checking Validation Program (TCVP) - Technician Eligibility and Training 855–041–5140
Technician Checking Validation Program (TCVP) - Initial Validation Process and Quality Assurance Process 855–041–5150
Technician Checking Validation Program (TCVP) - Checking Procedure 855–041–5160
Technician Checking Validation Program (TCVP) - Eligible Specialized Functions 855–041–5170
Technician Checking Validation Program (TCVP) - Records 855–041–6050
Definitions - Automated Distribution Cabinet (ADC) 855–041–6100
Registration 855–041–6150
General Pharmacy Requirements 855–041–6200
Chief Pharmacy Officer and Pharmacist in Charge 855–041–6220
Records 855–041–6240
Drug Administration 855–041–6250
Patient’s Own Drugs and Other Drugs from Outside Sources 855–041–6260
Investigational Drugs 855–041–6270
Labeling 855–041–6300
Absence of the Pharmacist 855–041–6305
Night Cabinet 855–041–6310
After Hours Access to Pharmacy 855–041–6400
Emergency Dispensing by a Nurse 855–041–6410
Emergency Department Distribution 855–041–6420
Emergency Kit and Code Cart 855–041–6500
Practitioner’s Drug Order 855–041–6510
In-patient Drug Profile 855–041–6520
Cart-Fill 855–041–6530
Robotic Distribution Systems 855–041–6540
Automated Distribution Cabinets 855–041–6550
Secondary and Remote Storage 855–041–6560
Floor-Stock 855–041–6570
Trays and Kits 855–041–6600
Controlled Drug Accountability 855–041–6610
Schedule II Drugs 855–041–6620
Electronic Safe Systems 855–041–6800
Supervision of Consulting Pharmacist 855–041–6840
Drug Distribution and Control from a Drug Room in a Hospital 855–041–7050
Definitions - Long Term Care Pharmacy 855–041–7060
Long Term Care Pharmacy - Drug Distribution and Control 855–041–7070
Long Term Care Pharmacy - Labeling and Distribution 855–041–7080
Pharmaceutical Care in Community Based Care Facilities 855–041–8050
Emergency Drug Supply in Home Health Care Agencies
Last Updated

Jun. 8, 2021

Rule 855-041-1036’s source at or​.us