Oregon Administrative Code

855-035-0023 Disposal of Drugs Drugs that are outdated, damaged, deteriorated, misbranded, or adulterated shall be quarantined and physically separated from other drugs until they are destroyed or returned to their supplier. Statutory/Other Authority: ORS 475.035, 689.155, 689.20…

855-035-0025 Seasonal Nonprescription Drug Outlets (1) Seasonal nonprescription drug outlets are defined as those outlets who either by location or weather are restricted to a seasonal demand for services. (2) Seasonal nonprescription drug outlets shall be exempt from delinquent …

855-035-0030 Medical Device, Equipment and Gas (MDEG) Outlet (Class C) (1) Medical Device, Equipment and Gas (MDEG) Outlets may sell: (a) Nonprescription drugs; (b) Specific drugs and materials that require the order or prescription of a practitioner: (A) USP Oxygen; (B) USP Sodi…

855-041-1001 Definitions “Drug room” is a drug storage area registered with the board which is secure and lockable. Statutory/Other Authority: ORS 689.205 & ORS 689.522 Statutes/Other Implemented: ORS 689.155 & ORS 689.522 History: BP 15-2022, amend filed 04/20/2022, effective 04…

855-041-1010 Outlet (Both Retail and Institutional Drug Outlets): Personnel Each Drug Outlet Pharmacy must: (1) Have one Pharmacist-in-charge (PIC) employed on a regular basis at that location who shall be responsible for the daily operation of the pharmacy. The Pharmacist-in-cha…

855-041-1015 Operation of Pharmacy (Both Retail and Institutional Drug Outlets) (1) Supervision. A pharmacy may only be operated when a pharmacist licensed to practice in this state is present. This means that the pharmacist must be physically present in the pharmacy or instituti…

855-041-1018 Outlet: General Requirements A Drug Outlet Pharmacy must: (1) Ensure each: (a) Prescription is dispensed in compliance with OAR 855-041, OAR 855-115, OAR 855-120, OAR 855-125, OAR 855-139, OAR 855-141 and OAR 855-143; (b) Controlled substance is dispensed in complian…

855-041-1020 Security of Prescription Area (1) The area in a registered pharmacy where legend and/or controlled substances are stored, possessed, prepared, manufactured, compounded, or repackaged shall be restricted in access, in such a manner as to ensure the security of those d…

855-041-1025 Disposal of Drugs Drugs that are outdated, damaged, deteriorated, misbranded, or adulterated shall be quarantined and physically separated from other drugs until they are destroyed or returned to their supplier. Statutory/Other Authority: ORS 475.035, 689.155, 689.20…

855-041-1030 Reporting Drug Loss (1) Disasters, accidents and emergencies which may affect the strength, purity, or labeling of drugs or devices must immediately be reported to the board. (2) The outlet must ensure that confirmed significant drug loss or any loss related to suspe…

855-041-1035 Minimum Equipment Requirements (1) Each retail drug outlet and institutional drug outlet must have the following: (a) Appropriate and current pharmaceutical references (e.g., pharmacology, injectables, and veterinary drugs) based on services offered by the outlet; (b…

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 con…

855-041-1040 Outlet: Policies and Procedures (1) The drug outlet pharmacy and its Pharmacist in Charge is accountable for establishing, maintaining, and enforcing written policies and procedures for the drug outlet pharmacy in compliance with federal and state regulations. The wr…

855-041-1045 Returned Drugs and Devices (1) Pharmacists, pharmacy technicians, certified Oregon pharmacy technicians and interns may not accept the return of controlled substances. (2) Pharmacists, pharmacies, pharmacy technicians, certified Oregon pharmacy technicians and intern…

855-041-1046 Secure and Responsible Drug Disposal (1) A pharmacy that operates a drug take back collection program or that participates in a drug take-back program under ORS 459A.200 to ORS 459A.266 as an authorized collector must be registered with the DEA as an authorized colle…

855-041-1050 Pharmacy Depots (1) Except when delivering directly to a patient, licensed pharmacists may not participate in the transfer of completed prescription medication containers to or from any location that is not a licensed pharmacy, unless the transfer occurs to: (a) The …

855-041-1055 Prohibited Practices: Disclosure of Patient Information A Retail Drug Outlet or Institutional Drug Outlet: (1) May not allow a licensee or registrant of the board who obtains any patient information to disclose that information to a third party without the consent of…

855-041-1060 Non-Resident Pharmacies (1) For the purpose of these rules, a non-resident pharmacy is any establishment located out of Oregon that engages in the dispensing, delivery or distribution of drugs to Oregon. A non-resident pharmacy also includes entities that provide pha…

855-041-1080 Pharmacy Registration (Both Retail and Institutional Drug Outlets) (1) Pharmacies must be registered as either retail drug outlets or institutional drug outlets or both. (2) An application for registration of a new pharmacy must be accompanied by a floor plan drawn t…

855-041-1085 Change of Location of a Pharmacy (Both Retail and Institutional Drug Outlets) (1) A change of location of a pharmacy requires the approval of the Board and a new certificate of registration. (2) Application for approval to relocate shall be on a form provided by the …

855-041-1090 Registration: Change of Business Name (Both Retail and Institutional Drug Outlets) A pharmacy must notify the board a minimum of 15 days prior to any change of business name of a pharmacy. The change must be reported by filing a new application for which no fee is re…

855-041-1092 Retail Drug Outlet Pharmacy Closures: Temporary, Permanent or Emergency (1) Temporary Closing. Unless subject to an exemption in OAR 855-041-1092(3), when a Retail Drug Outlet pharmacy is temporarily closed to the public the pharmacy must: (a) Post notification of cl…

855-041-1095 Pharmacy Advertising No person shall advertise or otherwise purport to operate as a pharmacy or to advertise or purport to provide pharmacy services unless the person is registered with the Board pursuant to ORS 689.305. Statutory/Other Authority: ORS 475.035, 689.15…

855-041-1105 Prescriptions: General Requirements Each Drug Outlet Pharmacy must ensure that: (1) Prescriptions, prescription refills, and drug orders are dispensed: (a) Accurately; (b) To the correct party; (c) Pursuant to a valid prescription; (d) Pursuant to a valid patient-pra…

855-041-1110 Tamper-resistant Prescription When the use of a tamper-resistant prescription is required by any federal or state law or rule, the term “tamper-resistant” shall have the meaning as defined in OAR 855-006-0005. Statutory/Other Authority: 689.205 Statutes/Other Impleme…

855-041-1115 Verification of Prescription Authenticity Alteration of a written prescription, other than by a pharmacist's or practitioner's authorization, in any manner constitutes an invalid order unless verified with the prescriber. Statutory/Other Authority: ORS 689.205 Statut…

855-041-1120 Prescription Refills (1) Where refill authority is given other than by the original prescription, documentation that such refill authorization was given, the date of authorization, and name of the authorizing prescriber or the prescriber's agent must be recorded. Thi…

855-041-1125 Prescription Expiration This section of rule addresses the expiration date of the prescription and not the expiration date of the drug. (1) After one year from date of issue, a prescription for a non-controlled substance becomes invalid and must be re-authorized by t…

855-041-1130 Retail Drug Outlet Pharmacy Prescription Labeling Except as described in SB 450 (2023), prescriptions must be labeled with the following information: (1) Name, address and telephone number of the pharmacy; (2) Date of fill; (3) Identifying number; (4) Name of patient…

855-041-1131 Prescription Reader Accessibility A pharmacy shall notify each person to whom a prescription drug is dispensed that a prescription reader is available to the person upon request; a prescription reader is a device designed to audibly convey labeling information. A pha…

855-041-1132 Limited English Proficiency and Accessibility (1) Upon request of a prescriber, patient or a patient’s agent, each drug dispensed by a pharmacy for a patient’s self-administration must bear a label in both English and the language requested for an individual with lim…

855-041-1133 Dispensing: Interpretation (1) Except as provided in subsection (2) of this section, a Pharmacist or Intern must work with a health care interpreter from the health care interpreter registry administered by the Oregon Health Authority under ORS 413.558 when communica…

855-041-1135 Defines Labeling and Container Requirements for Repackage Drugs (1) Drugs prepackaged by a pharmacy for later own use dispensing on prescription shall be in a container meeting USP standards and labeled to identify at a minimum: (a) Brand name, or generic name and ma…

855-041-1140 Customized Patient Medication Packages In lieu of dispensing two or more prescribed drug products in separate containers, a pharmacist may, with the consent of the patient, the patient’s caregiver, or a prescriber, provide a customized patient medication package (pat…

855-041-1145 New Containers Each pharmacy must dispense a drug in a new container that complies with the current provisions of the Poison Prevention Packaging Act in 16 CFR 1700 (v. 01/01/2025), 16 CFR 1701 (v. 01/01/2025), and 16 CFR 1702 (v. 01/01/2025). [Publications: Publicat…

855-041-1160 Records (1) Definitions. The following definitions apply to this rule: (a) An "original prescription" is a prescription maintained in the same physical manner in which a pharmacy first receives the prescription. For example, for a prescription received by the pharmac…

855-041-1165 Patient Medical Record A patient record system must be maintained by pharmacies for all patients for whom prescription drug orders are dispensed. The patient record system must provide for readily retrievable information necessary for the dispensing Pharmacist to ide…

855-041-1167 Patients Access to Pharmacy Records (1) Licensees and registrants of the board must make protected health information in the pharmacy record available to the patient or the patient’s representative upon their request, to inspect and obtain a copy of protected health …

855-041-1170 Outlet (RP & IP): Grounds for Discipline The State Board of Pharmacy may impose one or more of the following penalties which includes: suspend, revoke, or restrict the license of an outlet or may impose a civil penalty upon the outlet upon the following grounds: (1) …

855-041-1190 Operation of a Laboratory in Drug Outlet Pharmacy (1) A Drug Outlet pharmacy may perform a laboratory test when: (a) The Drug Outlet pharmacy possesses a valid laboratory license, including a certificate of a 42 CFR 493.35 waiver; (b) The laboratory test is permitted…

855-041-2100 Operation of a Double Set-Up Pharmacy in a Retail Drug Outlet A double set-up is an establishment having both a retail drug outlet registration and a nonprescription drug outlet registration. In a double set-up: (1) The retail drug outlet (pharmacy) must be a separat…

855-041-2115 Prescription: Transfers (1) Prescriptions may be transferred between pharmacies for the purpose of an initial or refill dispensing provided that: (a) The prescription is invalidated at the sending pharmacy; and (b) The receiving pharmacy obtains all the information c…

855-041-2310 Definitions The following words and terms, when used in OAR 855-041-2300 through 855-041-2320 shall have the following meanings, unless the context clearly indicates otherwise. (1) “Allergic reaction” means a medical condition caused by exposure to an allergen, with …

855-041-2320 Epinephrine (1) A pharmacist may fill an order for epinephrine to be used by trainees to treat an anaphylactic reaction. Trainees must be 18 years of age or older and must have responsibility for or contact with at least one (1) other person as a result of the traine…

855-041-3000 Central Fill and Remote Processing Outlet Designations (1) The purpose of OAR 855-041-3005 through 855-041-3045 is to provide minimum requirements of operation for centralized prescription drug filling by a pharmacy. (2) The purpose of OAR 855-041-3100 through 855-04…

855-041-3005 Central Fill - Purpose and Scope The purpose of OAR 855-041-3005 through 855-041-3045 is to provide minimum requirements of operation for centralized prescription drug filling by a pharmacy. Any facility established for the purpose of filling drug orders on behalf of…

855-041-3010 Central Fill - Definitions The following words and terms, when used in OAR 855-041-3005 through 855-041-3045 shall have the following meanings, unless the context clearly indicates otherwise. Any term not defined in this section shall have the definition set out in t…

855-041-3015 Central Fill - General Requirements An Oregon licensed pharmacy may outsource prescription drug filling to a central fill pharmacy provided that both pharmacies: (1) Have the same owner; or (2) Have a written shared pharmacy services contract or agreement that specif…

855-041-3020 Central Fill - Policies and Procedures (1) In addition to the requirements of OAR 855-041-1040, the central fill pharmacy and the primary pharmacy is each accountable for establishing, maintaining, and enforcing its written policies and procedures manual. The policie…

855-041-3025 Central Fill - Labeling (1) The label affixed to the prescription container filled by a central fill pharmacy on behalf of the primary pharmacy shall: (a) Include all information required by OAR 855-041-1130 and OAR 855-041-1140; (b) Comply with all labeling requirem…