Oregon Administrative Code

855-141-0305 Prescription: Tamper-resistant When the use of a tamper-resistant prescription is required by any federal or state law or rule, the term “tamper-resistant” has the meaning as defined in OAR 855-006-0005. Statutory/Other Authority: ORS 689.205 Statutes/Other Implement…

855-141-0310 Prescription: Verification of 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 Statu…

855-141-0315 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. Th…

855-141-0320 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 …

855-141-0325 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…

855-141-0345 Dispensing: General Requirements The PPK Affiliated Pharmacy must: (1) Ensure each prescription, prescription refill, and drug order is correctly dispensed from the PPK in accordance with the prescribing practitioner's authorization; and (2) Ensure the PPK dispenses …

855-141-0350 Dispensing: Containers Each PPK 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: Publi…

855-141-0400 Labeling: General Requirements Prescriptions must be labeled with the following information: (1) Name and address of the PPK. (2) Date; (3) Identifying number; (4) Name of patient; (5) Name of drug, strength, and quantity dispensed; when a generic name is used, the l…

855-141-0405 Labeling: Prescription Reader Accessibility (1) A PPK must 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 informatio…

855-141-0410 Labeling: Limited English Proficiency and Accessibility (1) Upon request of a prescriber, patient or a patient’s agent, each drug dispensed by the PPK for a patient’s self-administration must bear a label in both English and the language requested for an individual w…

855-141-0450 Drugs and Devices: Disposal Drugs and devices that are outdated, damaged, deteriorated, misbranded, or adulterated must be quarantined and physically separated from other drugs until they are destroyed or returned to their supplier. Statutory/Other Authority: ORS 475…

855-141-0455 Drug and Devices: Return A PPK or PPK Affiliated Pharmacy may accept the return of a drug or device as defined by ORS 689.005 once the drug or device have been dispensed from the PPK if they were dispensed in error, were defective, adulterated, misbranded, dispensed …

855-141-0500 Policies and Procedures (1) The PIC of the PPK Affiliated Pharmacy and the PPK Affiliated Pharmacy drug outlet is accountable for establishing, maintaining, and enforcing written policies and procedures for the PPK. The written policies and procedures must be maintai…

855-141-0550 Records: General Requirements (1) The recordkeeping requirements OAR 855-141 are in addition to the requirements of other recordkeeping rules of the board. Unless otherwise specified, all records and documentation required by these rules, must be retained for three y…

855-141-0555 Records: Patient A patient record system must be maintained by the PPK Affiliated Pharmacy for all patients for whom a prescription drug is dispensed. The patient record system must provide information necessary for the dispensing Pharmacist to identify previously di…

855-141-0600 Prohibited Practices: General A PPK must not: (1) Allow unlicensed personnel, Certified Oregon Pharmacy Technicians or Pharmacy Technicians to ask questions of a patient or patient's agent which screen and/or limit interaction with the Pharmacist; (2) Utilize a perso…

855-141-0602 Prohibited Practices: Disclosure of Patient Information A PPK must not: (1) 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 the patient except as provided in (a)-(e) …

855-141-0650 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) Any of the grounds…

855-143-0001 Purpose and Scope The purpose of OAR 855-143 is to provide minimum requirements for the operation of a Pharmacy Prescription Locker (PPL) by a PPL Affiliated Pharmacy. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 & ORS 689.527 Histor…

855-143-0005 Definitions The following words and terms, when used in OAR 855-143, have the following meanings, unless the context clearly indicates otherwise. Any term not defined in this section has the definition set out in OAR 855-006. (1) “Pharmacy Prescription Locker Affilia…

855-143-0010 Registration: General (1) Each PPL located in Oregon must be registered as a Retail Drug Outlet PPL. (2) A controlled substance registration will not be issued for a Retail Drug Outlet PPL. (3) A Retail Drug Outlet PPL application must specify the PPL Affiliated Phar…

855-143-0015 Registration: Application (1) An application for registration of a new PPL must include a floor plan drawn to scale with the location of the: (a) PPL at the facility; (b) Surveillance system cameras; and (c) Alarm system panel. (2) The certificate of registration for…

855-143-0020 Registration: Change of Owner, Location, or PPL Affiliated Pharmacy (1) A change of location of the PPL Affiliated Pharmacy or location of the PPL requires: (a) Submission of a new PPL application a minimum of 15 days prior to occurrence; (b) Registration fee; (c) Ap…

855-143-0025 Registration: Closure A PPL Affiliated Pharmacy must notify the board a minimum of 15 days prior to discontinuing operation of a PPL. Notification must include the: (1) Final disposition of drugs stored in the PPL including: (a) Name and location where the drugs are …

855-143-0030 Non-Resident PPL Affiliated Pharmacies (1) For the purpose of these rules, a non-resident pharmacy includes a PPL Affiliated Pharmacy located outside of Oregon and providing pharmacy services to a PPL located in Oregon. (2) Each non-resident PPL Affiliated Pharmacy m…

855-143-0050 Personnel (1) A PPL must have an Oregon licensed PIC at all times. (2) Prior to utilizing a PPL, the Oregon licensed Pharmacist, Intern, Certified Oregon Pharmacy Technician and Pharmacy Technician must have completed a training program on the proper use of the PPL. …

855-143-0100 Security (1) The PPL Affiliated Pharmacy, the PPL, Oregon licensed PIC of the PPL Affiliated Pharmacy and each Oregon licensed Pharmacist supervising the PPL is responsible for the security of the PPL including provisions for adequate safeguards against loss, theft o…

855-143-0120 Drug: Procurement A PPL may only receive prescription, non-prescription drugs, devices, and related supplies from the PPL Affiliated Pharmacy. Statutory/Other Authority: ORS 475.035 & ORS 689.205 Statutes/Other Implemented: ORS 689.155 & ORS 689.527 History: BP 21-20…

855-143-0125 Drug: Storage (1) A PPL 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 temp…

855-143-0130 Drug: Loss A PPL and its PPL Affiliated Pharmacy must: (1) Ensure that disasters, accidents and emergencies which may affect the strength, purity, or labeling of drugs or devices are reported to the board immediately. (2) Ensure that confirmed significant drug loss o…

855-143-0150 Outlet: Sanitation A PPL and its PPL Affiliated Pharmacy must ensure the PPL is kept clean. Statutory/Other Authority: ORS 689.305 Statutes/Other Implemented: ORS 689.305 & ORS 689.527 History: BP 21-2022, adopt filed 04/20/2022, effective 04/20/2022

855-143-0155 Outlet: Minimum Equipment Requirements (1) Each Oregon PPL must have the following: (a) Appropriate equipment and supplies as required by Oregon Revised Statutes, Oregon Administrative Rules, United States Code, Code of Federal Regulations, and standards adopted by r…

855-143-0200 Outlet: General Requirements (1) The PPL Affiliated Pharmacy and its PIC are responsible for all operations and enforcing all policies and procedures of the PPL. (2) A PPL Affiliated Pharmacy may operate more than one PPL. (3) A PPL Affiliated Pharmacy must be less t…

855-143-0205 Outlet: Technology A PPL and its PPL Affiliated Pharmacy must: (1) Utilize a shared computer system and have appropriate technology or interface to allow access to information required to dispense prescription and non-prescription drugs, devices, and related supplies…

855-143-0210 Outlet: Supervision A PPL and its PPL Affiliated Pharmacy must: (1) Ensure prescription and non-prescription drugs, devices, and related supplies are only dispensed at the PPL if an Oregon licensed Pharmacist is available for patient consultation and the PPL is fully…

855-143-0215 Outlet: Pharmacist Utilization A PPL and its PPL Affiliated Pharmacy must ensure that a prescription drug or device is not released from the PPL until the Oregon licensed Pharmacist or Intern has: (1) Provided counseling when required under OAR 855-115-0145 or when r…

855-143-0220 Outlet: Non-Prescription Drugs and Supplies If non-prescription drugs and related supplies are placed in the PPL, the PPL and its PPL Affiliated Pharmacy must ensure that only an Oregon licensed Pharmacist verifies non-prescription drugs and related supplies that wil…

855-143-0225 Outlet: Controlled Substances Controlled substances may not be stored in the PPL. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 & ORS 689.527 History: BP 21-2022, adopt filed 04/20/2022, effective 04/20/2022

855-143-0345 Dispensing: General Requirements The PPL Affiliated Pharmacy must: (1) Ensure each prescription, prescription refill, and drug order is correctly dispensed by the PPL in accordance with the prescribing practitioner's authorization; and (2) Ensure the PPL dispenses pr…

855-143-0500 Policies and Procedures (1) The Oregon licensed PIC of the PPL Affiliated Pharmacy and the PPL Affiliated Pharmacy drug outlet is accountable for establishing, maintaining, and enforcing written policies and procedures for the PPL. The written policies and procedures…

855-143-0550 Records: General Requirements (1) The recordkeeping requirements OAR 855-143 are in addition to the requirements of other recordkeeping rules of the board. Unless otherwise specified, all records and documentation required by these rules, must be retained for three y…

855-143-0600 Prohibited Practices: General A PPL may not: (1) Allow unlicensed personnel, Oregon licensed Pharmacy Technicians or Certified Oregon Pharmacy Technicians to ask questions of a patient or patient's agent which screen and/or limit interaction with the Oregon licensed …

855-143-0602 Prohibited Practices: Disclosure of Patient Information A Retail Drug Outlet PPL may not: (1) 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 the patient except as pr…

855-143-0650 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) Any of the grounds…

855-183-0001 Applicability (1) All Division 183 rules apply to sterile and non-sterile compounding of a drug for humans and animals. (2) Entities that are located in or outside Oregon that engage in the practice of compounding a drug for dispensing, delivery or distribution in Or…

855-183-0005 Definitions (1) Phrases or definitions used in OAR 855-183 are the same as provided in OAR 855-006, or as included in the USP standard adopted by reference unless otherwise specified. (2) “Compounding Area” means a location designated by the registrant that limits pe…

855-183-0010 Notification Requirements Each Drug Outlet must notify the board within 15 days of initiation of sterile compounding, non-sterile compounding or both using a form provided by the board. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 Hi…

855-183-0015 Requirements: General (1) All drug compounding must adhere to the following standards of the United States Pharmacopeia (USP) and the National Formulary (NF) including: (a) USP <795> Pharmaceutical Compounding- Non-Sterile Preparations (11/01/2023); (b) USP <797> Pha…

855-183-0020 Labeling (1) Labeling requirements for preparation of a compounded product must follow USP <795> (11/01/2023), and USP <797> (02/01/2026). (2) Labeling requirements for dispensing a compounded product must follow OAR 855-041, OAR 855-043, and OAR 855-139. (3) The Dru…

855-183-0030 Pharmacy Compounding for a Veterinarian – Non-Food Producing Animals (1) A patient specific prescription is not required to compound drugs for a licensed veterinarian when: (a) The request for drug compounding is submitted by a licensed veterinarian; and (b) The comp…