justicedao/ipfs_state_laws huggingface dataset:
855-141-0125 Drug: Storage (1) A PPK 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 (d) A PPK must quarantine drugs which are outdated, adulterated, misbranded or suspect. (2) A PPK 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 (35.6 to 46.4°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 PPK 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 a 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 Pharmacist at the time of in person physical inspection. Statutory/Other Authority: ORS 689.205 & ORS 689.325 Statutes/Other Implemented: ORS 689.155 & ORS 689.527 History: BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023
855-141-0130 Drug: Loss A PPK and its PPK 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 or any loss related to suspected drug theft is reported to the board within one business day. Statutory/Other Authority: ORS 689.205, ORS 689.305 & ORS 689.315 Statutes/Other Implemented: ORS 689.155 & ORS 689.527 History: BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023
855-141-0145 Outlet: Closure A PPK Affiliated Pharmacy must notify the board a minimum of 15 days prior to discontinuing operation of a PPK. Notification must include the: (1) Final disposition of drugs stored in the PPK including: (a) Name and location where the drugs are transferred; (b) Name and location where destruction occurred; and (c) Name and location of the site that will store all records; (2) Provide the board with: (a) Oregon Board of Pharmacy state license(s); and (b) Signed statement giving the effective date of closure. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155, ORS 689.305 & ORS 689.527 History: BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023
855-141-0150 Outlet: Sanitation A PPK and its PPK Affiliated Pharmacy must ensure the PPK is kept clean. Statutory/Other Authority: ORS 689.305 Statutes/Other Implemented: ORS 689.305 & ORS 689.527 History: BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023
855-141-0155 Outlet: Minimum Equipment Requirements (1) Each Oregon PPK 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 reference (e.g. USP) based on services offered by the PPK outlet; (b) Appropriate equipment to maintain the proper storage of drugs; (c) Signage in a location easily seen by the public at the PPK where prescription and non-prescription drugs, devices, and related supplies are dispensed: (A) Stating “The (insert name of PPK Affiliated Pharmacy) may be able to substitute a less expensive drug which is therapeutically equivalent to the one prescribed by your doctor unless you do not approve.” The printing on this sign must be in block letters not less than one inch in height. (B) Providing notification in each of the languages required in OAR 855-141-0410 of the right to free, competent oral interpretation and translation services, including translated prescription labels, for patients who are of limited English proficiency, in compliance with federal and state regulations if the pharmacy dispenses prescriptions for a patient's self-administration; (C) Stating "This location is a Pharmacy Prescription Kiosk, supervised by a Pharmacist from (insert name of PPK Affiliated Pharmacy, address, and telephone number)." The printing on the sign must be in block letters not less than one inch in height; and (D) Providing notification of accurate hours of operation at the PPK; and (d) Additional equipment and supplies that are determined as necessary by the PPK Affiliated Pharmacy or PIC. (e) As an alternative to posting the required signage, PPK's that utilize an electronic video monitor that the patient is required to acknowledge prior to retrieving medication from the PPK may display the information required by sub-paragraphs (1)(c)(A) - (D) electronically. (2) Failure to have, use and maintain required equipment constitutes unprofessional conduct under ORS 689.405(1)(a). Statutory/Other Authority: ORS 689.205 & ORS 689.654 Statutes/Other Implemented: ORS 689.155, ORS 689.515, ORS 689.654 & ORS 689.527 History: BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023
855-141-0200 Outlet: General Requirements (1) The PPK Affiliated Pharmacy and its PIC are responsible for all operations and enforcing all policies and procedures of the PPK. (2) A PPK Affiliated Pharmacy may operate more than one PPK. (3) A PPK Affiliated Pharmacy must be less than 120 miles apart via the shortest surface street route from the PPK. (4) A PPK and its PPK Affiliated Pharmacy must: (a) Have the same owner; or (b) Have a written contract that specifies: (A) The services to be provided by each licensee and registrant; (B) The responsibilities of each licensee and registrant; and (C) The accountabilities of each licensee and registrant; (c) Ensure prescription and non-prescription drugs, devices, and related supplies are dispensed in compliance with OAR 855-041, OAR 855-115, OAR 855-120, OAR 855-125, and OAR 855-141; (d) Ensure that the PPK Affiliated Pharmacy prevents duplicate dispensing of a prescription; (e) Comply with all applicable federal and state laws and rules; (f) Ensure that there is an PIC who is responsible for all operations and enforcing all policies and procedures of the PPK; (g) Designate in writing the Pharmacists, Interns, Certified Oregon Pharmacy Technicians and Pharmacy Technicians authorized to access the PPK; (h) Utilize complete chain of custody tracking; (i) Train the Pharmacists, Interns, Certified Oregon Pharmacy Technicians and Pharmacy Technicians in the operation of the telepharmacy system and PPK and document the training; (j) Develop, implement and enforce a continuous quality improvement program for dispensing services from a PPK designed to objectively and systematically: (A) Monitor, evaluate, document the quality and appropriateness of patient care; (B) Improve patient care; and (C) Identify, resolve and establish the root cause of dispensing and DUR errors and prevent their reoccurrence; (k) Provide a telephone number that a patient, patient’s agent or prescriber may use to contact the Pharmacist from the PPK Affiliated Pharmacy; and (l) Develop, implement and enforce a process for an in person physical inspection of the PPK by a Pharmacist at least once every 28 days or more frequently as deemed necessary by the PIC of the PPK Affiliated Pharmacy. The inspection must utilize the PPK self-inspection form, be documented, and records retained. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 & ORS 689.527 History: BP 36-2024, minor correction filed 04/10/2024, effective 04/10/2024 BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023
855-141-0205 Outlet: Technology A PPK and its PPK Affiliated Pharmacy must: (1) Utilize a shared telepharmacy system and have appropriate technology or interface to allow access to information required to dispense prescription and non-prescription drugs, devices, and related supplies and counsel the patient or patient’s agent; (2) Utilize barcode, radio-frequency identification or quick response code technology for stocking, destocking and dispensing at the PPK; (3) Test the telepharmacy system and PPK and verify the unit is operable and functioning in all aspects in accordance with minimum acceptable system or unit design specifications before dispensing prescription and non-prescription drugs, devices, and related supplies and after an upgrade or change is made to the system. The PPK Affiliated Pharmacy must make the results of such testing available to the board upon request; and (4) Develop, implement and enforce a plan for routine maintenance of the telepharmacy system and PPK. (5) Develop, implement and enforce a plan for responding to and recovering from an interruption of service where the PPK is not fully operational and functioning. (6) For verification of prescriptions, use still image capture or store and forward with a camera that is of sufficient quality and resolution so that the Pharmacist from the PPK Affiliated Pharmacy can visually identify each: (a) Source container including manufacturer, name, strength, lot, and expiration; (b) Dispensed product including the imprint and physical characteristics if applicable; (c) Completed prescription container including the label; and (7) Utilize barcode, radio-frequency identification or quick response code technology to record information in (6) if available. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 & ORS 689.527 History: BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023
855-141-0210 Outlet: Supervision A PPK and its PPK Affiliated Pharmacy must: (1) Ensure prescription and non-prescription drugs, devices, and related supplies are only dispensed at the PPK if a Pharmacist is available for patient consultation and the PPK is fully operational. (2) Ensure that stocking and destocking of prescription and non-prescription drugs, devices, and related supplies in a PPK is completed under the supervision, direction, and control of a Pharmacist. (3) Ensure that a Pharmacist verifies and documents that: (a) All prescription and non-prescription drugs, devices, and related supplies were correctly stocked into the PPK; (b) All prescription and non-prescription drugs, devices, and related supplies destocked from the PPK were returned to the PPK Affiliated Pharmacy; (c) Proper storage conditions were maintained during transfer per OAR 855-141-0125; and (d) Records are maintained per OAR 855-141-0550. (4) Drugs and devices destocked from a PPK that satisfy the requirements of this section may be returned to stock at the PPK Affiliated Pharmacy. Statutory/Other Authority: ORS 689.205 & ORS 689.225 Statutes/Other Implemented: ORS 689.151, ORS 689.155, ORS 689.305 & ORS 689.527 History: BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023
855-141-0215 Outlet: Pharmacist Utilization A PPK and its PPK Affiliated Pharmacy must ensure that a prescription drug or device is not released from the PPK until the Pharmacist or Intern has: (1) Provided counseling when required under OAR 855-115-0145 or when requested by the patient or patient’s agent; and (2) Documented the interaction. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 & ORS 689.527 History: BP 37-2024, minor correction filed 04/10/2024, effective 04/10/2024 BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023
855-141-0225 Outlet: Controlled Substances Controlled substances must not be stored in the PPK. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 & ORS 689.527 History: BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023
855-141-0300 Prescription: General Requirements (1) Prescriptions, prescription refills, and drug orders must be correctly dispensed in accordance with the prescribing practitioner's authorization. (2) Each PPK Affiliated Pharmacy must document the following information for each prescription: (a) The name and date of birth of the patient for whom the drug is prescribed, unless for an animal. (b) If for an animal, the name of the patient, name the owner and the species of the animal. (c) The full name, address, and contact phone number of the practitioner. (d) The name, strength, dosage forms of the substance, quantity prescribed and, if different from the quantity prescribed, the quantity dispensed; (e) The directions for use, if given by the practitioner; and (f) The date of filling, and the total number of refills authorized by the prescribing practitioner. (3) In accordance with ORS 689.515(3), a practitioner may specify in writing, by a telephonic communication or by electronic transmission that there may be no substitution for the specified brand name drug in a prescription. (a) For a hard copy prescription issued in writing or a prescription orally communicated over the telephone, instruction must use one of the following phrases or notations: (A) No substitution; (B) N.S.; (C) Brand medically necessary; (D) Brand necessary; (E) Medically necessary; (F) D.A.W. (Dispense As Written); or (G) Words with similar meaning. (b) For an electronically transmitted prescription, the prescriber or prescriber’s agent must clearly indicate substitution instructions by way of the text (without quotes) “brand medically necessary” or words with similar meaning, in the electronic prescription drug order, as well as all relevant electronic indicators sent as part of the electronic prescription transmission. (c) Such instructions must not be default values on the prescription. (4) A PPK or Pharmacist filling a prescription or order for a biological product must not substitute a biosimilar product for the prescribed biological product unless: (a) The biosimilar product has been determined by the United States Food and Drug Administration to be interchangeable with the prescribed biological product; (b) The prescribing practitioner has not designated on the prescription that substitution is prohibited; (c) The patient for whom the biological product is prescribed is informed of the substitution prior to dispensing the biosimilar product; (d) The PPK Affiliated Pharmacy or Pharmacist provides written, electronic or telephonic notification of the substitution to the prescribing practitioner or the prescribing practitioner’s staff within three business days of dispensing the biosimilar product; and (5) The PPK must dispense prescriptions accurately and to the correct party. Statutory/Other Authority: ORS 689.205 & ORS 689.522 Statutes/Other Implemented: ORS 689.505, ORS 689.515 & ORS 689.522 History: BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023
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 Implemented: ORS 689.155 History: BP 43-2024, minor correction filed 04/10/2024, effective 04/10/2024 BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023
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 Statutes/Other Implemented: ORS 689.151 & ORS 689.155 History: BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023
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. This documentation must be readily retrievable. (2) If the practitioner is not available and in the reasonable professional judgment of the Pharmacist from the PPK Affiliated Pharmacy an emergency need for the refill of a prescription drug has been demonstrated, the Pharmacist may authorize the PPK to prepare for Pharmacist verification a sufficient quantity of the drug consistent with the dosage regimen, to last until a practitioner can be contacted for authorization, but not to exceed a 72-hour supply. The practitioner must be promptly notified of the emergency refill. (3) Each refilling of a prescription must be accurately documented, readily retrievable, and uniformly maintained for three years by the PPK Affiliated Pharmacy. This record must include; (a) Date, time and identification of each individual and activity or function performed; (b) Name of the patient; (c) Name of the medication; (d) Date of refill; and (e) Quantity dispensed. (4) Refill quantities may be combined into a single filling if the prescription is not for a psychotherapeutic drug and the prescriber is notified of the change. (5) A PPK may only dispense a prescription refill upon request of the patient or patient’s agent. A request specific to each prescription medication is required. (6) A prescription must be refilled in context with the approximate dosage schedule unless specifically authorized by the prescriber. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.505 & ORS 689.515 History: BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023
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 the prescriber. (2) When “PRN” is used as a prescription refill designation: (a) The abbreviation means that the prescription can be refilled in proper context for a period of one year. (b) In conjunction with a definite time period, or a specific number of refills, the prescription can be refilled in proper context for a period not to exceed one year. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.505 & ORS 689.515 History: BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023
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 constituting the prescription and its relevant refill history in a manner that ensures accuracy and accountability. (2) Prescriptions for controlled substances can only be transferred one time. (3) Pharmacies using the same electronic prescription database are not required to transfer prescriptions for dispensing purposes. (4) An Oregon registered pharmacy must transfer a prescription: (a) To a pharmacy requesting a transfer on behalf of the patient or patient's agent unless the transfer would compromise patient safety or violate state or federal laws or rules; and (b) By the end of the next business day of the request. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 History: BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023
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 prescriptions accurately and to the correct party. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 & ORS 689.527 History: BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023
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. 01/01/2024), 16 CFR 1701 (v. 01/01/2024), and 16 CFR 1702 (v. 01/01/2024). [Publications: Publications referenced are available for review at the agency.] Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 History: BP 3-2025, amend filed 06/16/2025, effective 06/16/2025 BP 57-2024, amend filed 06/18/2024, effective 06/20/2024 BP 10-2023, amend filed 06/13/2023, effective 06/13/2023 BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023
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 label must also contain the identifier of the manufacturer or distributor; (6) Directions for use by the patient; (7) Name of practitioner; (8) Such other and further accessory cautionary information as required for patient safety; (9) An expiration date after which the patient should not use the drug or medicine. Expiration dates on prescriptions must be the same as that on the original container or one year from the date the drug was originally dispensed and placed in the new container, whichever date is earlier. Any drug expiring before the expected length of time for course of therapy must not be dispensed. (10) Any dispensed prescription medication, other than those in unit dose or unit of use packaging, must be labeled with its physical description, including any identification code that may appear on tablets and capsules; and (11) Name, address and telephone number of the PPK Affiliated Pharmacy. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.505 & ORS 689.515 History: BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023
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 information. (2) If a person informs the PPK Affiliated Pharmacy that the person identifies as a person who is blind, the pharmacy must provide to the person a prescription reader that is available to the person for at least the duration of the prescription, must confirm it is appropriate to address the person’s visual impairment, and must ensure that prescription labels are compatible with the prescription reader. This requirement does not apply to an institutional drug outlet, dispensing a drug intended for administration by a healthcare provider. (3) The PPK Affiliated Pharmacy must ensure a Pharmacist verifies and documents that the correct electronic label was placed on each prescription container and that the audio information produced by the prescription reader is accurate prior to dispensing the prescription. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.561 History: BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023