justicedao/ipfs_state_laws huggingface dataset:
855-139-0200 Outlet: General Requirements (1) A RDSP Affiliated Pharmacy may not be affiliated with more than two Remote Dispensing Site Pharmacies. (2) A RDSP and its RDSP 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 each prescription is dispensed in compliance with OAR 855-115, OAR 855-125 and OAR 855-139; (d) Comply with all applicable federal and state laws and rules; (e) Designate in writing the Oregon licensed Pharmacists and Certified Oregon Pharmacy Technicians authorized to access the RDSP and operate the telepharmacy system; (f) Train the Oregon licensed Pharmacists and Certified Oregon Pharmacy Technicians in the operation of the telepharmacy system and RDSP; (g) Develop, implement and enforce a continuous quality improvement program for dispensing services from a RDSP 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; (h) Provide a telephone number that a patient, patient’s agent or prescriber may use to contact the Oregon licensed Pharmacist from the RDSP Affiliated Pharmacy; and (i) Develop, implement and enforce a process for an in person physical inspection of the RDSP by an Oregon licensed Pharmacist at least once every 28 days or more frequently as deemed necessary by the Oregon licensed Pharmacist-in-charge of the RDSP Affiliated Pharmacy. The inspection must utilize the RDSP self-inspection form, be documented, and records retained. Statutory/Other Authority: ORS 689.205 & ORS 689.700 Statutes/Other Implemented: ORS 689.155 & ORS 689.700 History: BP 58-2024, amend filed 08/09/2024, effective 08/09/2024 BP 32-2024, minor correction filed 04/10/2024, effective 04/10/2024 BP 36-2022, amend filed 06/15/2022, effective 06/16/2022 BP 26-2022, temporary amend filed 04/22/2022, effective 04/22/2022 through 10/18/2022 BP 7-2022, minor correction filed 01/05/2022, effective 01/05/2022 BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022
855-139-0205 Outlet: Technology A RDSP and its RDSP Affiliated Pharmacy must: (1) Utilize a shared telepharmacy system and have appropriate technology or interface to allow access to information required to process and fill a prescription drug order; (2) Use still image capture or store and forward for verification of prescriptions with a camera that is of sufficient quality and resolution so that the Oregon licensed Pharmacist from the RDSP Affiliated Pharmacy can visually identify each: (a) Source container including manufacturer, name, strength, lot, and expiration; (b) Source ingredient including the imprint and physical characteristics if compounding; (c) Dispensed product including the imprint and physical characteristics; (d) Completed prescription container including the label; and (e) Ancillary document provided to patient at the time of dispensing. (3) Utilize barcode, radio-frequency identification or quick response code technology to record information in (2) if available; (4) Test the telepharmacy system and document that it operates properly before providing pharmacy services; and (5) Develop, implement and enforce a plan for routine maintenance of the telepharmacy system. Statutory/Other Authority: ORS 689.205 & 2021 SB 629 Statutes/Other Implemented: 2021 SB 629 & ORS 689.155 History: BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022
855-139-0210 Outlet: Supervision A RDSP and its RDSP Affiliated Pharmacy must: (1) Ensure prescription drugs are only dispensed at the RDSP if an Oregon licensed Pharmacist is supervising the Certified Oregon Pharmacy Technician or Pharmacy Technician, and the surveillance system is fully operational; (2) Ensure an Oregon licensed Pharmacist supervises, directs and controls each Certified Oregon Pharmacy Technician or Pharmacy Technician at the RDSP using an audiovisual communication system. All patient interactions must be recorded, reviewed and stored; (3) The Oregon licensed Pharmacist who is supervising the Certified Oregon Pharmacy Technician or Pharmacy Technician at a RDSP must: (a) Using reasonable professional judgment, determine the percentage of patient interactions for each licensee that must be reviewed to ensure public health and safety with a minimum of 10% of patient interactions observed or reviewed; (b) Review patient interactions within 48 hours of the patient interaction to ensure that each licensee is acting within the authority permitted under their license and patients are connected with a Pharmacist upon request; (c) Document the following within 24 hours of the review in (3)(b): (A) Number of each licensee’s patient interactions; (B) Number of each licensee’s patient interactions Pharmacist is reviewing; (C) Date and time of licensee patient interaction Pharmacist is reviewing; (D) Date and time of Pharmacist review of licensee’s patient interaction; and (E) Pharmacist notes of each interaction reviewed; and (d) Report any violation of OAR 855 to the RDSP Affiliated Pharmacy within 24 hours of discovery and to the board within 10 days. (4) The Oregon registered Drug Outlet Pharmacy must comply with the Pharmacist’s determination in (3)(a), employ adequate staff to allow for completion of the review within 48 hours, and retain records. (5) Ensure telephone audio is recorded, reviewed and stored for all patient interactions completed by the Certified Oregon Pharmacy Technician or Pharmacy Technician. (6) Develop, implement and enforce a plan for responding to and recovering from an interruption of service which prevents an Oregon licensed Pharmacist from supervising a Certified Oregon Pharmacy Technician or Pharmacy Technician at the RDSP. Statutory/Other Authority: ORS 689.205, ORS 689.225 & 2022 HB 4034 Statutes/Other Implemented: ORS 689.151, ORS 689.155, ORS 689.305 & 2022 HB 4034 History: BP 36-2022, amend filed 06/15/2022, effective 06/16/2022 BP 26-2022, temporary amend filed 04/22/2022, effective 04/22/2022 through 10/18/2022 BP 17-2022, amend filed 04/20/2022, effective 04/20/2022 BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022
855-139-0215 Outlet: Pharmacist Utilization A RDSP and its RDSP Affiliated Pharmacy must: (1) Utilize an Oregon licensed Pharmacist from the RDSP Affiliated Pharmacy to perform the professional tasks of interpretation, evaluation, DUR, verification and counseling before the prescription is dispensed; and (2) Utilize an Oregon licensed Pharmacist and an audiovisual communication system to provide counseling or accept the refusal of counseling from the patient or the patient’s agent for each prescription being dispensed when counseling is required under OAR 855-115-0145 and when requested and document the interaction. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 History: BP 33-2024, minor correction filed 04/10/2024, effective 04/10/2024 BP 17-2022, amend filed 04/20/2022, effective 04/20/2022 BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022
855-139-0220 Outlet: Non-Prescription Drugs If non-prescription drugs are offered for sale at the RDSP, the RDSP and its RDSP Affiliated Pharmacy must: (1) Ensure that the Certified Oregon Pharmacy Technician or Pharmacy Technician does not provide advice, information that requires judgment, or recommendations involving non-prescription drugs; and (2) Ensure that an Oregon-licensed Pharmacist is immediately available to provide counseling or recommendations involving non-prescription drugs. Statutory/Other Authority: ORS 689.205 & 2022 HB 4034 Statutes/Other Implemented: ORS 689.155 & 2022 HB 4034 History: BP 36-2022, amend filed 06/15/2022, effective 06/16/2022 BP 26-2022, temporary amend filed 04/22/2022, effective 04/22/2022 through 10/18/2022 BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022
855-139-0225 Outlet: Controlled Substances If controlled substances are at the RDSP, the RDSP and its RDSP Affiliated Pharmacy must: (1) Comply with controlled substance regulations; (2) Store all controlled substances in a secure locked cabinet; (3) Maintain an accurate controlled substance perpetual inventory; and (4) Ensure an Oregon licensed Pharmacist conducts a controlled substance inventory at least once every 28 days and reconciles all discrepancies at the time of in person physical inspection. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 History: BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022
855-139-0230 Outlet: Non-Sterile Compounding If non-sterile preparations are compounded at the RDSP, the RDSP and its RDSP Affiliated Pharmacy must: (1) Adhere to the requirements of OAR 855-045; (2) Ensure an Oregon licensed Pharmacist: (a) Supervises via an audiovisual communication system all steps of the compounding; and (b) Documents and visually verifies each item required in OAR 855-139-0205. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 History: BP 17-2022, amend filed 04/20/2022, effective 04/20/2022 BP 3-2022, minor correction filed 01/03/2022, effective 01/03/2022 BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022
855-139-0305 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 44-2024, minor correction filed 04/10/2024, effective 04/10/2024 BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022
855-139-0310 Prescription: Verification of Authenticity Alteration of a written prescription, other than by an Oregon licensed 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 43-2021, adopt filed 12/16/2021, effective 01/01/2022
855-139-0320 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 used alone as a prescription refill designation the abbreviation, "PRN" for a non-controlled substance means that the medication can be refilled in proper context for a period of one year. (a) When this abbreviation is used alone as a means to authorize refills for a controlled substance, the medication can be refilled in proper context for a period of six months or five refills, whichever comes first. (b) When this abbreviation is used in conjunction with a definite time period, or a specific number of refills, the non-controlled medication 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 43-2021, adopt filed 12/16/2021, effective 01/01/2022
855-139-0325 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 licensed Pharmacist from the RDSP Affiliated 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 32-2022, amend filed 06/15/2022, effective 06/16/2022 BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022
855-139-0350 Dispensing: 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. 01/01/2024), 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 27-2022, amend filed 06/15/2022, effective 06/16/2022 BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022
855-139-0360 Dispensing: Interpretation (1) Except as provided in subsection (2) of this section, a Pharmacist or Intern from the RDSP Affiliated Pharmacy must work with a health care interpreter from the health care interpreter registry administered by the Oregon Health Authority under ORS 413.558 when communicating with a patient who prefers to communicate in a language other than English or who communicates in signed language, unless the Pharmacist is proficient in the preferred language of the person with limited English proficiency. The Pharmacist or drug outlet may not charge for these services. (2) A Pharmacist or Intern who is otherwise required to work with a health care interpreter from the health care interpreter registry may work with a health care interpreter who is not listed on the health care interpreter registry only if the Pharmacist or Intern: (a) Verifies that the Pharmacist or Intern has made a good faith effort needed to obtain a health care interpreter from the health care interpreter registry in accordance with rules adopted by the authority under ORS 413.558 and has found that none are available to provide interpretation; or (b) Has offered the patient the services of a health care interpreter from the health care interpreter registry and the patient declined the offer and chose a different interpreter. (3) A Pharmacist or Intern must provide personal protective equipment, consistent with established national standards, to health care interpreters providing services on-site at no cost to the health care interpreter and may not suggest to the health care interpreter that the health care interpreter should procure the health care interpreter’s own personal protective equipment as a condition of working with the Pharmacist or Intern. (4) A Pharmacist or Intern must maintain records of: (a) Each patient encounter in which the Pharmacist or Intern worked with a health care interpreter from the health care interpreter registry; or (b) Each good faith effort to utilize a health care interpreter from the health care registry for each patient encounter in which the Pharmacist or Intern worked with an interpreter not on the health care interpreter registry and met one of the exceptions in (2) of this rule. (5) The records required in (4) must include: (a) The full name of the health care interpreter; (b) The health care interpreter’s registry number, if applicable; and (c) The language interpreted. (6) Pharmacists, Interns, Certified Oregon Pharmacy Technicians, Pharmacy Technicians and Pharmacies are required to comply with ORS 413.559. Statutory/Other Authority: ORS 689.205 & 2021 HB 2359 Statutes/Other Implemented: ORS 689.155 & 2021 HB 2359 History: BP 29-2022, adopt filed 06/15/2022, effective 09/01/2022
855-139-0400 Labeling: General Requirements Prescriptions must be labeled with the following information: (1) Name, address and telephone number of the RDSP; (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) Required precautionary information regarding controlled substances; (9) Such other and further accessory cautionary information as required for patient safety; (10) 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 unless, in the Oregon licensed Pharmacist's professional judgment, a shorter expiration date is warranted. Any drug bearing an expiration date must not be dispensed beyond the said expiration date of the drug; (11) 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 (12) Address and telephone number of the RDSP Affiliated Pharmacy. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.505 & ORS 689.515 History: BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022
855-139-0405 Labeling: Prescription Reader Accessibility (1) A pharmacy 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 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 pharmacy must ensure an Oregon licensed 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 43-2021, adopt filed 12/16/2021, effective 01/01/2022
855-139-0410 Labeling: 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 limited English proficiency, defined as a person who is not fluent in the English language. This does not apply to a drug outlet dispensing a drug intended for administration by a healthcare worker. (2) When dispensing a drug under (1), a pharmacy must provide labels and informational inserts in both English and one of the following languages: (a) Spanish; (b) Russian; (c) Somali; (d) Arabic; (e) Chinese (simplified); (f) Vietnamese; (g) Farsi; (h) Korean; (i) Romanian; (j) Swahili; (k) Burmese; (l) Nepali; (m) Amharic; and (n) Pashtu. (3) The board must reassess and update (2) as necessary and at least every ten years. Statutory/Other Authority: ORS 689.564 Statutes/Other Implemented: ORS 689.205 History: BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022
855-139-0450 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 475.035, ORS 689.205, ORS 689.305 & ORS 689.315 Statutes/Other Implemented: ORS 689.155 History: BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022
855-139-0455 Drugs and Devices: Return A Certified Oregon Pharmacy Technician or Pharmacy Technician 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 pharmacy if they were dispensed in error, were defective, adulterated, misbranded, dispensed beyond their expiration date, or are subject of a drug or device recall only if: (1) An Oregon licensed Pharmacist has approved the return; (2) The drugs or devices are accepted for destruction or disposal; and (3) An Oregon licensed Pharmacist verifies the destruction or disposal. Statutory/Other Authority: ORS 689.205 & 2022 HB 4034 Statutes/Other Implemented: ORS 689.305 & 2022 HB 4034 History: BP 43-2022, minor correction filed 08/23/2022, effective 08/23/2022 BP 36-2022, amend filed 06/15/2022, effective 06/16/2022 BP 26-2022, temporary amend filed 04/22/2022, effective 04/22/2022 through 10/18/2022 BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022
855-139-0500 Policies and Procedures (1) The Oregon licensed Pharmacist-in-charge of the RDSP Affiliated Pharmacy and the RDSP Affiliated Pharmacy drug outlet is accountable for establishing, maintaining, and enforcing written policies and procedures for the RDSP. The written policies and procedures must be maintained at the RDSP Affiliated Pharmacy and the RDSP and must be available to the board upon request. (2) The written policies and procedures must include at a minimum the responsibilities of the RDSP Affiliated Pharmacy and each RDSP including; (a) Security; (b) Operation, testing and maintenance of the telepharmacy system; (c) Sanitation; (d) Storage of drugs; (e) Dispensing; (f) Oregon licensed Pharmacist supervision, direction and control of pharmacy technicians; (g) Documenting the identity, function, location, date and time of the licensees engaging in telepharmacy; (h) Drug and/or device procurement; (i) Receiving of drugs and/or devices; (j) Delivery of drugs and/or devices; (k) Utilization of Oregon licensed Pharmacist (i.e. DUR, Counseling); (l) Recordkeeping; (m) Patient confidentiality; (n) On-site inspection by an Oregon licensed Pharmacist; (o) Continuous quality improvement; (p) Plan for discontinuing and recovering services if telepharmacy system disruption occurs; (q) Training: initial and ongoing; and (r) Interpretation, translation and prescription reader services. (3) If non-prescription drugs are offered for sale at the RDSP, the policies and procedures must outline the process for the Oregon licensed Pharmacist counseling and advice. (4) If non-sterile preparations are compounded at the RDSP, the policies and procedures must meet the requirements of OAR 855-045. (5) If controlled substances are stored at the RDSP, the policies and procedures must include the following processes: (a) Reviewing of controlled substance prescriptions for unauthorized alterations and inspected for legitimacy by the Oregon licensed Pharmacist during inspection visits; (b) Maintaining an accurate controlled substance perpetual inventory for all controlled substances that are stocked at the RDSP; and (c) Conducting and reconciling the controlled substance inventory. (6) A RDSP Affiliated Pharmacy that provides remote pharmacy services through a telepharmacy system at a RDSP must review its written policies and procedures every 12 months, revise them if necessary, and document the review. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 History: BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022