justicedao/ipfs_state_laws huggingface dataset:
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-charge shall be indicated on the application for a new or relocated pharmacy and for pharmacy renewal registration. (2) Ensure the PIC is qualified per OAR 855-115-0205 and complies with OAR 855-115-0210. (3) Report a change in PIC within 15 days of occurrence in the registrant’s electronic licensing record with the board. (4) Report terminating or allowing a board licensee to resign in lieu of termination to the board within 10 working days. The report must include the name of licensee, license number, the date, and the reason for the termination. (5) Provide a working environment that protects the health, safety and welfare of a patient which includes but not limited to: (a) Sufficient personnel to prevent fatigue, distraction or other conditions that interfere with a pharmacist’s ability to practice with reasonable competency and safety. (b) Appropriate opportunities for uninterrupted rest periods and meal breaks. (c) Adequate time for a Pharmacist to complete professional duties and responsibilities as specified in OAR 855-115; (d) Ensure there is sufficient staff to provide services in a safe manner. The outlet must abide by the Pharmacist-on-duty’s decision to temporarily shut down a service or services and must respond substantively to a Pharmacist who has identified staffing concerns. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.151, ORS 689.155 & ORS 689.305 History: BP 34-2023, amend filed 12/19/2023, effective 03/01/2024 BP 7-2023, amend filed 02/14/2023, effective 02/14/2023 BP 1-2017, f. & cert. ef. 2-23-17 Renumbered from 855-041-0020, BP 7-2012, f. & cert. ef. 12-17-12 BP 2-2008, f. & cert. ef. 2-20-08 BP 1-2001, f. & cert. ef. 3-5-01 PB 1-1996, f. & cert. ef. 4-5-96 PB 1-1995, f. & cert. ef. 4-27-95 PB 1-1994, f. & cert. ef. 2-2-94 PB 4-1992, f. & cert. ef. 8-25-92 PB 9-1989, f. & cert. ef. 7-20-89 PB 10-1987, f. & ef. 12-8-87 1PB 3-1986, f. & ef. 12-8-86 1PB 2-1980, f. & ef. 4-3-80 1PB 2-1979(Temp), f. & ef. 10-3-79
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 institutional facility. (2) Sanitation: (a) Pharmacies shall be kept clean. (b) Persons working in a pharmacy shall practice appropriate infection control. Statutory/Other Authority: ORS 689.305 Statutes/Other Implemented: ORS 689.305 History: BP 19-2022, amend filed 04/20/2022, effective 04/20/2022 BP 28-2021, temporary amend filed 11/19/2021, effective 11/19/2021 through 05/17/2022 Renumbered from 855-041-0025, BP 7-2012, f. & cert. ef. 12-17-12 PB 1-1997, f. & cert. ef. 9-22-97 PB 12-1989, f. & cert. ef. 8-11-89 1PB 2-1980, f. & ef. 4-3-80 1PB 2-1979(Temp), f. & ef. 10-3-79
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 compliance with OAR 855-080; (c) Compounded preparation is dispensed in compliance with OAR 855-045; and (d) Radiopharmaceutical is dispensed in compliance with OAR 855-042. (2) Comply with all applicable federal and state laws and rules; (3) Ensure all licensees are trained to appropriately perform their duties prior to engaging or assisting in the practice of pharmacy. (4) Ensure each licensed and non-licensed individual only perform duties they are licensed and trained to perform. (5) Be responsible for the actions of each licensed and non-licensed individual. (6) Establish, maintain and enforce the drug outlet written procedures required in OAR 855-041-1040. (7) Comply with the Pharmacist’s determination in OAR 855-115-0120(1)(k); (8) Develop, implement and enforce a continuous quality improvement program for dispensing services from a Drug Outlet Pharmacy 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. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.151 & ORS 689.155 History: BP 34-2023, amend filed 12/19/2023, effective 03/01/2024 BP 40-2022, renumbered from 855-041-0018, filed 06/24/2022, effective 06/24/2022 BP 28-2022, adopt filed 06/15/2022, effective 06/16/2022
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 drugs. (2) The pharmacist-in-charge and each pharmacist while on duty shall be responsible for the security of the prescription area including provisions for adequate safeguards against theft or diversion of prescription drugs, and records for such drugs. (3) When there is no pharmacist present, the pharmacy shall be secured to prevent entry. All entrances to the pharmacy shall be securely locked and any keys to the pharmacy shall remain in the possession of the pharmacist-in-charge and other employee pharmacists as authorized by the pharmacist-in-charge. When there is no pharmacist present, and it is necessary for non-pharmacist employees or owners to have access to the pharmacy, the prescription area shall be secured from entry as described in OAR 855-041- 2100. (4) Prescription drugs and devices and non-prescription Schedule V controlled substances shall be stored within the prescription area or a secured storage area. Statutory/Other Authority: ORS 475.035 & ORS 689.205 Statutes/Other Implemented: ORS 689.205 History: BP 17-2022, amend filed 04/20/2022, effective 04/20/2022 Renumbered from 855-041-0026, BP 7-2012, f. & cert. ef. 12-17-12 PB 1-1987, f. & ef. 2-3-87 1PB 5-1982, f. & ef. 8-6-82
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, 689.205, 689.305 & 689.315 History: Renumbered from 855-041-0036, BP 7-2012, f. & cert. ef. 12-17-12 PB 1-1992, f. & cert. ef. 1-31-92 (and corrected 2-7-92) PB 1-1990, f. & cert. ef. 1-23-90 1PB 2-1984, f. & ef. 3-7-84
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 suspected drug theft of a controlled substance is reported to the board within one business day. (3) At the time a Report of Theft or Loss of Controlled Substances (DEA Form 106) or Report of Theft or Loss of Listed Chemicals (DEA Form 107) is sent to the Drug Enforcement Administration, a copy is sent to the board. Statutory/Other Authority: ORS 475.035, ORS 689.155, ORS 689.205, ORS 689.305 & ORS 689.315 Statutes/Other Implemented: ORS 689.155 History: BP 42-2021, amend filed 12/16/2021, effective 01/01/2022 BP 2-2014, f. & cert. ef. 1-24-14 Renumbered from 855-041-0037, BP 7-2012, f. & cert. ef. 12-17-12 PB 1-1992, f. & cert. ef. 1-31-92 (and corrected 2-7-92) 1PB 1-1986, f. & ef. 6-5-86 1PB 2-1981, f. & ef. 8-20-81
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 written policies and procedures must be maintained at the drug outlet pharmacy and must be available to the board upon request. (2) The written policies and procedures must include at a minimum the responsibilities of the drug outlet pharmacy including; (a) Security; (b) Operation, testing and maintenance of pharmacy systems and equipment; (c) Sanitation; (d) Storage of drugs; (e) Dispensing; (f) Pharmacist supervision, direction and control of non-Pharmacists; (g) Documenting the date, time and identification of the licensee and the specific activity or function of the person performing each step in the dispensing process; (h) Utilization of Certified Oregon Pharmacy Technicians or Pharmacy Technicians; (i) Certified Oregon Pharmacy Technician or Pharmacy Technician final verification and/or vaccination, if utilized; (j) Drug and/or device procurement; (k) Receiving of drugs and/or devices; (l) Disposal of drugs and/or devices including hazardous and pharmaceutical waste; (m) Delivery of drugs and/or devices; (n) Utilization of Oregon licensed Pharmacist (i.e. DUR, Counseling); (o) Recordkeeping; (p) Patient confidentiality; (q) Continuous quality improvement; (r) Plan for discontinuing and recovering services in the event of a pharmacy closure; (s) Training: initial and ongoing; and (t) Interpretation, translation and prescription reader services. Statutory/Other Authority: ORS 689.205 & 2022 HB 4034 Statutes/Other Implemented: ORS 689.151, ORS 689.155, ORS 689.508 & 2022 HB 4034 History: BP 28-2023, amend filed 12/19/2023, effective 01/01/2024 BP 28-2022, amend filed 06/15/2022, effective 06/16/2022 BP 45-2021, amend filed 12/16/2021, effective 12/16/2021 BP 99-2020, amend filed 12/23/2020, effective 01/01/2021 BP 5-2018, amend filed 10/18/2018, effective 10/18/2018 Renumbered from 855-041-0060, BP 7-2012, f. & cert. ef. 12-17-12 BP 2-2008, f. & cert. ef. 2-20-08 BP 3-2005, f. & cert. ef. 4-14-05 PB 1-1994, f. & cert. ef. 2-2-94 1PB 2-1980, f. & ef. 4-3-80 1PB 2-1979(Temp), f. & ef. 10-3-79
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 interns may accept the return of drugs or devices as defined by ORS 689.005 once the drugs or devices have been removed from the pharmacy only if; (a) The drugs or devices are accepted for destruction or disposal and; (b) The drugs or devices were dispensed in error, were defective, adulterated, misbranded, dispensed beyond their expiration date, were unable to be delivered to the patient, or are subject of a drug or device recall; or (c) After consultation, a pharmacist determines that, in the pharmacist’s professional judgment, harm could result to the public or a patient if the drugs or devices were not accepted for return. (3) Not withstanding (2) of this rule, drugs or devices previously dispensed or distributed may be returned and redispensed or redistributed provided all the following conditions are met: (a) The drug is in an unopened, tamper-evident unit; (b) The drugs or devices have remained at all times in control of a person trained and knowledgeable in the storage and administration of drugs in long term care facilities or supervised living groups using the services of a consultant pharmacist; (c) The drug or device has not been adulterated or misbranded and has been stored according to the manufacturer recommendations. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.305 History: BP 17-2021, amend filed 06/15/2021, effective 06/15/2021 BP 1-2017, f. & cert. ef. 2-23-17 BP 7-2012, f. & cert. ef. 12-17-12, Renumbered from 855-041-0080 BP 2-2006, f. & cert. ef. 6-9-06 PB 8-1990, f. & cert. ef. 12-5-90 PB 5-1989, f. & cert. ef. 1-30-89 1PB 2-1981, f. & cert. ef. 8-20-81 1PB 1-1981(Temp), f. & ef. 4-1-81 1PB 2-1980, f. & cert. ef. 4-3-80 1PB 2-1979(Temp), f. & cert. ef. 10-3-79
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 office of the patient’s health care practitioner; or (b) The location of the patient; or (A) Patient’s primary residence; or (B) Alternate residence designated by the patient; or (C) Patient’s workplace; or (c) The hospital or medical care facility in which a patient is receiving care. (2) Upon written request, the Board may waive any of the requirements of this rule if a waiver will further public health or safety or the health and safety of a patient. A waiver granted under this section shall only be effective when it is issued by the Board in writing. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689 History: Renumbered from 855-041-0095, BP 7-2012, f. & cert. ef. 12-17-12 BP 1-2012, f. 4-26-12, cert. ef. 5-1-12 BP 9-2011, f. 12-30-11, cert. ef. 1-1-12 1PB 2-1980, f. & ef. 4-3-80 1PB 2-1979(Temp), f. & ef. 10-3-79
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 the patient except as provided in (a)-(e) of this rule. A licensee may disclose patient information: (a) To the board; (b) To a practitioner, Oregon licensed Pharmacist, Intern, Pharmacy Technician, or Certified Oregon Pharmacy Technician, if disclosure is authorized by an Oregon licensed Pharmacist who reasonably believes that disclosure is necessary to protect the patient's health or wellbeing; or (c) To a third party when disclosure is authorized or required by law; or (d) As permitted pursuant to federal and state patient confidentiality laws; or (e) To the patient or to persons as authorized by the patient. (2) May not allow a licensee or registrant of the board to access or obtain any patient information unless it is accessed or obtained for the purpose of patient care except as provided in (1)(a)-(e) of this rule. Statutory/Other Authority: ORS 689.205, ORS 689.305 & ORS 689.315 Statutes/Other Implemented: ORS 689.155 History: BP 22-2022, amend filed 04/20/2022, effective 04/20/2022 Renumbered from 855-041-0103, BP 7-2012, f. & cert. ef. 12-17-12 PB 5-1992, f. & cert. ef. 10-23-92
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 pharmacy services to Oregon, such as drugless/consulting outlets, even if the entity is not dispensing, delivering or distributing drugs into Oregon. (2) Every non-resident pharmacy that provides drugs, devices or services to a person in Oregon must be registered with the Oregon Board of Pharmacy. (3) To qualify for registration under these rules, every non-resident pharmacy must be registered with the Board of Pharmacy in the state where the pharmacy is physically located. (4) Every non-resident pharmacy must designate an Oregon licensed Pharmacist-in-Charge (PIC), who must be responsible for all pharmacy services provided to residents in Oregon, and to provide supervision and control in the pharmacy. To qualify for this designation, the person must: (a) Hold a license to practice pharmacy in the resident state; (b) Be normally present in the pharmacy for a minimum of 20 hours per week; (c) Annually complete a self-inspection form using the board's Non-Resident Retail Drug Outlet Self-Inspection Form prior to July 1; and (d) Provide the PIC Self-Inspection Form as requested by the board. (5) Every non-resident pharmacy will have a pharmacist-in-charge (PIC) who is licensed in Oregon within four months of initial licensure of the pharmacy. (6) When a change of Pharmacist-in-Charge (PIC) occurs, the non-resident pharmacy will notify the board within ten business days and identify a contact person. The pharmacy will have an Oregon licensed PIC employed within 90 days. The contact person must be a licensed pharmacist in the pharmacy’s state of residence and is responsible for the following: (a) Supervision of pharmacy staff and ensuring compliance with laws and rules; and (b) Responding to board correspondence and inquiries. (7) A new Pharmacist-in-Charge must be appointed, and communication made to the board within 90 days, or the non-resident pharmacy will cease drug distribution and provision of pharmacy services in Oregon. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.151, ORS 689.155 & ORS 689.225 History: BP 34-2023, amend filed 12/19/2023, effective 03/01/2024 BP 12-2023, amend filed 06/13/2023, effective 08/01/2023 BP 37-2021, amend filed 12/16/2021, effective 12/16/2021 BP 4-2015, f. & cert. ef. 7-1-15 Renumbered from 855-041-0300, BP 7-2012, f. & cert. ef. 12-17-12 BP 2-2008, f. & cert. ef. 2-20-08 PB 1-1994, f. & cert. ef. 2-2-94
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 to scale and must be approved by the board prior to opening. (3) The application must specify the location of the pharmacy and must indicate the owner, trustee, receiver, or other person applying for the registration. When an applicant is not the owner of the pharmacy, the application must indicate the owner and the applicant's affiliation with the owner: (a) If the owner is a partnership or other multiple owner, the names of the partners or persons holding the five largest interests must be indicated on the application; (b) If the owner is a corporation, the name filed must be the same as filed with the Corporation Commissioner. The name of the corporation, the names of the corporation officers and the names of the stockholders who own the five largest interests must be indicated on the application. (4) Upon request by the board, the applicant must furnish such information as required by the board regarding the partners, stockholders, or other persons not named in the application. (5) The application must also identify any person who has incidents of ownership in the pharmacy who also has financial interest in any long-term care facility as defined in ORS 442.015. (6) A certificate of registration will be issued upon board approval of the application. (7) All registration renewal applications must be accompanied by the annual fee and must contain the same information required in sections (3) and (4) of this rule. (8) The initial and annual registration fee for pharmacies is set out in OAR 855-110. (9) Pharmacy registration expires March 31, annually. If the annual registration fee referred to in OAR 855-110 is not paid by March 31 of the current year, a late fee as set out in OAR 855-110 must be included with the application for registration renewal. (10) The registration is not transferable and the registration fee cannot be prorated. (11) A change of ownership requires the approval of the board and new certificate of registration. Application must be on a form supplied by the board. (12) A change of ownership includes any change in the legal form of the business including additions or deletions of partners. (13) Applicants for change in ownership must provide the board with the information required in sections (3), (4), and (5) of this rule. (14) A change of ownership must be reported to the board 15 days prior to occurrence. (15) No pharmacy may be operated until a certificate of registration has been issued to the pharmacy by the board. Statutory/Other Authority: ORS 475.035 & ORS 689.205 Statutes/Other Implemented: ORS 689.155 History: BP 45-2021, amend filed 12/16/2021, effective 12/16/2021 Renumbered from 855-041-0005, BP 7-2012, f. & cert. ef. 12-17-12 PB 1-1994, f. & cert. ef. 2-2-94 PB 4-1992, f. & cert. ef. 8-25-92 PB 5-1990, f. & cert. ef. 4-12-90 1PB 2-1980, f. & ef. 4-3-80 1PB 2-1979(Temp), f. & ef. 10-3-79
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 Board and shall be accompanied by fees and a floor plan drawn to scale. (3) A certificate of registration will be issued upon Board approval of the application. (4) Following Board approval, a change of location, shall be reported to the Board within 15 days of the occurrence. (5) No pharmacy shall be operated until a certificate of registration has been issued to the pharmacy by the Board. Statutory/Other Authority: ORS 475.035 & 689.205 History: Renumbered from 855-041-0010, BP 7-2012, f. & cert. ef. 12-17-12 PB 1-1994, f. & cert. ef. 2-2-94 PB 5-1990, f. & cert. ef. 4-12-90 1PB 2-1980, f. & ef. 4-3-80 1PB 2-1979(Temp), f. & ef. 10-3-79
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 required. Statutory/Other Authority: ORS 475.035 & ORS 689.205 Statutes/Other Implemented: ORS 689.205 History: BP 32-2022, amend filed 06/15/2022, effective 06/16/2022 BP 10-2022, temporary amend filed 02/16/2022, effective 02/16/2022 through 06/07/2022 Renumbered from 855-041-0015, BP 7-2012, f. & cert. ef. 12-17-12 PB 1-1994, f. & cert. ef. 2-2-94 1PB 2-1980, f. & ef. 4-3-80 1PB 2-1979(Temp), f. & ef. 10-3-79
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, 689.155, 689.205, 689.305 & 689.315 History: Renumbered from 855-041-0017, BP 7-2012, f. & cert. ef. 12-17-12 PB 1-1992, f. & cert. ef. 1-31-92 (and corrected 2-7-92)
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 Implemented: ORS 689.155 History: BP 42-2024, minor correction filed 04/10/2024, effective 04/10/2024 Renumbered from 855-041-0061, BP 7-2012, f. & cert. ef. 12-17-12 BP 1-2008, f. & cert. ef. 2-5-08 BP 2-2007(Temp), f. & cert. ef. 8-27-07 thru 2-18-08
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 Statutes/Other Implemented: ORS 689.151, 689.155 & 689.508 History: Renumbered from 855-041-0086, BP 7-2012, f. & cert. ef. 12-17-12 BP 2-2008, f. & cert. ef. 2-20-08 1PB 2-1980, f. & ef. 4-3-80 1PB 2-1979(Temp), f. & ef. 10-3-79