justicedao/ipfs_state_laws huggingface dataset:
855-139-0550 Records: General Requirements (1) The recordkeeping requirements OAR 855-139 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 years and made available to the board for inspection upon request. Records must be stored onsite for at least one year and may be stored, after one year, in a secured off-site location if retrievable within three business days. Records and documentation may be written, electronic or a combination of the two. (2) The RDSP must maintain all required records unless these records are maintained in the RDSP Affiliated Pharmacy. (3) Records retained by the Drug Outlet must include, but are not limited to: (a) Patient profiles and records; (b) Date, time and identification of each individual and activity or function performed; (c) If filling prescriptions, date, time and identification of the licensee and the specific activity or function of the person performing each step in the dispensing process; (d) Controlled substance inventory and reconciliation; (e) Oregon licensed Pharmacist physical inspection of RDSP; (f) Audiovisual communication system testing and individual training on use of the audiovisual communication system; (g) Still image capture and store and forward images must be retained according to (1); (h) Data, telephone audio and surveillance system data must be retained for 6 months; and (i) Any errors or irregularities identified by the quality improvement program. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 & ORS 689.508 History: BP 17-2022, amend filed 04/20/2022, effective 04/20/2022 BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022
855-139-0555 Records: Patient A patient record system must be maintained by pharmacies for all patients for whom a prescription drug is dispensed. The patient record system must provide information necessary for the dispensing Oregon licensed Pharmacist to identify previously dispensed drugs at the time a prescription is presented for dispensing. The Pharmacist must make a reasonable effort to obtain, record, and maintain the following information: (1) Full name of the patient for whom the drug is intended; (2) Address and telephone number of the patient; (3) Patient's date of birth; (4) Patient's gender; (5) Patient’s preferred language for communication and prescription labeling; (6) Chronic medical conditions; (7) A list of all prescription drug orders obtained by the patient at the pharmacy maintaining the patient record showing the name of the drug or device, prescription number, name and strength of the drug, the quantity and date received, and the name of the prescriber; (8) Known allergies, drug reactions, and drug idiosyncrasies; and (9) If deemed relevant in the Oregon licensed Pharmacist's reasonable professional judgment: (a) Oregon licensed Pharmacist comments relevant to the individual's drug therapy, including any other information peculiar to the specific patient or drug; and (b) Additional information such as chronic conditions or disease states of the patient, the patient's current weight, and the identity of any other drugs, including over-the-counter drugs, or devices currently being used by the patient which may relate to prospective drug review. Statutory/Other Authority: ORS 689.205 & 2021 HB 2359 Statutes/Other Implemented: ORS 689.151, ORS 689.155, ORS 689.508 & 2021 HB 2359 History: BP 29-2022, amend filed 06/15/2022, effective 09/01/2022 BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022
855-139-0560 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 information about the individual, except as provided by law and this rule. The patient may request all or part of the record. A summary may substitute for the actual record only if the patient agrees to the substitution. Board licensees and registrants are encouraged to use the written authorization form provided by ORS 192.566. (2) For the purpose of this rule, “health information in the pharmacy record” means any oral, written or electronic information in any form or medium that is created or received and relates to: (a) The past, present, or future physical or mental health of the patient. (b) The provision of healthcare to the patient. (c) The past, present, or future payment for the provision of healthcare to the patient. (3) Upon request, the entire health information record in the possession of the board licensee will be provided to the patient. This includes records from other healthcare providers. Information which may be withheld includes: (a) Information which was obtained from someone other than a healthcare provider under a promise of confidentiality and access to the information would likely reveal the source of the information; (b) Psychotherapy notes; (c) Information compiled in reasonable anticipation of, or for use in, a civil, criminal, or administrative action or proceeding; and (d) Other reasons specified by federal regulation. (4) Registrants who have permanently closed must notify patients according to OAR 855-139-0145. (5) A reasonable cost may be imposed for the costs incurred in complying with the patient’s request for health information pursuant to ORS 192.563. (6) A patient may not be denied summaries or copies of pharmacy records because of inability to pay. (7) Requests for pharmacy records must be complied with within a reasonable amount of time not to exceed 30 days from the receipt of the request. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 192.553, ORS 192.556, ORS 192.558, ORS 192.563, ORS 192.566 & ORS 689.155 History: BP 47-2022, minor correction filed 11/17/2022, effective 11/17/2022 BP 32-2022, adopt filed 06/15/2022, effective 06/16/2022
855-139-0600 Prohibited Practices: General A Retail Drug Outlet RDSP must not: (1) Allow a Certified Oregon Pharmacy Technician or Pharmacy Technician to: (a) Refuse a request from a patient, patient’s agent, or practitioner to interact with a Pharmacist; and (b) Administer a vaccine. (2) 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; (3) Compound sterile preparations; or (4) Repackage drugs. Statutory/Other Authority: ORS 475.035, ORS 689.205, ORS 689.305 & ORS 689.700 Statutes/Other Implemented: ORS 689.315, ORS 689.155, ORS 689.700 & 2023 HB 2486 History: BP 28-2023, amend filed 12/19/2023, effective 01/01/2024 BP 54-2022, amend filed 12/20/2022, effective 12/21/2022 BP 38-2022, temporary amend filed 06/22/2022, effective 07/01/2022 through 12/27/2022 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
855-139-0602 Prohibited Practices: Disclosure of Patient Information A Retail Drug Outlet RDSP 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 provided in (2) of this rule. (2) 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 well-being; 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. (3) 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. 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
855-139-0650 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) Unprofessional conduct as defined in OAR 855-006-0020; (2) Advertising or soliciting that may jeopardize the health, safety, or welfare of the patient including, but not be limited to, advertising or soliciting that: (a) Is false, fraudulent, deceptive, or misleading; or (b) Makes any claim regarding a professional service or product or the cost or price thereof which cannot be substantiated by the licensee. (3) Failure to provide a working environment that protects the health, safety and welfare of a patient which includes but is not limited to: (a) Sufficient personnel to prevent fatigue, distraction or other conditions that interfere with an Oregon licensed Pharmacist’s ability to practice with reasonable competency and safety. (b) Appropriate opportunities for uninterrupted rest periods and meal breaks. (c) Adequate time for an Oregon licensed Pharmacist to complete professional duties and responsibilities including, but not limited to: (A) Drug Utilization Review; (B) Verification of the accuracy of a prescription; (C) Counseling; and (D) All other duties and responsibilities of an Oregon licensed Pharmacist as specified in OAR 855-115. (4) Introducing external factors such as productivity or production quotas or other programs to the extent that they interfere with the ability to provide appropriate professional services to the public. (5) Incenting or inducing the transfer of a prescription absent professional rationale. Statutory/Other Authority: ORS 689.151, ORS 689.155, ORS 689.205 & ORS 689.225 Statutes/Other Implemented: ORS 689.155 History: BP 34-2024, minor correction filed 04/10/2024, effective 04/10/2024 BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022
855-139-0710 Service: Epinephrine- Definitions The following words and terms, when used in OAR 855-139-0710 through OAR 855-139-0715 have the following meanings, unless the context clearly indicates otherwise. (1) “Allergic reaction” means a medical condition caused by exposure to an allergen, with physical symptoms that may be life threatening, ranging from localized itching to severe anaphylactic shock and death. (2) “Authorization to Obtain Epinephrine” means a certificate that contains the name, signature, and license number of the supervising professional authorizing the dispensing of epinephrine to the individual whose name appears on the certificate. Additionally, the certificate contains a record of the number of epinephrine orders filled to date. (3) “Statement of Completion” means a certificate that states the specific type of emergency the trainee was trained to respond to, the trainee’s name and address, the name of the authorized trainer and the date that the training was completed. (4) “Trainee” means an individual who has attended and successfully completed the formal training pursuant to the protocols and criteria established by the Oregon Health Authority, Public Health Division. Statutory/Other Authority: ORS 689.205 & ORS 689.681 Statutes/Other Implemented: ORS 689.681 & ORS 689.155 History: BP 5-2022, minor correction filed 01/03/2022, effective 01/03/2022 BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022
855-139-0725 Service: Expedited Partner Therapy (EPT)- Purpose (1) There is substantial evidence that rates of re-infection with certain sexually transmitted diseases can be reduced by treating all sexual partners for the disease, even when the treating clinician has not examined those partners. This practice is known as Expedited Partner Therapy. (2) Because of the important public health implications, the 2009 Oregon Legislature passed HB 3022 authorizing this practice. This law permits health professional regulatory boards to adopt rules permitting practitioners to practice Expedited Partner Therapy. (3) The law specifies that a prescription issued in the practice of Expedited Partner Therapy is valid, even if the name of the patient the prescription is intended for is not on the prescription. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.505 History: BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022
855-141-0001 Purpose and Scope The purpose of OAR 855-141 is to provide minimum requirements for the operation of a Pharmacy Prescription Kiosk (PPK) by a PPK Affiliated Pharmacy. 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
855-141-0005 Definitions (1) “Pharmacy Prescription Kiosk Affiliated Pharmacy” or “PPK Affiliated Pharmacy” means a Retail Drug Outlet Pharmacy registered in Oregon that operates a Pharmacy Prescription Kiosk. (2) “Pharmacy Prescription Kiosk” or “PPK” means an Oregon location registered as a Retail Drug Outlet Pharmacy Prescription Kiosk using a mechanical system that stores and dispenses patient-specific prescription and non-prescription drugs, devices, and related supplies. (3) “Telepharmacy system” means a system of telecommunications technologies that enables documenting and recording of the delivery of pharmacy services at a remote location by an electronic method. 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
855-141-0010 Registration: General (1) Each PPK located in Oregon must be registered as a Retail Drug Outlet PPK. (2) A controlled substance registration will not be issued for a Retail Drug Outlet PPK. (3) A Retail Drug Outlet PPK application must specify the PPK Affiliated Pharmacy and cannot operate without a PPK Affiliated Pharmacy that is registered by the board as a Retail Drug Outlet Pharmacy. (4) Each registration renewal application must be accompanied by the annual fee and must contain the same information required in OAR 855-141-0015(2) and additional information requested by the board. (5) The initial and annual registration fee for a PPK is set out in OAR 855-110. (6) A Retail Drug Outlet PPK registration expires March 31, annually. If the annual registration fee 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. (7) The registration is not transferable. (8) The registration fee cannot be prorated. (9) A PPK must not operate until a certificate of registration has been issued by the board. (10) The PPK Affiliated Pharmacy registration and the PPK registration must be on display at both the PPK Affiliated Pharmacy and at the PPK. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.151, ORS 689.155, ORS 689.225, ORS 689.305 & ORS 689.527 History: BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023
855-141-0015 Registration: Application (1) An application for registration of a PPK may be accessed on the board website. (2) The board may issue a license to a qualified applicant after the receipt of: (a) A completed application including; (A) Payment of the fee prescribed in OAR 855-110; (B) A floor plan drawn to scale with the location of the: (i) PPK within the building; (ii) Surveillance system cameras; and (iii) Alarm system panel; and (C) A detailed explanation and supporting documentation relating to the PPK Affiliated Pharmacy regarding all conduct that is required to be disclosed; (b) The PPK Affiliated Pharmacy name, Retail Drug Outlet registration number and Pharmacist-in-Charge; and (c) 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 owners, the names of the partners or persons holding the five largest interests must be indicated on the application; and (B) If the owner is a corporation, the name filed must be the same as filed with the Secretary of State. The name of the corporation, the names of the corporation officers and the names of the stockholders, if applicable, who own the five largest interests must be indicated on the application. (3) 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. (4) A registration may be denied for any of the following: (a) Failure to completely and accurately answer all questions on the application for registration or renewal of registration; (b) Failure to disclose any requested information on the application or requests resulting from the application; or (c) Any other grounds found in ORS 689.405. (5) An application submitted to the board that is not complete within 90 days from applicant submission will be expired. Once expired, an applicant who wishes to continue with the application process must reapply by submitting a new application, along with all documentation, and all fees. While a new application and documentation is required, the board may still consider information that was provided in previous applications. (6) The certificate of registration for a PPK must be issued prior to opening. (7) The registration for a PPK expires March 31 in each year and may be renewed annually. Statutory/Other Authority: ORS 475.035 & 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
855-141-0020 Registration: Change of Physical Address or Location (1) A change of physical address of the PPK requires: (a) Submission of a new PPK application a minimum of 15 days prior to occurrence; (b) Registration fee; (c) Approval of the board; and (d) Issuance of a new certificate of registration. (2) A change of location at the same physical address of the PPK requires the submission of an updated floor plan drawn to scale a minimum of 15 days prior to the change with the new location of the: (a) PPK within the building; (b) Surveillance system cameras; and (c) Alarm system panel. Statutory/Other Authority: ORS 475.035 & 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
855-141-0030 Non-Resident PPK Affiliated Pharmacies (1) For the purpose of these rules, a non-resident pharmacy includes a PPK Affiliated Pharmacy located outside of Oregon and providing pharmacy services under OAR 855-141 with a PPK located in Oregon. (2) Each non-resident PPK Affiliated Pharmacy must be registered with the Oregon Board of Pharmacy as a Retail Drug Outlet Pharmacy. (3) To qualify for registration under these rules, every non-resident PPK Affiliated Pharmacy must be registered and in good standing with the Board of Pharmacy in the pharmacy's state of residence. (4) The Pharmacist-in-Charge (PIC) of the non-resident PPK Affiliated Pharmacy is the PIC for each PPK. (5) The PIC is responsible for annually completing a self-inspection using the board's PPK Self-Inspection Form prior to July 1. (6) The PIC must comply with the requirements of OAR 855-115-0210. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.151, ORS 689.155, ORS 689.225 & ORS 689.527 History: BP 35-2024, minor correction filed 04/10/2024, effective 04/10/2024 BP 12-2023, amend filed 06/13/2023, effective 08/01/2023 BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023
855-141-0050 Personnel (1) A PPK must have a PIC at all times. (2) Prior to utilizing a PPK, a Pharmacist, Intern, Certified Oregon Pharmacy Technician and Pharmacy Technician must have completed a training program on the proper use of the PPK. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.151, ORS 689.155 & ORS 689.527 History: BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023
855-141-0100 Security (1) The PPK Affiliated Pharmacy, the PPK, PIC of the PPK Affiliated Pharmacy and each Pharmacist supervising the PPK is responsible for the security of the PPK including provisions for adequate safeguards against loss, theft or diversion of prescription and non-prescription drugs, devices, and related supplies, and records for such drugs, devices and related supplies. (2) The PPK Affiliated Pharmacy must ensure the PPK: (a) Is placed in a secure indoor location that is climate controlled and protected from the elements; (b) Is securely fastened to a permanent structure so that it cannot be removed; (c) Stores prescription and non-prescription drugs, devices, and related supplies in compliance with the provisions of OAR 855-141-0125; (3) The PPK must be secured to prevent access when: (a) There is no Pharmacist supervising and authorizing access in real-time to the PPK; or (b) There is no Pharmacist, Intern, Certified Oregon Pharmacy Technician or Pharmacy Technician employed by the PPK Affiliated Pharmacy present at the PPK; or (c) Any component of the PPK is not functioning. (4) A record must be maintained with the name and Oregon license number of each person accessing the PPK. (5) An Intern, Certified Oregon Pharmacy Technician, and Pharmacy Technician must only access the PPK when a Pharmacist is supervising the licensee and has authorized access to the PPK in real-time. (6) Unlicensed personnel (e.g. service or repair personnel) must only access the PPK when escorted and continuously observed by a licensee who is authorized by the Pharmacist who is supervising and authorizing access to the PPK in real-time. (7) Minimum security methods must include a properly functioning: (a) Alarm system at the PPK and real-time notification to a Pharmacist from the PPK Affiliated Pharmacy if unauthorized access occurs; (b) Electronic entry system that is controlled by a Pharmacist and records the: (A) Identification of the Pharmacist authorizing each access and securing the PPK; (B) Identification of the Pharmacist, Intern, Certified Oregon Pharmacy Technician or Pharmacy Technician accessing and securing the PPK; and (C) Date and time of each activity; and (c) Surveillance system that utilizes continuously accessible and recorded video between the PPK Affiliated Pharmacy and the PPK. The system must provide a clear view of the entire PPK including its access points. 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
855-141-0120 Drug: Procurement A PPK must only receive prescription and non-prescription drugs, devices, and related supplies from the PPK Affiliated Pharmacy. Statutory/Other Authority: ORS 475.035 & ORS 689.205 Statutes/Other Implemented: ORS 689.155 & ORS 6879.527 History: BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023