justicedao/ipfs_state_laws huggingface dataset:
855-141-0410 Labeling: Limited English Proficiency and Accessibility (1) Upon request of a prescriber, patient or a patient’s agent, each drug dispensed by the PPK for a patient’s self-administration must bear a label in both English and the language requested for an individual 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), the PPK 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 50-2022, adopt filed 12/20/2022, effective 02/15/2023
855-141-0450 Drugs and Devices: Disposal Drugs and devices that are outdated, damaged, deteriorated, misbranded, or adulterated must be quarantined and physically separated from other drugs until they are destroyed or returned to their supplier. Statutory/Other Authority: ORS 475.035, ORS 689.205, ORS 689.305 & ORS 689.315 Statutes/Other Implemented: ORS 689.155 History: BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023
855-141-0455 Drug and Devices: Return A PPK or PPK Affiliated Pharmacy may accept the return of a drug or device as defined by ORS 689.005 once the drug or device have been dispensed from the PPK if they were dispensed in error, were defective, adulterated, misbranded, dispensed beyond their expiration date, or are subject of a drug or device recall only if: (1) A Pharmacist has approved the return; (2) The drugs or devices are accepted for destruction or disposal; and (3) A Pharmacist verifies the destruction or disposal. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.305 History: BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023
855-141-0500 Policies and Procedures (1) The PIC of the PPK Affiliated Pharmacy and the PPK Affiliated Pharmacy drug outlet is accountable for establishing, maintaining, and enforcing written policies and procedures for the PPK. The written policies and procedures must be maintained at the PPK Affiliated 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 PPK Affiliated Pharmacy and each PPK including; (a) Security; (b) Operation, testing and maintenance of the telepharmacy system and the PPK; (c) Sanitation and cleaning; (d) Storage of drugs; (e) Stocking and destocking; (f) Dispensing; (g) Preventing duplicate dispensing; (h) Pharmacist supervision, direction and control of and licensed personnel accessing the PPK; (i) Documenting the identity, function, location, date and time of licensees engaging in telepharmacy and licensed personnel accessing the PPK; (j) Utilization of Interns, Certified Oregon Pharmacy Technicians or Pharmacy Technicians; (k) Utilization of Pharmacist (e.g. Counseling); (l) Drug and/or device procurement (m) Receiving of drugs and/or devices; (n) Delivery of drugs and/or devices; (o) Recordkeeping; (p) Patient confidentiality; (q) On-site inspection by a Pharmacist; (r) Continuous quality improvement; (s) Plan for discontinuing and recovering services if PPK disruption occurs; (t) Training: initial and ongoing; and (u) Interpretation, translation and prescription reader services. (3) A PPK Affiliated Pharmacy that provides prescription and non-prescription drugs, devices, and related supplies through a PPK 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 & ORS 689.527 History: BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023
855-141-0550 Records: General Requirements (1) The recordkeeping requirements OAR 855-141 are in addition to the requirements of other recordkeeping rules of the board. Unless otherwise specified, all records and documentation required by these rules, must be retained for three 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) All required records for the PPK must be maintained by the PPK Affiliated Pharmacy. (3) Records retained by the PPK Affiliated Pharmacy must include, but are not limited to: (a) Date, time and identification of each individual and activity or function performed via the PPK; (b) Pharmacist physical inspection of the PPK; (c) Telepharmacy system testing; (d) Licensee training on the proper use of the PPK; (e) Still image capture and store and forward images must be retained according to (1); (f) Data and surveillance system data must be retained for 6 months; and (g) Any errors or irregularities identified by the quality improvement program. (4) Records of dispensing from a PPK must include the: (a) Physical location of the PPK; (b) Identification of the patient or patient’s agent retrieving the prescription, non-prescription drugs, and supplies; (c) A digital image of the individual to whom the prescription was dispensed. (d) Date and time of transaction; (e) Each prescription number, patient name, prescriber name, drug name, strength, dosage form and quantity; (f) Each non-prescription drug and supply name, UPC or NDC number, and quantity; and (g) Name of Pharmacist or Intern who provided counseling to the patient or patient’s agent, if required, documentation that the counseling was performed or that the Pharmacist or Intern accepted the patient or patient’s agent request not to be counseled. (5) Records of stocking and destocking of prescriptions into or from a PPK must include the: (a) Date and time; (b) Each prescription number, patient name, prescriber name, drug name, strength, dosage form and quantity; (c) Each non-prescription drug and supply name, UPC or NDC number, and quantity; (d) Name and Oregon license number of the person stocking or destocking prescription, non-prescription drugs and supplies from the system; and (e) Identity of the Pharmacist who verifies that the system has been accurately stocked or destocked. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155, ORS 689.508 & ORS 689.527 History: BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023
855-141-0555 Records: Patient A patient record system must be maintained by the PPK Affiliated Pharmacy for all patients for whom a prescription drug is dispensed. The patient record system must provide information necessary for the dispensing Pharmacist to identify previously 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 age or 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 Pharmacist’s reasonable professional judgment: (a) 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 Statutes/Other Implemented: ORS 689.151, ORS 689.155 & ORS 689.508 History: BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023
855-141-0600 Prohibited Practices: General A PPK must not: (1) Allow unlicensed personnel, Certified Oregon Pharmacy Technicians or Pharmacy Technicians to ask questions of a patient or patient's agent which screen and/or limit interaction with the Pharmacist; (2) Utilize a person to dispense or deliver a prescription and non-prescription drug, device, and any related supply directly to the patient from the PPK; (3) Dispense drugs that require further manipulation prior to administration or dispensing (e.g. reconstitution, compounding, vaccines); and (4) Store or dispense controlled substances. Statutory/Other Authority: ORS 475.035, 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
855-141-0602 Prohibited Practices: Disclosure of Patient Information A PPK must not: (1) Allow a licensee or registrant of the board who obtains any patient information to disclose that information to a third party without the consent of the patient except as provided in (a)-(e) of this rule. A licensee can disclose patient information: (a) To the board; (b) To a practitioner, Pharmacist, Intern, Certified Oregon Pharmacy Technician or Pharmacy Technician, if disclosure is authorized by a 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) 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 475.035, 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
855-141-0650 Grounds for Discipline The State Board of Pharmacy may impose one or more of the following penalties which includes: suspend, revoke, or restrict the license of an outlet or may impose a civil penalty upon the outlet upon the following grounds: (1) Any of the grounds listed in ORS 689.405. (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. Statutory/Other Authority: ORS 689.151, ORS 689.155, ORS 689.205 & ORS 689.225 Statutes/Other Implemented: ORS 689.155, ORS 689.405 & ORS 689.527 History: BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023
855-143-0001 Purpose and Scope The purpose of OAR 855-143 is to provide minimum requirements for the operation of a Pharmacy Prescription Locker (PPL) by a PPL Affiliated Pharmacy. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 & ORS 689.527 History: BP 21-2022, adopt filed 04/20/2022, effective 04/20/2022
855-143-0005 Definitions The following words and terms, when used in OAR 855-143, have the following meanings, unless the context clearly indicates otherwise. Any term not defined in this section has the definition set out in OAR 855-006. (1) “Pharmacy Prescription Locker Affiliated Pharmacy” or “PPL Affiliated Pharmacy” means a Retail Drug Outlet Pharmacy registered in Oregon that operates a Pharmacy Prescription Locker. (2) “Pharmacy Prescription Locker” or “PPL” means an Oregon location registered as a Retail Drug Outlet Pharmacy Prescription Locker using a mechanical system that securely stores completed patient-specific prescription and non-prescription drugs, devices, and related supplies for pick up. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 & ORS 689.527 History: BP 21-2022, adopt filed 04/20/2022, effective 04/20/2022
855-143-0010 Registration: General (1) Each PPL located in Oregon must be registered as a Retail Drug Outlet PPL. (2) A controlled substance registration will not be issued for a Retail Drug Outlet PPL. (3) A Retail Drug Outlet PPL application must specify the PPL Affiliated Pharmacy and cannot operate without a PPL 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 855-143-0015(2) and additional information requested by the board. (5) The initial and annual registration fee for pharmacies is set out in OAR 855-110. (6) A Retail Drug Outlet PPL 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. (7) The registration is not transferable. (8) The registration fee cannot be prorated. (9) A PPL may not operate until a certificate of registration has been issued by the board. (10) The PPL Affiliated Pharmacy registration and PPL registration must be on display at both the PPL Affiliated Pharmacy and at the PPL. 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 21-2022, adopt filed 04/20/2022, effective 04/20/2022
855-143-0015 Registration: Application (1) An application for registration of a new PPL must include a floor plan drawn to scale with the location of the: (a) PPL at the facility; (b) Surveillance system cameras; and (c) Alarm system panel. (2) The certificate of registration for a PPL must be issued prior to opening. (3) The application must specify the location of the PPL 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 owners, 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 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. (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. Statutory/Other Authority: ORS 475.035 & ORS 689.205 Statutes/Other Implemented: ORS 689.155, ORS 689.305 & ORS 689.527 History: BP 21-2022, adopt filed 04/20/2022, effective 04/20/2022
855-143-0020 Registration: Change of Owner, Location, or PPL Affiliated Pharmacy (1) A change of location of the PPL Affiliated Pharmacy or location of the PPL requires: (a) Submission of a new PPL application a minimum of 15 days prior to occurrence; (b) Registration fee; (c) Approval of the board; and (d) New certificate of registration. (2) A change in the PPL Affiliated Pharmacy or ownership of the PPL requires: (a) Submission of a new PPL application a minimum of 15 days prior to occurrence; (b) Registration fee; (c) Approval of the board; and (d) New certificate of registration. (3) A change of ownership includes any change in the legal form of the business including additions or deletions of partners. (4) A certificate of registration will be issued upon board approval of the application. (5) A PPL that has changed location or ownership must not operate until the new certificate of registration has been approved and issued. Statutory/Other Authority: ORS 475.035 & ORS 689.205 Statutes/Other Implemented: ORS 689.155, ORS 689.305 & ORS 689.527 History: BP 21-2022, adopt filed 04/20/2022, effective 04/20/2022
855-143-0025 Registration: Closure A PPL Affiliated Pharmacy must notify the board a minimum of 15 days prior to discontinuing operation of a PPL. Notification must include the: (1) Final disposition of drugs stored in the PPL including: (a) Name and location where the drugs are 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 21-2022, adopt filed 04/20/2022, effective 04/20/2022
855-143-0030 Non-Resident PPL Affiliated Pharmacies (1) For the purpose of these rules, a non-resident pharmacy includes a PPL Affiliated Pharmacy located outside of Oregon and providing pharmacy services to a PPL located in Oregon. (2) Each non-resident PPL Affiliated Pharmacy 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 PPL Affiliated Pharmacy must be registered and in good standing with the Board of Pharmacy in the pharmacy's state of residence. (4) The Oregon licensed Pharmacist-in-Charge (PIC) of the non-resident PPL Affiliated Pharmacy is the PIC for each PPL. (5) The PIC is responsible for annually completing a self-inspection using the board's PPL 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 40-2024, minor correction filed 04/10/2024, effective 04/10/2024 BP 12-2023, amend filed 06/13/2023, effective 08/01/2023 BP 21-2022, adopt filed 04/20/2022, effective 04/20/2022
855-143-0050 Personnel (1) A PPL must have an Oregon licensed PIC at all times. (2) Prior to utilizing a PPL, the Oregon licensed Pharmacist, Intern, Certified Oregon Pharmacy Technician and Pharmacy Technician must have completed a training program on the proper use of the PPL. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.151, ORS 689.155 & ORS 689.527 History: BP 21-2022, adopt filed 04/20/2022, effective 04/20/2022
855-143-0100 Security (1) The PPL Affiliated Pharmacy, the PPL, Oregon licensed PIC of the PPL Affiliated Pharmacy and each Oregon licensed Pharmacist supervising the PPL is responsible for the security of the PPL including provisions for adequate safeguards against loss, theft or diversion of prescription and non-prescription drugs, devices, and related supplies, and records for such drugs, devices and related supplies. (2) The PPL Affiliated Pharmacy must ensure the PPL: (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 855-143-0125; (3) The PPL must be secured to prevent access when: (a) There is no Oregon licensed Pharmacist supervising and authorizing access in real-time to the PPL; or (b) There is no Pharmacist, Intern, Certified Oregon Pharmacy Technician or Pharmacy Technician employed by the PPL Affiliated Pharmacy present at the PPL; or (c) Any component of the PPL is not functioning. (4) A record must be maintained with the name and Oregon license number of each person accessing the PPL. (5) An Intern, Certified Oregon Pharmacy Technician, and Pharmacy Technician may only access the PPL when an Oregon licensed Pharmacist is supervising the licensee and has authorized access to the PPL in real-time. (6) Unlicensed personnel (e.g. vendor) may only access the PPL when escorted and continuously observed by a licensee who is authorized by the Oregon licensed Pharmacist who is supervising and authorizing access to the PPL in real-time. (7) Minimum security methods must include a properly functioning: (a) Alarm system at the PPL and real-time notification to an Oregon licensed Pharmacist of the PPL Affiliated Pharmacy if unauthorized access occurs; (b) Electronic entry system that is controlled by an Oregon licensed Pharmacist and records the: (A) Identification of the Oregon licensed Pharmacist authorizing access and securing the PPL; (B) Identification of the Pharmacist, Intern, Certified Oregon Pharmacy Technician or Pharmacy Technician accessing and securing the PPL; and (C) Date and time of each activity; and (c) Surveillance system that utilizes continuously accessible and recorded video between the PPL Affiliated Pharmacy and the PPL. The system must provide a clear view of the entire PPL including its access points. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 & ORS 689.527 History: BP 21-2022, adopt filed 04/20/2022, effective 04/20/2022
855-143-0120 Drug: Procurement A PPL may only receive prescription, non-prescription drugs, devices, and related supplies from the PPL Affiliated Pharmacy. Statutory/Other Authority: ORS 475.035 & ORS 689.205 Statutes/Other Implemented: ORS 689.155 & ORS 689.527 History: BP 21-2022, adopt filed 04/20/2022, effective 04/20/2022