justicedao/ipfs_state_laws huggingface dataset:
855-041-2310 Definitions The following words and terms, when used in OAR 855-041-2300 through 855-041-2320 shall 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 689.155 & ORS 689.681 History: BP 5-2019, minor correction filed 09/16/2019, effective 09/16/2019 BP 5-2017, amend filed 12/22/2017, effective 12/26/2017 BP 2-2014, f. & cert. ef. 1-24-14 BP 6-2013(Temp), f. 9-23-13, cert. ef. 9-24-13 thru 3-23-14
855-041-2320 Epinephrine (1) A pharmacist may fill an order for epinephrine to be used by trainees to treat an anaphylactic reaction. Trainees must be 18 years of age or older and must have responsibility for or contact with at least one (1) other person as a result of the trainee’s occupation or volunteer status, such as, but not limited to, a camp counselor, scout leader, forest ranger, school employee, tour guide or chaperone. (2) Individuals must successfully complete a training program approved by the Oregon Health Authority, Public Health Division. Upon successful completion, the trainee will receive the following certificates: (a) Statement of Completion; and (b) Authorization to Obtain Epinephrine. (3) Acquisition of epinephrine from a pharmacy to be used for the treatment of allergic emergencies may occur in the following manners: (a) A pharmacist may dispense epinephrine to a trainee upon presentation of the Statement of Completion and Authorization to Obtain Epinephrine certificate to a pharmacy when: (A) A pharmacist may generate a prescription for and dispense an emergency supply of epinephrine for not more than one adult and one child dose package, as specified by the supervising professional whose name, signature, and license number appear on the Authorization to Obtain Epinephrine certificate. (B) The pharmacist who generates the hardcopy prescription for epinephrine in this manner shall reduce the prescription to writing and file the prescription in a manner appropriate for a non-controlled substance. (C) Once the pharmacist generates the epinephrine prescription, the pharmacist shall write in the appropriate space provided on the Authorization to Obtain Epinephrine certificate the date and the number of doses dispensed and return the certificate to the trainee. (D) The Statement of Completion and the Authorization to Obtain Epinephrine certificate may be used to obtain epinephrine up to four (4) times within three (3) years from the date of the initial training. (E) Both the Statement of Completion and the Authorization to Obtain Epinephrine certificate expire three (3) years from the date of the trainee’s last Oregon Health Authority approved allergy response training. (F) Upon completion of the training, the trainee will receive a new Statement of Completion and Authorization to Obtain Epinephrine certificate, with a valid duration of three (3) years. (b) A pharmacist may dispense epinephrine to an entity when: (A) The epinephrine is acquired by a valid prescription presented to the pharmacy; (B) The prescription identifies the entity as the patient for the purpose of prescribing and labeling the prescription. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 & ORS 433.825 History: BP 16-2021, amend filed 06/15/2021, effective 06/15/2021 BP 6-2021, temporary amend filed 03/24/2021, effective 03/24/2021 through 09/19/2021 BP 4-2016, f. & cert. ef. 8-26-16 BP 2-2014, f. & cert. ef. 1-24-14 BP 6-2013(Temp), f. 9-23-13, cert. ef. 9-24-13 thru 3-23-14
855-041-3000 Central Fill and Remote Processing Outlet Designations (1) The purpose of OAR 855-041-3005 through 855-041-3045 is to provide minimum requirements of operation for centralized prescription drug filling by a pharmacy. (2) The purpose of OAR 855-041-3100 through 855-041-3130 is to provide minimum requirements of operation for remote prescription processing by a pharmacy. (3) Prior to initiating one of the above drug outlet models, a description of how the model will be utilized must be submitted to the board. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 History: BP 6-2024, amend filed 02/15/2024, effective 02/29/2024 BP 11-2020, minor correction filed 08/06/2020, effective 08/06/2020 BP 10-2013, f. & cert. ef. 11-6-13
855-041-3005 Central Fill - Purpose and Scope The purpose of OAR 855-041-3005 through 855-041-3045 is to provide minimum requirements of operation for centralized prescription drug filling by a pharmacy. Any facility established for the purpose of filling drug orders on behalf of an Oregon pharmacy shall be licensed as a retail or institutional drug outlet. An applicant must submit its policies and procedures to the Board of Pharmacy. An applicant must submit to the Board for approval policies and procedures and a description of how using central fill will improve patient safety and redirect a pharmacist at a primary pharmacy from a distributive task to a cognitive task. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 History: BP 66-2020, minor correction filed 08/06/2020, effective 08/06/2020 BP 10-2013, f. & cert. ef. 11-6-13
855-041-3010 Central Fill - Definitions The following words and terms, when used in OAR 855-041-3005 through 855-041-3045 shall have the following meanings, unless the context clearly indicates otherwise. Any term not defined in this section shall have the definition set out in the OAR chapter 855, division 006. (1) “Central Fill Pharmacy” means an Oregon licensed pharmacy that provides centralized prescription filling for both initial or prescription refills on behalf of a primary pharmacy. (2) “Primary Pharmacy” means a pharmacy located and licensed in Oregon that receives a patient’s or a prescribing practitioner’s request to fill a prescription, dispenses the prescription directly to the patient or patient’s agent, or the pharmacy delivers the drug to the patient’s agent for administration. The primary pharmacy maintains ownership of the prescription. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 History: BP 68-2020, minor correction filed 08/06/2020, effective 08/06/2020 BP 10-2013, f. & cert. ef. 11-6-13
855-041-3015 Central Fill - General Requirements An Oregon licensed pharmacy may outsource prescription drug filling to a central fill pharmacy provided that both pharmacies: (1) Have the same owner; or (2) Have a written shared pharmacy services contract or agreement that specifies: (a) The services to be provided by each pharmacy; (b) The responsibilities of each pharmacy; and (c) The accountabilities of each pharmacy. (3) Maintain a separate Oregon pharmacy license for each location involved in providing prescription drugs and services to Oregon patients; (4) Share a common electronic file or have appropriate technology or interface to allow access to information required to fill a prescription drug order; (5) Establish, maintain and enforce a policy and procedures manual as required by OAR 855-041-3020; (6) Ensure that each prescription has been properly processed and filled and that counseling has been provided to the patient; (7) Designate a pharmacist-in-charge. To qualify for this designation, the person must hold a license to practice pharmacy in the state of Oregon and in the state in which the pharmacy is located if the pharmacy is out-of-state. The pharmacist-in-charge must be in good standing with both licensing boards; (8) Conduct an annual review of the written policies and procedures and document such review; (9) Comply with all applicable federal and state laws and rules; (10) Direct all patient communication to the primary pharmacy. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 History: BP 70-2020, minor correction filed 08/06/2020, effective 08/06/2020 BP 10-2013, f. & cert. ef. 11-6-13
855-041-3020 Central Fill - Policies and Procedures (1) In addition to the requirements of OAR 855-041-1040, the central fill pharmacy and the primary pharmacy is each accountable for establishing, maintaining, and enforcing its written policies and procedures manual. The policies and procedures manual must include, but need not be limited to the following: (a) The responsibilities of each pharmacy; (b) The policies and procedures that protect confidentiality and ensure integrity of patient information; (c) Compliance with all applicable federal and state laws and rules; (d) Cancelation of a filled prescription after the prescription is filled by the primary pharmacy; (e) Records sufficient to identify by name, initials or unique identification code, the identify and specific activities of each pharmacist or technician who performed any centralized filling function, and the pharmacy where each activity was performed; (f) The mechanism for tracking the prescription drug order during each step in the filling and dispensing process; (g) Pharmacist completion of a Drug Utilization Review (DUR) on each prescription; (h) A continuous quality improvement program for pharmacy services designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, to pursue opportunities, to improve patient care, and to resolve identified problems; (i) Documentation of any errors or irregularities identified by the quality improvement program; (2) This manual shall be maintained at both the central fill and primary pharmacy and must be made available to the Board upon request. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 History: BP 71-2020, minor correction filed 08/06/2020, effective 08/06/2020 BP 10-2013, f. & cert. ef. 11-6-13
855-041-3025 Central Fill - Labeling (1) The label affixed to the prescription container filled by a central fill pharmacy on behalf of the primary pharmacy shall: (a) Include all information required by OAR 855-041-1130 and OAR 855-041-1140; (b) Comply with all labeling requirements identifying only the primary pharmacy. (2) If the Central Pharmacy dispenses the completed prescription to the patient, the label must also comply with retail labeling requirements in OAR 855-041-1130 through 855-041-1140. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 History: BP 73-2020, minor correction filed 08/06/2020, effective 08/06/2020 BP 10-2013, f. & cert. ef. 11-6-13
855-041-3030 Central Fill - Records (1) The recordkeeping requirements in OAR 855-041-3005 through 855-041-3045 are in addition to the requirements of other recordkeeping rules of the Board. (2) Each recordkeeping system must include quality improvement program documentation. (3) Unless otherwise specified, all records and documentation required by OAR 855-041-3005 through 855-041-3045 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 kept in hard copy, electronic copy, or a combination of the two. (4) Each pharmacy must be able to produce an audit trail which identifies each prescription process in their pharmacy. (5) The primary pharmacy shall maintain the original prescription for a period of three years from the date the prescription was filled. (6) The primary pharmacy must maintain records that: (a) Identify by prescription or drug order, the name or unique identification code of the pharmacist who performed the drug utilization review. Identify by prescription drug order the pharmacist or technician that transmitted the prescription drug order to the central fill pharmacy. These records may be maintained separately by each pharmacy and pharmacist or technician or in a common electronic file, as long as the data processing system is capable of producing a printout that lists each function performed by each pharmacy and pharmacist or technician, and identifies the pharmacist or technician who performed each function; (b) Document the date the filled prescription was received from the central fill pharmacy and the name of the person accepting delivery. (7) The central fill pharmacy must maintain records that: (a) List the name, address, telephone numbers, and all license and registration numbers of the pharmacies involved in centralized prescription filling; and (A) Document verification of each license and registration; and (B) Document the name of the individual responsible for verification of licensure and registration status. (b) Track the prescription drug order during each step in the filling process and identify the name, initials, or unique identification code and specific activity of each pharmacist or pharmacy technician who performed any portion of the process including transmission, filling, dispensing and delivery of information. (A) The date the prescription was received by the central fill pharmacy; (B) The name and address where the filled prescription was shipped; (C) The method of delivery (e.g., private, common, or contract carrier). Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 History: BP 74-2020, minor correction filed 08/06/2020, effective 08/06/2020 BP 10-2013, f. & cert. ef. 11-6-13
855-041-3035 Central Fill - Delivery of Medications (1) A central fill pharmacy may deliver or mail medications to the primary pharmacy or patient in compliance with OAR 855-041-1050. (2) A central fill pharmacy must comply with all federal and state requirements when using private, common or contract carriers to transport filled prescriptions for delivery. When a central fill pharmacy contracts with private, common or contract carriers to transport filled prescriptions the central fill pharmacy is responsible for reporting any in-transit loss upon detection by use of DEA Form 106. (3) A central fill pharmacy must maintain and use adequate storage or shipment containers and shipping processes to ensure drug stability and potency. Such shipping processes shall include the use of packaging material and devices to ensure that the drug is maintained at the temperature range required to maintain the integrity of the medication throughout the delivery process. (4) Filled prescriptions must be shipped in containers that are sealed in a manner that shows evidence of opening or tampering. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 History: BP 76-2020, minor correction filed 08/06/2020, effective 08/06/2020 BP 10-2013, f. & cert. ef. 11-6-13
855-041-3040 Central Fill - Filled Prescriptions (1) Any filled prescription that has not been picked up, may be put into the primary pharmacy’s inventory. Each pharmacy is responsible for documenting any such transfer of a drug. (2) A prescription for a controlled substance may be filled by a central fill pharmacy when permitted by law, consistent with federal requirements set forth at 21 C.F.R. § 1300 et seq; (3) The pharmacy that fills the prescription and the pharmacy to which the filled prescription is provided for dispensing to the patient shall each be responsible for ensuring the prescription has been properly filled. (4) A primary pharmacy will notify the patient of the possible use of a central fill pharmacy. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 History: BP 78-2020, minor correction filed 08/06/2020, effective 08/06/2020 BP 10-2013, f. & cert. ef. 11-6-13
855-041-3045 Central Fill - Prohibited Practices (1) A primary pharmacy may not use the services of a central fill pharmacy that is not registered with the Board. (2) A central fill pharmacy may not fill a prescription on behalf of a primary pharmacy that is not registered with the Board if the laws and rules of Oregon require the primary pharmacy to be registered with the Board. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 History: BP 80-2020, minor correction filed 08/06/2020, effective 08/06/2020 BP 10-2013, f. & cert. ef. 11-6-13
855-041-3100 Remote Processing - Purpose and Scope The purpose of OAR 855-041-3100 through 855-041-3130 is to provide minimum requirements of operation for remote prescription drug processing by a pharmacy. Any facility that processes drug orders on behalf of an Oregon pharmacy shall be licensed in Oregon as a retail or institutional drug outlet. An applicant must submit its policies and procedures to the Board of Pharmacy. An applicant must submit to the Board for approval policies and procedures and a description of how using remote processing will improve patient safety. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 History: BP 81-2020, minor correction filed 08/06/2020, effective 08/06/2020 BP 10-2013, f. & cert. ef. 11-6-13
855-041-3105 Remote Processing - Definitions The following words and terms, when used in OAR 855-041-3100 through 855-041-3130, shall have the following meanings, unless the context clearly indicates otherwise. Any term not defined in this section shall have the definition set out in OAR chapter 855, division 006. (1) “Remote Processing Pharmacy” means an Oregon licensed pharmacy operated under the direction of a pharmacist-in-charge that processes information related to the practice of pharmacy and engages in remote prescription processing, including central processing. (2) “Remote Processing Functions” may include, but are not limited to, data entry, prospective drug utilization reviews, refill authorizations and interventions. This does not include the filling process. (3) “Primary Pharmacy” means an instate Oregon licensed pharmacy that receives a patient’s or a prescribing practitioner’s request to fill a prescription or drug order and delivers the drug or device directly to the patient or patient’s agent, and maintains ownership of the prescription or drug order. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 History: BP 83-2020, minor correction filed 08/06/2020, effective 08/06/2020 BP 10-2013, f. & cert. ef. 11-6-13
855-041-3110 Remote Processing - General Requirements An Oregon licensed pharmacy may outsource prescription drug processing to a remote processing pharmacy provided both pharmacies: (1) Have the same owner; or (2) Have a written shared pharmacy services contract or agreement that specifies: (a) The services to be provided by each pharmacy; (b) The responsibilities of each pharmacy; and (c) The accountabilities of each pharmacy. (3) Maintain a separate Oregon pharmacy license for each location involved in providing services; (4) Share a common electronic file or have appropriate technology or interface to allow access to information required to process and fill a prescription drug order; (5) Establish, maintain and enforce a policy and procedures manual as required by OAR 855-041-3115; (6) Ensure that each prescription has been properly processed, filled and counseling has been provided to the patient; (7) Designate a pharmacist-in-charge. To qualify for this designation, the person must hold a license to practice pharmacy in the state of Oregon and in the pharmacy’s resident state if the pharmacy is out-of-state. The pharmacist-in-charge must be in good standing with both licensing Boards; (8) Allow prospective drug utilization reviews, refill authorizations, interventions, and patient counseling for an Oregon patient must be performed only by a licensed pharmacist in Oregon or in the state in which the pharmacy is located; (9) Ensure that each technician processing an order for an Oregon patient is a Certified Oregon Pharmacy Technician and is supervised by a licensed pharmacist or is a licensed technician in the state in which the pharmacy is located and is supervised by a licensed pharmacist in the state in which the pharmacy is located; (10) Comply with all applicable federal and state laws and rules; (11) Conduct an annual review of the written policies and procedures and document such review. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 History: BP 84-2020, minor correction filed 08/06/2020, effective 08/06/2020 BP 10-2013, f. & cert. ef. 11-6-13
855-041-3115 Remote Processing - Policies and Procedures (1) In addition to the requirements of OAR 855-041-1040, the primary and the remote processing pharmacy is each accountable for establishing, maintaining, and enforcing its own written policies and procedures manual. The policies and procedures manual must include, but need not be limited to the following: (a) The responsibilities of each pharmacy; (b) The policies and procedures that protect confidentiality and ensure the integrity of patient information; (c) Compliance with all applicable federal and state laws and rules; (d) Records sufficient to identify by name, initials, or unique identification code, the identity and the specific activities of each pharmacist or technician who performed any processing function, and the location where each activity was performed; (e) A continuous quality improvement program for pharmacy services designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, to pursue opportunities to improve patient care, and to resolve identified problems; and (f) Documentation of any errors or irregularities identified by the quality improvement program. (2) The written policies and procedures manual shall be maintained at all pharmacies involved in remote processing and must be available to the Board upon request. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 History: BP 82-2020, minor correction filed 08/06/2020, effective 08/06/2020 BP 10-2013, f. & cert. ef. 11-6-13