justicedao/ipfs_state_laws huggingface dataset:
855-143-0125 Drug: Storage (1) A PPL must maintain proper storage of all drugs. This includes, but is not limited to the following: (a) All drugs must be stored according to manufacturer’s published or USP guidelines. (b) All drugs must be stored in appropriate conditions of temperature, light, humidity, sanitation, ventilation, and space. (c) Appropriate storage conditions must be provided for, including during transfers between facilities and to patients. (d) A PPL must quarantine drugs which are outdated, adulterated, misbranded or suspect. (2) A PPL must store all drugs at the proper temperature according to manufacturer’s published guidelines (pursuant to FDA package insert or USP guidelines). (a) All drug refrigeration systems must: (A) Maintain refrigerated products between 2 to 8 °C (35.6 to 46.4°F); frozen products between -25 to -10 °C (-13 to 14 °F); or as specified by the manufacturer. (B) Utilize a centrally placed, accurate, and calibrated thermometer; (C) Be dedicated to pharmaceuticals only; (D) Be measured continuously and documented either manually twice daily to include minimum, maximum and current temperatures; or with an automated system capable of creating a producible history of temperature readings. (b) A PPL must adhere to a monitoring plan, which includes, but is not limited to: (A) Documentation of training of all personnel; (B) Maintenance of manufacturer recommended calibration of thermometers; (C) Maintenance of records of temperature logs for a minimum of three years; (D) Documentation of excursion detail, including, but not limited to, event date and name of persons(s) involved in excursion responses; (E) Documentation of action(s) taken, including decision to quarantine product for destruction, or determination by an Oregon licensed Pharmacist that it is safe for continued use. This documentation must include details of the information source; (F) A written emergency action plan; (G) Routine preventative maintenance and evaluation of refrigeration equipment and monitoring equipment; and (H) Documentation and review of temperature recordings at least once every 28 days by the Oregon licensed Pharmacist at the time of in person physical inspection. Statutory/Other Authority: ORS 689.205 & ORS 689.325 Statutes/Other Implemented: ORS 689.155 & ORS 689.527 History: BP 21-2022, adopt filed 04/20/2022, effective 04/20/2022
855-143-0130 Drug: Loss A PPL and its PPL Affiliated Pharmacy must: (1) Ensure that disasters, accidents and emergencies which may affect the strength, purity, or labeling of drugs or devices are reported to the board immediately. (2) Ensure that confirmed significant drug loss or any loss related to suspected drug theft is reported to the board within one business day. Statutory/Other Authority: ORS 689.205, ORS 689.305 & ORS 689.315 Statutes/Other Implemented: ORS 689.155 & ORS 689.527 History: BP 21-2022, adopt filed 04/20/2022, effective 04/20/2022
855-143-0150 Outlet: Sanitation A PPL and its PPL Affiliated Pharmacy must ensure the PPL is kept clean. Statutory/Other Authority: ORS 689.305 Statutes/Other Implemented: ORS 689.305 & ORS 689.527 History: BP 21-2022, adopt filed 04/20/2022, effective 04/20/2022
855-143-0155 Outlet: Minimum Equipment Requirements (1) Each Oregon PPL must have the following: (a) Appropriate equipment and supplies as required by Oregon Revised Statutes, Oregon Administrative Rules, United States Code, Code of Federal Regulations, and standards adopted by reference (e.g. USP) based on services offered by the PPL outlet; (b) Appropriate equipment to maintain the proper storage of drugs; (c) Signage in a location easily seen by the public at the PPL where prescription and non-prescription drugs, devices, and related supplies are dispensed: (A) Stating “The (insert name of PPL Affiliated Pharmacy) may be able to substitute a less expensive drug which is therapeutically equivalent to the one prescribed by your doctor unless you do not approve.” The printing on this sign must be in block letters not less than one inch in height. (B) Providing notification in each of the languages required in OAR 855-143-0410 of the right to free, competent oral interpretation and translation services, including translated prescription labels, for patients who are of limited English proficiency, in compliance with federal and state regulations if the pharmacy dispenses prescriptions for a patient's self-administration; (C) Stating "This location is a Pharmacy Prescription Locker, supervised by an Oregon licensed Pharmacist from (insert name of PPL Affiliated Pharmacy, address, and telephone number)." The printing on the sign must be in block letters not less than one inch in height; and (D) Providing notification of accurate hours of operation at the PPL; and (d) Additional equipment and supplies that are determined as necessary by the PPL Affiliated Pharmacy or PIC. (e) As an alternative to posting the required signage, PPL’s that utilize an electronic video monitor that the patient is required to acknowledge prior to retrieving medication from the PPL may display the information required by sub-paragraphs (1)(c)(A) – (D) electronically. (2) Failure to have, use and maintain required equipment constitutes unprofessional conduct under ORS 689.405(1)(a). Statutory/Other Authority: ORS 689.205 & ORS 689.654 Statutes/Other Implemented: ORS 689.155, ORS 689.515, ORS 689.527 & ORS 689.654 History: BP 30-2022, amend filed 06/15/2022, effective 06/16/2022 BP 21-2022, adopt filed 04/20/2022, effective 04/20/2022
855-143-0200 Outlet: General Requirements (1) The PPL Affiliated Pharmacy and its PIC are responsible for all operations and enforcing all policies and procedures of the PPL. (2) A PPL Affiliated Pharmacy may operate more than one PPL. (3) A PPL Affiliated Pharmacy must be less than 120 miles apart via the shortest surface street route from the PPL. (4) A PPL and its PPL Affiliated Pharmacy must: (a) Have the same owner; or (b) Have a written contract that specifies: (A) The services to be provided by each licensee and registrant; (B) The responsibilities of each licensee and registrant; and (C) The accountabilities of each licensee and registrant; (c) Ensure each prescription and non-prescription drugs, devices, and related supplies are dispensed in compliance with OAR 855-041, OAR 855-115, OAR 855-120, OAR 855-125 and OAR 855-143; (d) Ensure that the PPL Affiliated Pharmacy prevents duplicate dispensing of a prescription; (e) Comply with all applicable federal and state laws and rules; (f) Ensure that PPL Affiliated Pharmacy has received and documented consent by the patient or patient's agent for the patient’s prescription and non-prescription drugs, devices, and related supplies to be placed in the PPL; (g) Ensure that there is an Oregon licensed PIC who is responsible for all operations and enforcing all policies and procedures of the PPL; (h) Designate in writing the Oregon licensed Pharmacists, Interns, Pharmacy Technicians and Certified Oregon Pharmacy Technicians authorized to access the PPL; (i) Utilize complete chain of custody tracking; (j) Train the Oregon licensed Pharmacists, Interns, Pharmacy Technicians and Certified Oregon Pharmacy Technicians in the operation of the PPL and document the training; (k) Develop, implement and enforce a continuous quality improvement program for dispensing services from a PPL 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; (l) Provide a telephone number that a patient, patient’s agent or prescriber may use to contact the Oregon licensed Pharmacist from the PPL Affiliated Pharmacy; and (m) Develop, implement and enforce a process for an in person physical inspection of the PPL by an Oregon licensed Pharmacist at least once every 28 days or more frequently as deemed necessary by the Oregon licensed PIC of the PPL Affiliated Pharmacy. The inspection must utilize the PPL self-inspection form, be documented, and records retained. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 & ORS 689.527 History: BP 38-2024, minor correction filed 04/10/2024, effective 04/10/2024 BP 21-2022, adopt filed 04/20/2022, effective 04/20/2022
855-143-0205 Outlet: Technology A PPL and its PPL Affiliated Pharmacy must: (1) Utilize a shared computer system and have appropriate technology or interface to allow access to information required to dispense prescription and non-prescription drugs, devices, and related supplies and counsel the patient or patient’s agent; (2) Utilize barcode, radio-frequency identification or quick response code technology for stocking, destocking and dispensing at the PPL; (3) Test the PPL and verify the unit is operable and functioning in all aspects in accordance with minimum acceptable system or unit design specifications before dispensing prescription and non-prescription drugs, devices, and related supplies and after an upgrade or change is made to the system. The PPL Affiliated Pharmacy must make the results of such testing available to the board upon request; and (4) Develop, implement and enforce a plan for routine maintenance of the PPL. (5) Develop, implement and enforce a plan for responding to and recovering from an interruption of service where the PPL is not fully operational and functioning. 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
855-143-0210 Outlet: Supervision A PPL and its PPL Affiliated Pharmacy must: (1) Ensure prescription and non-prescription drugs, devices, and related supplies are only dispensed at the PPL if an Oregon licensed Pharmacist is available for patient consultation and the PPL is fully operational. (2) Ensure that stocking and destocking of prescription and non-prescription drugs, devices, and related supplies in a PPL is completed under the supervision, direction and control of a Pharmacist. (3) Ensure that an Oregon licensed Pharmacist verifies and documents that: (a) All prescription and non-prescription drugs, devices, and related supplies were correctly stocked into the PPL; (b) All prescription and non-prescription drugs, devices, and related supplies destocked from the PPL were returned to the PPL Affiliated Pharmacy; (c) Proper storage conditions were maintained during transfer per OAR 855-143-0125; and (d) Records are maintained per OAR 855-143-0550. (4) Drugs and devices destocked from a PPL that satisfy the requirements of this section may be returned to stock at the PPL Affiliated Pharmacy. Statutory/Other Authority: ORS 689.205 & ORS 689.225 Statutes/Other Implemented: ORS 689.151, ORS 689.155, ORS 689.305 & ORS 689.527 History: BP 30-2022, amend filed 06/15/2022, effective 06/16/2022 BP 21-2022, adopt filed 04/20/2022, effective 04/20/2022
855-143-0215 Outlet: Pharmacist Utilization A PPL and its PPL Affiliated Pharmacy must ensure that a prescription drug or device is not released from the PPL until the Oregon licensed Pharmacist or Intern has: (1) Provided counseling when required under OAR 855-115-0145 or when requested by the patient or patient’s agent; and (2) Documented the interaction. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 & ORS 689.527 History: BP 39-2024, minor correction filed 04/10/2024, effective 04/10/2024 BP 21-2022, adopt filed 04/20/2022, effective 04/20/2022
855-143-0220 Outlet: Non-Prescription Drugs and Supplies If non-prescription drugs and related supplies are placed in the PPL, the PPL and its PPL Affiliated Pharmacy must ensure that only an Oregon licensed Pharmacist verifies non-prescription drugs and related supplies that will be placed in the PPL. 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
855-143-0225 Outlet: Controlled Substances Controlled substances may not be stored in the PPL. 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
855-143-0345 Dispensing: General Requirements The PPL Affiliated Pharmacy must: (1) Ensure each prescription, prescription refill, and drug order is correctly dispensed by the PPL in accordance with the prescribing practitioner's authorization; and (2) Ensure the PPL dispenses prescriptions accurately and to the correct party. 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
855-143-0500 Policies and Procedures (1) The Oregon licensed PIC of the PPL Affiliated Pharmacy and the PPL Affiliated Pharmacy drug outlet is accountable for establishing, maintaining, and enforcing written policies and procedures for the PPL. The written policies and procedures must be maintained at the PPL 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 PPL Affiliated Pharmacy and each PPL including; (a) Security; (b) Operation, testing and maintenance of the PPL; (c) Sanitation and cleaning; (d) Storage of drugs; (e) Stocking and destocking; (f) Dispensing; (g) Preventing duplicate dispensing; (h) Oregon licensed Pharmacist supervision, direction and control of and licensed personnel accessing the PPL; (i) Documenting the identity, function, location, date and time of the licensed personnel accessing the PPL; (j) Utilization of Oregon licensed Pharmacist (i.e. Counseling); (k) Recordkeeping; (l) Patient consent and confidentiality; (m) On-site inspection by an Oregon licensed Pharmacist; (n) Continuous quality improvement; (o) Plan for discontinuing and recovering services if PPL disruption occurs; (p) Training: initial and ongoing; and (q) Interpretation, translation and prescription reader services. (3) If compounded preparations are compounded at the PPL Affiliated Pharmacy and placed in the PPL the policies and procedures must meet the requirements of OAR 855-045. (4) A PPL Affiliated Pharmacy that provides prescription and non-prescription drugs, devices, and related supplies through a PPL 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 21-2022, adopt filed 04/20/2022, effective 04/20/2022
855-143-0550 Records: General Requirements (1) The recordkeeping requirements OAR 855-143 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 Drug Outlet PPL must be maintained by the PPL Affiliated Pharmacy. (3) Records retained by the PPL Affiliated Pharmacy must include, but are not limited to: (a) Date, time and identification of each individual and activity or function performed on the PPL; (b) Oregon licensed Pharmacist physical inspection of the PPL; (c) Audiovisual communication system testing; (d) Licensee training on the proper use of the PPL; (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 30 days except when a PPL Affiliated Pharmacy becomes aware of an incident that requires review of surveillance data, the PPL Affiliated Pharmacy must retain the data related to that incident for 6 months from the date of review; and (g) Any errors or irregularities identified by the quality improvement program. (4) Records of dispensing from a PPL must include the: (a) Physical location of the PPL; (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 Oregon licensed Pharmacist or Oregon licensed 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 PPL 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 Oregon licensed 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 30-2022, amend filed 06/15/2022, effective 06/16/2022 BP 21-2022, adopt filed 04/20/2022, effective 04/20/2022
855-143-0600 Prohibited Practices: General A PPL may not: (1) Allow unlicensed personnel, Oregon licensed Pharmacy Technicians or Certified Oregon Pharmacy Technicians to ask questions of a patient or patient's agent which screen and/or limit interaction with the Oregon licensed Pharmacist; (2) Utilize a person to dispense or deliver a prescription and non-prescription drugs, devices, and related supplies directly to the patient; (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 21-2022, adopt filed 04/20/2022, effective 04/20/2022
855-143-0602 Prohibited Practices: Disclosure of Patient Information A Retail Drug Outlet PPL 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 & ORS 689.527 History: BP 21-2022, adopt filed 04/20/2022, effective 04/20/2022
855-143-0650 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 21-2022, adopt filed 04/20/2022, effective 04/20/2022
856-001-0000 Notice of Proposed Rule Prior to the adoption, amendment or repeal of any rules, the Board shall give notice of the intended action by mailing or furnishing a copy of the notice to: (1) The Associated Press; (2) The following groups: (a) Columbia River Pilots (b) Columbia River Bar Pilots; (c) Yaquina Bay Pilots; (d) Coos Bay Pilots Association; (e) Columbia River Steamship Operators Association, Inc.; (f) Capitol Press Room. Statutory/Other Authority: ORS 183 & ORS 776 Statutes/Other Implemented: ORS 183.025, ORS 183.335 & ORS 776.135 History: BMP 2-2022, amend filed 07/21/2022, effective 07/21/2022 BMP 4-2008, f. & cert. ef. 1-24-08 MP 1-1996, f. & cert. ef. 5-9-96 MP 3-1988, f. & cert. ef. 11-9-88 MP 2-1984, f. & cert. ef. 10-4-84, Renumbered from 856-020-0140 PC 1-1982, f. & cert. ef. 10-7-82 PC 9-1976, f. & cert. ef. 11-12-76
856-001-0005 Model Rules of Procedures The Model Rules of Procedure under the Administrative Procedures Act adopted by the Attorney General in 2014 are hereby adopted as the rules of procedure for the Board of Maritime Pilots, except as specified under OAR chapter 856, division 030, Ratemaking Procedures. [ED. NOTE: The full text of the Attorney General’s Model Rules of Procedure is available from the office of the Attorney General or Board of Maritime Pilots.] Statutory/Other Authority: ORS 776 Statutes/Other Implemented: ORS 183.341 History: BMP 5-2017, minor correction filed 12/11/2017, effective 12/11/2017 BMP 4-2008, f. & cert. ef. 1-24-08 BMP 1-2002, f. & cert. ef. 8-29-02 MP 1-1996, f. & cert. ef. 5-9-96 MP 3-1988, f. & cert. ef. 11-9-88 MP 1-1986, f. & ef. 10-6-86 MP 2-1984, f. & ef. 10-4-84
856-001-0010 Organization (1) The Board of Maritime Pilots, created by ORS Chapter 776, is responsible for licensing of pilots in the State of Oregon and setting of pilotage rates. (2) Information can be obtained from the Board’s office at 800 N.E. Oregon Street, Suite 507, Portland, OR 97232, telephone 971-673-1530. Statutory/Other Authority: ORS 776 Statutes/Other Implemented: ORS 776.115 History: BMP 3-2021, minor correction filed 02/18/2021, effective 02/18/2021 Reverted to MP 3-1988, f. & cert. ef. 11-9-88 MP 2-1992(Temp), f. & cert. ef. 4-29-92 MP 3-1988, f. & cert. ef. 11-9-88 MP 2-1984, f. & ef. 10-4-84