justicedao/ipfs_state_laws huggingface dataset:
855-041-4055 Home Dialysis - Duties of the Pharmacist (1) The pharmacist-in-charge must review, at least weekly, the drug outlet operation and perform, at least monthly, quality assurance audits that include the review of prescription orders prior to delivery for accuracy and completeness, and the review of the assembled order with the prescription order prior to delivery for accuracy and completeness. (2) The pharmacist-in-charge is responsible for the following on an ongoing basis: (a) Ensure compliance of dialysis distribution operation to all applicable federal and state pharmacy laws and rules; (b) Ensure valid prescriptions are received for all patient orders by performing periodic assessments of prescription files; (c) Perform periodic assessments of distribution processes and procedures to ensure quality and compliance; (d) Provide pharmaceutical care by reviewing all patient profiles and performing drug therapy assessments on those identified as abnormal; (e) Provide pharmaceutical care by responding on a toll free telephone access to questions received from any patient or health care provider; (f) Maintain, update and train personnel on policies and procedures specific to home dialysis patient deliveries and pharmacy requirements; (g) Prepare educational materials for staff members of dialysis clinics as requested; (h) Prepare and maintain on file monthly reports of activities performed; (i) Ensure security of the patient record area; and (j) Maintain a policy and procedure manual for the Drug Outlet operation that must include written protocols for the product delivery system, methods for supervising deliveries to patients, and a quality assurance program with which to monitor the qualifications, training and performance of personnel. (3) The pharmacist-in-charge must perform an annual inspection of the outlet on a form provided by the Board, and must provide a copy of this inspection to the Board upon request. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.305 History: BP 49-2020, minor correction filed 08/06/2020, effective 08/06/2020 Renumbered from 855-041-0365, BP 7-2012, f. & cert. ef. 12-17-12 BP 8-2000, f. & cert. ef. 6-29-00
855-041-4100 Definitions - Automated Pharmacy System (1) "Automated Pharmacy System" (APS) means a mechanical system that performs operations or activities, including but not limited to, those related to the storage, packaging, dispensing, or distribution of medications, but not including compounding or administration, and that collects, controls, and maintains all transaction information. (2) "Remote Dispensing Facility" (RDF) means a facility where drugs are prepared for administration and where requisite pharmacist supervision is provided remotely as approved by the Board. (3) "Remote Dispensing Machine" (RDM) means a component of an Automated Pharmacy System that contains drugs for dispensing. (4) "Responsible Pharmacy" means the licensed pharmacy that is responsible for the APS, and RDM. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 History: BP 48-2020, minor correction filed 08/06/2020, effective 08/06/2020 BP 1-2017, f. & cert. ef. 2-23-17 Renumbered from 855-041-0600, BP 7-2012, f. & cert. ef. 12-17-12 BP 3-2011, f. & cert. ef. 4-18-11 Reverted to BP 2-2005, f. 2-14-05, cert. ef. 3-1-05 BP 9-2010(Temp), f. & cert. ef. 7-9-10 thru 12-24-10 BP 2-2005, f. 2-14-05, cert. ef. 3-1-05
855-041-4110 Remote Dispensing Machine (RDM) - Duties and Responsibilities of the Pharmacist-in-Charge Each RDM must be under the supervision of the Pharmacist-in-Charge of the Responsible Pharmacy. The Pharmacist-in-Charge must: (1) Develop written policies and procedures prior to installation of the RDM that: (a) Ensure safety, accuracy, security, and patient confidentiality; (b) Define access to the RDM and to medications contained within or associated with the RDM, including but not limited to policies that assign, discontinue, or change access to the RDM and medications. (c) Ensure that access to the medications complies with state and federal laws and regulations. (2) Obtain written approval by the Board prior to installing any RDM. (3) Train all personnel who will access the APS (including the RDM) before being allowed access to the APS. Training must ensure the competence and ability of all personnel who operate any component of the APS. Documentation of original training and continuing education must be kept both in the pharmacy and at the site of the RDM, and readily available for inspection by the Board. (4) Ensure that the RDM is in good working order and accurately dispenses the correct strength, dosage form, and quantity of the drug prescribed while maintaining appropriate record-keeping and security safeguards. (5) Implement an ongoing quality assurance program that monitors performance of the APS, including the RDM, and the personnel who access it. (6) Notify the Board within 15 days of removal or closure of the RDM and the disposition of drugs contained in the RDM before it was removed or closed. (7) Ensure that the RDM is stocked accurately and in accordance with established, written policies and procedures. A pharmacist must check the accuracy of the product supplied for stocking the machine. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.151, ORS 689.155 & ORS 689.305 History: BP 46-2020, minor correction filed 08/06/2020, effective 08/06/2020 Renumbered from 855-041-0610, BP 7-2012, f. & cert. ef. 12-17-12 BP 2-2005, f. 2-14-05, cert. ef. 3-1-05
855-041-5005 Definitions - Institutional and Residential Pharmacy Drug Outlets For purposes of these rules, OAR 855-041-5000 through 855-041-9999 the following definitions apply: (1) "Institutional Facility" means a hospital or other health care facility which is an inpatient care facility referred to in ORS 442.015, which includes long-term care facilities and special inpatient care facilities, and such facility is licensed by the appropriate state agency. For the purpose of this rule, an Institutional Facility is a Residential Drug Outlet. (2) "Institutional Pharmacy" means a pharmacy where medications are dispensed to other health care professionals for administration to institutionalized patients served by an institutional facility, and which is: (a) Located within the institutional facility; (b) Located outside the facility but provides pharmaceutical services to institutionalized patients; and (c) For the purpose of this rule, an Institutional Pharmacy is a Residential Pharmacy. (3) "Drug Room" means a secure and lockable location within a facility that does not have a pharmacy and is a Board approved location associated with a licensed institutional pharmacy. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.151, ORS 689.155 & ORS 689.305 History: BP 41-2020, minor correction filed 08/06/2020, effective 08/06/2020 BP 1-2017, f. & cert. ef. 2-23-17 Renumbered from 855-041-0105 by BP 1-2012, f. 4-26-12, cert. ef. 5-1-12 PB 8-1990, f. & cert. ef. 12-5-90 1PB 2-1980, f. & ef. 4-3-80
855-041-5015 Registration All residential drug outlets shall register annually with the Board of Pharmacy. Residential drug outlets which also provide outpatient pharmacy services shall also register as retail drug outlets. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 History: Renumbered from 855-041-0115 by BP 1-2012, f. 4-26-12, cert. ef. 5-1-12 1PB 2-1980, f. & ef. 4-3-80
855-041-5050 Remote Distribution Facility (RDF) - Definitions (1) "Automated Pharmacy System" (APS) means a mechanical system that performs operations or activities, including but not limited to, those related to the storage, packaging, dispensing, or distribution of medications, but not including compounding or administration, and that collects, controls, and maintains all transaction information. (2) "Remote Distribution Facility" (RDF) means an in-state/resident facility where drugs are prepared for administration and where requisite pharmacist supervision is provided remotely as approved by the Board. (3) "Responsible Pharmacy" means the licensed resident pharmacy that is responsible for the RDF. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 History: BP 8-2017, adopt filed 12/22/2017, effective 12/26/2017
855-041-5055 Remote Distribution Facility (RDF) The purpose of these rules is to provide for the use of a Certified Oregon Pharmacy Technician functioning outside of a pharmacy to prepare drugs only for administration to a patient by another healthcare provider, and where requisite pharmacist supervision and verification is provided remotely by an Oregon licensed pharmacist via an audiovisual communication system. (1) A pharmacy physically located in Oregon may make written application to operate a RDF. (2) The board may approve an application for registration as a RDF which includes the following: (a) An operation plan; (b) Policies and Procedures; (c) A training plan; (d) A quality assurance plan for ensuring that there is a planned and systematic process for the monitoring and evaluation of the quality and appropriateness of pharmacy services and for identifying and resolving problems; and (e) The fee specified in Division 110. (3) Notwithstanding the definition of “supervision by a pharmacist” in Division 006, supervision in a RDF may be accomplished by a pharmacist via an audiovisual communication system from the applying pharmacy. (4) Notwithstanding rules in this Division and in Divisions 115 and 125, a Certified Oregon Pharmacy Technician who works in a RDF may have access to the facility without the physical presence of a pharmacist, but may only perform Board approved functions when under the supervision of a pharmacist. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 History: BP 45-2024, minor correction filed 04/11/2024, effective 04/11/2024 BP 17-2022, amend filed 04/20/2022, effective 04/20/2022 BP 8-2017, adopt filed 12/22/2017, effective 12/26/2017
855-041-6050 Definitions - Automated Distribution Cabinet (ADC) In these rules, OAR 855-041-6000 through 855-041-6999, the terms below have these meanings: (1) “Automated Distribution Cabinet” (ADC) means a computerized drug storage device or cabinet that allows a drug to be stored and dispensed near the point-of-care, while controlling and tracking drug distribution; (2) “Drug” means a drug, a prescription device, a biological medication, a chemical or any combination of these terms; (3) “Central pharmacy” means a pharmacy within a licensed hospital with a single location and inventory, which prepares and distributes drugs to secondary storage areas in the facility, and remote locations; (4) “Chief Pharmacy Officer” (CPO) means an Oregon licensed Pharmacist who supervises the pharmacy operations in a hospital. The CPO may hold the title of Pharmacy Manager, Pharmacy Director, Director of Pharmacy, Pharmacy Administrator or other pharmacy supervisory management title within the organization. The PIC may also be the CPO if there is only one pharmacy in the hospital; (5) “Drug profile” means a complete and comprehensive summary of a patient’s current drugs and details of each drug including information such as active ingredient, strength and form, dose and directions for use, and other supplementary information; (6) “Licensed Independent Practitioner” (LIP) means an individual permitted by law and by the organization to provide care and services, without direction or supervision, within the scope of the individual's license; (7) “Out-patient” means a person who is not residing in the facility but who is registered with the facility and is using the facility for treatment or diagnostic services; (8) “Remote storage area” means a patient care area which is part of the hospital that is under the supervision and control of the hospital’s central pharmacy but is not located in the same building as the central pharmacy; (9) “Secondary drug storage area” means an area in a hospital or licensed residential facility, which is supplied by a central pharmacy and may include facilities such as a drug room, a distribution cabinet or a hospital department; (10) “Unit-dose” means a quantity of a drug designed to be administered to a patient, such as: (a) An oral solid individually packaged or re-packaged; (b) An oral liquid drawn up in a labeled oral syringe; (c) An injectable product; or (d) A pre-mixed IV product. Statutory/Other Authority: ORS 689.205 & 2022 HB 4034 Statutes/Other Implemented: ORS 689.155 & 2022 HB 4034 History: BP 28-2022, amend filed 06/15/2022, effective 06/16/2022 BP 25-2022, temporary amend filed 04/22/2022, effective 04/22/2022 through 10/18/2022 BP 20-2020, minor correction filed 08/06/2020, effective 08/06/2020 BP 3-2010, f. 4-29-10, cert. ef. 4-30-10
855-041-6100 Registration (1) Each central pharmacy must be registered with the Board. In a hospital with multiple central pharmacies, each pharmacy location must be registered with the Board. (2) A secondary drug storage area within the hospital or in a structure physically attached to the hospital does not require a separate registration. (3) A registered pharmacy in a hospital may use additional locations within the hospital, supervised by a pharmacist, without acquiring separate registrations for each additional location. (4) A secondary drug storage area in a separate location must be registered as a drug room and must follow all rules that apply to secondary storage areas in the hospital. (5) A residential healthcare facility that is licensed by DHS and that has a central pharmacy must register the pharmacy with the Board. (6) 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. A waiver is not valid for more than five years. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 & ORS 689.305 History: BP 1-2023, minor correction filed 01/23/2023, effective 01/23/2023 BP 3-2010, f. 4-29-10, cert. ef. 4-30-10
855-041-6150 General Pharmacy Requirements (1) Each hospital pharmacy must have an Oregon licensed pharmacist designated as Pharmacist-in-Charge (PIC). (2) A hospital that has more than one pharmacy must designate an Oregon licensed pharmacist as CPO or an equivalent position who has responsibility for directing pharmacy services in the hospital. The CPO may also be the PIC of one of the pharmacies. (3) A hospital pharmacy may only be operated when under the direct supervision of an Oregon licensed pharmacist. The pharmacist shall be responsible for all areas of the hospital where drugs are stored, including remote storage areas (4) The pharmacy must be operated at least part-time, five days a week. (5) The hospital pharmacy must have adequate space so that drugs can be prepared in sanitary, well-lit, enclosed places. Space and equipment must be adequate for the pharmaceutical services provided including compounding, distributing, and storage of drugs and parenteral preparations. (6) As a minimum, the pharmacy must have the following: (a) Equipment listed in OAR 855-041-1035, except that a pharmacy that is only registered as an institutional drug outlet does not need to have an Official Poison and Exempt Narcotic Register; (b) A drug formulary approved by the appropriate hospital committee; (c) Pharmacy policy and procedures. (7) All areas occupied by a hospital pharmacy must be secured to prevent access by unauthorized personnel. (a) Whenever any area of a hospital pharmacy is not under direct supervision of a pharmacist, the area must be secured; (b) The CPO shall designate in writing, by title and specific area, those persons who may have access to specific areas within the pharmacy; (c) Unless otherwise permitted by these rules, a non-pharmacist may not have access to the pharmacy unless a pharmacist is on duty and present in the hospital. (8) A residential healthcare facility that has a central pharmacy must comply with these rules. (9) 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 in writing. A waiver is not valid for more than five years. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 History: BP 48-2024, minor correction filed 04/11/2024, effective 04/11/2024 BP 3-2010, f. 4-29-10, cert. ef. 4-30-10
855-041-6220 Records (1) All records and documents required by ORS 475, ORS 689, and OAR 855: (a) Must be stored on-site for 12 months and must be provided to the board immediately upon request. (b) May be stored in a secured off-site location after 12 months of on-site storage and must be provided to the board upon request within three business days; and (c) May be written or electronic format. (2) The PIC must ensure maintenance of written or electronic records and documents as necessary to ensure patient health, safety and welfare. Records must include: (a) Patient profiles and drug administration records; (b) Reports of suspected adverse drug reactions; (c) Inspections of drug storage areas; (d) Annual controlled substance inventories; (e) Controlled drug accountability reports; (f) Collaborative Drug Therapy agreements; (g) Current hospital drug formulary; (h) Any other records and reports required by state and federal laws and regulations. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 & ORS 689.508 History: BP 14-2021, amend filed 06/15/2021, effective 06/15/2021 BP 3-2010, f. 4-29-10, cert. ef. 4-30-10
855-041-6240 Drug Administration (1) In a hospital, a drug may only be administered upon an order initiated by: (a) A member of the medical staff who has been granted clinical privileges; (b) An authorized member of the house staff; or (c) An authorized licensed practitioner. (2) Each administration of a drug must be in accordance with policies and procedures approved by the appropriate committee of the hospital, must comply with all applicable laws, rules and regulations, and must follow usual and customary standards of good medical practice. (3) Self-administration. A patient may only be permitted to self-administer a drug when specifically authorized by the treating or ordering practitioner, and when the patient has been educated and trained in the proper self-administration of the drug. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 History: BP 3-2010, f. 4-29-10, cert. ef. 4-30-10
855-041-6250 Patient’s Own Drugs and Other Drugs from Outside Sources When a patient or a patient’s agent brings a drug into the hospital, the drug may only be administered to the patient if: (1) The practitioner or pharmacist has identified it and it is in a pharmacy labeled container; and (2) Any administration is pursuant to a practitioner’s order; or (3) In the pharmacist’s professional judgment, withholding the drug would be detrimental to the patient’s health. In such a case, the pharmacist may authorize administration of the drug pursuant to a practitioner’s order. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 History: BP 3-2010, f. 4-29-10, cert. ef. 4-30-10
855-041-6260 Investigational Drugs (1) All in-patient investigational drugs must be stored in the pharmacy and may only be distributed from the pharmacy when properly labeled. (2) Information concerning the dosage form, route of administration, strength, actions, uses, side effects, adverse effects, interactions and symptoms of toxicity of such drugs must be available in the pharmacy. (3) Investigational drugs may only be ordered by a designated physician-investigator or their authorized clinician, subject to the prior approval of the appropriate hospital committee. (4) Each order must include the appropriate protocol number. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 History: BP 3-2010, f. 4-29-10, cert. ef. 4-30-10
855-041-6270 Institutional Drug Outlet Pharmacy Prescription Labeling (1) Each pharmacy record keeping system must identify all pharmacy personnel involved in the repackaging including the pharmacist who verified the repackaged drug. (2) Each repackaged drug, prepared by the pharmacy and intended for use within the facility must be in an appropriate container with a label that meets the requirements of OAR 855-041-1135 and includes: (a) The brand or generic name and expiration date; (b) The manufacturer and lot number, or an internal pharmacy code that references manufacturer and lot number; (c) The strength of the drug. (3) In-patient: Each drug dispensed to an in-patient other than in a unit-dose or manufacturer’s unit-of-use packaging must be labeled with the following information: (a) Name and location of patient; (b) Name and strength of drug; (c) Route of administration, when necessary for clarification; (d) Manufacturer and lot number, or internal pharmacy code; (e) Auxiliary labels as needed, and (f) Expiration date. (4) A drug that is provided for outpatient use must be dispensed by a retail drug outlet. (5) When a new barcode or electronic label is used to identify a drug the pharmacist must verify and document the accuracy of the identification with all electronic verification systems prior to distribution. (6) When a drug is added to a parenteral solution under the direct supervision of a pharmacist, the admixture must be labeled with a distinctive supplementary label that includes the: (a) Name, quantity and concentration of the drug added and the primary solution; (b) Date and time of addition; (c) Expiration date; (d) Scheduled time for administration; (e) Infusion rate, when applicable; (f) Name or initials of person performing admixture; (g) Identification of the pharmacy where the admixture was performed; and (h) Name or initials of the verifying pharmacist. (7) The label applied at a secondary storage or remote storage area by a nurse or physician must include: the patient name or patient identifier, quantity and concentration of the drug added and the primary IV solution; the date and time of addition and the initials of the nurse or physician adding the drug. (8) Nothing in this rule is intended to restrict or conflict with HB 2395 (2023), SB 450 (2023), SB 1043 (2023). Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155, ORS 689.505, 2023 HB 2395, 2023 SB 450 & 2023 SB 1043 History: BP 5-2024, amend filed 02/15/2024, effective 02/15/2024 BP 35-2023, temporary amend filed 12/20/2023, effective 01/01/2024 through 06/28/2024 BP 45-2021, amend filed 12/16/2021, effective 12/16/2021 BP 3-2010, f. 4-29-10, cert. ef. 4-30-10
855-041-6300 Absence of the Pharmacist The CPO must make appropriate arrangements for provision of drugs to the medical staff and other authorized personnel by use of a night cabinet or by access to the pharmacy, or both, for situations when hospital pharmacy services are not available. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 & ORS 689.605 History: BP 5-2021, minor correction filed 03/11/2021, effective 03/11/2021 BP 3-2010, f. 4-29-10, cert. ef. 4-30-10