justicedao/ipfs_state_laws huggingface dataset:
855-043-0555 Dispensing Practitioner Drug Outlets - Records (1) A unique dispensing record must be maintained, be readily retrievable, and kept for a minimum of three years. The record must show, at a minimum, the following: (a) Name of patient; (b) Dose, dosage form, quantity dispensed and either the brand name of drug, or generic name and name of manufacturer or distributor; (c) Directions for use; (d) Date of dispensing; and (e) Initials of person dispensing the prescription. (2) All records of receipt and disposal of drugs must be kept for a minimum of three years. (3) 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 at the time of inspection; (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 in written or electronic format. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 & ORS 689.305 History: BP 40-2021, amend filed 12/16/2021, effective 01/01/2022 BP 4-2017, adopt filed 11/30/2017, effective 12/01/2017
855-043-0560 Dispensing Practitioner Drug Outlets - Inspections (1) The DPDO must annually complete a self-inspection using the board's DPDO Self-Inspection Form by July1 and retain for board inspection. (2) Each DPDO will be inspected per OAR 855-001-0040 on a routine basis and must be scheduled in advance with the DPDO, to occur during normal business hours. (3) The inspection must focus on the acquisition, storage, labeling and recordkeeping of drugs intended for dispensing and any violation will apply to the DPDO registration and not to the practitioner. (4) The Board of Pharmacy must notify the practitioner’s licensing board of any disciplinary action taken against a DPDO. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 & ORS 689.305 History: BP 12-2023, amend filed 06/13/2023, effective 08/01/2023 BP 40-2021, amend filed 12/16/2021, effective 01/01/2022 BP 4-2017, adopt filed 11/30/2017, effective 12/01/2017
855-043-0600 Correctional Facility - Purpose and Scope A correctional facility is defined as an institutional drug outlet and as such is subject to the rules of the State Board of Pharmacy. Drug dispensing in a correctional facility shall be from a pharmacy or from a drug room. The facility shall have a pharmacist who acts as a consultant to the institution, develops policies and procedures on drug distribution, procurement and management, monitors for compliance, performs drug utilization reviews, and may delegate registered nurses to withdraw drugs for administration to patient/inmates. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.005, ORS 689.155 & ORS 689.605 History: BP 39-2020, minor correction filed 08/06/2020, effective 08/06/2020 Renumbered from 855-041-0170, BP 7-2012, f. & cert. ef. 12-17-12 PB 1-1996, f. & cert. ef. 4-5-96
855-043-0610 Correctional Facility - Definitions (1) “Administer” means the direct application of a drug or device whether by injection, inhalation, ingestion, or any other means, to the body of a patient or research subject by: (a) A practitioner or the authorized agent thereof; or (b) The patient or research subject at the direction of the practitioner. (2) “Bulk Drug Container” means a bottle or package of medication, other than unit dose, labeled by a manufacturer or pharmacist. (3) “Container” is the device that holds the medication and that is or may be in direct contact with the medication. (4) “Correctional Facility” means any prison, jail, or detention facility for the confinement of juveniles or adults. (5) “Dispense” or “Dispensing” means the preparation and delivery of a prescription drug pursuant to the lawful order of a practitioner in a suitable container appropriately labeled for subsequent administration to or use by a patient or other individual entitled to receive the prescription drug. (6) “Drug Room” means a secure and lockable location within an inpatient care facility that does not have a licensed pharmacy. (7) “Institutional Drug Outlet” means hospitals and inpatient care facilities where medications are dispensed to another health care professional for administration to patients served by the hospitals or facilities. (8) “Medication card” means a medication container, labeled as required in OAR 855-041-0177(4), which provides multiple doses of a single medication with each dose contained in a separate, tamper-evident, sealed compartment. (9) “Practitioner” means a person licensed and operating within the scope of such license to prescribe and dispense, conduct research with respect to or administer drugs in the course of professional practice or research: (a) In this state; or (b) In another state or territory of the United States not residing in Oregon and registered under the Federal Controlled Substances Act. (10) “Unit dose” means a sealed, single-unit container so designed that the contents are administered to the patient as a single dose, direct from the container and which bears a separate label showing the name and strength of the medication, the name of the manufacturer or distributor, an identifying lot number and, if applicable, the expiration date of the medication. (11) “Unit Dose Dispensing System” means a system which utilizes unit dose as its principle means of distributing drugs within a correctional facility. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.005 & ORS 689.155 History: BP 35-2020, minor correction filed 08/06/2020, effective 08/06/2020 Renumbered from 855-041-0173, BP 7-2012, f. & cert. ef. 12-17-12 PB 1-1996, f. & cert. ef. 4-5-96
855-043-0620 Correctional Facility - Duties of the Pharmacist (1) May delegate to a registered nurse the authority to withdraw prescription drugs from a unit dose system or from a manufacturer’s or pharmacist’s labeled container for administration to persons confined in the facility; (2) Develop written policies and procedures with the practitioner representing the facility regarding medication management; (3) Monitor the facility’s compliance with policies and procedures regarding medication management; (4) Perform drug utilization review including timely, routine prospective review of specific individual therapies as well as retrospective drug regimen reviews, and drug use review and evaluation. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.605 & ORS 689.155 History: BP 34-2020, minor correction filed 08/06/2020, effective 08/06/2020 Renumbered from 855-041-0175, BP 7-2012, f. & cert. ef. 12-17-12 PB 1-1996, f. & cert. ef. 4-5-96
855-043-0700 Community Health Clinic (CHC) - Purpose and Scope (1) The purpose of 855-043-0700 to 855-043-0750 is to provide minimum requirements of operation for a Community Health Clinic (CHC) to utilize a Registered Nurse to dispense medications. A Community Health Clinic Drug Outlet registration replaces a Family Planning or County Health Drug Outlet registration. A legend or non-prescription drug may be dispensed to a client for the purpose of birth control, caries prevention, the treatment of amenorrhea, the treatment of a communicable disease, hormone deficiencies, urinary tract infections or sexually transmitted diseases by a practitioner who has been given dispensing privileges by their licensing Board, or a Registered Nurse, who is an employee of a clinic or local public health authority (LPHA), and is recognized by the Oregon Public Health Division for the purposes of providing public health services. (2) Dispensing must be pursuant to the order or prescription of a person authorized by their Board to prescribe a drug or established by the Medical Director or clinic practitioner with prescriptive and dispensing authority. (3) Family Planning or County Health Clinic registrations that expire March 31, 2017 will be converted to the CHC category upon renewal in 2017. However, rules take effect on July 1, 2016. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.305 History: BP 32-2020, minor correction filed 08/06/2020, effective 08/06/2020 BP 2-2016, f. 6-30-16, cert. ef. 7-1-16
855-043-0705 Community Health Clinic (CHC) - Registration (1) A Community Health Clinic Drug Outlet must register with the board on a form prescribed by the board, and must renew its registration annually on a renewal form prescribed by the board. (2) An initial application and renewal application must be accompanied by the fee established in OAR 855-110. (3) A certificate of registration will be issued upon board approval of the application. (4) The CHC Drug Outlet registration expires March 31, annually. If the annual renewal fee is not paid by March 31 of the current year, the applicant for renewal must submit the late renewal fee established in OAR 855-110 with the renewal application. (5) The registration is not transferable and the registration fee cannot be prorated. (6) The registrant must notify the board, within 15 days, of any substantial change to the information provided on the registration application. A substantial change shall include but not be limited to: a change of ownership; change of business address; change of normal business hours; any disciplinary action taken or pending by any state or federal authority against the registrant, or any of its principals, owners, directors, officers, or Medical Director. (7) A new registration form is required for a change of ownership or location and must be submitted to the board with the fees as specified in OAR 855-110 within 15 days of the change. (8) A CHC Drug Outlet may be inspected by the board. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.305 History: BP 40-2021, amend filed 12/16/2021, effective 01/01/2022 BP 31-2020, minor correction filed 08/06/2020, effective 08/06/2020 BP 2-2016, f. 6-30-16, cert. ef. 7-1-16
855-043-0710 Community Health Clinic (CHC) - Personnel (1) A Community Health Clinic Drug Outlet must employ a Medical Director who is an Oregon practitioner with prescriptive and dispensing authority. The Medical Director shall establish and enforce policies and procedures, drug dispensing formulary, and protocols for the dispensing of drugs by authorized persons in the CHC. (2) A CHC Drug Outlet must designate a representative employee who will act as the contact person for the Oregon Board of Pharmacy. The designated representative must be onsite the majority of the CHC’s normal operating hours. (a) The Medical Director or designated representative must conduct and document an annual review of the outlet on a form provided by the Board. The completed report must be filed in the outlet, retained on file for three years and be available to the Board for inspection. (b) The Medical Director shall develop policies and procedures for the outlet in collaboration with the designated representative. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.305 History: BP 29-2020, minor correction filed 08/06/2020, effective 08/06/2020 BP 2-2016, f. 6-30-16, cert. ef. 7-1-16
855-043-0715 Community Health Clinic (CHC) - Policies and Procedures The Community Health Clinic must: (1) Maintain written policies and procedures for drug management, including security, acquisition, storage, dispensing and drug delivery, disposal, and record keeping. (2) Establish procedures to train a Registered Nurse employed by the CHC to ensure continued competence in the dispensing of drugs. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.305 History: BP 26-2020, minor correction filed 08/06/2020, effective 08/06/2020 BP 2-2016, f. 6-30-16, cert. ef. 7-1-16
855-043-0720 Community Health Clinic (CHC) - Security (1) All drugs must be kept in a locked drug cabinet or designated drug storage area that is sufficiently secure to deny access to unauthorized persons. The drug cabinet or designated drug storage area must remain locked and secured when not in use. (2) Only a Physician, Clinical Nurse Specialist, Nurse Practitioner, or Registered Nurse shall have a key to the drug cabinet or drug room. In their absence, the drug cabinet or drug room must remain locked. (3) 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. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.305 History: BP 24-2020, minor correction filed 08/06/2020, effective 08/06/2020 BP 2-2016, f. 6-30-16, cert. ef. 7-1-16
855-043-0725 Community Health Clinic (CHC) - Drug Acquisition The CHC must verify that all drugs are acquired from a registrant of the Board. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.305 History: BP 22-2020, minor correction filed 08/06/2020, effective 08/06/2020 BP 2-2016, f. 6-30-16, cert. ef. 7-1-16
855-043-0730 Community Health Clinic (CHC) - Storage of Drugs All drugs, including drug samples, must be stored according to the manufacturer’s published guidelines and be stored in appropriate conditions of temperature, light, humidity, sanitation, ventilation, and space. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.305 History: BP 21-2020, minor correction filed 08/06/2020, effective 08/06/2020 BP 2-2016, f. 6-30-16, cert. ef. 7-1-16
855-043-0735 Community Health Clinic (CHC) - Labeling (1) Except as described in SB 450 (2023), a prescription must be labeled with the following information: (a) Unique identifier (i.e. prescription number); (b) Name of patient; (c) Name of prescriber; (d) Name, address, and phone number of the clinic; (e) Date of dispensing; (f) Name of drug, strength, and quantity dispensed; when a generic name is used, the label must also contain the identifier of the manufacturer or distributor; (g) Quantity dispensed; (h) Directions for use; (i) Initials of the practitioner who has been given dispensing privileges by their licensing Board or the Registered Nurse; (j) Cautionary statements, if any, as required by law; and (k) Manufacturer's expiration date, or an earlier date if preferable, after which the patient should not use the drug. (2) Notwithstanding any other requirements in this rule, when a drug is dispensed in the practice of an Expedited Partner Therapy treatment protocol, the name of the patient may be omitted from the label, the patient’s name may be omitted from the records and a drug may be dispensed to the patient to be given to the patient’s partner even if the partner has not been examined by a licensed health care provider acting within their scope of practice. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.305 & 2023 SB 450 History: BP 27-2023, amend filed 10/16/2023, effective 10/17/2023 BP 19-2020, minor correction filed 08/06/2020, effective 08/06/2020 BP 2-2016, f. 6-30-16, cert. ef. 7-1-16
855-043-0736 Community Health Clinic (CHC) - Limited English Proficiency and Accessibility (1) Upon request of a patient or a patient's agent, each drug dispensed by a drug outlet for a patient's selfadministration 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), a drug outlet 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 98-2020, adopt filed 12/23/2020, effective 01/01/2021
855-043-0740 Community Health Clinic (CHC) - Dispensing and Drug Delivery (1) A drug may only be dispensed by a practitioner who has been given dispensing privileges by their licensing Board or by a Registered Nurse. (2) A Registered Nurse may only provide over-the-counter drugs pursuant to established CHC protocols. (3) A Registered Nurse may only dispense a drug listed in, or for a condition listed in, the formulary. (4) Nonjudgmental dispensing functions may be delegated to staff assistants when the accuracy and completeness of the prescription is verified by a practitioner who has been given dispensing privileges by their licensing Board, or by a Registered Nurse, prior to being delivered or transferred to the patient. (5) The CHC will provide appropriate drug information for medications dispensed to a patient, which can be provided by the Registered Nurse or practitioner at the time of dispensing. (6) A CHC must dispense a drug in a new container that complies with the current provisions of the Poison Prevention Packaging Act in 16 CFR 1700 (v. 01/01/2024), 16 CFR 1701 (v. 01/01/2024) and 16 CFR 1702 (v. 01/01/2024). (7) Dispensed drugs must be packaged by the practitioner, Registered Nurse, a pharmacy; or a manufacturer registered with the board. (8) A CHC may not accept the return of drugs from a previously dispensed prescription and must maintain a list of sites in Oregon where drugs may be disposed. (9) A CHC must have access to the most current issue of at least one pharmaceutical reference with current, properly filed supplements and updates appropriate to and based on the standards of practice for the setting. (10) A CHC may deliver or mail prescription to the patient if: (a) Proper drug storage conditions are maintained; and (b) The CHC offers in writing, to provide direct counseling, information on how to contact the practitioner, and information about the drug, including, but not limited to: (A) Drug name, class and indications; (B) Proper use and storage; (C) Common side effects; (D) Precautions and contraindications; and (E) Significant drug interactions. (11) The CHC must ensure that all prescriptions, prescription refills, and drug orders are correctly dispensed in accordance with the prescribing practitioner's authorization and any other requirement of State or federal law. (12) Each authorized dispenser of a prescription drug product for which a Medication Guide is required must provide the Medication Guide directly to each patient or patient’s agent when the product is dispensed, unless an exemption applies. [Publications: Publications referenced are available for review at the agency.] Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.305 History: BP 3-2025, amend filed 06/16/2025, effective 06/16/2025 BP 57-2024, amend filed 06/18/2024, effective 06/20/2024 BP 10-2023, amend filed 06/13/2023, effective 06/13/2023 BP 27-2022, amend filed 06/15/2022, effective 06/16/2022 BP 40-2021, amend filed 12/16/2021, effective 01/01/2022 BP 17-2020, minor correction filed 08/06/2020, effective 08/06/2020 BP 2-2016, f. 6-30-16, cert. ef. 7-1-16
855-043-0745 Community Health Clinic (CHC) - Disposal of Drugs Drugs that are outdated, damaged, deteriorated, misbranded, adulterated, or identified as suspect or illegitimate must be documented, quarantined and physically separated from other drugs until they are destroyed or returned to the supplier. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.305 History: BP 15-2020, minor correction filed 08/06/2020, effective 08/06/2020 BP 2-2016, f. 6-30-16, cert. ef. 7-1-16
855-043-0750 Community Health Clinic (CHC) - Record Keeping (1) A dispensing record must be maintained separately from the patient chart and kept for a minimum of three years. The record must show, at a minimum, the following: (a) Name of patient; (b) Unique identifier (i.e. prescription number); (c) Dose, dosage form, quantity dispensed and either the brand name of drug, or generic name and name of manufacturer or distributor; (d) Directions for use; (e) Date of dispensing; and (f) Initials of person dispensing the prescription. (2) All records of receipt and disposal of drugs must be kept for a minimum of three years. (3) All records required by these rules or by other State and federal law must be readily retrievable and available for inspection by the Board. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.305 History: BP 13-2020, minor correction filed 08/06/2020, effective 08/06/2020 BP 2-2016, f. 6-30-16, cert. ef. 7-1-16
855-044-0001 Purpose The purpose of the program is to provide a process to make donated prescription drugs available to needy or uninsured individuals and those with limited access to pharmaceuticals. Under the rules in this Division, a Charitable Pharmacy that is registered with the Oregon Board of Pharmacy (Board) may accept drugs for donation and distribution within this state when the pharmacist can reasonably be assured of the purity and integrity of the drug. The program may not include categories of drugs specified by the Board as excluded from the program. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.772 & 689.774 History: BP 1-2017, f. & cert. ef. 2-23-17 BP 6-2010, f. & cert. ef. 6-29-10
855-044-0005 Definitions (1) “Charitable Pharmacy” means a facility registered with the Oregon Board of Pharmacy for the purpose of receiving and distributing donated drugs. (2) “Point-of-Contact” means an individual designated by a charitable pharmacy who serves as the primary contact person for the charitable pharmacy and who is responsible for managing the charitable pharmacy at that location. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.772 & 689.774 History: BP 6-2010, f. & cert. ef. 6-29-10
855-044-0010 Registration (1) A facility may not operate as a charitable pharmacy unless it is registered as such with the Board and has paid the fee specified in Division 110 of these rules. (2) The application for registration must be on a form provided by the Board and must include proposed policies and procedures and a description of the organization. (3) Each location must be registered separately. (4) An applicant for registration as a charitable pharmacy must name a point-of-contact for each registered location. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.774 History: BP 6-2010, f. & cert. ef. 6-29-10
855-044-0020 Personnel (1) A charitable pharmacy must have a licensed pharmacist. The pharmacist may also be the Point-of-Contact. (2) A charitable pharmacy that is co-located with an existing registered pharmacy may name a pharmacist employed by the existing pharmacy as its pharmacist. (3) A charitable pharmacy that is not co-located with an existing registered pharmacy and does not have a pharmacist on staff must employ a consultant pharmacist. (4) The pharmacist must develop policies and procedures for: (a) Receiving donated drugs; (b) Security; (c) Drug storage; (d) Distribution of drugs; (e) Record keeping; (f) Disposal of unusable drugs; and (g) Staff training. (5) The pharmacist must conduct a visual inspection of each donated drug to ensure that the drug has not expired, been adulterated or misbranded and is in its original, sealed packaging, and that based on this inspection and on the accuracy of the Donor’s Form, the drug is safe to distribute. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.774 History: BP 6-2010, f. & cert. ef. 6-29-10