justicedao/ipfs_state_laws huggingface dataset:
855-041-7060 Long Term Care Pharmacy - Drug Distribution and Control (1) Pharmacies or pharmacists that supply emergency drug kits to and/or accept returned medications from long term care facilities or community based care facilities must: (a) Assist in the establishment and supervision of: (A) The policies and procedures for the safe storage, distribution, administration, and disposition of drugs; (B) The maintenance of controlled drug accountability records; and (C) The policies and procedures for professional advice/medication counseling of patients and/or their care givers. (b) Have some pharmacists visit and provide consultant services on a regular basis; and (c) Supervise the implementation of the policies and procedures involving the security, storage, stocking, labeling, and notification of use of emergency drugs kits and supplemental drug supplies. (2) Arrangements can be made in advance by a provider pharmacy with a long term care facility or a community based care facility to: (a) Provide emergency drug kits to those facilities permitted by their license to have them; and (b) Allow only a designated licensed nurse present in the facility access to the emergency drug kit or the on-site pharmacy pursuant to OAR 855-041-6310. (3) An emergency drug kit consists of those drugs that may be required and are authorized by a practitioner to meet the immediate therapeutic needs of patients, when medication is not readily available directly from a pharmacy. (4) The emergency drug kit inventory is the property of the provider pharmacy, and the provider pharmacy consultant is responsible for developing the policy and procedures for storing and stocking the emergency drug kit. (5) Medication(s) can only be removed from the emergency drug kit or the on-site pharmacy by a designated licensed nurse pursuant to a practitioner's order. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.305 History: BP 16-2020, minor correction filed 08/06/2020, effective 08/06/2020 Renumbered from 855-041-0160, BP 7-2012, f. & cert. ef. 12-17-12 BP 4-2002, f. 6-27-02, cert. ef. 7-1-02 PB 8-1990, f. & cert. ef. 12-5-90 PB 1-1990, f. & cert. ef. 1-23-90 1PB 2-1981, f. & ef. 8-20-81 1PB 1-1981(Temp), f. & ef. 4-1-81 1PB 2-1980, f. & ef. 4-3-80
855-041-7070 Long Term Care Pharmacy - Labeling and Distribution (1) Except as provided in subsection (2) of this section, all drugs dispensed for individual patients must be labeled as required by OAR 855-041- 1120, or administered by health care professionals from a unit dose system as defined in OAR 855-041- 6050(j). (2) Pharmacies that provide long term care facilities or community based care facilities with pharmaceuticals can supply, on the order of a practitioner, and consistent with the policy and procedures of the pharmacy or pharmacist providing consultant services: (a) Injectables for immunization and screening; (b) Irrigation solutions; and (c) Bulk manufacturer's container(s) of topical scabicides and pediculicides. (3) Institutional pharmacies that dispense medications to patients in long term care facilities and community based care facilities must maintain for three years the records required by OAR 855-041-1120, and comply with the patient counseling requirements of OAR 855-115-0145. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.305 History: BP 46-2024, minor correction filed 04/11/2024, effective 04/11/2024 BP 14-2020, minor correction filed 08/06/2020, effective 08/06/2020 Renumbered from 855-041-0162, BP 7-2012, f. & cert. ef. 12-17-12 BP 4-2002, f. 6-27-02, cert. ef. 7-1-02
855-041-7080 Pharmaceutical Care in Community Based Care Facilities When a pharmacist provides pharmaceutical care to patients in a Community Based Care facility under an arrangement with the facility, the pharmacist may provide the following services: (1) Assist facilities in establishing the appropriate policies and procedures for distribution, storage, documentation and disposal of drugs; (2) Assist facilities in establishing and maintaining proper record keeping related to medication administration; (3) Visit the facility on a regularly scheduled basis; (4) Supervise the distribution and storage of drugs; (5) Assist in providing appropriate training, in-service education, and clinical support to facility staff; and (6) Communicate with physicians and other practitioners as needed. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.305 History: Renumbered from 855-041-0164, BP 7-2012, f. & cert. ef. 12-17-12 BP 4-2002, f. 6-27-02, cert. ef. 7-1-02
855-042-0005 Purpose and Scope (1) Any person who provides radiopharmaceutical services shall be a nuclear pharmacist or working under the supervision of a nuclear pharmacist and shall act in accordance with the State Board of Pharmacy and State Radiation Control Agency rules. (2) These rules shall not apply to anyone who is an “authorized practitioner” as that term is defined in these rules. (3) The requirements imposed by these nuclear pharmacy rules shall apply in addition to, and not in place of, any other requirements contained in rules of the State Board of Pharmacy, the State Radiation Control Agency, or any other state or federal agency. Statutory/Other Authority: ORS 689 History: PB 7-1987, f. & ef. 7-8-87
855-042-0010 Definitions (1) A “Nuclear Pharmacy” is a pharmacy providing radiopharmaceutical services. (2) “Nuclear Pharmacist” means a licensed pharmacist who has met the requirements of these rules regarding training, education, and experience, and has received a letter of notification from the board indicating the board recognizes the pharmacist, based on evidence submitted, as qualified to provide radiopharmaceutical services. (3) “Radiopharmaceutical Services” shall mean, but shall not be limited to, the compounding, dispensing, labeling and delivery or radiopharmaceuticals; the participation in radiopharmaceutical selection and radiopharmaceutical utilization reviews; the proper and safe storage and distribution of radiopharmaceuticals; the maintenance of radiopharmaceutical quality assurance; the responsibility for advising, where necessary or where regulated, of therapeutic values, hazards and use of radiopharmaceuticals; and the offering or performing of those acts, services, operations or transactions necessary in the conduct, operation management and control of a nuclear pharmacy. (4) A “Radiopharmaceutical” is any substance defined as a drug in Section 201(g)(1) of the federal Food, Drug and Cosmetic Act which exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons and includes any such drug which is intended to be made radioactive. This definition includes nonradioactive reagent kits and nuclide generators which are intended to be used in the preparation of any such substance but does not include drugs such as carbon-containing compounds or potassium-containing compounds or potassium-containing salts which contain trace quantities of naturally occurring radionuclides. (5) “Radiopharmaceutical Quality Assurance” means, but is not limited to, the performance of appropriate chemical, biological and physical tests on radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment authentication of product history and the keeping of proper records. (6) “Internal Test Assessment” means, but is not limited to, conducting those tests of quality assurance necessary to insure the integrity of the test. (7) “Authentication of Product History” means, but is not limited to, identifying the purchasing source, the ultimate fate, and intermediate handling of any component of a radiopharmaceutical. (8) “Authorized Practitioner” means a practitioner duly authorized by law to possess, use, and administer radiopharmaceuticals. Statutory/Other Authority: ORS 689 History: PB 7-1987, f. & ef. 7-8-87
855-042-0025 Minimum Equipment Requirements (1) Nuclear pharmacies shall have adequate equipment commensurate with the scope of radiopharmaceutical services to be provided. A detailed list of equipment and description of use must be submitted to the State Board of Pharmacy and Radiation Control Agency before approval of the license. (2) The State Board of Pharmacy may, for good cause shown, waive rules pertaining to the equipment and supplies required for nuclear pharmacies handling radiopharmaceuticals exclusively. Statutory/Other Authority: ORS 689 History: PB 7-1987, f. & ef. 7-8-87
855-043-0002 Definitions In this division of rules: (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 by: (a) A practitioner or the practitioner’s authorized agent; or (b) The patient at the direction of the practitioner. (2) "Counseling" means an oral or other appropriate communication process between a practitioner and a patient or a patient's agent in which the practitioner obtains information from the patient or patient's agent, and, where appropriate, the patient's medical records, assesses that information and provides the patient or patient's agent with professional advice regarding the safe and effective use of the drug or device for the purpose of assuring therapeutic appropriateness. (3) "Dispense" or "Dispensing" means the preparation and delivery of a prescription drug pursuant to a 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. (4) “Expedited Partner Therapy (EPT)” means the practice of prescribing or dispensing an antibiotic drug for the treatment of a sexually transmitted disease to the partner of a patient without first examining that partner. (5) "Formulary" means a list of drugs or classes of drugs, or a list of disease states, health conditions or preventative measures such as immunization or birth control approved by the board or by the Oregon Health Authority (OHA). (6) "Health Officer" means a physician licensed by the Oregon Medical Board or the Oregon Board of Naturopathic Medicine and employed by or under contract with a county or district health department or OHA. (7) “Supervising Physician Dispensing Outlet” (SPDO) means any clinic, office, health care center, treatment center, or other establishment from which a physician assistant dispenses drugs, but that is not otherwise registered with the Board in the category of Retail Drug Outlet. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 History: BP 40-2021, amend filed 12/16/2021, effective 01/01/2022 BP 3-2012, f. & cert. ef. 6-19-12 Renumbered from 855-043-0120, BP 1-2010, f. & cert. ef. 2-8-10 PB 4-1992, f. & cert. ef. 8-25-92 PB 2-1992, f. & cert. ef. 3-26-92
855-043-0003 Expedited Partner Therapy (1) There is substantial evidence that rates of re-infection with certain sexually transmitted diseases can be reduced by treating all sexual partners for the disease, even when the treating clinician has not examined those partners. This practice is known as Expedited Partner Therapy. (2) Because of the important public health implications, the 2009 Oregon Legislature passed HB 3022 authorizing this practice. This law permits health professional regulatory boards to adopt rules permitting practitioners to practice Expedited Partner Therapy. (3) The law specifies that a prescription issued in the practice of Expedited Partner Therapy is valid, even if the name of the patient the prescription is intended for is not on the prescription. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.505 History: BP 40-2021, amend filed 12/16/2021, effective 01/01/2022 BP 1-2010, f. & cert. ef. 2-8-10
855-043-0004 Expedited Partner Therapy (EPT) - Procedures (1) Notwithstanding any other rules in this division that mandate requirements for a valid prescription and for labeling, when a prescription is marked EPT or a similar notation by the prescribing practitioner, this rule governs. (2) An EPT prescription may only be dispensed for a drug that has been determined by the Oregon Health Authority to be appropriately used for EPT. Prescription (3) An EPT treatment protocol must conform to the following: (a) It must include a prescription for each named or unnamed partner of the patient; (b) It must contain a hand written or electronic signature of the prescribing practitioner; (c) The practitioner must identify the prescription in the following manner: (A) Write “for EPT,” or a similar notation, on the face of the prescription; (B) For a verbal order, the practitioner must identify the prescription as an “EPT Prescription,” or similar identification; (C) The practitioner must identify the prescription for each partner either by including the name of the patient, such as “John Doe – Partner 1” or by labeling the prescription as “EPT Partner” (d) An EPT Prescription expires 30 days after the date written; (e) An EPT Prescription may not be refilled; (f) If any component of the prescription is missing, the DPDO must contact the prescriber or the prescriber’s agent and must record the additional information on the prescription. (4) A patient may give the prescription to each unnamed partner for that person to fill at a pharmacy of their choice; or the patient may elect for a DPDO to dispense all prescriptions and then give the dispensed drugs to each unnamed partner. Labeling (5) The DPDO must label the drug for the named patient in accordance with normal procedures as specified in the other rules of this division, however when either the patient or partner is unnamed, the DPDO may create a unique identifier and use that instead of a name for both labeling and record keeping purposes. (6) The DPDO must assign a separate and unique identifier to each prescription and clearly identity this number on each corresponding prescription label. Counseling (7) The DPDO is not required to obtain an EPT patient’s or partner’s name, address, or demographics; however, the DPDO must: (a) Provide counseling in the form of written patient information to accompany each prescription for each partner and ask the patient about any known allergies or other drugs being taken by each partner. The DPDO should advise the patient to encourage each partner to call the DPDO before taking the drug if they have experienced any adverse effect from a drug in the past or if they are taking other drugs; (b) Document counseling. Records (8) All documentation required by this rule must be attached to the prescription and must be referenced to each partner’s prescription. Such documentation must be retained in accordance with the other rules in this division and must be made available to the board upon request. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.505 History: BP 40-2021, adopt filed 12/16/2021, effective 01/01/2022
855-043-0505 Dispensing Practitioner Drug Outlets - Purpose Unless subject to an exemption in OAR 855-043-0510(2), a practitioner that engages in dispensing human prescription drug therapies must register their dispensing site with the board as a Dispensing Practitioner Drug Outlet (DPDO). 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
855-043-0520 Dispensing Practitioner Drug Outlets - Policies and Procedures The registered DPDO must maintain written policies and procedures for the management of drugs intended for dispensing, to include security, acquisition, storage, dispensing and drug delivery, disposal and record keeping. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 & ORS 689.305 History: BP 24-2021, minor correction filed 10/21/2021, effective 10/21/2021 BP 4-2017, adopt filed 11/30/2017, effective 12/01/2017
855-043-0525 Dispensing Practitioner Drug Outlets - 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) A drug dispensing machine cannot be placed in a waiting room or an area that is accessible by the public. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 & ORS 689.305 History: BP 25-2021, minor correction filed 10/21/2021, effective 10/21/2021 BP 4-2017, adopt filed 11/30/2017, effective 12/01/2017
855-043-0530 Dispensing Practitioner Drug Outlets - Drug Procurement The registered DPDO may only receive drugs from an Oregon Registered Drug Outlet (e.g. Wholesaler, Manufacturer or Pharmacy). 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
855-043-0535 Dispensing Practitioner Drug Outlets - Drug Storage All drugs must be stored according to 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 689.155 & ORS 689.305 History: BP 26-2021, minor correction filed 10/21/2021, effective 10/21/2021 BP 4-2017, adopt filed 11/30/2017, effective 12/01/2017
855-043-0540 Dispensing Practitioner Drug Outlet - Labeling (1) Except as described in SB 450 (2023), a prescription must be labeled with the following information: (a) Name of patient; (b) Name of prescriber; (c) Name, address, and phone number of the clinic; (d) Date of dispensing; (e) Name and strength of the drug. If the drug does not have a brand name, then the generic name of the drug and the drug manufacturer must be stated; (f) Quantity dispensed; (g) Directions for use; (h) Cautionary statements, if any, as required by law; and (i) An expiration date after which the patient should not use the drug or medicine. Expiration dates on prescriptions must be the same as that on the original container or one year from the date the drug was originally dispensed and placed in the new container, whichever date is earlier. Any drug expiring before the expected length of time for course of therapy must not be dispensed. (j) Any dispensed prescription medication, other than those in unit dose or unit of use packaging, must be labeled with its physical description, including any identification code that may appear on tablets and capsules. (2) Not withstanding any other requirements in this rule, when a drug is dispensed in the practice of an Expedited Partner Therapy treatment protocol, as described in OAR 855-043-0004, the name of the patient may be omitted. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155, ORS 689.305 & 2023 SB 450 History: BP 27-2023, amend filed 10/16/2023, effective 10/17/2023 BP 40-2021, amend filed 12/16/2021, effective 01/01/2022 BP 4-2017, adopt filed 11/30/2017, effective 12/01/2017
855-043-0541 Dispensing Practitioner Drug Outlet - 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 self-administration must bear a label in both English and the language requested for an individual with limited English proficiency, defined as a person who is not fluent in the English language. This does not apply to a drug outlet dispensing a drug intended for administration by a healthcare worker. (2) When dispensing a drug under (1), 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
855-043-0545 Dispensing Practitioner Drug Outlets - Dispensing and Drug Delivery (1) Prescription drugs must be personally dispensed by the practitioner unless otherwise authorized by the practitioner's licensing board. (2) Drugs dispensed from the DPDO must be dispensed in compliance with the requirements of the practitioner's licensing board. (3) A DPDO must comply with all requirements of State or federal law. (4) A DPDO 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). (5) Dispensed drugs must be packaged by the DPDO, a pharmacy, or a manufacturer registered with the board. (6) A DPDO 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. (7) A DPDO may deliver or mail prescription to the patient if: (a) Proper drug storage conditions are maintained; and (b) The DPDO 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. (8) The DPDO 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. (9) 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 689.155 & 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 4-2017, adopt filed 11/30/2017, effective 12/01/2017
855-043-0550 Dispensing Practitioner Drug Outlets - Disposal of Drugs Drugs that are recalled, 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 689.155 & ORS 689.305 History: BP 27-2021, minor correction filed 10/21/2021, effective 10/21/2021 BP 4-2017, adopt filed 11/30/2017, effective 12/01/2017