reglab/statecodes huggingface dataset:
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 42 - NUCLEAR PHARMACIES AND PHARMACISTS › Section 855-042-0005 - Purpose and Scope

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
Stat. Auth.: ORS 689
Stats. Implemented:
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 42 - NUCLEAR PHARMACIES AND PHARMACISTS › Section 855-042-0010 - Definitions

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
Stat. Auth.: ORS 689
Stats. Implemented:
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 42 - NUCLEAR PHARMACIES AND PHARMACISTS › Section 855-042-0015 - Nuclear Pharmacies

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Every
			 nuclear pharmacy shall have a nuclear pharmacist designated on the nuclear
			 pharmacy registration as the pharmacist-in-charge who shall be responsible for
			 the nuclear pharmacy's compliance with laws and rules, both state and federal,
			 pertaining to the practice of nuclear pharmacy. All personnel performing tasks
			 in the preparation and distribution of radio-pharmaceuticals shall be under the
			 supervision of a nuclear pharmacist. The nuclear pharmacy pharmacist-in-charge
			 shall see that directives from the board are communicated to the owner(s),
			 management, other pharmacists, and interns of the nuclear pharmacy. A
			 pharmacist may be pharmacist-in-charge for no more than one nuclear pharmacy at
			 any one given time.
(2) Nuclear
			 pharmacies shall have adequate space, commensurate with the scope of services
			 to be provided. The nuclear pharmacy area shall be separate from the pharmacy
			 areas for nonradio-pharmaceuticals and shall be secured from access by
			 unauthorized personnel. Detailed floor plans shall be submitted to the State
			 Board of Pharmacy and the State Radiation Control Agency before approval of the
			 registration.
(3) Nuclear
			 pharmacies shall only dispense radiopharmaceuticals which comply with accepted
			 professional standards of radiopharmaceutical quality assurance.
(4) Nuclear pharmacies shall maintain records
			 of acquisition and disposition of all radiopharmaceuticals in accordance with
			 applicable rules of the state Board of Pharmacy, the State Radiation Control
			 Agency and other state and federal agencies.
(5) For nuclear pharmacies handling
			 radiopharmaceuticals exclusively, the State Board of Pharmacy may waive
			 regulations pertaining to the pharmacy registration for nonradiopharmaceuticals
			 for requirements that do not pertain to the practice of nuclear
			 pharmacy.
(6) Radiopharmaceuticals
			 are to be dispensed only upon a prescription from a practitioner authorized to
			 possess, use and administer radiopharmaceuticals. A nuclear pharmacy may also
			 furnish radiopharmaceuticals for office use to these practitioners.
(7) A nuclear pharmacist may transfer to
			 authorized persons radioactive materials not intended for drug use, in
			 accordance with regulations of the state radiation control agency.
(8) Prescriptions or medication orders for
			 radiopharmaceuticals shall include:
(a) The
			 name of the practitioner and/or institution;
(b) The name of the
			 radiopharmaceutical;
(c) The amount
			 of radioactivity to be contained in millicuries, microcuries, or the SI
			 equivalent at calibration;
(d) The
			 date and time of calibration, and volume.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 42 - NUCLEAR PHARMACIES AND PHARMACISTS › Section 855-042-0025 - Minimum Equipment Requirements

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
Stat. Auth.: ORS 689
Stats. Implemented:
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 43 - PRACTITIONER DISPENSING › Section 855-043-0002 - Definitions

Current through Register Vol. 63, No. 7, July 1, 2024
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.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 43 - PRACTITIONER DISPENSING › Section 855-043-0003 - Expedited Partner Therapy

Current through Register Vol. 63, No. 7, July 1, 2024
(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
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 43 - PRACTITIONER DISPENSING › Section 855-043-0004 - Expedited Partner Therapy (EPT) - Procedures

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 43 - PRACTITIONER DISPENSING › Section 855-043-0130 - Repealed

Current through Register Vol. 63, No. 7, July 1, 2024
Stat. Auth.: ORS
				  689.205 &
				  689.605
Stats. Implemented: ORS
				  689.155,
				  689.505 &
				  676.350
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 43 - PRACTITIONER DISPENSING › Section 855-043-0210

Current through Register Vol. 63, No. 7, July 1, 2024
Publications: Publications referenced are available from the
				  agency.
Statutory/Other Authority: ORS
				  678.390 & ORS
				  689.205
Statutes/Other Implemented: ORS
				  689.205
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 43 - PRACTITIONER DISPENSING › Section 855-043-0310 - Repealed

Current through Register Vol. 63, No. 7, July 1, 2024
Stat. Auth.: ORS
				  689.205
Stats. Implemented: ORS
				  689.305, 2009 OL Ch
				  522
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 43 - PRACTITIONER DISPENSING › Section 855-043-0405

Current through Register Vol. 63, No. 7, July 1, 2024
Statutory/Other Authority: ORS
				  689.205
Statutes/Other Implemented: ORS
				  689.155, ORS
				  689.305 & ORS
				  677.511
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 43 - PRACTITIONER DISPENSING › Section 855-043-0410

Current through Register Vol. 63, No. 7, July 1, 2024
Statutory/Other Authority: ORS
				  689.205
Statutes/Other Implemented: ORS
				  689.155, ORS
				  689.305 & ORS
				  677.511
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 43 - PRACTITIONER DISPENSING › Section 855-043-0415

Current through Register Vol. 63, No. 7, July 1, 2024
Statutory/Other Authority: ORS
				  689.205
Statutes/Other Implemented: ORS
				  689.155, ORS
				  689.305 & ORS
				  677.511
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 43 - PRACTITIONER DISPENSING › Section 855-043-0420

Current through Register Vol. 63, No. 7, July 1, 2024
Statutory/Other Authority: ORS
				  689.205
Statutes/Other Implemented: ORS
				  689.155, ORS
				  689.305 & ORS
				  677.511
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 43 - PRACTITIONER DISPENSING › Section 855-043-0425

Current through Register Vol. 63, No. 7, July 1, 2024
Statutory/Other Authority: ORS
				  689.205
Statutes/Other Implemented: ORS
				  689.155, ORS
				  689.305 & ORS
				  677.511
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 43 - PRACTITIONER DISPENSING › Section 855-043-0430

Current through Register Vol. 63, No. 7, July 1, 2024
Statutory/Other Authority: ORS
				  689.205
Statutes/Other Implemented: ORS
				  689.155, ORS
				  689.305 & ORS
				  677.511
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 43 - PRACTITIONER DISPENSING › Section 855-043-0435

Current through Register Vol. 63, No. 7, July 1, 2024
Statutory/Other Authority: ORS 689.20
Statutes/Other Implemented: ORS
				  689.155, ORS
				  689.305 & ORS
				  677.511
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 43 - PRACTITIONER DISPENSING › Section 855-043-0440

Current through Register Vol. 63, No. 7, July 1, 2024
Statutory/Other Authority: ORS
				  689.205
Statutes/Other Implemented: ORS
				  689.155, ORS
				  689.305 & ORS
				  677.511
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 43 - PRACTITIONER DISPENSING › Section 855-043-0445

Current through Register Vol. 63, No. 7, July 1, 2024
Statutory/Other Authority: ORS
				  689.205
Statutes/Other Implemented: ORS
				  689.155, ORS
				  689.305 & ORS
				  677.511
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 43 - PRACTITIONER DISPENSING › Section 855-043-0450

Current through Register Vol. 63, No. 7, July 1, 2024
Statutory/Other Authority: ORS
				  689.205
Statutes/Other Implemented: ORS
				  689.155, ORS
				  689.305 & ORS
				  677.511
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 43 - PRACTITIONER DISPENSING › Section 855-043-0455

Current through Register Vol. 63, No. 7, July 1, 2024
Statutory/Other Authority: ORS
				  689.205
Statutes/Other Implemented: ORS
				  689.155, ORS
				  689.305 & ORS
				  677.511
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 43 - PRACTITIONER DISPENSING › Section 855-043-0505 - Dispensing Practitioner Drug Outlets - Purpose

Current through Register Vol. 63, No. 7, July 1, 2024
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
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 43 - PRACTITIONER DISPENSING › Section 855-043-0510 - Dispensing Practitioner Drug Outlets - Registration

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Unless subject to an exemption in OAR
			 855-043-0510(2),
			 a practitioner that engages in dispensing human prescription drug therapies
			 must register the dispensing site with the board as a DPDO on a form prescribed
			 by the board, and must renew its registration annually on a renewal form
			 prescribed by the board.
(2) A
			 practitioner's facility is exempt from this registration requirement if the
			 practitioner and facility only engages in:
(A) Dispensing FDA approved drug samples;
			 or
(B) Dispensing Medication
			 Assistance Program (MAP) drugs; or
(C) Dispensing homeopathic products;
			 or
(D) Dispensing natural thyroid
			 supplemental products; or
(E)
			 Dispensing a small amount of drugs to start therapy or incidental to a
			 procedure or office visit, up to a 72 hour supply; or
(F) An amount greater than a 72 hour supply
			 if the drug is:
(i) A drug in the
			 manufacturer's original unit-of-use packaging, such as a metered-dose-inhaler
			 or bottle of fluoride rinse; or
(ii) A full course of therapy, if in the
			 professional judgment of the practitioner would be in the patient's best
			 interest, such as a course of antibiotic therapy.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 43 - PRACTITIONER DISPENSING › Section 855-043-0520 - Dispensing Practitioner Drug Outlets - Policies and Procedures

Current through Register Vol. 63, No. 7, July 1, 2024
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
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 43 - PRACTITIONER DISPENSING › Section 855-043-0525 - Dispensing Practitioner Drug Outlets - Security

Current through Register Vol. 63, No. 7, July 1, 2024
(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
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 43 - PRACTITIONER DISPENSING › Section 855-043-0530 - Dispensing Practitioner Drug Outlets - Drug Procurement

Current through Register Vol. 63, No. 7, July 1, 2024
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
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 43 - PRACTITIONER DISPENSING › Section 855-043-0535 - Dispensing Practitioner Drug Outlets - Drug Storage

Current through Register Vol. 63, No. 7, July 1, 2024
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
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 43 - PRACTITIONER DISPENSING › Section 855-043-0540 - Dispensing Practitioner Drug Outlet - Labeling

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 43 - PRACTITIONER DISPENSING › Section 855-043-0541 - Dispensing Practitioner Drug Outlet - Limited English Proficiency and Accessibility

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 43 - PRACTITIONER DISPENSING › Section 855-043-0545 - Dispensing Practitioner Drug Outlets - Dispensing and Drug Delivery

Current through Register Vol. 63, No. 7, July 1, 2024
(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 (01/01/2023),
			 16 CFR 1701 (01/01/2023) and 16 CFR 1702 (01/01/2023).
(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.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 43 - PRACTITIONER DISPENSING › Section 855-043-0550 - Dispensing Practitioner Drug Outlets - Disposal of Drugs

Current through Register Vol. 63, No. 7, July 1, 2024
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
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 43 - PRACTITIONER DISPENSING › Section 855-043-0555 - Dispensing Practitioner Drug Outlets - Records

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 43 - PRACTITIONER DISPENSING › Section 855-043-0560 - Dispensing Practitioner Drug Outlets - Inspections

Current through Register Vol. 63, No. 7, July 1, 2024
(1) The DPDO must
			 complete the board Self Inspection Form by February 1, annually.
(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
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 43 - PRACTITIONER DISPENSING › Section 855-043-0600 - Correctional Facility - Purpose and Scope

Current through Register Vol. 63, No. 7, July 1, 2024
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
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 43 - PRACTITIONER DISPENSING › Section 855-043-0610 - Correctional Facility - Definitions

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 43 - PRACTITIONER DISPENSING › Section 855-043-0620 - Correctional Facility - Duties of the Pharmacist

Current through Register Vol. 63, No. 7, July 1, 2024
(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
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 43 - PRACTITIONER DISPENSING › Section 855-043-0630 - Correctional Facility - Drug Delivery and Control

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Policies and Procedures: The Pharmacist
			 and the practitioner representing the facility are responsible for establishing
			 written policies and procedures for medication management including, but not
			 limited to, drug procurement, dispensing, administration, labeling, medication
			 counseling, drug utilization review, medication records, parenterals, emergency
			 and nonroutine dispensing procedures, stop orders, over-the-counter drugs,
			 security, storage and disposal of drugs withing the facility. Policies and
			 procedures must be reviewed and updated annually by the Pharmacist and the
			 practitioner, maintained in the facility; and be made available to the board
			 for inspection. The facility must submit to the board for approval, the name of
			 any employee Pharmacist or a written agreement between the Pharmacist and the
			 facility regarding drug policies and procedures. The facility must notify the
			 board of any change of Pharmacist within 15 days of the change.
(2) Dispensing: Prescription drugs must be
			 dispensed by a Pharmacist or by a practitioner authorized to dispense in either
			 an individual container, medication card, or in a unit dose system.
(3) Unit Dose Dispensing System. The "Unit
			 Dose Dispensing System" is that drug distribution system which is pharmacy
			 based and which uses unit dose packaging in a manner which removes traditional
			 drug stock from patient care areas and enables the selection and distribution
			 of unit dose packaging to be pharmacy based and controlled:
(a) A unit dose dispensing system must:
(A) By nature of the system;
(i) Provide for separation of medications by
			 patient name and location; and
(ii)
			 Provide for separating medications by day of administration.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 43 - PRACTITIONER DISPENSING › Section 855-043-0700 - Community Health Clinic (CHC) - Purpose and Scope

Current through Register Vol. 63, No. 7, July 1, 2024
(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
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 43 - PRACTITIONER DISPENSING › Section 855-043-0705 - Community Health Clinic (CHC) - Registration

Current through Register Vol. 63, No. 7, July 1, 2024
(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
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 43 - PRACTITIONER DISPENSING › Section 855-043-0710 - Community Health Clinic (CHC) - Personnel

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 43 - PRACTITIONER DISPENSING › Section 855-043-0715 - Community Health Clinic (CHC) - Policies and Procedures

Current through Register Vol. 63, No. 7, July 1, 2024
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
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 43 - PRACTITIONER DISPENSING › Section 855-043-0720 - Community Health Clinic (CHC) - Security

Current through Register Vol. 63, No. 7, July 1, 2024
(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
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 43 - PRACTITIONER DISPENSING › Section 855-043-0725 - Community Health Clinic (CHC) - Drug Acquisition

Current through Register Vol. 63, No. 7, July 1, 2024
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
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 43 - PRACTITIONER DISPENSING › Section 855-043-0730 - Community Health Clinic (CHC) - Storage of Drugs

Current through Register Vol. 63, No. 7, July 1, 2024
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
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 43 - PRACTITIONER DISPENSING › Section 855-043-0735 - Community Health Clinic (CHC) - Labeling

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 43 - PRACTITIONER DISPENSING › Section 855-043-0736 - Community Health Clinic (CHC) - Limited English Proficiency and Accessibility

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 43 - PRACTITIONER DISPENSING › Section 855-043-0740 - Community Health Clinic (CHC) - Dispensing and Drug Delivery

Current through Register Vol. 63, No. 7, July 1, 2024
(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 (01/01/2023), 16 CFR 1701
			 (01/01/2023) and 16 CFR 1702 (01/01/2023).
(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.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 43 - PRACTITIONER DISPENSING › Section 855-043-0745 - Community Health Clinic (CHC) - Disposal of Drugs

Current through Register Vol. 63, No. 7, July 1, 2024
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
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 43 - PRACTITIONER DISPENSING › Section 855-043-0750 - Community Health Clinic (CHC) - Record Keeping

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 44 - CHARITABLE PHARMACIES › Section 855-044-0001 - Purpose

Current through Register Vol. 63, No. 7, July 1, 2024
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.
Stat. Auth.: ORS
				  689.205
Stats. Implemented: ORS
				  689.772 &
				  689.774
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 44 - CHARITABLE PHARMACIES › Section 855-044-0005 - Definitions

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
Stat. Auth.: ORS
				  689.205
Stats. Implemented: ORS
				  689.772 &
				  689.774
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 44 - CHARITABLE PHARMACIES › Section 855-044-0010 - Registration

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
Stat. Auth.: ORS
				  689.205
Stats. Implemented: ORS
				  689.774
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 44 - CHARITABLE PHARMACIES › Section 855-044-0020 - Personnel

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 44 - CHARITABLE PHARMACIES › Section 855-044-0030 - Drug Donation

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A charitable
			 pharmacy may not accept:
(a) Any controlled
			 substance or any kit, package or blister pack that contains any controlled
			 substance;
(b) A non-prescription
			 drug;
(c) A drug in a container or
			 package that does not contain a product identification label (PIL), except that
			 a drug in a manufacturer's original container or a manufacturer's blister pack
			 does not need to bear a PIL;
(d) An
			 FDA REMS (Risk Evaluation and Mitigation Strategy) drug;
(e) A drug donated from another
			 state.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 44 - CHARITABLE PHARMACIES › Section 855-044-0040 - Storage and Security

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A
			 charitable pharmacy must store all donated drugs securely and physically
			 separate from any existing inventory.
(2) All charitable pharmacy records must be
			 secured to comply with HIPAA and all state and federal regulations.
(3) Outdated and unusable drugs intended for
			 destruction must be quarantined and stored securely.
(4) A charitable pharmacy co-located with an
			 existing pharmacy must use storage and record keeping procedures that maintain
			 separation of charitable pharmacy records and drugs from other pharmacy records
			 and inventory.
Stat. Auth.: ORS
				  689.205
Stats. Implemented: ORS
				  689.774