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BOARD OF PHARMACY

 

DIVISION 41

OPERATION OF PHARMACIES (AMBULATORY AND RESIDENTIAL DRUG OUTLETS)

855-041-0005 [Renumbered to 855-041-1080]

855-041-0010 [Renumbered to 855-041-1085]

855-041-0015 [Renumbered to 855-041-1090]

855-041-0016 [Renumbered to 855-041-1170]

855-041-0017 [Renumbered to 855-041-1095]

855-041-0020 [Renumbered to 855-041-1010]

855-041-0025 [Renumbered to 855-041-1015]

855-041-0026 [Renumbered to 855-041-1020]

855-041-0035 [Renumbered to 855-041-2100]

855-041-0036 [Renumbered to 855-041-1025]

855-041-0037 [Renumbered to 855-041-1030]

855-041-0040 [Renumbered to 855-041-1035]

855-041-0055 [Renumbered to 855-041-1145]

855-041-0056 [Renumbered to 855-041-1135]

855-041-0057 [Renumbered to 855-041-1140]

855-041-0060 [Renumbered to 855-041-1040]

855-041-0061 [Renumbered to 855-041-1110]

855-041-0065 [Renumbered to 855-041-1105, 855-041-1120, 855-041-1125, 855-041-1130]

855-041-0075 [Renumbered to 855-041-2115]

855-041-0080 [Renumbered to 855-041-1045]

855-041-0086 [Renumbered to 855-041-1115]

855-041-0095 [Renumbered to 855-041-1050]

855-041-0103 [Renumbered to 855-041-1055]

855-041-0105 [Renumbered to 855-041-5005]

855-041-0115 [Renumbered to 855-041-5015]

855-041-0135 [Renumbered to 855-041-6800]

855-041-0140 [Renumbered to 855-041-6840]

855-041-0145 [Renumbered to 855-041-7050]

855-041-0160 [Renumbered to 855-041-7060]

855-041-0162 [Renumbered to 855-041-7070]

855-041-0164 [Renumbered to 855-041-7070]

855-041-0165 [Renumbered to 855-041-8050]

855-041-0170 [Renumbered to 855-043-0600]

855-041-0173 [Renumbered to 855-043-0610]

855-041-0175 [Renumbered to 855-043-0620]

855-041-0177 [Renumbered to 855-043-0630]

855-041-0300 [Renumbered to 855-041-1060]

855-041-0350 [Renumbered to 855-041-4025]

855-041-0355 [Renumbered to 855-041-4035]

855-041-0360 [Renumbered to 855-041-4045]

855-041-0365 [Renumbered to 855-041-4055]

855-041-0600 [Renumbered to 855-041-4100]

855-041-0610 [Renumbered to 855-041-4110]

855-041-0620 [Renumbered to 855-041-4120]

855-041-0645 [Renumbered to 855-041-4200]

General

855-041-1001

Definitions

(1) “Biological product” means, with respect to the prevention, treatment or cure of a disease or condition of human beings, a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component, blood derivative, allergenic product, protein other than a chemically synthesized polypeptide, analogous products or arsphenamine or any other trivalent organic arsenic compound.

(2) “Biosimilar product” means a biological product licensed by the United States Food and Drug Administration pursuant to 42 U.S.C. 262(k)(3)(A)(i).

(3) “Interchangeable” means, in reference to a biological product, that the United States Food and Drug Administration has determined that a biosimilar product meets the safety standards set forth in 42 U.S.C. 262(k)(4).

(4) “Reference biological product” means the biological product licensed pursuant to 42 U.S.C. 262(a) against which a biological product is evaluated in an application submitted to the United States Food and Drug Administration for licensure of a biological product as a biosimilar product or for determination that a biosimilar product is interchangeable.

Stat. Auth.: ORS 689.205 & 2013 OL Ch 342
Stats. Implemented: ORS 689.155 & 2013 OL Ch 342
Hist.: BP 2-2014, f. & cert. ef. 1-24-14

855-041-1010

Personnel (Both Retail and Institutional Drug Outlets)

(1) Each pharmacy must have one pharmacist-in-charge employed on a regular basis at that location who shall be responsible for the daily operation of the pharmacy. The pharmacist-in-charge shall be indicated on the application for a new or relocated pharmacy and for pharmacy renewal registration.

(2) The pharmacy must ensure that it is in compliance with all state and federal laws and rules governing the practice of pharmacy and that all controlled substance records and inventories are maintained in conformance with the keeping and inventory requirements of federal law and board rules.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.151, 689.155, 689.305
Hist.: 1PB 2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; 1PB 3-1986, f. & ef. 12-8-86; PB 10-1987, f. & ef. 12-8-87; PB 9-1989, f. & cert. ef. 7-20-89; PB 4-1992, f. & cert. ef. 8-25-92; PB 1-1994, f. & cert. ef. 2-2-94; PB 1-1995, f. & cert. ef. 4-27-95; PB 1-1996, f. & cert. ef. 4-5-96; BP 1-2001, f. & cert. ef. 3-5-01; BP 2-2008, f. & cert. ef. 2-20-08; Renumbered from 855-041-0020, BP 7-2012, f. & cert. ef. 12-17-12

855-041-1015

Operation of Pharmacy (Both Retail and Institutional Drug Outlets)

(1) Supervision. A pharmacy may only be operated when a pharmacist licensed to practice in this state is present. This means that the pharmacist must be physically present in the pharmacy or institutional facility.

(2) Sanitation:

(a) Pharmacies shall be kept clean.

(b) Persons working in a pharmacy shall practice appropriate infection control.

Stat. Auth.: ORS 689.305
Stats. Implemented: ORS 689.305
Hist.: 1PB 2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; PB 12-1989, f. & cert. ef. 8-11-89; PB 1-1997, f. & cert. ef. 9-22-97; Renumbered from 855-041-0025, BP 7-2012, f. & cert. ef. 12-17-12

855-041-1020

Security of Prescription Area

(1) The area in a registered pharmacy where legend and/or controlled substances are stored, possessed, prepared, manufactured, compounded, or repackaged shall be restricted in access, in such a manner as to ensure the security of those drugs.

(2) The pharmacist-in-charge and each pharmacist while on duty shall be responsible for the security of the prescription area including provisions for adequate safeguards against theft or diversion of prescription drugs, and records for such drugs.

(3) When there is no pharmacist present, the pharmacy shall be secured to prevent entry. All entrances to the pharmacy shall be securely locked and any keys to the pharmacy shall remain in the possession of the pharmacist-in-charge and other employee pharmacists as authorized by the pharmacist-in-charge. When there is no pharmacist present, and it is necessary for non-pharmacist employees or owners to have access to the pharmacy, the prescription area shall be secured from entry as described in OAR 855-041- 2100.

(4) Prescription drugs and devices and non-prescription Schedule V controlled substances shall be stored within the prescription area or a secured storage area.

(5) Any security system deviating from the requirements of this section, except as provided in OAR 855-041- 6310, shall be approved by the Board prior to implementation. Requests for such approval shall be in writing and provide a detailed description of the proposed system. A written description of such security system, as approved by the Board, shall be maintained in the pharmacy.

Stat. Auth.: ORS 475.035 & 689.205
Stats. Implemented: ORS 689.205
Hist.: 1PB 5-1982, f. & ef. 8-6-82; PB 1-1987, f. & ef. 2-3-87; Renumbered from 855-041-0026, BP 7-2012, f. & cert. ef. 12-17-12

855-041-1025

Disposal of Drugs

Drugs that are outdated, damaged, deteriorated, misbranded, or adulterated shall be quarantined and physically separated from other drugs until they are destroyed or returned to their supplier.

Stat. Auth.: ORS 475.035, 689.155, 689.205, 689.305 & 689.315
Stats. Implemented:
Hist.: 1PB 2-1984, f. & ef. 3-7-84; PB 1-1990, f. & cert. ef. 1-23-90; PB 1-1992, f. & cert. ef. 1-31-92 (and corrected 2-7-92); Renumbered from 855-041-0036, BP 7-2012, f. & cert. ef. 12-17-12

855-041-1030

Reporting Drug Loss

(1) Disasters, accidents and emergencies which may affect the strength, purity, or labeling of drugs or devices shall immediately be reported to the Board.

(2) The outlet shall notify the Board in the event of a significant drug loss or violation related to drug theft within one (1) business day.

(3) At the time a Report of Theft or Loss of Controlled Substances (D.E.A. Form 106) is sent to the Drug Enforcement Administration, a copy shall be sent to the Board.

Stat. Auth.: ORS 475.035, 689.155, 689.205, 689.305 & 689.315
Stats. Implemented: ORS 689.155
Hist.: 1PB 2-1981, f. & ef. 8-20-81; 1PB 1-1986, f. & ef. 6-5-86; PB 1-1992, f. & cert. ef. 1-31-92 (and corrected 2-7-92); Renumbered from 855-041-0037, BP 7-2012, f. & cert. ef. 12-17-12; BP 2-2014, f. & cert. ef. 1-24-14

855-041-1035

Minimum Equipment Requirements (Both Retail and Institutional Drug Outlets)

The minimum equipment requirement to open and operate a retail drug outlet and institutional drug outlet in the state of Oregon shall consist of not less than the following:

(1) 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.

(2) Current and properly filed Oregon Revised Statutes, Chapters 689, and 475; current and properly filed Oregon Administrative Rules, chapter 855; and a minimum of three years of the Board of Pharmacy quarterly newsletters maintained in house or other readily retrievable means.

(3) Official Poison and Exempt Narcotic Register if poisons and exempt narcotics are sold or distributed.

(4) Suitable refrigeration.

(5) A sink with running hot and cold water.

(6) Equipment and supplies appropriate to and based on the standards of practice for the setting as determined by the Pharmacy and Pharmacist-in-Charge.

(7) Failure to have and use equipment necessary to your practice setting constitutes unprofessional conduct for purposes of ORS 689.405(1)(a).

(8) If an outlet files original prescriptions electronically, then the outlet must have a computer and software capable of storing and accessing electronically filed original prescriptions. Exceptions to the above list may be approved by the Board of Pharmacy.

Stat. Auth.:ORS 689.205 & 689.508
Stats. Implemented: ORS 689.205 & 689.508
Hist.: 1PB 2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; 1PB 1-1981(Temp), f. & ef. 4-1-81; 1PB 2-1981, f. & ef. 8-20-81; 1PB 4-1986, f. & ef. 12-8-86; PB 8-1987, f. & ef. 9-30-87; PB 12-1989, f. & cert. ef. 8-11-89; PB 4-1991, f. & cert. ef. 9-19-91; PB 1-1992, f. & cert. ef. 1-31-92 (and corrected 2-7-92); PB 4-1992, f. & cert. ef. 8-25-92; PB 1-1994, f. & cert. ef. 2-2-94; BP 3-2005, f. & cert. ef. 4-14-05); Renumbered from 855-041-0040, BP 7-2012, f. & cert. ef. 12-17-12

855-041-1040

Drug Outlet Procedures

Each drug outlet is accountable for establishing, maintaining, and enforcing their written procedures for:

(1) Securing their legend drugs and the area in which they are prepared, compounded, stored or repackaged;

(2) Performing mandatory prospective drug utilization reviews; on all prescriptions both new and refilled;

(3) Verifying the accuracy of all completed prescriptions and medical orders before they leave the pharmacy's secured legend area;

(4) Documenting the identification of the pharmacist responsible for the verification of each dispensed medication;

(5) Ensuring the delivery of each completed prescription to the correct party;

(6) Providing appropriate confidential professional advice concerning medications to patients or their agents;

(7) Ensuring that all who work in the pharmacy are appropriately licensed and adequately trained to perform their duties and;

(8) Establishing and maintaining a Continuous Quality Assurance Program.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.151, 689.155, 689.508
Hist.: 1PB 2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; PB 1-1994, f. & cert. ef. 2-2-94; BP 3-2005, f. & cert. ef. 4-14-05; BP 2-2008, f. & cert. ef. 2-20-08; Renumbered from 855-041-0060, BP 7-2012, f. & cert. ef. 12-17-12

855-041-1045

Returned Drugs and Devices

(1) Pharmacists, pharmacies, pharmacy technicians, and certified pharmacy technicians may only accept the return of controlled substances upon receiving a waiver from the Board of Pharmacy.

(2) Pharmacists, pharmacies, pharmacy technicians, and certified pharmacy technicians may accept the return of drugs or devices as defined by ORS 689.005 once the drugs or devices have been removed from the pharmacy only if;

(a) The drugs or devices are accepted for destruction or disposal and;

(b) The drugs or devices were dispensed in error, were defective, adulterated, misbranded, dispensed beyond their expiration date, were unable to be delivered to the patient, or are subject of a drug or device recall; or

(c) After consultation, a pharmacist determines that, in the pharmacist’s professional judgment, harm could result to the public or a patient if the drugs or devices were not accepted for return.

(3) Not withstanding section 2 of this rule, drugs or devices previously dispensed or distributed may be returned and redispensed or redistributed provided all the following conditions are met:

(a) The drug is in an unopened, tamper-evident unit;

(b) The drugs or devices have remained at all times in control of a person trained and knowledgeable in the storage and administration of drugs in long term care facilities or supervised living groups using the services of a consultant pharmacist;

(c) The drug or device has not been adulterated or misbranded and has been stored under conditions meeting United States Pharmacopeia standards.

(4) Upon written request, the Board may waive any of the requirements of this rule if a waiver will further public heath 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.

Stat. Auth.: ORS 475 & 689
Stats. Implemented:
Hist.: 1PB 2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; 1PB 1-1981(Temp), f. & ef. 4-1-81; 1PB 2-1981, f. & ef. 8-20-81; PB 5-1989, f. & cert. ef. 1-30-89; PB 8-1990, f. & cert. ef. 12-5-90; BP 2-2006, f. & cert. ef. 6-9-06); Renumbered from 855-041-0080, BP 7-2012, f. & cert. ef. 12-17-12

855-041-1050

Pharmacy Depots

(1) Except when delivering directly to a patient, licensed pharmacists may not participate in the transfer of completed prescription medication containers to or from any location that is not a licensed pharmacy, unless the transfer occurs to:

(a) The office of the patient’s health care practitioner; or

(b) The location of the patient; or

(A) Patient’s primary residence; or

(B) Alternate residence designated by the patient; or

(C) Patient’s workplace; or

(c) The hospital or medical care facility in which a patient is receiving care.

(2) 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.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689
Hist.: 1PB 2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; BP 9-2011, f. 12-30-11, cert. ef. 1-1-12; BP 1-2012, f. 4-26-12, cert. ef. 5-1-12; Renumbered from 855-041-0095, BP 7-2012, f. & cert. ef. 12-17-12

855-041-1055

Confidentiality

(1) No licensee or registrant of the Board who obtains any patient information shall disclose that information to a third party without the consent of the patient.

(2) Section (1) of this rule does not apply to:

(a) Any disclosure made to the Board;

(b) Any disclosure made to a practitioner or to another pharmacist when the pharmacist reasonably believes that disclosing such information is necessary to protect the patient’s health or well being; or

(c) To a third party when disclosure is otherwise authorized or required by law.

Stat. Auth.: ORS 689.155 & 689.205
Stats. Implemented:
Hist.: PB 5-1992, f. & cert. ef. 10-23-92; Renumbered from 855-041-0103, BP 7-2012, f. & cert. ef. 12-17-12

855-041-1060

Out-of State Pharmacies

(1) Every out-of-state pharmacy that delivers prescription drugs or devices to a resident in this state shall be registered with the Oregon Board of Pharmacy.

(2) To qualify for registration under these rules, every out-of-state pharmacy shall be registered and in good standing with the Board of Pharmacy in the pharmacy's state of residence.

(3) Every out-of-state pharmacy shall designate a pharmacist-in-charge, who shall be responsible for all prescription drugs and devices delivered to residents in Oregon. To qualify for this designation, the person must hold a license to practice pharmacy in the state of residence of the out-of-state pharmacy and in Oregon, and be in good standing with both licensing boards.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.151, 689.155, 689.225
Hist.: PB 1-1994, f. & cert. ef. 2-2-94; BP 2-2008, f. & cert. ef. 2-20-08; Renumbered from 855-041-0300, BP 7-2012, f. & cert. ef. 12-17-12

Licensure

855-041-1080

Pharmacy Registration (Both Retail and Institutional Drug Outlets)

(1) Pharmacies shall be registered as either retail drug outlets or institutional drug outlets or both.

(2) An application for registration of a new pharmacy shall be accompanied by a floor plan drawn to scale and shall be approved by the Board prior to opening.

(3) The application shall specify the location of the pharmacy and shall indicate the owner, trustee, receiver, or other person applying for the registration. When an applicant is not the owner of the pharmacy, the application shall indicate the owner and the applicant's affiliation with the owner:

(a) If the owner is a partnership or other multiple owner, the names of the partners or persons holding the five largest interests shall be indicated on the application;

(b) If the owner is a corporation, the name filed shall be the same as filed with the Corporation Commissioner. The name of the corporation, the names of the corporation officers and the names of the stockholders who own the five largest interests shall be indicated on the application.

(4) Upon request by the Board, the applicant shall furnish such information as required by the Board regarding the partners, stockholders, or other persons not named in the application.

(5) The application shall also identify any person who has incidents of ownership in the pharmacy who also has financial interest in any long-term care facility as defined in ORS 442.015.

(6) A certificate of registration will be issued upon Board approval of the application.

(7) All registration renewal applications shall be accompanied by the annual fee and shall contain the same information required in sections (3) and (4) of this rule.

(8) The initial and annual registration fee for pharmacies is set out in division 110 of this chapter.

(9) Pharmacy registration expires March 31, annually. If the annual registration fee referred to in Division 110 of this Chapter is not paid by March 31 of the current year, a delinquent fee as set out in Division 110 of this Chapter shall be included with the application for registration renewal.

(10) The registration is not transferable and the registration fee cannot be prorated.

(11) A change of ownership requires the approval of the Board and new certificate of registration. Application shall be on a form supplied by the Board.

(12) A change of ownership includes any change in the legal form of the business including additions or deletions of partners.

(13) Applicants for change in ownership shall provide the Board with the information required in sections (3), (4), and (5) of this rule.

(14) A change of ownership shall be reported to the Board within 15 days of the occurrence.

(15) No pharmacy shall be operated until a certificate of registration has been issued to the pharmacy by the Board.

Stat. Auth.: ORS 475.035 & 689.205
Stats. Implemented: ORS 689.155   
Hist.: 1PB 2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; PB 5-1990, f. & cert. ef. 4-12-90; PB 4-1992, f. & cert. ef. 8-25-92; PB 1-1994, f. & cert. ef. 2-2-94; Renumbered from 855-041-0005, BP 7-2012, f. & cert. ef. 12-17-12

855-041-1085

Change of Location of a Pharmacy (Both Retail and Institutional Drug Outlets)

(1) A change of location of a pharmacy requires the approval of the Board and a new certificate of registration.

(2) Application for approval to relocate shall be on a form provided by the Board and shall be accompanied by fees and a floor plan drawn to scale.

(3) A certificate of registration will be issued upon Board approval of the application.

(4) Following Board approval, a change of location, shall be reported to the Board within 15 days of the occurrence.

(5) No pharmacy shall be operated until a certificate of registration has been issued to the pharmacy by the Board.

Stat. Auth.: ORS 475.035 & 689.205
Stats. Implemented:
Hist.: 1PB 2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; PB 5-1990, f. & cert. ef. 4-12-90; PB 1-1994, f. & cert. ef. 2-2-94; Renumbered to 855-041-0010, BP 7-2012, f. & cert. ef. 12-17-12

855-041-1090

Change of Business Name, Closure (Both Retail and Institutional Drug Outlets)

(1) Any change of business name of a pharmacy must be reported to the Board within 15 days by filing a new application for which no fee is required.

(2) Any closure of a pharmacy shall be reported to the Board within 15 days and include notification of the disposition of controlled substances, dangerous, legend, and restricted drugs.

Stat. Auth.: ORS 475.035 & 689.205
Stats. Implemented: ORS 689.205
Hist.: 1PB 2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; PB 1-1994, f. & cert. ef. 2-2-94; Renumbered from 855-041-0015, BP 7-2012, f. & cert. ef. 12-17-12

855-041-1095

Pharmacy Advertising

No person shall advertise or otherwise purport to operate as a pharmacy or to advertise or purport to provide pharmacy services unless the person is registered with the Board pursuant to ORS 689.305.

Stat. Auth.: ORS 475.035, 689.155, 689.205, 689.305 & 689.315
Stats. Implemented:
Hist.: PB 1-1992, f. & cert. ef. 1-31-92 (and corrected 2-7-92); Renumbered from 855-041-0017, BP 7-2012, f. & cert. ef. 12-17-12

Prescriptions

855-041-1105

Requirements for Prescriptions

(1) Prescriptions, prescription refills, and drug orders must be correctly dispensed in accordance with the prescribing practitioner's authorization. When a prescription is transmitted orally, both the receiving pharmacist's name or initials and the name of the person transmitting must be noted on the prescription.

(2) Each pharmacy must document the following information:

(a) The name of the patient for whom or the owner of the animal and the species of the animal for which the drug is dispensed;

(b) The full name and, in the case of controlled substances, the address and the Drug Enforcement Administration registration number of the practitioner or other number as authorized under rules adopted by reference under rule OAR 855-080-0085;

(c) The name, strength, dosage forms of the substance, quantity prescribed and, if different from the quantity prescribed, the quantity dispensed;

(d) The directions for use, if given by the practitioner; and

(e) The date of filling, and the total number of refills authorized by the prescribing practitioner.

(3) In accordance with ORS 689.515(3), a practitioner may specify in writing, by a telephonic communication or by electronic transmission that there may be no substitution for the specified brand name drug in a prescription.

(a) For a hard copy prescription issued in writing or a prescription orally communicated over the telephone, instruction may use any one of the following phrases or notations:

(A) No substitution;

(B) N.S.;

(C) Brand medically necessary;

(D) Brand necessary;

(E) Medically necessary;

(F) D.A.W. (Dispense As Written); or

(G) Words with similar meaning.

(b) For an electronically transmitted prescription, the prescriber or prescriber’s agent shall clearly indicate substitution instructions by way of the text (without quotes) “brand medically necessary” or words with similar meaning, in the electronic prescription drug order, as well as all relevant electronic indicators sent as part of the electronic prescription transmission.

(c) Such instructions shall not be default values on the prescription.

(4) A pharmacy or pharmacist filling a prescription or order for a biological product may not substitute a biosimilar product for the prescribed biological product unless:

(a) The biosimilar product has been determined by the United States Food and Drug Administration to be interchangeable with the prescribed biological product;

(b) The prescribing practitioner has not designated on the prescription that substitution is prohibited;

(c) The patient for whom the biological product is prescribed is informed of the substitution prior to dispensing the biosimilar product;

(d) The pharmacy or pharmacist provides written, electronic or telephonic notification of the substitution to the prescribing practitioner or the prescribing practitioner’s staff within three (3) business days of dispensing the biosimilar product; and

(e) The pharmacy or pharmacist retains a record of the substitution for a period of not less than three (3) years.

(5) Upon written request and for good cause, the Board may waive any of the requirements of this rule. A waiver granted under this section shall only be effective when it is issued by the Board in writing.

Stat. Auth.: ORS 689.205 & 2013 OL Ch. 342
Stats. Implemented: ORS 689.505, 689.515 & 2013 OL Ch. 342
Hist.: 1PB 2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; 1PB 3-1984, f. & ef. 4-16-84; 1PB 1-1986, f. & ef. 6-5-86; PB 8-1987, f. & ef. 9-30-87; PB 10-1989, f. & cert. ef. 7-20-89; PB 1-1991, f. & cert. ef. 1-24-91; PB 4-1991, f. & cert. ef. 9-19-91; PB 1-1992, f. & cert. ef. 1-31-92 (and corrected 2-7-92); PB 4-1992, f. & cert. ef. 8-25-92; PB 1-1995, f. & cert. ef. 4-27-95; PB 1-1996, f. & cert. ef. 4-5-96; PB 3-1997(Temp), f. & cert. ef. 11-12-97; BP 1-1998(Temp), f. & cert. ef. 1-27-98 thru 5-4-98; BP 2-1998, f. & cert. ef. 3-23-98; BP 2-1999(Temp), f. & cert. ef. 8-9-99 thru 1-17-00; BP 2-2000, f. & cert. ef. 2-16-00; BP 3-2000, f. & cert. ef. 2-16-00; BP 6-2000, f. & cert. ef. 6-29-00; BP 1-2002, f. & cert. ef. 1-8-02; BP 1-2003, f. & cert. ef. 1-14-03; BP 12-2010, f. & cert. ef. 12-23-10; Renumbered from 855-041-0065, BP 7-2012, f. & cert. ef. 12-17-12; BP 2-2014, f. & cert. ef. 1-24-14

855-041-1110

Tamper-resistant Prescription

When the use of a tamper-resistant prescription is required by any federal or state law or rule, the term “tamper-resistant” shall have the meaning as defined in OAR 855-006-0015.

Stat. Auth.: 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 2-2007(Temp), f. & cert. ef. 8-27-07 thru 2-18-08; BP 1-2008, f. & cert. ef. 2-5-08); Renumbered from 855-041-0061, BP 7-2012, f. & cert. ef. 12-17-12

855-041-1115

Verification of Prescription Authenticity

Alteration of a written prescription, other than by a pharmacist's or practitioner's authorization, in any manner constitutes an invalid order unless verified with the prescriber.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.151, 689.155, 689.508
Hist.: 1PB 2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; BP 2-2008, f. & cert. ef. 2-20-08; Renumbered from 855-041-0086, BP 7-2012, f. & cert. ef. 12-17-12

855-041-1120

Prescription Refills

(1) Where refill authority is given other than by the original prescription, documentation that such refill authorization was given, the date of authorization, and name of the authorizing prescriber or the prescriber's agent must be recorded. This documentation must be readily retrievable. Prescriptions for controlled substances in Schedules III and IV are limited to five refills or six months from date of issue, whichever comes first.

(2) If the practitioner is not available and in the professional judgment of the pharmacist an emergency need for the refill of a prescription drug has been demonstrated, the pharmacist may dispense a sufficient quantity of the drug consistent with the dosage regimen, provided it is not a controlled substance, to last until a practitioner can be contacted for authorization, but not to exceed a 72-hour supply. The practitioner shall be promptly notified of the emergency refill.

(3) Each refilling of a prescription must be accurately documented, readily retrievable, and uniformly maintained for three years. This record must include.;

(a) The identity of the responsible pharmacist;

(b) Name of the patient;

(c) Name of the medication;

(d) Date of refill; and

(e) Quantity dispensed.

(4) Refill quantities maybe combined into a single filling if the prescription is not for a controlled substance or psychotherapeutic drug and the prescriber is notified of the change.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.505 & 689.515
Hist.: 1PB 2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; 1PB 3-1984, f. & ef. 4-16-84; 1PB 1-1986, f. & ef. 6-5-86; PB 8-1987, f. & ef. 9-30-87; PB 10-1989, f. & cert. ef. 7-20-89; PB 1-1991, f. & cert. ef. 1-24-91; PB 4-1991, f. & cert. ef. 9-19-91; PB 1-1992, f. & cert. ef. 1-31-92 (and corrected 2-7-92); PB 4-1992, f. & cert. ef. 8-25-92; PB 1-1995, f. & cert. ef. 4-27-95; PB 1-1996, f. & cert. ef. 4-5-96; PB 3-1997(Temp), f. & cert. ef. 11-12-97; BP 1-1998(Temp), f. & cert. ef. 1-27-98 thru 5-4-98; BP 2-1998, f. & cert. ef. 3-23-98; BP 2-1999(Temp), f. & cert. ef. 8-9-99 thru 1-17-00; BP 2-2000, f. & cert. ef. 2-16-00; BP 3-2000, f. & cert. ef. 2-16-00; BP 6-2000, f. & cert. ef. 6-29-00; BP 1-2002, f. & cert. ef. 1-8-02; BP 1-2003, f. & cert. ef. 1-14-03; BP 12-2010, f. & cert. ef. 12-23-10; Renumbered from 855-041-0065, BP 7-2012, f. & cert. ef. 12-17-12

855-041-1125

Prescription Expiration

This section of rule addresses the expiration date of the prescription and not the expiration date of the drug.

(1) After one year from date of issue, a prescription for a non-controlled substance becomes invalid and must be re-authorized by the prescriber.

(2) When used alone as a prescription refill designation the abbreviation, "PRN" for a non-controlled substance means that the medication can be refilled in proper context for a period of one year.

(a) When this abbreviation is used alone as a means to authorize refills for a controlled substance, the medication can be refilled in proper context for a period of six months or five refills, whichever comes first.

(b) When this abbreviation is used in conjunction with a definite time period, or a specific number of refills, the non-controlled medication can be refilled in proper context for a period not to exceed one year.

(3) The prescription shall not be refilled out of context with the approximate dosage schedule unless specifically authorized by the prescriber.

(4) A "non-controlled substance" means those drugs defined as "legend" pursuant to ORS 689.005(29) but does not include those drugs or substances controlled under the jurisdiction of the United States Department of Justice Drug Enforcement Administration.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.505 & 689.515
Hist.: 1PB 2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; 1PB 3-1984, f. & ef. 4-16-84; 1PB 1-1986, f. & ef. 6-5-86; PB 8-1987, f. & ef. 9-30-87; PB 10-1989, f. & cert. ef. 7-20-89; PB 1-1991, f. & cert. ef. 1-24-91; PB 4-1991, f. & cert. ef. 9-19-91; PB 1-1992, f. & cert. ef. 1-31-92 (and corrected 2-7-92); PB 4-1992, f. & cert. ef. 8-25-92; PB 1-1995, f. & cert. ef. 4-27-95; PB 1-1996, f. & cert. ef. 4-5-96; PB 3-1997(Temp), f. & cert. ef. 11-12-97; BP 1-1998(Temp), f. & cert. ef. 1-27-98 thru 5-4-98; BP 2-1998, f. & cert. ef. 3-23-98; BP 2-1999(Temp), f. & cert. ef. 8-9-99 thru 1-17-00; BP 2-2000, f. & cert. ef. 2-16-00; BP 3-2000, f. & cert. ef. 2-16-00; BP 6-2000, f. & cert. ef. 6-29-00; BP 1-2002, f. & cert. ef. 1-8-02; BP 1-2003, f. & cert. ef. 1-14-03; BP 12-2010, f. & cert. ef. 12-23-10; Renumbered from 855-041-0065, BP 7-2012, f. & cert. ef. 12-17-12

Labeling

855-041-1130

Prescription Labeling

(1) Prescriptions must be labeled with the following information:

(a) Name, address and telephone number of the pharmacy;

(b) Date;

(c) Identifying number;

(d) Name of patient;

(e) 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;

(f) Directions for use by the patient;

(g) Name of practitioner;

(h) Required precautionary information regarding controlled substances;

(i) Such other and further accessory cautionary information as required for patient safety;

(j) 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 unless, in the pharmacist's professional judgment, a shorter expiration date is warranted. Any drug bearing an expiration date shall not be dispensed beyond the said expiration date of the drug; and

(k) Any dispensed prescription medication, other than those in unit dose or unit of use packaging, shall be labeled with its physical description, including any identification code that may appear on tablets and capsules.

(l) Upon written request and for good cause, the Board may waive any of the requirements of this rule. A waiver granted under this section shall only be effective when it is issued by the Board in writing.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.505 & 689.515
Hist.: 1PB 2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; 1PB 3-1984, f. & ef. 4-16-84; 1PB 1-1986, f. & ef. 6-5-86; PB 8-1987, f. & ef. 9-30-87; PB 10-1989, f. & cert. ef. 7-20-89; PB 1-1991, f. & cert. ef. 1-24-91; PB 4-1991, f. & cert. ef. 9-19-91; PB 1-1992, f. & cert. ef. 1-31-92 (and corrected 2-7-92); PB 4-1992, f. & cert. ef. 8-25-92; PB 1-1995, f. & cert. ef. 4-27-95; PB 1-1996, f. & cert. ef. 4-5-96; PB 3-1997(Temp), f. & cert. ef. 11-12-97; BP 1-1998(Temp), f. & cert. ef. 1-27-98 thru 5-4-98; BP 2-1998, f. & cert. ef. 3-23-98; BP 2-1999(Temp), f. & cert. ef. 8-9-99 thru 1-17-00; BP 2-2000, f. & cert. ef. 2-16-00; BP 3-2000, f. & cert. ef. 2-16-00; BP 6-2000, f. & cert. ef. 6-29-00; BP 1-2002, f. & cert. ef. 1-8-02; BP 1-2003, f. & cert. ef. 1-14-03; BP 12-2010, f. & cert. ef. 12-23-10; Renumbered from 855-041-0065, BP 7-2012, f. & cert. ef. 12-17-12

855-041-1135

Defines Labeling and Container Requirements for Repackage Drugs

(1) Drugs prepackaged by a pharmacy for later own use dispensing on prescription shall be in a container meeting USP standards and labeled to identify at a minimum:

(a) Brand name, or generic name and manufacturer;

(b) Strength;

(c) Lot number;

(d) Manufacturer’s expiration date, or any earlier date which, in the pharmacist’s professional judgment, is preferable.

(2) An internal control number which references manufacturer and lot number may be utilized.

Stat. Auth.: ORS 689
Stats. Implemented:
Hist.: PB 6-1987, f. & ef. 5-1-87); Renumbered from 855-041-0056, BP 7-2012, f. & cert. ef. 12-17-12

855-041-1140

Customized Patient Medication Packages

In lieu of dispensing two or more prescribed drug products in separate containers, a pharmacist may, with the consent of the patient, the patient’s caregiver, or a prescriber, provide a customized patient medication package (patient med pak). A patient med pak is a package prepared by a pharmacist for a specific patient comprising a series of containers and containing two or more prescribed solid oral dosage forms. The patient med pak is so designed for each container is so labeled as to indicate the day and time, or period of time, that the contents within each container are to be taken:

(1) Label:

(a) The patient med pak shall bear a label stating:

(A) The name of the patient;

(B) A serial number for each patient med pak itself and a separate identifying serial number for each of the prescription orders for each of the drug products contained therein;

(C) The name, strength, physical description or identification, and total quantity of each drug product contained therein;

(D) The directions for use and cautionary statements, if any, contained in the prescription order for each drug product therein;

(E) Any storage instructions or cautionary statements required by the official compedia;

(F) The name of the prescriber of each drug product;

(G) The date of preparation of the patient med pak and the beyond-use date assigned to the patient med pak (such beyond-use date shall be no later than 60 days from the date of preparation);

(H) The name, address, and telephone number of the dispenser and the dispenser’s registration number where necessary; and

(I) Any other information, statements, or warnings required for any of the drug products contained therein.

(b) If the patient med pak allows for the removal or separation of the intact containers therefrom, each individual container shall bear a label identifying each of the drug products contained therein.

(2) Labeling: The patient med pak shall be accompanied by a patient package insert, in the event that any medication therein is required to be dispensed with such insert as accompanying labeling. Alternatively, such required information may be incorporated into a single, overall educational insert provided by the pharmacist for the total patient med pak.

(3) Packaging:

(a) In the absence of more stringent packaging requirements for any of the drug products contained therein, each container of the patient med pak shall comply with the moisture permeation requirements for a Class B single-unit or unit-dose container. Each container shall be either not reclosable or so designed as to show evidence of having been opened;

(b) There is no special exemption for patient med paks from the requirements of the Poison Prevention Packaging Act. Thus the patient med pak, if it does not meet child-resistant standards shall be placed in an outer package that does comply, or the necessary consent of the purchaser or physician, to dispense in a container not intended to be child-resistant, shall be obtained.

(4) Guidelines: It is the responsibility of the dispenser, when preparing a patient med pak, to take into account any applicable compendia requirements or guidelines and the physical and chemical compatibility of the dosage forms placed within each container, as well as any therapeutic incompatibilities that may attend the simultaneous administration of the medications. In this regard, pharmacists are encouraged to report to USP headquarters any observed or report incompatibilities.

(5) Recordkeeping: In addition to any individual prescription filing requirements, a record of each patient med pak shall be made and filed. Each record shall contain, as a minimum:

(a) The name and address of the patient;

(b) The serial number of the prescription order for each drug product contained therein;

(c) The name of the manufacturer or labeler and lot number for each drug product contained therein;

(d) Information identifying or describing the design, characteristics, or specifications of the patient med pak sufficient to allow subsequent preparation of an identical patient med pak for the patient;

(e) The date of preparation of the patient med pak and the beyond-use date that was assigned;

(f) Any special labeling instructions; and

(g) The name or initials of the pharmacist who prepared the patient med pak.

(4) 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.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: PB 1-1989, f. & cert. ef. 1-3-89; Renumbered from 855-041-0057, BP 7-2012, f. & cert. ef. 12-17-12; BP 8-2013, f. & cert. ef. 9-25-13

Dispensing

855-041-1145

New Containers

In filling the original prescriptions, nothing but new containers may be used. A patient’s original container may be refilled if clean and the label is legible and up-to-date. The container shall comply with the current provisions of the Federal Consumer Packaging Act (Public Law 91-601, 91st Congress, S. 2162) and rules or regulations adopted thereunder. It must also conform with the current United States Pharmacopoeia/National Formulary monographs for preservation, packaging, storage and labeling.

[Publications: Publications referenced are available from the agency.]

Stat. Auth.: ORS 689
Stats. Implemented:
Hist.: 1PB 2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80); Renumbered from 855-041-0055, BP 7-2012, f. & cert. ef. 12-17-12

Records

855-041-1160

Prescription Records and Retention

(1) Definitions. The following definitions apply to this rule:

(a) An "original prescription" is a prescription maintained in the same physical manner in which a pharmacy first receives the prescription. For example, for a prescription received by the pharmacy in writing on a prescription form, the original prescription consists of the original writing on the prescription form. For a prescription received by the pharmacy orally over the telephone, the original consists of the writing or electronic record that reflects receipt of the oral prescription.

(b) "Filing" and "file" mean the storage of the original prescription in such a manner that the original prescription is safeguarded and readily retrievable.

(2) Every pharmacy and pharmacist-in-charge of a pharmacy must ensure that original prescriptions are properly filed in compliance with this rule.

(3) All original prescriptions shall be filed for a minimum of three years from the date of first dispensing and shall at all times be open for inspection by the prescriber, and the Board of Pharmacy or its duly authorized agent.

(4) After 120 days, the paper prescription may be destroyed and filed in an electronic form if:

(a) The electronic form shows the exact and legible image of the original prescription;

(b) Notes of clarifications of and changes to the prescription are directly associated with the electronic form of the prescriptions; and

(c) The prescription is not for a controlled substance.

(5) This rule is not intended to alter or supersede the recordkeeping requirements of any other federal or Oregon statute or rule, including but not limited to ORS 689.508, OAR 855-041-1120, and rules related to records for prescriptions for controlled substances.

(6) Unless specified otherwise, all records and documentation required by OAR 855 Division 041 must be retained for three years and made available to the Board for inspection upon request. Records must be stored onsite for at least one year and may be stored in a secured off-site location if retrievable within three business days. Records and documentation may be written, electronic or a combination of the two.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.151, 689.155, 689.508
Hist.: 1PB 2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; PB 1-1994, f. & cert. ef. 2-2-94; BP 3-2005, f. & cert. ef. 4-14-05; BP 2-2008, f. & cert. ef. 2-20-08; Renumbered from 855-041-0060, BP 7-2012, f. & cert. ef. 12-17-12

855-041-1165

Patient Medical Record

(1) A patient record system shall be maintained by pharmacies for all patients for whom prescription drug orders are dispensed, except for those patients who the pharmacist has good reason to believe will not return to that pharmacy to obtain drugs. The patient record system shall provide for readily retrievable information necessary for the dispensing pharmacist to identify previously dispensed drugs at the time a prescription drug order is presented for dispensing. The pharmacist shall make a reasonable effort to obtain, record, and maintain the following information:

(a) Full name of the patient for whom the drug is intended;

(b) Address and telephone number of the patient;

(c) Patient's age or date of birth;

(d) Patient's gender;

(e) Chronic medical conditions;

(f) A list of all prescription drug orders obtained by the patient at the pharmacy maintaining the patient record showing the name of the drug or device, prescription number, name and strength of the drug, the quantity and date received, and the name of the prescriber;

(g) Known allergies, drug reactions, and drug idiosyncrasies; and

(h) If deemed relevant in the pharmacist's professional judgment:

(A) Pharmacist comments relevant to the individual's drug therapy, including any other information peculiar to the specific patient or drug; and

(B) Additional information such as chronic conditions or disease states of the patient, the patient's current weight, and the identity of any other drugs, including over-the-counter drugs, or devices currently being used by the patient which may relate to prospective drug review.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.151, 689.155, 689.508
Hist.: 1PB 2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; PB 1-1994, f. & cert. ef. 2-2-94; BP 3-2005, f. & cert. ef. 4-14-05; BP 2-2008, f. & cert. ef. 2-20-08; Renumbered from 855-041-0060, BP 7-2012, f. & cert. ef. 12-17-12

855-041-1170

Grounds for Discipline

The State Board of Pharmacy may impose one or more of the following penalties which includes: suspend, revoke, or restrict the license of an outlet or may impose a civil penalty upon the outlet upon the following grounds:

(1) Unprofessional conduct as defined in OAR 855-006-0005;

(2) Advertising or soliciting that may jeopardize the health, safety, or welfare of the patient including, but not be limited to, advertising or soliciting that:

(a) Is false, fraudulent, deceptive, or misleading; or

(b) Makes any claim regarding a professional service or product or the cost or price thereof which cannot be substantiated by the licensee.

(3) Failure to provide a working environment that protects the health, safety and welfare of a patient which includes but is not limited to:

(a) Sufficient personnel to prevent fatigue, distraction or other conditions that interfere with a pharmacist’s ability to practice with reasonable competency and safety.

(b) Appropriate opportunities for uninterrupted rest periods and meal breaks.

(c) Adequate time for a pharmacist to complete professional duties and responsibilities including, but not limited to:

(A) Drug Utilization Review;

(B) Immunization;

(C) Counseling;

(D) Verification of the accuracy of a prescription; and

(E) All other duties and responsibilities of a pharmacist as specified in Division 19 of this chapter of rules.

(4) Introducing external factors such as productivity or production quotas or other programs to the extent that they interfere with the ability to provide appropriate professional services to the public.

(5) Incenting or inducing the transfer of a prescription absent professional rationale.

Stat. Auth: ORS 689.151, 689.155(2), 689.205, 689.225(4)
Stats. Implemented: ORS 689.155
Hist.: BP 2-2012, f. & cert. ef 6-12-12; Renumbered from 855-041-0016, BP 7-2012, f. & cert. ef. 12-17-12

General Community Pharmacy

855-041-2100

Operation of a Double Set-Up Pharmacy in a Retail Drug Outlet

A double set-up is an establishment having both a retail drug outlet registration and a nonprescription drug outlet registration. In a double set-up:

(1) The retail drug outlet (pharmacy) must be a separate operation, completely contained by an enclosure which assures safe storage. This enclosure must be from floor to ceiling or be at least ten feet from the floor. This area is to be easily distinguished by the public. When the retail drug outlet (pharmacy department) is closed, then as a nonprescription drug outlet the establishment is subject to the provisions of OAR 855-035-0005 and 855-035-0020.

(2) When a pharmacist is not in attendance, a closed sign shall be posted at the entrances stating the hours of the pharmacy's operation. All entrances to the retail drug outlet shall be closed off and securely locked. Any keys to the retail drug outlet (pharmacy) shall remain in the possession of the pharmacist-in-charge and other employee pharmacists as authorized by the pharmacist-in-charge if the retail drug outlet (pharmacy) is closed while the nonprescription outlet (shopkeeper) remains open.

(3) Any system deviating from the requirement of this section, except as provided in OAR 855-041- 6310, shall be approved by the Board prior to implementation. Requests for such approval shall be in writing and provide a detailed description of the proposed system. A written description of such system, as approved by the Board, shall be maintained in the pharmacy.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.205
Hist.: 1PB 2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; PB 1-1989, f. & cert. ef. 1-3-89; Administrative correction 9-8-97; Renumbered from 855-041-0035, BP 7-2012, f. & cert. ef. 12-17-12

855-041-2115

Transfer of Prescription Information Between Pharmacies

(1) Prescriptions may be transferred between pharmacies for the purpose of refill dispensing provided that:

(a) The prescription is invalidated at the sending pharmacy; and

(b) The receiving pharmacy obtains all the information constituting the prescription and its relevant refill history in a manner that ensures accuracy and accountability.

(2) Prescriptions for controlled substances can only be transferred one time.

(3) Pharmacies using the same electronic prescription database are not required to transfer prescriptions for dispensing purposes.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: 1PB 2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; 1PB 3-1982, f. & ef. 3-8-82; 1PB 1-1986, f. & ef. 6-5-86; PB 2-1990, f. & cert. ef. 2-9-90; PB 1-1992, f. & cert. ef. 1-31-92 (and corrected 2-7-92); BP 2-1998, f. & cert. ef. 3-23-98; BP 6-2000, f. & cert. ef. 6-29-00; Renumbered from 855-041-0075, BP 7-2012, f. & cert. ef. 12-17-12

Distribution of Emergency Medication

855-041-2300

Purpose and Scope

The purpose of OAR 855-041-2300 through 855-041-2330 is to define the procedures for distributing emergency medication to certain authorized individuals for the use in emergency health circumstances. The authorized person is someone who has been trained under the guidelines set forth in 333-055-0110.

Stat. Auth: ORS 689.205& 2013 OL Ch. 340
Stats. Implemented: ORS 689.155 & 2013 OL Ch. 34
Hist.: BP 6-2013(Temp), f. 9-23-13, cert. ef. 9-24-13 thru 3-23-14; BP 2-2014, f. & cert. ef. 1-24-14

855-041-2310

Definitions

The following words and terms, when used in OAR 855-041-2300 through 855-041-2330 shall have the following meanings, unless the context clearly indicates otherwise.

(1) “Allergic reaction” means a medical condition caused by exposure to an allergen, with physical symptoms that may be life threatening, ranging from localized itching to severe anaphylactic shock and death.

(2) “Authorization to Obtain Epinephrine” means a certificate that contains the name, signature, and license number of the supervising professional authorizing the dispensing of epinephrine to the individual whose name appears on the certificate. Additionally, the certificate contains a record of the number of epinephrine orders filled to date.

(3) “Authorization to Obtain Naloxone” means a certificate that contains the name, signature, and license number of the supervising professional authorizing the dispensing of naloxone to the individual whose name appears on the certificate. Additionally, the certificate contains a record of the number of naloxone orders filled to date.

(4) “Opiate” means a narcotic drug that contains: opium, any chemical derivative of opium, or any synthetic or semi-synthetic drug with opium-like effects.

(5) “Opiate overdose” means a medical condition that causes depressed consciousness and mental functioning, decreased movement, depressed respiratory function, and the impairment of vital functions as a result of ingesting opiates in any amount larger than can be physically tolerated.

(6) “Statement of Completion” means a certificate that states the specific type of emergency the trainee was trained to respond to, the trainee’s name and address, the name of the authorized trainer and the date that the training was completed.

(7) “Supervising Professional” means a physician or nurse practitioner licensed to practice in this state who has prescription writing authority.

(8) “Trainee” means an individual who has attended and successfully completed the formal training pursuant to the protocols and criteria established by the Oregon Health Authority, Public Health Division.

(9) “Trainer” means an individual conducting the formal training as directed by the supervising professional and in accordance with the protocols and criteria established by the Oregon Health Authority, Public Health Division.

Stat. Auth: ORS 689.205 & 2013 OL Ch. 340
Stats. Implemented: ORS 689.155 & 2013 OL Ch. 340
Hist.: BP 6-2013(Temp), f. 9-23-13, cert. ef. 9-24-13 thru 3-23-14; BP 2-2014, f. & cert. ef. 1-24-14

855-041-2320

Epinephrine

(1) A pharmacist may fill an order for epinephrine to be used by trainees to treat an anaphylactic reaction. Trainees must be 18 years of age or older and must have responsibility for or contact with at least one (1) other person as a result of the trainee’s occupation or volunteer status, such as, but not limited to, a camp counselor, scout leader, forest ranger, school employee, tour guide or chaperone.

(2) Individuals must successfully complete a training program approved by the Oregon Health Authority, Public Health Division. Upon successful completion, the trainee will receive the following certificates:

(a) Statement of Completion; and

(b) Authorization to Obtain Epinephrine.

(3)(a) Distribution of epinephrine from a pharmacy to be used for the treatment of allergic emergencies may occur in the following manner:

(b) A trainee may obtain epinephrine upon presentation of the Statement of Completion and Authorization to Obtain Epinephrine certificate to a pharmacy which:

(A) A pharmacist may generate a prescription for, and dispense an emergency supply of epinephrine for not more than one (1) child and one (1) adult in an automatic injection device, as specified by the supervising professional whose name, signature, and license number appear on the Authorization to Obtain Epinephrine certificate.

(B) The pharmacist who generates the hardcopy prescription for epinephrine in this manner shall reduce the prescription to writing, and file the prescription in a manner appropriate for a non-controlled substance.

(C) Once the pharmacist generates the epinephrine prescription, the pharmacist shall write in the appropriate space provided on the Authorization to Obtain Epinephrine certificate, the date and the number of doses dispensed, and return the certificate to the trainee.

(4) The Statement of Completion and the Authorization to Obtain Epinephrine certificate may be used to obtain epinephrine up to four (4) times within three (3) years from the date of the initial training.

(a) Both the Statement of Completion and the Authorization to Obtain Epinephrine certificate expire three (3) years from the date of the trainee’s last Oregon Health Authority approved allergy response training.

(b) Upon completion of the training, the trainee will receive a new Statement of Completion and Authorization to Obtain Epinephrine certificate, with a valid duration of three (3) years.

Stat. Auth: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 6-2013(Temp), f. 9-23-13, cert. ef. 9-24-13 thru 3-23-14; BP 2-2014, f. & cert. ef. 1-24-14

855-041-2330

Naloxone

(1) A Pharmacy may fill orders for unit-of-use naloxone to be used by trainees for opiate overdose emergencies. Individuals must successfully complete a training program approved by the Oregon Health Authority, Public Health Division. Upon successful completion, the trainee will receive the following certificates:

(a) Statement of Completion; and

(b) Authorization to Obtain Naloxone.

(2) Distribution of naloxone from a pharmacy to be used for opiate overdose emergencies may occur in the following ways:

(a) A supervising professional may obtain a supply of naloxone for a program pursuant to a request by the supervising professional and a pharmacy sale by invoice. The pharmacy shall keep the invoice on record for three (3) years.

(b) A trainee may obtain naloxone upon presentation of the Statement of Completion and Authorization to Obtain Naloxone certificate to a pharmacy which:

(A) A pharmacist may generate a prescription for, and dispense up to two (2) unit-of-use doses of naloxone as specified by the supervising professional whose name, signature, and license number appear on the Authorization to Obtain Naloxone certificate.

(B) The pharmacist who generates the hardcopy prescription for naloxone in this manner shall reduce the prescription to writing and file the prescription in a manner appropriate for a non-controlled substance.

(C) Once the pharmacist generates the naloxone prescription, the pharmacist shall write in the appropriate space provided on the Authorization to Obtain Naloxone certificate the date and the number of doses dispensed, and return the certificate to the trainee.

(3) The Statement of Completion and Authorization to Obtain Naloxone certificate may be used to obtain naloxone up to six (6) times within three (3) years from the date of the initial training.

(a) Both the Statement of Completion and the Authorization to Obtain Naloxone certificate expire three (3) years from the date of the trainee’s last Oregon Health Authority, Public Health Division approved naloxone training.

(b) Upon completion of the training, the trainee will receive a new Statement of Completion and Authorization to Obtain Naloxone, with a valid duration of three (3) years.

(4) The naloxone container must be labeled with the following information:

(a) A statement that the naloxone is intended for use in the Oregon Opiate Overdose Treatment program;

(b) Trainees name; and

(c) Trainer; or

(d) Supervising Professional.

Stat. Auth: ORS 689.205 & 2013 OL Ch. 340
Stats. Implemented: ORS 689.155 & 2013 OL Ch. 340
Hist.: BP 6-2013(Temp), f. 9-23-13, cert. ef. 9-24-13 thru 3-23-14; BP 2-2014, f. & cert. ef. 1-24-14

Central Fill Drug Outlets, Remote Processing Drug Outlets and Consulting or Drugless Pharmacies

855-041-3000

Purpose and Scope

(1) The purpose of OAR 855-041-3005 through 855-041-3045 is to provide minimum requirements of operation for centralized prescription drug filling by a pharmacy.

(2) The purpose of OAR 855-041-3100 through 855-041-3130 is to provide minimum requirements of operation for remote prescription processing by a pharmacy.

(3) Prior to initiating one of the above drug outlet models, a description of how the model will be utilized must be submitted to the Board.

(4) The purpose of OAR 855-041-3300 through 855-041-3340 is to establish a secure environment where a consulting pharmacist can provide pharmaceutical care and store health protected information in a consulting or drugless pharmacy. Prior to initiating this model, a description of how the model will be utilized to improve patient safety must be submitted to the Board.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 10-2013, f. & cert. ef. 11-6-13

Central Fill Drug Outlets

855-041-3005

Purpose and Scope

The purpose of OAR 855-041-3005 through 855-041-3045 is to provide minimum requirements of operation for centralized prescription drug filling by a pharmacy. Any facility established for the purpose of filling drug orders on behalf of an Oregon pharmacy shall be licensed as a retail or institutional drug outlet. An applicant must submit its policies and procedures to the Board of Pharmacy. An applicant must submit to the Board for approval policies and procedures and a description of how using central fill will improve patient safety and redirect a pharmacist at a primary pharmacy from a distributive task to a cognitive task.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 10-2013, f. & cert. ef. 11-6-13

855-041-3010

Definitions

The following words and terms, when used in OAR 855-041-3005 through 855-041-3045 shall have the following meanings, unless the context clearly indicates otherwise. Any term not defined in this section shall have the definition set out in the OAR chapter 855, division 006.

(1) “Central Fill Pharmacy” means an Oregon licensed pharmacy that provides centralized prescription filling for both initial or prescription refills on behalf of a primary pharmacy.

(2) “Primary Pharmacy” means a pharmacy located and licensed in Oregon that receives a patient’s or a prescribing practitioner’s request to fill a prescription, dispenses the prescription directly to the patient or patient’s agent, or the pharmacy delivers the drug to the patient’s agent for administration. The primary pharmacy maintains ownership of the prescription.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 10-2013, f. & cert. ef. 11-6-13

855-041-3015

General Requirements

An Oregon licensed pharmacy may outsource prescription drug filling to a central fill pharmacy provided that both pharmacies:

(1) Have the same owner; or

(2) Have a written shared pharmacy services contract or agreement that specifies:

(a) The services to be provided by each pharmacy;

(b) The responsibilities of each pharmacy; and

(c) The accountabilities of each pharmacy.

(3) Maintain a separate Oregon pharmacy license for each location involved in providing prescription drugs and services to Oregon patients;

(4) Share a common electronic file or have appropriate technology or interface to allow access to information required to fill a prescription drug order;

(5) Establish, maintain and enforce a policy and procedures manual as required by OAR 855-041-3020;

(6) Ensure that each prescription has been properly processed and filled and that counseling has been provided to the patient;

(7) Designate a pharmacist-in-charge. To qualify for this designation, the person must hold a license to practice pharmacy in the state of Oregon and in the state in which the pharmacy is located if the pharmacy is out-of-state. The pharmacist-in-charge must be in good standing with both licensing boards;

(8) Conduct an annual review of the written policies and procedures and document such review;

(9) Comply with all applicable federal and state laws and rules;

(10) Direct all patient communication to the primary pharmacy.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 10-2013, f. & cert. ef. 11-6-13

855-041-3020

Policies and Procedures

(1) In addition to the requirements of OAR 855-041-1040, the central fill pharmacy and the primary pharmacy is each accountable for establishing, maintaining, and enforcing its written policies and procedures manual. The policies and procedures manual must include, but need not be limited to the following:

(a) The responsibilities of each pharmacy;

(b) The policies and procedures that protect confidentiality and ensure integrity of patient information;

(c) Compliance with all applicable federal and state laws and rules;

(d) Cancelation of a filled prescription after the prescription is filled by the primary pharmacy;

(e) Records sufficient to identify by name, initials or unique identification code, the identify and specific activities of each pharmacist or technician who performed any centralized filling function, and the pharmacy where each activity was performed;

(f) The mechanism for tracking the prescription drug order during each step in the filling and dispensing process;

(g) Pharmacist completion of a Drug Utilization Review (DUR) on each prescription;

(h) A continuous quality improvement program for pharmacy services designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, to pursue opportunities, to improve patient care, and to resolve identified problems;

(i) Documentation of any errors or irregularities identified by the quality improvement program;

(2) This manual shall be maintained at both the central fill and primary pharmacy and must be made available to the Board upon request.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 10-2013, f. & cert. ef. 11-6-13

855-041-3025

Labeling

(1) The label affixed to the prescription container filled by a central fill pharmacy on behalf of the primary pharmacy shall:

(a) Include all information required by OAR 855-041-1130 and OAR 855-041-1140;

(b) Comply with all labeling requirements identifying only the primary pharmacy.

(2) If the Central Pharmacy dispenses the completed prescription to the patient, the label must also comply with retail labeling requirements in OAR 855-041-1130 through 855-041-1140.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 10-2013, f. & cert. ef. 11-6-13

855-041-3030

Records

(1) The recordkeeping requirements in OAR 855-041-3005 through 855-041-3045 are in addition to the requirements of other recordkeeping rules of the Board.

(2) Each recordkeeping system must include quality improvement program documentation.

(3) Unless otherwise specified, all records and documentation required by OAR 855-041-3005 through 855-041-3045 must be retained for three years and made available to the Board for inspection upon request. Records must be stored onsite for at least one year and may be stored, after one year, in a secured off-site location if retrievable within three business days. Records and documentation may be kept in hard copy, electronic copy, or a combination of the two.

(4) Each pharmacy must be able to produce an audit trail which identifies each prescription process in their pharmacy.

(5) The primary pharmacy shall maintain the original prescription for a period of three years from the date the prescription was filled.

(6) The primary pharmacy must maintain records that:

(a) Identify by prescription or drug order, the name or unique identification code of the pharmacist who performed the drug utilization review. Identify by prescription drug order the pharmacist or technician that transmitted the prescription drug order to the central fill pharmacy. These records may be maintained separately by each pharmacy and pharmacist or technician or in a common electronic file, as long as the data processing system is capable of producing a printout that lists each function performed by each pharmacy and pharmacist or technician, and identifies the pharmacist or technician who performed each function;

(b) Document the date the filled prescription was received from the central fill pharmacy and the name of the person accepting delivery.

(7) The central fill pharmacy must maintain records that:

(a) List the name, address, telephone numbers, and all license and registration numbers of the pharmacies involved in centralized prescription filling; and

(A) Document verification of each license and registration; and

(B) Document the name of the individual responsible for verification of licensure and registration status.

(b) Track the prescription drug order during each step in the filling process and identify the name, initials, or unique identification code and specific activity of each pharmacist or pharmacy technician who performed any portion of the process including transmission, filling, dispensing and delivery of information.

(A) The date the prescription was received by the central fill pharmacy;

(B) The name and address where the filled prescription was shipped;

(C) The method of delivery (e.g., private, common, or contract carrier).

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 10-2013, f. & cert. ef. 11-6-13

855-041-3035

Delivery of Medications

(1) A central fill pharmacy may deliver or mail medications to the primary pharmacy or patient in compliance with OAR 855-041-1050.

(2) A central fill pharmacy must comply with all federal and state requirements when using private, common or contract carriers to transport filled prescriptions for delivery. When a central fill pharmacy contracts with private, common or contract carriers to transport filled prescriptions the central fill pharmacy is responsible for reporting any in-transit loss upon detection by use of DEA Form 106.

(3) A central fill pharmacy must maintain and use adequate storage or shipment containers and shipping processes to ensure drug stability and potency. Such shipping processes shall include the use of packaging material and devices to ensure that the drug is maintained at the temperature range required to maintain the integrity of the medication throughout the delivery process.

(4) Filled prescriptions must be shipped in containers that are sealed in a manner that shows evidence of opening or tampering.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 10-2013, f. & cert. ef. 11-6-13

855-041-3040

Filled Prescriptions

(1) Any filled prescription that has not been picked up, may be put into the primary pharmacy’s inventory. Each pharmacy is responsible for documenting any such transfer of a drug.

(2) A prescription for a controlled substance may be filled by a central fill pharmacy when permitted by law, consistent with federal requirements set forth at 21 C.F.R. § 1300 et seq;

(3) The pharmacy that fills the prescription and the pharmacy to which the filled prescription is provided for dispensing to the patient shall each be responsible for ensuring the prescription has been properly filled.

(4) A primary pharmacy will notify the patient of the possible use of a central fill pharmacy.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 10-2013, f. & cert. ef. 11-6-13

855-041-3045

Prohibited Practices

(1) A primary pharmacy may not use the services of a central fill pharmacy that is not registered with the Board.

(2) A central fill pharmacy may not fill a prescription on behalf of a primary pharmacy that is not registered with the Board if the laws and rules of Oregon require the primary pharmacy to be registered with the Board.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 10-2013, f. & cert. ef. 11-6-13

Remote Processing Drug Outlets

855-041-3100

Purpose and Scope

The purpose of OAR 855-041-3100 through 855-041-3130 is to provide minimum requirements of operation for remote prescription drug processing by a pharmacy. Any facility that processes drug orders on behalf of an Oregon pharmacy shall be licensed in Oregon as a retail or institutional drug outlet. An applicant must submit its policies and procedures to the Board of Pharmacy. An applicant must submit to the Board for approval policies and procedures and a description of how using remote processing will improve patient safety.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 10-2013, f. & cert. ef. 11-6-13

855-041-3105

Definitions

The following words and terms, when used in OAR 855-041-3100 through 855-041-3130, shall have the following meanings, unless the context clearly indicates otherwise. Any term not defined in this section shall have the definition set out in OAR chapter 855, division 006.

(1) “Remote Processing Pharmacy” means an Oregon licensed pharmacy operated under the direction of a pharmacist-in-charge that processes information related to the practice of pharmacy and engages in remote prescription processing, including central processing.

(2) “Remote Processing Functions” may include, but are not limited to, data entry, prospective drug utilization reviews, refill authorizations and interventions. This does not include the filling process.

(3) “Primary Pharmacy” means an instate Oregon licensed pharmacy that receives a patient’s or a prescribing practitioner’s request to fill a prescription or drug order and delivers the drug or device directly to the patient or patient’s agent, and maintains ownership of the prescription or drug order.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 10-2013, f. & cert. ef. 11-6-13

855-041-3110

General Requirements

An Oregon licensed pharmacy may outsource prescription drug processing to a remote processing pharmacy provided both pharmacies:

(1) Have the same owner; or

(2) Have a written shared pharmacy services contract or agreement that specifies:

(a) The services to be provided by each pharmacy;

(b) The responsibilities of each pharmacy; and

(c) The accountabilities of each pharmacy.

(3) Maintain a separate Oregon pharmacy license for each location involved in providing services;

(4) Share a common electronic file or have appropriate technology or interface to allow access to information required to process and fill a prescription drug order;

(5) Establish, maintain and enforce a policy and procedures manual as required by OAR 855-041-3115;

(6) Ensure that each prescription has been properly processed, filled and counseling has been provided to the patient;

(7) Designate a pharmacist-in-charge. To qualify for this designation, the person must hold a license to practice pharmacy in the state of Oregon and in the pharmacy’s resident state if the pharmacy is out-of-state. The pharmacist-in-charge must be in good standing with both licensing Boards;

(8) Allow prospective drug utilization reviews, refill authorizations, interventions, and patient counseling for an Oregon patient must be performed only by a licensed pharmacist in Oregon or in the state in which the pharmacy is located;

(9) Ensure that each technician processing an order for an Oregon patient is a Certified Oregon Pharmacy Technician and is supervised by a licensed pharmacist or is a licensed technician in the state in which the pharmacy is located and is supervised by a licensed pharmacist in the state in which the pharmacy is located;

(10) Comply with all applicable federal and state laws and rules;

(11) Conduct an annual review of the written policies and procedures and document such review.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 10-2013, f. & cert. ef. 11-6-13

855-041-3115

Policies and Procedures

(1) In addition to the requirements of OAR 855-041-1040, the primary and the remote processing pharmacy is each accountable for establishing, maintaining, and enforcing its own written policies and procedures manual. The policies and procedures manual must include, but need not be limited to the following:

(a) The responsibilities of each pharmacy;

(b) The policies and procedures that protect confidentiality and ensure the integrity of patient information;

(c) Compliance with all applicable federal and state laws and rules;

(d) Records sufficient to identify by name, initials, or unique identification code, the identity and the specific activities of each pharmacist or technician who performed any processing function, and the location where each activity was performed;

(e) A continuous quality improvement program for pharmacy services designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, to pursue opportunities to improve patient care, and to resolve identified problems; and

(f) Documentation of any errors or irregularities identified by the quality improvement program.

(2) The written policies and procedures manual shall be maintained at all pharmacies involved in remote processing and must be available to the Board upon request.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 10-2013, f. & cert. ef. 11-6-13

855-041-3120

Records

(1) The recordkeeping requirements OAR 855-041-3100 through 855-041-3130 are in addition to the requirements of other recordkeeping rules of the Board.

(2) The remote processing pharmacy must maintain all required records unless these records are maintained in the primary pharmacy.

(3) Both recordkeeping systems must:

(a) List the name, address, telephone number, and all license and registration numbers of each pharmacy involved in remote prescription processing;

(A) Document verification of each license and registration;

(B) Document the name of the individual responsible for verification of licensure and registration status.

(b) Identify by name, initials, or unique identification code the identity and the specific activities of each pharmacist or technician who performed any part of the prescription process;

(c) Include quality improvement program documentation;

(d) Be able to produce an audit trail showing each prescription process.

(4) Unless otherwise specified, all records and documentation required by these rules, must be retained for three years and made available to the Board for inspection upon request. Records must be stored onsite for at least one year and may be stored, after one year, in a secured off-site location if retrievable within three business days. Records and documentation may be written, electronic or a combination of the two;

(5) The primary pharmacy shall maintain records that:

(a) Indicate the date the request for processing was transmitted to the remote processing pharmacy; and

(b) Indicate the date the prescription information was received by the primary pharmacy.

(6) The remote processing pharmacy shall maintain records that:

(a) Track the prescription drug order during each step in the order entry process;

(b) Identify the name, initials, or unique identification code and the specific activity of each pharmacist or pharmacy technician who performed any activity related to processing the prescription including receipt, transmission or delivery of information.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 10-2013, f. & cert. ef. 11-6-13

855-041-3125

Prescription or Drug Order Processing

A prescription or drug order for a controlled substance may be processed by a remote processing pharmacy when permitted by law and consistent with federal rules.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 10-2013, f. & cert. ef. 11-6-13

855-041-3130

Prohibited Practices

A remote processing pharmacy may not process a prescription on behalf of a primary pharmacy that is not registered with the Board, if required by the laws and rules of Oregon to be registered.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 10-2013, f. & cert. ef. 11-6-13

Consulting or Drugless Pharmacies

855-041-3300

Purpose and Scope

The purpose of OAR 855-041-3300 through 855-041-3340 is to establish a secure environment where a consulting pharmacist can provide pharmaceutical care and store health protected information in a single physical location. This location may be an office located in a home or other secure location. Registration is not required if records used or generated by a consulting pharmacist are stored in a location registered by the Board as a retail or institutional drug outlet or if the location is under the control of a practitioner who uses the services of the consulting pharmacist. The consulting pharmacist must be able to provide the Board with documentation of their pharmaceutical care activities. These rules are intended to ensure that a location where a pharmacist is engaged in Independent Pharmacy Practice may safely store records and protected health information. An applicant must submit to the Board for approval policies and procedures and a description of how their consulting or drugless pharmacy will be utilized to improve patient safety.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 10-2013, f. & cert. ef. 11-6-13

855-041-3305

Definitions

The following words and terms, when used OAR 855-041-3300 through 855-041-3340 shall have the following meanings, unless the context clearly indicates otherwise. Any term not defined in this section shall have the definition set out in the OAR chapter 855, division 6.

(1) “Consulting or Drugless Pharmacy” means any single physical location where pharmaceutical care services are performed or protected health information may be stored without the storage, possession, or ownership of any drug.

(2) “Consulting Pharmacist” means any pharmacist as defined by OAR chapter 855, division 6 and is described by chapter 855, division 19.

(3) “Independent Pharmacy Practice” means the provision of pharmaceutical services not related to physically handling or dispensing pharmaceuticals drugs or devices. This practice is characterized by the practice of an Oregon licensed pharmacist acting as an independent contractor whether or not directly employed or affiliated with an entity that is licensed by the Board. This service also does not include the provision of pharmaceutical care that is conducted within the physical confines or location of a licensed pharmacy registered with the Board.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 10-2013, f. & cert. ef. 11-6-13

855-041-3310

Registration

(1) The Consulting Pharmacy shall be registered as a retail or institutional drug outlet and comply with all the requirements of licensure as defined in OAR 855-041-1080 through 855-041-1100.

(2) The location must be available for inspection by the Board.

(3) A consulting pharmacist for an Oregon licensed healthcare facility must perform all duties and functions required by the healthcare facility's licensure, as well as any applicable federal and state laws and rules.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 10-2013, f. & cert. ef. 11-6-13

855-041-3315

Personnel

(1) Each pharmacy must have a pharmacist-in-charge. To qualify for this designation, the person must hold a license to practice pharmacy in the state of Oregon and in the state in which the pharmacy is located if the pharmacy is out-of-state. The pharmacist-in-charge must be in good standing with both licensing Boards;

(2) The pharmacy must comply with all applicable state and federal laws and rules governing the practice of pharmacy and maintain records in compliance with requirements of federal law and Board rules;

(3) A consulting pharmacist who provides services to any person or facility located in Oregon, must be an Oregon licensed pharmacist except that a pharmacist working in an out-of-state pharmacy, who only performs the professional tasks of interpretation, evaluation, DUR, counseling and verification associated with their dispensing of a drug to a patient in Oregon; and

(4) Prospective drug utilization reviews, refill authorizations, interventions and patient counseling not associated with the dispensing of a drug for an Oregon patient must be performed by an Oregon licensed pharmacist.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 10-2013, f. & cert. ef. 11-6-13

855-041-3320

Confidentiality

(1) Each consulting pharmacy must comply with all applicable federal and state laws and rules regarding confidentiality, integrity and privacy of patient information.

(2) Each consulting pharmacy must ensure that electronic data systems are secure and comply with applicable federal and state laws and rules.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 10-2013, f. & cert. ef. 11-6-13

855-041-3325

General Provisions and Minimum Standards

(1) A consulting pharmacy shall:

(a) Maintain appropriate reference materials for drug information according to the scope of consulting services.

(b) Be located in a secure room with a door and suitable lock, and accessible only to persons authorized by the pharmacist-in-charge.

(c) Provide storage sufficient to secure confidential documents and any hardware necessary to access information.

(d) Be constructed in a manner of materials that make the space separate and distinct from the rest of the home or office building, and that protects the records from unauthorized access.

(2) A consulting pharmacy located in a residence must be approved by the Board.

(3) The consulting pharmacist must be able to provide the Board, upon request, with documentation of their pharmaceutical care activities.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 10-2013, f. & cert. ef. 11-6-13

855-041-3330

Security Requirements

(1) All consulting services must occur in a secure environment that includes but is not limited to:

(a) A closed system or other electronic storage device that is password protected;

(b) A secure room or safe that is locked to store records when the pharmacist is not directly monitoring them;

(c) Sufficient encryption for securing confidential documents and any hardware used in accessing authorized patient health information by electronic connection; and

(d) A data processing system that complies with all federal and state laws and rules to ensure compliant security software.

(2) Records stored at a practitioner’s office must be kept secure either with other records at the facility or independently in a locked room where only the pharmacist, and physician and their agents have access;

(3) All records must be stored at the approved consulting or drugless pharmacy; and

(4) Any breach in the security of the system or breach of confidentiality must be documented and reported to the Board within seven days.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 10-2013, f. & cert. ef. 11-6-13

855-041-3335

Policies and Procedures

The consulting pharmacy must maintain a current policy and procedures manual that includes at a minimum:

(1) A policy on protecting confidentiality and integrity of patient information;

(2) An outline of responsibilities and scope of services;

(3) A policy on compliance with federal and state laws and rules;

(4) An operational Quality Assurance Program;

(5) A policy that describes use of computer systems.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 10-2013, f. & cert. ef. 11-6-13

855-041-3340

Records

(1) The recordkeeping and storage requirements in OAR 855-041-3300 through 855-041-3340 are in addition to the requirements of other recordkeeping and storage rules of the Board. Records and documentation may be written, electronic or a combination of the two.

(2) Each recordkeeping system must include quality improvement program documentation;

(3) The PIC must ensure maintenance of written or electronic records and reports as necessary to ensure patient health, safety, and welfare. Records must include but need not be limited to:

(a) Patient profiles and records;

(b) A list of current employees and their license numbers;

(A) Verification of each license and registration;

(B) The name of the individual responsible for verification of licensure and registration status.

(c) Copies of all contracts for consulting services and collaborative therapy agreements;

(d) Copies of all consultation reports submitted to practitioners and facilities.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 10-2013, f. & cert. ef. 11-6-13

Expedited Partner Therapy

855-041-4000

Purpose

(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.

Stat. Auth.: ORS 689.205
Stats. Implemented: 2009 OL Ch 522
Hist.: BP 1-2010, f. & cert. ef. 2-8-10

855-041-4005

Procedures

(1) 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.

(2) 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 shall govern.

(3) An EPT prescription may only be dispensed for a drug that has been determined by the Department of Human Services (DHS) to be appropriately used for EPT.

Prescription

(4) 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 pharmacist must contact the prescriber or the prescriber’s agent and must record the additional information on the prescription.

(5) 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 give all prescriptions to one pharmacy and then give the dispensed drugs to each unnamed partner.

Labeling

(6) The pharmacist 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 pharmacy may create a unique identifier and use that instead of a name for both labeling and record keeping purposes.

(7) The pharmacist must assign a separate and unique identifier to each prescription and clearly identity this number on each corresponding prescription label.

Counseling

(8) The pharmacist is not required to obtain an EPT patient’s or partner’s name, address, or demographics; however, the pharmacist 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 pharmacist should advise the patient to encourage each partner to call the pharmacist 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

(9) 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.

Stat. Auth.: ORS 689.205
Stats. Implemented: 2009 OL Ch 522
Hist.: BP 1-2010, f. & cert. ef. 2-8-10

Retail Drug Outlet for Home Dialysis Supplies

855-041-4025

Purpose and Scope

A Retail Drug Outlet for Home Dialysis supplies may provide dialysis solutions under the general supervision and direction of a pharmacist with special training in renal disease and dialysis to end stage renal disease (ESRD) patients who have chosen the option of home dialysis therapy and who have been appropriately trained.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.305
Hist.: BP 8-2000, f. & cert. ef. 6-29-00; Renumbered from 855-041-0350, BP 7-2012, f. & cert. ef. 12-17-12

855-041-4035

Definitions

“Dialysis solutions” means peritoneal dialysis solutions, dialysate solutions, and legend devices including hardware, bloodlines and dialysis tubing and connectors.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.305
Hist.: BP 8-2000, f. & cert. ef. 6-29-00; Renumbered from 855-041-0355, BP 7-2012, f. & cert. ef. 12-17-12

855-041-4045

Drug Delivery and Control

(1) An Oregon licensed pharmacist must be designated as the pharmacist-in-charge who will provide direction and supervision of the operation and staff.

(2) Deliveries of supplies must be made only pursuant to a current prescription order from an authorized prescriber. The prescription order must be maintained on file at the outlet. Supplies will be limited to dialysis solutions as defined in OAR 855-041 — 4035. No other legend medication ordered for the patient may be provided by the outlet.

(3) All patient records must be maintained in a secure area with a locking door. Access to the patient records area is allowed only when a pharmacist is present except in the event of an emergency. In the event of an emergency, any entry by individuals other than the pharmacist must be documented. In the absence of a pharmacist, the door to the patient records area must remain locked at all times.

(4) Copies of all prescriptions must be reviewed by the pharmacist and a complete set of prescription records for all patients serviced by the outlet must be maintained in the patient records area for a minimum of three years.

(5) A minimum of two current reference books that are specific and relevant to dialysis therapy must be maintained in the outlet to assist in the appropriate delivery of care to patients. Other reference material and equipment must be maintained to be consistent with the scope of services provided by the outlet.

(6) A current copy of Oregon Revised Statutes, Chapter 689, a current copy of Oregon Administrative Rules, chapter 855, and a minimum of three years of the Oregon Board of Pharmacy quarterly newsletters must be maintained in a loose leaf binder or other readily retrievable means.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.305
Hist.: BP 8-2000, f. & cert. ef. 6-29-00; Renumbered from 855-041-0360, BP 7-2012, f. & cert. ef. 12-17-12

855-041-4055

Duties of the Pharmacist

(1) The pharmacist-in-charge must review, at least weekly, the drug outlet operation and perform, at least monthly, quality assurance audits that include the review of prescription orders prior to delivery for accuracy and completeness, and the review of the assembled order with the prescription order prior to delivery for accuracy and completeness.

(2) The pharmacist-in-charge is responsible for the following on an ongoing basis:

(a) Ensure compliance of dialysis distribution operation to all applicable federal and state pharmacy laws and rules;

(b) Ensure valid prescriptions are received for all patient orders by performing periodic assessments of prescription files;

(c) Perform periodic assessments of distribution processes and procedures to ensure quality and compliance;

(d) Provide pharmaceutical care by reviewing all patient profiles and performing drug therapy assessments on those identified as abnormal;

(e) Provide pharmaceutical care by responding on a toll free telephone access to questions received from any patient or health care provider;

(f) Maintain, update and train personnel on policies and procedures specific to home dialysis patient deliveries and pharmacy requirements;

(g) Prepare educational materials for staff members of dialysis clinics as requested;

(h) Prepare and maintain on file monthly reports of activities performed;

(i) Ensure security of the patient record area; and

(j) Maintain a policy and procedure manual for the Drug Outlet operation that must include written protocols for the product delivery system, methods for supervising deliveries to patients, and a quality assurance program with which to monitor the qualifications, training and performance of personnel.

(3) The pharmacist-in-charge must perform an annual inspection of the outlet on a form provided by the Board, and must provide a copy of this inspection to the Board upon request.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.305
Hist.: BP 8-2000, f. & cert. ef. 6-29-00; Renumbered from 855-041-0365, BP 7-2012, f. & cert. ef. 12-17-12

Remote Dispensing

855-041-4100

Definitions

(1) "Automated Pharmacy System" (APS) means a mechanical system that performs operations or activities, including but not limited to, those related to the storage, packaging, dispensing, or distribution of medications, but not including compounding or administration, and that collects, controls, and maintains all transaction information.

(2) "Remote Dispensing Facility" (RDF) means a facility where drugs are prepared for administration and where requisite pharmacist supervision is provided remotely as approved by the Board.

(3) "Remote Dispensing Machine" (RDM) means a component of an Automated Pharmacy System that contains prepackaged drugs for dispensing.

(4) "Responsible Pharmacy" means the licensed pharmacy that is responsible for the APS, and RDM.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 2-2005, f. 2-14-05, cert. ef. 3-1-05; BP 9-2010(Temp), f. & cert. ef. 7-9-10 thru 12-24-10; Administrative correction 1-25-11; BP 3-2011, f. & cert. ef. 4-18-11; Renumbered from 855-041-0600, BP 7-2012, f. & cert. ef. 12-17-12

855-041-4110

Duties and Responsibilities of the Pharmacist-in-Charge.

Each RDM must be under the supervision of the Pharmacist-in-Charge of the Responsible Pharmacy. The Pharmacist-in-Charge must:

(1) Develop written policies and procedures prior to installation of the RDM that:

(a) Ensure safety, accuracy, security, and patient confidentiality;

(b) Define access to the RDM and to medications contained within or associated with the RDM, including but not limited to policies that assign, discontinue, or change access to the RDM and medications.

(c) Ensure that access to the medications complies with state and federal laws and regulations.

(2) Obtain written approval by the Board prior to installing any RDM.

(3) Train all personnel who will access the APS (including the RDM) before being allowed access to the APS. Training must ensure the competence and ability of all personnel who operate any component of the APS. Documentation of original training and continuing education must be kept both in the pharmacy and at the site of the RDM, and readily available for inspection by the Board.

(4) Ensure that the RDM is in good working order and accurately dispenses the correct strength, dosage form, and quantity of the drug prescribed while maintaining appropriate record-keeping and security safeguards.

(5) Implement an ongoing quality assurance program that monitors performance of the APS, including the RDM, and the personnel who access it.

(6) Notify the Board within 15 days of removal or closure of the RDM and the disposition of drugs contained in the RDM before it was removed or closed.

(7) Ensure that the RDM is stocked accurately and in accordance with established, written policies and procedures. A pharmacist must check the accuracy of the product supplied for stocking the machine.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.205
Hist.: BP 2-2005, f. 2-14-05, cert. ef. 3-1-05; Renumbered from 855-041-0610, BP 7-2012, f. & cert. ef. 12-17-12

855-041-4120

Drug Delivery and Control

(1) Each RDM must be registered with the Board, under the control of and connected via computer with a Responsible Pharmacy, but not located in a pharmacy. RDMs must be used only in settings with an established program of pharmaceutical care that ensures prescription orders are reviewed by a pharmacist before release to the patient. The Responsible Pharmacy must establish the policies and procedures necessary to fulfill the requirements of all applicable state and federal laws and regulations.

(2) The following must be conspicuously displayed at the site of the RDM:

(a) RDM license;

(b) DEA registration if required;   

(c) A certified copy of the Responsible Pharmacy license; and

(d) A certified copy of the Pharmacist-In-Charge license.

(3) Documentation as to type of equipment, serial numbers, content, policies and procedures, and location shall be maintained in the pharmacy for review by the board. Such documentation must include, but is not limited to:

(a) Location of RDM(s);

(b) Manufacturer's name and model for each RDM;

(c) Description of how the RDM is used;

(d) Quality assurance procedures to determine continued appropriate use of the automated device; and

(e) Policies and procedures for training of appropriate personnel, system operation, safety, security, accuracy, patient confidentiality, oral counseling by a pharmacist or pharmacist-intern, access, and malfunction.

(4) Policies and procedures addressing the operation of the RDM must be maintained in the pharmacy responsible for the APS and at the location at which the RDM has been installed.

(5) All events involving the contents of the RDM must be recorded electronically. Records must be maintained by the pharmacy for a minimum of three years and must be readily available to the Board. Such records shall include:

(a) Identity of RDM accessed;

(b) Identification of the individual accessing the RDM;

(c) Type of transaction;

(d) Date and time of transaction;

(e) Name, strength, dosage form, and quantity of the drug accessed;

(f) Name of the patient for whom the drug was ordered;

(g) Name of the prescribing practitioner

(h) Such additional information as the pharmacist-in-charge may deem necessary; and

(6) Only an Oregon registered technician or an Oregon licensed pharmacist may have access to the RDM.

(7) Only an Oregon registered technician or an Oregon licensed pharmacist may stock medications in the RDM.

(8) All containers of medications stored in the RDM shall be packaged and labeled in accordance with state and federal laws and regulations, including OAR 855-041-1130.

(9) All aspects of handling controlled substances shall meet the requirements of all state and federal laws and regulations.

(10) Oral counseling, as required by OAR 855-019-0230, shall be provided by the pharmacist at the time of dispensing by a two-way audio and video hookup with the Responsible Pharmacy.

(11) The Automated Pharmacy Systems shall provide a mechanism for securing and accounting for wasted, discarded or unused medications in accordance with existing state and federal laws and regulations.

(12) The RDM must be clearly marked with the name, address, and phone number of the Responsible Pharmacy and Pharmacist-In-Charge.

(13) A Responsible Pharmacy located outside of Oregon that operates a RDM in Oregon must be currently licensed and in good standing in Oregon. The Pharmacist-In-Charge must also be currently licensed and in good-standing both in Oregon and in the state in which the Responsible Pharmacy is located.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.205
Hist.: BP 2-2005, f. 2-14-05, cert. ef. 3-1-05; Renumbered from 855-041-0620, BP 7-2012, f. & cert. ef. 12-17-12

Remote Dispensing Facilities

855-041-4200

Remote Dispensing Facility (RDF)

(1) A pharmacy physically located in Oregon may make written application to operate an RDF.

(2) At its discretion, the Board may approve an application for registration as an RDF which includes the following:

(a) An operation plan;

(b) Policies and Procedures;

(c) A training plan;

(d) A quality assurance plan for ensuring that there is a planned and systematic process for the monitoring and evaluation of the quality and appropriateness of pharmacy services and for identifying and resolving problems; and

(e) The fee specified in OAR 855-110-0007(14).

(3) Notwithstanding the definition of “supervision by a pharmacist” in OAR 855-006-0005, supervision in an RDF may be accomplished by a pharmacist via an audio-visual technology from the applying pharmacy.

(4) Notwithstanding rules in this division and in Division 19, a Certified Pharmacy Technician who works in an RDF may have access to the facility without the physical presence of a pharmacist, but may only perform Board approved functions when under the supervision of a pharmacist.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 3-2011, f. & cert. ef. 4-18-11; Renumbered from 855-041-0645, BP 7-2012, f. & cert. ef. 12-17-12; BP 1-2014, f. & cert. ef. 1-3-14

Residential Drug Outlets

855-041-5005

Definitions

For purposes of these rules, OAR 855-041-5000 through 855-041-9999 the following definitions apply:

(1) "Institutional Facility" means a hospital or other health care facility which is an inpatient care facility referred to in ORS 442.015, which includes long-term care facilities and special inpatient care facilities, and such facility is licensed by the appropriate state agency. For the purpose of this rule, an Institutional Facility is a Residential Drug Outlet.

(2) "Institutional Pharmacy" means a pharmacy where medications are dispensed to other health care professionals for administration to institutionalized patients served by an institutional facility, and which is:

(a) Located within the institutional facility;

(b) Located outside the facility but provides pharmaceutical services to institutionalized patients; and

(c) For the purpose of this rule, an Institutional Pharmacy is a Residential Pharmacy.

(3) "Drug Room" means a secure and lockable location within an inpatient care facility that does not have a pharmacy.

(4) "Pharmaceutical Service" means the control of the utilization of drugs, biologicals and chemicals including procuring, manufacturing, compounding, dispensing, distribution and storing of drugs, biologicals and chemicals under the conditions prescribed by this rule. The provision of drug information to patients and to other health professionals is included within the meaning of pharmaceutical services.

(5) "Supervision" means stationed within the same work area, coupled with the ability to control and be responsible for an action.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: 1PB 2-1980, f. & ef. 4-3-80; PB 8-1990, f. & cert. ef. 12-5-90; Renumbered from 855-041-0105 by BP 1-2012, f. 4-26-12, cert. ef. 5-1-12

855-041-5015

Registration

All residential drug outlets shall register annually with the Board of Pharmacy. Residential drug outlets which also provide outpatient pharmacy services shall also register as retail drug outlets.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: 1PB 2-1980, f. & ef. 4-3-80; Renumbered from 855-041-0115 by BP 1-2012, f. 4-26-12, cert. ef. 5-1-12

Technician Checking Validation Program (TCVP)

NOTE: The TCVP is a tool to allow the re-direction of a pharmacist from a distributive task to a cognitive task. It is designed to allow a pharmacist to improve patient safety by focusing on assessing the accuracy and appropriateness of the medications ordered and on educating staff and patients. The development of individualized training programs is the responsibility of each pharmacy in order to tailor the program to the patient population and medication distribution system of the institution. Assessment questions must be tailored to the site and be changed periodically as appropriate. It is the responsibility of the pharmacist-in-charge to ensure that all training is completed and documented prior to a technician performing as a technician checker.

855-041-5100

Definitions

(1) “Error” in Automated Distribution Cabinet (ADC) is any occurrence of a wrong drug, dose, quantity, or dosage form or the inclusion of any drug with an expired date in a line item. All errors in a line item counts as one error.

(2) “Error” in a unit of use cart is any occurrence of a wrong drug, dose, quantity, or dosage form or the inclusion of any drug with an expired date. All errors in any single dose count as one error.

(3) “Line Item” is a checking unit for ADC restocking (example: one specific drug and dose, regardless of quantity).

(4) “Technician Checker” is an Oregon certified technician who has completed the TCVP validation process and is currently authorized to check another technician’s work.

(5) “Technician Checking Validation Program (TCVP)” is a program that uses a technician checker to check functions completed by another technician.

(6) “Unit Dose” is the physical quantity of a drug product designed to be administered to a patient specifically labeled to identify the drug name, strength, dosage amount and volume, if applicable. The unit dosed drug can be obtained from the manufacturer or repackaged from an external re-packager. A drug may be repackaged on-site through a batch repackaging process that includes a pharmacist as a check. Unit dose examples include oral solids individually packaged by a manufacturer or re-packaged, oral liquids drawn up in a labeled oral syringe, all individually labeled injectable products, and pre-mixed IV products.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 1-2012, f. 4-26-12, cert. ef. 5-1-12

855-041-5120

Hospital and Pharmacist in Charge Requirements

(1) Only a hospital pharmacy may apply to participate in a TCVP. To participate in the TCVP, the hospital pharmacy must meet the following requirements:

(a) The hospital pharmacy must develop policies and procedures for the TCVP to include a list of high-risk medications that are excluded from the TCVP. The policies and procedures for the TCVP must be available in the pharmacy for board inspectors.

(b) The hospital pharmacy must obtain approval from the appropriate committee before the TCVP can be implemented;

(c) The hospital pharmacy must have a drug distribution system that is structured to allow for one additional check of the distributed medications by a licensed nurse or other licensed health care professional with authority to administer medications after the delivery of checked medications; and

(d) The Pharmacist-in-Charge is responsible for the TCVP and will document any error, or irregularity in the quality assurance documentation records.

(2) A hospital may not operate a TCVP without prior written approval from the Oregon Board of Pharmacy. To apply for approval, the hospital must submit the following to the Board:

(a) Copies of written training material that will be used to train technicians as technician checkers;

(b) Copies of quality assurance documentation records and forms that will be used to evaluate the technician checkers and the proposed TCVP;

(c) Copies of the policy and procedures for the proposed TCVP; and

(d) A description of how the proposed TVCP will improve patient safety by focusing on assessing the accuracy and appropriateness of the medications ordered and on educating staff and patients.

(e) Other items as requested by the Board.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 1-2012, f. 4-26-12, cert. ef. 5-1-12

855-041-5130

Technician Eligibility and Training

(1) Only Oregon certified technicians who undergo specific training may work as technician checkers. The training must include the following:

(a) A minimum of one year of drug distribution experience;

(b) Didactic lecture or equivalent training with a self-learning packet;

(c) Practical sessions that consist of individual training in checking a cart fill or ADC that is provided by a pharmacist; and

(d) Initial Validation Process as described in OAR 855-041-5140(1).

(2) The practical training sessions must include:

(a) The trainee observing a technician checker or pharmacist performing the checking process that the trainee is learning;

(b) The trainee performing the initial check with a pharmacist verifying all doses;

(c) The trainee completing the validation process with a pharmacist verifying all doses;

(d) The introduction of artificial errors into a live or simulated environment, to monitor the ability of the technician to catch errors. Artificial errors introduced into the live environment, which are not corrected by the technician, must be removed.

(e) The pharmacist must document and notify a technician checker of any errors found during training.

(3) If at any time a TCVP technician loses his or her validation the technician must be retrained and revalidated before acting as a technician checker.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 1-2012, f. 4-26-12, cert. ef. 5-1-12

855-041-5140

Initial Validation Process and Quality Assurance Process

(1) Initial Validation Process: The initial process to validate a trainee’s ability to accurately check another technician’s work must include:

(a) Unit of Use: For initial validation of a trainee to check a unit of use cart fill, the trainee must obtain a 99.8% accuracy rate in 1500 total doses, divided among five separate training checks. A trainee who makes more than three errors in 1500 doses fails the validation and may not work as a technician checker until the checking process is repeated and until successfully completed.

(A) In each initial validation check, a pharmacist must check the accuracy of all unit of use medications after the trainee has checked them. The pharmacist must document any errors in the unit of use cart and discuss them with the trainee.

(B) In each initial validation check, the pharmacist will introduce at least three errors. The pharmacist coordinating the training check will keep a record of the introduced errors and will ensure that all introduced errors are removed before medications are distributed.

(C) The pharmacist must document the results of each initial validation check and retain the results in the quality assurance file.

(b) ADC or non-emergent trays and kits: For initial validation of a trainee to fill ADC or non-emergent trays and kits, the trainee must obtain a 99.8% accuracy rate in 500 total line items, divided among five separate training checks. A trainee who makes more than one error in 500 line items fails the validation and may not work as a technician checker until the checking process is repeated and until successfully completed.

(A) In each initial validation check, a pharmacist must check the accuracy of all ADC or non-emergent tray or kit medications after the trainee has checked them. The pharmacist must document any errors and discuss them with the trainee.

(B) In each initial validation check, the pharmacist will artificially introduce at least three errors. The pharmacist will keep a record of the introduced errors and will ensure that all introduced errors are removed before medications are distributed.

(C) The pharmacist must document the results of each initial validation check and retain the results in the quality assurance file.

(2) Quality Assurance Process: The Quality Assurance Process that ensures on-going competency of technician checkers must include:

(a) Quality checks conducted in the same manner as the applicable initial validation process described in section one of this rule, except that the quality check sample must consist of at least 300 doses for technicians checking unit of use carts and at least 100 line items for technicians checking ADC or non-emergent trays and kits.

(b) The quality checks must occur on random and unannounced dates and times.

(c) A technician checker who makes more than one error fails the quality check and may not work as a technician checker unless the technician first passes a second quality check within 30 days of the failed quality check. If the technician does not pass the second quality check within 30 days, the technician must be retrained and revalidated before working as a technician checker.

(d) The results of each quality check must be documented, including the total number of doses or line items checked, a description of each error, the total number of errors, and the percent error rate. Documentation must be retained in the quality assurance file.

(3) Timing and Frequency of Quality Checks: A technician checker must undergo a quality check at least monthly. A technician checker who has successfully completed three consecutive monthly quality checks must be checked at least quarterly for at least one year. A technician checker who has successfully completed four consecutive quarterly quality checks must be checked at least every six months.

(4) A technician checker who does not perform TCVP duties for more than six months must undergo initial validation as described in section one of this rule.

(5) A description of the quality assurance process must be included in the hospital’s and the pharmacy’s quality assurance program and error reporting system.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 1-2012, f. 4-26-12, cert. ef. 5-1-12

855-041-5150

Checking Procedure

(1) A technician checker must use the following procedure when checking another technician’s work:

(a) A pharmacy technician fills the medication for the cart fill or ADC restocking batch or non-emergent trays and kits.

(b) A technician checker must check the accuracy of cart fill batches or ADC or non-emergent trays and kits. The technician checker shall review the medications for the correct drug, dose, dosage form, and quantity and must review the expiration dates of medications.

(c) If the technician checker discovers a filling error the technician checker must record the error and return the product to the technician who originally filled it, if available, or to another technician. The filling technician must correct the error and the technician checker must check the correction. A pharmacist or another technician checker must check any cart fill batches, ADC or non-emergent tray or kit, or medication corrections filled by a technician checker

(d) If a technician checker is not available, then all doses must be checked by a pharmacist.

(2) This checking process continues until all doses have been checked and determined to be correct.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 1-2012, f. 4-26-12, cert. ef. 5-1-12

855-041-5160

Eligible Specialized Functions

(1) The following specialized functions are eligible for participation in the TCVP:

(a) Cart fill;

(b) ADC batch replacement; and

(c) Non-Emergent kits and trays.

(2) Upon written request, the Board may permit additional specialized functions if to do so will further public health or safety. A waiver granted under this section shall be effective only when issued in writing and approved by the Board.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 1-2012, f. 4-26-12, cert. ef. 5-1-12

855-041-5170

Records

(1) Unless specified otherwise, all records and documentation required by these rules must be retained for three years and made available to the Board for inspection upon request. Records must be stored onsite for at least one year and may be stored in a secured off-site location if retrievable within three business days. Records and documentation may be written, electronic or a combination of the two.

(2) The PIC must ensure maintenance of written or electronic records and reports as necessary to ensure patient health, safety and welfare. Records must include:

(a) Technician checker training documents;

(b) List of high risk medications;

(c) Documentation of any errors, irregularities and results of each initial validation check.

(d) Documentation of quality assurance and forms used to evaluate the technician checker including:

(A) Total number of doses or line item checks;

(B) Description of errors;

(C) Total number of errors; and

(D) Percent error rate.

(e) Documentation of the initial validation check.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 1-2012, f. 4-26-12, cert. ef. 5-1-12

Hospitals with Pharmacies

855-041-6050

Definitions

(1) In these rules, OAR 855-041-6000 through 855-041-6999, the terms below have these meanings:

(a) “Automated Distribution Cabinet” (ADC) means a computerized drug storage device or cabinet that allows a drug to be stored and dispensed near the point-of-care, while controlling and tracking drug distribution;

(b) “Drug” means a drug, a prescription device, a biological medication, a chemical or any combination of these terms;

(c) “Central pharmacy” means a pharmacy within a licensed hospital with a single location and inventory, which prepares and distributes drugs to secondary storage areas in the facility, and remote locations;

(d) “Chief Pharmacy Officer” (CPO) means an Oregon licensed pharmacist who supervises the pharmacy operations in a hospital. The CPO may hold the title of Pharmacy Manager, Pharmacy Director, Director of Pharmacy, Pharmacy Administrator or other pharmacy supervisory management title within the organization. The PIC may also be the CPO if there is only one pharmacy in the hospital;

(e) “Drug profile” means a complete and comprehensive summary of a patient’s current drugs and details of each drug including information such as active ingredient, strength and form, dose and directions for use, and other supplementary information;

(f) “Licensed Independent Practitioner” (LIP) means an individual permitted by law and by the organization to provide care and services, without direction or supervision, within the scope of the individual's license;

(g) “Out-patient” means a person who is not residing in the facility but who is registered with the facility and is using the facility for treatment or diagnostic services;

(h) “Remote storage area” means a patient care area which is part of the hospital that is under the supervision and control of the hospital’s central pharmacy but is not located in the same building as the central pharmacy;

(i) “Secondary drug storage area” means an area in a hospital or licensed residential facility, which is supplied by a central pharmacy and may include facilities such as a drug room, a distribution cabinet or a hospital department;

(j) “Unit-dose” means a quantity of a drug designed to be administered to a patient, such as:

(A) An oral solid individually packaged or re-packaged;

(B) An oral liquid drawn up in a labeled oral syringe;

(C) An injectable product; or

(D) A pre-mixed IV product.

(2) Not withstanding 855-006-0005 and 855-019-0200(2) and (3), for the purpose of these rules, OAR 855-041-6000 through 855-041-6999, verification or final verification means the confirmation by a pharmacist of the correctness, exactness and accuracy of the act, tasks, or function as specified elsewhere in this Division of rules.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 3-2010, f. 4-29-10, cert. ef. 4-30-10

855-041-6100

Registration

(1) Each central pharmacy must be registered with the Board. In a hospital with multiple central pharmacies, each pharmacy location must be registered with the Board.

(2) A secondary drug storage area within the hospital or in a structure physically attached to the hospital does not require a separate registration.

(3) A registered pharmacy in a hospital may use additional locations within the hospital, supervised by a pharmacist, without acquiring separate registrations for each additional location.

(4) A secondary drug storage area in a separate location must be registered as a drug room and must follow all rules that apply to secondary storage areas in the hospital.

(5) A residential healthcare facility that is licensed by DHS and that has a central pharmacy must register the pharmacy with the Board.

(6) Upon written request, the Board may waive any of the requirements of this rule if a waiver will further public heath or safety or the health and safety of a patient. A waiver granted under this section shall only be effective when it is issued by the Board in writing. A waiver is not valid for more than five years.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155 & 689.305
Hist.: BP 3-2010, f. 4-29-10, cert. ef. 4-30-10

855-041-6150

General Pharmacy Requirements

(1) Each hospital pharmacy must have an Oregon licensed pharmacist designated as Pharmacist-in-Charge (PIC).

(2) A hospital that has more than one pharmacy must designate an Oregon licensed pharmacist as CPO or an equivalent position who has responsibility for directing pharmacy services in the hospital. The CPO may also be the PIC of one of the pharmacies.

(3) A hospital pharmacy may only be operated when under the direct supervision of an Oregon licensed pharmacist. The pharmacist shall be responsible for all areas of the hospital where drugs are stored, including remote storage areas

(4) The pharmacy must be operated at least part-time, five days a week.

(5) The hospital pharmacy must have adequate space so that drugs can be prepared in sanitary, well-lit, enclosed places. Space and equipment must be adequate for the pharmaceutical services provided including compounding, distributing, and storage of drugs and parenteral preparations.

(6) As a minimum, the pharmacy must have the following:

(a) Equipment listed in OAR 855-041-0040, except that a pharmacy that is only registered as an institutional drug outlet does not need to have an Official Poison and Exempt Narcotic Register;

(b) A drug formulary approved by the appropriate hospital committee;

(c) Pharmacy policy and procedures.

(7) All areas occupied by a hospital pharmacy must be secured to prevent access by unauthorized personnel.

(a) Whenever any area of a hospital pharmacy is not under direct supervision of a pharmacist, the area must be secured;

(b) The CPO shall designate in writing, by title and specific area, those persons who may have access to specific areas within the pharmacy;

(c) Unless otherwise permitted by these rules, a non-pharmacist may not have access to the pharmacy unless a pharmacist is on duty and present in the hospital.

(8) A residential healthcare facility that has a central pharmacy must comply with these rules.

(9) Upon written request, the Board may waive any of the requirements of this rule if a waiver will further public health or safety or the health and safety of a patient. A waiver granted under this section shall only be effective when it is in writing. A waiver is not valid for more than five years.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 3-2010, f. 4-29-10, cert. ef. 4-30-10

Drug Distribution and Control

855-041-6200

Chief Pharmacy Officer and Pharmacist in Charge

(1) The CPO must specify the respective responsibilities of the CPO and the PIC if separate individuals hold these positions.

(2) In addition to the duties listed in this rule, the PIC has the responsibilities listed in OAR 855-019-0300.

(3) The CPO must establish policies and procedures that include:

(a) Procedures for general distribution of drugs throughout the hospital;

(b) A procedure for review and revision of the policies and procedures not less than every three years;

(c) Procedures for the supervision of pharmacy services including storage, distribution, control and accountability for drugs including controlled drugs;

(d) Procedures to ensure that all areas of the hospital where drugs are stored are inspected not less than every two months to verify proper drug storage, documentation of distribution and administration of controlled substances, absence of outdated drugs, and the integrity of the emergency drug supplies;

(e) Policies and procedures that govern the preparation, verification and sterilization of parenteral drugs compounded within the hospital. Procedures must comply with OARs 855-045-0200 through 855-045-0270 and these rules;

(f) Procedures for administration of drugs, including self-administration;

(g) Procedures for labeling drugs;

(h) Policies and procedures that govern the filling and labeling of containers from which drugs are to be administered;

(i) Procedures for a Quality Assurance program to ensure that there is a planned, ongoing and systematic process for the monitoring and evaluation of the quality and appropriateness of pharmacy services, and for identifying and resolving problems. Such monitoring and evaluation must be accomplished through ongoing collection of information and periodic assessment of the collected information;

(j) Emergency drug distribution;

(k) Procedures for procurement of all drugs subject to approval of the appropriate committee of the hospital;

(l) Procedures to ensure that discontinued, outdated, adulterated or misbranded drugs are returned to the pharmacy for proper disposition, or that the PIC makes proper disposition or disposal of such drugs at the storage site;

(m) A recall procedure that can be quickly activated to assure the CPO and pharmacy staff, and the medical staff that all drugs included in the recall have been returned to the pharmacy for proper disposition;

(n) Policies and procedures for the use of investigational drugs;

(o) Procedures to be followed in the absence of the pharmacist.

(4) The CPO must:

(a) Participate in the development and revisions of a hospital formulary;

(b) Maintain an emergency and disaster plan for pharmacy services, and participate in the facility’s emergency and disaster plan;

(c) Ensure that records of all transactions of the hospital pharmacy that are required by state and federal laws and regulations are maintained, and maintain accurate control and accountability for all pharmaceutical materials;

(d) Participate in the hospital’s Quality Assurance program related to drugs;

(e) Comply with all inspection and other requirements of the pharmacy in accordance with all applicable state and federal laws and regulations.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 3-2010, f. 4-29-10, cert. ef. 4-30-10

855-041-6220

Records

(1) Unless specified otherwise, all records and documentation required by these rules, OAR 855-041-6000 through 855-041-6999 must be retained for three years and made available to the Board for inspection upon request. Records must be stored onsite for at least one year and may be stored in a secured off-site location if retrievable within three business days. Records and documentation may be written, electronic or a combination of the two.

(2) The PIC must ensure maintenance of written or electronic records and reports as necessary to ensure patient health, safety and welfare. Records must include:

(a) Patient profiles and drug administration records;

(b) Reports of suspected adverse drug reactions;

(c) Inspections of drug storage areas;

(d) Annual controlled substance inventories;

(e) Controlled drug accountability reports;

(f) Collaborative Drug Therapy agreements;

(g) Current hospital drug formulary;

(h) Any other records and reports required by state and federal laws and regulations.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155 & 689.508
Hist.: BP 3-2010, f. 4-29-10, cert. ef. 4-30-10

855-041-6240

Drug Administration

(1) In a hospital, a drug may only be administered upon an order initiated by:

(a) A member of the medical staff who has been granted clinical privileges;

(b) An authorized member of the house staff; or

(c) An authorized licensed practitioner.

(2) Each administration of a drug must be in accordance with policies and procedures approved by the appropriate committee of the hospital, must comply with all applicable laws, rules and regulations, and must follow usual and customary standards of good medical practice.

(3) Self-administration. A patient may only be permitted to self-administer a drug when specifically authorized by the treating or ordering practitioner, and when the patient has been educated and trained in the proper self-administration of the drug.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 3-2010, f. 4-29-10, cert. ef. 4-30-10

855-041-6250

Patient’s Own Drugs and Other Drugs from Outside Sources

When a patient or a patient’s agent brings a drug into the hospital, the drug may only be administered to the patient if:

(1) The practitioner or pharmacist has identified it and it is in a pharmacy labeled container; and

(2) Any administration is pursuant to a practitioner’s order; or

(3) In the pharmacist’s professional judgment, withholding the drug would be detrimental to the patient’s health. In such a case, the pharmacist may authorize administration of the drug pursuant to a practitioner’s order.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 3-2010, f. 4-29-10, cert. ef. 4-30-10

855-041-6260

Investigational Drugs

(1) All in-patient investigational drugs must be stored in the pharmacy and may only be distributed from the pharmacy when properly labeled.

(2) Information concerning the dosage form, route of administration, strength, actions, uses, side effects, adverse effects, interactions and symptoms of toxicity of such drugs must be available in the pharmacy.

(3) Investigational drugs may only be ordered by a designated physician-investigator or their authorized clinician, subject to the prior approval of the appropriate hospital committee.

(4) Each order must include the appropriate protocol number.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 3-2010, f. 4-29-10, cert. ef. 4-30-10

855-041-6270

Labeling

(1) Each pharmacy record keeping system must identify and document the pharmacist who verifies the drug.

(2) Each pre-packed drug, including a unit-dosed drug, prepared by the pharmacy and intended for use within the facility shall be in an appropriate container with a label that contains:

(a) The brand or generic name and expiration date;

(b) The manufacturer and lot number, or an internal pharmacy code that references manufacturer and lot number;

(c) The strength of the drug.

(3) In-patient: Each drug dispensed to an in-patient other than in a unit-dose or manufacturer’s unit-of-use packaging must be labeled with the following information:

(a) Name and location of patient;

(b) Name and strength of drug;

(c) Route of administration, when necessary for clarification;

(d) Manufacturer and lot number, or internal pharmacy code;

(e) Auxiliary labels as needed, and

(f) Expiration date.

(4) A drug that is to be sent with the patient upon discharge must be labeled in accordance with ORS 689.505(5) and other rules in this Division. Drug counseling information must be provided to the patient or patient’s agent.

(5) A label for an outpatient prescription must comply with ORS 689.505(5) and other rules in this Division.

(6) New bar coding or electronic label: When a new barcode or electronic label is used to identify a drug the pharmacist must verify and document the accuracy of the identification with all electronic verification systems prior to distribution.

(7) Whenever a drug is added to a parenteral solution under the direct supervision of a pharmacist, the admixture must be labeled with a distinctive supplementary label that contains

(a) The name, quantity and concentration of the drug added and the primary solution;

(b) The date and time of addition;

(c) The expiration date;

(d) The scheduled time for administration;

(e) The infusion rate, when applicable;

(f) The name or initials of person performing admixture;

(g) The identification of the pharmacy where the admixture was performed; and

(h) The name or initials of the verifying pharmacist.

(8) The label applied at a secondary storage or remote storage area by a nurse or physician must include: the patient name or patient identifier, quantity and concentration of the drug added and the primary IV solution; the date and time of addition and the initials of the nurse or physician adding the drug.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155 & 689.505
Hist.: BP 3-2010, f. 4-29-10, cert. ef. 4-30-10

Absence of a Pharmacist

855-041-6300

Untitled

The CPO must make appropriate arrangements for provision of drugs to the medical staff and other authorized personnel by use of a night cabinet or by access to the pharmacy, or both, for situations when hospital pharmacy services are not available.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155 & 689.605
Hist.: BP 3-2010, f. 4-29-10, cert. ef. 4-30-10

855-041-6305

Night Cabinet

(1) If a night cabinet is used, the following procedures must be followed:

(a) The cabinet or other enclosure located outside the pharmacy must be secure from unauthorized access;

(b) Only one authorized registered nurse on a shift may have access to the night cabinet and may remove drugs. Such nurse must be designated in writing by the appropriate committee of the hospital and prior to being given access to the night cabinet, must receive appropriate training in the proper procedures for access, removal of drugs, and recordkeeping;

(c) The PIC or designee must give this training, and must require, at a minimum, the following procedures:

(A) A drug may only be removed from the night cabinet on a practitioner's written order or a verbal order that has been reduced to writing;

(B) A copy of the practitioner's order must be left in the night cabinet for the pharmacist to verify for accuracy. Both the nurse supervisor and the verifying pharmacist must initial the order.

(2) In conjunction with the appropriate hospital committee, the CPO must develop an inventory of those drugs to be included in each cabinet and establish procedures to ensure that:

(a) Drugs are available and labeled as required by these rules;

(b) Only prepackaged drugs are placed in the cabinet;

(c) Quantities do not exceed those reasonable for immediate therapeutic requirements;

(d) Whenever a cabinet has been accessed, a written record is kept of the drug order and certification of the drug use;

(e) Controlled substances are kept securely and are accounted for using a reconciled perpetual inventory;

(f) An audit of controlled substances in the cabinet is conducted at least once per month. If a tamper-evident seal system is not used, a quality assurance program must be in place to identify any diversion.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155 & 689.605
Hist.: BP 3-2010, f. 4-29-10, cert. ef. 4-30-10

855-041-6310

After Hours Access to Pharmacy

When a drug required to treat the immediate needs of a patient is not available from floor-stock or a night cabinet, it may be obtained from the pharmacy in accordance with the following procedures:

(1) Only one registered nurse supervisor on a shift may have access to the pharmacy and may remove drugs. The nurse supervisor must be designated in writing by the appropriate hospital committee and prior to being permitted to obtain access to the pharmacy, must receive appropriate training in the proper procedures for access, removal of drugs, and recordkeeping;

(2) The PIC or designee must give such education and training, and must require, at a minimum, the following procedures:

(a) A drug may only be removed from the pharmacy on a practitioner's order that has been posted to the patient’s medical record;

(b) A copy of the practitioner's order must be left either with the container from which the drug was removed or with an identical unit-dose, and must be placed conspicuously for a pharmacist to verify for accuracy;

(c) A record of each drug removed from the pharmacy by the nurse supervisor must include:

(A) Name and hospital location of the patient;

(B) Name and strength of drug distributed;

(C) Units used;

(D) Date and time of distribution;

(E) Initials of the nurse supervisor distributing the drug;

(F) Date and initials of the pharmacist who confirmed the accuracy of the transaction.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155 & 689.605
Hist.: BP 3-2010, f. 4-29-10, cert. ef. 4-30-10

Outpatient Drug Distribution

855-041-6400

Emergency Dispensing by a Nurse

A hospital may provide for the emergency dispensing of a drug to an outpatient who is under the care of a practitioner who is a member of the hospital medical staff, when there is a legitimate medical need as described in hospital policies and procedures.

(1) A designated registered nurse may dispense a drug to an outpatient subject to the following:

(a) There is a prescription from a practitioner authorized to prescribe the drug or a verbal order that the nurse has reduced to writing. A practitioner who issues a verbal order or prescription must send a written prescription to the hospital pharmacy within seven days;

(b) The drug is in a manufacturer’s bulk unit-of-use, such as an inhaler, or hospital pre-pack that has been labeled by the pharmacy with;

(A) Name of drug, strength, and number of units. When a generic name is used, the label must also contain the name of the manufacturer or distributor;

(B) Accessory cautionary information as required for patient safety;

(C) Product identification label if the drug is not in unit-of-use packaging;

(D) An expiration date after which the patient should not use the drug;

(E) Name, address and phone number of the hospital pharmacy.

(c) The following information must be added to the drug container by the nurse before dispensing to the patient:

(A) Name of patient;

(B) Directions for use by the patient;

(C) Date of issue;

(D) Unique identifying number;

(E) Name of prescribing practitioner;

(F) Initials of the dispensing nurse or practitioner.

(d) The patient must be given instructions on the use and precautions for taking the drug;

(e) A prescription must be completed by the practitioner or nurse. This prescription must contain:

(A) Name of patient;

(B) Date of issuance;

(C) Name and strength of drug distributed;

(D) Units issued;

(E) Name of practitioner and initials of dispensing nurse;

(F) Instructions given to the patient.

(f) Any additional information required by state and federal laws and regulations for the distribution of a drug to an outpatient.

(2) The patient may not be given more than an emergency supply, as that is defined in the hospital policy and procedures.

(3) The pharmacist must verify, document and date the original prescription.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155 & 689.505
Hist.: BP 3-2010, f. 4-29-10, cert. ef. 4-30-10

855-041-6410

Emergency Department Distribution

(1) A practitioner or associate practitioner with prescriptive authority in Oregon who is a member of the hospital's medical staff may dispense an emergency supply of drugs to a patient examined by them or by an associate practitioner subject to the following requirements:

(a) The prescriber shall offer the patient the option of being provided a prescription that may be filled at the pharmacy of the patient’s choice.

(b) During consultation with the patient or the patient’s caregiver, the prescriber shall clearly explain the appropriate use of the drug supplied and the need to have a prescription for any additional supply of the drug filled at a pharmacy of the patient’s choice.

(c) The patient must be given instructions on the use and precautions for taking the drug;

Labeling

(d) The drug is in a manufacturer’s unit-of-use container, such as an inhaler, or hospital pre-pack that has been labeled by the pharmacy with:

(A) Name of drug, strength, and number of units. When a generic name is used, the label must also contain the identifier of the manufacturer or distributor;

(B) Accessory cautionary information as required for patient safety;

(C) Product identification label if the drug is not in unit-of-use packaging;

(D) An expiration date after which the patient should not use the drug; and

(E) Name, address and phone number of the hospital pharmacy.

(e) The following information must be added to the drug container by the practitioner or nurse before dispensing to the patient:

(A) Name of patient;

(B) Directions for use by the patient;

(C) Date of issue;

(D) Unique identifying number as determined by policy and procedure;

(E) Name of prescribing practitioner; and

(F) Initials of the dispensing nurse or practitioner.

Distribution Record

(f) A prescription or record of the distribution must be completed by the practitioner or nurse. This record must contain:

(A) Name of patient;

(B) Date of issuance;

(C) Drug name and strength distributed;

(D) Units issued;

(E) Name of practitioner;

(F) Initials of the dispensing nurse or practitioner; and

(G) Instructions given to the patient as labeled.

(g) Any additional information required by state and federal laws and regulations for the distribution of a drug to an outpatient;

(h) The record must be reviewed and documented by a pharmacist for accuracy and completeness. The pharmacist shall review the record of dispensing of drugs within 24 hours. However, if the pharmacy is closed, records shall be reviewed during the first day the pharmacy is open but not to exceed 72 hours following the dispensing; and

(i) Errors and discrepancies will be included in hospital and pharmacy QA review process and available to the Board.

(2) A controlled substance may only be distributed or dispensed to an outpatient by the examining practitioner after the patient has been examined by the practitioner and a legitimate medical purpose for a controlled substance has been determined. Distribution of a controlled substance must comply with all applicable state and federal laws and regulations.

(3) The CPO or PIC and appropriate hospital committee will establish a limited selection and quantity of drugs to be included in the Emergency Department formulary and the amount contained in each prepak that may be distributed to meet only the acute care needs of a patient; for example, an emergency supply of drugs. The amount dispensed may not exceed a 48 hour supply except for:

(a) A drug in the manufacturer’s unit-of-use packaging such as an inhalant or a topical drug;

(b) A full course of therapy that may be dispensed if in the professional judgment of the pharmacist or practitioner this would be in the patient’s best interest such as an antibiotic;

(4) Any additional preparation for use of the medication must be completed prior to discharge; for example, reconstituting antibiotics;

Automated Dispensing Machine

(5) For the purpose of this rule an Automated Dispensing Machine (ADM) is a machine or contrivance which will prepare a completed and labeled prescription which is ready for dispensing to the patient or patient’s representative.

(6) An Automated Dispensing Machine; may only be located within the Emergency Department in a secure environment that has no direct public access, and when used, must be part of the discharge procedure;

(7) When the patient or patient’s representative receives the prescription from an ADM;

(a) A registered nurse or practitioner or pharmacist must be present at the time of dispensing; and

(b) A registered nurse or practitioner or pharmacist will grant access to the ADM for the release of the drugs to be dispensed using a password protected or biometric security system; and

(c) The patient or patient’s representative will obtain the drug using a specific patient access code.

(8) Only a pharmacy technician, certified pharmacy technician, intern or pharmacist may access the drug supply in the ADM.

(9) The CPO or PIC will establish policies and procedures for use of the ADM including, but not limited to emergency access and down time procedures for the ADM.

(10) Upon written request, the Board may waive any of the requirements of this rule if a waiver will further public health or safety. A waiver granted under this section shall only be effective when it is issued in writing and will be time limited.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155 & 689.505
Hist.: BP 3-2010, f. 4-29-10, cert. ef. 4-30-10; BP 8-2012, f. & cert. ef. 12-21-12

In-Patient Drug Distribution

855-041-6420

Emergency Kit and Code Cart

An emergency kit consists of those drugs which may be required to meet the immediate therapeutic needs of in-patients and which are not available from any other authorized source in sufficient time to prevent risk of harm to patients.

(1) An emergency kit may be placed in a code cart or as a stand-alone emergency kit.

(2) A pharmacist must verify and document the contents of each emergency kit.

(3) The CPO in cooperation with the appropriate hospital committee shall determine the list and quantity of drugs to be included in an emergency kit. The CPO must ensure that this list is reviewed annually.

(4) An emergency drug kit must use a tamper-evident system and be stored to prevent unauthorized access.

(5) All drugs in emergency kits and code carts must be labeled in accordance with OAR 855-041-6270.

(6) An emergency kit or code cart must be labeled to indicate that it is a drug supply for emergency use. A label must also contain the name, strength, quantity of all drugs in the kit or code cart and the expiration date of the kit. The label shall be affixed to or be available on the exterior of the code cart.

(7) The expiration date of an emergency kit or code cart must be the same as the earliest expiration date of any drug in the kit or cart. Prior to the expiration date, the pharmacist must replace expired drugs.

(8) Only an authorized person may remove a drug from an emergency kit or code cart. Any removal must be pursuant to a valid order or approved protocol.

(9) The pharmacy must be notified when an emergency kit or code cart has been opened or has expired and the pharmacist must restock or replace the emergency kit within a reasonable time.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 3-2010, f. 4-29-10, cert. ef. 4-30-10

855-041-6500

Practitioner’s Drug Order

(1) An order for a drug for an in-patient must be transmitted to the pharmacy using a system that produces a direct or an electronic copy.

(2) A pharmacist must review the drug order before the initial dose is dispensed, and must document the review and DUR except:

(a) When a drug is dispensed under OAR 855-041-6310;

(b) In an emergency;

(c) When pharmacy services are not available; or

(d) When a LIP is present.

(3) An order for a drug must contain:

(a) The patient’s name and location;

(b) The drug name and strength;

(c) Route of administration;

(d) Directions for use;

(e) The date and time; and

(f) The practitioner’s written or electronic signature, or the signature of the practitioner’s agent.

(4) The hospital must follow the following procedures for verbal drug orders:

(a) A verbal drug order should be used infrequently;

(b) A verbal drug order of an authorized individual may be accepted and transcribed only by a qualified person who has been identified by title or category in the hospital policies and procedures;

(c) A verbal order must be reduced to writing and read back to the prescribing practitioner to verify accuracy;

(d) A verbal order must be signed or initialed by the prescribing practitioner as soon as possible.

(5) A drug administered to a patient must be ordered by an authorized prescribing practitioner or otherwise allowed by these rules.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 3-2010, f. 4-29-10, cert. ef. 4-30-10

855-041-6510

In-patient Drug Profile

(1) Each pharmacist must ensure that a drug order for a patient requiring continuous drug therapy is entered into the patient’s drug profile. The profile must contain:

(a) The patient's name, location and important clinical data such as age, height, weight, sex, chronic disease states, problem list and allergies;

(b) The drug name, strength, dosage form, route of administration and directions for administration;

(c) The drug therapy start and end date as applicable;

(d) The name or ID of the pharmacist responsible for entry or verification of the drug order.

(2) Prior to the drug being released for access by the nurse, a pharmacist must enter the drug order into a drug profile and perform a DUR except when:

(a) The drug is being dispensed from an after-hours cabinet in the absence of a pharmacist;

(b) The drug is from an emergency drug kit; or

(c) A system override is being used by a LIP or nurse to treat the emergency needs of a patient. Subject to a prescriber’s order, a sufficient quantity to meet the emergency needs of the patient may be used until a pharmacist is available to review and confirm the drug order.

(3) The pharmacist must continue to monitor the appropriateness of the patient’s drug utilization throughout the patient’s stay in the hospital.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 3-2010, f. 4-29-10, cert. ef. 4-30-10

855-041-6520

Cart-Fill

(1) A unit-dose cart-fill system is a pharmacy controlled unit-of-use drug distribution system.

(a) A unit-dose cart-fill system must provide for separation of drugs by patient name and location, and must be designed to record in an individual patient’s record:

(A) The drug, dose strength, and dosing regimen of those drugs dispensed by the pharmacy;

(B) The number of doses dispensed;

(C) The date of the original order, and the date the order is discontinued.

(b) The system must:

(A) Provide a means for the pharmacist to verify the prescriber's original order;

(B) Provide a means for the pharmacist to verify the accuracy of the selected drug before the dose is delivered for administration to the patient; and

(C) Provide a mechanism to identify controlled substances.

(c) The pharmacist must verify the prescriber’s original order and the accuracy of the selected drug.

(2) Controlled substances may be included in the unit-dose system if the system complies with all applicable state and federal laws and regulations.

(3) Each drug must be in unit-dose packaging when dispensed except when this is impracticable.

(4) A drug not dispensed in unit-dose packaging must be labeled in accordance with other rules in this Division.

(5) A drug in a single container multiple-dose package such as an inhaler or a topical drug must be labeled with the patient’s name and location within the facility.

(6) A pharmacy technician, certified pharmacy technician, intern or pharmacist may fill daily unit-dose drug supplies for a hospital in-patient or a nursing home patient.

(7) The pharmacist must verify the accuracy of a unit-dose package before the dose is delivered for administration to the patient.

(8) Each drug must be stored in a locked area or locked cart.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 3-2010, f. 4-29-10, cert. ef. 4-30-10

855-041-6530

Robotic Distribution Systems

(1) A robotic drug distribution system used in a central pharmacy must be in a secure area under the control of the PIC and must be connected with the system that contains the patient’s drug profile.

(2) The pharmacy must maintain the following documentation for each system:

(a) Details of the equipment including manufacturer's name, model and serial number;

(b) A description of how the system is used;

(c) Policies and procedures that include:

(A) Quality assurance performed at least quarterly including a requirement that a pharmacist visually verifies the accuracy of the electronic or bar code labeling using an audit procedure that includes random sampling;

(B) Procedures for training personnel in safe system operation, security, accuracy, patient confidentiality, access and downtime procedures.

(3) All distribution records must be recorded electronically and retained for 3 years or as approved by the Board. Records must include:

(a) Identity of robotic drug distribution system accessed;

(b) Type of transaction;

(c) Date and time of transaction;

(d) Name, strength, dosage form, and quantity of the drug accessed;

(e) Identity of the patient for whom the drug was ordered;

(f) Any other information the PIC may deem necessary.

(4) Only a pharmacy technician, certified pharmacy technician, intern, pharmacist or a person designated by the PIC may have access to the system.

(5) Only a pharmacy technician, certified pharmacy technician, intern or pharmacist may stock drugs in the system.

(6) All drugs in the system must be packaged and labeled in accordance with state and federal laws and regulations.

(7) Controlled Substances:

(a) Controlled substances must be handled in accordance with all applicable state and federal laws and regulations;

(b) Schedule III, IV and V drugs may be stocked in a robotic drug distribution system provided there is adequate security to limit access to those personnel designated by the PIC;

(c) Schedule II drugs may not be stocked in any robotic drug distribution system.

(8) Drugs prepared by a robotic system must be packaged and separated by patient or as approved by hospital protocol, prior to distribution for administration.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155 & 689.508
Hist.: BP 3-2010, f. 4-29-10, cert. ef. 4-30-10

855-041-6540

Automated Distribution Cabinets

(1) Each ADC must be under the control of the pharmacy. The PIC must establish policies and procedures to meet the requirements of all applicable state and federal laws and regulations.

(2) Policies and procedures addressing the operation of the ADC must be maintained in the pharmacy. They must include:

(a) Training of personnel granted access to the ADC;

(b) System operation, safety, security, access, accuracy and patient confidentiality;

(c) Cabinet replenishment procedures;

(d) Downtime procedures;

(e) A procedure for securing and accounting for any wasted, discarded or unused drug in accordance with existing state and federal laws and regulations.

(3) All events involving the contents of the ADC must be recorded and must include:

(a) Identity of ADC accessed;

(b) Identification of the individual accessing the ADC;

(c) Type of transaction;

(d) Date and time of transaction;

(e) Name, strength, dosage form and quantity of the drug accessed;

(f) Name of the patient or patient identifier for whom the drug was ordered;

(g) Such additional information as the PIC may deem necessary.

(4) Only a pharmacist, pharmacy technician, certified pharmacy technician, intern or other person designated by the PIC may have access to the ADC.

(5) Stocking drugs in an ADC:

(a) Only a pharmacy technician, certified pharmacy technician, intern, pharmacist or other licensed healthcare personnel designated by the PIC may stock drugs in the ADC;

(b) A pharmacist must visually or electronically verify the name, strength and accuracy of the drug to be released from the central pharmacy for restocking;

(c) When a barcode or other electronic system is used to confirm the accuracy of the replenishment of the stock in an ADC, the system must receive an initial quality assurance validation;

(d) When all drug doses for an individual storage unit or bin have been packaged in one container, a single barcode verification may be used;

(e) The PIC must monitor the accuracy of the replenishment of drugs with a quality assurance process that includes:

(A) Reconciling the ADC fill list with established unit specific drugs using the drug profile, ADC discrepancy and inventory reports; and

(B) Monitoring the accuracy of the restocking and withdrawal procedures used by all hospital staff approved for drug administration.

(f) The PIC may permit medical supplies and devices to be included in the ADC.

(6) All drugs stored in the ADC must be packaged and labeled in accordance with state and federal laws and regulations.

(7) A drug that has been removed from the ADC for any purpose may not be returned to the system unless:

(a) A pharmacist has examined the drug, the packaging, and the labeling and determined that reuse of the drug is appropriate; or

(b) It is a drug, such as a multi-dose vial, which has been exempted by the appropriate hospital committee.

(8) At the time of loading, unloading, inventorying, removing or accessing any controlled substance from the ADC, a blind count or confirmation of the correct count must be conducted. Any discrepancy must be reported immediately to the PIC or pharmacist on duty who is responsible for reconciliation of the unresolved discrepancy or proper reporting of the loss.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 3-2010, f. 4-29-10, cert. ef. 4-30-10

855-041-6550

Secondary and Remote Storage

(1) All drugs must be stored in designated areas to ensure proper sanitation, temperature, light, ventilation, moisture control, and security.

(2) Drugs may only be stored in nursing units when space is available for the storage, security, and preparation of drug doses. Such space must include:

(a) A locked drug cabinet or room that is equipped so that each patient’s drugs are separated physically or electronically. Drugs may be stored in secured individual patient storage areas or individually labeled for each patient;

(b) A container or compartment that is permanently attached to a storage cart or the drug room in which controlled substances can be secured;

(c) Alcohol and other flammables must be stored in areas that meet local building code requirements for the storage of volatiles, and such other laws and regulations that apply.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 3-2010, f. 4-29-10, cert. ef. 4-30-10

Floor-stock and Non–emergency Trays and Kits

855-041-6560

Floor-Stock

(1) A minimal quantity of drugs may be stocked in patient care areas to meet the immediate therapeutic needs of a patient where delay would interrupt the continuity of, or compromise the care of the patient.

(2) A hospital pharmacy must not use a floor-stock drug distribution system as its primary system of drug distribution except in departments staffed with a LIP such as the Emergency Room, Operating Rooms and Radiology.

(3) The CPO, in consultation with nursing staff, must prepare a list of drugs by identity and quantity for each area where such supplies are stocked. This list must be kept in the pharmacy.

(4) Floor-stock drug supplies must be stored in a secure area only accessible to pharmacy-authorized personnel.

(5) All drugs in floor-stock must be labeled in accordance with other rules in this Division.

(6) Drugs may only be removed from floor-stock by personnel authorized by the appropriate hospital committee. A drug may only be removed pursuant to a valid prescriber’s order. Removal from stock must be recorded in accordance with policy and in the patient's medical record.

(7) The CPO may permit medical supplies and devices to be included in the floor-stock.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 3-2010, f. 4-29-10, cert. ef. 4-30-10

855-041-6570

Trays and Kits

(1) All drug trays and kits must be prepared by the pharmacy prior to release from the central pharmacy except that trays and kits may be prepared from floor-stock by an LIP who administers the drug or by authorized hospital staff in the case of emergency use if:

(a) The pharmacy and appropriate hospital departments jointly develop guidelines for the proper use, preparation, and security for the trays or kits; and

(b) The pharmacy has a quality assurance program for monitoring the proper use, preparation and security of the kits.

(2) A pharmacist must verify the accuracy and secure the contents of each tray or kit prepared in the pharmacy prior to release from the central pharmacy.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 3-2010, f. 4-29-10, cert. ef. 4-30-10

Controlled Substances

855-041-6600

Controlled Drug Accountability

(1) The hospital must establish procedures and maintain records to account for all controlled substances and any other drugs designated by the appropriate hospital committee. Records must include:

(a) Name of drug;

(b) Dose ordered, dose dispensed, and dose administered;

(c) Identity of patient;

(d) Date and time of administration;

(e) Person administering the drug;

(f) Verification and documentation of any wasted drug including partial doses.

(2) The pharmacy must provide separately locked, securely affixed compartments for storage of controlled drugs and other drugs subject to abuse, except when the facility uses single-unit packaged drug distribution systems in which the quantity stored is minimal and a missing dose can be readily detected.

(3) The pharmacy must obtain a delivery receipt for all controlled drugs supplied as floor-stock. This record must include the date, drug name and strength, quantity, hospital unit receiving drug and the signatures of the distributing pharmacist and the receiving nurse.

(4) A record must be kept of each administration of a controlled drug from floor-stock. The record must be returned to the pharmacy monthly and the PIC or designee must:

(a) Match returned records with delivery receipts to verify that all records are returned;

(b) Periodically audit administration records for completeness;

(c) Reconcile administration records with inventory and verify that sums carried from one record to the next are correctly recorded;

(d) Periodically verify that doses documented on administration records are reflected in the medical record; and

(e) Initial the returned record and file by date of issue.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 475.165 & 689.155
Hist.: BP 3-2010, f. 4-29-10, cert. ef. 4-30-10

855-041-6610

Schedule II Drugs

(1) In addition to the requirements above, Schedule II record keeping must include:

(a) A perpetual inventory system for all Schedule II drugs received, stored and distributed by the pharmacy. The perpetual inventory must be reconciled with an actual inventory at least monthly and the results and any discrepancies must be noted;

(b) Schedule II drugs stored as floor-stock in patient-care areas must be controlled with a perpetual inventory system that includes an actual inventory count and reconciliation when the department or nursing unit is open. The CPO must develop policies and procedure to ensure a regular audit of the inventory;

(c) Quality assurance procedures for the random sample of perpetual inventory sheets including sign-out sheets or other dose-by-dose documentation, must be performed at least quarterly and must be used to determine the accuracy and effectiveness of Schedule II floor-stock drug control;

(d) All Schedule II drugs stored in the pharmacy must be kept in a locked area or secured storage system that tracks the identity of each person making entry into and out of the system whenever a pharmacist is not physically present in the department.

(2) Policies and Procedures must specify the conditions under which Schedule II controlled substances can be transferred into or removed from an ADC.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 475.165 & 689.155
Hist.: BP 3-2010, f. 4-29-10, cert. ef. 4-30-10

855-041-6620

Electronic Safe Systems

(1) The pharmacy must maintain policies and procedures that address the operation of any electronic safe system. These policies must include:

(a) Training of personnel granted access to the electronic safe system;

(b) System operation, safety, security, access, accuracy and patient confidentiality;

(c) Downtime procedures.

(2) All events involving the contents of the electronic safe system must be recorded electronically. Such records must include:

(a) Identity of electronic safe system accessed;

(b) Identification of the individual accessing the electronic safe system;

(c) Type of transaction;

(d) Date and time of transaction;

(e) Name, strength, dosage form, and quantity of the drug accessed;

(f) Name of the patient for whom the drug was ordered when applicable;

(g) Any additional information that the CPO requires.

(3) Only a pharmacist, pharmacy technician, certified pharmacy technician or intern may have access to the electronic safe system.

(4) Only a pharmacist, pharmacy technician, certified pharmacy technician or intern may stock drugs in the electronic safe system.

(5) All activities involving the electronic safe system must comply with all applicable state and federal laws and regulations.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 475.165 & 689.155
Hist.: BP 3-2010, f. 4-29-10, cert. ef. 4-30-10

Hospitals with Drug Rooms

855-041-6800

Supervision of Consulting Pharmacist

(1) In a hospital having a drug room and no pharmacy, the drug room must be supervised by a licensed pharmacist who provides his or her services with sufficient professionalism, quality and availability to adequately protect the safety of the patients and to properly serve the needs of the facility. The arrangements for a consulting pharmacist shall be in writing, and shall, at a minimum, provide that:

(a) The pharmacist is to act in the capacity of a part-time director;

(b) The pharmacist shall provide on-call service at all times;

(c) Adequate storage facilities for drugs will be provided; and

(d) All drugs supplies shall be labeled so as to insure that recalls can be effected and that proper control and supervision of such drugs may be exercised.

(2) One registered nurse supervisor and only one in any given shift may have access to the drug room and may remove drugs therefrom, except in an emergency situation. In that case, such nurse may designate another licensed nurse to obtain the required drug(s). Any access to the drug room deviating from the requirements of this section must be approved by the Board prior to implementation. The registered nurse supervisor shall be designated in writing by the appropriate committee of the hospital and shall, prior to being permitted to obtain access to the drug room, receive thorough education and training in the proper methods of access, removal of drugs, and records and procedures required. Such education and training shall be given by the director of pharmacy, who shall require, at a minimum, the following records and procedures:

(a) Drugs can only be removed from the drug room on a practitioner's written order, or verbal order which has been reduced to writing;

(b) A log of drugs withdrawn from a drug room shall be maintained and initialed by the registered nurse;

(c) Drugs shall be removed for outpatients only in compliance with section (3) of this rule.

(3) The consultant pharmacist who is the part-time director of pharmaceutical services shall in concert with the appropriate committee of the hospital medical staff, develop policies and procedures which shall be implemented to provide emergency pharmaceuticals to outpatients during the hours when normal community or hospital pharmacy services are not available. Such policies shall allow the designated registered nurse supervisor to issue medications pursuant to the pharmacist's standing orders, which shall provide:

(a) A written order of a practitioner authorized to prescribe a drug is presented;

(b) The medication is prepackaged by a pharmacist and contains:

(A) Name, address and telephone number of the hospital;

(B) Name of drug, strength, and number of units; when a generic name is used, the label shall also contain the name of the manufacturer or distributor;

(C) Required precautionary information regarding controlled substances;

(D) Such other and further accessory cautionary information as required for patient safety;

(E) An expiration date after which the patient should not use the medication.

(c) No more than a 24-hour supply is provided to the patient, except when the pharmacist has informed the nurse supervisor that normal services will not be available within 24 hours;

(d) The container is labeled by the nurse supervisor before presenting to the patient, and shows the following:

(A) Name of patient;

(B) Directions for use to the patient;

(C) Date;

(D) Identifying number;

(E) Name of prescribing practitioner;

(F) Initials of the supervisor.

(e) The original written order by the prescriber is retained for verification by the pharmacist after completion by the nurse supervisor and shall bear:

(A) Name and address of patient;

(B) Date of issuance;

(C) Units issued;

(D) Initials of supervisor issuing medication.

(f) The original written order is verified by the pharmacist, initialed, dated, and filed in a separate location for a period of three years for Board inspection;

(g) The withdrawal of a single dose for immediate administration to the patient need not follow the requirements of subsection (d) of this section.

(4) Emergency Kits:

(a) Emergency Kit Drugs Defined. Emergency kit drugs are those drugs which may be required to meet the immediate therapeutic needs of in-patients, and which are not available from any other authorized source in sufficient time to prevent risk of harm to patients by delay resulting from obtaining such drugs from such other source;

(b) Supplying Pharmacist. All emergency kit drugs shall be prepared by a licensed pharmacist;

(c) Drugs Included. The director of pharmacy and the medical staff of the hospital shall jointly determine and prepare a list of drugs, by identity and quantity, in amounts sufficient for immediate therapeutic requirements, to be included in emergency kits. Such list of drugs shall be reviewed annually by the appropriate medical staff committee;

(d) Storage. Emergency kits shall be stored in areas to prevent unauthorized access and to insure a proper environment for preservation of the drugs within them, as required in official compendia;

(e) Labeling — Interior. All drugs contained in emergency kits shall be labeled in accordance with OAR 855-041-6420;

(f) Labeling — Exterior. The exterior of emergency kits shall be labeled to clearly and unmistakably indicate that it is an emergency drug kit and it is for use in emergencies only; such label shall also contain a listing of the name, strength and quantity of the drugs contained therein and an expiration date;

(g) Expiration Date. The expiration date of an emergency kit shall be the earliest expiration date on any drug supplied in the kit. Upon the occurrence of the expiration date, the supplying pharmacist shall open the kit and replace expired drugs;

(h) Removal of Drugs. Drugs shall be removed from emergency kits by authorized personnel only pursuant to a valid order or by the supplying pharmacist;

(i) Notifications. Whenever an emergency kit is opened or has expired, the supplying pharmacist shall be notified and the pharmacist shall restock and reseal the kit within a reasonable time so as to prevent risk of harm to patients.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.205
Hist.: 1PB 3-1979(Temp), f. & ef. 10-31-79; 1PB 2-1980, f. & ef. 4-3-80; PB 12-1989, f. & cert. ef. 8-11-89; Renumbered from 855-041-0135, BP 7-2012, f. & cert. ef. 12-17-12

855-041-6840

Drug Distribution and Control from a Drug Room in a Hospital

(1) General. The director of pharmacy shall establish and implement written procedures for the safe and efficient distribution of pharmaceutical products. An annually updated copy of such procedures shall be available for inspection by the Board.

(2) Availability. A pharmacist providing pharmaceutical services to a hospital maintaining a drug room shall be engaged by the hospital and shall schedule on-premises visits on at least a weekly basis.

(3) Span of Control. The pharmacist’s span of supervision shall extend to all areas of the hospital where drugs are stored. No less than every two months inspections of these areas shall be conducted and substantiated by records so as to verify at least proper drug storage, documentation of distribution and administration of controlled substances, absence of outdated drugs, and the integrity of the required emergency drug supply.

(4) Director’s Absence. In the absence of the director of the pharmaceutical service, pharmaceutical services shall be directed by a designated pharmacist.

(5) Responsibility. The director of pharmacy shall be responsible for procedures for the safe and efficient distribution of, control of and accountability for drugs. Accordingly, the director shall be responsible for, at a minimum, the following:

(a) Procedures for preparation and sterilization of parenteral medications manufactured within the hospital;

(b) Procedures for admixture of parenteral products, including education and training of nursing personnel concerning incompatibility and provision of proper incompatibility information. When the admixture of parenteral products is not accomplished under the direct supervision of a pharmacist, such preparation shall be limited to a practitioner or registered nurse;

(c) Manufacture and compounding of drugs;

(d) Procedures for establishment of specifications for procurement of all pharmaceutical materials, including drugs, chemicals and biologicals, subject to approval of the appropriate committee of the hospital;

(e) Procedures for participation in the development and revisions of a hospital formulary system;

(f) Procedures for filling and labeling all stock containers from which drugs are to be administered;

(g) Maintaining and making available a sufficient inventory of antidotes and other emergency drugs, as well as current antidote information, telephone numbers of poison control center(s) and other emergency assistance organizations, and such other materials and information as may be deemed necessary by the appropriate committee of the hospital;

(h) Records of all transactions of the hospital relating to pharmaceutical services as may be required by state or federal law, and maintenance of accurate control over and accountability for all pharmaceutical materials. The procedures shall include the keeping of accurate and complete records of the receipt, withdrawal from stock and use or other disposal of all legend drugs stored in the drug room and all other locations in the hospital;

(i) Participation in those aspects of the hospital’s patient care evaluation program which relate to pharmaceutical material utilization and effectiveness;

(j) Meeting all inspection and other requirements of the pharmacy and drug laws of this state and rules thereunder.

Stat. Auth.: ORS 689
Stats. Implemented:
Hist.: 1PB 3-1979(Temp), f. & ef. 10-31-79; 1PB 2-1980, f. & ef. 4-3-80; Renumbered from 855-041-0140, BP 7-2012, f. & cert. ef. 12-17-12

Pharmacists Serving Long Term Care Facilities and Community Based Care Facilities

855-041-7050

Definitions

As used in OAR 855-041- 7000 through 855-041- 7080:

(1)(a) "Long term care facility" means a facility with permanent facilities that include inpatient beds, providing medical services, including nursing services but excluding surgical procedures except as may be permitted by the rules of the director, to provide treatment for two or more unrelated patients. "Long Term Care facility" includes skilled nursing facilities and intermediate care facilities but may not be construed to include facilities licensed and operated pursuant to ORS 443.400 to 443.455.

(b) For the purposes of Schedule II prescriptions in 21 CFR 1306.11-1306.13, the DEA definition of "long term care facility" as defined in 21 CFR 1300.01(25) includes "community based care facilities."

(2) "Community Based Care Facility" means a home, facility or supervised living environment licensed or certified or otherwise recognized by an agency of the state of Oregon which provides 24-hour care, supervision, and assistance with medication administration. These include but are not limited to Adult Foster Homes, Residential Care Facilities (RCF), Assisted Living Facilities (ALF), Group Homes for the Developmentally Disabled and Mentally Retarded and Inpatient Hospice.

(3) "Pharmaceutical Care" means the responsible provision of any or all of the following services by the pharmacist:

(a) Develop and maintain policies and procedures for pharmaceutical services;

(b) Provide direction and oversight regarding all aspects of the acquisition, disposition, handling, storage, and administration of drugs including but not limited to the following:

(A) Receipt and interpretation of physician's orders;

(B) Ordering and receiving of medications;

(C) Handling of emergency drugs and supplies;

(D) Labeling of all drugs;

(E) Selection of drug delivery systems;

(F) Development of systems to provide timely delivery of drugs and supplies;

(G) Monitoring of drug storage conditions and expiration dates;

(H) Monitoring accuracy and efficiency of medication administration and compliance with physician's orders;

(I) Establishing and monitoring of appropriate record keeping;

(J) Accountability of controlled substances;

(K) Return, release, and/or destruction of discontinued or outdated drugs; and

(L) Compliance with state and federal laws and regulations related to pharmaceutical services and medication management.

(c) Provide training and in-service education to facility staff;

(d) Perform drug regimen review for each resident on a regularly scheduled basis for the purpose of promoting therapeutic appropriateness and achieving the desired drug therapy outcomes by identifying issues such as:

(A) Over-utilization or underutilization;

(B) Therapeutic duplication;

(C) Drug-disease contraindications;

(D) Drug-drug interactions;

(E) Incorrect drug, drug dosage or duration of drug treatment;

(F) Drug-allergy interaction;

(G) Clinical abuse/misuse;

(H) Untreated indication;

(I) Monitoring and assessing of drug therapy outcomes;

(e) Communicate effectively with residents' physicians and facility staff; and

(f) Participate in resident care planning.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.0305
Hist.: 1PB 2-1980, f. & ef. 4-3-80; PB 8-1990, f. & cert. ef. 12-5-90; BP 4-2002, f. 6-27-02, cert. ef. 7-1-02; Renumbered from 855-041-0145, BP 7-2012, f. & cert. ef. 12-17-12

855-041-7060

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.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.305
Hist.: 1PB 2-1980, f. & ef. 4-3-80; 1PB 1-1981(Temp), f. & ef. 4-1-81; 1PB 2-1981, f. & ef. 8-20-81; PB 1-1990, f. & cert. ef. 1-23-90; PB 8-1990, f. & cert. ef. 12-5-90; BP 4-2002, f. 6-27-02, cert. ef. 7-1-02; Renumbered from 855-041-0160, BP 7-2012, f. & cert. ef. 12-17-12

855-041-7070

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 855-19-0230.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.305
Hist.: BP 4-2002, f. 6-27-02, cert. ef. 7-1-02; Renumbered from 855-041-0162, BP 7-2012, f. & cert. ef. 12-17-12

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.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.305
Hist.: BP 4-2002, f. 6-27-02, cert. ef. 7-1-02; Renumbered from 855-041-0164, BP 7-2012, f. & cert. ef. 12-17-12

Home Health Care Agencies

855-041-8050

Emergency Drug Supply in Home Health Care Agencies

Pharmacists serving home health care agencies may provide for an emergency supply of drugs to be made available to registered nurses to treat immediate therapeutic needs of their patients or clients during such time as the pharmacy services are not available. Arrangements shall be made in advance by the provider pharmacist for provision of the emergency drug supply:

(1) Emergency drugs defined. Emergency drugs are those non-controlled substances which may be required to meet the immediate therapeutic needs of patients and which are not available from any other authorized source in a timely manner;

(2) Portable Container. Subject to all provisions of this section, a licensed pharmacy may furnish to a home health agency licensed by the State an emergency drug supply in a portable container for emergency in home treatment or adjustment of drug therapy by the home health agency nurse;

(3) Drugs included. The pharmacist(s) and the practitioner(s) who represent the agency shall jointly determine and review annually a list of items and quantities to be included in the emergency supply. Drugs shall only be available therein, in amounts sufficient for immediate therapeutic requirements. The selected list shall include only drugs to treat the following specific conditions:

(a) Allergic reactions;

(b) Diabetic emergencies;

(c) Severe nausea and vomiting;

(d) Pulmonary congestion or congestive heart failure;

(e) Local or topical anesthetics for catheter and needle placement;

(f) Hydration due to hypovolemia or shock;

(g) Routine catheter maintenance; and

(h) Narcotic analgesic overdose.

(4) Security. The emergency drug supply shall be stored in a manner to prevent loss of drugs, and available only to authorized licensed personnel. It may be kept in a room adjacent to the locked pharmacy, or in a secure area in the Home Health/Home I.V. nursing office;

(5) Storage. The emergency drug supply shall be stored in areas suitable to prevent unauthorized access and to insure a proper environment for preservation of the drugs as required in official compendia;

(6) Labeling-Exterior. The exterior of the emergency drug supply shall be labeled to clearly indicate it as an emergency supply. Labeling shall also include the expiration date of the drug supply. A complete listing of the contents of the supply shall be readily available;

(7) Labeling-Interior. All drugs contained in the emergency medication supply shall in the manufacturer's container or be labeled in accordance with OAR 855-041-1135;

(8) Drugs added to parenteral solutions. Whenever any drug is added to a parenteral solution, whether within or outside the direct personal supervision of a pharmacist, such admixtures shall be labeled with a distinctive supplementary label indicating the name and amount of the drug added, date and time of addition, expiration date, administration time and infusion rate when applicable, and name or initials of person so adding. This excludes any single dose medication prepared and totally administered immediately;

(9) Removal of drugs. Emergency drugs shall be removed for administration only by authorized licensed personnel pursuant to a prescriber's order. A copy of this order shall be forwarded to the provider pharmacist within 72 hours to be reviewed and filed in the pharmacy. Verification of this review shall be a hand written initial of the reviewing pharmacist on that copy of the order;

(10) Expiration Date. The expiration date of the emergency drug supply shall indicate the month and year, and shall be the earliest expiration date of any drug in the supply. The provider pharmacist shall examine the supply and replace drugs prior to their expiration.

Stat. Auth.: ORS 475.035 & 689.205
Stats. Implemented: ORS 689.225
Hist. PB 1-1996, f. & cert. ef. 4-5-96; Renumbered from 855-041-0183; BP 4-2002, f. 6-27-02, cert. ef. 7-1-02; Renumbered from 855-041-0165, BP 7-2012, f. & cert. ef. 12-17-12

The official copy of an Oregon Administrative Rule is contained in the Administrative Order filed at the Archives Division, 800 Summer St. NE, Salem, Oregon 97310. Any discrepancies with the published version are satisfied in favor of the Administrative Order. The Oregon Administrative Rules and the Oregon Bulletin are copyrighted by the Oregon Secretary of State. Terms and Conditions of Use

Oregon Secretary of State • 136 State Capitol • Salem, OR 97310-0722
Phone: (503) 986-1523 • Fax: (503) 986-1616 • oregon.sos@state.or.us

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