Board of Pharmacy_855

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The Oregon Administrative Rules contain OARs filed through January 15, 2010

BOARD OF PHARMACY

DIVISION 41

OPERATION OF PHARMACIES (RETAIL AND INSTITUTIONAL DRUG OUTLETS)
CONSULTING PHARMACISTS AND OPERATION OF DRUG ROOMS

855-041-0005

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 section (7) of this rule 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) Following Board approval 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:

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

855-041-0007

Applicability of Rules

(1) In conjunction with the rules in division 19 of this chapter, these rules, OAR 855-041-0015 through 855-041-0620 apply to all retail and institutional drug outlets doing business in Oregon, and to the pharmacists working in these outlets.

(2) The provisions of OAR 855-041-0015 through 855-041-0100 are applicable to all retail drug outlets, including the practice of pharmacy in such outlets, and are applicable to all institutional drug outlets except where OAR 855-041-0105 through 855-041-0160 provide specific exemption or exceptions or where 855-041-0105 through 855-041-0160 are in direct conflict in which case 855-041-0105 through 855-041-0160 shall apply.

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; PB 1-1989, f. & cert. ef. 1-3-89; Renumbered from 855-041-0050, BP 2-2008, f. & cert. ef. 2-20-08

855-041-0010

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

855-041-0015

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. New certificates of registration will be issued at the next regular renewal period.

(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:

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

855-041-0017

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)

855-041-0020

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

855-041-0025

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

855-041-0026

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 insure 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 855-041-0035.

(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 855-041-0120, 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 & 689
Stats. Implemented:
Hist.: 1PB 5-1982, f. & ef. 8-6-82; PB 1-1987, f. & ef. 2-3-87

855-041-0030

Loss of Pharmacy Certificate of Registration (Both Retail and Institutional)

In case of loss of certificate of registration, the Board may require a sworn statement before a notary public to be filed in the Board office before duplicate certificates of registration can be issued.

Stat. Auth.: ORS 689
Stats. Implemented:
Hist.: 1PB 2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80

855-041-0035

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 855-041-0120, 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
Stats. Implemented:
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

855-041-0036

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)

855-041-0037

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) When there are reasonable grounds to believe that drugs have been stolen, the pharmacist shall immediately notify the Board.

(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 bent to the Board. When loss of controlled substances is due to burglary or robbery, a copy of the police report shall be sent to the Board.

Stat. Auth.: ORS 475.035, 689.155, 689.205, 689.305 & 689.315
Stats. Implemented:
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)

855-041-0040

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

855-041-0055

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

855-041-0056

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;

(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

855-041-0057

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;

(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.

Stat. Auth.: ORS 689
Stats. Implemented:
Hist.: PB 1-1989, f. & cert. ef. 1-3-89

855-041-0060

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

(5) 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;

(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.

(6) Patient records shall be maintained for a period of not less than three years.

(7) Drug Outlet Procedures:

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

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

(b) Performing mandatory prospective drug utilization reviews;

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

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

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

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

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

(8) 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 855-041-0065, and rules related to records for prescriptions for controlled substances.

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

855-041-0061

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

855-041-0065

Requirements for Prescriptions -- Prescription Refills

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.

(1) Each pharmacy must document the following information:

(a) The name of the patient for whom, or the owner 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;

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

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

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

(g) One of the following phrases or notations, in the prescribing practitioner's handwriting or, if the prohibition was communicated by telephone, the pharmacist's handwriting, if the practitioner wishes to prohibit the substitution of a brand name drug specified in the prescription:

(A) No substitution;

(B) N.S.;

(D) Brand necessary;

(E) Medically necessary;

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

(G) Words with similar meaning.

(2) 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.

(3) 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.

(4) 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;

(d) Date of refill; and

(e) Quantity dispensed.

(5) After two years from date of issue, a prescription for a non-controlled substance becomes invalid and must be re-authorized by the prescriber. 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. 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. 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 two years. The prescription shall not be refilled out of context with the approximate dosage schedule unless specifically authorized by the prescriber. 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.

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

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

(b) Date;

(d) Name of patient;

(e) Name of drug, strength, and quantity dispensed; when a generic name is used, the label shall also contain the name 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 judgement, 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) After July 1, 2000, 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. Between the implementation date of July 1, 2000, and June 30, 2002, the Board will not take formal disciplinary action against a licensee or registrant for failure to achieve full compliance with this rule. During this period, the Board will issue a letter of noncompliance requiring a response as to the reason(s) for the failure to comply and the plan to reach compliance. A letter of noncompliance will not be considered a disciplinary action, nor will it initiate or affect any other disciplinary action. Failure to respond to a letter of noncompliance or failure to demonstrate a good faith effort to comply may result in disciplinary action.

(7) 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
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

855-041-0075

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

855-041-0080

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

855-041-0086

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

855-041-0095

Pharmacy Depots

No licensed pharmacist shall participate in any arrangement or agreement whereby prescriptions may be left at, picked up from, accepted by, or delivered to any place of business not licensed as a pharmacy. This shall apply to the prescription order blank and to the completed prescription medication container. Provided, however, that nothing in this rule shall prohibit a licensed pharmacist or a licensed pharmacy by means of its employee or by use of a common carrier, from picking up prescriptions, or delivering prescriptions, at the office or home of the prescriber, at the residence of the patient, or at the hospital or medical care facility in which a patient is confined.

Stat. Auth.: ORS 689
Stats. Implemented:
Hist.: 1PB 2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80

855-041-0103

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

Stat. Auth.: ORS 689.155 & 689.205
Stats. Implemented:
Hist.: PB 5-1992, f. & cert. ef. 10-23-92

Institutional Drug Outlets

855-041-0105

Definitions

For purposes of these rules, OAR 855-041-0105 through 855-041-0160, 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.

(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.

(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
Stats. Implemented:
Hist.: 1PB 2-1980, f. & ef. 4-3-80; PB 8-1990, f. & cert. ef. 12-5-90

855-041-0110

Applicability of Rules

The provisions of OAR 855-041-0005 through 855-041-0100 are applicable to all retail drug outlets and are applicable to all institutional drug outlets except where OAR 855-041-0105 through 855-041-0160 provide specific exemptions or exceptions or where OAR 855-041-0105 through 855-041-0160 are in direct conflict, in which case OAR 855-041-0105 through 855-041-0160 shall apply.

Stat. Auth.: ORS 689
Stats. Implemented:
Hist.: 1PB 2-1980, f. & ef. 4-3-80; PB 1-1989, f. & cert. ef. 1-3-89

855-041-0115

Registration

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

Stat. Auth.: ORS 689
Stats. Implemented:
Hist.: 1PB 2-1980, f. & ef. 4-3-80

Hospitals with Pharmacies

855-041-0120

Absence of Pharmacist

(1) General. During such times as hospital pharmacy services are not available, arrangements shall be made in advance by the director for provision of drugs to the medical staff and other authorized personnel of the hospital by use of night cabinets and/or by access to the pharmacy under the standing order of the director.

(2) Night Cabinets. If night cabinets are used, the following shall prevail:

(a) In the absence of a registered pharmacist, medication for inpatients shall be obtained from a locked cabinet(s) or other enclosure(s) located outside the pharmacy to which only a licensed nurse may obtain access by key or combination, and which is sufficiently secure to deny access to unauthorized persons. One licensed nurse and only one in any given shift may have access to the night cabinet and may remove drugs there from. Such nurse shall be designated in writing by the appropriate committee of the hospital and shall, prior to being permitted to obtain access to the night cabinet, 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 or designees, who shall require, at a minimum, the following records and procedures:

(A) Drugs can only be removed from the night cabinet on a practitioner's written order, or verbal order, which has been reduced to writing;

(B) The practitioner's order shall be left in the night cabinet so that it will be found by a pharmacist and verified for accuracy. The order shall be initialed by both the licensed nurse and the certifying pharmacist.

(b) The director shall, in conjunction with the appropriate committee of the hospital facility, develop inventory listings of those drugs to be included in such cabinet(s) and shall insure that:

(A) Such drugs are available therein, properly labeled as designated in OAR 855-041-0130(7);

(B) Only prepackaged drugs are available therein, in amounts sufficient for immediate therapeutic requirements;

(C) Whenever access to such cabinet(s) shall have been gained, written medical staff orders and proofs of use, if applicable, are provided;

(D) All drugs therein are inventoried no less than once per week;

(E) A complete audit of all activity concerning such cabinet(s) is conducted no less than once per month; and

(F) Written policies and procedures are established to implement the requirements of section (2) of this rule.

(3) Access to Pharmacy. Whenever any drug is not available from floor supplies or night cabinets, and such drug is required to treat the immediate needs of a patient whose health would otherwise be jeopardized, such drug may be obtained from the pharmacy in accordance with the requirements of this section. One registered nurse supervisor and only one in any given shift may have access to the pharmacy and may remove drugs there from. Such nurse shall be designated in writing by the appropriate committee of the hospital and shall, prior to being permitted to obtain access to the pharmacy, 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 or designees, who shall require, at a minimum, the following records and procedures:

(a) Drugs can only be removed from the pharmacy on a practitioner's written order, or verbal order, which has been reduced to writing;

(b) The practitioner's order shall be left with either the container from which the drug was removed or an identical unit dose and both placed conspicuously so that it will be found by a pharmacist and verified for accuracy. The order shall be initialed by both the nurse supervisor and the certifying pharmacist.

(4) Emergency Outpatient Medication. Hospitals that provide for the dispensing of emergency pharmaceuticals to outpatients during hours when normal community or outpatient hospital pharmacy services are not available may:

(a) Allow a designated nurse supervisor on the original written order of a practitioner as provided in ORS 689.605 to dispense medications pursuant to the following requirements, which shall be in the form of pharmacist's standing orders:

(A) A written order of a practitioner authorized to prescribe a drug is presented;

(B) The medication is prepackaged by a pharmacist and contains:

(i) Name, address and telephone number of the hospital;

(ii) 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;

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

(iv) An expiration date after which the patient should not use the medication.

(C) No more than an emergency supply, as defined by the PIC in the hospital policy and procedures, is provided to the patient.

(D) The container is labeled by the nurse supervisor before presenting to the patient and shows the following:

(i) Name of patient;

(ii) Directions for use to the patient;

(iii) Date;

(iv) Identifying number;

(v) Name of prescribing practitioner;

(vi) 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:

(i) Name and address of patient;

(ii) Date of issuance;

(iii) Units issued;

(iv) Initials of supervisor issuing medication.

(F) The original written order is verified by the pharmacist, initialed, dated and filed separately for a period of three years for Board inspection.

(b) Allow practitioners, as provided in ORS 689.225, who are members of the hospital's medical staff, to dispense an emergency supply of medications to patients examined by them in the institution pursuant to the following requirements, which shall be in the form of pharmacist's standing orders:

(A) A written order of a practitioner authorized to prescribe a drug is documented in the patient's medical record;

(B) The medication is prepackaged by a pharmacist and contains:

(i) Name, address and telephone number of hospital;

(ii) 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;

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

(iv) An expiration date after which the patient should not use the medication.

(i) Name of patient;

(ii) Directions for use to the patient;

(iii) Date;

(iv) Identifying number;

(v) Name of prescribing practitioner.

(D) A record of the dispensing is completed by the practitioner for verification by the pharmacists, retained for three years for Board inspection, and shall bear:

(i) Name of patient;

(ii) Date of issuance;

(iii) Medication dispensed;

(iv) Units issued;

(v) Name of practitioner.

(c) Allowed controlled substances to be dispensed to outpatients by the examining practitioner only after the patient has been examined by the practitioner and a legitimate medical need for a controlled substance has been determined.

(5) Emergency Kits:

(a) Emergency Kit Drugs Defined. Emergency kit drugs are those drugs which may be required to meet the immediate therapeutic needs of inpatients 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) Supply 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, 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 855-041-0130(7);

(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 supply pharmacist;

(i) Notifications. Whenever an emergency kit is opened or has expired, the supply pharmacist shall be notified and the pharmacist shall restock and reseal the kit within a reasonable time to prevent risk of harm to patients.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155, 689.605
Hist.: 1PB 2-1980, f. & ef. 4-3-80; PB 12-1989, f. & cert. ef. 8-11-89; PB 4-1991, f. & cert. ef. 9-19-91; BP 1-2007, f. & cert. ef. 6-29-07

855-041-0125

Physical Requirements

(1) Area. The hospital pharmacy shall have floor space allocated to it to insure that drugs are prepared in sanitary, well-lighted and enclosed places, and meet the other requirements of this section. Floor space shall be allotted to conduct the activities involved with the scope of pharmaceutical services provided.

(2) Equipment and Materials. The hospital pharmacy shall have equipment and physical facilities for proper compounding, dispensing and storage for drugs, including parenteral preparations. As a minimum, the pharmacy shall have the following:

(a) Minimum equipment listed in OAR 855-041-0040, except for the Official Poison and Exempt Narcotic Register, provided that if the pharmacy is registered as both an institutional drug outlet and a retail drug outlet, this exception does not apply;

(b) Drugs to meet the needs of the patients of the hospital;

(3) Storage:

(a) All drugs shall be stored in designated areas within the hospital to insure proper sanitation, temperature, light, ventilation, moisture control, and security;

(b) When drugs are stored on nursing service units, space shall be available at each unit for the storage, safeguarding and preparation of medication doses, and shall include provision of at least the following:

(A) A locked drug cabinet or room shall be equipped to insure physical separation of individual patient prescribed medications. Medications may be stored in secured individual patient storage areas or secured portable storage carts providing separate compartments for individual patients;

(B) A container or compartment which is capable of securing controlled substances with a lock or other safeguard system shall be permanently attached to storage carts or medication rooms;

(C) Alcohol and Flammables. Alcohol and flammables shall be stored in areas that shall, at a minimum, meet basic local building code requirements for the storage of volatiles and such other laws, ordinances or regulations as may apply.

(4) Unattended Areas. In the absence of a pharmacist, and whenever any area of a hospital pharmacy is not under the personal and direct supervision of a pharmacist, such area shall be locked. All areas occupied by a hospital pharmacy shall be capable of being locked by key or combination, so as to prevent access by unauthorized personnel. The director shall designate in writing, by title and specific area, those persons who shall have access to particular areas within the pharmacy. 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. Any deviation from the requirements of this section must be approved in writing by the Board.

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

Stat. Auth.: ORS 475 & 689
Stats. Implemented:
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 12-1989, f. & cert. ef. 8-11-89

855-041-0130

Drug Distribution and Control

(1) General. The director of pharmacy shall establish 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) Pharmacy Operation and Supervision. A hospital pharmacy shall only be operated under the direct supervision of at least one licensed pharmacist. The pharmacy shall be operated at least part time, five days a week.

(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 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) Preparation and sterilization of parenteral medications manufactured within the hospital;

(b) 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;

(d) 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) Participation in the development and revisions of a hospital formulary system;

(f) Filling and labeling all containers from which drugs are to be administered;

(g) Maintaining and making available a sufficient inventory of antidotes and other emergency drugs, both in the pharmacy and inpatient care areas, 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 pharmacy as may be required by state or federal law, and maintenance of accurate control over and accountability for all pharmaceutical materials;

(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.

(6) Practitioner's Orders. All orders for drugs shall be transmitted to the pharmacy by the prescriber or by means of an order format which produces a direct copy or an electronically reproduced facsimile. A pharmacist shall review the practitioner's order before the initial dose of medication is dispensed, provided that in emergencies or when pharmacy services are not available as otherwise contemplated in this division, the medication order shall be reviewed by the pharmacist as soon thereafter as possible. Verification of the accuracy of the medication dispensed and of any transcriptions made of that order shall be documented by the initials of the pharmacist so certifying:

(a) Drug orders for use by inpatients. Orders for drugs for use by inpatients shall, at a minimum, contain: Patient name and location, drug name, strength, directions for use, date and practitioner's signature or signature of practitioner's agent;

(b) Drug orders for use by outpatients. Orders for use by outpatients shall meet the requirements of OAR 855-041-0065.

(7) Labeling:

(a) All drugs intended for use within the facility shall be in appropriate containers and adequately labeled as to identify at a minimum: Brand name or generic name and manufacturer, strength, lot number, and expiration date. An internal code which centrally references manufacturer and lot number can be utilized;

(b) Exemption. As provided in ORS 689.505(1)(b), drugs dispensed by a hospital pharmacy for inpatient use shall be exempt from the labeling requirements of ORS 689.505(5) and OAR 855-041-0065(7) provided that the drugs are to be adminis-tered by a health care professional;

(c) Inpatient: All drugs dispensed to individual inpatients other than those dispensed pursuant to section (8) of this rule shall be labeled with the following information:

(A) Identification of pharmacy;

(B) Name and location of patient;

(D) Route of administration of drug, when necessary for clarification;

(E) Strength of drug;

(F) Auxiliary labels as needed;

(G) Expiration date, if applicable;

(H) Date dispensed.

(d) Outpatient. Labels for outpatient prescriptions shall comply with ORS 689.505(5) and OAR 855-041-0065(7). Drugs originally dispensed to an inpatient shall be returned to the pharmacy for proper labeling before leaving the hospital premises;

(e) Drugs added to parenteral solutions. Whenever any drugs are added to parenteral solutions, whether within or outside the direct and 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, if applicable, administration time and infusion rate when applicable, and name or initials of person so adding.

(8) Unit Dose Dispensing System. The "Unit Dose Dispensing System" is that drug distribution system which is pharmacy based and which uses unit dose packaging in a manner which removes traditional drug stock from patient care areas and enables the selection and distribution of unit dose packaging to be pharmacy based and controlled:

(a) A unit dose dispensing system shall:

(A) By nature of the system:

(i) Provide for separation of medications by patient name and bed number;

(ii) Provide for separating medications by day of administration.

(B) By means of an individual patient medication record:

(i) Record the drug and dosing regimen of those drugs dispensed by the pharmacy;

(ii) Record the actual doses dispensed and returned to the pharmacy;

(iii) Record the date of the original order and the date the order is discontinued;

(iv) Provide a means for the pharmacist to verify the prescriber's original order;

(v) Provide a means for the pharmacist to certify the accuracy of the selected medication before the dose is delivered for administration to the patient;

(vi) Provide a mechanism to easily identify those drugs dispensed by pharmacy that are controlled substances.

(b) Each hospital pharmacy utilizing a unit dose dispensing system shall establish written policies specifying the categories of drugs which will or will not be dispensed under the unit dose distribution system. Such policies shall be available in the pharmacy for inspection by the Board:

(A) Proper utilization of the unit dose system requires that inasfar as is practicable, all medications be in unit dose packaging when dispensed;

(B) Controlled substances may be included in the unit dose system if the methods of including such drugs in the system are in compliance with applicable federal and state laws and rules;

(c) The pharmacist shall certify the accuracy of the selected unit dose packages before the dose is delivered for administration to the patient;

(d) All medication shall be stored in a locked area or locked cart.

(9) Floor Stock/STAT Medication Supplies:

(a) Floor Stock/STAT medication supplies defined. A minimal quantity of medications may be stocked in patient care areas to meet immediate therapeutic patient needs where delay would interrupt the continuity of care;

(b) Limitations. No hospital pharmacy shall utilize a floor stock drug distribution system as its primary system of drug distribution. Such a system, if used, must simply augment the unit-dose drug distribution system in such cases where the quality of patient care is improved or there is an enhancement to drug security and accountability;

(c) Drugs Included. The director of pharmacy and/or pharmacist designee, shall, with input from nursing jointly determine and prepare a written list of drugs by identity and quantity for each area where such supplies are stocked;

(d) Storage. Floor stock/STAT medication supplies shall be stored in a secure area accessible to authorized licensed personnel only;

(e) Labeling. All drugs contained in Floor Stock/STAT medication inventory shall be labeled in accordance with subsection (7)(a) of these rules and regulations;

(f) Removal of Drugs. Drugs shall be removed from Floor Stock/STAT supplies by authorized licensed personnel pursuant to a valid physician's order. Documentation of the removal from stock shall be referenced as directed by policy as well as in the patient's medical record.

(10) Discontinued Drugs. The director shall develop and implement policies and procedures to insure that discontinued and outdated drugs and containers with worn, illegible, or missing labels are returned to the pharmacy for proper disposition, or that the director or his or her designee make proper disposition or dispose of such drugs at the storage site.

(11) Controlled Drug Accountability. The hospital shall establish and implement effective procedures and maintain adequate records regarding use and accountability of controlled substances and such other drugs as the appropriate hospital committee may designate which shall specify at least the following:

(a) Name of drug;

(b) Dose;

(d) Patient;

(e) Date and time of administration;

(f) Person administering the drug.

(12) Schedule II -- Drug Recordkeeping:

(a) Records shall be kept in a readily retrievable form documenting receipt and distribution of all Schedule II drugs by the institutional pharmacy;

(b) These documents shall be made available for Board inspection for the purpose of quantifying any shortages or excesses in Schedule II drugs in the institutional pharmacy;

(c) Schedule II drugs stored as floor stock in patient care areas shall be controlled by a perpetual inventory system which includes an actual inventory count and reconciliation at least once every 24 hours when the department or nursing unit is open;

(d) A random sample of proof of use sheets (sign-out sheets or other dose by dose documentation) shall be performed at least quarterly and used to determine the accuracy and effectiveness of Schedule II floor stock drug control after these drugs leave the physical control of the pharmacy;

(e) All Schedule II drugs stored in the pharmacy shall be kept in a locked storage area whenever a pharmacist is not physically present in the department. Filled prescriptions waiting to be picked up by outpatients are exempt from this requirement;

(f) A perpetual inventory system is required for all Schedule II drugs received, stored and distributed by the institutional pharmacy. The perpetual inventory shall be reconciled with an actual inventory at least monthly with the results and any discrepancies noted on the perpetual inventory.

(13) Recall. The director shall develop and implement a recall procedure that can be readily activated to assure the medical staff of the hospital, the pharmacy staff and the director that all drugs included on the recall, within the hospital, are returned to the pharmacy for proper disposition.

(14) Records and Reports. The recordkeeping requirements of OAR 855-041-0060 and 855-041-0065 shall not apply to hospital inpatient drug orders (as defined in ORS 689.005(12)) except as provided in section (6), subsection (8)(b), and section (14) of this rule and OAR 855-041-0132. The director shall maintain for three years such records and reports as are required to insure patient health, safety and welfare and, at a minimum, the following:

(a) Pharmacy patient profiles and/or medication administration records;

(b) Reports of suspected adverse drug reactions;

(d) Biennial controlled substances inventories;

(e) Alcohol and flammables reports;

(f) Such other and further records and reports as may be required by law and these rules; and

(g) Controlled drug accountability report.

(15) Drugs from Outside Sources. Whenever patients bring drugs into a hospital, such drugs shall not be administered unless they have been precisely identified by the practitioner or pharmacist; administration shall be pursuant to a practitioner's order specifically by name of drug, strength, and directions for use only. Under no circumstances shall unlabeled, mislabeled, mixed or adulterated drugs be allowed to be used.

(16) Investigational Drugs. All investigational drugs shall be stored in the pharmacy and distributed only from the pharmacy. Basic information concerning the dosage form, route of administration, strength, actions, uses, side effects, adverse effects, interactions and symptoms of toxicity of such drugs shall be available in the pharmacy. Investigational drugs shall be properly labeled and shall be administered only under the personal and direct supervision of the principal physician-investigator or his or her authorized clinician(s) with prior approval of the appropriate committee(s) of the hospital and with verifications that the patient (or his legal designee) has signed the informed consent form.

(17) Administration of Drugs:

(a) General. Drugs shall be administered in a hospital only upon the orders of those members of the medical staff who have been granted clinical privileges or who are authorized members of the house staff, or by authorized licensed practitioners in accordance with policies and procedures specified by the appropriate committee of the hospital, under applicable law and rules and regulations and by usual and customary standards of good medical practice;

(b) Self-administration. Self-administration of drugs by patients shall be permitted only when specifically authorized by the treating or ordering practitioner, provided, however, the patient has been educated and trained in the proper manner of self-administration.

(18) Extensions of Pharmacy Services Under Registration. A registered pharmacy in a hospital may utilize additional locations within the hospital without the necessity of securing additional registration provided, however, that the pharmacist in charge of any such hospital pharmacy shall designate another licensed pharmacist to assume professional responsibility, in accordance with ORS 689.315(5) for the practice of pharmacy in each such additional location.

Stat. Auth.: ORS 689
Stats. Implemented:
Hist.: 1PB 2-1980, f. & ef. 4-3-80; PB 12-1989, f. & cert. ef. 8-11-89; PB 4-1991, f. & cert. ef. 9-19-91

855-041-0132

Quality Assurance

Quality Assurance:

(1) The pharmacist-in-charge shall establish written procedures 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. Such monitoring and evaluation are accomplished through the routine collection and periodic assessment of the collected information.

(2) The findings from and conclusions of monitoring, evaluation, and problem solving activities are documented and are made available for Board inspection.

Stat. Auth.: ORS 689
Stats. Implemented:
Hist.: PB 12-1989, f. & cert. ef. 8-11-89

Hospitals with Drug Rooms

855-041-0135

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;

(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;

(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;

(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;

(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;

(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 855-041-0130(7);

(f) Labeling -- Exterior. The exterior of emergency kits shall be labeled to clearly and unmistakable indicate that is 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;

(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
Stats. Implemented:
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

855-041-0140

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.

(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;

(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

Pharmacists Serving Long Term Care Facilities and Community Based Care Facilities

855-041-0145

Definitions

As used in OAR 855-041-0145 through 855-041-0164:

(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;

(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.

(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;

(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

855-041-0160

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

(b) Have some pharmacists visit and provide consultant services on a regular basis;

(d) 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 855-041-0120(3).

(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

855-041-0162

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 855-041-0065(6), or administered by health care professionals from a unit dose system as defined in OAR 855-041-0130(8).

(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

(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 855-041-0065(4), and comply with the patient counseling requirements of OAR 855-041-0100(1).

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.305
Hist.: BP 4-2002, f. 6-27-02, cert. ef. 7-1-02

855-041-0164

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

855-041-0165

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;

(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 manu facturer's container or be labeled in accordance with OAR 855-041-0056;

(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

Correctional Facilities

855-041-0170

Purpose and Scope

A correctional facility is defined as an institutional drug outlet and as such is subject to the rules of the State Board of Pharmacy. Drug dispensing in a correctional facility shall be from a pharmacy or from a drug room. The facility shall have a pharmacist who acts as a consultant to the institution, develops policies and procedures on drug distribution, procurement and management, monitors for compliance, performs drug utilization reviews, and may delegate registered nurses to withdraw drugs for administration to patient/inmates.

Stat. Auth. : ORS 689.205
Stats. Implemented: ORS 689.005, 689.155 & 689.605
Hist. PB 1-1996, f. & cert. ef. 4-5-96

855-041-0173

Definitions

(1) "Administer" means the direct application of a drug or device whether by injection, inhalation, ingestion, or any other means, to the body of a patient or research subject by:

(a) A practitioner or the authorized agent thereof; or

(b) The patient or research subject at the direction of the practitioner.

(2) "Bulk Drug Container" means a bottle or package of medication, other than unit dose, labeled by a manufacturer or pharmacist.

(3) "Container" is the device that holds the medication and that is or may be in direct contact with the medication.

(4) "Correctional Facility" means any prison, jail, or detention facility for the confinement of juveniles or adults.

(5) "Dispense" or "Dispensing" means the preparation and delivery of a prescription drug pursuant to the lawful order of a practitioner in a suitable container appropriately labeled for subsequent administration to or use by a patient or other individual entitled to receive the prescription drug.

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

(7) "Institutional Drug Outlet" means hospitals and inpatient care facilities where medications are dispensed to another health care professional for administration to patients served by the hospitals or facilities.

(8) "Medication card" means a medication container, labeled as required in OAR 855-041-0177(4), which provides multiple doses of a single medication with each dose contained in a separate, tamper-evident, sealed compartment.

(9) "Practitioner" means a person licensed and operating within the scope of such license to prescribe and dispense, conduct research with respect to or administer drugs in the course of professional practice or research:

(a) In this state; or

(b) In another state or territory of the United States not residing in Oregon and registered under the Federal Controlled Substances Act.

(10) "Unit dose" means a sealed, single-unit container so designed that the contents are administered to the patient as a single dose, direct from the container and which bears a separate label showing the name and strength of the medication, the name of the manufacturer or distributor, an identifying lot number and, if applicable, the expiration date of the medication.

(11) "Unit Dose Dispensing System" means a system which utilizes unit dose as its principle means of distributing drugs within a correctional facility.

Stat. Auth. : ORS 689.205
Stats. Implemented: ORS 689.005 & 689.155
Hist. PB 1-1996, f. & cert. ef. 4-5-96

855-041-0175

Duties of the Pharmacist

(1) May delegate to a registered nurse the authority to withdraw prescription drugs from a unit dose system or from a manufacturer's or pharmacist's labeled container for administration to persons confined in the facility;

(2) Develop written policies and procedures with the practitioner representing the facility regarding medication management;

(3) Monitor the facility's compliance with policies and procedures regarding medication management;

(4) Perform drug utilization review including timely, routine prospective review of specific individual therapies as well as retrospective drug regimen reviews, and drug use review and evaluation.

Stat. Auth. : ORS 689.205
Stats. Implemented: ORS 689.605 & 689.155
Hist. PB 1-1996, f. & cert. ef. 4-5-96

855-041-0177

Drug Delivery and Control

(1) Policies and Procedures: The pharmacist and the practitioner representing the facility shall be responsible for establishing written policies and procedures for medication management including, but not limited to, drug procurement, dispensing, administration, labeling, medication counseling, drug utilization review, medication records, parenterals, emergency and nonroutine dispensing procedures, stop orders, over-the-counter drugs, security, storage and disposal of drugs withing the facility. Policies and procedures shall be reviewed and updated annually by the pharmacist and the practitioner, maintained in the facility; and be made available to the Board for inspection. The facility shall submit to the Board for approval, the name of any employee pharmacist or a written agreement between the pharmacist and the facility regarding drug policies and procedures. The facility shall notify the Board of any change of pharmacist within 15 days of the change.

(2) Dispensing: Prescription drugs shall be dispensed by a pharmacist or by a practitioner authorized to dispense in either an individual container, medication card, or in a unit dose system.

(3) Unit Dose Dispensing System. The "Unit Dose Dispensing System" is that drug distribution system which is pharmacy based and which uses unit dose packaging in a manner which removes traditional drug stock from patient care areas and enables the selection and distribution of unit dose packaging to be pharmacy based and controlled:

(a) A unit dose dispensing system shall:

(A) By nature of the system;

(i) Provide for separation of medications by patient name and location; and

(ii) Provide for separating medications by day of administration.

(B) By means of an individual patient medication record:

(i) Record the drug and dosing regimen of those drugs dispensed by the pharmacy;

(ii) Record the actual doses dispensed and returned to the pharmacy;

(iii) Record the date of the original order and the date the order is discontinued;

(iv) Provide a means for the pharmacist to verify the prescriber's original order;

(v) Provide a means for the pharmacist to certify the accuracy of the selected medication before the dose is delivered for administration to the patient; and

(vi) Provide a mechanism to easily identify those drugs dispensed by pharmacy that are controlled substances.

(b) Each correctional facility utilizing a unit dose dispensing system shall establish written policies specifying the categories of drugs which will or will not be dispensed under the unit dose distribution system. Such policies shall be available in the pharmacy for inspection by the Board:

(A) Proper utilization of the unit dose system requires that, in as far as is practicable, all medications be in unit dose packaging when dispensed.

(B) Controlled substances may be included in the unit dose system if the methods of including such drugs in the system are in compliance with applicable federal and state laws and rules.

(c) The pharmacist shall certify the accuracy of the selected unit dose packages before the dose is delivered for administration to the patient.

(d) All medication shall be stored in a locked area or locked cart.

(4) Labeling: Prescription drugs dispensed in individual containers or medication cards shall be labeled with the following information:

(a) Name and identifying number of the patient/inmate;

(b) Name, strength, and quantity of the drug dispensed. If the drug does not have a brand name, then the generic name of the drug and the drug manufacturer must be stated;

(d) Initials of the dispenser and the date of dispensing;

(e) Directions for use;

(f) Auxiliary labels and cautionary statements as required;

(g) Manufacturer's expiration date, or an earlier date if preferable; and

(h) Name of the pharmacy.

(5) Patient counseling:

(a) Upon receipt of a prescription drug order and following review by the pharmacist of the patient's record, the pharmacist shall initiate and provide oral counseling to the patient or to the patient's agent or care giver in all ambulatory care settings and for discharge medications in institutions:

(A) Upon request; or

(B) On matters which a reasonable and prudent pharmacist would deem significant; or

(D) Whenever the patient's medication record shows the drug has not been previously dispensed to the patient in the same dosage, form, strength or with the same written directions.

(b) When counseling is provided it shall include information that a reasonable and prudent pharmacist would deem necessary to provide for the safe and effective use of the drug. Such information may include the following:

(A) The name and description of the drug;

(B) The dosage form, dose, route of administration, and duration of drug therapy;

(D) Special directions and precautions for preparation, administration, and use by the patient;

(E) Common severe side or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur;

(F) The possible dangers of taking the drug with alcohol, or taking the drug and then operating a motor vehicle or other hazardous machinery;

(G) Techniques for self-monitoring drug therapy;

(H) Proper storage;

(I) Prescription refill information;

(J) Action to be taken in the event of a missed dose; and

(K) Pharmacist comments relevant to the patient's drug therapy, including any other information peculiar to the specific patient or drug.

(c) Patient counseling shall be in person whenever practicable. Whenever the prescription is delivered outside the confines of the pharmacy by mail or other third party delivery, counseling shall be in writing and by free access to the pharmacist by phone.

(d) Subsections (a) and (b) of this section shall not apply to those prescription drug orders for inpatients in hospitals or institutions where the drug is to be administered by a nurse or other individual authorized to administer drugs.

(e) Notwithstanding the requirements set forth in subsection (a), a pharmacist is not required to provide oral counseling when a patient refuses the pharmacist's attempt to counsel, or when the pharmacist, on a case by case basis and in the exercise of professional judgment, determines that another form of counseling would be more effective.

(f) Board rules for patient counseling must be observed for patient/inmates who self administer or who are given prescription drugs when they are released from the correctional facility.

(6) Administration: Drugs shall be administered to inmate/ patients by a practitioner or nurse, or by an unlicensed person who has been trained to administer drugs as defined in Nursing Board administrative rule 851-047-0020. Drugs selected by registered nurses from manufacturer's or pharmacist's bulk drug containers shall not be administered by unlicensed persons, except under certain emergency and nonroutine situations as described in the facility's policies and procedures.

Stat. Auth. : ORS 689.205
Stats. Implemented: ORS 689
Hist. PB 1-1996, f. & cert. ef. 4-5-96; Administrative correction 11-3-99; BP 4-2002, f. 6-27-02, cert. ef. 7-1-02

Technicians

855-041-0300

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

Retail Drug Outlet for Home Dialysis Supplies

855-041-0350

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

855-041-0355

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

855-041-0360

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 855-041-0355. 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

855-041-0365

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;

(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

Remote Dispensing

855-041-0600

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

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

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.205
Hist.: BP 2-2005, f. 2-14-05, cert. ef. 3-1-05

855-041-0610

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.

(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

855-041-0620

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;

(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;

(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;

(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 855-041-0065(6)(a)-(k).

(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 855-041-0100, 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

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