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BOARD OF PHARMACY

 

DIVISION 43

PRACTITIONER DISPENSING

855-043-0002

Definitions

In this division of rules:

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

(a) A practitioner or the practitioner’s authorized agent; or

(b) The patient at the direction of the practitioner.

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

(3) "Formulary" means a list of drugs or classes of drugs, or a list of disease states, health conditions or preventative measures such as immunization or birth control approved by the Board or by the Department of Human Services (DHS).

(4) "Health Officer" means a physician licensed by the Oregon Medical Board or the Oregon Board of Naturopathic Medicine and employed by or under contract with a county or district health department or DHS.

(5) “Supervising Physician Dispensing Outlet” (SPDO) means any clinic, office, health care center, treatment center, or other establishment from which a physician assistant dispenses drugs, but that is not otherwise registered with the Board in the category of Retail Drug Outlet.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: PB 2-1992, f. & cert. ef. 3-26-92; PB 4-1992, f. & cert. ef. 8-25-92; Renumbered from 855-043-0120 by BP 1-2010, f. & cert. ef. 2-8-10; BP 3-2012, f. & cert. ef. 6-19-12

855-043-0003

Expedited Partner Therapy

(1) Expedited Partner Therapy (EPT) means the practice of prescribing or dispensing an antibiotic drug for the treatment of a sexually transmitted disease to the partner of a patient without first examining that partner.

(2) An EPT prescription may only be dispensed for a drug and a disease that has been determined by DHS to be appropriately addressed by EPT.

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

855-043-0005

Practitioner Labeling

All drugs dispensed by a practitioner must be labeled with the following information:

(1) Name, address and telephone number of the practitioner;

(2) Date;

(3) Name of the patient or the owner of the animal for which the drug is dispensed. If the prescription is for an animal, the species of the animal for which the drug is dispensed;

(4) Name of drug, strength, the quantity dispensed. When a generic name is used, the label must also contain the name of the manufacturer or distributor;

(5) Direction for use;

(6) Required precautionary information regarding controlled substances;

(7) Such other cautionary information as required for patient safety; and

(8) An expiration date after which the patient should not use the drug or medicine. The expiration date on a drugs dispensed must be the same as that on the original container unless, in the practitioner’s professional judgment, a shorter expiration date is warranted. A drug must not be dispensed after the expiration date of the drug.

(9) Not withstanding the labeling requirements in this rule, when a drug is dispensed in the practice of an Expedited Partner Therapy treatment protocol, the name of the patient or the patient’s partner may be omitted from the label.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155, ORS 689.505 & 2009 OL Ch 522
Hist.: PB 4-1992, f. & cert. ef. 8-25-92; Renumbered from 855-043-0001 by BP 1-2010, f. & cert. ef. 2-8-10

Nurse Practitioner Dispensing

855-043-0210

Purpose and Scope

The Oregon State Board of Nursing may grant to a certified nurse practitioner or Clinical Nurse Specialist the privilege of writing prescriptions described in the formulary under ORS 678.385. A certified nurse practitioner or Clinical Nurse Specialist may submit an application to the Oregon State Board of Nursing to dispense prescription drugs. An application for the authority to dispense prescription drugs as authorized by ORS 678.385 shall include evidence of completion of a prescription drug dispensing training program jointly developed and adopted by rule by the Oregon State Board of Nursing (851-050-0162) and the State Board of Pharmacy. The training program shall be as follows:

(1) Documented review of content regarding safe dispensing listed below:

(a) Board of Nursing handbook "Prescriptive Authority in Oregon for Nurse Practitioners and Clinical Nurse Specialists";

(b) The Drug Enforcement Administration Pharmacist's Manual (2004);

(c) OAR 851, division 56;

(d) ORS Chapter 689 and OAR chapter 855;

(e) US Consumer Product Safety Commission publication "Poison Prevention Packaging: A Text for Pharmacist's and Physicians;"

(f) The Institute for Safe Medication Practices (ISMP) "List of Error-Prone Abbreviations, Symbols, and Dose Designations" (Nov. 2006); and

(g) Information on available electronic or hard copy prescription drug references which provide information to professionals authorized to dispense prescription medications

(2) Successful self examination as provided by the Board of Nursing on these materials.

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

Stat. Auth.: ORS 678.390 & 689.205
Stats. Implemented: ORS 689.205
Hist.: BP 3-2003(Temp), f. 12-29-03, cert. ef. 12-31-03 thru 6-28-04; BP 4-2004, f. 5-21-04 cert. ef. 6-1-04; BP 1-2010, f. & cert. ef. 2-8-10

Supervising Physician Dispensing Outlets

855-043-0405

Purpose and Scope

A supervising physician or supervising physician organization that supervises a physician assistant with dispensing authority must register the dispensing site with the Board as a Supervising Physician Dispensing Outlet (SPDO) and must comply with the rules in OAR chapter 855, division 43.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155, 689.305, 2012 OL Ch 34
Hist.: BP 3-2012, f. & cert. ef. 6-19-12

855-043-0410

Registration

(1) A Supervising Physician Dispensing Outlet must register with the Board as a SPDO in the category of Retail Drug Outlet on a form provided by the Board, and must renew its registration annually on a renewal form provided by the Board.

(2) The initial application must state the location of the SPDO and the name of the person applying for registration. When the person applying for registration is not the owner of the dispensing site, the application must disclose the name and address of the owner and the applicant’s affiliation with the owner.

(a) If more than one individual owns the dispensing site, the names and addresses of the partners or persons holding the three largest ownership interests in the dispensing site must be disclosed on the application.

(b) If the owner is a corporation, the application must state the name of the corporation as filed with the Corporation Division of the Oregon Secretary of State, including the names of the corporation’s officers.

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

(4) An initial application must be accompanied by the fee established in division 110 of this chapter.

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

(6) All registration renewal applications must be accompanied by the annual renewal fee established in Division 110 of this chapter and must contain the information required in sections (2) and (3) of this rule.

(7) The SPDO registration expires March 31, annually. If the annual renewal fee referred to in section (5) of this rule is not paid by February 28 of the current year, the applicant for renewal must submit the delinquent fee established in division 110 of this chapter with the renewal application.

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

(9) The registrant must notify the Board, within 15 days, of any substantial change to the information provided on the registration application. Substantial change shall include but not be limited to: change of ownership; change of business address; change of normal business hours; any disciplinary action taken or pending by any state or federal authority against the registrant, or any of its principals, owners, directors, officers, consultant pharmacist or supervising physician.

(10) A new registration form is required for a change of ownership or location and must be submitted to the Board with the fees as specified in division 110 of this chapter within 15 days of the change.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155, 689.305, 2012 OL Ch 34
Hist.: BP 3-2012, f. & cert. ef. 6-19-12

855-043-0415

Consulting Pharmacist

(1) A SPDO must retain a pharmacist licensed in Oregon for consultation purposes.

(2) The consulting pharmacist must conduct and document an annual inspection of the outlet on a form provided by the Board. The completed inspection report form must be filed in the outlet, retained on file for three years and be available to the Board for inspection.

(3) The duties of the consulting pharmacist shall be clearly defined in writing within the organization. The consulting pharmacist must:

(a) Develop policies and procedures for the outlet in collaboration with the supervising physician; and

(b) Work in consultation with the supervising physician in the development of the formulary of drugs and classes of drugs for the outlet.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155, 689.305, 2012 OL Ch 34
Hist.: BP 3-2012, f. & cert. ef. 6-19-12

855-043-0420

Policies and Procedures

The registered SPDO must:

(1) Maintain written policies and procedures for drug management, including storage, security, integrity, access, dispensing, disposal, record keeping and accountability;

(2) Maintain all drug records required by federal and state law;

(3) Establish procedures for procurement of drugs; and

(4) Establish procedures to train physician assistants who dispense drugs and to ensure the continued competence of physician assistants who dispense drugs.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155, 689.305, 2012 OL Ch 34
Hist.: BP 3-2012, f. & cert. ef. 6-19-12

855-043-0425

Security

(1) All drugs must be kept in a locked drug cabinet or designated drug storage area that is sufficiently secure to deny access to unauthorized persons. The drug cabinet or designated drug storage area must remain locked and secured when not in use.

(2) No drug dispensing machine may be placed in a waiting room or an area that is accessible by the public.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155, 689.305, 2012 OL Ch 34
Hist.: BP 3-2012, f. & cert. ef. 6-19-12

855-043-0430

Storage of Drugs

All drugs, including drug samples, must be stored under conditions that ensure proper sanitation, temperature, light, ventilation, moisture control, and any other condition recommended by the manufacturer.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155, 689.305, 2012 OL Ch 34
Hist.: BP 3-2012, f. & cert. ef. 6-19-12

855-043-0435

Labeling

(1) A prescription must be labeled with the following information:

(a) Unique identifier;

(b) Name of patient;

(c) Name of prescriber;

(d) Name, address, and phone number of the clinic;

(e) Date of dispensing;

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

(g) Quantity dispensed;

(h) Directions for use;

(i) Initials of the physician assistant or practitioner dispensing;

(j) Cautionary statements, if any, as required by law; and

(k) Manufacturer's expiration date, or an earlier date if preferable, after which the patient should not use the drug; and

(l) 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.

(2) Not withstanding any other requirements in this rule, when a drug is dispensed in the practice of an Expedited Partner Therapy treatment protocol, as described in OAR 855-041-4000 through 4005, the name of the patient may be omitted.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155, 689.305, 2012 OL Ch 34
Hist.: BP 3-2012, f. & cert. ef. 6-19-12

855-043-0440

Dispensing and Drug Delivery

(1) Drugs dispensed from a SPO by a physician assistant with dispensing authority or a practitioner must be personally dispensed by the practitioner or physician assistant.

(2) Prior to dispensing a medication a drug utilization review must be performed by the physician assistant or practitioner which includes but is not limited to drug interactions, drug allergies and duplicate drug therapy.

(3) The physician assistant or practitioner must orally counsel the patient concerning all new drugs, unless circumstances would render oral counseling ineffective.

(4) When dispensed, a drug must be accompanied by written information that contains at least the following information:

(a) Drug name, class and indications;

(b) Proper use and storage;

(c) Common side effects;

(d) Precautions and contraindications; and

(e) Significant drug interactions.

(5) Each authorized dispenser of a prescription drug product for which a Medication Guide is required must provide the Medication Guide directly to each patient or patient’s agent when the product is dispensed, unless an exemption applies.

(6) Any other requirement of State or federal law.

(7) A SPDO must dispense a drug in a new container that complies with the current provisions of the Federal Consumer Packaging Act (Public Law 91-601, 91st Congress, S. 2162) and rules or regulations and with the current United States Pharmacopoeia/National Formulary monographs for preservation, packaging, storage and labeling.

(8) Drugs must be prepackaged by a pharmacy or manufacturer registered with the Board.

(9) A SPDO may not accept the return of drugs from a previously dispensed prescription and must maintain a list of sites in Oregon where drugs may be disposed.

(10) 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.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155, 689.305, 2012 OL Ch 34
Hist.: BP 3-2012, f. & cert. ef. 6-19-12

855-043-0445

Drug Dispensing Training Program

A physician assistant must complete a drug dispensing training program jointly developed by the Oregon Medical Board and the Board of Pharmacy before dispensing drugs to patients.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155, 689.305, 2012 OL Ch 34
Hist.: BP 3-2012, f. & cert. ef. 6-19-12

855-043-0450

Disposal of Drugs

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

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155, 689.305, 2012 OL Ch 34
Hist.: BP 3-2012, f. & cert. ef. 6-19-12

855-043-0455

Record Keeping

(1) A dispensing record must be maintained separately from the patient chart and kept for a minimum of three years. The record must show, at a minimum, the following:

(a) Name of patient;

(b) Unique identifier;

(c) Dose, dosage form, quantity dispensed and either the brand name of drug, or generic name and name of manufacturer or distributor;

(d) Directions for use;

(e) Date of dispensing; and

(f) Initials of person dispensing the prescription.

(2) All records of receipt and disposal of drugs must be kept for a minimum of three years.

(3) Records documenting training required by OAR 855-043-0445 must be kept for three years.

(4) All records required by these rules or by other State and federal law must be readily retrievable and available for inspection by the Board.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155, 689.305, 2012 OL Ch 34
Hist.: BP 3-2012, f. & cert. ef. 6-19-12

Correctional Facilities

855-043-0600

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; Renumbered from 855-041-0170, BP 7-2012, f. & cert. ef. 12-17-12

855-043-0610

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; Renumbered from 855-041-0173, BP 7-2012, f. & cert. ef. 12-17-12

855-043-0620

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; Renumbered from 855-041-0175, BP 7-2012, f. & cert. ef. 12-17-12

855-043-0630

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) Drugs not dispensed in unit dose packaging must be labeled in accordance with OAR 855-041-0177(4).

(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;

(c) Name of the prescriber;

(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

(C) Whenever the drug prescribed has not previously been dispensed to the patient; 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;

(C) The intended use of the drug and expected actions;

(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; Renumbered from 855-041-0177, BP 7-2012, f. & cert. ef. 12-17-12

Community Health Clinic Drug Outlet

855-043-0700

Purpose and Scope

(1) The purpose of 855-043-0700 to 855-043-0750 is to provide minimum requirements of operation for a Community Health Clinic (CHC) to utilize a Registered Nurse to dispense medications. A Community Health Clinic Drug Outlet registration replaces a Family Planning or County Health Drug Outlet registration. A legend or non-prescription drug may be dispensed to a client for the purpose of birth control, caries prevention, the treatment of amenorrhea, the treatment of a communicable disease, hormone deficiencies, urinary tract infections or sexually transmitted diseases by a practitioner who has been given dispensing privileges by their licensing Board, or a Registered Nurse, who is an employee of a clinic or local public health authority (LPHA), and is recognized by the Oregon Public Health Division for the purposes of providing public health services.

(2) Dispensing must be pursuant to the order or prescription of a person authorized by their Board to prescribe a drug or established by the Medical Director or clinic practitioner with prescriptive and dispensing authority.

(3) Family Planning or County Health Clinic registrations that expire March 31, 2017 will be converted to the CHC category upon renewal in 2017. However, rules take effect on July 1, 2016.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.305
Hist.: BP 2-2016, f. 6-30-16, cert. ef. 7-1-16

855-043-0705

Registration

(1) A Community Health Clinic Drug Outlet must register with the Board on a form prescribed by the Board, and must renew its registration annually on a renewal form prescribed by the Board.

(2) An initial application and renewal application must be accompanied by the fee established in division 110 of this Chapter.

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

(4) The CHC Drug Outlet registration expires March 31, annually. If the annual renewal fee is not paid by February 28 of the current year, the applicant for renewal must submit the delinquent fee established in division 110 of this Chapter with the renewal application.

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

(6) The registrant must notify the Board, within 15 days, of any substantial change to the information provided on the registration application. A substantial change shall include but not be limited to: a change of ownership; change of business address; change of normal business hours; any disciplinary action taken or pending by any state or federal authority against the registrant, or any of its principals, owners, directors, officers, or Medical Director.

(7) A new registration form is required for a change of ownership or location and must be submitted to the Board with the fees as specified in division 110 of this Chapter within 15 days of the change.

(8) A CHC Drug Outlet may be inspected by the Board.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.305
Hist.: BP 2-2016, f. 6-30-16, cert. ef. 7-1-16

855-043-0710

Personnel

(1) A Community Health Clinic Drug Outlet must employ a Medical Director who is an Oregon practitioner with prescriptive and dispensing authority. The Medical Director shall establish and enforce policies and procedures, drug dispensing formulary, and protocols for the dispensing of drugs by authorized persons in the CHC.

(2) A CHC Drug Outlet must designate a representative employee who will act as the contact person for the Oregon Board of Pharmacy. The designated representative must be onsite the majority of the CHC’s normal operating hours.

(a) The Medical Director or designated representative must conduct and document an annual review of the outlet on a form provided by the Board. The completed report must be filed in the outlet, retained on file for three years and be available to the Board for inspection.

(b) The Medical Director shall develop policies and procedures for the outlet in collaboration with the designated representative.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.305
Hist.: BP 2-2016, f. 6-30-16, cert. ef. 7-1-16

Policies and Procedures

855-043-0715

Policies and Procedures

The Community Health Clinic must:

(1) Maintain written policies and procedures for drug management, including security, acquisition, storage, dispensing and drug delivery, disposal, and record keeping.

(2) Establish procedures to train a Registered Nurse employed by the CHC to ensure continued competence in the dispensing of drugs.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.305
Hist.: BP 2-2016, f. 6-30-16, cert. ef. 7-1-16

855-043-0720

Security

(1) All drugs must be kept in a locked drug cabinet or designated drug storage area that is sufficiently secure to deny access to unauthorized persons. The drug cabinet or designated drug storage area must remain locked and secured when not in use.

(2) Only a Physician, Clinical Nurse Specialist, Nurse Practitioner, or Registered Nurse shall have a key to the drug cabinet or drug room. In their absence, the drug cabinet or drug room must remain locked.

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

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.305
Hist.: BP 2-2016, f. 6-30-16, cert. ef. 7-1-16

855-043-0725

Drug Acquisition

The CHC must verify that all drugs are acquired from a registrant of the Board.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.305
Hist.: BP 2-2016, f. 6-30-16, cert. ef. 7-1-16

855-043-0730

Storage of Drugs

All drugs, including drug samples, must be stored according to the manufacturer’s published guidelines and be stored in appropriate conditions of temperature, light, humidity, sanitation, ventilation, and space.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.305
Hist.: BP 2-2016, f. 6-30-16, cert. ef. 7-1-16

855-043-0735

Labeling

(1) A prescription must be labeled with the following information:

(a) Unique identifier (i.e. prescription number);

(b) Name of patient;

(c) Name of prescriber;

(d) Name, address, and phone number of the clinic;

(e) Date of dispensing;

(f) Name of drug, strength, and quantity dispensed; when a generic name is used, the label must also contain the identifier of the manufacturer or distributor;

(g) Quantity dispensed;

(h) Directions for use;

(i) Initials of the practitioner who has been given dispensing privileges by their licensing Board or the Registered Nurse;

(j) Cautionary statements, if any, as required by law; and

(k) Manufacturer's expiration date, or an earlier date if preferable, after which the patient should not use the drug.

(2) Notwithstanding any other requirements in this rule, when a drug is dispensed in the practice of an Expedited Partner Therapy treatment protocol, the name of the patient may be omitted from the label, the patient’s name may be omitted from the records and a drug may be dispensed to the patient to be given to the patient’s partner even if the partner has not been examined by a licensed health care provider acting within their scope of practice.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.305
Hist.: BP 2-2016, f. 6-30-16, cert. ef. 7-1-16

855-043-0740

Dispensing and Drug Delivery

(1) A drug may only be dispensed by a practitioner who has been given dispensing privileges by their licensing Board or by a Registered Nurse.

(2) A Registered Nurse may only provide over-the-counter drugs pursuant to established CHC protocols.

(3) A Registered Nurse may only dispense a drug listed in, or for a condition listed in, the formulary.

(4) Nonjudgmental dispensing functions may be delegated to staff assistants when the accuracy and completeness of the prescription is verified by a practitioner who has been given dispensing privileges by their licensing Board, or by a Registered Nurse, prior to being delivered or transferred to the patient.

(5) The CHC will provide appropriate drug information for medications dispensed to a patient, which can be provided by the Registered Nurse or practitioner at the time of dispensing.

(6) All drugs must be dispensed in a new container that complies with the current provisions of the Federal Consumer Packaging Act (Public Law 91-601, 91st Congress, S. 2162) and rules or regulations and with the current United States Pharmacopoeia/National Formulary monographs for preservation, packaging, storage and labeling.

(7) Drugs must be repackaged by the practitioner, Registered Nurse, a pharmacy; or a manufacturer registered with the Board.

(8) A CHC may not accept the return of drugs from a previously dispensed prescription and must maintain a list of sites in Oregon where drugs may be disposed.

(9) A CHC must have access to the most current issue of at least one pharmaceutical reference with current, properly filed supplements and updates appropriate to and based on the standards of practice for the setting.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.305
Hist.: BP 2-2016, f. 6-30-16, cert. ef. 7-1-16

855-043-0745

Disposal of Drugs

Drugs that are outdated, damaged, deteriorated, misbranded, adulterated, or identified as suspect or illegitimate must be documented, quarantined and physically separated from other drugs until they are destroyed or returned to the supplier.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.305
Hist.: BP 2-2016, f. 6-30-16, cert. ef. 7-1-16

855-043-0750

Record Keeping

(1) A dispensing record must be maintained separately from the patient chart and kept for a minimum of three years. The record must show, at a minimum, the following:

(a) Name of patient;

(b) Unique identifier (i.e. prescription number);

(c) Dose, dosage form, quantity dispensed and either the brand name of drug, or generic name and name of manufacturer or distributor;

(d) Directions for use;

(e) Date of dispensing; and

(f) Initials of person dispensing the prescription.

(2) All records of receipt and disposal of drugs must be kept for a minimum of three years.

(3) All records required by these rules or by other State and federal law must be readily retrievable and available for inspection by the Board.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.305
Hist.: BP 2-2016, f. 6-30-16, cert. ef. 7-1-16

The official copy of an Oregon Administrative Rule is contained in the Administrative Order filed at the Archives Division, 800 Summer St. NE, Salem, Oregon 97310. Any discrepancies with the published version are satisfied in favor of the Administrative Order. The Oregon Administrative Rules and the Oregon Bulletin are copyrighted by the Oregon Secretary of State. Terms and Conditions of Use