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Oregon Bulletin

August 1, 2012

Board of Pharmacy, Chapter 855

Rule Caption: Amend or adopt new Definitions, Practitioner Dispensing Outlet and Controlled Substances rules.

Adm. Order No.: BP 3-2012

Filed with Sec. of State: 6-19-2012

Certified to be Effective: 6-19-12

Notice Publication Date: 5-1-2012

Rules Adopted: 855-043-0405, 855-043-0410, 855-043-0415, 855-043-0420, 855-043-0425, 855-043-0430, 855-043-0435, 855-043-0440, 855-043-0445, 855-043-0450, 855-043-0455

Rules Amended: 855-006-0005, 855-043-0002, 855-080-0100

Subject: Division 006 rules are amended to define “Board” and add “dispense” to existing definitions. Division 043 Practitioner Dispensing Outlet rules implement 2012 Oregon Laws Chapter 34. These rules define “Supervising Physician Dispensing Outlet” and identify which entities must register as well as their requirements. Division 80 Animal Euthanasia rules are amended to correct an outdated fee reference.

 The complete text of these rules are available on the Board’s website at www.pharmacy.state.or.us

Rules Coordinator: Karen MacLean—(971) 673-0001

855-006-0005

Definitions

As used in OAR chapter 855:

(1) “Board” means the Oregon Board of Pharmacy unless otherwise specified or required by the context.

(2) “Certified Pharmacy Technician” means a person licensed by the State Board of Pharmacy who assists the pharmacist in the practice of pharmacy pursuant to rules of the Board and has completed the specialized education program pursuant to OAR 855-025-0005. Persons used solely for clerical duties, such as recordkeeping, cashiering, bookkeeping and delivery of medications released by the pharmacist are not considered pharmacy technicians.

(3) “Collaborative Drug Therapy Management” means the participation by a pharmacist in the management of drug therapy pursuant to a written protocol that includes information specific to the dosage, frequency, duration and route of administration of the drug, authorized by a practitioner and initiated upon a prescription order for an individual patient and:

(a) Is agreed to by one pharmacist and one practitioner; or

(b) Is agreed to by one or more pharmacists at a single pharmacy registered by the board and one or more practitioners in a single organized medical group, such as a hospital medical staff, clinic or group practice, including but not limited to organized medical groups using a pharmacy and therapeutics committee.

(4) “Compounding” means the preparation, mixing, assembling, packaging, or labeling of a drug or device:

(a) As the result of a practitioner’s prescription drug order, or initiative based on the relationship between the practitioner, the pharmacist and the patient, in the course of professional practice; or

(b) For the purpose of, or as an incident to, research, teaching, or chemical analysis and not for sale or dispensing; or

(c) The preparation of drugs or devices in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns; or

(d) As a component of a Shared Pharmacy Service agreement as defined in section (21) of this rule.

(5) “Confidential Information” means any patient information obtained by a pharmacist or pharmacy.

(6) “Consulting Pharmacist” means a pharmacist that provides a consulting service regarding a patient medication, therapy management, drug storage and management, security, education, or any other pharmaceutical service.

(7) The “Container” is the device that holds the drug and that is or may be in direct contact with the drug.

(8) “Dispensing or Dispense” 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.

(9) “Interpretation and evaluation of prescription orders” means the review of the order for therapeutic and legal correctness. Therapeutic review includes identification of the prescription drug ordered, its applicability and its relationship to the other known medications used by the patient and determination of whether or not the dose and time interval of administration are within accepted limits of safety. The legal review for correctness of the prescription order includes a determination that the order is valid and has not been altered, is not a forgery, is prescribed for a legitimate medical purpose, contains all information required by federal and state law, and is within the practitioner’s scope of practice.

(10) “Labeling” means the process of preparing and affixing of a label to any drug container exclusive, however, of the labeling by a manufacturer, packer or distributor of anon-prescription drug or commercially packaged legend drug or device.

(11) “Monitoring of therapeutic response or adverse effect of drug therapy” means the follow up of the therapeutic or adverse effect of medication upon a patient, including direct consultation with the patient or his agent and review of patient records, as to result and side effect, and the analysis of possible interactions with other medications that may be in the medication regimen of the patient. This section shall not be construed to prohibit monitoring by practitioners or their agents.

(12) “Medication Therapy Management (MTM)” means a distinct service or group of services that is intended to optimize therapeutic outcomes for individual patients. Medication Therapy Management services are independent of, but can occur in conjunction with, the provision of a medication product.

(13) “Nationally Certified Exam” means an exam that is approved by the Board which demonstrates successful completion of a Specialized Education Program. The exam must be reliable, psychometrically sound, legally defensible and valid.

(14) “Non-legend drug” means a drug which does not require dispensing by prescription and which is not restricted to use by practitioners only.

(15) “Offering or performing of those acts, services, operations or transactions necessary in the conduct, operation, management and control of pharmacy” means, among other things:

(a) The creation and retention of accurate and complete patient records;

(b) Assuming authority and responsibility for product selection of drugs and devices;

(c) Developing and maintaining a safe practice setting for the pharmacist, for pharmacy staff and for the general public;

(d) Maintaining confidentiality of patient information.

(16) “Oral Counseling” means an oral communication process between a pharmacist and a patient or a patient’s agent in which the pharmacist obtains information from the patient (or agent) and the patient’s pharmacy records, assesses that information and provides the patient (or agent) with professional advice regarding the safe and effective use of the prescription drug for the purpose of assuring therapeutic appropriateness.

(17) Participation in Drug Selection and Drug Utilization Review:

(a) “Participation in drug selection” means the consultation with the practitioner in the selection of the best possible drug for a particular patient.

(b) “Drug utilization review” means evaluating prescription drug order in light of the information currently provided to the pharmacist by the patient or the patient’s agent and in light of the information contained in the patient’s record for the purpose of promoting therapeutic appropriateness by identifying potential problems and consulting with the prescriber, when appropriate. Problems subject to identification during drug utilization review include, but are not limited to:

(A) Over-utilization or under-utilization;

(B) Therapeutic duplication;

(C) Drug-disease contraindications;

(D) Drug-drug interactions;

(E) Incorrect drug dosage;

(F) Incorrect duration of treatment;

(G) Drug-allergy interactions; and

(H) Clinical drug abuse or misuse.

(18) “Pharmaceutical Care” means the responsible provision of drug therapy for the purpose of achieving definite outcomes that improve a patient’s quality of life. These outcomes include:

(a) Cure of a disease;

(b) Elimination or reduction of a patient’s symptomatology;

(c) Arrest or slowing of a disease process; or

(d) Prevention of a disease or symptomatology.

(19) “Pharmacy Technician” means a person licensed by the State Board of Pharmacy who assists the pharmacist in the practice of pharmacy pursuant to rules of the Board but has not completed the specialized education program pursuant to OAR855-025-0010.

(20) “Prescription released by the pharmacist” means, a prescription which has been reviewed by the pharmacist that does not require further pharmacist intervention such as reconstitution or counseling.

(21) “Prohibited conduct” means conduct by a licensee that:

(a) Constitutes a criminal act against a patient or client; or

(b) Constitutes a criminal act that creates a risk of harm to a patient or client.

(22) “Proper and safe storage of drugs and devices and maintenance of proper records therefore” means housing drugs and devices under conditions and circumstances that:

(a) Assure retention of their purity and potency;

(b) Avoid confusion due to similarity of appearance, packaging, labeling or for any other reason;

(c) Assure security and minimize the risk of their loss through accident or theft;

(d) Accurately account for and record their receipt, retention, dispensing, distribution or destruction;

(e) Protect the health, safety and welfare of the pharmacist, pharmacy staff and the general public from harmful exposure to hazardous substances.

(23) “Responsibility for advising, when necessary or when regulated, of therapeutic values, content, hazards and use of drugs and devices” means advice directly to the patient, either verbally or in writing as required by these rules or federal regulation, of the possible therapeutic response to the medication, the names of the chemicals in the medication, the possible side effects of major importance, and the methods of use or administration of a medication.

(24) “Shared Pharmacy Service” means a written agreement, that has been approved in writing by the board, that exists for the processing by a pharmacy of a request from another pharmacy or a practitioner licensed to prescribe the drug, to fill or refill a prescription or a drug order, or to perform processing functions including but not limited to:

(a) Dispensing;

(b) Drug utilization review;

(c) Claims adjudication;

(d) Refill authorizations;

(e) Compounding; and

(f) Therapeutic interventions.

(25) “Specialized Education Program” means;

(a) A program providing education for persons desiring licensure as pharmacy technicians that is approved by the board and offered by an accredited college or university that grants a two-year degree upon successful completion of the program; or

(b) A structured program approved by the board and designed to educate pharmacy technicians in one or more specific issues of patient health and safety that is offered by:

(A) An organization recognized by the board as representing pharmacists or pharmacy technicians;

(B) An employer recognized by the board as representing pharmacists or pharmacy technicians; or

(C) A trade association recognized by the board as representing pharmacies.

(26) “Supervision by a pharmacist” means being stationed within the same work area as the pharmacy technician or certified pharmacy technician being supervised, coupled with the ability to control and be responsible for the pharmacy technician or certified pharmacy technician’s action.

(27) “Therapeutic substitution” means the act of dispensing a drug product with a different chemical structure for the drug product prescribed under circumstances where the prescriber has not given clear and conscious direction for substitution of the particular drug for the one which may later be ordered.

(28) “Unprofessional conduct” means conduct unbecoming a licensee or detrimental to the best interests of the public, including conduct contrary to recognized standards of ethics of pharmacy or conduct that endangers the health, safety or welfare of a patient or client. Unprofessional conduct includes but is not limited to:

(a) Fraud or misrepresentation in dealings relating to pharmacy practice with:

(A) Customers, patients or the public;

(B) Practitioners authorized to prescribe drugs, medications or devices;

(C) Insurance companies;

(D) Wholesalers, manufactures or distributors of drugs, medications or devices;

(E) Health care facilities;

(F) Government agencies; or

(G) Drug outlets.

(b) Illegal use of drugs, medications or devices without a practitioner’s prescription, or otherwise contrary to federal or state law or regulation;

(c) Any use of intoxicants, drugs or controlled substances that endangers or could endanger the licensee or others;

(d) Theft of drugs, medications or devices, or theft of any other property or services under circumstances which bear a demonstrable relationship to the practice of pharmacy;

(e) Dispensing a drug, medication or device where the pharmacist knows or should know due to the apparent circumstances that the purported prescription is bogus or that the prescription is issued for other than a legitimate medical purpose, including circumstances such as:

(A) Type of drug prescribed;

(B) Amount prescribed; or

(C) When prescribed out of context of dose.

(f) Any act or practice relating to the practice of pharmacy that is prohibited by state or federal law or regulation;

(g) The disclosure of confidential information in violation of Board rule;

(h) Engaging in collaborative drug therapy management in violation of ORS Chapter 689 and the rules of the Board;

(i) Authorizing or permitting any person to practice pharmacy in violation of the Oregon Pharmacy Act or the rules of the Board;

(j) Any conduct or practice by a licensee or registrant which the Board determines is contrary to accepted standards of practice; or

(k) Failure to cooperate with the Board pursuant to OAR 855-001-0035.

(29) “Verification” means the confirmation by the pharmacist of the correctness, exactness, accuracy and completeness of the acts, tasks, or functions performed by an intern or a pharmacy technician or a certified pharmacy technician.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.151, 689.155, 689.305, 689.405 & 689.455
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; PB 2-1988, f. & cert. ef. 5-3-88; PB 2-1989, f. & cert. ef. 1-30-89; PB 4-1992, f. & cert. ef. 8-25-92; PB 1-1994, f. & cert. ef. 2-2-94; BP 4-1998, f. & cert. ef. 8-14-98; BP 1-2006, f. & cert. ef. 6-9-06; BP 12-2006, f. & cert. ef. 12-19-06; BP 2-2008, f. & cert. ef. 2-20-08; BP 6-2010, f. & cert. ef. 6-29-10; BP 3-2012, f. & cert. ef. 6-19-12

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

855-043-0405

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

855-080-0100

Animal Euthanasia

(1) The following requirements shall be met in order for a humane society or animal control agency to be registered or registration renewed to allow the purchase, possession and administration of sodium pentobarbital for euthanizing injured, sick, homeless or unwanted domestic pets and other animals:

(a) Storage. All supplies of sodium pentobarbital shall be kept in a locked cabinet. An assigned person designated in writing shall be responsible for the security of the sodium pentobarbital. Such designated person shall allow withdrawal of the drug only to a person certified by the Oregon State Veterinary Medical Examining Board to administer sodium pentobarbital;

(b) Records. The following records shall be made at the time of the occurrence and shall be maintained for a minimum of three years, available for inspection by the Board of Pharmacy and its agents:

(A) A record of the withdrawal of sodium pentobarbital, signed by the person who takes possession of the sodium pentobarbital for administration;

(B) A record of the weight, species of animal and dosage administered for euthanasia signed by the person who administers the drug and by the designated person responsible for security;

(C) A record of all wastage signed by the person administering the drug and the designated person responsible for security; and

(D) A weekly record of verification of the stock on hand, minus the amounts withdrawn for administration, signed by the designated person responsible for security;

(E) A record of disposal of any expired or unwanted sodium pentobarbital. Disposal shall be in a conformance with 21 CFR 1307.21.

(c) Audits. The registrant shall submit to random audits of records and analysis of prepared solutions by the State Board of Pharmacy or its agents.

(2) The fee for registration shall be paid as specified in division 110 of this chapter of rules.

(3) The Board will suspend or revoke the registration of any humane society or animal control agency which allows a person to administer sodium pentobarbital who is not certified by the Oregon State Veterinary Medical Examining Board to administer such drug.

Stat. Auth.: ORS 475.095, 475.190, 689.205
Stats. Implemented: ORS 689.151 & 689.155
Hist.: 1PB 2-1984, f. & ef. 3-7-84; PB 9-1990, f. & cert. ef. 12-5-90; PB 5-1991, f. & cert. ef. 9-19-91; BP 6-2011(Temp), f. 10-20-11, cert. ef. 10-31-11 thru 4-27-12; BP 7-2011(Temp), f. & cert. ef. 12-15-11 thru 4-27-12; Administrative correction, 5-25-12; BP 3-2012, f. & cert. ef. 6-19-12


 

Rule Caption: Amends Class II Wholesaler definition to include Oxygen USP.

Adm. Order No.: BP 4-2012(Temp)

Filed with Sec. of State: 6-19-2012

Certified to be Effective: 6-19-12 thru 12-16-12

Notice Publication Date:

Rules Amended: 855-065-0005

Subject: This rule amends the definition of Class II Wholesaler to include Oxygen USP.

 The complete text of these rules is available on the Board’s website at www.pharmacy.state.or.us

Rules Coordinator: Karen MacLean—(971) 673-0001

855-065-0005

Definitions

(1) “Authenticate” means to verify that each transaction listed on the pedigree and other accompanying documentation has occurred and is accurately recorded.

(2) “Authorized Distributor of Record” means a wholesale distributor with whom a manufacturer has established an ongoing relationship to distribute the manufacturer’s prescription drug. An ongoing relationship is deemed to exist between such wholesale distributor and a manufacturer when the wholesale distributor, including any affiliated group of the wholesale distributor, as defined in Section 1504 of the Internal Revenue Code, complies with either or both of the following:

(a) The wholesale distributor has a written agreement currently in effect with the manufacturer evidencing such ongoing relationship; or

(b) The wholesale distributor is listed on the manufacturer’s current list of authorized distributors of record, which is updated by the manufacturer no less than monthly.

(3) “Broker” means a person engaged in the marketing, offering, or contracting for wholesale distribution and sale of a drug into, within, or out of Oregon and who does not take physical possession of the brokered substance.

(4) “Chain Pharmacy Warehouse” means a physical location for drugs that acts as a central warehouse and performs intra company sales or transfers of drugs to a group of chain pharmacies that have the same common ownership and control.

(5) “Closed Door Pharmacy” means a pharmacy that provides pharmaceutical services to a defined and exclusive group of patients and is not open for dispensing to the general patient population and cannot be registered as a wholesale distributor.

(6) “Co-Manufacturing Partner” means a pharmaceutical manufacturer that has entered into an agreement with another pharmaceutical manufacturer to engage in a business activity or occupation related to the manufacture or distribution of a prescription drug.

(7) “Common Carrier” means an organization that is available to the public to transport a product or service using its facilities, or those of other carriers.

(8) “Contraband Drug” means a drug that is counterfeit, stolen, misbranded, obtained by fraud, or purchased by an entity for its own use and placed in commerce in violation of an own-use agreement for that drug.

(9) “Cooperative Pharmacy Warehouse” means a physical location for drugs that acts as a central warehouse and is owned, operated or affiliated with a group purchasing organization or pharmacy buying cooperative and distributes drugs exclusively to its members. To be considered part of the Normal Chain of Distribution as defined in section (16) of this rule, a Cooperative Pharmacy Warehouse must also be listed as an Authorized Distributor of Record for that manufacturer.

(10) “Designated Representative” means an individual designated by each wholesale distributor registered by the Board who will serve as the primary contact person for the wholesale distributor with the Board and who is responsible for managing the company’s operations at that registered location.

(11) “Drop Shipment” means a drug transaction whereby the manufacturer, that manufacturer’s co-manufacturing partner, that manufacturer’s third-party logistics provider, or that manufacturer’s exclusive distributor delivers a drug directly to a chain pharmacy warehouse, a cooperative pharmacy warehouse, a pharmacy, or other person authorized to administer or dispense prescription drugs to a patient, but transfers title to the drug to a wholesale distributor. A drop shipment shall be considered as part of a normal chain of distribution as defined in section (16) of this rule.

(12) “Drug Sample” means a unit of a drug that is intended to promote the sale of the drug, but which is not itself for sale.

(13) “Intra Company Transfer” means the transfer of any drug between a division, subsidiary, parent, and an affiliated or related company under the common ownership and control of a corporate entity.

(14) “Manufacturer” means anyone, including a manufacturer’s co-manufacturing partner, who is engaged in manufacturing, preparing, propagating, compounding, processing, packaging, repackaging, or labeling of a drug, except when the process is part of a shared pharmacy service agreement as defined in OAR 855-006-0005.

(15) “Manufacturer’s Exclusive Distributor” means an entity, including a manufacturer’s wholly owned distributor, that contracts with a manufacturer who is registered under Division 60 of this chapter of rules, to provide or coordinate warehousing, distribution, or other services on behalf of a manufacturer and takes title to that manufacturer’s drug, but does not have general responsibility to direct the drug’s sale or disposition. To be considered part of the Normal Chain of Distribution as defined in section (16) of this rule, a Manufacturer’s Exclusive Distributor must also be listed as an Authorized Distributor of Record for that manufacturer.

(16) “Normal Chain of Distribution” means a chain of distribution, including a drop-shipment, for a prescription drug that goes from: a manufacturer; a manufacturer’s co-manufacturing partner; a manufacturer’s exclusive distributor; or a manufacturer’s third-party logistics provider to:

(a) A pharmacy or a person authorized to administer or dispense a prescription drug to a patient; or

(b) A manufacturer’s authorized distributor of record, to a pharmacy or a person authorized to administer or dispense a prescription drug to a patient; or

(c) A manufacturer’s authorized distributor of record, to a chain pharmacy warehouse, to that chain pharmacy warehouse’s intra company pharmacy, to a patient or a person authorized to administer or dispense a prescription drug to a patient; or

(d) A chain pharmacy warehouse, to that chain pharmacy warehouse’s intra company pharmacy, to a patient or a person authorized to administer or dispense a prescription drug to a patient; or

(e) A manufacturer’s authorized distributor of record, to a specialty wholesaler, to a pharmacy or a person authorized to administer or dispense a prescription drug to a patient; or

(f) A manufacturer’s authorized distributor of record to a cooperative pharmacy warehouse, to a member of the affiliated group purchasing organization or pharmacy buying cooperative, to a patient or a person authorized to administer or dispense a prescription drug to a patient.

(17) “Pedigree” means a statement or record in a written or electronic form that accurately records each wholesale distribution of a prescription drug from the sale by a manufacturer through acquisition and sale by any wholesale distributor or repackager until final sale to a pharmacy or other person authorized to administer or dispense the drug. The pedigree must include, but not be limited to, the following information for each transaction:

(a) The source of the prescription drug, including the name and principal address of the seller;

(b) The proprietary and established name of the prescription drug, the National Drug Code number, the amount of the prescription drug, its dosage form and dosage strength, the date of the purchase, the sales invoice number or other unique shipping document number that identifies the transaction, container size, number of containers, expiration date, and lot number or control number of the prescription drug;

(c) The business name and address of each owner of the prescription drug and its shipping information, including the name and address of the facility of each person certifying delivery or receipt of the prescription drug.

(18) “Prescription Drug” means any drug required by law to be dispensed only by a prescription.

(19) “Repackage” means repackaging or otherwise changing the container, wrapper, or labeling to further the distribution of a prescription drug excluding that completed by the pharmacist responsible for dispensing the product to a patient.

(20) “Specialty Wholesale Distributor” means an entity that exclusively distributes a limited product line of drugs to a specific group of pharmacies or registered practitioners as approved in writing by the Board. To be considered part of the Normal Chain of Distribution as defined in section (16) of this rule, a Specialty Wholesale Distributor must also be listed as an Authorized Distributor of Record for that manufacturer.

(21) “Third-Party Logistics Provider” means an entity that contracts with a manufacturer who is registered under these rules to provide or coordinate warehousing, distribution, or other services on behalf of the manufacturer, but does not take title to the drug or have general responsibility to direct the sale or disposition of the drug. To be considered part of the Normal Chain of Distribution as defined in section (16) of this rule, a Third-Party Logistics Provider must also be listed as an Authorized Distributor of Record for that manufacturer.

(22) “Wholesale Distribution” means distribution of a drug to a person other than a consumer or patient, but does not include:

(a) Delivery by a retail pharmacy of a prescription drug to a patient or patient’s agent pursuant to the lawful order of a licensed practitioner.

(b) The sale of minimal quantities of a prescription drug by retail pharmacies to licensed practitioners for office use.

(c) The sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug for emergency medical reasons, including but not limited to transfer of a drug by a pharmacy to another pharmacy to alleviate a temporary shortage.

(d) Intra company transfer of drugs as defined in these rules.

(e) The lawful distribution of a drug sample by a manufacturer’s or a distributor’s representative.

(f) The sale of a drug by a charitable organization described under 501(c)(3) of the Internal Revenue Code to a non-profit affiliate of the organization to the extent permitted by law.

(g) The purchase or acquisition of a drug by a hospital or other health care entity that is a member of a group purchasing organization, for the hospital’s or health care entity’s own use, from the group purchasing organization or from other hospitals or health care entities that are members of the organization or under common control.

(h) The transfer of a prescription drug between pharmacies pursuant to a shared pharmacy service agreement as defined in OAR 855-006-0005.

(i) The distribution by a manufacturer, as part of a prescription assistance program, of a drug intended for a specific patient, to a person authorized to prescribe, administer or dispense prescription drugs.

(j) The sale, purchase, or trade of blood and blood components intended for transfusion.

(k) Drug returns, when conducted in accordance with state and federal laws and regulations. A drug return includes the sale or transfer from a retail pharmacy or chain pharmacy warehouse of expired, damaged, returned or recalled drugs to the original manufacturer, wholesale distributor, or to a third-party returns processor or reverse wholesaler, and the returns of saleable drugs to the original manufacturer or wholesaler.

(L) The transporting of a drug by common carrier where the common carrier does not take title to the drug and does not have responsibility to direct the drug’s sale or distribution.

(m) The sale, transfer, merger or consolidation of all or part of the business of a pharmacy from or with another pharmacy.

(n) The distribution of drugs by a manufacturer registered under Division 60 of this chapter of rules of its own products to a person other than a patient.

(23) “Wholesale Distributor” means any entity engaged in the wholesale distribution of drugs, including any entity whose business name appears on any invoice or other type of shipping document indicating possession or title. The term “Wholesale Distributor” includes but is not limited to, own-label distributors; private-label distributors; warehouses, including manufacturers’ and distributors’ warehouses; drug wholesalers or distributors; independent wholesale drug traders; third-party logistics providers; cooperative pharmacy warehouses; retail pharmacies that conduct wholesale distribution; and chain pharmacy warehouses that conduct wholesale distribution. To be considered part of the Normal Chain of Distribution as defined in section (16) of this rule, a Wholesale Distributor must also be listed as an Authorized Distributor of Record for that manufacturer.

(24) “Wholesaler” means any wholesale distributor:

(a) “Class I Wholesaler” means any person operating or maintaining a wholesale distribution center, wholesale business or any other business in which prescription drugs, medicinal chemicals, or poisons are sold, dispensed, stocked, exposed or offered for sale at wholesale to a pharmacy or other legally licensed drug outlets or persons;

(b) “Class II Wholesaler” means any person operating or maintaining a wholesale distribution center, wholesale business or any other business in which any of the products in paragraphs (A) -(E) below are stored, or offered for sale or distribution at wholesale to a drug outlet or practitioner legally authorized to resell, distribute, dispense or administer:

(A) Non-prescription drugs;

(B) Drugs distributed exclusively for veterinary use. If any prescription drugs not intended for veterinary use are offered for sale, the wholesaler must register as a Class I wholesaler;

(C) Prescription devices that do not contain a prescription drug;

(D) Drugs or devices possessed by a state or local government agency, or non-profit relief organization approved by the Board.

(E) Oxygen USP.

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; PB 3-1992, f. & cert. ef. 3-26-92 (and corrected 4-8-92); BP 12-2006, f. & cert. ef. 12-19-06; BP 2-2009(Temp), f. 6-22-09, cert. ef. 6-26-09 thru 12-23-09; BP 5-2009, f. & cert. ef. 12-24-09; BP 4-2012(Temp), f. & cert. ef. 6-19-12 thru 12-16-12


 

Rule Caption: Amends fees to add fees for the registration and renewal of Supervising Physician Dispensing Outlets.

Adm. Order No.: BP 5-2012(Temp)

Filed with Sec. of State: 6-19-2012

Certified to be Effective: 6-19-12 thru 12-16-12

Notice Publication Date:

Rules Amended: 855-110-0007

Subject: These rules implement a licensing and delinquent fee for the registration and renewal of Supervising Physician Dispensing Outlets as required by 2012 Senate Bill 1565

 The complete text of these rules is available on the Board’s website at www.pharmacy.state.or.us

Rules Coordinator: Karen MacLean—(971) 673-0001

855-110-0007

Fees for Registration, Renewal, and Reinspection of Drug Outlets

(1) County Health Clinic (including family planning clinics). Expires March 31 annually – $100. Delinquent renewal fee (postmarked after February 28) – $25.

(2) Drug Distribution Agent. Expires September 30 annually – $400. Delinquent renewal fee (postmarked after August 31) – $100.

(3) Drug Room (including correctional facility). Expires March 31 annually – $100. Delinquent renewal fee (postmarked after February 28) – $75.

(4) Manufacturer. Expires September 30 annually – $400. Delinquent renewal fee (postmarked after August 31) – $100.

(5) Medical Device, Equipment & Gas Class C. Expires January 31 annually – $50. Delinquent renewal fee (postmarked after December 31) – $25.

(6) Nonprescription Class A. Expires January 31 annually – $50. Delinquent renewal fee (postmarked after December 31) – $25.

(7) Nonprescription Class B. Expires January 31 annually – $50. Delinquent renewal fee (postmarked after December 31) – $25.

(8) Nonprescription Class D. Expires January 31 annually – $100. Delinquent renewal fee (postmarked after December 31) – $25.

(9) Prophylactic and/or Contraceptive Wholesaler and/or Manufacturer – $100. Expires December 31 annually.

(10) Re-inspection fee – $100. Applies to any re-inspection of a drug outlet occasioned to verify corrections of violations found in an initial inspection.

(11) Retail or Institutional Drug Outlet. Expires March 31 annually – $300. Delinquent renewal fee (postmarked after February 28) – $75.

(12) Wholesaler Class I, Expires September 30 annually – $400. Delinquent renewal fee (postmarked after August 31) – $100.

(13) Wholesaler Class II. Expires September 30 annually – $400. Delinquent renewal fee (postmarked after August 31) – $100.

(14) Remote Dispensing Machine/Facility. Expires March 31 annually – $100. Due by February 28 annually.

(15) Charitable Pharmacy. Expires March 31 annually – $75. Delinquent renewal fee (postmarked after February 28) – $25.

(16) Home Dialysis. Expires March 31 annually – $300. Delinquent renewal fee (postmarked after February 28) – $75.

(17) Supervising Physician Dispensing Outlet. Expires March 31 annually – $300. Delinquent renewal fee (postmarked after February 28) – $25.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.135, 689.774, 2012 OL Ch 34
Hist.: PB 1-1996, f. & cert. ef. 4-5-96; PB 1-1997, f. & cert. ef. 9-22-97; BP 3-1998, f. & cert. ef. 3-23-98; BP 2-2001(Temp), f. & cert. ef. 7-26-01 thru 1-22-02; BP 1-2002, f. & cert. ef. 1-8-02; BP 4-2002, f. 6-27-02, cert. ef. 7-1-02; BP 2-2005, f. 2-14-05, cert. ef. 3-1-05; BP 2-2009(Temp), f. 6-22-09, cert. ef. 6-26-09 thru 12-23-09; BP 5-2009, f. & cert. ef. 12-24-09; BP 6-2010, f. & cert. ef. 6-29-10; BP 5-2011(Temp), f. 6-24-11, cert. ef. 7-1-11 thru 12-27-11; BP 8-2011, f. & cert. ef. 12-15-11; BP 5-2012(Temp), f. & cert. ef. 6-19-12 thru 12-16-12

Notes
1.) This online version of the OREGON BULLETIN is provided for convenience of reference and enhanced access. The official, record copy of this publication is contained in the original Administrative Orders and Rulemaking Notices filed with the Secretary of State, Archives Division. Discrepancies, if any, are satisfied in favor of the original versions. Use the OAR Revision Cumulative Index found in the Oregon Bulletin to access a numerical list of rulemaking actions after November 15, 2011.

2.) Copyright 2012 Oregon Secretary of State: Terms and Conditions of Use

Oregon Secretary of State • 136 State Capitol • Salem, OR 97310-0722
Phone: (503) 986-1523 • Fax: (503) 986-1616 • oregon.sos@state.or.us

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