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Oregon Bulletin

December 1, 2013

Board of Pharmacy, Chapter 855

Rule Caption: Controlled substance rules amended to include certain synthetic cannabinoids subject to abuse.

Adm. Order No.: BP 9-2013

Filed with Sec. of State: 10-28-2013

Certified to be Effective: 10-28-13

Notice Publication Date: 6-1-2013

Rules Amended: 855-080-0021

Subject: By adding additional synthetic cannabinoids to Schedule 1 of the Oregon list of controlled substances, the Board gives law enforcement the authority needed to prosecute the sale and possession of these substances under the Oregon Uniform Controlled Substances Act.

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

855-080-0021

Schedule I

(1) Schedule I consists of the drugs and other substances, by whatever official, common, usual, chemical, or brand name designated, listed in 21CFR part 1308.11, and unless specifically excepted or unless listed in another schedule, any quantity of the following substances, including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation:

(a) 1,4-butanediol;

(b) Methamphetamine, except as listed in OAR 855-080-0022;

(c) Substituted derivatives of cathinone and methcathinone that are not listed in OARs 855-080-0022 through 0026 (Schedules II through V) or are not FDA approved drugs, including but not limited to,

(A) Methylmethcathinone (Mephedrone);

(B) Methylenedioxypyrovalerone (MDPV);

(C) Methylenedioxymethylcathinone (Methylone);

(D) 2-Methylamino-3’, 4’-(methylenedioxy)-butyrophenone (Butylone);

(E) Fluoromethcathinone (Flephedrone);

(F) 4-Methoxymethcathinone (Methedrone).

(2) Schedule I also includes any compounds in the following structural classes (2a–2k) and their salts, or isomers that are not FDA approved drugs, unless specifically excepted or when in the possession of an FDA registered manufacturer or a registered research facility, or a person for the purpose of sale to an FDA registered manufacturer or a registered research facility:

(a) Naphthoylindoles: Any compound containing a 3-(1-naphthoyl)indole structure with substitution at the nitrogen atom of the indole ring whether or not further substituted in the indole ring to any extent and whether or not substituted in the naphthyl ring to any extent. Examples of this structural class include but are not limited to: JWH-015, JWH-018, JWH-019, JWH-073, JWH-081, JWH-122, JWH-200, JWH-210, AM-1220, MAM-2201 and AM-2201;

(b) Phenylacetylindoles: Any compound containing a 3-phenylacetylindole structure with substitution at the nitrogen atom of the indole ring whether or not further substituted in the indole ring to any extent, whether or not substituted in the phenyl ring to any extent. Examples of this structural class include but are not limited to: JWH-167, JWH -201, JWH-203, JWH-250, JWH-251, JWH-302 and RCS-8;

(c) Benzoylindoles: Any compound containing a 3-(benzoyl)indole structure with substitution at the nitrogen atom of the indole ring whether or not further substituted in the indole ring to any extent and whether or not substituted in the phenyl ring to any extent. Examples of this structural class include but are not limited to: RCS-4, AM-694, AM-1241, and AM-2233;

(d) Cyclohexylphenols: Any compound containing a 2-(3-hydroxycyclohexyl)phenol structure with substitution at the 5-position of the phenolic ring whether or not substituted in the cyclohexyl ring to any extent. Examples of this structural class include but are not limited to: CP 47,497 and its C8 homologue (cannabicyclohexanol);

(e) Naphthylmethylindoles: Any compound containing a 1H-indol-3-yl-(1-naphthyl)methane structure with substitution at the nitrogen atom of the indole ring whether or not further substituted in the indole ring to any extent and whether or not substituted in the naphthyl ring to any extent;

(f) Naphthoylpyrroles: Any compound containing a 3-(1-naphthoyl)pyrrole structure with substitution at the nitrogen atom of the pyrrole ring whether or not further substituted in the pyrrole ring to any extent and whether or not substituted in the naphthyl ring to any extent;

(g) Naphthylmethylindenes: Any compound containing a 1-(1-naphthylmethyl)indene structure with substitution at the 3-position of the indene ring whether or not further substituted in the indene ring to any extent and whether or not substituted in the naphthyl ring to any extent;

(h) Cyclopropanoylindoles: Any compound containing an 3-(cyclopropylmethanoyl)indole structure with substitution at the nitrogen atom of the indole ring, whether or not further substituted in the indole ring to any extent and whether or not substituted in the cyclopropyl ring to any extent. Examples of this structural class include but are not limited to: UR-144, XLR-11 and A-796,260;

(i) Adamantoylindoles: Any compound containing a 3-(1-adamantoyl)indole structure with substitution at the nitrogen atom of the indole ring, whether or not further substituted in the indole ring to any extent and whether or not substituted in the adamantyl ring to any extent. Examples of this structural class include but are not limited to: AM-1248 and AB-001;

(j) Adamantylindolecarboxamides: Any compound containing an N-adamantyl-1-indole-3-carboxamide with substitution at the nitrogen atom of the indole ring, whether or not further substituted in the indole ring to any extent and whether or not substituted in the adamantyl ring to any extent. Examples of this structural class include but are not limited to: STS-135 and 2NE1; and

(k) Adamantylindazolecarboxamides: Any compound containing an N-adamantyl-1-indazole-3-carboxamide with substitution at the nitrogen atom of the indazole ring, whether or not further substituted in the indazole ring to any extent and whether or not substituted in the adamantyl ring to any extent. Examples of this structural class include but are not limited to: AKB48.

Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 475.035, 475.059 & 475.065

Hist.: PB 4-1987, f. & ef. 3-30-87; PB 8-1987, f. & ef. 9-30-87; PB 10-1987, f. & ef. 12-8-87; PB 15-1989, f. & cert. ef. 12-26-89; PB 9-1990, f. & cert. ef. 12-5-90; PB 5-1991, f. & cert. ef. 9-19-91; PB 1-1992, f. & cert. ef. 1-31-92 (and corrected 2-7-92); PB 1-1994, f. & cert. ef. 2-2-94; PB 1-1996, f. & cert. ef. 4-5-96; PB 1-1997, f. & cert. ef. 9-22-97; BP 4-2000, f. & cert. ef. 2-16-00; BP 9-2000, f. & cert. ef. 6-29-00; BP 2-2002(Temp), f. & cert. ef. 2-4-02 thru 7-31-02; BP 3-2002(Temp), f. & cert. ef. 3-1-02 thru 8-23-02; BP 4-2002, f. 6-27-02, cert. ef. 7-1-02; BP 5-2002, f. & cert. ef. 11-14-02; BP 1-2003, f. & cert. ef. 1-14-03; BP 1-2007, f. & cert. ef. 6-29-07; BP 8-2010, f. & cert. ef. 6-29-10; BP 10-2010(Temp), f. & cert. ef. 10-15-10 thru 4-11-11; BP 2-2011, f. & cert. ef. 4-11-11; BP 9-2013, f. & cert. ef. 10-28-13


Rule Caption: Adopt Central Fill, Remote Processing, and Consulting/Drugless pharmacy rules and amend Consulting Pharmacist Practice rules

Adm. Order No.: BP 10-2013

Filed with Sec. of State: 11-6-2013

Certified to be Effective: 11-6-13

Notice Publication Date: 6-1-2013

Rules Adopted: 855-041-3000, 855-041-3005, 855-041-3010, 855-041-3015, 855-041-3020, 855-041-3025, 855-041-3030, 855-041-3035, 855-041-3040, 855-041-3045, 855-041-3100, 855-041-3105, 855-041-3110, 855-041-3115, 855-041-3120, 855-041-3125, 855-041-3130, 855-041-3300, 855-041-3305, 855-041-3310, 855-041-3315, 855-041-3320, 855-041-3325, 855-041-3330, 855-041-3335, 855-041-3340

Rules Amended: 855-019-0240

Subject: The Consulting Pharmacist Practice rules in Division 019 are amended to refer consulting pharmacists to the Consulting or Drugless Pharmacy rules defined in division 41.

   The division 41 Central Fill, Remote Processing, and Consulting or Drugless Pharmacy rules provide minimum requirements of operation for new drug outlet retail and/or institutional models. They also accommodate modern practices and new technologies while promoting patient safety.

   Copies of the full text of these rules can be obtained on the Board’s website at www.pharmacy.state.or.us, or by calling the Board office at (971) 673-0001.

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

855-041-3000

Purpose and Scope

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

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

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

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

Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 689.155

Hist.: BP 10-2013, f. & cert. ef. 11-6-13

855-041-3005

Purpose and Scope

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

Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 689.155

Hist.: BP 10-2013, f. & cert. ef. 11-6-13

855-041-3010

Definitions

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

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

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

Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 689.155

Hist.: BP 10-2013, f. & cert. ef. 11-6-13

855-041-3015

General Requirements

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

(1) Have the same owner; or

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

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

(b) The responsibilities of each pharmacy; and

(c) The accountabilities of each pharmacy.

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

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

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

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

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

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

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

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

Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 689.155

Hist.: BP 10-2013, f. & cert. ef. 11-6-13

855-041-3020

Policies and Procedures

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

(a) The responsibilities of each pharmacy;

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

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

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

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

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

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

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

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

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

Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 689.155

Hist.: BP 10-2013, f. & cert. ef. 11-6-13

855-041-3025

Labeling

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

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

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

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

Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 689.155

Hist.: BP 10-2013, f. & cert. ef. 11-6-13

855-041-3030

Records

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

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

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

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

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

(6) The primary pharmacy must maintain records that:

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

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

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

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

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

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

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

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

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

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

Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 689.155

Hist.: BP 10-2013, f. & cert. ef. 11-6-13

855-041-3035

Delivery of Medications

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

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

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

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

Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 689.155

Hist.: BP 10-2013, f. & cert. ef. 11-6-13

855-041-3040

Filled Prescriptions

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

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

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

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

Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 689.155

Hist.: BP 10-2013, f. & cert. ef. 11-6-13

855-041-3045

Prohibited Practices

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

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

Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 689.155

Hist.: BP 10-2013, f. & cert. ef. 11-6-13

855-041-3100

Purpose and Scope

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

Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 689.155

Hist.: BP 10-2013, f. & cert. ef. 11-6-13

855-041-3105

Definitions

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

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

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

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

Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 689.155

Hist.: BP 10-2013, f. & cert. ef. 11-6-13

855-041-3110

General Requirements

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

(1) Have the same owner; or

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

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

(b) The responsibilities of each pharmacy; and

(c) The accountabilities of each pharmacy.

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

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

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

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

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

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

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

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

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

Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 689.155

Hist.: BP 10-2013, f. & cert. ef. 11-6-13

855-041-3115

Policies and Procedures

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

(a) The responsibilities of each pharmacy;

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

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

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

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

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

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

Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 689.155

Hist.: BP 10-2013, f. & cert. ef. 11-6-13

855-041-3120

Records

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

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

(3) Both recordkeeping systems must:

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

(A) Document verification of each license and registration;

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

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

(c) Include quality improvement program documentation;

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

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

(5) The primary pharmacy shall maintain records that:

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

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

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

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

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

Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 689.155

Hist.: BP 10-2013, f. & cert. ef. 11-6-13

855-041-3125

Prescription or Drug Order Processing

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

Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 689.155

Hist.: BP 10-2013, f. & cert. ef. 11-6-13

855-041-3130

Prohibited Practices

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

Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 689.155

Hist.: BP 10-2013, f. & cert. ef. 11-6-13

855-041-3300

Purpose and Scope

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

Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 689.155

Hist.: BP 10-2013, f. & cert. ef. 11-6-13

855-041-3305

Definitions

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

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

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

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

Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 689.155

Hist.: BP 10-2013, f. & cert. ef. 11-6-13

855-041-3310

Registration

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

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

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

Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 689.155

Hist.: BP 10-2013, f. & cert. ef. 11-6-13

855-041-3315

Personnel

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

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

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

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

Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 689.155

Hist.: BP 10-2013, f. & cert. ef. 11-6-13

855-041-3320

Confidentiality

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

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

Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 689.155

Hist.: BP 10-2013, f. & cert. ef. 11-6-13

855-041-3325

General Provisions and Minimum Standards

(1) A consulting pharmacy shall:

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

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

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

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

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

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

Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 689.155

Hist.: BP 10-2013, f. & cert. ef. 11-6-13

855-041-3330

Security Requirements

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

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

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

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

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

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

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

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

Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 689.155

Hist.: BP 10-2013, f. & cert. ef. 11-6-13

855-041-3335

Policies and Procedures

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

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

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

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

(4) An operational Quality Assurance Program;

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

Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 689.155

Hist.: BP 10-2013, f. & cert. ef. 11-6-13

855-041-3340

Records

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

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

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

(a) Patient profiles and records;

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

(A) Verification of each license and registration;

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

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

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

Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 689.155

Hist.: BP 10-2013, f. & cert. ef. 11-6-13

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, 2012.

2.) Copyright 2013 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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