Loading
 

 

Oregon Bulletin

November 1, 2013

Board of Pharmacy, Chapter 855

Rule Caption: Defines the procedures for distributing Naloxone to certain authorized individuals in opiate overdose circumstances.

Adm. Order No.: BP 6-2013(Temp)

Filed with Sec. of State: 9-23-2013

Certified to be Effective: 9-24-13 thru 3-23-14

Notice Publication Date:

Rules Adopted: 855-041-2300, 855-041-2310, 855-041-2320, 855-041-2330

Subject: Oregon Laws 2013, Chapter 340 amends Oregon Revised Statutes Chapter 689 and requires the Board of Pharmacy to establish rules for the distribution of unit-of-use naloxone and the necessary medical supplies to administer it in opiate overdose emergency situations. Administration of naloxone may only take place by those who have successfully completed training or who have been identified in OL 2013, Chapter 340.

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

855-041-2300

Purpose and Scope

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

Stat. Auth: OL 2013, Ch. 340 & ORS 689.205

Stats. Implemented: OL 2013, Ch. 340 & ORS 689.155

Hist.: BP 6-2013(Temp), f. 9-23-13, cert. ef. 9-24-13 thru 3-23-14

855-041-2310

Definitions

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

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

(2) Reserved

(3) “Authorization to Obtain Naloxone” means a certificate that contains the name, signature, and license number of the supervising professional authorizing an order for naloxone to be generated for the individual whose name appears on the Statement of Completion, it also contains a record of the number of naloxone orders filled to date.

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

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

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

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

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

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

Stat. Auth: OL 2013, Ch. 340 & ORS 689.205

Stats. Implemented: OL 2013, Ch. 340 & ORS 689.155

Hist.: BP 6-2013(Temp), f. 9-23-13, cert. ef. 9-24-13 thru 3-23-14

855-041-2320

Reserved

Hist.: BP 6-2013(Temp), f. 9-23-13, cert. ef. 9-24-13 thru 3-23-14

855-041-2330

Naloxone

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

(a) Statement of Completion; and

(b) Authorization to Obtain Naloxone.

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

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

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

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

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

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

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

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

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

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

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

(b) Trainees name; and

(c) Trainer; or

(d) Supervising Professional.

Stat. Auth: OL 2013, Ch. 340 & ORS 689.205

Stats. Implemented: OL 2013, Ch. 340 & ORS 689.155

Hist.: BP 6-2013(Temp), f. 9-23-13, cert. ef. 9-24-13 thru 3-23-14


Rule Caption: Amends certain licensure fees to implement revenue surplus reduction pursuant to ORS 291.055(3)

Adm. Order No.: BP 7-2013

Filed with Sec. of State: 9-23-2013

Certified to be Effective: 9-23-13

Notice Publication Date: 8-1-2013

Rules Amended: 855-110-0005, 855-110-0007, 855-110-0010

Rules Repealed: 855-110-0005(T), 855-110-0007(T), 855-110-0010(T)

Subject: These rules implement revenue surplus reductions pursuant to ORS 291.055(3) for certain licensing fees as approved in the Board’s 2013-15 Legislatively Approved Budget. The following fees are included: Pharmacist, Reciprocity, County Health Clinics, Family Planning, Clinics, Drug Rooms, Correctional Facilities, Prophylactic/Contraceptive Outlets, Retail and Institutional Drug Outlets, Home Dialysis Drug Outlets and all Controlled Substance registration fees.

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

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

855-110-0005

Licensing Fees

(1) Pharmacist license examination (NAPLEX) and re-examination fee — $50.

(2) Pharmacist jurisprudence (MPJE) re-examination fee — $25.

(3) Pharmacist licensing by reciprocity fee — $200*. (*Temporary revenue surplus fee reduction pursuant to ORS 291.055(3)).

(4) Pharmacist licensing by score transfer fee — $300.

(5) Intern license fee. Expires November 30 every two years — $50.

(6) Pharmacist:

(a) License fee. Expires June 30 annually — $120*. Delinquent renewal fee, (postmarked after May 31) — $50. (*Temporary revenue surplus fee reduction pursuant to ORS 291.055(3)).

(b) Electronic Prescription Monitoring Fund fee. Due by June 30 annually — $25. (This is a mandatory fee, required by ORS 431.972 that must be paid with the pharmacist license renewal fee).

(c) Workforce Data Collection fee. Due by June 30 biennially — $5. (This is a mandatory fee, it may be charged annually at $2.50 per year as required by OAR 409-026-0130 that must be paid with the pharmacist license renewal fee.

(7) Certification of approved provider of continuing education course fee, none at this time.

(8)(a) Pharmacy Technician license fee. (This is a one year non-renewable license unless under the age of 19) — $50.

(b) Under 19 years of age expires September 30 annually — $50. Delinquent renewal fee, (postmarked after August 31) — $20.

(9) Certified Pharmacy Technician:

(a) License fee. Expires September 30 annually — $50. Delinquent renewal fee, (postmarked after August 31) — $20.

(b) Workforce Data Collection fee. Due by June 30 biennially — $5. (This is a mandatory fee, it may be charged annually at $2.50 per year as required by OAR 409-026-0130 that must be paid with the Certified Pharmacy Technician license renewal fee.

Stat. Auth.: ORS 689.205 & 291.055

Stats. Implemented: ORS 689.135, 431.972, 676.410 & 2013 OL Ch. 503

Hist.: 1PB 2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. &ef. 4-3-80; 1PB 3-1980, f. 5-3-80, ef. 5-3-80 & 7-1-80; 1PB 2-1982, f. 3-8-82, ef. 4-1-82; 1PB 1-1984, f. & ef. 2-16-84; 1PB 3-1985, f. & ef. 12-2-85; PB 3-1988, f. & cert. ef. 5-23-88; PB 7-1989, f. & cert. ef. 5-1-89; PB 15-1989, f. & cert. ef. 12-26-89; PB 10-1990, f. & cert. ef. 12-5-90; PB 3-1991, f. & cert. ef. 9-19-91; PB 1-1992, f. & cert. ef. 1-31-92 (and corrected 2-7-92); PB 4-1992, f. & cert. ef. 8-25-92; PB 1-1994, f. & cert. ef. 2-2-94; PB 1-1996, f. & cert. ef. 4-5-96; PB 2-1997(Temp), f. 10-2-97, cert. ef. 10-4-97; BP 2-1998, f. & cert. ef. 3-23-98; BP 1-2001, f. & cert. ef. 3-5-01; BP 2-2001(Temp), f. & cert. ef. 7-26-01 thru 1-22-02; BP 1-2002, f. & cert. ef. 1-8-02; BP 1-2003, f. & cert. ef. 1-14-03; BP 1-2006, f. & cert. ef. 6-9-06; BP 5-2006(Temp), f. & cert. ef. 8-25-06 thru 1-20-07; BP 9-2006, f. & cert. ef. 12-19-06; BP 5-2009, f. & cert. ef. 12-24-09; BP 5-2010(Temp), f. 5-3-10, cert. ef. 5-4-10 thru 10-30-10; 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 2-2013(Temp), f. 4-4-13, cert. ef. 4-5-13 thru 9-28-13; BP 3-2013(Temp), f. 6-27-13, cert. ef. 7-1-13 thru 12-28-13; BP 4-2013(Temp), f. & cert. ef. 7-9-13 thru 1-5-14; BP 7-2013, f. & cert. ef. 9-23-13

855-110-0007

Fees for Registration, Renewal, and Reinspection of Drug Outlets

(1) County Health Clinic (including family planning clinics). Expires March 31 annually — $75*. Delinquent renewal fee (postmarked after February 28) — $25. (*Temporary revenue surplus fee reduction pursuant to ORS 291.055(3)).

(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 — $75*. Delinquent renewal fee (postmarked after February 28) — $75. (*Temporary revenue surplus fee reduction pursuant to ORS 291.055(3)).

(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 — $50*. Expires December 31 annually. (*Temporary revenue surplus fee reduction pursuant to ORS 291.055(3)).

(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 — $175*. Delinquent renewal fee (postmarked after February 28) — $75. (*Temporary revenue surplus fee reduction pursuant to ORS 291.055(3)).

(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 — $175*. Delinquent renewal fee (postmarked after February 28) — $75. (*Temporary revenue surplus fee reduction pursuant to ORS 291.055(3)).

(17) Supervising Physician Dispensing Outlet. Expires March 31 annually — $300. Delinquent renewal fee (postmarked after February 28) — $75.

Stat. Auth.: ORS 689.205 & 291.055

Stats. Implemented: ORS 689.135, 689.774, 2012 OL Ch. 34 & 2013 OL Ch. 503

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; BP 6-2012, f. & cert. ef. 12-13-12; BP 3-2013(Temp), f. 6-27-13, cert. ef. 7-1-13 thru 12-28-13; BP 4-2013(Temp), f. & cert. ef. 7-9-13 thru 1-5-14; BP 7-2013, f. & cert. ef. 9-23-13

855-110-0010

Fees for Registration for Controlled Substances under ORS 475.095

(1) Animal Euthanasia controlled substance registration fee — $50 annually.

(2) Drug Distribution Agent controlled substance registration fee — $50* annually. (*Temporary revenue surplus fee reduction pursuant to ORS 291.055(3)).

(3) Drug Room (including correctional facility) controlled substance registration fee — $50* annually. (*Temporary revenue surplus fee reduction pursuant to ORS 291.055(3)).

(4) Manufacturer controlled substance registration fee — $50* annually. (*Temporary revenue surplus fee reduction pursuant to ORS 291.055(3)).

(5) Retail or Institutional Drug Outlet controlled substance registration fee — $50* annually. (*Temporary revenue surplus fee reduction pursuant to ORS 291.055(3)).

(6) Schedule II Precursor registration fee — $50* annually. (*Temporary revenue surplus fee reduction pursuant to ORS 291.055(3)).

(7) Wholesaler controlled substance registration fee — $50* annually. (*Temporary revenue surplus fee reduction pursuant to ORS 291.055(3)).

(8) Remote Dispensing Facility controlled substance registration fee — $50* annually. (*Temporary revenue surplus fee reduction pursuant to ORS 291.055(3)).

Stat. Auth.: ORS 689.205 & 291.055

Stats. Implemented: ORS 689.135 & 2013 OL Ch. 503

Hist.: 1PB 2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; 1PB 6-1982, f. & ef. 8-6-82; 1PB 2-1984, f. & ef. 3-7-84; PB 15-1989, f. & cert. ef. 12-26-89; PB 10-1990, f. & cert. ef. 12-5-90; PB 3-1991, f. & cert. ef. 9-19-91; PB 1-1996, f. & cert. ef. 4-5-96; 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 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 3-2013(Temp), f. 6-27-13, cert. ef. 7-1-13 thru 12-28-13; BP 4-2013(Temp), f. & cert. ef. 7-9-13 thru 1-5-14; BP 7-2013, f. & cert. ef. 9-23-13


Rule Caption: Amends customized patient medication packages rules to incorporate a waiver clause.

Adm. Order No.: BP 8-2013

Filed with Sec. of State: 9-25-2013

Certified to be Effective: 9-25-13

Notice Publication Date: 6-1-2013

Rules Amended: 855-041-1140

Subject: The customized patient medication packages rules are amended to incorporate a waiver clause. The amendment allows the Board to waive any of the requirements of the customized patient medication packages rules if a waiver will further public health or safety or the health and safety of a patient.

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

855-041-1140

Customized Patient Medication Packages

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

(1) Label:

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

(A) The name of the patient;

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

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

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

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

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

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

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

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

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

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

(3) Packaging:

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

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

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

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

(a) The name and address of the patient;

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

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

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

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

(f) Any special labeling instructions; and

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

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

Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 689.155

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

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

© 2013 State of Oregon All Rights Reserved​