Chapter 313 Oregon Laws 2005

AN ACT

SB 512

Relating to pharmacy; creating new provisions; amending ORS 689.005, 689.151, 689.342, 689.344, 689.348, 689.352, 689.354, 689.356, 689.405, 689.486, 689.490 and 689.495; and declaring an emergency.

Be It Enacted by the People of the State of Oregon:

SECTION 1. ORS 689.342 is amended to read:

689.342. (1) There is established a [Pharmacists] Pharmacy Diversion Program Supervisory Council consisting of five members appointed by the State Board of Pharmacy for the purpose of developing and implementing a diversion program for chemically dependent licensees regulated under this chapter. No current board member or staff shall serve on the council.

(2) The term of office of each member is two years, but a member serves at the pleasure of the board. Before the expiration of the term of a member, the board shall appoint a successor whose term begins July 1 next following. A member is eligible for reappointment. If there is a vacancy for any cause, the board shall make an appointment to become immediately effective for the unexpired term.

(3) A member of the council is entitled to compensation and expenses as provided in ORS 292.495.

(4) The council shall select one of its members as chairperson and another as vice chairperson, for such terms and with duties and powers the council determines necessary for the performance of the functions of such office.

(5) A majority of the members of the council constitutes a quorum for the transaction of business.

SECTION 2. ORS 689.344 is amended to read:

689.344. (1) Subject to approval of the State Board of Pharmacy, the [Pharmacists] Pharmacy Diversion Program Supervisory Council may appoint a program director to serve at the pleasure of the council. The program director shall be an employee of the board.

(2) The program director shall administer, under the control and supervision of the council, the diversion program for chemically dependent licensees.

(3) The board may appoint such employees as may be necessary to carry out the duties of the council under the control and supervision of the council.

SECTION 3. ORS 689.348 is amended to read:

689.348. (1) In addition to or in lieu of any disciplinary action under ORS 689.405, the State Board of Pharmacy may refer a licensee who is chemically dependent to a diversion program administered by the [Pharmacists] Pharmacy Diversion Program Supervisory Council.

(2) The council shall report to the board and provide all pertinent information concerning any licensee who is referred to the council under subsection (1) of this section and fails to complete the diversion program or fails to participate in the diversion program in good faith.

SECTION 4. ORS 689.352 is amended to read:

689.352. (1) All records of the [Pharmacists] Pharmacy Diversion Program Supervisory Council are confidential and shall not be subject to public disclosure, nor shall the records be admissible as evidence in any judicial proceeding.

(2) The members, employees, contractors and past or present clients of the council shall not be subject to the disclosure requirements in ORS 689.455, nor shall they disclose information or be examined regarding any participant in the program, except as provided in ORS 689.348 (2).

(3) Any licensee who in good faith voluntarily participates in an approved diversion program and successfully completes the program shall not be subject to sanction unless the licensee is suspected of a violation of this chapter other than ORS 689.405 (1)(d).

SECTION 5. ORS 689.354 is amended to read:

689.354. The State Board of Pharmacy, the [Pharmacists] Pharmacy Diversion Program Supervisory Council and their members, employees and contractors shall be immune from any civil liability arising from simple negligent acts taken pursuant to ORS 689.342 to 689.356.

SECTION 6. ORS 689.356 is amended to read:

689.356. In addition to any other powers granted by ORS 689.342 to 689.356, the State Board of Pharmacy may adopt necessary and proper rules for administration of ORS 689.342 to 689.356 including, but not limited to, establishing fees and charges to carry out its legal responsibilities, subject to prior approval by the Oregon Department of Administrative Services and a report to the Emergency Board prior to adopting the fees and charges. The fees and charges established under this section shall not exceed the cost of administering the program of the [Pharmacists] Pharmacy Diversion Program Supervisory Council, as authorized by the Legislative Assembly within the board’s budget, or as the budget may be modified by the Emergency Board, and shall be maintained in an account separate from other funds of the board.

SECTION 7. ORS 689.486 is amended to read:

689.486. (1) It shall be unlawful for any person to perform the duties of a pharmacy technician or use the title of pharmacy technician unless [registered] licensed to do so under the provisions of this chapter.

(2) To be [registered] licensed to perform the duties of a pharmacy technician, a person shall:

(a) Submit a [registration] license application in the manner prescribed by the State Board of Pharmacy; and

(b) Pay the [registration] license fee established by the board.

(3) The [registration] license application prescribed by the board shall include, but not be limited to:

(a) The name and address of the applicant;

(b) The educational qualifications of the applicant;

(d) The applicant’s criminal offender record of any conviction or of any arrest less than one year old on which there has been no acquittal or dismissal.

(4) A [registration] license under this section expires annually. To renew a [registration] license to perform the duties of a pharmacy technician, a person shall:

(a) Submit the application for renewal of [registration] a license in the form prescribed by the board;

(b) Pay the license renewal fee established by the board;

(d) Provide updated information regarding educational qualifications, work history and criminal arrest and conviction history; and

(e) Comply with all other requirements for [registration] license renewal established by the board.

(5) No person may employ an individual to perform the duties of a pharmacy technician unless the individual is [registered] licensed to perform the duties of a pharmacy technician under this chapter.

(6) A person [registered] licensed to perform the duties of a pharmacy technician may perform the duties of a pharmacy technician only under the supervision, direction and control of a licensed pharmacist.

SECTION 8. ORS 689.490 is amended to read:

689.490. (1) In accordance with any applicable provisions of ORS chapter 183, the State Board of Pharmacy, by rule, shall establish a [registration] licensing system for persons who perform the duties of a pharmacy technician. The [registration] licensing system shall include but not be limited to the following provisions:

(a) Prescribing the form and content of and the procedures for submitting an application for the issuance or renewal of a technician [registration] license.

(b) Prescribing the fee for the original [registration] license and for renewal of a [registration] license in an amount not to exceed $50 and the fee for delinquent license renewal in an amount not to exceed $50.

(2) The board may refuse to issue or renew, or may suspend, revoke or restrict a technician [registration to any person on one or more of the following grounds] license:

[(a) Arrest or conviction for violation of the drug laws of this state or of statutes, rules or regulations of any other state or of the federal government;]

[(b) Arrest or conviction for a theft offense;]

[(c) Disciplinary action by another state regarding a license, registration, certificate or any other permit required to assist a pharmacist in the practice of pharmacy or to practice pharmacy that, in the judgment of the board, indicates the applicant may pose a threat to the public safety;]

[(d)] (a) For any reason listed under ORS 689.405 (1);

(b) If the applicant is not authorized to work for hire under Oregon law; or

[(e)] (c) For any other grounds that the board, in its discretion, believes would disqualify the applicant for [registration] a license.

(3) Denial of a [registration] license under subsection (2) of this section shall be considered a contested case under ORS chapter 183.

SECTION 9. ORS 689.495 is amended to read:

689.495. (1) Upon the written request of a pharmacist, the State Board of Pharmacy shall provide the name, address, educational qualifications, work history, technician [registration] license history and criminal arrest and conviction history of any pharmacy technician [registered] licensed with the board. Information provided by the board pursuant to a request under this section shall be in writing and may be provided to the requester by means of facsimile or other electronic transmission or the United States Postal Service.

(2) For purposes of this section:

(a) “Written request” includes but is not limited to a request received by means of facsimile or other electronic transmission.

(b) “Work history” includes but is not limited to information reported to the board pursuant to ORS 689.497 to the extent the information is not exempt from disclosure under ORS 676.175.

SECTION 10. ORS 689.151 is amended to read:

689.151. The State Board of Pharmacy shall be responsible for the control and regulation of the practice of pharmacy in this state including, but not limited to, the following:

(1) The licensing by examination or by reciprocity of applicants who are qualified to engage in the practice of pharmacy under the provisions of this chapter;

(2) The renewal of licenses to engage in the practice of pharmacy;

(3) The determination and issuance of standards based on nationally recognized standards of practice and accreditation criteria for recognition and approval of schools and colleges of pharmacy whose graduates shall be eligible for licensure in this state, and the specification and enforcement of requirements for practical training, including internship;

(4) The enforcement of those provisions of this chapter relating to the conduct or competence of pharmacists practicing in this state, and the suspension, revocation or restriction of licenses to engage in the practice of pharmacy; [and]

(5) The training, qualifications and employment of pharmacy interns[.]; and

(6) The [registration] licensing of pharmacy technicians.

SECTION 11. ORS 689.005 is amended to read:

689.005. As used in this chapter:

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

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

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

(2) “Approved continuing pharmacy education program” means those seminars, classes, meetings, workshops and other educational programs on the subject of pharmacy approved by the board.

(3) “Board of pharmacy” or “board” means the State Board of Pharmacy.

(4) “Continuing pharmacy education” means professional, pharmaceutical post-graduate education in the general areas of socio-economic and legal aspects of health care; the properties and actions of drugs and dosage forms; and the etiology, characteristics and therapeutics of the disease state.

(5) “Continuing pharmacy education unit” means the unit of measurement of credits for approved continuing education courses and programs.

(6) “Deliver” or “delivery” means the actual, constructive or attempted transfer of a drug or device other than by administration from one person to another, whether or not for a consideration.

(7) “Device” means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar or related article, including any component part or accessory, which is required under federal or state law to be prescribed by a practitioner and dispensed by a pharmacist.

(8) “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.

(9) “Distribute” means the delivery of a drug other than by administering or dispensing.

(10) “Drug” means:

(a) Articles recognized as drugs in the official United States Pharmacopoeia, official National Formulary, official Homeopathic Pharmacopoeia, other drug compendium or any supplement to any of them;

(b) Articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in a human or other animal;

(c) Articles (other than food) intended to affect the structure or any function of the body of humans or other animals; and

(d) Articles intended for use as a component of any articles specified in paragraph (a), (b) or (c) of this subsection.

(11) “Drug order” means a written order, in a hospital or other inpatient care facility, for an ultimate user of any drug or device issued and signed by a practitioner, or an order transmitted by other means of communication from a practitioner, that is immediately reduced to writing by a pharmacist, licensed nurse or other practitioner.

(12) “Drug outlet” means any pharmacy, nursing home, shelter home, convalescent home, extended care facility, drug abuse treatment center, penal institution, hospital, family planning clinic, student health center, retail store, wholesaler, manufacturer [or], mail-order vendor or other establishment with facilities located within or out of this state that is engaged in dispensing, delivery or distribution of drugs within this state.

(13) “Drug room” means a secure and lockable location within an inpatient care facility that does not have a licensed pharmacy.

(14) “Electronically transmitted” or “electronic transmission” means a communication sent or received through technological apparatuses, including computer terminals or other equipment or mechanisms linked by telephone or microwave relays, or any similar apparatus having electrical, digital, magnetic, wireless, optical, electromagnetic or similar capabilities.

(15) “Institutional drug outlet” means hospitals and inpatient care facilities where medications are dispensed to another health care professional for administration to patients served by the hospitals or facilities.

(16) “Intern” means any person who has completed the junior or third academic year of a course of study at an approved college of pharmacy and is licensed with the board as an intern.

(17) “Internship” means a professional and practical experience program approved by the board under the supervision of a licensed pharmacist registered with the board as a preceptor.

(18) “Itinerant vendor” means all persons who sell or otherwise distribute nonprescription drugs by passing from house to house, or by haranguing the people on the public streets or in public places, or who use the customary devices for attracting crowds and therewith recommending their wares and offering them for sale.

(19) “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 a nonprescription drug or commercially packaged legend drug or device. Any such label shall include all information required by federal and state law or regulation.

(20) “Manufacture” means the production, preparation, propagation, compounding, conversion or processing of a device or a drug, either directly or indirectly by extraction from substances of natural origin or independently by means of chemical synthesis or by a combination of extraction and chemical synthesis and includes any packaging or repackaging of the substances or labeling or relabeling of its container, except that this term does not include the preparation or compounding of a drug by an individual for their own use or the preparation, compounding, packaging or labeling of a drug:

(a) By a practitioner as an incident to administering or dispensing of a drug in the course of professional practice; or

(b) By a practitioner or by the practitioner’s authorization under supervision of the practitioner for the purpose of or as an incident to research, teaching or chemical analysis and not for sale.

(21) “Manufacturer” means a person engaged in the manufacture of drugs.

(22) “Nonprescription drug outlet” means shopkeepers and itinerant vendors registered under ORS 689.305.

(23) “Nonprescription drugs” means drugs which may be sold without a prescription and which are prepackaged for use by the consumer and labeled in accordance with the requirements of the statutes and regulations of this state and the federal government.

(24) “Person” means an individual, corporation, partnership, association or any other legal entity.

(25) “Pharmacist” means an individual licensed by this state to engage in the practice of pharmacy.

(26) “Pharmacy” means a place that meets the requirements of rules of the board, is licensed and approved by the board where the practice of pharmacy may lawfully occur and includes apothecaries, drug stores, dispensaries, hospital outpatient pharmacies, pharmacy departments and prescription laboratories but does not include a place used by a manufacturer or wholesaler.

(27) “Pharmacy technician” means a person [registered] licensed by the State Board of Pharmacy who assists the pharmacist in the practice of pharmacy pursuant to rules of the board.

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

(a) In this state; or

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

(29) “Preceptor” means a pharmacist licensed and in good standing, registered by the board to supervise the internship training of a licensed intern.

(30) “Prescription drug” or “legend drug” means a drug which is:

(a) Required by federal law, prior to being dispensed or delivered, to be labeled with either of the following statements:

(A) “Caution: Federal law prohibits dispensing without prescription”; or

(B) “Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian”; or

(b) Required by any applicable federal or state law or regulation to be dispensed on prescription only or is restricted to use by practitioners only.

(31) “Prescription” or “prescription drug order” means a written, oral or electronically transmitted direction, given by a practitioner authorized to prescribe drugs, for the preparation and use of a drug. When the context requires, “prescription” also means the drug prepared under such written, oral or electronically transmitted direction.

(32) “Retail drug outlet” means a place used for the conduct of the retail sale, administering or dispensing or compounding of drugs or chemicals or for the administering or dispensing of prescriptions and licensed by the board as a place wherein the practice of pharmacy may lawfully occur.

(33) “Shopkeeper” means a business or other establishment, open to the general public, for the sale or nonprofit distribution of [nonlegend] drugs[, in the original and unbroken package, properly labeled according to state and federal laws, in conformity with the rules of the board].

(34) “Unit dose” means a sealed single-unit container so designed that the contents are administered to the patient as a single dose, direct from the container. Each unit dose container must bear a separate label, be labeled with the name and strength of the medication, the name of the manufacturer or distributor, an identifying lot number and, if applicable, the expiration date of the medication.

(35) “Wholesale drug outlet” means any person who imports, stores, distributes or sells for resale any drugs including legend drugs and nonprescription drugs.

(36) “Class I wholesaler” means any person operating or maintaining a wholesale distribution center, wholesale business or any other business in which 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.

(37) “Class II wholesaler” means any person operating or maintaining a wholesale distribution center, wholesale business or any other business in which nonprescription drugs are offered for sale at wholesale to a drug outlet legally authorized to resell.

SECTION 12. ORS 689.405 is amended to read:

689.405. (1) The State Board of Pharmacy may refuse to issue or renew, or may suspend, revoke or restrict the license of any person or the certificate of registration of any drug outlet upon one or more of the following grounds:

(a) Unprofessional conduct as that term is defined by the rules of the board.

(b) Repeated or gross negligence.

(c) Incapacity of a nature that prevents a person from engaging in the activity for which the person is licensed with reasonable skill, competence and safety to the public.

(d) Habitual or excessive use of intoxicants, drugs or controlled substances.

(e) Being found guilty by the board of a violation of subparagraph (B) of this paragraph, or by a court of competent jurisdiction of one or more of the following:

(A) A felony, as defined by the laws of this state; or

(B) Violations of the pharmacy or drug laws of this state or rules pertaining thereto, or of statutes, rules or regulations of any other state, or of the federal government.

(f) Fraud or intentional misrepresentation by a licensee or registrant in securing or attempting to secure the issuance or renewal of a license.

(g) Engaging or aiding and abetting an individual to engage in the practice of pharmacy without a license, or falsely using the title of pharmacist.

(h) Aiding and abetting an individual in performing the duties of a pharmacy technician without [registering] licensing.

(i) Being found by the board to be in violation of any of the provisions of ORS 435.010 to 435.130, 453.025, 453.045, 475.035 to 475.190, 475.805, 475.940 to 475.999 or this chapter or rules adopted pursuant to ORS 435.010 to 435.130, 453.025, 453.045, 475.035 to 475.190, 475.805, 475.940 to 475.999 and this chapter.

(j) Disciplinary action by another state regarding a license, based upon acts by the licensee similar to acts described in this subsection. A certified copy of the record of disciplinary action of the state taking the disciplinary action is conclusive evidence thereof.

(2) Upon receipt of a complaint under this chapter, the board shall conduct an investigation as described under ORS 676.165.

(3) Actions taken under subsection (1) of this section shall be considered a contested case under ORS chapter 183.

SECTION 13. The amendments to ORS 689.490 by section 8 of this 2005 Act apply to acts that occur on or after the effective date of this 2005 Act.

SECTION 14. A person registered as a pharmacy technician under ORS 689.486 on the effective date of this 2005 Act shall be considered to be licensed as a pharmacy technician in accordance with the amendments to ORS 689.486 and 689.490 by sections 7 and 8 of this 2005 Act.

SECTION 15. Section 16 of this 2005 Act is added to and made a part of ORS chapter 689.

SECTION 16. (1)(a) The State Board of Pharmacy may by rule identify activities performed by a pharmacy technician for which a specialized education program may be required.

(b) If the board identifies an activity requiring specialized education under this subsection, the board shall approve no fewer than two specialized education programs to provide the specialized education.

(c) Upon receipt of evidence satisfactory to the board that a pharmacy technician has satisfactorily completed a specialized education program approved by the board, the board shall note the specialized education on the license of the pharmacy technician.

(2) The board may establish standards for renewal or revocation of a notation of specialized education under this section.

(3) As used in this section, “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.

SECTION 17. This 2005 Act being necessary for the immediate preservation of the public peace, health and safety, an emergency is declared to exist, and this 2005 Act takes effect on its passage.

Approved by the Governor June 28, 2005

Filed in the office of Secretary of State June 28, 2005

Effective date June 28, 2005

__________