Bill Text: OR HB3424 | 2011 | Regular Session | Introduced
Bill Title: Relating to drug outlets; declaring an emergency.
Sponsorship: Committee Bill
Status: (Failed) 2011-06-30 - In committee upon adjournment. [HB3424 Detail]
Download: Oregon-2011-HB3424-Introduced.html
76th OREGON LEGISLATIVE ASSEMBLY--2011 Regular Session
NOTE: Matter within { + braces and plus signs + } in an
amended section is new. Matter within { - braces and minus
signs - } is existing law to be omitted. New sections are within
{ + braces and plus signs + } .
LC 3428
House Bill 3424
Sponsored by COMMITTEE ON HEALTH CARE (at the request of Oregon
State Pharmacy Association)
SUMMARY
The following summary is not prepared by the sponsors of the
measure and is not a part of the body thereof subject to
consideration by the Legislative Assembly. It is an editor's
brief statement of the essential features of the measure as
introduced.
Requires dispensing drug outlet in which drugs are stored and
dispensed by health care practitioner to register with State
Board of Pharmacy.
Declares emergency, effective on passage.
A BILL FOR AN ACT
Relating to drug outlets; creating new provisions; amending ORS
689.005 and 689.305; and declaring an emergency.
Be It Enacted by the People of the State of Oregon:
SECTION 1. 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 practitioner's authorized agent; 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:
(a) Professional, pharmaceutical post-graduate education in the
general areas of socio-economic and legal aspects of health care;
(b) The properties and actions of drugs and dosage forms; and
(c) 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) 'Dispensing drug outlet' means a facility in which
drugs are stored and may be dispensed by a practitioner to a
patient or other individual entitled to receive the drug. + }
{ - (9) - } { + (10) + } 'Distribute' means the delivery of
a drug other than by administering or dispensing.
{ - (10) - } { + (11) + } '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) - } { + (12) + } '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) - } { + (13) + } '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, 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) - } { + (14) + } 'Drug room' means a secure and
lockable location within an inpatient care facility that does not
have a licensed pharmacy.
{ - (14) - } { + (15) + } '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) - } { + (16) + } '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) - } { + (17) + } 'Intern' means a person who is
enrolled in or has completed a course of study at a school or
college of pharmacy approved by the board and who is licensed
with the board as an intern.
{ - (17) - } { + (18) + } 'Internship' means a professional
experiential program approved by the board under the supervision
of a licensed pharmacist registered with the board as a
preceptor.
{ - (18) - } { + (19) + } 'Itinerant vendor' means a person
who sells or distributes nonprescription drugs by passing from
house to house, or by haranguing the people on the public streets
or in public places, or who uses the customary devices for
attracting crowds, recommending their wares and offering them for
sale.
{ - (19) - } { + (20) + } '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.
{ - (20) - } { + (21) + } '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) - } { + (22) + } 'Manufacturer' means a person
engaged in the manufacture of drugs.
{ - (22) - } { + (23) + } 'Nonprescription drug outlet'
means shopkeepers and itinerant vendors registered under ORS
689.305.
{ - (23) - } { + (24) + } '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) - } { + (25) + } 'Person' means an individual,
corporation, partnership, association or any other legal entity.
{ - (25) - } { + (26) + } 'Pharmacist' means an individual
licensed by this state to engage in the practice of pharmacy.
{ - (26) - } { + (27) + } '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) - } { + (28) + } '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.
{ - (28) - } { + (29) + } 'Practice of pharmacy' means:
(a) The interpretation and evaluation of prescription orders;
(b) The compounding, dispensing and labeling of drugs and
devices, except labeling by a manufacturer, packer or distributor
of nonprescription drugs and commercially packaged legend drugs
and devices;
(c) The administering of vaccines and immunizations pursuant to
ORS 689.645;
(d) The administering of drugs and devices to the extent
permitted under ORS 689.655;
(e) The participation in drug selection and drug utilization
reviews;
(f) The proper and safe storage of drugs and devices and the
maintenance of proper records therefor;
(g) The responsibility for advising, where necessary or where
regulated, of therapeutic values, content, hazards and use of
drugs and devices;
(h) The monitoring of therapeutic response or adverse effect to
drug therapy; and
(i) The offering or performing of those acts, services,
operations or transactions necessary in the conduct, operation,
management and control of pharmacy.
{ - (29) - } { + (30) + } '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 if the
person does not reside in Oregon and is registered under the
federal Controlled Substances Act.
{ - (30) - } { + (31) + } 'Preceptor' means a pharmacist or
a person licensed by the board to supervise the internship
training of a licensed intern.
{ - (31) - } { + (32) + } '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.
{ - (32) - } { + (33) + } '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.
{ - (33) - } { + (34) + } '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.
{ - (34) - } { + (35) + } 'Shopkeeper' means a business or
other establishment, open to the general public, for the sale or
nonprofit distribution of drugs.
{ - (35) - } { + (36) + } '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.
{ - (36) - } { + (37) + } 'Wholesale drug outlet' means any
person who imports, stores, distributes or sells for resale any
drugs including legend drugs and nonprescription drugs.
SECTION 2. ORS 689.305 is amended to read:
689.305. (1) All drug outlets shall annually register with the
State Board of Pharmacy.
(2)(a) Each drug outlet shall apply for a certificate of
registration in one or more of the following classifications:
(A) Retail drug outlet.
(B) Institutional drug outlet.
(C) Manufacturing drug outlet.
(D) Wholesale drug outlet.
(E) Nonprescription drug outlet.
{ + (F) Dispensing drug outlet. + }
(b) { - No - } { + An + } individual who is employed by a
corporation
{ - which - } { + that + } is registered under any
classification listed in paragraph (a) of this subsection
{ - need - } { + is not required to + } register under the
provisions of this section.
(3) The board shall establish by rule under the powers granted
to it under ORS 689.155 and 689.205 the criteria { - which - }
{ + that + } each drug outlet must meet to qualify for
registration in each classification designated in subsection
(2)(a) of this section. The board may issue various types of
certificates of registration with varying restrictions to the
designated outlets where the board deems it necessary by reason
of the type of drug outlet requesting a certificate.
(4) { - It shall be lawful for - } A drug outlet registered
under this section { - to - } { + may + } sell and distribute
nonprescription drugs. Drug outlets engaging in the sale and
distribution of such items
{ - shall not be deemed to be - } { + are not + } improperly
engaged in the practice of pharmacy.
SECTION 3. { + (1) The amendments to ORS 689.005 and 689.305
by sections 1 and 2 of this 2011 Act become operative on January
1, 2012.
(2) The State Board of Pharmacy may take any action before the
operative date specified in subsection (1) of this section to
enable the board to exercise, on and after the operative date
specified in subsection (1) of this section, all the duties,
functions and powers conferred on the board by the amendments to
ORS 689.005 and 689.305 by sections 1 and 2 of this 2011 Act. + }
SECTION 4. { + This 2011 Act being necessary for the immediate
preservation of the public peace, health and safety, an emergency
is declared to exist, and this 2011 Act takes effect on its
passage. + }
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