73rd OREGON LEGISLATIVE ASSEMBLY--2005 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 1470
Senate Bill 1004
Sponsored by Senator SCHRADER
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 manufacturer, wholesale drug outlet and pharmacy to
create and maintain record of each sale, trade or transfer of
prescription drug except to final consumer. Requires wholesale
drug outlets and pharmacies that resell prescription drugs to
wholesale drug outlets to verify prior sales of prescription
drugs.
Prescribes requirements for registration and renewal of
registration of wholesale drug outlets.
Requires wholesale drug outlets, including retail pharmacies
that conduct wholesale distribution, to sell, distribute or
transfer each calendar month minimum of 95 percent of total sales
of prescription drugs to pharmacies or other persons with
authority to dispense or administer prescription drugs.
Prohibits establishment of accounts for purchase of
prescription drugs unless account bears names of certain persons
associated with entity authorized to purchase prescription drugs.
Requires certain persons associated with wholesale drug outlets
to submit fingerprints for nationwide criminal records check
prior to registration or renewal of registration of wholesale
drug outlet.
Requires wholesale drug outlets to furnish bond prior to
registration or renewal of registration.
Prescribes testing and other requirements of designated
representative of wholesale drug outlet prior to registration or
renewal of registration.
Prescribes penalties.
A BILL FOR AN ACT
Relating to wholesale drug outlets; creating new provisions; and
amending ORS 689.005 and 689.995.
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 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 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 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. - }
{ + (30)(a) 'Prescription drug' or 'legend drug' means a drug
required by federal law to be dispensed only by prescription.
(b) 'Prescription drug' or 'legend drug' includes, but is not
limited to:
(A) Biological products, except as provided in paragraph (c) of
this subsection; and
(B) Finished dosage forms and bulk drug substances subject to
section 503(b) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 353(b)).
(c) 'Prescription drug' or 'legend drug' does not include:
(A) Blood or blood components intended for transfusion; or
(B) Biological products that are medical devices. + }
(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 establishment, open to the
general public, for the sale 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. - }
{ + engaged in the wholesale distribution of prescription drugs,
including, but not limited to:
(a) Repackagers;
(b) Own-label distributors;
(c) Private-label distributors;
(d) Jobbers;
(e) Brokers;
(f) Warehouses, including manufacturers' and distributors'
warehouses, chain drug warehouses and wholesale drug warehouses;
(g) Independent wholesale drug traders; and
(h) Retail pharmacies that conduct wholesale distribution. + }
{ - (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 2. { + Sections 3 to 10 of this 2005 Act are added to
and made a part of ORS chapter 689. + }
SECTION 3. { + The State Board of Pharmacy shall require, in
addition to any other criteria under ORS 689.305 or 689.315, the
following from each applicant for a wholesale drug outlet
registration or renewal of registration:
(1) Name, business address and telephone number of the
applicant;
(2) All current or former trade or business names used by the
applicant;
(3) Name, address and telephone number of the contact person
for each location or facility used by the applicant for the
storage or distribution of prescription drugs;
(4) Identity of the wholesale drug outlet as a sole
proprietorship, partnership or corporation and, if a corporation,
the state of incorporation;
(5) The name of each partner or the name and title of each
corporate officer or director of the wholesale drug outlet;
(6) A list of all licenses, registrations or permits issued by
any other state to the applicant that authorize the purchase or
possession of prescription drugs by the applicant; and
(7) The name of the manager, the next four highest ranking
employees, all affiliated parties and the designated
representative of the wholesale drug outlet. For each person
identified in this paragraph, all of the following information
must be provided:
(a) Place of residence for the past seven years.
(b) Date and place of birth.
(c) Occupations, job titles, names and addresses of places of
employment and corporate offices held during the past seven
years.
(d) A statement regarding whether the person was the subject of
any proceeding for the revocation or suspension of any license,
registration or permit related to manufacturing, distributing,
delivering, dispensing, administering or storing drugs during the
past seven years and, if so, the nature and disposition of the
proceeding.
(e) A statement regarding whether the person has been enjoined
by a court of competent jurisdiction from violating any federal
or state law regulating the possession, control or distribution
of prescription drugs and, if so, a copy of the injunction and
information on the current status of the proceeding.
(f) A statement describing any involvement by the person during
the past seven years with any business that manufactures,
administers, prescribes, distributes, dispenses or stores
prescription drugs, and a description of any lawsuits in which
the business was named a party. For purposes of this paragraph, '
involvement' includes financial investment in a business, but
does not include ownership of stock in a publicly traded company
or a mutual fund.
(g) A description of any felony criminal offense for which the
person was found guilty. If a criminal conviction is under
appeal, a copy of the notice of appeal must be submitted with the
application, and, within 15 days after the disposition of the
appeal, a copy of the disposition must be submitted to the board.
(h) A photograph of the person taken within 30 days preceding
submission of the application for registration or renewal of
registration.
(8) A wholesale drug outlet shall obtain a registration for
each location or facility that stores or distributes prescription
drugs.
(9) All registered wholesale drug outlets must report to the
board, in a form and manner prescribed by the board, any change
in the information submitted to the board under this section.
(10) The board by rule shall determine the information to be
provided under this section. + }
SECTION 4. { + The State Board of Pharmacy may not issue or
renew a wholesale drug outlet registration unless the designated
representative of the applicant meets all of the following
criteria:
(1) Is at least 18 years of age.
(2) Has been employed full-time for at least three years in a
pharmacy or wholesale drug outlet in a capacity related to the
dispensing and distribution of prescription drugs and
recordkeeping of the sales of prescription drugs.
(3) Has received a score of 75 percent or higher on an
examination approved by the board on federal and state laws
governing wholesale distribution of prescription drugs. The
designated representative must retake the examination and receive
a score of 75 percent or higher each time the applicant applies
for renewal of registration if the designated representative is
to continue in that capacity for the applicant.
(4) Is employed full-time in a managerial level position by the
applicant.
(5) Is actively involved in and is aware of the daily operation
of the wholesale drug outlet.
(6) Is physically present at the wholesale drug outlet during
regular business hours.
(7) Is serving as the designated representative for only one
applicant at a time.
(8) Has not been convicted of any offense relating to wholesale
or retail distribution of prescription drugs or controlled
substances.
(9) Has not been convicted of any felony under local, state or
federal law. + }
SECTION 5. { + (1) The State Board of Pharmacy shall require
each wholesale drug outlet applying for registration or renewal
of registration to furnish a full set of fingerprints from each
person required to submit information pursuant to section 3 of
this 2005 Act. The fingerprints shall be used to conduct a
nationwide criminal records check. The board shall submit
completed fingerprint cards to the Department of State Police.
The Department of State Police is authorized to submit the
fingerprint cards to the Federal Bureau of Investigation for a
nationwide criminal records check. The board may use information
obtained from the nationwide criminal records check to determine
the person's eligibility for licensing or renewal or in the
conduct of investigations under ORS 676.165 or 677.320.
(2) Notwithstanding the provisions of ORS 192.410 to 192.505
relating to public records, the fingerprints and any photographs,
records or reports compiled under this section are confidential
and exempt from public inspection, except:
(a) As ordered by a court; or
(b) For access by the person who is the subject of the
fingerprints, photographs, records or reports. + }
SECTION 6. { + (1) The State Board of Pharmacy shall require
every wholesale drug outlet applying for registration or renewal
of registration to submit a bond of at least $_____ or other
equivalent means of security established by the board by rule.
(2) The bond or security shall be used solely for the purpose
of paying any fine, penalty, fee or cost assessed by the board
against the applicant for registration or renewal of registration
that the applicant fails to pay within 30 days after the fine,
penalty, fee or cost becomes final.
(3) The board may make a claim against the bond or security for
a period not to exceed one year after the registration ceases to
be valid. + }
SECTION 7. { + (1) At least 95 percent of the total amount of
dollars a wholesale drug outlet receives each month for the sale,
distribution or transfer of prescription drugs must be to
pharmacies or other persons with authority to dispense or
administer prescription drugs.
(2)(a) A wholesale drug outlet may not purchase or otherwise
receive a prescription drug from a pharmacy unless the
prescription drug was originally purchased by the pharmacy from
the wholesale drug outlet.
(b) A wholesale drug outlet may not pay a pharmacy for a
prescription drug, in cash or credit, an amount greater than the
amount originally paid by the pharmacy to the wholesale drug
outlet. + }
SECTION 8. { + A manufacturer or wholesale drug outlet subject
to ORS 689.305:
(1) May not sell or otherwise distribute or dispense
prescription drugs except to a person registered by the State
Board of Pharmacy under ORS 689.305 and at the premises listed on
the registration of the person registered under ORS 689.305.
(2) May sell or otherwise distribute prescription drugs to a
person registered by the board under ORS 689.305 provided:
(a) The identity and registration of the person is established;
and
(b) The transfer of prescription drugs is limited to what is
necessary to meet the immediate needs of a particular patient of
the registered person. + }
SECTION 9. { + A manufacturer or wholesale drug outlet may not
accept payment, or allow the use of credit to establish an
account, for the purchase of prescription drugs from any person
other than the owner of record, the chief executive officer or
the chief financial officer of an entity authorized by the State
Board of Pharmacy to purchase prescription drugs. An account
established by a manufacturer or wholesale drug outlet for the
purchase of prescription drugs must bear the name of the
purchasing entity. + }
SECTION 10. { + (1) As used in this section:
(a) 'Authenticate' or 'authentication' means verification,
before distribution of a prescription drug, that each transaction
listed on a pedigree has occurred.
(b) 'Pedigree' means a record of each sale, trade or transfer
of a prescription drug from manufacture through final sale to a
pharmacy or other entity for dispensing or administering.
(2) A person, including a manufacturer, repackager or pharmacy,
that sells, trades or transfers a prescription drug other than to
a final consumer shall retain a pedigree of the sale, trade or
transfer.
(3) A person that sells, trades or transfers a prescription
drug other than to a final consumer shall provide a copy of the
pedigree to the person purchasing or receiving the prescription
drug, and shall affirmatively verify before distribution that
each transaction listed on the pedigree has occurred.
(4) A sale, trade or transfer of a prescription drug between
licensees with a common ownership or to meet emergency needs is
not subject to this section.
(5) For each sale, trade or transfer required by this section
to be recorded, the pedigree shall be in a form adopted by the
State Board of Pharmacy by rule and shall contain the following
information:
(a) Name, address, telephone number and, if available,
electronic mail address of each purchaser of the prescription
drug and of each wholesale drug outlet that takes possession of
but not title to the prescription drug;
(b) Signature of each purchaser of the prescription drug and of
each wholesale drug outlet that takes possession of but not title
to the prescription drug;
(c) Name and address of each location from which the
prescription drug was shipped;
(d) Date of each sale, trade or transfer;
(e) Certification that each recipient of the prescription drug
has authenticated the pedigree;
(f) Name of each prescription drug;
(g) Dosage form and strength of each prescription drug;
(h) Size of each container;
(i) Number of containers;
(j) Lot number of each prescription drug; and
(k) Names of the manufacturers of the finished dosage forms.
(6) Each person required by this section to produce or receive
a pedigree shall maintain the pedigree for three years. + }
SECTION 11. ORS 689.995 is amended to read:
689.995. (1) Violation of any provision of this chapter or of
any rule of the State Board of Pharmacy is a misdemeanor.
(2) Failure to comply with any notice, citation or subpoena
issued by the board under ORS 689.135 (13) is a misdemeanor. Each
day during which the violation continues is a separate offense.
(3) Refusal to furnish information required under this chapter
or willfully furnishing false information, is a misdemeanor.
(4) Any attempt to secure or the securing of registration or
licensure for any person under any certificate, license or permit
authorized by this chapter by making or causing to be made any
false representations is a misdemeanor.
{ + (5) Violation of any provisions of sections 3, 4, 7, 8, 9
or 10 of this 2005 Act is punishable by a fine not to exceed
$500,000 or imprisonment for life, or both. + }
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