Oregon Code § 689.505·Enacted ·Last updated March 01, 2026
Statute Text
Labeling requirements; rules.
(1)(a) Except as specifically provided by law and in compliance with ORS
689.564, a person may not distribute or dispense any drug without affixing to
the authorized container a clear and legible label, either printed or written,
bearing the name of the drug and the name and place of business of the person
distributing or dispensing the drug, and any other information required by
state law or rules or federal law or regulations under whose supervision the
drug is delivered or dispensed.
(b) Labeling
requirements regarding any drug may be changed or exemption therefrom granted
by the State Board of Pharmacy in the form of a special permit if the board
determines that a change or exemption is in the best interest of public health
and safety.
(2)(a) A
manufacturer or wholesaler subject to ORS 689.305 may not sell or otherwise
distribute, or offer to sell or otherwise distribute, any drug for use in a:
(A) Parcel,
package or container not bearing a label specifying the name, active
ingredients or contents, quality and quantity of the drug.
(B) Misbranded
parcel, package or container.
(b) A parcel,
package or container is misbranded:
(A) If its
labeling is false or misleading in any particular.
(B) Unless it
bears a label containing the name and business address of the manufacturer,
packer, distributor or wholesaler, and an accurate statement of the quantity of
the drug in terms of weight, measure or numerical count, exclusive of wrappers,
cartons, containers or other materials packed with such drug.
(C) In case it
contains controlled substances that the board finds and by rule designates
after reasonable notice and opportunity for hearing to be habit forming, unless
it bears the statement Warning--May Be Habit Forming.
(D) Unless it
bears a label with adequate directions for the safe use of the drug for
specified conditions, and adequate warning against use in those pathological
conditions or by children where such use may be dangerous to the health or
welfare of a user.
(E) Unless it
bears a label with true representations of the intended uses of the drug and no
false claims or representations are made of the drug in accompanying literature
or advertising.
(3) This section
does not apply to parcels, packages or containers containing:
(a) Drugs
prepared and packaged solely for use by a pharmacist in compounding
prescriptions or for dispensing in dosage unit form upon a prescription, except
that such parcels, packages or containers must bear the name and business
address of the manufacturer and, if different, the name and business address of
the distributor of the drug, and the legend Caution: Federal Law Prohibits
Dispensing Without Prescription or an equivalent legend.
(b) Drugs
intended solely for use in the professional diagnosis of disease, except that
such parcels, packages or containers shall bear the statement Diagnostic
Reagent--For Professional Use Only.
(c) Coloring
agents, emulsifiers, excipients, flavorings, lubricants, preservatives and
other like inactive ingredients used in the manufacture of drugs.
(4) The board
shall by rule exempt from any labeling or packaging requirement of this section
drugs that are, in accordance with the practice of the trade, to be processed,
labeled or repacked in substantial quantities at establishments other than
those where originally processed or packed. However, such drugs must not be
adulterated or misbranded upon removal from such processing, labeling or
repacking establishment.
(5) A pharmacist
or pharmacy intern may not dispense, on the prescription of a practitioner, any
drug without affixing to the container thereof a clear and legible label. The
label may be printed or written. Except as provided in subsection (6) of this section,
the pharmacist or pharmacy intern shall state or cause to be stated on the
label the following:
(a) The name of
the drug. If the dispensed drug does not have a brand name, the prescription
label shall indicate the generic name of the drug dispensed along with the name
of the drug distributor or manufacturer, its quantity per unit and the
directions for its use stated in the prescription. However, if the drug is a
compound, the quantity per unit need not be stated.
(b) The name of
the practitioner prescribing the drug.
(c) The name and
place of business of the pharmacist or the name and place of business of the
pharmacy for which the pharmacist or pharmacy intern is acting.
(d) The name of
the patient, unless the drug is prescribed to a partner of a patient as defined
in ORS 676.350 in accordance with rules adopted under ORS 676.350 authorizing
the practice of expedited partner therapy.
(e) When
applicable and as determined by the board, an expiration date after which the
patient should not use the drug.
(6) If the
prescribing practitioner so directs, the prescription label may not state the
name and quantity per unit of the dru