Oregon Statutes 689.505 – 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.
Terms Used In Oregon Statutes 689.505
- 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. See Oregon Statutes 689.005
- Distribute: means the delivery of a drug other than by administering or dispensing. See Oregon Statutes 689.005
- 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. See Oregon Statutes 689.005
- 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. See Oregon Statutes 689.005
- 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. See Oregon Statutes 689.005
- Manufacturer: means a person engaged in the manufacture of drugs. See Oregon Statutes 689.005
- Person: means an individual, corporation, partnership, association or other legal entity. See Oregon Statutes 689.005
- Pharmacist: means an individual licensed by this state to engage in the practice of pharmacy or to engage in the practice of clinical pharmacy. See Oregon Statutes 689.005
- 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. See Oregon Statutes 689.005
- 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. See Oregon Statutes 689.005
(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 drug.
(7) The board shall determine those drugs that must bear an expiration date under subsection (5)(e) of this section.
(8) As used in this section, ‘compound’ means a drug containing two or more medically active ingredients.
(9) A person may not deliver or dispense any drug for use by the ultimate consumer without labeling the drug container as required in this section.
(10) In addition to the labeling requirements imposed by subsections (1) to (9) of this section, the board may impose by rule requirements for drug code imprints on solid dose legend drugs. [1979 c.777 § 34a; 1993 c.571 § 13; 2009 c.522 § 2; 2019 c.465 § 3]