Oregon Administrative Code

855-043-0740 Community Health Clinic (CHC) - Dispensing and Drug Delivery (1) A drug may only be dispensed by a practitioner who has been given dispensing privileges by their licensing Board or by a Registered Nurse. (2) A Registered Nurse may only provide over-the-counter drugs …

855-043-0745 Community Health Clinic (CHC) - Disposal of Drugs Drugs that are outdated, damaged, deteriorated, misbranded, adulterated, or identified as suspect or illegitimate must be documented, quarantined and physically separated from other drugs until they are destroyed or r…

855-043-0750 Community Health Clinic (CHC) - Record Keeping (1) A dispensing record must be maintained separately from the patient chart and kept for a minimum of three years. The record must show, at a minimum, the following: (a) Name of patient; (b) Unique identifier (i.e. pres…

855-044-0001 Purpose The purpose of the program is to provide a process to make donated prescription drugs available to needy or uninsured individuals and those with limited access to pharmaceuticals. Under the rules in this Division, a Charitable Pharmacy that is registered with…

855-044-0005 Definitions (1) “Charitable Pharmacy” means a facility registered with the Oregon Board of Pharmacy for the purpose of receiving and distributing donated drugs. (2) “Point-of-Contact” means an individual designated by a charitable pharmacy who serves as the primary c…

855-044-0010 Registration (1) A facility may not operate as a charitable pharmacy unless it is registered as such with the Board and has paid the fee specified in Division 110 of these rules. (2) The application for registration must be on a form provided by the Board and must in…

855-044-0020 Personnel (1) A charitable pharmacy must have a licensed pharmacist. The pharmacist may also be the Point-of-Contact. (2) A charitable pharmacy that is co-located with an existing registered pharmacy may name a pharmacist employed by the existing pharmacy as its phar…

855-044-0030 Drug Donation (1) A charitable pharmacy may not accept: (a) Any controlled substance or any kit, package or blister pack that contains any controlled substance; (b) A non-prescription drug; (c) A drug in a container or package that does not contain a product identifi…

855-044-0040 Storage and Security (1) A charitable pharmacy must store all donated drugs securely and physically separate from any existing inventory. (2) All charitable pharmacy records must be secured to comply with HIPAA and all state and federal regulations. (3) Outdated and …

855-044-0050 Drug Distribution (1) A charitable pharmacy may not distribute a donated prescription drug that: (a) Fails to meet the requirements of the program; (b) Has not been stored in accordance with manufacturer’s recommendations; (c) Has been repackaged, except that a drug …

855-044-0060 Labeling (1) Except as defined in SB 450 (2023), the label on a drug dispensed or distributed from a charitable pharmacy must meet all federal rules and laws and must contain: (a) The name, address and telephone number of the pharmacy; (b) The name of the prescribing…

855-044-0061 Charitable Pharmacies - Limited English Proficiency and Accessibility (1) Upon request of a prescriber, patient or a patient's agent, each drug dispensed by a pharmacy for a patient's self-administration must bear a label in both English and the language requested fo…

855-044-0070 Records (1) A charitable pharmacy must maintain a donation record of all drugs received that includes: (a) Donor’s name and address; (b) Drug manufacturer, lot number, name and strength; (c) Drug quantity; (d) Expiration date of the drug; (e) Date donated; and (f) Th…

855-044-0080 Fees (1) A charitable pharmacy may not charge a fee for accepting a donation. (2) A charitable pharmacy may not sell a donated drug. (3) A charitable pharmacy may charge a dispensing fee that does not exceed two and a half times Oregon’s current Medicaid dispensing f…

855-044-0090 Liability In accordance with ORS 689.780, a person who accepts or distributes donated prescription drugs through the charitable pharmacy program is not subject to criminal prosecution or civil liability for any injury, death or loss of or damage to person or property…

855-045-0200 Application (1) Any person, including any business entity, located in or outside Oregon that engages in the practice of compounding a drug for use or distribution in Oregon must register with the board as a drug outlet and comply with board regulations. (2) These rul…

855-045-0205 Compliance with New Standards As an alternative to the requirements in OAR 855-045-0200(3)(a) and (3)(b) registrants may comply with any or all standards contained in: (1) USP <795> Pharmaceutical Compounding—Non-Sterile Preparations (11/1/2023). (2) USP <797> Pharma…

855-045-0210 Registration (1) A non-resident drug outlet that distributes a non-patient specific compounded drug into Oregon must be registered with the FDA as a 503B Outsourcing Facility and must register with the Board as a manufacturer drug outlet. (2) A resident drug outlet t…

855-045-0220 Personnel and Responsibilities (1) All personnel who prepare and supervise the preparation of a compound must complete appropriate training and be capable and qualified to perform assigned duties. (2) The Pharmacist-in-Charge (PIC) and the drug outlet must establish,…

855-045-0240 Labeling of Compounded Drugs In addition to the labeling requirements specified in OAR 855-041, the label of a compounded drug dispensed or distributed must contain the following, at a minimum: (1) The generic or official name of each active ingredient; (2) The stren…

855-045-0270 Records (1) All records must be maintained in written or electronic format, stored in an organized manner, retained for a minimum of three years and be made readily available for inspection by the Board. Records must be stored onsite for at least one year and then ma…

855-060-0001 Application No place of manufacturing, wholesaling or repackaging of drugs or medicines, as defined in ORS 689.005(20), (35), and (36) may be conducted or operated until it has been registered by the State Board of Pharmacy. (1) All applications for registration of a…

855-060-0002 Definitions (1) “Affiliate” means a business entity that has a relationship with a second business entity if, directly or indirectly: (a) One business entity controls, or has the power to control, the other business entity; or (b) A third party controls, or has the p…

855-060-0004 Registration (1) Any person that manufactures, or contracts for the manufacture of a drug or prescription device that is intended for sale, distribution, dispensing or administration in Oregon must register with the Oregon Board of Pharmacy. (2) Any person that holds…

855-060-0005 General Provisions and Minimum Standards In order to qualify for a manufacturing registration, the applicant shall meet certain minimum standards: (1) Organization: The physical plant of the manufacturer shall be properly organized with adequate facilities and qualif…

855-060-0010 Sanitation and Plant Safety (1) The manufacturing plant, its equipment and facilities, shall be maintained in a clean and orderly condition. (2) The physical facilities of the manufacturing plant, shall be maintained so as to conform with the laws of this state and t…

855-060-0015 Classification of Manufacturers (1) Class I. A Class I manufacturer is required to employ an Oregon licensed pharmacist or a person approved by the Board who by experience and education possesses the necessary qualifications to supervise manufacturing procedures for …

855-060-0020 Qualifications of Manufacturing and Wholesaling Personnel (1) Only qualified personnel shall be employed to manufacture products. (2) No drugs or medical supplies shall be manufactured in this state except under the personal supervision of a licensed pharmacist, chem…

855-060-0025 Labeling (1) All stocks and materials, as well as products produced, shall be labeled and conform to the strength and purity as required by law. (2) A sample label of each product manufactured shall be supplied to the State Board of Pharmacy upon request. Statutory/O…

855-060-0027 Identification of Prescription Drugs (1) All prescription drug products in tablet or capsule form intended for oral administration will be required to be specifically identified. These drug products, when sold or distributed in Oregon, must be marked by the manufactu…

855-060-0029 Disposal of Drugs Drugs that are outdated, damaged, deteriorated, misbranded, adulterated, or illegitimate shall be quarantined and physically separated from other drugs until they are destroyed or returned to their supplier. Statutory/Other Authority: ORS 475.035, 6…

855-060-0035 Registration of Mobile Manufacturers (1) A mobile manufacturer means a manufacturer who manufactures within a vehicle equipped to provide unit dose packaging and repackage capabilities operated by a currently licensed pharmacist in this state. (2) Stock medication fo…

855-062-0003 Application (1) The following persons must register as a Drug Distribution Agent under this Division of rules: (a) A broker; (b) An import broker; (c) An agent for a foreign manufacturer who is registered with the Food and Drug Administration (FDA); (d) Sales and mar…

855-062-0005 Definitions (1) "Broker" means a person engaged in the marketing, offering, or contracting for wholesale distribution and sale of a drug into, within, or out of Oregon and who does not take physical possession of the drug. (2) "Closed Door Pharmacy" means a pharmacy …

855-062-0020 Registration (1) Any person engaged in any part of the process of manufacture or wholesale distribution of a drug into, out of, or within Oregon must be registered with the board. A person must register as either: (a) A manufacturer under Division 60 of this chapter …

855-062-0030 Minimum Qualifications The Board may deny an application for registration or renewal of registration as a Drug Distribution Agent on any of the following grounds: (1) The applicant has been found by the Board or by a court to have violated the pharmacy or drug laws o…

855-062-0040 Record Keeping (1) A Drug Distribution Agent must establish and maintain records regarding the distribution or other disposition of a drug. (a) If a Drug Distribution Agent distributes product to a wholesaler or pharmacy, the record must contain, but is not limited t…

855-062-0050 Prohibited Practices (1) The following practices are expressly prohibited: (a) A Drug Distribution Agent may not participate in the purchase of a drug from a closed-door pharmacy; (b) A Drug Distribution Agent may not participate in any way in the sale, distribution …

855-065-0001 Application (1) These rules (OAR 855-065-0001 to 855-065-0013) apply to any person, including any business entity, located in or outside Oregon that engages in the wholesale distribution of prescription or non-prescription drugs in Oregon except that a manufacturer t…

855-065-0005 Definitions (1) “Affiliate” means a business entity that has a relationship, or is an authorized trading partner, with a second business entity if, directly or indirectly: (a) One business entity controls, or has the power to control, the other business entity; or (b…

855-065-0006 Registration Requirements (1) Every wholesale distributor, wherever located, that engages in wholesale distribution into, out of, or within Oregon must be registered with the Board in accordance with the laws and regulations of Oregon before engaging in wholesale dis…

855-065-0007 Minimum Qualifications The Board may deny an application for an initial registration or renewal of registration as a wholesale distributor on any of the following grounds: (1) The applicant has been found by the Board or by a court to have violated the pharmacy or dr…

855-065-0009 Personnel As a part of the registration or re-registration application, an applicant for registration as a Class I Wholesaler must name a Designated Representative (DR) for each wholesale distributor registered under these rules. The DR must: (1) Be employed in a ful…

855-065-0010 Minimum Requirements for Reporting, Record Keeping and Inventory Management (1) A Wholesale distributor must establish and maintain inventories and records of all transactions regarding the receipt and distribution or other disposition of drugs. These records must co…

855-065-0012 Storage of Drugs (1) As a condition for receiving and retaining a wholesale distributor registration issued under these rules, an applicant must satisfy the Board that the applicant has and will continuously maintain acceptable storage and handling conditions and fac…

855-065-0013 Prohibited Practices (1) The following practices are expressly prohibited: (a) A wholesale distributor may not purchase drugs from a closed-door pharmacy. (b) A wholesale distributor may not sell, distribute or transfer a drug to a person who is required by the laws …

855-070-0001 Definitions (1) Prophylactic means a drug, device or medical preparation intended for or having special utility in the prevention of a sexually transmitted disease, or in the prevention of conception. (2) Contraceptive means a drug, device or medical preparation inte…

855-070-0005 Applications, Fees, and Licenses to Sell Prophylactics and Contraceptives (1) Every wholesaler or manufacturer of prophylactics or contraceptives who distributes in Oregon goods of the class specified in ORS 435.010 shall annually submit an application for a license …

855-070-0010 Labeling and Storage of Prophylactics and Contraceptives (1) The use of detachable slip labels or removable ink stamps listing names and addresses of manufacturer, brand name, and expiration date do not meet the labeling requirements of ORS 435.090. (2) As of Decembe…

855-080-0015 Definitions As used in these rules: (1) "Act" means the Uniform Controlled Substances Act, ORS Chapter 475, and rules thereunder; (2) "CFR" means Code of Federal Regulations; (3) "USC" means United States Code; (4) "Emergency Situations" means those situations in whi…