justicedao/ipfs_state_laws huggingface dataset:
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 identification label (PIL), except that a drug in a manufacturer’s original container or a manufacturer’s blister pack does not need to bear a PIL; (d) An FDA REMS (Risk Evaluation and Mitigation Strategy) drug; (e) A drug donated from another state. (2) A charitable pharmacy may accept: (a) A prescription drug received in original, sealed, tamper-evident packaging that displays the lot number and expiration date of the drug; and (b) Sealed single unit dose packages received in opened packages containing multiple single unit doses. (3) The following are examples of acceptable packaging: (a) Manufacturer’s original container; (b) Single-dose blister packs in sealed outer package; (c) Single-dose blister packs in opened outer package; (d) Tamper-evident hospice kit containing manufacturer’s original containers. (4) Donated drugs that do not meet the above criteria or are judged by the pharmacist to be unsafe for re-dispensing must be stored separately from the drug supply until they can be destroyed. (5) A charitable pharmacy may accept a drug from: (a) An individual; (b) A long-term care facility; (c) A pharmacy; (d) A practitioner who has been given dispensing privileges by their licensing board and is acting within their scope of practice; (e) Another registered charitable pharmacy; (f) A medical clinic; (g) A drug manufacturer or wholesaler; (h) A Medication Assistance Program (MAP) such as those supported by drug manufacturers. (6) The donor must certify on a Donor Form provided by the Board that the donated drug has been properly stored, in accordance with manufacturer’s recommendations, and has never been opened, used, adulterated or misbranded. (7) Upon written request, the Board may waive any of the requirements of this rule if a waiver will further public health and safety. A waiver granted under this section shall only be effective when it is issued in writing. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.772 & 689.774 History: BP 1-2017, f. & cert. ef. 2-23-17 BP 6-2010, f. & cert. ef. 6-29-10
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 unusable drugs intended for destruction must be quarantined and stored securely. (4) A charitable pharmacy co-located with an existing pharmacy must use storage and record keeping procedures that maintain separation of charitable pharmacy records and drugs from other pharmacy records and inventory. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.774 History: BP 6-2010, f. & cert. ef. 6-29-10
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 that has been repackaged for a long-term care pharmacy may be distributed; (d) Bears an expiration date that is less than nine months from the date the drug is donated; (e) Is adulterated or misbranded; (f) Is a controlled substance; (g) Is a drug that requires a special registration for dispensing; (h) Is an over-the-counter drug; (i) Requires specialty storage or handling; (j) Requires refrigeration; (k) Is a compounded drug; or (L) In the pharmacist’s professional judgment, may be unfit for dispensing. (2) A charitable pharmacy may only dispense a drug to a person who: (a) Has a valid prescription for the drug; and (b) Is a resident of Oregon; and (c) Is underinsured or does not have adequate health insurance coverage for the prescription drug requested; or (d) Is enrolled in a program of public assistance as defined in ORS 411.010; (3) A drug may only be dispensed by a pharmacist or by a practitioner who has been given dispensing privileges by their licensing board and is acting within their scope of practice, or by a registered nurse subject to the following: (a) A registered nurse who is an employee of a charitable pharmacy may dispense a drug to a client of the charitable pharmacy; and (b) Such dispensing by a registered nurse shall be pursuant to the order of a person authorized to prescribe the drug. (4) The dispensing practitioner must provide the patient with appropriate counseling on the use of the drug and any potential side effects, and may provide written drug information; (5) A recipient of a drug under this program must sign a Recipient Form, provided by the Board, that attests that the recipient has been notified that: (a) The prescription drug was donated to the program; (b) A visual inspection was conducted by a pharmacist to ensure that the drug has not expired, been adulterated or misbranded, and is in its original, sealed packaging; (c) A pharmacist has determined that the drug is safe to distribute based on the accuracy of the Donor’s Form and the visual inspection by the pharmacist; (d) Participants in the program are immune from liability as provided in ORS 689.780; and (e) That they are qualified to receive the drug as specified in section (2) of this rule. (6) Upon written request the Board may waive any of the requirements of this rule if a waiver will further public health and safety. A waiver granted under this section shall only be effective when it is issued in writing. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.772 & 689.774 History: BP 6-2010, f. & cert. ef. 6-29-10
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 practitioner; (c) The initials of the dispensing practitioner; (d) Date dispensed; (e) The name of the patient; (f) Name and manufacturer of drug, drug strength, the quantity dispensed; (g) Directions for use; (h) The expiration date; (i) A unique identifier; and (j) Any further cautionary information required for patient safety. (2) All original patient identification must be removed. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.774 & 2023 SB 450 History: BP 27-2023, amend filed 10/16/2023, effective 10/17/2023 BP 92-2020, minor correction filed 10/22/2020, effective 10/22/2020 BP 6-2010, f. & cert. ef. 6-29-10
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 for an individual with limited English proficiency, defined as a person who is not fluent in the English language. This does not apply to a drug outlet dispensing a drug intended for administration by a healthcare worker. (2) When dispensing a drug under (1), a pharmacy must provide labels and informational inserts in both English and one of the following languages: (a) Spanish; (b) Russian; (c) Somali; (d) Arabic; (e) Chinese (simplified); (f) Vietnamese; (g) Farsi; (h) Korean; (i) Romanian; (j) Swahili; (k) Burmese; (l) Nepali; (m) Amharic; and (n) Pashtu. (3) The board must reassess and update (2) as necessary and at least every ten years. (4) A pharmacy that dispenses prescriptions for a patient's self-administration must post signage to provide notification of the right to free, competent oral interpretation and translation services for patients who are of limited English proficiency, in compliance with federal and state regulations. Statutory/Other Authority: ORS 689.564 Statutes/Other Implemented: ORS 689.205 History: BP 97-2020, adopt filed 12/23/2020, effective 01/01/2021
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) The unique identifier. (2) A charitable pharmacy must maintain a distribution and dispensing record that includes: (a) Drug name and strength; (b) Quantity distributed; (c) Name of manufacturer; (d) Lot number and expiration date; (e) Date of distribution or dispensing; (f) Name and address of recipient. (3) A charitable pharmacy must maintain a record of all drugs that are destroyed. (4) In addition to the above records, a charitable pharmacy must cross-reference the donation record and the distribution and dispensing record with the appropriate donor and recipient forms. (5) A charitable pharmacy must make an annual report to the Board by completing a form provided by the Board and submitting it with their application for renewal of registration. (6) All records required by these rules must be retained for three years and made available to the Board upon request. (7) Upon written request the Board may waive any of the requirements of this rule if a waiver will further public health and safety. A waiver granted under this section shall only be effective when it is issued in writing. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.774 History: BP 9-2014, f. & cert. ef. 12-4-14 BP 6-2010, f. & cert. ef. 6-29-10
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 fee. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.772 & 689.774 History: BP 6-2010, f. & cert. ef. 6-29-10
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 that results from the acceptance or distribution of the donated prescription drugs if the participant accepts or distributes the donated prescription drugs in good faith. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.774 & 689.780 History: BP 6-2010, f. & cert. ef. 6-29-10
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 rules apply to sterile and non-sterile compounding of a drug. (3) All drug compounding must adhere to standards of the current edition of the United States Pharmacopeia (USP) and the National Formulary (NF) including: (a) USP <795> Pharmaceutical Compounding- Non-Sterile Preparations (05/01/2020 v. 2014); (b) USP <797> Pharmaceutical Compounding—Sterile Preparations (05/01/2020 v. 2008); (c) USP <800> Hazardous Drugs—Handling in Healthcare Settings (07/01/2020 v. 2020); (d) USP <825> Radiopharmaceuticals—Preparation, Compounding, Dispensing, and Repackaging (01/01/2024); and (e) All Chapters of USP and USP-NF related to the compounding practices at any location. This includes, but is not limited to Chapters 7 (09/01/2023), 51 (05/01/2018), 71 (2013), 85 (05/01/2018),151 (05/01/2017), 659 (04/01/2021), 660 (10/01/2023), 671 (12/01/2020), 695 (2013), 731 (11/01/2020), 821 (05/01/2017), 823 (2013), 1066 (08/01/2015), 1072 (2013), 1116 (2013), 1151 (05/01/2021), 1160 (12/01/2020), 1163 (12/01/2020), 1176 (05/01/2019), 1191 (05/01/2018), 1211 (03/01/2019), 1229.5 (08/01/2022), 1231 (12/01/2021), and 1821 (05/01/2017). [Publications: Publications referenced are available for review at the agency or from the United States Pharmacopoeia.] Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 History: BP 57-2024, amend filed 06/18/2024, effective 06/20/2024 BP 10-2023, amend filed 06/13/2023, effective 06/13/2023 BP 27-2022, amend filed 06/15/2022, effective 06/16/2022 BP 45-2021, amend filed 12/16/2021, effective 12/16/2021 BP 12-2019, amend filed 12/20/2019, effective 12/20/2019 BP 2-2008, f. & cert. ef. 2-20-08
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> Pharmaceutical Compounding—Sterile Preparations (11/1/2023). [Publications: Publications referenced are available for review at the agency or from the United States Pharmacopoeia.] Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 History: BP 57-2024, amend filed 06/18/2024, effective 06/20/2024 BP 25-2023, adopt filed 10/16/2023, effective 10/17/2023 BP 9-2023, temporary adopt filed 04/19/2023, effective 05/05/2023 through 10/31/2023
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 that distributes a non-patient specific human compounded drug within or outside of Oregon must register with the FDA as a 503B Outsourcing Facility and must register with the Board as a manufacturer drug outlet. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 History: BP 12-2019, amend filed 12/20/2019, effective 12/20/2019 BP 2-2008, f. & cert. ef. 2-20-08
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, maintain and enforce policies and procedures in accordance with the standards required in OAR 855-045-0200(3) for all aspects of the compounding operation according to the type of compounding performed and must include written procedures for: (a) Personnel qualifications, to include training, evaluation and requalification; (b) Hand hygiene; (c) Garbing; (d) Engineering and environmental controls, to include equipment certification and calibration, air and surface sampling, and viable particles; (e) Cleaning activities, to include sanitizing and disinfecting, including those compounding personnel and other staff responsible for cleaning; (f) Components, to include selection, handling, and storage; (g) Creating master formulation records, with documented pharmacist approval; (h) Creating compounding records; (i) Establishing beyond-use dates (BUDs); (j) Continuous quality assurance program and quality controls, to include release testing, end-product evaluation, and quantitative/qualitative testing; (k) Completed compounded preparations, to include handling, packaging, storage and transport; (l) Adverse event reporting process and recall procedure. The recall procedure must include notification to the board within 10 working days in the event of a patient-level recall of a compounded drug. (3) The Pharmacist-in-Charge (PIC) must annually complete a self-inspection using the board’s Compounding Self-Inspection Form by July 1 and retain for board inspection. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 History: BP 12-2023, amend filed 06/13/2023, effective 08/01/2023 BP 45-2021, amend filed 12/16/2021, effective 12/16/2021 BP 12-2019, amend filed 12/20/2019, effective 12/20/2019 BP 3-2011, f. & cert. ef. 4-18-11 BP 2-2008, f. & cert. ef. 2-20-08
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 strength or concentration of each active ingredient, to include primary solution for a sterile parenteral preparation; (3) The dosage form and route of administration; (4) Rate of infusion, for a sterile parenteral preparation; (5) The total quantity of the drug product; (6) A beyond-use date (BUD), compliant with standards required in OAR 855-045-0200(3); and (7) Handling, storage or drug specific instructions, cautionary information, and warnings as necessary or appropriate for proper use and patient safety. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 History: BP 45-2021, amend filed 12/16/2021, effective 12/16/2021 BP 12-2019, amend filed 12/20/2019, effective 12/20/2019 BP 3-2011, f. & cert. ef. 4-18-11 Renumbered from 855-041-0063, BP 2-2008, f. & cert. ef. 2-20-08 BP 7-2005, f. 12-14-05, cert. ef. 12-15-05 PB 12-1989, f. & cert. ef. 8-11-89 PB 5-1987, f. & ef. 5-1-87
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 new or relocated manufacturer shall be accompanied by the required fees as set forth in OAR 855-110. (2) Application must specify the location of the manufacturer premises. When the applicant is not the owner of the business, the application shall indicate the owner and the applicant's affiliation with the owner; (a) If the owner is a partnership or other multiple owner, the names of the partners or person holding the five largest interests shall be indicated on the application. (b) If the owner is a corporation, the name filed must be the same as filed with the Corporation Commissioner. The name of the corporation, the names of the corporation officers and the names of the stockholders who own the five largest interests must be indicated on the application. (c) Upon request by the board, the applicant must furnish such information as required by the board regarding the partners, stockholders, or other persons not named in the application. (3) All registration renewal applications must be accompanied by the annual fee and contain the same information required in subsection (2)(a), (b), and (c) of this rule. (4) A change of ownership or location requires a new application, fee and registration within 15 days. (5) The registration certificate is issued to a person or firm and is non-transferable. Additions or deletions of a partner/partners must be considered as a change of ownership. (6) Manufacturer registration expires September 30th annually. The registration cannot be prorated. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155, ORS 689.305, ORS 689.315 & ORS 689.325 History: BP 12-2006, f. & cert. ef. 12-19-06 BP 38-2021, amend filed 12/16/2021, effective 01/01/2022 BP 1-2002, f. & cert. ef. 1-8-02 PB 1-1994, f. & cert. ef. 2-2-94 1PB 2-1980, f. & ef. 4-3-80
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 one or more of the following registrations with the Food and Drug Administration (FDA) must register as a Manufacturer. (a) A New Drug Application number (NDA); (b) An Abbreviated New Drug Application number (ANDA); (c) A Labeler Code number (LC) or National Drug Code number (NDC); (d) An FDA Central File Number (CFN); (e) An FDA Establishment Identifier number (FEI); (f) A Biologic License Application (BLA); (g) An Outsourcing Facility Registration. (3) A person that is registered with the FDA as a repackager must register as a Manufacturer. (4) A person who is a third-party logistics provider as defined in Division 62 or whose sole purpose is the marketing, brokering or arranging the initial distribution of drugs manufactured by a manufacturer must register as a Drug Distribution Agent under Division 62. (5) A person who is registered with the FDA as the agent for a foreign manufacturer must register as a Drug Distribution Agent under Division 62. (6) An applicant for a new or renewal of registration must provide all information specified on the form provided by the Board, and pay the fee as specified in OAR 855-110-0007. The applicant must also provide any additional information requested by the Board. An application that does not contain all required information is incomplete and will not be processed. (7) The registration is non-transferable. Addition or deletion of an owner shall be considered as a change of ownership except where the registrant is a publicly held corporation. A new application for registration and payment of a new registration fee is required when a registrant changes ownership or location. This new application must be submitted to the Board at least 15 days prior to the change. (8) A person who compounds a drug that is distributed in Oregon not based on a patient specific prescription must register with the Board as a Manufacturer, unless done so pursuant to a Shared Pharmacy Services agreement, as defined in OAR 855-006-0005, between two in-state entities. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 & 689.305 History: BP 4-2015, f. & cert. ef. 7-1-15 BP 5-2013, f. & cert. ef. 8-29-13 BP 1-2013(Temp), f. 3-6-13, cert. ef. 3-7-13 thru 9-3-13 BP 9-2011, f. 12-30-11, cert. ef. 1-1-12
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 the rules and regulations of the Workers Compensation Department, the Occupational Safety and Health Division, relating to sanitation and safety. (The provisions of this section shall be applicable to storerooms, toilets, washrooms, basements, and all other portions of the plant wherein business is conducted.) (3) Toilet and washroom accommodations shall be maintained separately and distinct from the manufacturing facilities. The doors to toilet and washroom accommodations shall at all times remain closed, except as a means of ingress or egress. (4) The walls, ceilings, windows, and floors of the manufacturing plant shall be clean and maintained in good repair. (5) The manufacturing plant shall be well lighted, ventilated, and kept free of obnoxious odors. (6) No waste materials shall be permitted to collect upon the floors, counters, or other portions of the manufacturing plant. Waste receptacles shall be placed in convenient places for disposal of waste materials. (7) No merchandise shall be stored in toilets or washrooms or be permitted to stand or to be stored or placed in any portion of the manufacturing plant except in a storeroom. Storerooms shall be maintained at a cool temperature, shall be dry and ventilated, free from rodents, insects, obnoxious odors, and shall be equipped with adequate lighting facilities. Merchandise shall be arranged in an orderly manner. (8) The plumbing of the manufacturing plant shall be maintained in good repair. (9) Equipment and materials necessary for processing or producing items to be manufactured shall be maintained in an orderly and clean condition. All instruments and equipment shall be thoroughly cleansed following use. Statutory/Other Authority: ORS 689 History: 1PB 2-1980, f. & ef. 4-3-80 Reverted to 1PB 33, f. 2-14-74, ef. 3-11-74 1PB 2-1979(Temp), f. & ef. 10-3-79 1PB 33, f. 2-14-74, ef. 3-11-74 1PB 18, f. & ef. 10-14-64