reglab/statecodes huggingface dataset:
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 44 - CHARITABLE PHARMACIES › Section 855-044-0050 - Drug Distribution

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 44 - CHARITABLE PHARMACIES › Section 855-044-0060 - Labeling

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 44 - CHARITABLE PHARMACIES › Section 855-044-0061 - Charitable Pharmacies - Limited English Proficiency and Accessibility

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 44 - CHARITABLE PHARMACIES › Section 855-044-0070 - Records

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 44 - CHARITABLE PHARMACIES › Section 855-044-0080 - Fees

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
Stat. Auth.: ORS
				  689.205
Stats. Implemented: ORS
				  689.772 &
				  689.774
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 44 - CHARITABLE PHARMACIES › Section 855-044-0090 - Liability

Current through Register Vol. 63, No. 7, July 1, 2024
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.
Stat. Auth.: ORS
				  689.205
Stats. Implemented: ORS
				  689.774 &
				  689.780
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 45 - DRUG COMPOUNDING › Section 855-045-0200 - Application

Current through Register Vol. 63, No. 7, July 1, 2024
(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).
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 45 - DRUG COMPOUNDING › Section 855-045-0205 - Compliance with New Standards

Current through Register Vol. 63, No. 7, July 1, 2024
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
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 45 - DRUG COMPOUNDING › Section 855-045-0210 - Registration

Current through Register Vol. 63, No. 7, July 1, 2024
(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
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 45 - DRUG COMPOUNDING › Section 855-045-0220 - Personnel and Responsibilities

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 45 - DRUG COMPOUNDING › Section 855-045-0240 - Labeling of Compounded Drugs

Current through Register Vol. 63, No. 7, July 1, 2024
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
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 45 - DRUG COMPOUNDING › Section 855-045-0270 - Records

Current through Register Vol. 63, No. 7, July 1, 2024
(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 may be stored in a secure off-site location if then retrievable within
			 three business days. Required records include, but are not limited to:
(a) Standard operating procedures, including
			 documented annual review;
(b)
			 Personnel training according to the type of compounding performed, including
			 competency assessment, and qualification records, including corrective actions
			 for any failures, including gloved fingertip and thumb sampling test and
			 aseptic manipulation validation. The pharmacy must maintain a training record
			 for each person, including temporary personnel, who compound preparations. At a
			 minimum, the record must contain:
(A) Name
			 and signature of the person receiving the training;
(B) Documentation of initial and continuing
			 competency evaluation, to include dates and results of required elements
			 outlined in the outlet's policies and procedures; and
(C) Name and signature of the pharmacist who
			 is designated as responsible for validation of the completion of all
			 training.
(c)
			 Engineering and environmental control records, including equipment,
			 calibration, certification, environmental air and surface monitoring procedures
			 and results, as well as documentation of any corrective actions taken;
			 and
(d) Cleaning and disinfecting
			 of all compounding areas and equipment.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 60 - PHARMACEUTICAL MANUFACTURERS › Section 855-060-0001 - Application

Current through Register Vol. 63, No. 7, July 1, 2024
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.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 60 - PHARMACEUTICAL MANUFACTURERS › Section 855-060-0002 - Definitions

Current through Register Vol. 63, No. 7, July 1, 2024
(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 power to control, both of the business entities.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 60 - PHARMACEUTICAL MANUFACTURERS › Section 855-060-0004 - Registration

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 60 - PHARMACEUTICAL MANUFACTURERS › Section 855-060-0005 - General Provisions and Minimum Standards

Current through Register Vol. 63, No. 7, July 1, 2024
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 qualified
			 personnel to operate the same under the direction of a technically trained or
			 professionally competent supervisor:
(a) The
			 production supervisor in charge shall be responsible to the proper
			 administrative authority of the manufacturer for the developing, supervising,
			 and coordinating of all the activities of the manufacturing plant so far as
			 production techniques are involved;
(b) Departmentalization shall follow good
			 administrative procedure integrated with the administration of the
			 manufacturing firm in general;
(c)
			 The organizational structure of the manufacturing operation may vary depending
			 upon the size and character of the particular products manufactured. (It is not
			 the intent of the minimum standard requirements set out in the rules herein
			 provided to cast all manufacturers in the same mold, although it is their
			 intent to assure the establishment of fundamental principles which will enable
			 competent production with sufficient freedom to supply the demand for adequate
			 pharmaceutical products.)
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 60 - PHARMACEUTICAL MANUFACTURERS › Section 855-060-0010 - Sanitation and Plant Safety

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
Stat. Auth.: ORS 689
Stats. Implemented:
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 60 - PHARMACEUTICAL MANUFACTURERS › Section 855-060-0015 - Classification of Manufacturers

Current through Register Vol. 63, No. 7, July 1, 2024
(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 United States Pharmacopeia, National Formulary, Accepted Dental Remedies
			 products and including the manufacture of other internal medicines, controlled
			 substances, dangerous external preparations, injectables, products requiring
			 the prescription legend, poisons, and pure (U.S.P. and N.F. chemicals).
(2) Class II. A Class II
			 manufacturer is required to employ personnel with a Bachelor of Science degree
			 or equivalent, but not necessarily a licensed pharmacist to supervise
			 manufacturing procedures and must comply with 503B manufacturing requirements
			 of
			 21
			 USC 353 and is exempted from labeling and
			 research requirements.
(3) Class
			 III. Repackagers or distributors of non-legend drugs will not be required to
			 have a licensed pharmacist but is required to have competent supervisory
			 personnel.
Stat. Auth.: ORS
				  689.205
Stats. Implemented: ORS
				  689.155
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 60 - PHARMACEUTICAL MANUFACTURERS › Section 855-060-0020 - Qualifications of Manufacturing and Wholesaling Personnel

Current through Register Vol. 63, No. 7, July 1, 2024
(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, chemist, or other person qualified by scientific or technical
			 training or experience to perform such duties of supervision, as may be
			 necessary, to protect the public health and safety. The manufacture of drugs
			 and medicines shall be limited to persons having the necessary professional
			 and/or technical qualifications and such persons may be required to submit
			 properly attested documents of proof of formal education qualifying them for
			 these positions.
Stat. Auth.: ORS 689
Stats. Implemented:
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 60 - PHARMACEUTICAL MANUFACTURERS › Section 855-060-0025 - Labeling

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
Stat. Auth.: ORS 689
Stats. Implemented:
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 60 - PHARMACEUTICAL MANUFACTURERS › Section 855-060-0027 - Identification of Prescription Drugs

Current through Register Vol. 63, No. 7, July 1, 2024
(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 manufacturer with a code imprint identifying the
			 drug product and the manufacturer or distributor of the drug product.
(2) "Code imprint" means an
			 individual symbol, number, company name, words, letters, marking, National Drug
			 Code, or any combination thereof, identifying the drug product and the
			 manufacturer or distributor of the drug product.
(3) Exceptions to the requirement are:
(a) Drug products which are manufactured by
			 or upon the order of a practitioner licensed by law to prescribe or administer
			 drugs and which are to be used solely by the patient for whom prescribed;
(b) Drug products which are used
			 for experimentation or research purposes.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 60 - PHARMACEUTICAL MANUFACTURERS › Section 855-060-0029 - Disposal of Drugs

Current through Register Vol. 63, No. 7, July 1, 2024
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.
Stat. Auth.: ORS
				  475.035,
				  689.155,
				  689.205,
				  689.305 &
				  689.315
Stats. Implemented: ORS
				  689.155
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 60 - PHARMACEUTICAL MANUFACTURERS › Section 855-060-0035 - Registration of Mobile Manufacturers

Current through Register Vol. 63, No. 7, July 1, 2024
(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 for packaging and repacking will be furnished by the purchaser and
			 shall exclude controlled substances.
(3) The vehicle shall be secure against
			 pilferage, maintained and operated in accordance with good manufacturing
			 practices standards in this division.
(4) All unit dose packages must be labeled in
			 conformity with ORS 689.005.
(5) Records shall be maintained of all
			 package operations of receipt and disposition of drugs.
(6) The building in which this vehicle is
			 stored shall be its permanent address and shall maintain security of
			 vehicle.
(7) Vehicle shall be
			 registered annually; registration shall expire annually on July 1, of each
			 year.
(8) Applicant must show to
			 the Board that he will be actively in charge of equipment in this vehicle at
			 all times it is in operation.
(9)
			 If so required, the vehicle shall be registered with the federal Food and Drug
			 Administration.
(10) The vehicle
			 shall not display insignia or device to indicate that drugs are stored within
			 or represent it as a pharmacy.
Stat. Auth.: ORS
				  475.035 &
				  689.205
Stats. Implemented:
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 62 - DRUG DISTRIBUTION AGENT › Section 855-062-0003 - Application

Current through Register Vol. 63, No. 7, July 1, 2024
(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 marketing office for a drug;
(e) A Drug Order Contractor;
(f) A Third-Party Logistics
			 Provider; and
(g) A person
			 registered with the FDA as the holder of a New Drug Application (NDA) or an
			 Abbreviated New Drug Application (ANDA) that contracts with a third-party for
			 the manufacture of a drug but does not take physical possession of the drug,
			 does not have its name on the label and is not accountable to the FDA for the
			 purity and integrity of the drug.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 62 - DRUG DISTRIBUTION AGENT › Section 855-062-0005 - Definitions

Current through Register Vol. 63, No. 7, July 1, 2024
(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
			 that provides pharmaceutical services to a defined and exclusive group of
			 patients and is not open for dispensing to the general patient population and
			 cannot be registered as a wholesale distributor.
(3) "Co-Manufacturing Partner" means a
			 pharmaceutical manufacturer that has entered into an agreement with another
			 pharmaceutical manufacturer to engage in a business activity or occupation
			 related to the manufacture or distribution of a prescription drug.
(4)"Common Carrier" means an organization
			 that is available to the public to transport a product or service using its
			 facilities, or those of other carriers.
(5) "Drug": In this Division of rules, the
			 term "drug" shall mean any drug and any prescription device as these terms are
			 defined in ORS 689.005.
(6) "Illegitimate Product" means a product
			 for which credible evidence shows that the product is:
(a) Counterfeit, diverted, or stolen;
(b) Intentionally adulterated such
			 that the product would result in serious adverse health consequences or death
			 to humans;
(c) The subject of a
			 fraudulent transaction; or
(d)
			 Otherwise unfit for distribution such that the product would be reasonably
			 likely to result in serious adverse health consequences or death.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 62 - DRUG DISTRIBUTION AGENT › Section 855-062-0020 - Registration

Current through Register Vol. 63, No. 7, July 1, 2024
(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 of rules; or
(b) A wholesaler under Division 65 of this
			 chapter of rules; or
(c) A Drug
			 Distribution Agent under this division of rules.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 62 - DRUG DISTRIBUTION AGENT › Section 855-062-0030 - Minimum Qualifications

Current through Register Vol. 63, No. 7, July 1, 2024
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 or
			 rules of this state or of any other state, or of the federal
			 government;
(2) The applicant has a
			 history of non-compliance with state or federal rules or laws regulating the
			 manufacture, distribution, or dispensing of drugs;
(3) The applicant has made a material
			 misrepresentation to the Board in the course of applying for an initial or
			 renewal of registration;
(4)
			 Disciplinary action has been taken by the federal government or by any state,
			 or local government regarding any license or registration currently or
			 previously held by the applicant for the manufacture, distribution or
			 dispensing of any drugs;
(5) The
			 applicant has engaged in any conduct involving moral turpitude;
(6) The Board determines that granting the
			 registration is not consistent with the public health or safety or is otherwise
			 not in the public interest.
Stat. Auth.: ORS
				  689.205
Stats. Implemented: ORS
				  689.155
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 62 - DRUG DISTRIBUTION AGENT › Section 855-062-0040 - Record Keeping

Current through Register Vol. 63, No. 7, July 1, 2024
(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 to the following:
(A) The source of
			 the drug, including the name and physical address of the seller or transferor
			 and any broker or other person involved in the transaction, the address of the
			 location from which the drug was shipped and the address of the location to
			 which the drug was shipped;
(B) The
			 name, dose and quantity of the drug distributed;
(C) The date of distribution or other
			 disposition of the drug.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 62 - DRUG DISTRIBUTION AGENT › Section 855-062-0050 - Prohibited Practices

Current through Register Vol. 63, No. 7, July 1, 2024
(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 or transfer of a drug to a
			 person who is required by the laws and rules of Oregon to be registered with
			 the Board and who is not appropriately registered. Before authorizing or
			 facilitating the distribution of a drug, a Drug Distribution Agent must verify
			 that the person supplying or receiving the drug is appropriately registered
			 with the Board.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 65 - WHOLESALE DRUG OUTLETS › Section 855-065-0001 - Application

Current through Register Vol. 63, No. 7, July 1, 2024
(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 that is registered under division 60 of
			 this chapter of rules does not also need to register as a wholesale distributor
			 under these rules if they only distribute their own products or those
			 manufactured by a Co-Manufacturing Partner as defined in OAR
			 855-065-0005.
(2) Any person who is a Third-Party Logistics
			 Provider as defined in division 62 or whose sole purpose is the marketing,
			 brokering or arranging the distribution of drugs manufactured by a manufacturer
			 must register as a Drug Distribution Agent in accordance with division 62 of
			 this chapter of rules.
Stat. Auth.: ORS
				  689.205
Stats. Implemented: ORS
				  689.155
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 65 - WHOLESALE DRUG OUTLETS › Section 855-065-0005 - Definitions

Current through Register Vol. 63, No. 7, July 1, 2024
(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) A third party controls, or has the power
			 to control, both of the business entities.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 65 - WHOLESALE DRUG OUTLETS › Section 855-065-0006 - Registration Requirements

Current through Register Vol. 63, No. 7, July 1, 2024
(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
			 distribution of drugs. Every applicant for registration or renewal of
			 registration must pay the appropriate fee in accordance with OAR
			 855-110-0007 and
			 855-110-0010. An applicant must
			 register as a Class I Wholesaler or a Class II Wholesaler unless the applicant
			 qualifies for registration as a Drug Distribution Agent under Division 62 of
			 this chapter of rules.
(2)
			 Application for registration must be on a form approved by the Board and must
			 include, but not be limited to, the following information:
(a) The name, business address, social
			 security number and federal tax identification number of each owner, officer,
			 and stockholder owning more than 10 per cent of the stock of the company,
			 unless the stock of the company is publicly traded;
(b) All trade or business names used by the
			 applicant including any businesses outside Oregon;
(c) The names, addresses and telephone
			 numbers of the designated representatives for all facilities used by the
			 applicant that engage in wholesale distribution into, out of, or within
			 Oregon;
(d) The normal business
			 hours for the applicant; and
(e)
			 Any disciplinary action taken by any state or federal authority against the
			 applicant or any other wholesale distributor under common ownership or control,
			 or any owner, principal or designated representative of the applicant, in
			 connection with the drug laws or regulations of any state or the federal
			 government.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 65 - WHOLESALE DRUG OUTLETS › Section 855-065-0007 - Minimum Qualifications

Current through Register Vol. 63, No. 7, July 1, 2024
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 drug laws or
			 rules of this state or of any other state or of the federal
			 government.
(2) The applicant has
			 been convicted of any offence under federal, state, or local laws.
(3) The applicant has a history of
			 non-compliance with state or federal rules or laws regulating the manufacture,
			 distribution, or dispensing of drugs.
(4) The applicant has made a material
			 misrepresentation to the Board in the course of applying for an initial or
			 renewal of registration.
(5)
			 Disciplinary action has been taken by the federal government or by any state,
			 or local government regarding any license or registration currently or
			 previously held by the applicant for the manufacture, distribution or
			 dispensing of any drugs.
(6) The
			 applicant has engaged in any conduct involving moral turpitude.
(7) The Board determines that granting the
			 registration is not consistent with the public health or safety or is otherwise
			 not in the public interest.
Stat. Auth.: ORS
				  689.205
Stats. Implemented: ORS
				  475.135,
				  689.155,
				  689.305,
				  689.315 &
				  689.405
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 65 - WHOLESALE DRUG OUTLETS › Section 855-065-0009 - Personnel

Current through Register Vol. 63, No. 7, July 1, 2024
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 full-time managerial position by the wholesale distributor and may not be
			 listed as the DR for more than one registrant without the specific written
			 authority of the Board.
(2) Have at
			 least two years verifiable full-time managerial or supervisory experience in a
			 pharmacy or with a wholesale distributor registered under these rules or with
			 another state.
(3) Have verifiable
			 experience in record keeping and storage of prescription drugs.
(4) Be actively involved in and aware of the
			 daily operations of the wholesale distributor.
(5) Be knowledgeable about all policies and
			 procedures of the wholesale distributor.
(6) Be physically present at the wholesale
			 distributor during normal business hours, which must be posted to be visible to
			 the public, except when absent due to emergency, authorized absence or
			 legitimate business reason (as used in this rule, "normal business hours" means
			 at least six hours between 6.00 am and 7.00 pm on at least five days between
			 Monday and Saturday every week, excluding national and local holidays). Class I
			 wholesalers located within Oregon must designate a replacement DR and notify
			 the Board accordingly, when any absence of the DR exceeds 15 days.
(7) The DR must conduct a self-inspection of
			 the facility by September 1 each year, and document the results of this
			 self-inspection on Oregon Wholesaler Self-Inspection Form provided by the
			 Board. The DR must certify in writing, under penalties of perjury, that the
			 information recorded on the Oregon Wholesaler Self-Inspection Form is correct.
			 This form must be retained for three years and must be made available to the
			 Board within two days upon request.
(8) The DR must ensure that the wholesale
			 drug outlet has policies and procedures in effect and implemented to ensure
			 that the outlet employs adequate personnel with the education and experience
			 necessary to engage in the wholesale distribution of drugs safely and
			 lawfully.
Stat. Auth.: ORS
				  689.205
Stats. Implemented: ORS
				  689.155 &
				  689.315,
				  689.325
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 65 - WHOLESALE DRUG OUTLETS › Section 855-065-0012 - Storage of Drugs

Current through Register Vol. 63, No. 7, July 1, 2024
(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 facilities standards for each facility at which drugs are
			 received, stored, warehoused, handled, held, offered, marketed, or displayed,
			 or from which drugs are transported, including:
(a) Suitable construction of the facility and
			 appropriate monitoring equipment to ensure that drugs in the facility are
			 maintained in accordance with labeling or in compliance with official
			 compendium standards.
(b) Suitable
			 size and construction to facilitate cleaning, maintenance, and proper wholesale
			 distribution operations.
(c)
			 Adequate storage areas to provide appropriate lighting, ventilation,
			 temperature, sanitation, humidity, space, equipment, and security
			 conditions.
(d) A quarantine area
			 for the separate storage of drugs that are outdated, damaged, deteriorated,
			 misbranded, adulterated, counterfeit, suspected counterfeit, otherwise unfit
			 for distribution, or contained in immediate or sealed secondary containers that
			 have been opened.
(e) Maintenance
			 of the facility in a clean and orderly condition.
(f) Maintenance of the facility in a
			 commercial, nonresidential building.
(g) Freedom of the facility from infestation
			 by insects, rodents, birds or vermin of any kind.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 65 - WHOLESALE DRUG OUTLETS › Section 855-065-0013 - Prohibited Practices

Current through Register Vol. 63, No. 7, July 1, 2024
(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 and rules
			 of Oregon to be registered with the Oregon Board of Pharmacy and who is not
			 appropriately registered by the Board. Before furnishing a drug to any person
			 not known to the wholesale distributor, the wholesale distributor must verify
			 that the person is legally authorized to receive the drug.
(c) A wholesale distributor may not purchase
			 any drug from a person who is required by the laws and rules of Oregon to be
			 registered with the Oregon Board of Pharmacy and who is not appropriately
			 registered by the Board. Before purchasing a drug from any person not known to
			 the wholesale distributor, the wholesale distributor must verify that the
			 person is legally authorized to sell the drug.
(d) A Class 1 Wholesaler who is classified as
			 a "Specialty Wholesaler Distributor" as defined in OAR 855-065-005(20) may not:
(A) Sell, distribute or transfer a
			 prescription drug to a pharmacy or to a practitioner who is licensed to
			 prescribe the prescription drug, without providing a complete pedigree for the
			 prescription drug, unless the prescription drug was purchased directly from the
			 manufacturer or from the manufacturer's authorized distributor of record.
(B) Sell, distribute or transfer a
			 prescription drug to a wholesale distributor, without providing a complete
			 pedigree for the prescription drug.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 70 - PROPHYLACTICS AND CONTRACEPTIVES › Section 855-070-0001 - Definitions

Current through Register Vol. 63, No. 7, July 1, 2024
(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 intended for the
			 prevention of conception.
(3) Male
			 condom means a prophylactic or contraceptive device in the form of a sheath
			 which completely covers the penis with a closely fitting membrane.
(4) Female condom means a prophylactic or
			 contraceptive device in the form of an intravaginal pouch that consists of a
			 sheath with a flexible ring on each end.
Stat. Auth.: ORS
				  689.155 &
				  689.205
Stats. Implemented:
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 70 - PROPHYLACTICS AND CONTRACEPTIVES › Section 855-070-0005 - Applications, Fees, and Licenses to Sell Prophylactics and Contraceptives

Current through Register Vol. 63, No. 7, July 1, 2024
(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 issued by the Board of Pharmacy:
(a) The application shall be made in writing
			 on a form prepared by the Board and be accompanied by the fee listed in
			 division 110;
(b) One such
			 application shall be submitted and license obtained for each location or
			 separate address from which goods are distributed;
(c) Licenses shall be issued upon receipt of
			 the fee listed in division 110 and shall be in effect for one year from January
			 1 of each year. Licenses are not transferable;
(d) Licenses shall be publicly or
			 conspicuously displayed and the wholesaler or manufacturer to whom they are
			 issued shall be open to inspection by the Board or other authorized persons
			 designated by the Board;
(e) Each
			 application for a license shall include a list of all products or brands of
			 prophylactics and contraceptives the applicant wishes to have approved for sale
			 in the state.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 70 - PROPHYLACTICS AND CONTRACEPTIVES › Section 855-070-0010 - Labeling and Storage of Prophylactics and Contraceptives

Current through Register Vol. 63, No. 7, July 1, 2024
(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 December 31, 1994, all
			 prophylactics and contraceptives shall bear an expiration date. Prophylactics
			 and contraceptives bearing an expiration date shall not be sold or otherwise
			 distributed beyond that date.
(3)
			 Prophylactics and contraceptives shall be stored, displayed, or sold from an
			 area removed from excessive extremes of temperatures which may affect the
			 quality of the products.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 80 - SCHEDULE OF CONTROLLED SUBSTANCES › Section 855-080-0015 - Definitions

Current through Register Vol. 63, No. 7, July 1, 2024
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 which the prescribing practitioner who
			 authorizes an oral prescription of a controlled substance listed in schedule II
			 of the Federal Controlled Substances Act determines that:
(a) Immediate administration of the
			 controlled substance is necessary, for proper treatment of the intended
			 ultimate user; and
(b) No
			 appropriate alternative treatment is available, including administration of a
			 drug which is not a controlled substance under schedule II of the Act,
			 and
(c) It is not reasonably
			 possible for the prescribing practitioner to provide a written prescription to
			 be presented to the person dispensing the substanceprior to the
			 dispensing.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 80 - SCHEDULE OF CONTROLLED SUBSTANCES › Section 855-080-0020 - Schedules

Current through Register Vol. 63, No. 7, July 1, 2024
Pursuant to ORS
				475.005(6)
				those drugs and their immediate precursors classified in Schedules I through V
				under the Federal Controlled Substances Act,
				21 USC
				811 (03/23/2024),
				21 USC
				812 (03/23/2024) and as amended by the board
				pursuant to ORS 475.035 are the controlled
				substances for purposes of regulation and control under the Act. Those
				schedules are set out in OAR
				855-080-0021 through
				855-080-0026.
Publications: Publications referenced are available for
				  review at the agency.
Statutory/Other Authority: ORS
				  689.205
Statutes/Other Implemented: ORS
				  475.035