justicedao/ipfs_state_laws huggingface dataset:
855-007-0060 SNS and State Stockpile Emergency Drugs (1) General: When drugs from the Strategic National Stockpile (SNS) are delivered to the state, the drugs may be delivered to a state Receipt, Staging and Storage center (RSS) for further distribution to Points of Dispensing (PODs) selected by OSPHD. State drugs (state stockpile) may also be delivered to the RSS. (2) Temporary storage of drugs from SNS or state stockpile: (a) The RSS, PODs and local health departments (LHD) are authorized to store any drugs from the SNS or state stockpile prior to and during an emergency without any registration from the Board. (b) All such drugs must be stored in accordance with manufacturers’ guidelines. (c) This authority to possess drugs shall extend beyond the declared emergency until procedures issued by OSPHD for the return or destruction of unused drugs have been completed. (3) A long-term drug storage area for state and federal emergency medications not otherwise registered as a drug outlet must be approved by the Board, comply with storage and security requirements, and register as a Drug Room. Statutory/Other Authority: ORS 401.065, 433.441 & 689.205 Statutes/Other Implemented: ORS 689.155 History: BP 1-2017, f. & cert. ef. 2-23-17 BP 4-2009, f. & cert. ef. 12-24-09 BP 1-2009, f. & cert. ef. 6-22-09 BP 4-2008(Temp), f. 12-31-08, cert. ef. 1-5-09 thru 7-3-09
855-007-0086 Compliance with Governor’s Executive Orders (1) During a declared emergency, unprofessional conduct includes failing to comply with any applicable provision of a Governor’s Executive Orders or any provision of this rule. (2) Failing to comply as described in subsection (1) includes, but is not limited to: (a) Failing to comply with any requirements of a Board of Pharmacy guidance implementing an Executive Order; and, (b) Failing to comply with Oregon Health Authority (OHA) guidance implementing an Executive Order, including but not limited to: (A) Failing to satisfy required criteria in OHA guidance prior to resuming elective and non-emergent patient care services or procedures; (B) Failing to implement a measured approach when resuming elective and non-emergent patient care services or procedures in accordance with OHA guidance; (C) Failing to screen individuals or clients in accordance with OHA guidance prior to providing services; (D) Failing to implement OHA guidance on mask and face covering and physical distancing for businesses; and (E) Failing to clean and disinfect in accordance with OHA guidance. (3) No disciplinary action or penalty action shall be taken under this rule if the Executive Order alleged to have been violated is not in effect at the time of the alleged violation. (4) Penalties for violating this rule may include, but are not limited to: civil penalties, restrictions on licensure, probation, suspension, and revocation. Any such penalties shall be imposed in accordance with ORS Ch. 183. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.151 History: BP 95-2020, adopt filed 12/23/2020, effective 12/23/2020 BP 10-2020, temporary adopt filed 07/16/2020, effective 07/16/2020 through 01/11/2021
855-007-0090 Emergency Pharmacy Rules (1) Refills: A pharmacist in the area covered by a declared emergency or in an area engaged in disaster assistance may dispense a refill of a prescription drug without a valid prescription provided that: (a) In the pharmacist’s professional judgment, the drug is essential to the maintenance of the patient’s health or the continuation of therapy; and (b) The pharmacist provides no more than a 30-day supply; and (c) The pharmacist records all relevant information and indicates that it is an Emergency Prescription; and (d) The pharmacist informs the patient or the patient’s agent that the drug is being provided without a prescriber’s authorization and that a prescriber authorization is required for any additional refill. (e) If the refill is for a controlled substance, permission has been granted by the DEA for this type of refill, either by waiver of appropriate controlled substance regulations or by notification to the Board. (2) New and modified drug therapy: A pharmacist in the area covered by a declared emergency or in an area engaged in disaster assistance may, after consultation with any authorized prescriber, initiate or modify any drug therapy, and dispense an amount of the drug to meet the patient’s health needs until that patient can be seen by a health-care practitioner, provided that: (a) The pharmacist acts in accordance with currently accepted standards of care; and (b) In the pharmacist’s professional judgment, the drug is essential to the maintenance of the patient’s health or to the continuation of therapy; and (c) The pharmacist records all relevant information to a form and indicates that a drug therapy has been initiated or modified and that this is an Emergency Prescription; and (d) The pharmacist informs the patient or the patient’s agent at the time of dispensing that the drug is being provided in the absence of a valid patient — prescriber relationship but that a prescriber was consulted regarding the appropriateness of the drug therapy; and (e) The pharmacist informs the patient or the patient’s agent that a prescriber authorization is required for any refill. Statutory/Other Authority: ORS 401.065, 433.441 & 689.205 Statutes/Other Implemented: ORS 689.155 History: BP 4-2009, f. & cert. ef. 12-24-09 BP 1-2009, f. & cert. ef. 6-22-09 BP 4-2008(Temp), f. 12-31-08, cert. ef. 1-5-09 thru 7-3-09
855-007-0100 Temporary Pharmacies (1) When these rules are in effect, the Board may issue a Temporary Pharmacy Registration to any facility or mobile facility. (2) A facility, including a mobile pharmacy, holding a Temporary Pharmacy Registration may store and dispense drugs in accordance with the requirements of OAR 855-041 and these rules. The supervising pharmacist of a mobile pharmacy shall notify the Board of the pharmacy location within three working days of commencing business, and within three working days of any change in location. (3) A Temporary Pharmacy Registration automatically expires when the state of emergency ends unless specifically extended by the Board. (4) Within 30 days of the end of the declared emergency, the holder of a Temporary Pharmacy Registration shall notify the Board as to the disposition of its drug inventory and records. (5) A temporary or mobile pharmacy that is established for the sole purpose of expediting distribution of emergency immunizations, antibiotics or antiviral drugs under OAR 855-007-0080, is located adjacent to an existing pharmacy registered with the Board and is under the supervision of the PIC of the existing pharmacy, does not need to be registered as a temporary pharmacy. Statutory/Other Authority: ORS 401.065, 433.441 & 689.205 Statutes/Other Implemented: ORS 689.155 History: BP 4-2009, f. & cert. ef. 12-24-09 BP 1-2009, f. & cert. ef. 6-22-09 BP 4-2008(Temp), f. 12-31-08, cert. ef. 1-5-09 thru 7-3-09
855-007-0110 Emergency Recordkeeping All records initiated during a state of emergency shall be disposed of as follows: (1) POD intake forms and Individual Data Collection Forms or electronic records shall be transferred to OSPHD at the end of the emergency; (2) Community Partner’s Logs: (a) Vaccines: Logs shall be transferred to OSPHD within 14 days of administration to be entered into the statewide immunization information system. If the Community Partner is a registered health-care facility or under the control of a licensed health-care provider, a copy of the log shall be made before submission and retained for three years. (b) Antivirals and other drugs: Logs shall be transferred to OSPHD at the end of the emergency unless the Community Partner is a registered health-care facility or under the control of a licensed health-care provider in which case logs shall be stored securely by the Community Partner; (3) Emergency Prescriptions and Individual Data Collection Forms for drugs dispensed from a pharmacy that is not a Temporary or Mobile Pharmacy shall be stored at the pharmacy. (4) Emergency Prescriptions and Individual Data Collection Forms for drugs dispensed from a Temporary or Mobile Pharmacy shall be stored at whichever of the following locations is most appropriate: (a) At the parent pharmacy that provided the majority of the drugs to the Temporary or Mobile Pharmacy; or (b) At the pharmacy that employs the supervising pharmacist of the Temporary or Mobile Pharmacy; or (c) At the pharmacy that receives the unused drugs from the Temporary or Mobile Pharmacy at the end of the emergency. (5) Unless otherwise specified, all records are to be retained for three years and must be made available to the Board upon request. Statutory/Other Authority: ORS 401.065, 433.441 & 689.205 Statutes/Other Implemented: ORS 689.155 History: BP 4-2009, f. & cert. ef. 12-24-09 BP 1-2009, f. & cert. ef. 6-22-09 BP 4-2008(Temp), f. 12-31-08, cert. ef. 1-5-09 thru 7-3-09
855-007-0120 Damage to a Pharmacy and Drug Integrity (1) If a pharmacy prescription department sustains damage, whether by flood or otherwise, the entire drug inventory, including any prescriptions that are awaiting pickup, is unfit for dispensing, must be classified as adulterated and must be destroyed unless, the drugs are deemed safe for dispensing pursuant to OAR 855-041-1036. Any incident of this nature must be reported to the board within three working days. (2) If a pharmacy loses power that affects temperature or humidity controls such that the proper storage of drugs pursuant to OAR 855-041-1036 has been violated, such drugs must be classified as adulterated and may not be dispensed. (3) Controlled substances damaged, lost or stolen must be documented and reported to the DEA and the board on DEA Form 41, DEA Form 106, or DEA Form 107 as appropriate. (4) A pharmacy that is required to temporarily close or relocate due to an emergency must report this event to the board within three working days. 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 4-2009, f. & cert. ef. 12-24-09 BP 1-2009, f. & cert. ef. 6-22-09 BP 4-2008(Temp), f. 12-31-08, cert. ef. 1-5-09 thru 7-3-09
855-011-0005 Definitions When used in this division of rules: (1) “Health Professionals’ Service Program (the Program)” means the impaired health professional program established by the Oregon Health Authority pursuant to authority granted by ORS 676.190. (2) “Impaired” means that the licensee is unable to practice with professional skill and safety by reason of habitual or excessive use or abuse of drugs, alcohol or other substances that impair ability, or by reason of a mental health disorder. (3) “Mental-health disorder” means a clinically significant behavioral or psychological syndrome or pattern that occurs in an individual and that is associated with present distress or disability or with a significantly increased risk of suffering death, pain, disability, or an important loss of freedom that is identified in the DSM-IV-TR, (published by the American Psychiatric Association). “Mental-health disorder” includes gambling disorders. (4) “Non-treatment compliance monitoring,” means the non-medical, non-therapeutic services employed by the vendor to track and report the licensee’s compliance with the monitoring agreement. (5) "Substance Abuse Disorder" means a disorder related to the taking of a drug of abuse including alcohol, to the side effects of a medication, and to a toxin exposure. The disorders include: substance abuse disorders such as substance dependence and substance abuse, and substance-induced disorders, including substance intoxication, withdrawal, delirium, and dementia, as well as substance induced psychotic disorder, mood disorder, etc, as defined in DSM-IV-TR, (published by the American Psychiatric Association) criteria. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 676.200 History: BP 12-2010, f. & cert. ef. 12-23-10 BP 7-2010(Temp), f. & cert. ef. 6-29-10 thru 12-24-10
855-011-0020 Participation in Health Professional’s Service Program (1) Effective July 1, 2010, the Oregon Board of Pharmacy (Board) will participate in the Program. (2) The Board may only refer licensees of the Board to the Program if they meet the referral criteria established by the Board. (3) The Board may refer a licensee to the Program in lieu of or in addition to public discipline. (4) A licensee who has not been referred to the Program by the Board may participate in the Program as permitted by ORS 676.190. Licensees may not refer themselves to the Program unless they certify that, to the best of their knowledge, they are not currently under investigation by the Board. Statutory/Other Authority: ORS 689.205 & 2013 OL Ch 367 Statutes/Other Implemented: ORS 676.200 & 2013 OL Ch 367 History: BP 2-2014, f. & cert. ef. 1-24-14 BP 12-2010, f. & cert. ef. 12-23-10 BP 7-2010(Temp), f. & cert. ef. 6-29-10 thru 12-24-10
855-011-0030 Procedure to refer Board licensees to the Program (1) When the Board has information that a licensee may be impaired by alcohol or a substance abuse disorder or dependency, or a mental-health disorder, the Board may consider referring the licensee to the Program. (2) Before the Board refers a licensee to the Program, the Board shall: (a) Obtain a copy of a written report that diagnoses the licensee with alcohol or a substance abuse disorder or dependency, or a mental-health disorder and provides treatment options; (b) Investigate to determine whether the licensee’s professional practice while impaired has presented or presents a danger to the public; (c) Obtain the licensee’s written agreement to report any arrest for or conviction of a misdemeanor or felony to the Board within three business days after the licensee is arrested or convicted; (d) Obtain the licensee’s written agreement to pay the costs of participation in the Program, including the cost of laboratory or toxicology tests, treatment, consultation group meetings and evaluations; and (e) Obtain the licensee’s written consent allowing disclosure and exchange of information between the Program, the Board, the monitoring entity, the licensee’s employers, and evaluators and treatment entities. (3) The report referred to in subsection (2)(a) of this rule must be prepared by an independent evaluator approved by the Board under OAR 855-011-0040 to evaluate alcohol or a substance abuse disorder or dependency, and mental-health disorders. (4) The Board may only refer to the Program a licensee who has been diagnosed with alcohol or a substance abuse disorder or dependency, or a mental health disorder. (5) The Board will consider all relevant factors before determining whether to refer a licensee to the Program. Relevant factors shall include but are not limited to: (a) Licensee’s disciplinary history; (b) The severity and duration of the licensee’s impairment; (c) The extent to which licensee’s practice can be limited or managed to eliminate danger to the public; (d) The likelihood that licensee’s impairment can be managed with treatment; and (e) The likelihood that the licensee will follow the conditions of the program. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 676.200 History: BP 12-2010, f. & cert. ef. 12-23-10 BP 7-2010(Temp), f. & cert. ef. 6-29-10 thru 12-24-10
855-011-0040 Approval by the Board of an Independent Evaluator (1) The Board may approve a person to act as an evaluator provided that the person: (a) Is licensed as required by the jurisdiction in which they work; (b) Possesses a master’s degree or a doctorate in a mental health discipline; (c) Can document training and experience in one of the following: (A) US Department of Transportation, Substance Abuse Professional Qualification training; (B) Certification by the National Association of Alcoholism and Drug Abuse Counselors Certification Commission as a Certified Alcohol and Drug Abuse Counselor (CADC) level II or III; or (C) Board certification in Addiction Medicine by either the American Society of Addiction Medicine or American Board of Psychiatry and Neurology. (d) Is able to provide a multi-disciplinary assessment and written report describing a licensee’s diagnosis, degree of impairment and treatment options; and (e) Certifies that, if required, they are willing to defend their evaluation in a court of law. (2) The Board may not approve an evaluator in a case if, in the Board’s judgment, the evaluator’s judgment is likely to be influenced by a personal or professional relationship with a licensee. (3) The Board shall maintain a list of approved independent evaluators on the Board’s website or the Board may approve a list of evaluators that meet the above criteria that is approved and published by the Program contractor. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 676.200 History: BP 12-2010, f. & cert. ef. 12-23-10 BP 7-2010(Temp), f. & cert. ef. 6-29-10 thru 12-24-10
855-011-0050 Additional requirements for licensees referred to the Program (1) In addition to the requirements established by ORS 676.185 to 676.200, a licensee who participates in the Program must: (a) Participate in the Program for as long as specified in the disciplinary order but not less than two years, except that a licensee who has been enrolled in a prior Board approved program for at least two years may count up to one year of that program towards this requirement; (b) Meet all conditions of probation specified in the disciplinary order; and (c) Pay all costs of attendance at non-treatment compliance monitoring group meetings. (2) A licensee may petition the Board for early removal from the Program if: (a) They are in good standing with the Program; (b) They have been in the Program for at least two years; and (c) They have complied with all conditions of their Board disciplinary order. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 676.200 History: BP 12-2010, f. & cert. ef. 12-23-10 BP 7-2010(Temp), f. & cert. ef. 6-29-10 thru 12-24-10
855-035-0007 Sales Sales by drug outlets except itinerant vendors shall be made only from the premises at the location registered by the Board. Statutory/Other Authority: ORS 475.035 & 689.205 Statutes/Other Implemented: ORS 689.305, 689.315 & 689.325 History: PB 1-1996, f. & cert. ef. 4-5-96 PB 1-1992, f. & cert. ef. 1-31-92 1PB 2-1981, f. & ef. 8-20-81
855-035-0010 Minimum Standards for Nonprescription and Medical Gas Drug Outlets (1) Drug outlets shall have floor space and shelving to insure that drugs are stocked and stored in sanitary, well-lighted areas. Where applicable, temperature, ventilation and moisture controls shall be employed. (2) Expiration dates on drug outlet drugs shall be the responsibility of each drug outlet to insure products are in date. (3) There shall be no advertisements of any kind by a drug outlet using the following or similar terms: “drug store,” “pharmacy,” “apothecary.” Statutory/Other Authority: ORS 475.035 & 689.205 Statutes/Other Implemented: ORS 689.305 & 689.325 History: PB 1-1996, f. & cert. ef. 4-5-96 PB 1-1992, f. & cert. ef. 1-31-92 1PB 2-1980, f. & ef. 4-3-80 1PB 2-1979(Temp), f. & ef. 10-3-79
855-035-0015 Change of Business Name, Closure (1) Any change of business name of a drug outlet must be reported to the Board within 15 days by filing a new application for which no fee is required. New certificates of registration will be issued at the next regular renewal period. (2) Any closure of a drug outlet shall be reported to the Board within 15 days. Statutory/Other Authority: ORS 475.035 & 689.205 Statutes/Other Implemented: ORS 689.325 History: PB 1-1996, f. & cert. ef. 4-5-96 1PB 2-1980, f. & ef. 4-3-80 1PB 2-1979(Temp), f. & ef. 10-3-79
855-035-0020 Sales of Non-Prescription Drugs Registered nonprescription drug outlets may sell or donate non-prescription drugs in the original and unbroken packages only, properly labeled according to state and federal law, in conformity with rules of the Board. A nonprescription drug outlet shall not purchase or receive nonprescription drugs from a source not registered with the Board. Statutory/Other Authority: ORS 475.035 & 689.205 Statutes/Other Implemented: ORS 689.135 & 689.305 689.315 History: BP 2-2008, f. & cert. ef. 2-20-08 PB 1-1996, f. & cert. ef. 4-5-96 PB 1-1992, f. & cert. ef. 1-31-92 1PB 2-1980, f. & ef. 4-3-80 1PB 2-1979(Temp), f. & ef. 10-3-79
855-035-0023 Disposal of Drugs Drugs that are outdated, damaged, deteriorated, misbranded, or adulterated shall be quarantined and physically separated from other drugs until they are destroyed or returned to their supplier. Statutory/Other Authority: ORS 475.035, 689.155, 689.205, 689.305 & 689.315 History: PB 1-1992, f. & cert. ef. 1-31-92 1PB 2-1984, f. & ef. 3-7-84
855-035-0025 Seasonal Nonprescription Drug Outlets (1) Seasonal nonprescription drug outlets are defined as those outlets who either by location or weather are restricted to a seasonal demand for services. (2) Seasonal nonprescription drug outlets shall be exempt from delinquent fees for nonprescription registration if renewals are paid no later than June 1 of current year. Statutory/Other Authority: ORS 475.035 & 689.205 Statutes/Other Implemented: ORS 689.325 History: PB 1-1996, f. & cert. ef. 4-5-96 PB 1-1992, f. & cert. ef. 1-31-92 1PB 2-1981, f. & ef. 8-20-81 1PB 1-1981(Temp), f. & ef. 4-1-81
855-035-0030 Medical Device, Equipment and Gas (MDEG) Outlet (Class C) (1) Medical Device, Equipment and Gas (MDEG) Outlets may sell: (a) Nonprescription drugs; (b) Specific drugs and materials that require the order or prescription of a practitioner: (A) USP Oxygen; (B) USP Sodium Chloride Irrigation; (C) USP Sodium Chloride Injection; (D) Sterile water for irrigation; (E) Urological catheters; and (F) Respiratory devices. (2) Medicinal Gas Drug Outlets shall distribute medicinal Nitrous Oxide only to practitioners or institutional drug outlets. (3) Record keeping: All records of receipt and distribution of medical devices, equipment, and gas must be maintained for a minimum of three years and must be readily retrievable. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.305 History: BP 1-2002, f. & cert. ef. 1-8-02 PB 1-1996, f. & cert. ef. 4-5-96 PB 1-1992, f. & cert. ef. 1-31-92
855-041-1001 Definitions “Drug room” is a drug storage area registered with the board which is secure and lockable. Statutory/Other Authority: ORS 689.205 & ORS 689.522 Statutes/Other Implemented: ORS 689.155 & ORS 689.522 History: BP 15-2022, amend filed 04/20/2022, effective 04/20/2022 BP 45-2021, amend filed 12/16/2021, effective 12/16/2021 BP 1-2017, f. & cert. ef. 2-23-17 BP 2-2014, f. & cert. ef. 1-24-14