justicedao/ipfs_state_laws huggingface dataset:
855-041-1125 Prescription Expiration This section of rule addresses the expiration date of the prescription and not the expiration date of the drug. (1) After one year from date of issue, a prescription for a non-controlled substance becomes invalid and must be re-authorized by the prescriber. (2) When used alone as a prescription refill designation the abbreviation, "PRN" for a non-controlled substance means that the medication can be refilled in proper context for a period of one year. (a) When this abbreviation is used alone as a means to authorize refills for a controlled substance, the medication can be refilled in proper context for a period of six months or five refills, whichever comes first. (b) When this abbreviation is used in conjunction with a definite time period, or a specific number of refills, the non-controlled medication can be refilled in proper context for a period not to exceed one year. (3) The prescription shall not be refilled out of context with the approximate dosage schedule unless specifically authorized by the prescriber. (4) A "non-controlled substance" means those drugs defined as "legend" pursuant to ORS 689.005 but does not include those drugs or substances controlled under the jurisdiction of the United States Department of Justice Drug Enforcement Administration. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.505 & 689.515 History: BP 47-2024, minor correction filed 04/11/2024, effective 04/11/2024 Renumbered from 855-041-0065, BP 7-2012, f. & cert. ef. 12-17-12 BP 12-2010, f. & cert. ef. 12-23-10 BP 1-2003, f. & cert. ef. 1-14-03 BP 1-2002, f. & cert. ef. 1-8-02 BP 6-2000, f. & cert. ef. 6-29-00 BP 3-2000, f. & cert. ef. 2-16-00 BP 2-2000, f. & cert. ef. 2-16-00 Reverted to BP 2-1998, f. & cert. ef. 3-23-98 BP 2-1999(Temp), f. & cert. ef. 8-9-99 thru 1-17-00 BP 2-1998, f. & cert. ef. 3-23-98 BP 1-1998(Temp), f. & cert. ef. 1-27-98 thru 5-4-98 PB 3-1997(Temp), f. & cert. ef. 11-12-97 PB 1-1996, f. & cert. ef. 4-5-96 PB 1-1995, f. & cert. ef. 4-27-95 PB 4-1992, f. & cert. ef. 8-25-92 PB 1-1992, f. & cert. ef. 1-31-92 (and corrected 2-7-92) PB 4-1991, f. & cert. ef. 9-19-91 PB 1-1991, f. & cert. ef. 1-24-91 PB 10-1989, f. & cert. ef. 7-20-89 PB 8-1987, f. & ef. 9-30-87 1PB 1-1986, f. & ef. 6-5-86 1PB 3-1984, f. & ef. 4-16-84 1PB 2-1980, f. & ef. 4-3-80 1PB 2-1979(Temp), f. & ef. 10-3-79
855-041-1130 Retail Drug Outlet Pharmacy Prescription Labeling Except as described in SB 450 (2023), prescriptions must be labeled with the following information: (1) Name, address and telephone number of the pharmacy; (2) Date of fill; (3) Identifying number; (4) Name of patient; (5) Name of drug, strength, and quantity dispensed; when a generic name is used, the label must also contain the identifier of the manufacturer or distributor; (6) Directions for use by the patient; (7) Name of practitioner; (8) Required precautionary information regarding controlled substances; (9) Such other and further accessory cautionary information as required for patient safety; (10) An expiration date after which the patient should not use the drug or medicine. Expiration dates on prescriptions must not exceed: (a) That on the manufacturer’s container if dispensed in the manufacturer’s container; or (b) The earliest date of either: (A) The manufacturer’s expiration date; or (B) One year from the date the drug was repackaged and dispensed. (11) Any drug expiring before the expected length of time for the course of therapy must not be dispensed. (12) Any dispensed prescription medication, other than those in unit dose or unit of use packaging, must be labeled with its physical description, including any identification code that may appear on tablets and capsules. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.505, ORS 689.515 & 2023 SB 450 History: BP 27-2023, amend filed 10/16/2023, effective 10/17/2023 BP 49-2022, amend filed 12/20/2022, effective 12/21/2022 BP 45-2022, temporary amend filed 10/17/2022, effective 10/17/2022 through 04/14/2023 BP 45-2021, amend filed 12/16/2021, effective 12/16/2021 Renumbered from 855-041-0065, BP 7-2012, f. & cert. ef. 12-17-12 BP 12-2010, f. & cert. ef. 12-23-10 BP 1-2003, f. & cert. ef. 1-14-03 BP 1-2002, f. & cert. ef. 1-8-02 BP 6-2000, f. & cert. ef. 6-29-00 BP 3-2000, f. & cert. ef. 2-16-00 BP 2-2000, f. & cert. ef. 2-16-00 Reverted to BP 2-1998, f. & cert. ef. 3-23-98 BP 2-1999(Temp), f. & cert. ef. 8-9-99 thru 1-17-00 BP 2-1998, f. & cert. ef. 3-23-98 BP 1-1998(Temp), f. & cert. ef. 1-27-98 thru 5-4-98 PB 3-1997(Temp), f. & cert. ef. 11-12-97 PB 1-1996, f. & cert. ef. 4-5-96 PB 1-1995, f. & cert. ef. 4-27-95 PB 4-1992, f. & cert. ef. 8-25-92 PB 1-1992, f. & cert. ef. 1-31-92 (and corrected 2-7-92) PB 4-1991, f. & cert. ef. 9-19-91 PB 1-1991, f. & cert. ef. 1-24-91 PB 10-1989, f. & cert. ef. 7-20-89 PB 8-1987, f. & ef. 9-30-87 1PB 1-1986, f. & ef. 6-5-86 1PB 3-1984, f. & ef. 4-16-84 1PB 2-1980, f. & ef. 4-3-80 1PB 2-1979(Temp), f. & ef. 10-3-79
855-041-1131 Prescription Reader Accessibility A pharmacy shall notify each person to whom a prescription drug is dispensed that a prescription reader is available to the person upon request; a prescription reader is a device designed to audibly convey labeling information. A pharmacy that provides a prescription reader shall make it available to the person for at least the duration of the prescription, shall confirm it is appropriate to address the person’s visual impairment, and shall ensure that prescription labels are compatible with the prescription reader. This requirement does not apply to an institutional drug outlet, dispensing a drug intended for administration by a healthcare provider. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.561 History: BP 8-2020, adopt filed 06/22/2020, effective 06/23/2020 BP 8-2019, temporary adopt filed 12/17/2019, effective 01/01/2020 through 06/28/2020
855-041-1132 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. Statutory/Other Authority: ORS 689.564 Statutes/Other Implemented: ORS 689.205 History: BP 99-2020, adopt filed 12/23/2020, effective 01/01/2021
855-041-1133 Dispensing: Interpretation (1) Except as provided in subsection (2) of this section, a Pharmacist or Intern must work with a health care interpreter from the health care interpreter registry administered by the Oregon Health Authority under ORS 413.558 when communicating with a patient who prefers to communicate in a language other than English or who communicates in signed language, unless the Pharmacist is proficient in the preferred language of the person with limited English proficiency. The Pharmacist or drug outlet may not charge for these services. (2) A Pharmacist or Intern who is otherwise required to work with a health care interpreter from the health care interpreter registry may work with a health care interpreter who is not listed on the health care interpreter registry only if the Pharmacist or Intern: (a) Verifies that the Pharmacist or Intern has made a good faith effort needed to obtain a health care interpreter from the health care interpreter registry in accordance with rules adopted by the authority under ORS 413.558 and has found that none are available to provide interpretation; or (b) Has offered the patient the services of a health care interpreter from the health care interpreter registry and the patient declined the offer and chose a different interpreter. (3) A Pharmacist or Intern must provide personal protective equipment, consistent with established national standards, to health care interpreters providing services on-site at no cost to the health care interpreter and may not suggest to the health care interpreter that the health care interpreter should procure the health care interpreter’s own personal protective equipment as a condition of working with the Pharmacist or Intern. (4) A Pharmacist or Intern must maintain records of: (a) Each patient encounter in which the Pharmacist or Intern worked with a health care interpreter from the health care interpreter registry; or (b) Each good faith effort to utilize a health care interpreter from the health care registry for each patient encounter in which the Pharmacist or Intern worked with an interpreter not on the health care interpreter registry and met one of the exceptions in (2) of this rule. (5) The records required in (4) must include: (a) The full name of the health care interpreter; (b) The health care interpreter’s registry number, if applicable; and (c) The language interpreted. (6) Pharmacists, Interns, Certified Oregon Pharmacy Technicians, Pharmacy Technicians and Pharmacies are required to comply with ORS 413.559. Statutory/Other Authority: ORS 689.205 & 2021 HB 2359 Statutes/Other Implemented: ORS 689.155 & 2021 HB 2359 History: BP 29-2022, adopt filed 06/15/2022, effective 09/01/2022
855-041-1135 Defines Labeling and Container Requirements for Repackage Drugs (1) Drugs prepackaged by a pharmacy for later own use dispensing on prescription shall be in a container meeting USP standards and labeled to identify at a minimum: (a) Brand name, or generic name and manufacturer; (b) Strength; (c) Lot number; (d) Manufacturer’s expiration date, or any earlier date which, in the pharmacist’s professional judgment, is preferable. (2) An internal control number which references manufacturer and lot number may be utilized. Statutory/Other Authority: ORS 689 History: Renumbered from 855-041-0056, BP 7-2012, f. & cert. ef. 12-17-12 PB 6-1987, f. & ef. 5-1-87
855-041-1145 New Containers Each pharmacy must dispense a drug in a new container that complies with the current provisions of the Poison Prevention Packaging Act in 16 CFR 1700 (v. 01/01/2024), 16 CFR 1701 (v. 01/01/2024), and 16 CFR 1702 (v. 01/01/2024). [Publications: Publications referenced are available for review at the agency.] Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 History: BP 3-2025, amend filed 06/16/2025, effective 06/16/2025 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 Renumbered from 855-041-0055, BP 7-2012, f. & cert. ef. 12-17-12 1PB 2-1980, f. & ef. 4-3-80 1PB 2-1979(Temp), f. & ef. 10-3-79
855-041-1160 Records (1) Definitions. The following definitions apply to this rule: (a) An "original prescription" is a prescription maintained in the same physical manner in which a pharmacy first receives the prescription. For example, for a prescription received by the pharmacy in writing on a prescription form, the original prescription consists of the original writing on the prescription form. For a prescription received by the pharmacy orally over the telephone, the original consists of the writing or electronic record that reflects receipt of the oral prescription. (b) "Filing" and "file" mean the storage of the original prescription in such a manner that the original prescription is safeguarded and readily retrievable. (2) Every pharmacy and pharmacist-in-charge of a pharmacy must ensure that original prescriptions are properly filed in compliance with this rule. (3) After 120 days, the paper prescription may be destroyed and filed in an electronic form if: (a) The electronic form shows the exact and legible image of the original prescription; (b) Notes of clarifications of and changes to the prescription are directly associated with the electronic form of the prescriptions; and (c) The prescription is not for a controlled substance. (4) This rule is not intended to alter or supersede the recordkeeping requirements of any other federal or Oregon statute or rule, including but not limited to ORS 689.508, OAR 855-041-1120, and rules related to records for prescriptions for controlled substances. (5) All records and documents required by ORS 475, ORS 689, and OAR 855: (a) Must be stored on-site for 12 months and must be provided to the board immediately upon request. (b) May be stored in a secured off-site location after 12 months of on-site storage and must be provided to the board upon request within three business days; and (c) May be in written, or electronic format. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.151, ORS 689.155 & ORS 689.508 History: BP 14-2021, amend filed 06/15/2021, effective 06/15/2021 Renumbered from 855-041-0060, BP 7-2012, f. & cert. ef. 12-17-12 BP 2-2008, f. & cert. ef. 2-20-08 BP 3-2005, f. & cert. ef. 4-14-05 PB 1-1994, f. & cert. ef. 2-2-94 1PB 2-1980, f. & ef. 4-3-80 1PB 2-1979(Temp), f. & ef. 10-3-79
855-041-1165 Patient Medical Record A patient record system must be maintained by pharmacies for all patients for whom prescription drug orders are dispensed. The patient record system must provide for readily retrievable information necessary for the dispensing Pharmacist to identify previously dispensed drugs at the time a prescription drug order is presented for dispensing. The Pharmacist must make a reasonable effort to obtain, record, and maintain the following information: (1) Full name of the patient for whom the drug is intended; (2) Address and telephone number of the patient; (3) Patient's date of birth; (4) Patient's gender; (5) Patient’s preferred language for communication and prescription labeling; (6) Chronic medical conditions; (7) A list of all prescription drug orders obtained by the patient at the pharmacy maintaining the patient record showing the name of the drug or device, prescription number, name and strength of the drug, the quantity and date received, and the name of the prescriber; (8) Known allergies, drug reactions, and drug idiosyncrasies; and (9) If deemed relevant in the Pharmacist's reasonable professional judgment: (a) Pharmacist comments relevant to the individual's drug therapy, including any other information peculiar to the specific patient or drug; and (b) Additional information such as chronic conditions or disease states of the patient, the patient's current weight, and the identity of any other drugs, including over-the-counter drugs, or devices currently being used by the patient which may relate to prospective drug review. Statutory/Other Authority: ORS 689.205 & 2021 HB 2359 Statutes/Other Implemented: ORS 689.151, ORS 689.155, ORS 689.508 & 2021 HB 2359 History: BP 42-2022, minor correction filed 07/20/2022, effective 07/20/2022 BP 29-2022, amend filed 06/15/2022, effective 09/01/2022 Renumbered from 855-041-0060, BP 7-2012, f. & cert. ef. 12-17-12 BP 2-2008, f. & cert. ef. 2-20-08 BP 3-2005, f. & cert. ef. 4-14-05 PB 1-1994, f. & cert. ef. 2-2-94 1PB 2-1980, f. & ef. 4-3-80 1PB 2-1979(Temp), f. & ef. 10-3-79
855-041-1167 Patients Access to Pharmacy Records (1) Licensees and registrants of the board must make protected health information in the pharmacy record available to the patient or the patient’s representative upon their request, to inspect and obtain a copy of protected health information about the individual, except as provided by law and this rule. The patient may request all or part of the record. A summary may substitute for the actual record only if the patient agrees to the substitution. Board licensees and registrants are encouraged to use the written authorization form provided by ORS 192.566. (2) For the purpose of this rule, “health information in the pharmacy record” means any oral, written or electronic information in any form or medium that is created or received and relates to: (a) The past, present, or future physical or mental health of the patient. (b) The provision of healthcare to the patient. (c) The past, present, or future payment for the provision of healthcare to the patient. (3) Upon request, the entire health information record in the possession of the board licensee will be provided to the patient. This includes records from other healthcare providers. Information which may be withheld includes: (a) Information which was obtained from someone other than a healthcare provider under a promise of confidentiality and access to the information would likely reveal the source of the information; (b) Psychotherapy notes; (c) Information compiled in reasonable anticipation of, or for use in, a civil, criminal, or administrative action or proceeding; and (d) Other reasons specified by federal regulation. (4) Registrants who have permanently closed must notify patients according to OAR 855-041-1092. (5) A reasonable cost may be imposed for the costs incurred in complying with the patient’s request for health information pursuant to ORS 192.563. (6) A patient may not be denied summaries or copies of pharmacy records because of inability to pay. (7) Requests for pharmacy records must be complied with within a reasonable amount of time not to exceed 30 days from the receipt of the request. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 192.553, ORS 192.556, ORS 192.558, ORS 192.563 & ORS 192.566 History: BP 32-2022, adopt filed 06/15/2022, effective 06/16/2022
855-041-1170 Outlet (RP & IP): Grounds for Discipline The State Board of Pharmacy may impose one or more of the following penalties which includes: suspend, revoke, or restrict the license of an outlet or may impose a civil penalty upon the outlet upon the following grounds: (1) Unprofessional conduct as defined in OAR 855-006-0020; (2) Advertising or soliciting that may jeopardize the health, safety, or welfare of the patient including, but not be limited to, advertising or soliciting that: (a) Is false, fraudulent, deceptive, or misleading; or (b) Makes any claim regarding a professional service or product or the cost or price thereof which cannot be substantiated by the licensee. (3) Failing to provide a working environment that protects the health, safety and welfare of a patient as required in OAR 855-041-1010. (4) Incentivizing or inducing the transfer of a prescription. (5) Overriding or interfering with the Pharmacist-on-duty’s control of all aspects of the practice of pharmacy. (6) Any other grounds found in ORS 689.405 or ORS 689.490. Statutory/Other Authority: ORS 689.151, ORS 689.155, ORS 689.205 & ORS 689.225 Statutes/Other Implemented: ORS 689.155 History: BP 7-2023, amend filed 02/14/2023, effective 02/14/2023 BP 1-2019, minor correction filed 01/22/2019, effective 01/22/2019 Renumbered from 855-041-0016, BP 7-2012, f. & cert. ef. 12-17-12 BP 2-2012, f. & cert. ef 6-12-12
855-041-1190 Operation of a Laboratory in Drug Outlet Pharmacy (1) A Drug Outlet pharmacy may perform a laboratory test when: (a) The Drug Outlet pharmacy possesses a valid laboratory license, including a certificate of a 42 CFR 493.35 waiver; (b) The laboratory test is permitted under the laboratory license; and (c) Requested by a physician, dentist, pharmacist or other person authorized by law to use the findings of laboratory examinations or without a practitioner order as permitted in ORS 438.010, ORS 438.030, ORS 438.040, ORS 438.050, ORS 438.055, ORS 438.060, ORS 438.070, ORS 438.110, ORS 438.120, ORS 438.130, ORS 438.140, ORS 438.150, ORS 438.160, ORS 438.210, ORS 438.220, ORS 438.310, ORS 438.320, ORS 438.420, ORS 438.430, ORS 438.435, ORS 438.440, ORS 438.450, 438.510. (2) The Drug Outlet pharmacy must: (a) Display the laboratory license in a prominent place in view of the public; and (b) Report, to the local health department or state, reportable conditions as required in OAR 333-018. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.661 History: BP 34-2023, adopt filed 12/19/2023, effective 03/01/2024
855-041-2100 Operation of a Double Set-Up Pharmacy in a Retail Drug Outlet A double set-up is an establishment having both a retail drug outlet registration and a nonprescription drug outlet registration. In a double set-up: (1) The retail drug outlet (pharmacy) must be a separate operation, completely contained by an enclosure which assures safe storage. This enclosure must be from floor to ceiling or be at least ten feet from the floor. This area is to be easily distinguished by the public. When the retail drug outlet (pharmacy department) is closed, then as a nonprescription drug outlet the establishment is subject to the provisions of OAR 855-035-0005 and 855-035-0020. (2) When a pharmacist is not in attendance, a closed sign shall be posted at the entrances stating the hours of the pharmacy's operation. All entrances to the retail drug outlet shall be closed off and securely locked. Any keys to the retail drug outlet (pharmacy) shall remain in the possession of the pharmacist-in-charge and other employee pharmacists as authorized by the pharmacist-in-charge if the retail drug outlet (pharmacy) is closed while the nonprescription outlet (shopkeeper) remains open. (3) Any system deviating from the requirement of this section, except as provided in OAR 855-041- 6310, shall be approved by the Board prior to implementation. Requests for such approval shall be in writing and provide a detailed description of the proposed system. A written description of such system, as approved by the Board, shall be maintained in the pharmacy. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.205 History: Renumbered from 855-041-0035, BP 7-2012, f. & cert. ef. 12-17-12 PB 1-1989, f. & cert. ef. 1-3-89 1PB 2-1980, f. & ef. 4-3-80 1PB 2-1979(Temp), f. & ef. 10-3-79
855-041-2115 Prescription: Transfers (1) Prescriptions may be transferred between pharmacies for the purpose of an initial or refill dispensing provided that: (a) The prescription is invalidated at the sending pharmacy; and (b) The receiving pharmacy obtains all the information constituting the prescription and its relevant refill history in a manner that ensures accuracy and accountability. (2) Prescriptions for controlled substances can only be transferred one time unless otherwise permitted or forbidden by federal regulation. (3) A pharmacy that transmits or receives prescription information to or from another pharmacy electronically must ensure as appropriate: (a) The accurate transfer of prescription information between pharmacies; (b) The creation of an original prescription or image of an original prescription containing all the information constituting the prescription and its relevant refill history in a manner that ensures accuracy and accountability and that the pharmacist will use in verifying the prescription; (c) The prescription is invalidated at the sending pharmacy; and (d) For controlled substances, complies with the rules adopted by reference in OAR 855-080. (4) An Oregon registered pharmacy must transfer a prescription: (a) To a pharmacy requesting a transfer on behalf of the patient or patient’s agent unless the transfer would compromise patient safety or violate state or federal laws or rules; and (b) By the end of the next business day of the request. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 History: BP 34-2023, amend filed 12/19/2023, effective 03/01/2024 BP 32-2022, amend filed 06/15/2022, effective 06/16/2022 Renumbered from 855-041-0075, BP 7-2012, f. & cert. ef. 12-17-12 BP 6-2000, f. & cert. ef. 6-29-00 BP 2-1998, f. & cert. ef. 3-23-98 PB 1-1992, f. & cert. ef. 1-31-92 (and corrected 2-7-92) PB 2-1990, f. & cert. ef. 2-9-90 1PB 1-1986, f. & ef. 6-5-86 1PB 3-1982, f. & ef. 3-8-82 1PB 2-1980, f. & ef. 4-3-80 1PB 2-1979(Temp), f. & ef. 10-3-79