justicedao/ipfs_state_laws huggingface dataset:
836-200-0555 Assessments Against Prescription Drug Manufacturers for 2023 and prior (1) Once annually, no later than October 1, all reporting manufacturers will pay an assessment of $400. The director may by order reduce the fees assessed for any specific year. (2) Once annually, no later than October 1, reporting manufacturers that have filed one or more reports under OAR 836-200-0515 to 836-200-0532 between August 1 of the previous year and July 31 of the current year must pay an additional assessment for each report filed. (3) For the purposes of section (2), the director shall determine the amount of the assessment by subtracting the revenue collected under section (1) from the amount of revenue needed to cover the department's estimated expenses in administering ORS 646A.689 and OAR 836-200-0500 to 836-200-0550, and dividing the resulting amount by the total number of filings subject to assessment between August 1 of the previous year and July 31 of the current year. The director shall determine the amount of revenue needed by considering the legislatively approved expenditures for administration of ORS 646A.689 and OAR 836-200-0500 to 836-200-0555, as well as the timing of cash revenues and expenditures. (4) The revenue collected under sections (1) and (2) of this rule must be used solely for expenses incurred in the administration of ORS 646A.689 and OAR 836-200-0500 to 836-200-0555. (5) A manufacturer must pay each assessment imposed under this rule no later than 30 days after the date of the assessment by the department. A manufacturer must pay interest at nine percent per annum on any assessment that is not paid when due. (6) Reporting manufacturers shall be subject to the assessment requirements set forth in sections (1) to (5) of this rule for billing periods through July 31, 2023. For billing periods on or after August 1, 2023, reporting manufacturers shall be subject to the annual fee set forth in OAR 836-200-0553. Statutory/Other Authority: ORS 646A.689 Statutes/Other Implemented: ORS 646A.689 History: ID 2-2025, amend filed 03/26/2025, effective 04/01/2025 ID 14-2024, amend filed 07/31/2024, effective 08/01/2024 ID 2-2024, minor correction filed 03/20/2024, effective 03/20/2024 ID 1-2020, amend filed 01/29/2020, effective 02/01/2020 ID 2-2019, adopt filed 02/26/2019, effective 03/01/2019
836-200-0560 Civil Penalties (1) The director may impose civil penalties on reporting manufacturers for violations of ORS 646A.689 or OAR 836-200-0500 to 836-200-0560 including the following: (a) Failing to provide required information, or providing inaccurate or incomplete information; (b) Failing to respond in a timely manner to a written request by the department for additional information; or (c) Failing to submit timely required reports. (2) For a reporting manufacturer’s first violation of ORS 646A.689 or OAR 836-200-0500 to 836-200-0560, the civil penalties imposed under this section will adhere to the following schedule: (a) For failing to provide required information or providing inaccurate or incomplete information, and for each missing, inaccurate or incomplete data element. No greater than $500 per day of violation for the first 30 days, and no greater than $1,000 per day of violation thereafter. (b) For failing to respond in a timely manner to a written request by the department for additional information. No greater than $1,500 per day of violation for the first 30 days, and no greater than $3,000 per day of violation thereafter. (c) For failing to submit timely required reports. No greater than $2,500 per day of violation for the first 30 days, and no greater than $5,000 per day of violation thereafter. (3) For reporting manufacturers that have previously violated ORS 646A.689 or OAR 836-200-0500 to 836-200-0560, the civil penalties imposed under this section will adhere to the following schedule: (a) For failing to provide required information or providing inaccurate or incomplete information, and for each missing, inaccurate or incomplete data element. No greater than $1,000 per day of violation. (b) For failing to respond in a timely manner to a written request by the department for additional information. No greater than $3,000 per day of violation. (c) For failing to submit timely required reports. No greater than $5,000 per day of violation. (4) For any other violation, including any violation constituting a breach of the good faith expectations specified in OAR 836-200-0525, any violation committed with intent to obstruct the department’s administration of ORS 646A.689 or OAR 836-200-0500 to 836-200-0560, or any violation committed with intent to engage in conduct injurious to the public, the civil penalty imposed under this section will be no greater than $10,000 per day of violation. Statutory/Other Authority: ORS 646A.689 & 646A.692 Statutes/Other Implemented: ORS 646A.689 & 646A.692 History: ID 2-2025, amend filed 03/26/2025, effective 04/01/2025 ID 2-2019, adopt filed 02/26/2019, effective 03/01/2019
836-200-0600 Purpose and Statutory Authority The purpose of OAR 836-200-0600 to 836-200-0670 is to administer the licensure of pharmaceutical representatives doing business in the state of Oregon pursuant to Oregon Laws 2021, chapter 593. Statutory/Other Authority: ORS 731.244 & Or Laws 2021, ch 593 Statutes/Other Implemented: Or Laws 2021, ch 593 History: ID 2-2022, adopt filed 06/16/2022, effective 06/17/2022 ID 13-2021, temporary adopt filed 12/20/2021, effective 12/20/2021 through 06/17/2022
836-200-0605 Definitions For the purposes of OAR 836-200-0600 to 836-200-0670 the following definitions apply, unless the context requires otherwise: (1) The “department” means the Oregon Department of Consumer and Business Services. (2) “Pharmaceutical product” means a medication approved for human use by the federal Food and Drug Administration that may be legally dispensed only with a valid prescription from a health care provider. (3) “Pharmaceutical representative” means a person that markets or promotes pharmaceutical products to health care providers. (4) “License” means a license issued to a pharmaceutical representative by the department pursuant to OAR 836-200-0600 to 836-200-0670. (5) “Licensee” means a person that holds a valid and unexpired license issued under this section. (6) “Calendar year” means each successive period of 12 calendar months commencing on January 1 and ending on December 31. (7) “Material change in a licensee’s business operations” means any change in the following information: (a) A change in the business activity in which the licensee engages; (b) Termination for cause from any employer or company that the licensee represents; (c) Any complaints made to the licensee, the licensee’s employer, or a company that the licensee represents regarding the licensee’s activities conducted under a license issued under these rules. (8) “Monetary value,” for the purposes of describing the value of drug samples for reports made pursuant to OAR 836-200-0620(3)(e), means the monetary value of an equivalent volume or quantity of the prescription drug estimated using the WAC price for the most comparable NDC. (9) “In writing” means through NIPR as allowed or by electronic mail. (10) “Gift” means anything of economic value given to, or for the personal benefit of, a health care provider without consideration of equivalent or market value. Statutory/Other Authority: ORS 731.244 & Or Laws 2021, ch 593 Statutes/Other Implemented: Or Laws 2021, ch 593 History: ID 2-2022, adopt filed 06/16/2022, effective 06/17/2022 ID 13-2021, temporary adopt filed 12/20/2021, effective 12/20/2021 through 06/17/2022
836-200-0610 License Required (1) A pharmaceutical representative who does business with health care professionals located within the state of Oregon must acquire a license from the department prior to doing business in the state on 15 or more days in a calendar year. (2) A license issued pursuant to these rules is valid until the end of the calendar year in which the license was issued. (3) A license issued pursuant to these rules is not transferable. (4) A pharmaceutical representative must show their license or an exact copy of it when a health care provider asks to see it. An exact copy may include a legible reproduction, such as a photocopy or an image saved or produced on an electronic device. Statutory/Other Authority: ORS 731.244 & Or Laws 2021, ch 593 Statutes/Other Implemented: Or Laws 2021, ch 593 History: ID 2-2022, adopt filed 06/16/2022, effective 06/17/2022 ID 13-2021, temporary adopt filed 12/20/2021, effective 12/20/2021 through 06/17/2022
836-200-0620 Licensee Reporting Requirements (1) A licensee must report to the department in writing, in a form specified by the department, any changes to the information submitted in an initial license application submitted pursuant to OAR 836-200-0615(1) or a renewal application submitted pursuant to OAR 836-200-0615(2), including any material changes made in the licensee’s business operations, as defined in OAR 836-200-0605(7). (2) A licensee must report the information regarding contacts specified in subsection (3) of this rule no later than April 1, 2023, and each year thereafter. (3) The report described in subsection (2) of this rule must contain the following information in a form specified by the department: (a) A list of health care providers within this state that the licensee contacted during the preceding calendar year; (b) The number of times the licensee contacted each health care provider during the preceding calendar year; (c) The location and duration of the licensee’s contact with each health care provider; (d) Which pharmaceutical products the licensee promoted; (e) Whether the licensee provided the health care provider with any product samples, materials or gifts, and, if so, the monetary value of the samples, materials or gifts; and (f) Whether and how the licensee otherwise compensated the health care provider for contact with the licensee. Statutory/Other Authority: ORS 731.244 & Or Laws 2021, ch 593 Statutes/Other Implemented: Or Laws 2021, ch 593 History: ID 2-2022, adopt filed 06/16/2022, effective 06/17/2022
836-200-0625 Prohibited Conduct for Licensees A licensee may not: (1) Engage in any deceptive or misleading marketing of a pharmaceutical product, including knowingly concealing, suppressing, omitting, misrepresenting, or misstating material facts concerning or related to a pharmaceutical product; (2) Use a title or designation that could reasonably lead a health care provider or an employee of a health care provider to believe that the licensee is a health care provider if the licensee is not licensed as a health care provider or otherwise authorized to provide health care services; (3) Attend an examination of a patient without the patient’s consent; or (4) Make or file, or cause to be made or filed, to or with the director of the Department of Consumer and Business Services, any statement, report or document which is known to be false in any material respect or matter. Statutory/Other Authority: ORS 731.244 & Or Laws 2021, ch 593 Statutes/Other Implemented: Or Laws 2021, ch 593 History: ID 2-2022, adopt filed 06/16/2022, effective 06/17/2022 ID 13-2021, temporary adopt filed 12/20/2021, effective 12/20/2021 through 06/17/2022
836-200-0630 Civil Penalties and License Revocation The department may impose civil penalties on licensees, or to unlicensed pharmaceutical representatives under subsection (1)(c) of this rule, for violations of Oregon Laws 2021, chapter 593 and OAR 836-200-0600 to 836-200-0670, including but not limited to the following: (1) Engaging in any of the prohibited conduct described in OAR 836-200-0625; (2) Failure to timely report any of the information described OAR 836-200-0620; (3) Engaging in business as a pharmaceutical representative in the state of Oregon for 15 or more days without first obtaining a license from the department. Statutory/Other Authority: ORS 731.244 & Or Laws 2021, ch 593 Statutes/Other Implemented: Or Laws 2021, ch 593 History: ID 2-2022, adopt filed 06/16/2022, effective 06/17/2022 ID 13-2021, temporary adopt filed 12/20/2021, effective 12/20/2021 through 06/17/2022
836-200-0635 Education Requirements (1) Education requirements for initial licensure. In order to satisfy the education requirement for an initial pharmaceutical representative license, applicants must complete a course of education of at least 10 hours. The education program must be approved by the department under OAR 836-200-0635 to 836-200-0670.The coursework must cover at least the following topics, and may also include any of the topics described in subsection (2)(a) of this rule: (a) The comparative clinical effectiveness of pharmaceutical products, evidence based medicine, or basic pharmacology; (b) The comparative cost effectiveness of pharmaceutical products, or pharmoeconomics; and (c) Legal and ethical issues related to promoting pharmaceutical products to healthcare professionals, or professional ethics generally. (2) Education requirement for license renewal. In order to renew a pharmaceutical representative license, applicants must complete at least five hours of education. By applying for renewal, an applicant is affirming that they have completed five hours of education during the preceding 12 months. The education must be approved by the department under OAR 836-200-0635 to 836-200-0670. Education coursework under this section must be in one or more of the following subject areas: (a) General medical and pharmaceutical terminology and abbreviations; (b) Food and Drug Administration laws and regulations pertaining to drug marketing, labeling, and clinical trials; (c) The comparative cost effectiveness of pharmaceutical products; (d) Therapeutic drug classes and categories; (e) Professional ethics; (f) Properties and actions of drugs and drug delivery mechanisms; (g) Etiologies, characteristics, and therapeutics of disease states; (h) Pharmacology; (i) The anatomical and physiological effect of pharmaceuticals; (j) The comparative effectiveness of pharmaceutical products; (k) How to read and analyze peer-reviewed literature on pharmaceutical products; or (l) Safe prescribing practices to prevent abuse. Statutory/Other Authority: ORS 731.244 & Or Laws 2021, ch 593 Statutes/Other Implemented: Or Laws 2021, ch 593 History: ID 2-2022, adopt filed 06/16/2022, effective 06/17/2022 ID 13-2021, temporary adopt filed 12/20/2021, effective 12/20/2021 through 06/17/2022
836-200-0640 Education To demonstrate completion of a professional education course for the purpose of initial licensure as a pharmaceutical representative under these rules or renewal of licensure, documentation shall be submitted as follows: (1) To the extent possible, the education provider offering the course shall submit electronically a transcript, certificate of completion or grade or course completion report, whichever is issued by the education provider offering the course, or a copy thereof. If it is not possible for the education provider offering the course to submit a transcript, certificate of completion or grade or course completion report, the pharmaceutical representative shall submit the transcript, certificate of completion or grade or course completion report in accordance with directions provided on the Department of Consumer and Business Services website. (2) The department may accept evidence of completion of a course from education providers through electronic means as specified by the department. Statutory/Other Authority: ORS 731.244 & Or Laws 2021, ch 593 Statutes/Other Implemented: Or Laws 2021, ch 593 History: ID 2-2022, adopt filed 06/16/2022, effective 06/17/2022
836-200-0645 Education; Standards for Granting Credit Hours (1) Subject to the subject matter requirements of OAR 836-200-0635, a pharmaceutical representative may receive credit for a course registered under OAR 836-200-0655: (a) For not more than the credit hours authorized by the d irector; (b) Only if an hour includes at least 50 minutes of instruction or study; (c) For class hours in which a pharmaceutical representative is an instructor of a course if the course meets the education requirements of a pharmaceutical representative attending it. Credit may be taken by pharmaceutical representative with respect to a course only once in each renewal period in which the pharmaceutical representative instructs the course; (2) A pharmaceutical representative successfully completes the course if the pharmaceutical representative is present for the full approved time. (3) A pharmaceutical representative may not take education credit for: (a) Hours devoted to preparation for a course; when the pharmaceutical representative is acting as an instructor for the course; (b) Travel time; (c) Time exceeding the actual class time; (d) Unplanned or incidental learning experiences; (e) Any course not completed; or (f) Any course repeated within a two year period. Statutory/Other Authority: ORS 731.244 & Or Laws 2021, ch 593 Statutes/Other Implemented: Or Laws 2021, ch 593 History: ID 2-2022, adopt filed 06/16/2022, effective 06/17/2022
836-200-0650 Education; Education Provider Registration A provider of education courses must register with the department in order to register courses under OAR 836-200-0655. An education provider must register electronically in the method required by the director. The registration of an education provider shall include the education provider's business name, business address, and the business telephone number. In addition, a direct contact name and telephone number employed by the provider. (1) A provider shall notify the department of any change in the address, telephone number, email address or contact person of the education provider within 30 days after any such change takes effect. (2) Subject to revocation of registration under OAR 836-200-0665, an education provider registration expires on the second January 1 following the date of registration. Statutory/Other Authority: ORS 731.244 & Or Laws 2021, ch 593 Statutes/Other Implemented: Or Laws 2021, ch 593 History: ID 2-2022, adopt filed 06/16/2022, effective 06/17/2022
836-200-0655 Education; Course Registration (1) An education provider registered under OAR 836-200-0650 shall apply to the department for registration of each course to be offered by the provider for education credit. Application for registration shall be made electronically in the method required by the department and shall include the name of the provider, the education provider's registration number assigned by the department, the course title and credit hours suggested by the education provider for the course. The education provider shall include the course outline with the registration application and shall submit any other information requested by the department. The course outline must show instruction in 50-minute periods. In order to ensure that a course is eligible to be registered prior to the date of the first meeting of the course, a registered education provider must apply for registration of the course not later than the 60th day preceding the first date. (2) The registration of a course expires on the last day of the 24th month after the date the course is registered unless the course is renewed prior to the date on which registration expires. (3) Each course registration application is subject to review by the department for the purpose of evaluating and assigning credit hours and determining compliance with requirements of course content under OAR 836-200-0635. The department may reject a course for registration or terminate a course's registration if the department determines that the course submitted fails to provide accurate, sufficient, or germane information, or fails to show good faith with meeting educational goals. (4) A registered education provider shall resubmit a registered course for review and approval whenever the provider substantially changes the content of the course as registered. (5) All materials required under this rule shall be submitted electronically in accordance with directions of the department set forth on the division’s website. Statutory/Other Authority: ORS 731.244 & Or Laws 2021, ch 593 Statutes/Other Implemented: Or Laws 2021, ch 593 History: ID 2-2022, adopt filed 06/16/2022, effective 06/17/2022
836-200-0660 Education; Provider Trade Practices (1) A registered education provider shall not engage in false, misleading or deceptive advertising. (2) A registered education provider must disclose in writing the charges for a course to each pharmaceutical representative applying to take the course, prior to enrollment of the course. (3) If a registered education provider cancels a course for any reason, the education provider must refund all charges in full unless the refund policy is clearly described in the enrollment application for the course. (4) A registered education provider shall ensure that each registered course and each course for which registration is sought provides students with current and accurate information. (5) A registered education provider shall include a statement in all material published by the education provider to advertise or promote pharmaceutical representative education that the education provider and courses are registered with the department and that registration does not imply endorsement by the department. (6) A registered education provider may not advertise education hours until the course has been approved by the department. If approval has been applied for, however, a registered education provider may so advertise. (7) A registered education provider shall not give credit for a course unless the department has approved the registration application for the course and the registered provider. (8) A registered education provider of courses shall maintain an accurate record of each course offered, instructors and student attendance records for not less than three years after the date of completion of the course. Statutory/Other Authority: ORS 731.244 & Or Laws 2021, ch 593 Statutes/Other Implemented: Or Laws 2021, ch 593 History: ID 2-2022, adopt filed 06/16/2022, effective 06/17/2022
836-200-0670 Education; Credit for Unregistered Courses (1) A pharmaceutical representative may apply for credit as provided in this rule for a course that is not registered. In order to apply for credit, the pharmaceutical representative must submit to the department an application on a form provided by the department and substantiation of the course as provided in this rule. The application and substantiation must be submitted not later than the 180th day after the date of completion of the course. (2) If an unregistered course is on a subject permitted under OAR 836-200-0635, the pharmaceutical representative must substantiate to the department's satisfaction that the course meets the requirements of OAR 836-200-0645 and that the pharmaceutical representative attended and completed the course. To make the substantiation, the pharmaceutical representative must submit documentation of the proof of attendance and course completion provided by the education provider concerning the course. (3) The application and substantiation required under this rule are subject to review by the department for the purpose of determining whether to certify the course for credit and evaluating and assigning credit hours. The department may certify the course, or may reject it if the department determines that the course does not meet applicable requirements. Statutory/Other Authority: ORS 731.244 & Or Laws 2021, ch 593 Statutes/Other Implemented: Or Laws 2021, ch 593 History: ID 2-2022, adopt filed 06/16/2022, effective 06/17/2022