Board of Pharmacy Statutory/Other Authority:ORS 689.564 The amount of the reporting fee varies depending on the number of reports the department receives each year from all manufacturers and is included in the annual billing. PDF Manufacturer Application - Oregon.gov : State of Oregon OAR 836-200-0500 through OAR 836-200-0560for Oregon's Drug Price Transparency program. (1) The DPDO must complete the board Self Inspection Form by February 1, annually. Drugs that are outdated, damaged, deteriorated, misbranded, adulterated, or identified as suspect or illegitimate must be documented, quarantined and physically separated from other drugs until they are destroyed or returned to the supplier. A lock icon ( ) or https:// means youve safely connected to the .gov website. Biscom external user guide. (6) No waste materials shall be permitted to collect upon the floors, counters, or other portions of the manufacturing plant. An official website of the State of Oregon . Board action including but not limited to, Notice and Final Orders may be disclosed. 12-17-12 (8) A person who compounds a drug that is distributed in Oregon not based on a patient specific prescription must register with the Board as a Manufacturer, unless done so pursuant to a Shared Pharmacy Services agreement, as defined in OAR 855-006-0005, between two in-state entities. Please enter search criteria below to start your search. At least five hours of those hours must be in a classroom setting. Statutes/Other Implemented:ORS 689.155 Licensees Update or Renew My License/Registration Update or Renew My License/Registration License/Registration Renewal Information Visit mylicense/eGov to update or renew your license/registration. (2) Establish procedures to train a Registered Nurse employed by the CHC to ensure continued competence in the dispensing of drugs. Oregon Secretary of State Administrative Rules Some companies have multiple entities in their organization that meet this definition, so each entity must be registered and pay the annual assessment. Statutes/Other Implemented:ORS 689.305 ef. (f) Board rules for patient counseling must be observed for patient/inmates who self administer or who are given prescription drugs when they are released from the correctional facility. 1PB 33, f. 2-14-74, ef. 4-3-80 (3) A DPDO must comply with all requirements of State or federal law. The biennial license fee is - $250. (The spirit of the minimum standard requirements for licensees is one of helpful cooperation.). (Application fee is non-refundable. (2) When dispensing a drug under (1), a drug outlet must provide labels and informational inserts in both Englishand one of the following languages: (3) The board must reassess and update (2) as necessary and at least every ten years. Only share sensitive information on official, secure websites. (2) A CHC Drug Outlet must designate a representative employee who will act as the contact person for the Oregon Board of Pharmacy. Complaints can be made by completing and submitting the online complaint form located below. BP 40-2021, amend filed 12/16/2021, effective 01/01/2022 If so, a new application and fee are required. History: Renumbered from 855-041-0173, BP 7-2012, f. & cert. (4) Facilities: Adequate pharmaceutical and administrative facilities shall be provided including particularly: (a) Essential manufacturing equipment to process properly the products to be manufactured; (b) An adequate, up-to-date library for information concerning drugs and pharmaceutical products; (c) Refrigeration for storage of thermolabile products; (e) Sanitary facilities, lighting, ventilation, and plant safety as prescribed by the Workers Compensation Department, the Occupational Safety and Health Division. The OBOP is not liable for errors or for any damages resulting from the use of the information contained herein. Admin. The average price of the calendar year that just ended is compared to the average price of the previous calendar year and the price has increased by 10 percent or more. This practice is known as Expedited Partner Therapy. (6) A certificate of registration will be issued upon board approval of the application. Oregon Secretary of State Administrative Rules (7) The DPDO registration expires March 31, annually. (6) A CHC must dispense a drug in a new container that complies with the current provisions of the Poison Prevention Packaging Act in 16 CFR 1700 (01/01/2021), 16 CFR 1701 (01/01/2021) and 16 CFR 1702 (01/01/2021). 1PB 23, f. 2-14-74, ef. (b) Electronic Prescription Monitoring Fund fee. 7-1-78 Every company should have at least one registered user with the appropriate permissions to adjust users on the manufacturer's account and a contact. Statutes/Other Implemented:ORS 689.155 & ORS 689.305 We will generally send this to the person who submitted the report that was reviewed. It has known security flaws and may not display all features of this and other websites. The price at any point during the calendar year that just ended was $100 or more for a one-month supply or for a course of treatment lasting less than one month. BP 33-2020, minor correction filed 08/06/2020, effective 08/06/2020 (3) An EPT treatment protocol must conform to the following: (a) It must include a prescription for each named or unnamed partner of the patient; (b) It must contain a hand written or electronic signature of the prescribing practitioner; (c) The practitioner must identify the prescription in the following manner: (A) Write for EPT, or a similar notation, on the face of the prescription; (B) For a verbal order, the practitioner must identify the prescription as an EPT Prescription, or similar identification; (C) The practitioner must identify the prescription for each partner either by including the name of the patient, such as John Doe Partner 1 or by labeling the prescription as EPT Partner. The use of the eGov Online Renewal System is required. See OAR 855-135 for CPE requirements for all renewals received 7/1/2023 or later. 2-2-94 Online Facility License/Registration Verification. (5) The registration certificate is issued to a person or firm and is non-transferable. Those listed as contacts for a manufacturer are automatically notified when a message is posted in iReg if they have all required notices selected on their contact profile. (d) Otherwise unfit for distribution such that the product would result in serious adverse health consequences or death to humans. Pharmacy Licensing: Department of Health ef. Oregon Secretary of State Administrative Rules The Boards Online License/Registration Verification database can be used to as a convenience resource for you, your vendors and customers to check the status of the registration at any time. BP 38-2021, amend filed 12/16/2021, effective 01/01/2022 Renewals postmarked or submitted after the registration expiration will be subject to a late fee per OAR 855-110-0007(7). , 1 hour in pain management provided by the, 2 hours of cultural competency CPE either approved by the, 23 hours of additional continuing pharmacy education*. You, or your employercan check the status of your license by usingour Online License/Registration Verificationdatabase. Any drug expiring before the expected length of time for course of therapy must not be dispensed. The OBOP relies upon information provided by licensees to be true and correct, as required by statute. CPE must be completed prior to the submission of the license renewal. Statutory/Other Authority:ORS 689.205 endstream endobj 46 0 obj <. (4) A change of ownership or location requires a new application, fee and registration within 15 days. (a) If more than one individual owns the dispensing site, the names and addresses of the partners or persons holding the three largest ownership interests in the dispensing site must be disclosed on the application. They are available from 8 a.m. to 4 p.m. (Pacific time) Monday through Friday. The Oregon law is similar to those in California and New York, although it requires more languages . (b) If the owner is a corporation, the name filed mustbe 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 mustbe indicated on the application. (C) Drugs not dispensed in unit dose packaging must be labeled in accordance with OAR 855-041-0177(4). (7) Supervising Physician Dispensing Outlet (SPDO) means any clinic, office, health care center, treatment center, or other establishment from which a physician assistant dispenses drugs, but that is not otherwise registered with the Board in the category of Retail Drug Outlet. (2) A drug dispensing machine cannot be placed in a waiting room or an area that is accessible by the public. (2) "Counseling" means an oral or other appropriate communication process between a practitioner and a patient or a patient's agent in which the practitioner obtains information from the patient or patient's agent, and, where appropriate, the patient's medical records, assesses that information and provides the patient or patient's agent with professional advice regarding the safe and effective use of the drug or device for the purpose of assuring therapeutic appropriateness. Pharmacists, except for those who graduated in the past year, must complete at least fifteen hours (1.5 continuing education units) of continuing education courses sponsored by a recognized provider, annually. (4) The Board of Pharmacy must notify the practitioners licensing board of any disciplinary action taken against a DPDO. Check or money order in the amount of $700.00 made payable to SC Board of Pharmacy. BP 2-2016, f. 6-30-16, cert. It has known security flaws and may not display all features of this and other websites. If you believe a violation of Oregon Administrative Rules or Oregon Revised Statutes might have occurred, you may want to file a complaint with the board. Manufacturers are sent the demand to pay and reminders by email to the contacts or users on the account. ef. This does not apply to a drug outletdispensing a drug intended for administration by a healthcare worker. 12-17-12 It's important that both users and contacts are up to date and the correct people are receiving the notices. (12) All Supervising Physician Dispensing Outlet registrations expire on March 31, 2022. Such documentation must be retained in accordance with the other rules in this division and must be made available to the board upon request. (3) Toilet and washroom accommodations shall be maintained separately and distinct from the manufacturing facilities. *PerOAR 855-019-0205a pharmacist must notify the Board in writing, within 15 days, of any change in email address, employment location or residence address. 10-14-64, 855-060-0015Classification of Manufacturers. (c) Patient counseling shall be in person whenever practicable. The Oregon State Board of Pharmacy (OBOP) presents this information as a service to the public. It has known security flaws and may not display all features of this and other websites. Statutes/Other Implemented:ORS 689.155 (1) Notwithstanding any other rules in this division that mandate requirements for a valid prescription and for labeling, when a prescription is marked EPT or a similar notation by the prescribing practitioner, this rule governs. 7-1-16, BP 40-2021, amend filed 12/16/2021, effective 01/01/2022, BP 40-2021, adopt filed 12/16/2021, effective 01/01/2022, BP 4-2017, adopt filed 11/30/2017, effective 12/01/2017, BP 24-2021, minor correction filed 10/21/2021, effective 10/21/2021, BP 25-2021, minor correction filed 10/21/2021, effective 10/21/2021, BP 26-2021, minor correction filed 10/21/2021, effective 10/21/2021, BP 98-2020, adopt filed 12/23/2020, effective 01/01/2021, BP 27-2022, amend filed 06/15/2022, effective 06/16/2022, BP 27-2021, minor correction filed 10/21/2021, effective 10/21/2021, BP 39-2020, minor correction filed 08/06/2020, effective 08/06/2020, BP 35-2020, minor correction filed 08/06/2020, effective 08/06/2020, BP 34-2020, minor correction filed 08/06/2020, effective 08/06/2020, BP 33-2020, minor correction filed 08/06/2020, effective 08/06/2020, BP 32-2020, minor correction filed 08/06/2020, effective 08/06/2020, BP 31-2020, minor correction filed 08/06/2020, effective 08/06/2020, BP 29-2020, minor correction filed 08/06/2020, effective 08/06/2020, BP 26-2020, minor correction filed 08/06/2020, effective 08/06/2020, BP 24-2020, minor correction filed 08/06/2020, effective 08/06/2020, BP 22-2020, minor correction filed 08/06/2020, effective 08/06/2020, BP 21-2020, minor correction filed 08/06/2020, effective 08/06/2020, BP 19-2020, minor correction filed 08/06/2020, effective 08/06/2020, BP 17-2020, minor correction filed 08/06/2020, effective 08/06/2020, BP 15-2020, minor correction filed 08/06/2020, effective 08/06/2020, BP 13-2020, minor correction filed 08/06/2020, effective 08/06/2020. BP 34-2020, minor correction filed 08/06/2020, effective 08/06/2020 (d) Subsections (a) and (b) of this section shall not apply to those prescription drug orders for inpatients in hospitals or institutions where the drug is to be administered by a nurse or other individual authorized to administer drugs. 1PB 8-1978, f. & ef. The information provided on this website is from the Oregon Board of Pharmacys official database. 1PB 2-1980, f. & ef. The law CE programs may contain information on State or Federal regulations such as DEA, FDA, HIPAA or Medicare part D. After completing your payment through our secure online payment system, you will have the option of printing an online renewal confirmation page, which will include payment information. BP 2-2016, f. 6-30-16, cert. All reporting manufacturers are required to report on prescription drug price increases and on new prescription drugs that exceed the threshold for that reporting requirement. How you know BP 40-2021, amend filed 12/16/2021, effective 01/01/2022 Continuing Education (CE) requirements for pharmacy technicians are listed in OAR 855-021-0009. The Unit Dose Dispensing System is that drug distribution system which is pharmacy based and which uses unit dose packaging in a manner which removes traditional drug stock from patient care areas and enables the selection and distribution of unit dose packaging to be pharmacy based and controlled: (i) Provide for separation of medications by patient name and location; and. The OBOP makes no warranty or guarantee concerning the accuracy or reliability of the content of the website or the content of any other website to which this may link. (b) Each correctional facility utilizing a unit dose dispensing system shall establish written policies specifying the categories of drugs which will or will not be dispensed under the unit dose distribution system. Statutes/Other Implemented:ORS 689.155 & ORS 689.305 BP 27-2022, amend filed 06/15/2022, effective 06/16/2022 Statutory/Other Authority:ORS 689.205 4-3-80 Pharmacy Law - Oregon and National Flashcards | Quizlet ef. Or. Admin. R. 855-060-0004 - LII / Legal Information Institute 1PB 2-1980, f. & ef. (4) Correctional Facility means any prison, jail, or detention facility for the confinement of juveniles or adults. (3) The law specifies that a prescription issued in the practice of Expedited Partner Therapy is valid, even if the name of the patient the prescription is intended for is not on the prescription. If the drug does not have a brand name, then the generic name of the drug and the drug manufacturer must be stated; (d) Initials of the dispenser and the date of dispensing; (f) Auxiliary labels and cautionary statements as required; (g) Manufacturer's expiration date, or an earlier date if preferable; and. 2022-1045 Motion to grant technician license and close with Board direction. PB 1-1994, f. & cert. ef. (b) The patient at the direction of the practitioner. 3-7-13 thru 9-3-13 Statutes/Other Implemented:ORS 689.305 ef. Here's what it looks like: The billings tab in iReg will show which debts are in collections. 6-19-12 Click the link below to log into your eGov account to verify all facility information, renew, update the mailing address/contact information and order certified license copies. (2) Stock medication for packaging and repacking will be furnished by the purchaser and shall exclude controlled substances. (6) Manufacturing of drug substances shall be separated from manufacturing of food substances. (2). (5) The manufacturing plant shall be well lighted, ventilated, and kept free of obnoxious odors. Learn how. 1PB 2-1980, f. & ef. Details page for a billing shows the reports associated with that billing and allows a user to print the payment coupon if the status is pending. (6) Manufacturer registration expires September 30th annually. Feb. 16, 2023, Manufacturer guidance webinar, May 30, 2019, Street:350 Winter St. NERoom 410Salem, OR, 503-378-4140 (Salem)888-877-4894 (toll-free in Oregon)503-947-7862 (fax)Contact usAbout us. (2) Class II. Board of Pharmacy Room 205 3 Capitol Hill Providence, RI 02908-5097 Instructions and Application For Distributor License and . Statutory/Other Authority:ORS 689.205 (10) The vehicle shall not display insignia or device to indicate that drugs are stored within or represent it as a pharmacy. 855-043-0600Correctional Facility - Purpose and Scope. endstream endobj startxref (2) Bulk Drug Container means a bottle or package of medication, other than unit dose, labeled by a manufacturer or pharmacist. (3) The vehicle shall be secure against pilferage, maintained and operated in accordance with good manufacturing practices standards in this division. PB 2-1992, f. & cert. (8) The DPDO must ensure that all prescriptions, prescription refills, and drug orders are correctly dispensed in accordance with the prescribing practitioner's authorization and any other requirement of State or federal law. (2) Because of the important public health implications, the 2009 Oregon Legislature passed HB 3022 authorizing this practice. (4) Labeling: Prescription drugs dispensed in individual containers or medication cards shall be labeled with the following information: (a) Name and identifying number of the patient/inmate; (b) Name, strength, and quantity of the drug dispensed.