Or. Admin. Code § 855-045-0200
Current through Register Vol. 64, No. 1, January 1, 2025
Section 855-045-0200 - Application(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).Or. Admin. Code § 855-045-0200
BP 2-2008, f. & cert. ef. 2-20-08; BP 12-2019, amend filed 12/20/2019, effective 12/20/2019; BP 45-2021, amend filed 12/16/2021, effective 12/16/2021; BP 27-2022, amend filed 06/15/2022, effective 6/16/2022; BP 10-2023, amend filed 06/13/2023, effective 6/13/2023; BP 57-2024, amend filed 06/18/2024, effective 6/20/2024Publications: 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