Or. Admin. Code § 855-045-0210
Current through Register Vol. 64, No. 1, January 1, 2025
Section 855-045-0210 - Registration(1) A non-resident drug outlet that distributes a non-patient specific compounded drug into Oregon must be registered with the FDA as a 503B Outsourcing Facility and must register with the Board as a manufacturer drug outlet.(2) A resident drug outlet that distributes a non-patient specific human compounded drug within or outside of Oregon must register with the FDA as a 503B Outsourcing Facility and must register with the Board as a manufacturer drug outlet.Or. Admin. Code § 855-045-0210
BP 2-2008, f. & cert. ef. 2-20-08; BP 12-2019, amend filed 12/20/2019, effective 12/20/2019Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155