Or. Admin. Code § 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.
Notes
Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
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