Oregon Administrative Rules
Chapter 855 - BOARD OF PHARMACY
Division 60 - PHARMACEUTICAL MANUFACTURERS
Section 855-060-0015 - Classification of Manufacturers

Universal Citation: OR Admin Rules 855-060-0015

Current through Register Vol. 63, No. 3, March 1, 2024

(1) Class I. A Class I manufacturer is required to employ an Oregon licensed pharmacist or a person approved by the Board who by experience and education possesses the necessary qualifications to supervise manufacturing procedures for United States Pharmacopeia, National Formulary, Accepted Dental Remedies products and including the manufacture of other internal medicines, controlled substances, dangerous external preparations, injectables, products requiring the prescription legend, poisons, and pure (U.S.P. and N.F. chemicals).

(2) Class II. A Class II manufacturer is required to employ personnel with a Bachelor of Science degree or equivalent, but not necessarily a licensed pharmacist to supervise manufacturing procedures and must comply with 503B manufacturing requirements of 21 USC 353 and is exempted from labeling and research requirements.

(3) Class III. Repackagers or distributors of non-legend drugs will not be required to have a licensed pharmacist but is required to have competent supervisory personnel.

Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 689.155

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