Or. Admin. R. 855-060-0015 - Classification of Manufacturers

(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.

Notes

Or. Admin. R. 855-060-0015

1PB 18, f. & ef. 10-14-64; 1PB 33, f. 2-14-74, ef. 3-11-74; 1PB 6-1978(Temp), f. & ef. 7-1-78; 1PB 8-1978, f. & ef. 10-17-78; 1PB 2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; BP 4-2015, f. & cert. ef. 7/1/2015

Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 689.155