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).
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
and is exempted from labeling and
III. Repackagers or distributors of non-legend drugs will not be required to
have a licensed pharmacist but is required to have competent supervisory
Or. Admin. R.
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;
4-2015, f. & cert. ef.
Stat. Auth.: ORS
Stats. Implemented: ORS