All dangerous drug distributors, wholesale and terminal, who fill containers with compressed medical gases must comply with the current good manufacturing practice regulations issued by the federal "Food and Drug Administration (F.D.A.)" pursuant to the "Federal Food, Drug and Cosmetic Act" (3/26/2015) and the current guidelines issued pursuant to Title 21 CFR 10.90(3/26/2015). Any deviation from the current guidelines issued by the federal F.D.A. must be submitted to the federal F.D.A. for written approval before implementation. Documentation that the different procedures have been approved shall be maintained by dangerous drug distributors for review and copying by agents of the board.
Five Year Review (FYR) Dates: 03/04/2015 and 05/24/2020
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.51, 4729.52, 4729.53, 4729.54, 4729.55
Prior Effective Dates: 08/16/94(Emer), 11/25/94