FDA Regulation of E-Liquid Manufacturing
While most large scale production facilities have standardized manufacturing controls, those mixing liquids in small facilities without environmental controls may struggle to receive pre-market approval.
While most large scale production facilities have standardized manufacturing controls, those mixing liquids in small facilities without environmental controls may struggle to receive pre-market approval.
New USP guidelines may present challenges for compounding facilities. Some facilities need infrastructural and mechanical modifications for compliance. System evaluation includes duct systems, HEPA fan filters, differential pressure standards, air monitoring, and external air exhaust equipment.