FDA Stakeholder Update - November 26, 2019

FDA in Brief FDA Explains Policy for Manufacturers of Battery-operated Tobacco Products and E-liquids who are Considering Making Limited Safety-related Modifications to their Products

FDA issued a guidance, Compliance Policy for Limited Modifications to Certain Marketed Tobacco Products, which sets out the FDA’s compliance policy for limited safety modifications to: tobacco products on the market as of Aug. 8, 2016: Battery-operated tobacco products modified solely and only to the extent necessary to comply with the voluntary industry UL 8139 battery standard. E-liquid products containing nicotine modified solely and only to the extent necessary to comply with the restricted-flow requirements for liquid nicotine containers set out in the Child Nicotine Poisoning Prevention Act of 2015.

This guidance explains that the FDA does not intend to enforce violations of the premarket review requirements against such modified products on the basis of these limited modifications. Download Final Compliance Policy Guide [11/25/2019] FDA Issues Draft Guidance on Compounding Certain Animal Drugs from Bulk Drug Substances FDA issued a new draft guidance for industry (GFI) #256, “Compounding Animal Drugs from Bulk Drug Substances,” which addresses situations in which, if the guidance is finalized, the FDA does not intend to take action for certain violations of the Food, Drug, & Cosmetic Act when pharmacists and veterinarians compound or oversee the compounding of animal drugs from bulk drug substances to: fill patient-specific prescriptions for nonfood-producing animals compound “office stock” (certain drugs kept in the veterinarians’ supply) for nonfood-producing animals. compound antidotes for food-producing animals. [11/19/2019]