Summary


In Section R156-17b-102, the proposed amendments create separate definitions for "co-licensed partner" and "co-licensed product" in order to add clarification and to add "device" in the definition for "co-licensed product". A definition for "FDA-approved" is also added to this section. Also in this section, the United States Pharmacopeia (USP)/National Formulary(NF) books are updated to USP 39-NF 34, which will be effective on 05/01/2016. In Section R156-17b-615, amendments modify to exempt FDA-registered device manufacturers from obtaining a Class C pharmacy license (i.e. an entity that manufactures, produces, wholesales, or distributes drugs or devices). The proposed amendments include: 1) the term "device"; 2) products that are referred to as convenience kits, which contain certain drugs or materials with the device to ensure a health care provider has everything necessary when the device is needed for use; and 3) a reference to the federal rule under which a device manufacturer must register with the FDA.