Summary


The rule promulgation will delete the definition for the terms: “Affiliated group”; “Propagation of a drug”; “Specified drug”; Wholesale distribution”; and “Written agreement”. The rule promulgation will add definitions for the terms: “Broker”; “Limited quantities” and “Principal address.” The rule promulgation, in response to possible objections from The Joint Administrative Procedure Committee (JAPC), clarifies the definition of the state “good manufacturing practices” term for drugs and devices. The rule promulgation also materially revises the following terms in this section: “Directly from the manufacturer”; “Established safe and effective indications”; “Intracompany transfer”; “Legend Device or Restricted Device”; “Readily available” and “readily retrievable”; “Sale”; “Separate and distinct cosmetic product”; “Separate and distinct device product”; “Separate and distinct drug product”; “Specific unit of a prescription drug”; and “Verifiable account”.