The proposed amendment to Rule 64F-12.001, F.A.C., adds the definition of “propagation” as this term appears in the definition of “manufacture” at Section 499.003(27), F.S. The definition clarifies that the manufacturing process includes the various establishments that may be part of that process, including a private relabeler and an affiliated or contract distribution center. The proposed amendment to Rule 64F-12.015, F.A.C., expands the scope of the on-site inspection requirement to additional permit applicants within the scope of Chapter 499, F.S. The amendment to this rule also provides the department with an option to on-site inspection of a permit applicant’s establishment. This option is designed to protect public health when the department’s workload requires an alternative to an inspection. Finally, the proposed amendment to this rule also adopts a new attachment to the Application for Permit under Chapter 499, F.S., which attachment is directed to manufacturer and prescription drug repackager permit applicants located in Florida.