Summary


The proposed rule changes will clarify that establishment and adherence to policies and procedures for random authentication of copies of pedigrees according to statistically valid standards is required in some situations. The proposed rule changes will also require establishment and adherence to policies and procedures that provide for the random verification of the authenticity of pedigrees for the purposes of establishing a wholesaler purchased prescription drugs directly from the manufacturer according to statistically valid standards, in some situations. The proposed rule adds the requirement that a repackager notify the Department of discovery of a significant loss of prescription drugs. The proposed rule requires that a chain pharmacy warehouse or person authorized to administer or dispense a prescription drug that receives a prescription drug, is required to verify that the information on the corresponding pedigree matches up with the drug received.