Kentucky pharmacists take note: soon you may have to update your prescription drug tracking and dispensation procedures to reflect proposed changes to the Kentucky Administrative Regulations. Section 045 of Chapter 55 in Title 902 of the Kentucky Administrative Regulations currently contains a list of drugs that are excluded from the licensing, distribution, recordkeeping and reporting requirements of the Kentucky Controlled Substances Act. The drugs listed in this provision are intended to be consistent with drugs excluded by the Drug Enforcement Agency from the reporting requirements of the Federal Controlled Substances Act.

Freshly proposed changes to the regulation suggest that the list of prescription drugs in this section be removed due to its obsolescence. Replacing the list would be a provision placing all drugs currently exempt from the Federal Regulations within the exceptions to the Kentucky Controlled Substances Act. The purpose of this change is to maintain consistency between the state and federal exempted prescription product lists.

A second section was also proposed to clarify that all products containing the drug Butalbital are not to be excluded from the requirements of the Kentucky Controlled Substances Act. This provision is to ensure that all products containing Butalbital are reported to the Kentucky All Schedule Prescription Electronic Reporting (“KASPER”) system to track the dispensation of the drug. There is no requirement to report products listed on the federal and state exemption list to KASPER.

The Cabinet of Health and Family Services expects these amendments to come before the Administrative Regulation Review subcommittee in August for further evaluation. If accepted, the amendments would require all Kentucky pharmacists to review their current reporting procedures to ensure compliance with the excluded drugs listed in the Code of Federal Regulations.