Kentucky has Filed Amendments to Regulations and/or New Regulations

| by: Deneen Fumich, RPh | Article Posted: July 27, 2023 |

Kentucky has filed amendments to Regulations and/or New Regulations impacting licenses and permit fees for pharmacies, wholesalers, and manufacturers along with formatting changes and additional amendments to resident and nonresident pharmacies.

There is an open comment period till August 31 with a public hearing on August 30th. Below is the summary that will impact us once approved:

201 KAR 2:050, Licenses and permits; fees.

• • increases the license/permit initial and renewal fees by $25 for pharmacies, wholesalers, and manufacturers. This amendment also ensures the fee for a change of address or change of ownership is congruent with the initial license/permit fee since those changes require a new application.
• • resident and nonresident pharmacy applications have been amended for reformatting and including additional questions regarding the website, registration status with the Secretary of State, date of last controlled substance inventory, stocking of emergency medication kits, stocking long-term care facilities, using automation for prescription dispensing and if compounding is being performed and if so, what type. For the non-resident application, pursuant to KRS 315.0351(1)(b), a question has been added to collect the names of all pharmacists who dispense prescription drugs to residents in the Commonwealth.

201 KAR 2:105. Requirements for wholesalers, medical gas wholesalers, wholesale distributors, and virtual wholesale distributors. – The wholesaler initial and renewal forms have been amended to include the proposed fee increase and to make other formatting changes.

201 KAR 2:320. Requirements for Manufacturers and Virtual Manufacturers. – This amendment revises the fee amount listed in the applications to be congruent with the proposed change in 201 KAR 2:050. This amendment also makes formatting changes.

201 KAR 2:390. Requirements for third-party logistics providers. – This amendment increases the fee for third-party logistics providers to $400. This amendment also makes formatting changes to the applications.

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