Support for Those Impacted by Devastating Storms

• By: admin
• On: 05/19/2025 10:31:40
• In: KPhA Updates

The recent tornadoes and severe storms that tore through Somerset, London, and surrounding areas have left a path of devastation that is difficult to put into words. These storms have tragically claimed the lives of at least 18 Kentuckians, and our hearts are heavy with grief for the families and communities who are mourning and beginning the long process of recovery.

To our pharmacy colleagues serving in these hard-hit areas: please know that you are not alone. We see you. We stand with you. And we are here to support you however we can.

Disaster Relief Assistance Available

KPhA offers disaster relief funds to pharmacists and pharmacy technicians directly impacted by this tragedy. If you or someone you know has experienced loss or damage, please reach out to me directly at bmudd@kphanet.org. We want to help ease the burden where we can.

Emergency Pharmacy Provisions Activated

Governor Andy Beshear has issued Executive Order 2025-307, declaring a state of emergency and activating emergency pharmacy measures statewide. Effective May 17 through June 17 (unless extended), pharmacists may:

• Dispense a 30-day emergency supply of any non-controlled medication to residents of any Kentucky county.
• Temporarily operate a pharmacy in an area not listed on the pharmacy’s permit if located in an affected county.

These provisions, enabled by KRS 315.500 and 201 KAR 2:330, are in place to ensure Kentuckians maintain access to critical medications during this time.

KPhA Emergency Support Contact

Michele Pinkston, who oversees Pharmacy Emergency Preparedness at KPhA, has been reaching out to pharmacies in the impacted counties. If you have not yet connected with her or need assistance navigating any aspect of the response, please don’t hesitate to contact her at michele@kphanet.org. Michele is here to support you.

We will continue monitoring the situation and providing updates and resources as they become available. Thank you for the care you provide, especially in times of crisis. Please take care of yourselves — and each other.

With deepest sympathy and unwavering support,

Ben Mudd, PharmD
Executive Director
Kentucky Pharmacists Association

Understanding the DEA Exempted Product List

• By: admin
• On: 05/12/2025 09:17:38
• In: KPhA Updates

When working directly with prescription medications in the pharmacy, it is generally easy to tell which drugs are controlled substances and which aren’t. Controlled medications are typically packaged and shipped separately from non-controlled medications and the manufacturer bottles contain a required Symbol¹ (i.e., C-II, C-III, C-IV or C-V).
However, Title 21 of the Code of Federal Regulations, Part §1308.31 Application for exemption of a nonnarcotic prescription product², provides exemptions for certain drug products from the Controlled Substance Act (CSA). Exemptions are given when the products meet specific criteria, including the presence of active ingredients believed to reduce the potential for abuse. The DEA publishes a list of Exempted Prescription Products³ which details the NDCs that are not considered a controlled substance. A manufacturer must apply for the exemption to receive the designation. Therefore, you may see two different manufacturers of the same drug product not linked in your pharmacy software system because one is flagged as a controlled substance, another as a non-controlled. An example of a drug that is on the list is butalbital/APAP/caffeine capsules. The NDC manufactured by Dr. Reddy (NDC 75907-0009-01) is not on the exempted list (it’s a Schedule III), but the one made by Aurobindo (NDC 13107-0075-01) is on the list.  If the manufacturer has received an exemption, it will be listed in the above-mentioned table. This table is updated periodically by the DEA (last update was February 2025).
PAAS Tips:

• Check drugs containing controlled substances against the DEA Table of Exempted Drug Products (and look for the required Symbol if the product is in stock) to determine which rules to follow
  • If the NDC is not on the list, consider this product a controlled substance
• Check your software system to see if it flags products as a controlled substance down to the NDC level. There is a risk of refilling a controlled substance (that you thought was non-controlled) beyond the prescription expiration date or allowed refills
• PAAS National® recommends proceeding cautiously when medications have controlled and non-controlled versions to avoid any controlled substance law violations

 
By Trenton Thiede, PharmD, MBA, President at PAAS National^®, expert third party audit assistance, FWA/HIPAA and USP 800 compliance.
 
References:

1. https://www.ecfr.gov/current/title-21/chapter-II/part-1302
2. https://www.ecfr.gov/current/title-21/chapter-II/part-1308/subject-group-ECFR4b1bd9cfc7cf95f/section-1308.31
3. https://www.deadiversion.usdoj.gov/schedules/exempt/exempt_rx_list.pdf

Copyright © 2025 PAAS National, LLC. Unauthorized use or distribution prohibited. All use subject to terms at https://paasnational.com/terms-of-use/.