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

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