The New Year is upon us and 2023 has already delivered some regulatory news that’s worth sharing.

The Drug Enforcement Agency (DEA) maintains a database called the Exempt Prescription Products List (often referred to as the Exempt List), according to the Code of Federal Regulations Title 21, Part 1308, Exempt Chemical Preparations. The Exempt List is a catalogue of products that contain butalbital, chlordiazepoxide, and phenobarbital in combination with other active ingredients, which are exempted from being assigned a controlled substance schedule per the Code of Federal Regulations, Section 1308.32. The products referenced in this section are exempted by the DEA individually by NDC.

The Exempt List is an exclusive list. According to the DEA, if a product is not specifically listed on the Exempt List, then it must be treated as a controlled substance. In short:

• Any butalbital, chlordiazepoxide, or phenobarbital combination NDC appearing on the Exempt List will NOT have a DEA code populated at the item level in Medi-Span Core Drug files.

• Any butalbital, chlordiazepoxide, or phenobarbital combination NDC not appearing on the Exempt List will have a DEA code populated at the item level in Medi-Span Core Drug files. 
  

This is where things get complicated.   Butalbital products may or may not be classified as controlled substances, depending on whether they appear on the Exempt List. Further, state pharmacy laws may also classify these products as controlled substances, even if they do appear on the Exempt List.

For pharmacies that dispense medications into multiple states, this issue quickly becomes a perplexing regulatory puzzle. The exempt List creates a scenario where both controlled and non-controlled drugs would have the same Medi-Span identifiers such as GPI and Drug Descriptor Identifier (DDID).

For example, the Medi-Span Drug Information for some NDCs of butalbital/acetaminophen/caffeine tablets are listed as Schedule III drugs, while others are not listed as controlled substances. This results in a confusing situation, making it challenging to assign appropriate limits to dispensing and/or refill quantities.

Wolters Kluwer recommends that when butalbital, phenobarbital, or chlordiazepoxide is present in a product with more than one active ingredient, customers should evaluate these products at the item (full 11-digit NDC) level rather than the DDID or GPI grouping.

In May of 2022, the DEA proposed removing butalbital-containing products from the Exempt List. Though the comment period has ended, no further action has been taken at this time.

Fortunately, the SoftWriters team has you covered. Long-term care pharmacies often face complex regulatory environments related to multi-state dispensing. FrameworkLTC allows users to set DEA Class overrides at the formulary level. Facility-specific expiration date setup by GPI or NDC allows for effortless built-in control mechanisms to help ensure compliance with state-specific drug classifications.

For more information, please contact support@softwriters.com