SUPPLEMENTARY INFORMATION:

Legal Authority

The Controlled Substances Act (CSA) authorizes the Attorney General, by regulation, to exempt from certain provisions of the CSA any compound, mixture, or preparation containing certain nonnarcotic controlled substances if he finds that it is both (1) approved for prescription use, and (2) contains one or more other active ingredients which are not listed in any schedule and which are included in such combinations, quantity, proportion, or concentration as to vitiate the potential for abuse.^[1] The Attorney General has delegated this authority to the Administrator of DEA (Administrator).^[2] The Administrator may also revoke a previously granted exemption by following the same procedures that are used to evaluate an application for exemption—namely, by publishing in the Federal Register a general notice of the proposed rulemaking (NPRM) for revoking the exemption, permitting interested persons to file written comments on or objections to the proposed revocation, considering any comments submitted, and publishing a final order in the Federal Register that sets forth the findings of fact and conclusions of law upon which the order is based.^[3]

This final determination revokes the exemption status for certain prescription products previously granted exemption because the National Drug Codes (NDC) of these products are no longer active and/or the companies that originally filed for their exemption no longer exist. This action revokes the exemption status for a number of products and removes them from DEA's Table of Exempted Prescription Products. While this action revokes the exemption status, this action will have no effect on these products because they are no longer marketed.

Background: Exempted Prescription Products

DEA has exempted prescription drug products from certain parts of the CSA when the products meet the requirements for exemption, including the requirement to contain active ingredients believed to vitiate the potential for abuse. The current table of products that have been granted exempted prescription product status, pursuant to 21 CFR 1308.31 and 1308.32, can be found on the DEA Diversion Control Division website.^[4]

Butalbital is classified as an intermediate acting barbiturate. Butalbital is a schedule III nonnarcotic controlled substance that falls under DEA Controlled Substances Code Number 2100, as it is a derivative of barbituric acid.^[5] Originally, some butalbital prescription products were exempted by the Bureau of Drug Abuse Control (BDAC) of the Food and Drug Administration (FDA), the predecessor to the Bureau of Narcotics and Dangerous Drugs and later DEA. A panel of public health physicians and FDA medical officers developed the criteria used to exempt butalbital prescription products by BDAC in 1967. These criteria were based upon the expectation that combining the controlled substance with an amount of counteractive drug sufficient to cause early deterrent side effects would vitiate the potential for abuse. For products containing long or intermediate acting barbiturates in combination with analgesics, the criteria provided that an exemption would be granted if, for every 15 mg of barbiturate, the product contained at least (1) 188 mg aspirin; (2) 375 mg salicylamide; or (3) 70 mg phenacetin, acetanilid, or acetaminophen.

Following the establishment of the criteria, DEA approved subsequent applications by new manufacturers based upon the same criteria, whereby the inclusion of these other active ingredients was thought to be in sufficient quantities to vitiate the potential for abuse. The criteria developed in 1967 was originally found to meet the standard for exemption currently described in 21 U.S.C. 811(g)(3)(A), such that if a prescription drug was found to meet the 1967 criteria for exemption, then it also met the test to contain an ingredient that vitiated the potential for abuse under the CSA standard.

Currently, there are 189 butalbital products listed by their NDC on DEA's Table of Exempted Prescription Products. Using the FDA's National Drug Code Directory ^[6] and the U.S. ( printed page 64619) National Institute of Health (NIH)—National Library of Medicines DailyMed database,^[7] DEA determined that 160 of the NDCs correlating to butalbital products on the exempt prescription product list are no longer active and marketed. DEA confirmed with FDA these products are no longer marketed. Thereafter, on May 26, 2026, DEA published an NPRM in the Federal Register proposing to remove these inactive products from the exempted prescription product list to accurately portray which products are currently on the market.^[8]

Comments Received

DEA received one comment in response to the NPRM for the removal of butalbital products on the exempt prescription product table that are no longer active and marketed.

Comment: One commenter was concerned about the use of FDA's National Drug Code Directory and the NIH DailyMed database to identify products that are no longer marketed to remove them from the DEA Exempted Prescription Product table. The commentor mentioned that a drug product manufactured by a contract manufacturing organization and labeled for a private label distributor may have NDCs that do not appear on the NDC directory or in the DailyMed database. The commenter proposed that all drug products with currently certified NDC numbers remain on the DEA Exempted Prescription Product Table, and that DEA should utilize FDA's complete drug listing.

DEA Response: DEA appreciates the comment submitted. Items on the DEA Exempted Prescription Product Table are NDC number specific, and the prescription product must be labeled with the exempted NDC number for identification purposes. According to the FDA National Drug Code Directory website, “The NDC Directory contains information on active and certified, finished and unfinished drugs submitted to FDA in structured product labeling electronic listing files by labelers. The NDC Directory contains product listing data submitted for all finished drugs including prescription and over-the-counter drugs, approved and unapproved drugs, as well as repackaged and relabeled drugs.” ^[9] Because the NDC directory contains the information for the certified finished drugs, in line with the request by the commenter, this directory was used to search for active pharmaceutical products that contain the NDCs of those butalbital products on DEA's exempt prescription product list.

The NIH—National Library of Medicines DailyMed database contains labeling information and product information that has been submitted to FDA by companies. This database was also searched in conjunction with FDA's NDC directory to confirm products are no longer being marketed.

DEA also reached out directly to FDA prior to the publication of the NPRM as well as in response to the commenter to confirm if these products were active and currently being marketed. DEA confirmed with FDA these products are no longer marketed.

Lastly, there were no comments received from any of the parties that would be directly affected by the removal of these NDCs from the Table of Exempted Prescription Products. Likewise, any product that is no longer exempted under the CSA may still be manufactured and sold, so long as the company and the product conform to all DEA regulations and the CSA.

Therefore, the final determination is being published without any changes.

List of Products To Be Removed From the Table of Exempted Prescription Products

For reasons detailed above, DEA is removing the following prescription products from DEA's Table of Exempted Prescription Products, as set forth below:

Regulatory Analyses

Executive Orders 12866, 13563, 14192, and 14294

DEA has determined that this rulemaking is not a “significant regulatory action” under section 3(f) of E.O. 12866, Regulatory Planning and Review. This rule has been drafted and reviewed in accordance with E.O. 12866, “Regulatory Planning and Review,” section 1(b), Principles of Regulation and E.O. 13563, “Improving Regulation and Regulatory Review,” section 1(b), General Principles of Regulation. This action is also not subject to E.O. 14192, “Unleashing Prosperity Through Deregulation,” or E.O 14294, “Fighting Overcriminalization in Federal Regulations.”.

Executive Order 12988, Civil Justice Reform

This regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of E.O. 12988 to eliminate drafting errors and ambiguity, minimize litigation, provide a clear legal standard for affected conduct, and promote simplification and burden reduction.

Executive Order 13132, Federalism

This rulemaking does not have federalism implications warranting the application of E.O. 13132. The rule does not have substantial direct effects on the States, on the relationship between the national government and the States, or ( printed page 64623) the distribution of power and responsibilities among the various levels of government.

Executive Order 13175, Consultation and Coordination With Indian Tribal Governments

This rule does not have tribal implications warranting the application of E.O. 13175. It does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.

Regulatory Flexibility Act

The Administrator, in accordance with the Regulatory Flexibility Act,^[10] has reviewed this rule and, by approving it, certifies that it will not have a significant economic impact on a substantial number of small entities. There would be no economic impact because the products being removed from DEA's prescription product exempt list are no longer marketed.

Unfunded Mandates Reform Act of 1995

In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995,^[11] DEA has determined and certifies that this action would not result in any Federal mandate that may result “in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any 1 year . . . .” Therefore, neither a Small Government Agency Plan nor any other action is required under UMRA of 1995.

Paperwork Reduction Act of 1995

This rule would not impose a new collection of information under the Paperwork Reduction Act of 1995.^[12] Also, this rule would not impose new or modify existing recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations.

Signing Authority

This document of the Drug Enforcement Administration was signed on October 6, 2026, by DEA Administrator Terrance C. Cole. That document with the original signature and date is maintained by DEA. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DEA Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of DEA. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register .