# Schedules of Controlled Substances; Removal of Exemption Status for Inactive Butalbital Products > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A2026-10379 ## Record - **Collection:** Federal Register - **Document type:** Proposed Rule - **Published:** May 26, 2026 - **Citation:** 91 FR 30527 ## Text DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 [Docket No. DEA-1664] RIN 1117-ZA08 Schedules of Controlled Substances; Removal of Exemption Status for Inactive Butalbital Products AGENCY: Drug Enforcement Administration, Department of Justice. ACTION: Notice of proposed rulemaking. SUMMARY: The Drug Enforcement Administration (DEA) proposes to revoke the exempted status for certain nonnarcotic prescription products that are currently on DEA's Table of Exempted Prescription Products list but whose National Drug Code (NDC) is inactive because they are no longer available and/or the company that applied for the exemption no longer exists. If finalized, these products would be removed from DEA's Table of Exempted Prescription Products list, and they would no longer be considered exempt prescription products under the Controlled Substances Act. This action will not impact exempted prescription products with active NDC numbers. DATES: Comments must be submitted electronically or postmarked on or before June 25, 2026. ADDRESSES: Interested persons may file written comments on this proposal in accordance with 21 CFR 1308.31(c)-(d), and 21 CFR 1308.43(g). Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period. To ensure proper handling of comments, please reference “Docket No. DEA-1664” on all correspondence, including any attachments. • Electronic comments: DEA encourages that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or to attach a file for lengthier comments. Please go to https://www.regulations.gov and follow the online instructions at that site to submit comments. Upon completion of your submission, you will receive a Comment Tracking Number. Please be aware that submitted comments are not instantaneously available for public view on Regulations.gov. If you have received a Comment Tracking Number, you have successfully submitted your comment, and there is no need to resubmit the same comment. • Paper comments: Paper comments that duplicate the electronic submission are not necessary. Should you wish to mail a paper comment in lieu of an electronic comment, send via regular or express mail to: Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. FOR FURTHER INFORMATION CONTACT: Terrence L. Boos, Ph.D., Diversion Control Division, Drug Enforcement Administration; Telephone: (571) 362-3249. As required by 5 U.S.C. 553(b)(4), a summary of this proposed rule may be found in the docket for this proposed rulemaking at www.regulations.gov. SUPPLEMENTARY INFORMATION: Posting of Public Comments Please note that all comments received in response to this docket are considered part of the public record. The Drug Enforcement Administration (DEA) will make comments available for public inspection online at https://www.regulations.gov, unless reasonable cause is given. Such information includes personal identifying information (such as your name, address, etc.) voluntarily submitted by the commenter. Commenters submitting comments which include personal identifying information (PII), confidential, or proprietary business information that the commenter does not want to be made publicly available should submit two copies of the comment. One copy must be marked “CONTAINS CONFIDENTIAL INFORMATION” and should clearly identify all PII or business information the commenter does not want to be made publicly available, including any supplemental materials. DEA will review this copy, including the claimed PII and confidential business information, in its consideration of comments. The second copy should be marked “TO BE PUBLICLY POSTED” and must have all claimed confidential PII and business information already redacted. DEA will post only the redacted comment on http://www.regulations.gov for public inspection. DEA generally will not redact additional information contained in the comment marked “TO BE PUBLICLY POSTED.” The Freedom of Information Act applies to all comments received. The Freedom of Information Act applies to all comments received. For easy reference, an electronic copy of this document and supplemental information to this proposed rule are available at https://www.regulations.gov. 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 she 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 1 21 U.S.C. 811(g)(3)(A); 21 CFR 1308.31, 1308.32. 2 28 CFR 0.100. 3 See 21 CFR 1308.31(c), (d). This notice proposes to revoke the exemption status for certain prescription products previously granted exemption because the National Drug Codes (NDCs) of these products are no longer active and/or the companies that originally filed for their exemption are no longer in existence. If finalized, this action will revoke the exemption status for a number of products and remove them from DEA's Table of Exempted Prescription Products list. While this action would revoke the exemption status, this action should 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 4 Available at https://www.deadiversion.usdoj.gov/schedules/exempt/exempt_rx_list.pdf. Butalbital is classified as an intermediate acting barbiturate. Butalbital is a schedule III nonnarcotic controlled substance that falls under DEA Administration Controlled Substances Code Number 2100, as it is a derivative of barbituric acid. 5 Originally, some butalbital prescription products were excepted 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 exception 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. 5 21 CFR 1308.13(c)(3). 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 exception, 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. National Institute of Health-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. Therefore, DEA is proposing to remove these inactive products from the exempted prescription product list for clarity and to accurately portray which products are currently on the market. DEA welcomes comments from any company who believes their product is being erroneously removed from the exempt prescription product list because their product is still available for sale. 6 FDA's NDC directory contains information about finished, unfinished ( e.g., active pharmaceutical ingredients) and compounded drugs. 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. Drug establishments are required to provide FDA with a current list of all drugs, including active pharmaceutical ingredients manufactured, prepared, propagated, compounded, or processed for sale in the United States at their facilities. Drugs are identified and reported using a unique NDC, which serves as the FDA's identifier for drugs. FDA publishes the listed NDC numbers in the NDC directory, which is updated daily. Database queried January 27-February 3, 2026. 7 The DailyMed database contains labeling, submitted to the FDA by companies, for the following products: FDA-approved products, including prescription drug and biological products for human use (labeling includes Prescribing Information, patient labeling, and carton and container labeling); drug products and biological products; nonprescription ( e.g., over-the-counter) drug and biological products for human use; certain medical devices for human use; medical gases for human and animal use; and prescription and nonprescription drugs for animal use. Also, additional products regulated, but not approved, by the FDA may be found on DailyMed, such as certain medical devices; cosmetics; dietary supplements; medical foods; and unapproved prescription and nonprescription products. Database queried January 27-February 3, 2026. 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: Company Trade Name NDC code Form Controlled substance (mg or mg/ml) Alpha Scriptics Inc Butacet Capsules 53121-0133 CA Butalbital 50 Alphagen Laboratories, Inc Butalbital and Acetaminophen Capsules 50mg/650mg 00603-2542 CA Butalbital 50 Alphagen Laboratories, Inc Geone Capsules 59743-0004 CA Butalbital 50 Altana, Inc Axocet (Butalbital and Acetaminophen) 0281-0389 TB Butalbital 50 Althon Pharmaceuticals, Inc Butalbital, Acetaminophen and Caffeine Tablets USP 66813-074 TB Butalbital 50 Alvogen, Inc Butalbital and Acetaminophen Tablets USP 50/325 47781-0535 TB Butalbital 50 Alvogen, Inc Butalbital, Acetaminophen and Caffeine Tablets USP 50/325/40 47781-0536 TB Butalbital 50 Alvogen, Inc Butalbital and Acetaminophen Tablets 50/325 47781-0628 TB Butalbital 50 Alvogen, Inc Butalbital, Acetaminophen and Caffeine Tablets (50/325/40) 47781-0625 TB Butalbital 50 Alvogen, Inc Butalbital and Acetaminophen Tablets (50/300) 47781-0644 TB Butalbital 50 American Pharmaceuticals, Inc AMERICET Tablets 58605-0501 TB Butalbital 50 American Urologicals Inc Butace 00539-0906 CA Butalbital 50 Amerisource Health Services Corporation Butalbital, Acetaminophen and Caffeine Tablets 50/325/40mg 68084-0396 TB Butalbital 50 Aphena Pharma Solutions Butalbital, Acetaminophen and Caffeine Tablets (50/325/40mg 71610-0042 TB Butalbital 50 Atland Pharmaceuticals Butalbital and Acetaminophen Tablets (25 mg/325 mg) 71993-301 TB Butalbital 25 Atley Pharmaceuticals Butalbital, Acetaminophen and Caffeine Tablets 59702-661 TB Butalbital 50 AvKare, Inc Butalbital, Acetaminophen and Caffeine Tablets USP 50/325/40 50268-139 TB Butalbital 50 Baucum Laboratories Inc Butalbital, Acetaminophen and Caffeine Tablets 54696-0513 TB Butalbital 50 Blansett Pharm Co Anolor 300 Capsules 51674-0009 CA Butalbital 50 Cardinal Health Butalbital, Acetaminophen and Caffeine Tablets 50mg/325mg/40mg 55154-7988 TB Butalbital 50 Cardinal Health Butalbital, Acetaminophen and Caffeine Tablets 50mg/325mg/40mg 55154-7147 TB Butalbital 50 Cardinal Health Butalbital, Acetaminophen and Caffeine Tablets 50mg/325mg/40mg 0904-6538 TB Butalbital 50 Carnrick Labs Inc Phrenilin 00086-0050 TB Butalbital 50 Carpenter Pharmacal Co ALAGESIC Tablets 55726-0300 TB Butalbital 50 Cody Laboratories, Inc BU-TAB AC 65893-100 TB Butalbital 50 Columbia Drug Co Isopap Capsules 11735-0400 CA Butalbital 50 CTEX Pharmaceuticals, Inc Butex Forte Capsules 62022-0070 CA Butalbital 50 CTEX Pharmaceuticals, Inc Butex Forte Capsules 62022-0074 CA Butalbital 50 D.M. Graham Laboratories, Inc Butalbital, Acetaminophen and Caffeine Tablets 00756-0111 TB Butalbital 50 Diversified Health Care Services Geone Capsules 59743-004 CA Butalbital 50 Dunhall Pharmacal Inc Triaprin 00217-2811 CA Butalbital 50 Duramed Pharmaceuticals Butalbital, Acetaminophen and Caffeine Tablets 51285-0849 TB Butalbital 50 EconoMed Pharmaceuticals, Inc ARCET Capsules 38130-0325 CA Butalbital 50 EconoMed Pharmaceuticals, Inc ARCET Compound Tablets 38130-0111 TB Butalbital 50 Equipharm Corp EQUI-CET Tablets 57779-0111 TB Butalbital 50 Everett Laboratories, Inc Repan Capsules 00642-0164 CA Butalbital 50 Everett Laboratories, Inc Repan Capsules 00642-0163 CA Butalbital 50 Everett Laboratories, Inc Repan Tablets 00642-0162-10 TB Butalbital 50 Forest Pharmacal Inc Acetaminophen 325 mg/Butalbital 50 mg 00456-0674 TB Butalbital 50 Forest Pharmacal Inc Acetaminophen 500 mg/Butalbital 50 mg 00456-0671 TB Butalbital 50 Forest Pharmacal Inc Bancap 00456-0546 CA Butalbital 50 Forest Pharmacal Inc Esgic Capsules 00456-0631 CA Butalbital 50 Forest Pharmacal Inc ESGIC PLUS Capsules 00456-0679 CA Butalbital 50 Forest Pharmacal Inc Esgic Tablets 00456-0630 TB Butalbital 50 Forest Pharmacal Inc ESGIC-PLUS 00456-0678 TB Butalbital 50 Genetco Inc Butalbital, Apap and Caffeine 00302-0490 TB Butalbital 50 Geneva Pharmaceuticals, Inc Butalbital, Acetaminophen and Caffeine Tablets 00781-1901 TB Butalbital 50 GM Pharmaceuticals (Manufactured by Mikart, Inc.) Vanatol S (Butalbital, Acetaminophen, & Caffeine Soln 50/325/40 58809-359 LQ Butalbital 50 GM Pharmaceuticals (Manufactured by Mikart, Inc.) Vanatol LQ (Butalbital, Acetaminophen, & Caffeine Soln 50/325/40 58809-820 LQ Butalbital 50 Goldline Laboratories Butalbital, APAP and Caffeine Tablets 00182-1274 TB Butalbital 50 GSMS Incorporated Butalbital, Acetaminophen and Caffeine Tablets USP (50/325/40) 60429-589 TB Butalbital 50 GSMS Incorporated Butalbital, Acetaminophen and Caffeine Capsules USP (50/300/40) 51407-200 CA Butalbital 50 Halsey Drug Co Inc Blue Cross Butalbital, APAP and Caffeine Tablets 00879-0567 TB Butalbital 50 Halsey Drug Co Inc Butalbital and Acetaminophen Tablets 00879-0543 TB Butalbital 50 Hyrex Pharmaceutical Two-Dyne Revised 00314-2229 TB Butalbital 50 International Ethical Laboratories, Inc Tencon Tablets 11584-029-01 TB Butalbital 50 Interstate Drug Exchange IDE-Cet Tablets 00814-3820 TB Butalbital 50 Intetlab CON-TEN 11584-1029 CA Butalbital 50 Inwood Laboratories, Inc Butalbital, Acetaminophen and Caffeine Tablets, USP 0258-3657 TB Butalbital 50 Keene Pharmacal Inc Endolar 00588-7777 CA Butalbital 50 Kenco Axotal 00013-1301 TB Butalbital 50 Landry Pharmacal Inc Febridyne Plain Capsules 05383-001 CA Butalbital 50 Larken Laboratories, Inc Butalbital and Acetaminophen Tablets (25 mg/325 mg) 68047-722 TB Butalbital 25 Lasalle Laboratories Pacaps Modified Formula 48534-0884 CA Butalbital 50 Lemmon Company Acetaminophen/Butalbital/Caffeine Tablets 00093-0854 TB Butalbital 50 LGM Pharma Solutions, LLC Butalbital, Acetaminophen and Caffeine Capsules (50/300/40 mg) 79739-7029 CA Butalbital 50 LGM Pharma Solutions, LLC Butalbital and Acetaminophen Tablets (50/300 mg) 79739-7075 TB Butalbital 50 Lunsco Inc Pacaps Capsules 10892-0116 CA Butalbital 50 Major Pharmaceuticals Fabophen Tablets 00904-3280 TB Butalbital 50 Mallard Consumer Products Anaquan Tablets 59441-0343 TB Butalbital 50 Mallard Inc Anoquan Modified Formula 00166-0881 CA Butalbital 50 Mallinckrodt Inc Butalbital, Acetaminophen, and Caffeine (“BAC”) Tablets USP 00406-0970 TB Butalbital 50 Marlop Pharmacal Inc Dolmar 12939-0812 CA Butalbital 50 Marnel Pharmaceuticals Margesic Capsules 00682-0804 CA Butalbital 50 Marnel Pharmaceuticals Marten-Tab Tablets 00682-1400 TB Butalbital 50 Martec Pharmacal Inc Butalbital, Acetaminophen and Caffeine Tablets 52555-0079 TB Butalbital 50 Mayne Pharma Butalbital, Acetaminophen, & Caffeine Capsules 50/300/40 51862-542 CA Butalbital 50 Mayrand Pharmaceuticals, Inc Sedapap-10 Tablets 00259-1278 TB Butalbital 50 Midlothian Laboratories (Manufactured by Mikart, Inc.) Esgic (Butalbital, Acetaminophen, & Caffeine Capsules 50/325/40 68308-219 CA Butalbital 50 Midlothian Laboratories (Manufactured by Mikart, Inc.) Esgic (Butalbital, Acetaminophen, & Caffeine Tablets 50/325/40 68308-220 TB Butalbital 50 Midlothian Laboratories (Manufactured by Mikart, Inc.) Zebutal (Butalbital, Acetaminophen, & Caffeine Capsules 50/325/40 68308-554 CA Butalbital 50 Mikart, Inc Alagesic Capsules 50991-302 CA Butalbital 50 Mikart, Inc Bupap 00095-0240 TB Butalbital 50 Mikart, Inc Butalbital and Acetaminophen Tablets 50/325 46672-0099 TB Butalbital 50 Mikart, Inc Butalbital and Acetaminophen Tablets 50/650 11584-0029 TB Butalbital 50 Mikart, Inc Butalbital and Acetaminophen Tablets 50/650 46672-0098 TB Butalbital 50 Mikart, Inc Butalbital, Acetaminophen and Caffeine Capsules 46672-0228 CA Butalbital 50 Mikart, Inc Butalbital, Acetaminophen and Caffeine Capsules 00588-7788 CA Butalbital 50 Mikart, Inc Butalbital, Acetaminophen and Caffeine Eilixer 46672-0633 EL Butalbital 50 Mikart, Inc Butalbital, Acetaminophen and Caffeine Tablets 52555-0647 TB Butalbital 50 Mikart, Inc Butalbital, Acetaminophen and Caffeine Tablets USP 49884-0811 TB Butalbital 50 Mikart, Inc Butalbital, Acetaminophen and Caffeine Tablets USP 00258-3665 TB Butalbital 50 Mikart, Inc Butalbital, Acetaminophen and Caffeine Tablets USP (50/325/40) 51862-540 TB Butalbital 50 Mikart, Inc Butalbital, Acetaminophen and Caffeine Tablets, USP 0591-3416 TB Butalbital 50 Mikart, Inc Butalbital and Acetaminophen Capsules 50/300 46672-286 CA Butalbital 50 Mikart, Inc Butalbital and Acetaminophen Tablets 50/300 46672-856 TB Butalbital 50 Mikart, Inc Butalbital, Acetaminophen and Caffeine Tablets, USP 46672-184 TB Butalbital 50 Mikart, Inc Butalbital, Acetaminophen, and Caffeine Oral Solution 66813-073 LQ Butalbital 50 Mikart, Inc Butalbital, Acetaminophen, and Caffeine Tablets 51432-0034 TB Butalbital 50 Mikart, Inc Butalbital, Acetaminophen, and Caffeine Tablets 46672-0059 TB Butalbital 50 Mikart, Inc Capacet (Butalbital, Acetaminophen, and Caffeine 50/325/40) 58407-534 CA Butalbital 50 Mikart, Inc Cephadyn Tablets 59702-0650 TB Butalbital 50 Mikart, Inc Dolgic Plus Tablets 68453-074 TB Butalbital 50 Mikart, Inc Dolgic Tablets 62022-0073 TB Butalbital 50 Mikart, Inc DOLMAR Tablets 12939-0811 TB Butalbital 50 Mikart, Inc Esgic Capsules 00535-0012 CA Butalbital 50 Mikart, Inc Esgic Tablets 00535-0011 TB Butalbital 50 Mikart, Inc Promacet 58605-524 TB Butalbital 50 Mikart, Inc Sedapap Tablets 00259-0392 TB Butalbital 50 Mikart, Inc. (on behalf of Mayne Pharma) Butalbital and Acetaminophen Capsules 50/300 51862-544 CA Butalbital 50 Mikart, Inc. (on behalf of Mayne Pharma) Butalbital and Acetaminophen Tablets 50/300 51862-538 TB Butalbital 50 Mikart, Inc. (on behalf of Monarch PCM, LLC) Vtol LQ (Butalbital, Acetaminophen, Caffeine Oral Solution) 70154-111 LQ Butalbital 50 Mikart, Inc./Shionogi, Inc Dolgic Plus Tablets 59630-074 TB Butalbital 50 Moore Medical Corporation Butalbital, Acetaminophen and Caffeine Tablets 00839-7831 TB Butalbital 50 Nexgen Pharma BUPAP (Butalbital and Acetaminophen 50mg/300mg) 0095-3000 TB Butalbital 50 Nexgen Pharma Butalbital with Acetaminophen and Caffeine Tablets 0722-7029 TB Butalbital 50 Nexgen Pharma Butalbital, Acetaminophen and Caffeine Tablets(50mg/325mg/40mg) 0722-7320 TB Butalbital 50 Northampton Medical, Inc FEMCET 58436-0703 TB Butalbital 50 PD-Rx Pharmaceuticals, Inc Butalbital/APAP/Caffeine Tablets (50mg/325mg/40mg) 55289-0879 TB Butalbital 50 Pharmaceutical Basics Inc Butalbital, Acetaminophen and Caffeine Tablets 00832-1102 TB Butalbital 50 Phlight Pharma, LLC Allzital (Butalbital and Acetaminophen Tablets (25 mg/325 mg)) 70569-150 TB Butalbital 25 Poly Pharmaceuticals, Inc Alagesic 50991-0302 CA Butalbital 50 Private Formula Inc Sangesic 00511-1627 TB Butalbital 30 ProficientRx Butalb/Acet/Caffeine 50mg/300mg/40mg 71205-962 CA Butalbital 50 Qualitest Pharmaceuticals, Inc Butalbital, Acetaminophen and Caffeine Tablets 50/325/40mg 0603-2544 TB Butalbital 50 Qualitest Pharmaceuticals, Inc Butalbital, Acetaminophen and Caffeine Tablets USP 0603-2547 TB Butalbital 50 Qualitest Pharmaceuticals, Inc Butalbital, Acetaminophen and Caffeine Tablets, USP 0603-2551 TB Butalbital 50 Qualitest Products Inc Butalbital, Acetaminophen and Caffeine Tablets 52446-0544 TB Butalbital 50 Redi-Med Butalbital Compound Capsules 53506-0103 CA Butalbital 50 Roberts Pharmaceutical Corporation Anoquan 54092-0178 TB Butalbital 50 Roberts Pharmaceutical Corporation Tencet Tablets 59441-0153 TB Butalbital 50 Rotex Pharmaceuticals, Inc Rogesic Capsules 31190-0008 CA Butalbital 50 Rugby Laboratories Inc Butalbital, Acetaminophen and Caffeine Tablets, USP 0536-5567 TB Butalbital 50 Rugby Laboratories Inc ISOCET Tablets 00536-3951 TB Butalbital 50 Russ Pharmaceuticals, Inc FEMCET Capsules 50474-0703 CA Butalbital 50 Savage Laboratories AXOTAL 00281-1301 TB Butalbital 50 Shoals Pharmaceuticals, Inc Tencet 47649-0370 TB Butalbital 50 Shoals Pharmaceuticals, Inc Tencet Capsules 47649-0560 CA Butalbital 50 Skylar Laboratories, LLC Allzital (Butalbital and Acetaminophen Tablets) (25 mg/325 mg) 70362-722 TB Butalbital 25 Skylar Laboratories, LLC Butalbital and Acetaminophen Tablets (50 mg/325 mg) 70362-721 TB Butalbital 50 Solubiomix Butalbital and Acetaminophen Tablets (50 mg/325 mg) 69499-302 TB Butalbital 50 Solubiomix Butalbital and Acetaminophen Capsules (50 mg/300 mg) 69499-342 CA Butalbital 50 Stewart Jackson Pharmacal, Inc Ezol 45985-0578 CA Butalbital 50 STI Pharma, LLC Butalbital and Acetaminophen Tablets (50 mg/325 mg) 54879-026 TB Butalbital 50 Tedor Pharma, Inc Butalbital and Acetaminophen Tablets (50 mg/300 mg) 47781-534 TB Butalbital 50 Tedor Pharma, Inc Butalbital and Acetaminophen Tablets (50 mg/325 mg) 43199-053 TB Butalbital 50 Tedor Pharma, Inc. (Manufactured for Xspire Pharma) Butalbital, Acetaminophen and Caffeine Caps (50mg/300mg/40mg) 42195-955 CA Butalbital 50 Trimen Labs Amaphen Capsules (reformulated) 11311-0954 CA Butalbital 50 U.S. Pharmaceuticals Medigesic Capsules 52747-0600 CA Butalbital 50 UAD Laboratories Inc Bucet Capsules 00785-2307 CA Butalbital 50 US Pharmaceuticals Inc Medigesic Tablets 52747-0311 TB Butalbital 50 Valeant Pharmaceuticals Phrenilin Forte 0187-0844 CA Butalbital 50 Victory Pharma Inc. (Manuf. By West-Ward Pharmaceutical) Zebutal Brand Butalbital, Acetaminophen, and Caffeine Capsules 68453-170 CA Butalbital 50 WE Hauck Inc G-1 Capsules 43797-0244 CA Butalbital 50 West-Ward Pharmaceutical Corp Butalbital with Acetaminophen and Caffeine Tablets 00143-1787 TB Butalbital 50 West-Ward Pharmaceutical Corp Butalbital, Acetaminophen and Caffein Capsules 00143-3001 CA Butalbital 50 West-Ward Pharmaceutical Corp Butalbital, Acetaminophen, and Caffeine Tablets, USP 00143-1115 TB Butalbital 50 West-Ward Pharmaceutical Corp Zebutal Brand Butalbital, Acetaminophen, and Caffeine Capsules 59630-0170 CA Butalbital 50 Wraser Pharmaceuticals Phrenilin Forte (Butalbital, Acetaminophen and Caffeine) 50/300/40 66992-955 CA Butalbital 50 Zenith Goldline Pharmaceuticals Butalbital, Acetaminophen and Caffeine Tablets 00182-2659 TB Butalbital 50 Regulatory Analyses Executive Orders 12866, 13563, 14192, and 14294 DEA has determined that this proposed rulemaking is not a “significant regulatory action” under section 3(f) of E.O. 12866, Regulatory Planning and Review. This proposed 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,” as this action is neither a deregulation nor invokes criminal penalties. Executive Order 12988, Civil Justice Reform This proposed 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 proposed rulemaking does not have federalism implications warranting the application of E.O. 13132. The proposed rule does not have substantial direct effects on the States, on the relationship between the national government and the States, or the distribution of power and responsibilities among the various levels of government. Executive Order 13175, Consultation and Coordination With Indian Tribal Governments This proposed 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, 8 has reviewed this proposed 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. 8 5 U.S.C. 601-602. Unfunded Mandates Reform Act of 1995 In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 9 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. 9 2 U.S.C. 1501 et seq. Paperwork Reduction Act of 1995 This proposed rule would not impose a new collection of information under the Paperwork Reduction Act of 1995. 10 Also, this proposed rule would not impose new or modify existing recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations. 10 44 U.S.C. 3501-3521. Signing Authority This document of the Drug Enforcement Administration was signed on May 14, 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 . Heather Achbach, Federal Register Liaison Officer, Drug Enforcement Administration. [FR Doc. 2026-10379 Filed 5-22-26; 8:45 am] BILLING CODE 4410-09-P --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2026-10379. Public record. Not legal advice.