2026-20757: Schedules of Controlled Substances; Removal of Exemption Status for Inactive Butalbital Products

Federal Register, Volume 91 Issue 195 (Friday, October 9, 2026) [Federal Register Volume 91, Number 195 (Friday, October 9, 2026)] [Rules and Regulations] [Pages 64618-64623] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2026-20757] ----------------------------------------------------------------------- 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

Final determination. -----------------------------------------------------------------------

Summary

The Drug Enforcement Administration (DEA) is revoking the exempted status for certain nonnarcotic prescription products that are currently on DEA's Table of Exempted Prescription Products, but whose National Drug Codes (NDC) are inactive because they are no longer available and/or the company that applied for the exemption no longer exists. These products will be removed from DEA's Table of Exempted Prescription Products and will no longer be considered exempt prescription products under the Controlled Substances Act. This action does not impact exempted prescription products with active NDC numbers.

Dates

This final determination is effective on November 9, 2026.

For Further Information Contact

Terrence L. Boos, Ph.D., Diversion Control Division, Drug Enforcement Administration; Telephone: (571) 362-3249.

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\ --------------------------------------------------------------------------- \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 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\ --------------------------------------------------------------------------- \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 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. --------------------------------------------------------------------------- \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 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. [[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\ --------------------------------------------------------------------------- \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. \8\ Schedules of Controlled Substances; Removal of Exemption Status for Inactive Butalbital Products, 91 FR 30527 (May 26, 2026). --------------------------------------------------------------------------- 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. --------------------------------------------------------------------------- \9\ https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory. --------------------------------------------------------------------------- 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: ---------------------------------------------------------------------------------------------------------------- (mg or Company Trade name NDC code Form Controlled substance mg/ml) ---------------------------------------------------------------------------------------------------------------- Alpha Scriptics Inc.......... Butacet Capsules 53121-0133 CA Butalbital........... 50 Alphagen Laboratories, Inc... Butalbital and 00603-2542 CA Butalbital........... 50 Acetaminophen Capsules 50mg/ 650mg. Alphagen Laboratories, Inc... Geone Capsules.. 59743-0004 CA Butalbital........... 50 Altana, Inc.................. Axocet 0281-0389 TB Butalbital........... 50 (Butalbital and Acetaminophen). Althon Pharmaceuticals, Inc.. Butalbital, 66813-074 TB Butalbital........... 50 Acetaminophen and Caffeine Tablets USP. Alvogen, Inc................. Butalbital and 47781-0535 TB Butalbital........... 50 Acetaminophen Tablets USP 50/ 325. Alvogen, Inc................. Butalbital, 47781-0536 TB Butalbital........... 50 Acetaminophen and Caffeine Tablets USP 50/ 325/40. Alvogen, Inc................. Butalbital and 47781-0628 TB Butalbital........... 50 Acetaminophen Tablets 50/325. Alvogen, Inc................. Butalbital, 47781-0625 TB Butalbital........... 50 Acetaminophen and Caffeine Tablets (50/325/ 40). Alvogen, Inc................. Butalbital and 47781-0644 TB Butalbital........... 50 Acetaminophen Tablets (50/ 300). American Pharmaceuticals, Inc AMERICET Tablets 58605-0501 TB Butalbital........... 50 American Urologicals Inc..... Butace.......... 00539-0906 CA Butalbital........... 50 Amerisource Health Services Butalbital, 68084-0396 TB Butalbital........... 50 Corporation. Acetaminophen and Caffeine Tablets 50/325/ 40mg. Aphena Pharma Solutions...... Butalbital, 71610-0042 TB Butalbital........... 50 Acetaminophen and Caffeine Tablets (50/325/ 40mg. Atland Pharmaceuticals....... Butalbital and 71993-301 TB Butalbital........... 25 Acetaminophen Tablets (25 mg/ 325 mg). [[Page 64620]] Atley Pharmaceuticals........ Butalbital, 59702-661 TB Butalbital........... 50 Acetaminophen and Caffeine Tablets. AvKare, Inc.................. Butalbital, 50268-139 TB Butalbital........... 50 Acetaminophen and Caffeine Tablets USP 50/ 325/40. Baucum Laboratories Inc...... Butalbital, 54696-0513 TB Butalbital........... 50 Acetaminophen and Caffeine Tablets. Blansett Pharm Co............ Anolor 300 51674-0009 CA Butalbital........... 50 Capsules. Cardinal Health.............. Butalbital, 55154-7988 TB Butalbital........... 50 Acetaminophen and Caffeine Tablets 50mg/ 325mg/40mg. Cardinal Health.............. Butalbital, 55154-7147 TB Butalbital........... 50 Acetaminophen and Caffeine Tablets 50mg/ 325mg/40mg. Cardinal Health.............. Butalbital, 0904-6538 TB Butalbital........... 50 Acetaminophen and Caffeine Tablets 50mg/ 325mg/40mg. 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 62022-0070 CA Butalbital........... 50 Capsules. CTEX Pharmaceuticals, Inc.... Butex Forte 62022-0074 CA Butalbital........... 50 Capsules. D.M. Graham Laboratories, Inc Butalbital, 00756-0111 TB Butalbital........... 50 Acetaminophen and Caffeine Tablets. Diversified Health Care Geone Capsules.. 59743-004 CA Butalbital........... 50 Services. Dunhall Pharmacal Inc........ Triaprin........ 00217-2811 CA Butalbital........... 50 Duramed Pharmaceuticals...... Butalbital, 51285-0849 TB Butalbital........... 50 Acetaminophen and Caffeine Tablets. EconoMed Pharmaceuticals, Inc ARCET Capsules.. 38130-0325 CA Butalbital........... 50 EconoMed Pharmaceuticals, Inc ARCET Compound 38130-0111 TB Butalbital........... 50 Tablets. 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 00456-0674 TB Butalbital........... 50 325 mg/ Butalbital 50 mg. Forest Pharmacal Inc......... Acetaminophen 00456-0671 TB Butalbital........... 50 500 mg/ Butalbital 50 mg. Forest Pharmacal Inc......... Bancap.......... 00456-0546 CA Butalbital........... 50 Forest Pharmacal Inc......... Esgic Capsules.. 00456-0631 CA Butalbital........... 50 Forest Pharmacal Inc......... ESGIC PLUS 00456-0679 CA Butalbital........... 50 Capsules. Forest Pharmacal Inc......... Esgic Tablets... 00456-0630 TB Butalbital........... 50 Forest Pharmacal Inc......... ESGIC-PLUS...... 00456-0678 TB Butalbital........... 50 Genetco Inc.................. Butalbital, Apap 00302-0490 TB Butalbital........... 50 and Caffeine. Geneva Pharmaceuticals, Inc.. Butalbital, 00781-1901 TB Butalbital........... 50 Acetaminophen and Caffeine Tablets. GM Pharmaceuticals Vanatol S 58809-359 LQ Butalbital........... 50 (Manufactured by Mikart, (Butalbital, Inc.). Acetaminophen, & Caffeine Soln 50/325/40. GM Pharmaceuticals Vanatol LQ 58809-820 LQ Butalbital........... 50 (Manufactured by Mikart, (Butalbital, Inc.). Acetaminophen, & Caffeine Soln 50/325/40. Goldline Laboratories........ Butalbital, APAP 00182-1274 TB Butalbital........... 50 and Caffeine Tablets. GSMS Incorporated............ Butalbital, 60429-589 TB Butalbital........... 50 Acetaminophen and Caffeine Tablets USP (50/ 325/40). GSMS Incorporated............ Butalbital, 51407-200 CA Butalbital........... 50 Acetaminophen and Caffeine Capsules USP (50/300/40). Halsey Drug Co Inc........... Blue Cross 00879-0567 TB Butalbital........... 50 Butalbital, APAP and Caffeine Tablets. Halsey Drug Co Inc........... Butalbital and 00879-0543 TB Butalbital........... 50 Acetaminophen Tablets. Hyrex Pharmaceutical......... Two-Dyne Revised 00314-2229 TB Butalbital........... 50 International Ethical Tencon Tablets.. 11584-029-01 TB Butalbital........... 50 Laboratories, Inc. Interstate Drug Exchange..... IDE-Cet Tablets. 00814-3820 TB Butalbital........... 50 Intetlab..................... CON-TEN......... 11584-1029 CA Butalbital........... 50 Inwood Laboratories, Inc..... Butalbital, 0258-3657 TB Butalbital........... 50 Acetaminophen and Caffeine Tablets, USP. Keene Pharmacal Inc.......... Endolar......... 00588-7777 CA Butalbital........... 50 Kenco........................ Axotal.......... 00013-1301 TB Butalbital........... 50 Landry Pharmacal Inc......... Febridyne Plain 05383-001 CA Butalbital........... 50 Capsules. Larken Laboratories, Inc..... Butalbital and 68047-722 TB Butalbital........... 25 Acetaminophen Tablets (25 mg/ 325 mg). Lasalle Laboratories......... Pacaps Modified 48534-0884 CA Butalbital........... 50 Formula. Lemmon Company............... Acetaminophen/ 00093-0854 TB Butalbital........... 50 Butalbital/ Caffeine Tablets. LGM Pharma Solutions, LLC.... Butalbital, 79739-7029 CA Butalbital........... 50 Acetaminophen and Caffeine Capsules (50/ 300/40 mg). LGM Pharma Solutions, LLC.... Butalbital and 79739-7075 TB Butalbital........... 50 Acetaminophen Tablets (50/300 mg). 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 00166-0881 CA Butalbital........... 50 Formula. Mallinckrodt Inc............. Butalbital, 00406-0970 TB Butalbital........... 50 Acetaminophen, and Caffeine (``BAC'') Tablets USP. Marlop Pharmacal Inc......... Dolmar.......... 12939-0812 CA Butalbital........... 50 [[Page 64621]] Marnel Pharmaceuticals....... Margesic 00682-0804 CA Butalbital........... 50 Capsules. Marnel Pharmaceuticals....... Marten-Tab 00682-1400 TB Butalbital........... 50 Tablets. Martec Pharmacal Inc......... Butalbital, 52555-0079 TB Butalbital........... 50 Acetaminophen and Caffeine Tablets. Mayne Pharma................. Butalbital, 51862-542 CA Butalbital........... 50 Acetaminophen, & Caffeine Capsules 50/300/ 40. Mayrand Pharmaceuticals, Inc. Sedapap-10 00259-1278 TB Butalbital........... 50 Tablets. Midlothian Laboratories Esgic 68308-219 CA Butalbital........... 50 (Manufactured by Mikart, (Butalbital, Inc.). Acetaminophen, & Caffeine Capsules 50/325/ 40. Midlothian Laboratories Esgic 68308-220 TB Butalbital........... 50 (Manufactured by Mikart, (Butalbital, Inc.). Acetaminophen, & Caffeine Tablets 50/325/ 40. Midlothian Laboratories Zebutal 68308-554 CA Butalbital........... 50 (Manufactured by Mikart, (Butalbital, Inc.). Acetaminophen, & Caffeine Capsules 50/325/ 40. Mikart, Inc.................. Alagesic 50991-302 CA Butalbital........... 50 Capsules. Mikart, Inc.................. Bupap........... 00095-0240 TB Butalbital........... 50 Mikart, Inc.................. Butalbital and 46672-0099 TB Butalbital........... 50 Acetaminophen Tablets 50/325. Mikart, Inc.................. Butalbital and 11584-0029 TB Butalbital........... 50 Acetaminophen Tablets 50/650. Mikart, Inc.................. Butalbital and 46672-0098 TB Butalbital........... 50 Acetaminophen Tablets 50/650. Mikart, Inc.................. Butalbital, 46672-0228 CA Butalbital........... 50 Acetaminophen and Caffeine Capsules. Mikart, Inc.................. Butalbital, 00588-7788 CA Butalbital........... 50 Acetaminophen and Caffeine Capsules. Mikart, Inc.................. Butalbital, 46672-0633 EL Butalbital........... 50 Acetaminophen and Caffeine Eilixer. Mikart, Inc.................. Butalbital, 52555-0647 TB Butalbital........... 50 Acetaminophen and Caffeine Tablets. Mikart, Inc.................. Butalbital, 49884-0811 TB Butalbital........... 50 Acetaminophen and Caffeine Tablets USP. Mikart, Inc.................. Butalbital, 00258-3665 TB Butalbital........... 50 Acetaminophen and Caffeine Tablets USP. Mikart, Inc.................. Butalbital, 51862-540 TB Butalbital........... 50 Acetaminophen and Caffeine Tablets USP (50/ 325/40). Mikart, Inc.................. Butalbital, 0591-3416 TB Butalbital........... 50 Acetaminophen and Caffeine Tablets, USP. Mikart, Inc.................. Butalbital and 46672-286 CA Butalbital........... 50 Acetaminophen Capsules 50/300. Mikart, Inc.................. Butalbital and 46672-856 TB Butalbital........... 50 Acetaminophen Tablets 50/300. Mikart, Inc.................. Butalbital, 46672-184 TB Butalbital........... 50 Acetaminophen and Caffeine Tablets, USP. Mikart, Inc.................. Butalbital, 66813-073 LQ Butalbital........... 50 Acetaminophen, and Caffeine Oral Solution. Mikart, Inc.................. Butalbital, 51432-0034 TB Butalbital........... 50 Acetaminophen, and Caffeine Tablets. Mikart, Inc.................. Butalbital, 46672-0059 TB Butalbital........... 50 Acetaminophen, and Caffeine Tablets. Mikart, Inc.................. Capacet 58407-534 CA Butalbital........... 50 (Butalbital, Acetaminophen, and Caffeine 50/ 325/40). Mikart, Inc.................. Cephadyn Tablets 59702-0650 TB Butalbital........... 50 Mikart, Inc.................. Dolgic Plus 68453-074 TB Butalbital........... 50 Tablets. 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 Butalbital and 51862-544 CA Butalbital........... 50 Mayne Pharma). Acetaminophen Capsules 50/300. Mikart, Inc. (on behalf of Butalbital and 51862-538 TB Butalbital........... 50 Mayne Pharma). Acetaminophen Tablets 50/300. Mikart, Inc. (on behalf of Vtol LQ 70154-111 LQ Butalbital........... 50 Monarch PCM, LLC). (Butalbital, Acetaminophen, Caffeine Oral Solution). Mikart, Inc./Shionogi, Inc... Dolgic Plus 59630-074 TB Butalbital........... 50 Tablets. Moore Medical Corporation.... Butalbital, 00839-7831 TB Butalbital........... 50 Acetaminophen and Caffeine Tablets. Nexgen Pharma................ BUPAP 0095-3000 TB Butalbital........... 50 (Butalbital and Acetaminophen 50mg/300mg). Nexgen Pharma................ Butalbital with 0722-7029 TB Butalbital........... 50 Acetaminophen and Caffeine Tablets. Nexgen Pharma................ Butalbital, 0722-7320 TB Butalbital........... 50 Acetaminophen and Caffeine Tablets(50mg/ 325mg/40mg). Northampton Medical, Inc..... FEMCET.......... 58436-0703 TB Butalbital........... 50 PD-Rx Pharmaceuticals, Inc... Butalbital/APAP/ 55289-0879 TB Butalbital........... 50 Caffeine Tablets (50mg/ 325mg/40mg). Pharmaceutical Basics Inc.... Butalbital, 00832-1102 TB Butalbital........... 50 Acetaminophen and Caffeine Tablets. Phlight Pharma, LLC.......... Allzital 70569-150 TB Butalbital........... 25 (Butalbital and Acetaminophen Tablets (25 mg/ 325 mg)). Poly Pharmaceuticals, Inc.... Alagesic........ 50991-0302 CA Butalbital........... 50 Private Formula Inc.......... Sangesic........ 00511-1627 TB Butalbital........... 30 ProficientRx................. Butalb/Acet/ 71205-962 CA Butalbital........... 50 Caffeine 50mg/ 300mg/40mg. [[Page 64622]] Qualitest Pharmaceuticals, Butalbital, 0603-2544 TB Butalbital........... 50 Inc. Acetaminophen and Caffeine Tablets 50/325/ 40mg. Qualitest Pharmaceuticals, Butalbital, 0603-2547 TB Butalbital........... 50 Inc. Acetaminophen and Caffeine Tablets USP. Qualitest Pharmaceuticals, Butalbital, 0603-2551 TB Butalbital........... 50 Inc. Acetaminophen and Caffeine Tablets, USP. Qualitest Products Inc....... Butalbital, 52446-0544 TB Butalbital........... 50 Acetaminophen and Caffeine Tablets. Redi-Med..................... Butalbital 53506-0103 CA Butalbital........... 50 Compound Capsules. Roberts Pharmaceutical Anoquan......... 54092-0178 TB Butalbital........... 50 Corporation. Roberts Pharmaceutical Tencet Tablets.. 59441-0153 TB Butalbital........... 50 Corporation. Rotex Pharmaceuticals, Inc... Rogesic Capsules 31190-0008 CA Butalbital........... 50 Rugby Laboratories Inc....... Butalbital, 0536-5567 TB Butalbital........... 50 Acetaminophen and Caffeine Tablets, USP. 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 70362-722 TB Butalbital........... 25 (Butalbital and Acetaminophen Tablets) (25 mg/ 325 mg). Skylar Laboratories, LLC..... Butalbital and 70362-721 TB Butalbital........... 50 Acetaminophen Tablets (50 mg/ 325 mg). Solubiomix................... Butalbital and 69499-302 TB Butalbital........... 50 Acetaminophen Tablets (50 mg/ 325 mg). Solubiomix................... Butalbital and 69499-342 CA Butalbital........... 50 Acetaminophen Capsules (50 mg/ 300 mg). Stewart Jackson Pharmacal, Ezol............ 45985-0578 CA Butalbital........... 50 Inc. STI Pharma, LLC.............. Butalbital and 54879-026 TB Butalbital........... 50 Acetaminophen Tablets (50 mg/ 325 mg). Tedor Pharma, Inc............ Butalbital and 47781-534 TB Butalbital........... 50 Acetaminophen Tablets (50 mg/ 300 mg). Tedor Pharma, Inc............ Butalbital and 43199-053 TB Butalbital........... 50 Acetaminophen Tablets (50 mg/ 325 mg). Tedor Pharma, Inc. Butalbital, 42195-955 CA Butalbital........... 50 (Manufactured for Xspire Acetaminophen Pharma). and Caffeine Caps (50mg/ 300mg/40mg). Trimen Labs.................. Amaphen Capsules 11311-0954 CA Butalbital........... 50 (reformulated). U.S. Pharmaceuticals......... Medigesic 52747-0600 CA Butalbital........... 50 Capsules. UAD Laboratories Inc......... Bucet Capsules.. 00785-2307 CA Butalbital........... 50 US Pharmaceuticals Inc....... Medigesic 52747-0311 TB Butalbital........... 50 Tablets. Valeant Pharmaceuticals...... Phrenilin Forte. 0187-0844 CA Butalbital........... 50 Victory Pharma Inc. (Manuf. Zebutal Brand 68453-170 CA Butalbital........... 50 By West-Ward Pharmaceutical). Butalbital, Acetaminophen, and Caffeine Capsules. WE Hauck Inc................. G-1 Capsules.... 43797-0244 CA Butalbital........... 50 West-Ward Pharmaceutical Corp Butalbital with 00143-1787 TB Butalbital........... 50 Acetaminophen and Caffeine Tablets. West-Ward Pharmaceutical Corp Butalbital, 00143-3001 CA Butalbital........... 50 Acetaminophen and Caffein Capsules. West-Ward Pharmaceutical Corp Butalbital, 00143-1115 TB Butalbital........... 50 Acetaminophen, and Caffeine Tablets, USP. West-Ward Pharmaceutical Corp Zebutal Brand 59630-0170 CA Butalbital........... 50 Butalbital, Acetaminophen, and Caffeine Capsules. Wraser Pharmaceuticals....... Phrenilin Forte 66992-955 CA Butalbital........... 50 (Butalbital, Acetaminophen and Caffeine) 50/300/40. Zenith Goldline Butalbital, 00182-2659 TB Butalbital........... 50 Pharmaceuticals. Acetaminophen and Caffeine Tablets. ---------------------------------------------------------------------------------------------------------------- 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 [[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. --------------------------------------------------------------------------- \10\ 5 U.S.C. 601-602. --------------------------------------------------------------------------- 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. --------------------------------------------------------------------------- \11\ 2 U.S.C. 1501 et seq. --------------------------------------------------------------------------- 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. --------------------------------------------------------------------------- \12\ 44 U.S.C. 3501-3521. --------------------------------------------------------------------------- * * * * * 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. Heather Achbach, Federal Register Liaison Officer, Drug Enforcement Administration. [FR Doc. 2026-20757 Filed 10-8-26; 8:45 am] BILLING CODE 4410-09-P