Schedules of Controlled Substances; Removal of Exemption Status for Inactive Butalbital Products
Federal RegisterMay 26, 2026
Ask Donna
What actually matters in this document.
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
This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.