Proposed Rule2026-10379
Schedules of Controlled Substances; Removal of Exemption Status for Inactive Butalbital Products
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Published
May 26, 2026
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 91 Issue 100 (Tuesday, May 26, 2026)</title>
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<body><pre>
[Federal Register Volume 91, Number 100 (Tuesday, May 26, 2026)]
[Proposed Rules]
[Pages 30527-30532]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-10379]
[[Page 30527]]
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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.
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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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="http://Regulations.gov">Regulations.gov</a>. If you have received a Comment Tracking
Number, you have successfully submitted your comment, and there is no
need to resubmit the same comment.
<bullet> 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
<a href="http://www.regulations.gov">www.regulations.gov</a>.
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>, 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 <a href="http://www.regulations.gov">http://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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\
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\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).
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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
[[Page 30528]]
1308.32, can be found on the DEA Diversion Control Division website.\4\
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\4\ Available at <a href="https://www.deadiversion.usdoj.gov/schedules/exempt/exempt_rx_list.pdf">https://www.deadiversion.usdoj.gov/schedules/exempt/exempt_rx_list.pdf</a>.
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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.
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\5\ 21 CFR 1308.13(c)(3).
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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.
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\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.
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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 (Butalbital and 0281-0389 TB Butalbital.......... 50
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).
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 Capsules... 51674-0009 CA Butalbital.......... 50
Cardinal Health............... Butalbital, 55154-7988 TB Butalbital.......... 50
Acetaminophen and
Caffeine Tablets 50mg/
325mg/40mg.
[[Page 30529]]
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 Capsules.. 62022-0070 CA Butalbital.......... 50
CTEX Pharmaceuticals, Inc..... Butex Forte Capsules.. 62022-0074 CA Butalbital.......... 50
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 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/ 00456-0674 TB Butalbital.......... 50
Butalbital 50 mg.
Forest Pharmacal Inc.......... Acetaminophen 500 mg/ 00456-0671 TB Butalbital.......... 50
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 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 00302-0490 TB Butalbital.......... 50
Caffeine.
Geneva Pharmaceuticals, Inc... Butalbital, 00781-1901 TB Butalbital.......... 50
Acetaminophen and
Caffeine Tablets.
GM Pharmaceuticals Vanatol S (Butalbital, 58809-359 LQ Butalbital.......... 50
(Manufactured by Mikart, Acetaminophen, &
Inc.). 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 and 00182-1274 TB Butalbital.......... 50
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 Butalbital, 00879-0567 TB Butalbital.......... 50
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
Marnel Pharmaceuticals........ Margesic Capsules..... 00682-0804 CA Butalbital.......... 50
Marnel Pharmaceuticals........ Marten-Tab Tablets.... 00682-1400 TB Butalbital.......... 50
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 Tablets.... 00259-1278 TB Butalbital.......... 50
[[Page 30530]]
Midlothian Laboratories Esgic (Butalbital, 68308-219 CA Butalbital.......... 50
(Manufactured by Mikart, Acetaminophen, &
Inc.). Caffeine Capsules 50/
325/40.
Midlothian Laboratories Esgic (Butalbital, 68308-220 TB Butalbital.......... 50
(Manufactured by Mikart, Acetaminophen, &
Inc.). Caffeine Tablets 50/
325/40.
Midlothian Laboratories Zebutal (Butalbital, 68308-554 CA Butalbital.......... 50
(Manufactured by Mikart, Acetaminophen, &
Inc.). Caffeine Capsules 50/
325/40.
Mikart, Inc................... Alagesic Capsules..... 50991-302 CA Butalbital.......... 50
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 (Butalbital, 58407-534 CA Butalbital.......... 50
Acetaminophen, and
Caffeine 50/325/40).
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 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 (Butalbital, 70154-111 LQ Butalbital.......... 50
Monarch PCM, LLC). Acetaminophen,
Caffeine Oral
Solution).
Mikart, Inc./Shionogi, Inc.... Dolgic Plus Tablets... 59630-074 TB Butalbital.......... 50
Moore Medical Corporation..... Butalbital, 00839-7831 TB Butalbital.......... 50
Acetaminophen and
Caffeine Tablets.
Nexgen Pharma................. BUPAP (Butalbital and 0095-3000 TB Butalbital.......... 50
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 (Butalbital 70569-150 TB Butalbital.......... 25
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/Caffeine 71205-962 CA Butalbital.......... 50
50mg/300mg/40mg.
Qualitest Pharmaceuticals, Inc Butalbital, 0603-2544 TB Butalbital.......... 50
Acetaminophen and
Caffeine Tablets 50/
325/40mg.
Qualitest Pharmaceuticals, Inc Butalbital, 0603-2547 TB Butalbital.......... 50
Acetaminophen and
Caffeine Tablets USP.
Qualitest Pharmaceuticals, Inc Butalbital, 0603-2551 TB Butalbital.......... 50
Acetaminophen and
Caffeine Tablets, USP.
Qualitest Products Inc........ Butalbital, 52446-0544 TB Butalbital.......... 50
Acetaminophen and
Caffeine Tablets.
Redi-Med...................... Butalbital Compound 53506-0103 CA Butalbital.......... 50
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
[[Page 30531]]
Shoals Pharmaceuticals, Inc... Tencet................ 47649-0370 TB Butalbital.......... 50
Shoals Pharmaceuticals, Inc... Tencet Capsules....... 47649-0560 CA Butalbital.......... 50
Skylar Laboratories, LLC...... Allzital (Butalbital 70362-722 TB Butalbital.......... 25
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, Inc Ezol.................. 45985-0578 CA Butalbital.......... 50
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 and
Pharma). Caffeine Caps (50mg/
300mg/40mg).
Trimen Labs................... Amaphen Capsules 11311-0954 CA Butalbital.......... 50
(reformulated).
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 Zebutal Brand 68453-170 CA Butalbital.......... 50
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 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.
---------------------------------------------------------------------------
[[Page 30532]]
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
</pre></body>
</html>Indexed from Federal Register on May 26, 2026.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.