Rule2026-20757
Schedules of Controlled Substances; Removal of Exemption Status for Inactive Butalbital Products
Primary source
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Published
October 9, 2026
Effective
November 9, 2026
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 91 Issue 195 (Friday, October 9, 2026)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-20757]
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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: Final determination.
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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\
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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 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\
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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 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.
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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 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\
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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.
\8\ Schedules of Controlled Substances; Removal of Exemption
Status for Inactive Butalbital Products,
91 FR 30527 (May 26, 2026).
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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.
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\9\ <a href="https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory">https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory</a>.
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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
</pre></body>
</html>Indexed from Federal Register on October 9, 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.