[Federal Register Volume 87, Number 70 (Tuesday, April 12, 2022)]
[Proposed Rules]
[Pages 21588-21599]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-07572]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-384]
RIN 1117-AB75


Schedules of Controlled Substances; Exempted Prescription 
Products

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Drug Enforcement Administration proposes to revoke the 
exempted prescription product status for all butalbital products 
previously granted exemptions. Upon publication of a final rule, these 
products shall become subject to all schedule III controls under the 
Controlled Substances Act. If finalized, this action would impose the 
regulatory controls and administrative, civil, and criminal sanctions 
applicable to schedule III controlled substances on persons who handle 
(manufacture, distribute, import, export, engage in research, conduct 
instructional activities or chemical analysis, or possess) or propose 
to handle butalbital products. This rulemaking also proposes to make 
changes to our regulations to clarify that DEA may revoke ``(either 
individually or categorically)'' any previously granted exemptions, and 
adds regulations to clarify that products exempted from application of 
all or any part of the Controlled Substances Act are listed in the 
Table of Exempted Prescription Products available on the DEA Diversion 
Control website (https://www.deadiversion.usdoj.gov/).

DATES: Comments must be submitted electronically or postmarked on or 
before May 12, 2022.

ADDRESSES: Interested persons may file written comments on this 
proposal in accordance with 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-384'' on all correspondence, including any 
attachments.
     Electronic comments: The Drug Enforcement Administration 
(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., Chief (DOE), 
Diversion Control Division, Drug Enforcement Administration; Telephone: 
(202) 362-3249.

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

[[Page 21589]]

cause is given. Such information includes personal identifying 
information (such as your name, address, etc.) voluntarily submitted by 
the commenter. The Freedom of Information Act applies to all comments 
received. If you want to submit personal identifying information (such 
as your name, address, etc.) as part of your comment, but do not want 
to make it publicly available, you must include the phrase ``PERSONAL 
IDENTIFYING INFORMATION'' in the first paragraph of your comment. You 
must also place all of the personal identifying information you do not 
want made publicly available in the first paragraph of your comment and 
identify what information you want redacted.
    If you want to submit confidential business information as part of 
your comment, but do not want to make it publicly available, you must 
include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the first 
paragraph of your comment. You must also prominently identify 
confidential business information to be redacted within the comment.
    DEA will make publicly available in redacted form comments 
containing personal identifying information and confidential business 
information identified as directed above. If a comment has so much 
confidential business information or personal identifying information 
that DEA cannot redact it effectively, all or part of that comment may 
not be made publicly available. Comments posted to https://www.regulations.gov may include any personal identifying information 
(such as name, address, and phone number) included in the text of your 
electronic submission that is not identified, as directed above, as 
confidential.
    An electronic copy of this document and supplemental information to 
this proposed rule are available at https://www.regulations.gov for 
easy reference.

Legal Authority

    Pursuant to the Controlled Substances Act (CSA), under 21 U.S.C. 
811(g)(3), 21 CFR 1308.31, and 21 CFR 1308.32, the Attorney General 
(and thus the Administrator of DEA by delegation) may, by regulation, 
exempt any compound, mixture, or preparation containing a nonnarcotic 
controlled substance from the application of all or any part of this 
subchapter if he finds that it is approved for prescription use, and 
that it 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. By regulation, the Administrator may 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 in revoking the 
exemption, permitting interested persons to file written comments on or 
objections to the revocation, considering any comments submitted, and 
publishing in the Federal Register a final order on the proposal to 
revoke the exemption. See 21 CFR 1308.31(c), (d).
    This rulemaking proposes to make changes to 21 Code of Federal 
Regulations (CFR) 1308.21(d) to clarify that DEA may revoke ``(either 
individually or categorically)'' any previously granted exemptions, and 
adds Sec.  1308.31(e) to clarify that products exempted from 
application of all or any part of the Controlled Substances Act 
pursuant to section 201(g)(3)(A), of the Act (21 U.S.C. 811(g)(3)(A)) 
are listed in the Table of Exempted Prescription Products available on 
the DEA Diversion Control website. In addition, this rulemaking 
proposes the removal of exempted prescription product status for 
butalbital products previously granted exemption. If finalized, this 
action would impose the regulatory controls and administrative, civil, 
and criminal sanctions of schedule III controlled substances on any 
person who handles or proposes to handle butalbital products that were 
previously exempted from control under 21 CFR 1308.31 and 1308.32.

Background: Exempted Prescription Products

    Over time, 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 at https://www.deadiversion.usdoj.gov/schedules/exempt/exempt_rx_list.pdf. The list, dated February 11, 2022, contains 
189 prescription products containing butalbital. These butalbital 
products were granted exempted status due to the quantity of 
acetaminophen in the formulation, which was believed at the time to 
vitiate the potential for abuse.
    Many of the preparations granted exempted prescription product 
status 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 by BDAC 
in 1967. Following the establishment of the criteria, DEA approved 
subsequent applications by new manufacturers over the years based upon 
the same criteria, whereby the inclusion of other active ingredients 
was thought to be in sufficient quantities to vitiate the potential for 
abuse. These criteria developed in 1967 were 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.
    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 (a) 188 mg aspirin; (b) 375 mg salicylamide; or (c) 
70 mg phenacetin, acetanilid or acetaminophen.
    Butalbital is classified as an intermediate acting barbiturate. 
Butalbital is a schedule III controlled substance that falls under 
Administration Controlled Substances Code Number 2100 as it is a 
derivative of barbituric acid. 21 CFR 1308.13(c)(3). In 1967, products 
such as Fioricet, which contained butalbital (50 mg) in combination 
with acetaminophen (300 mg) and caffeine (40 mg), qualified for the 
exception under the above criteria. However, products such as Fiorinal, 
which contained butalbital (50 mg) in combination with aspirin (325 mg) 
and caffeine (40 mg), did not contain sufficient quantities of aspirin 
to meet the exception criteria, and therefore did not qualify for the 
exception. As such, Fiorinal was a schedule III controlled product, 
while Fioricet and similar butalbital combination products containing 
sufficient amounts of acetaminophen were automatically granted exempted 
prescription product status under the BDAC criteria once an application 
under 21 CFR 1308.31 was received. The rationale behind the difference 
between Fiorinal and Fioricet was that the acetaminophen quantity in

[[Page 21590]]

Fioricet would deter the product's abuse due to the potential liver 
toxicity resulting from the ingestion of high doses of acetaminophen.
    However, subsequent experience has shown that the presence of 
acetaminophen in these butalbital products has not adequately deterred 
abuse and diversion. DEA has observed a pattern of diversion, online 
distribution, and abuse of exempted butalbital products. In particular, 
DEA has observed exploitation of the exempted prescription product 
status of butalbital combination products to enable abuse. Therefore, 
because the inclusion of acetaminophen has not vitiated the abuse 
potential of these products, DEA has concluded that these products do 
not meet the exemption criteria found in 21 U.S.C. 811(g)(3)(A).
    Sellers have utilized websites to exploit the exempted prescription 
product status to make butalbital/acetaminophen and butalbital/
acetaminophen/caffeine combination products available over the 
internet. In addition, DEA has documented a significant number of law 
enforcement encounters with butalbital/acetaminophen and butalbital/
acetaminophen/caffeine products. DEA is actively investigating cases 
where individuals are exploiting the exempted prescription product 
status and are using such products to provide the controlled substance 
butalbital for drug abuse purposes. DEA, therefore, proposes to revoke 
the previously issued exempted prescription product status of all 
butalbital products. Upon publication of a final rule, these products 
shall become subject to the schedule III regulatory controls under the 
CSA.

Increase in Website Activity Relating to Exempted Prescription Products

    The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 
(Pub. L. 110-425) (Ryan Haight Act) was enacted on October 15, 2008 and 
became effective on April 13, 2009. The Ryan Haight Act amended the CSA 
to prevent the illegal distribution and dispensing of controlled 
substances by means of the internet and made it illegal under Federal 
law to ``deliver, distribute, or dispense a controlled substance by 
means of the internet, except as authorized by [the CSA]'' or to aid or 
abet such activity. 21 U.S.C. 841(h)(1). The Ryan Haight Act applies to 
all controlled substances in all schedules.
    Under the Ryan Haight Act, for every controlled substance that is 
delivered, distributed, or sold, there must be a ``valid 
prescription.'' This means not only that the prescription must comply 
with the longstanding requirement of being issued for a legitimate 
medical purpose by a practitioner acting in the usual course of 
professional practice, but also that the prescribing practitioner must 
either (i) have conducted at least one in-person medical evaluation of 
the patient or (ii) meet the definition of a ``covering practitioner.'' 
21 U.S.C. 829(e)(2)(A). Alternatively, a practitioner may write a 
prescription when engaged in the practice of telemedicine under the 
limited circumstances enumerated at 21 U.S.C. 802(54). 21 U.S.C. 
829(e)(3)(A). Any practitioner who writes a prescription for a 
controlled substance that fails to comply with this provision of the 
CSA, as well as any pharmacy that knowingly or intentionally fills such 
a prescription, violates 21 U.S.C. 841(h)(1).
    Hence, the Ryan Haight Act makes it unambiguous that, except in 
limited and specified circumstances, it is a per se violation of the 
CSA for a practitioner to issue a prescription for a controlled 
substance by means of the internet without having conducted at least 
one in-person medical evaluation.
    After the Ryan Haight Act became effective, online pharmacies could 
no longer deliver, distribute, or dispense controlled substances 
without registering with DEA as online pharmacies and complying with 
associated laws and regulations, including the requirement of a 
prescription issued after an in-person medical evaluation of the 
patient in most circumstances. In response, DEA has seen a significant 
increase in the number of online pharmacies highlighting the 
availability of exempted prescription products containing butalbital/
acetaminophen and butalbital/acetaminophen/caffeine and providing 
online dispensing. These sites are thereby exploiting the exempted 
prescription product status so customers can obtain butalbital. Thus, 
DEA finds a need to remove the exempted prescription product status for 
these products. If this proposed rule goes into effect, online 
pharmacies will be required to cease the sale and distribution of the 
products containing butalbital unless they comply with all relevant CSA 
requirements, including the requirements of the Ryan Haight Act and 
associated regulations.
    DEA does not have data for the volume of exempted butalbital 
products dispensed via the internet. Therefore, DEA requests that 
online pharmacies/websites provide such volume data in their comments, 
so DEA can assess the potential impact of this proposed rulemaking.

Seizure Data

    The National Forensic Laboratory Information System (NFLIS),\1\ 
System to Retrieve Information from Drug Evidence (STRIDE), and 
STARLiMS databases \2\ indicate that there were 3,122 butalbital drug 
reports identified that were submitted to Federal, state, and local 
forensic laboratories from January 1, 2010 to December 31, 2020.\3\ In 
2010, there were 402 butalbital reports, 420 reports in 2011, 363 
reports in 2012, 328 reports in 2013, 330 reports in 2014, 340 reports 
in 2015, 302 reports in 2016, 252 reports in 2017, 148 reports in 2018, 
132 reports in 2019 and 105 reports in 2020.
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    \1\ NFLIS is a national drug forensic laboratory reporting 
system that systematically collects results from drug chemistry 
analyses conducted by state and local forensic laboratories across 
the country. The NFLIS participation rate, defined as the percentage 
of the national drug caseload represented by laboratories that have 
joined NFLIS, is over 97 percent. NFLIS includes drug chemistry 
results from completed analyses only.
    \2\ STRIDE is a database of drug exhibits sent to DEA 
laboratories for analysis. Exhibits from the database are from DEA, 
other Federal agencies, and law enforcement agencies. On October 1, 
2014, STARLiMS replaced STRIDE as the DEA laboratory drug evidence 
data system of record.
    \3\ NFLIS database was queried on August 19, 2021, by date of 
submission, all drugs reported; STRIDE and STARLiMS databases were 
queried August 19, 2021, by date of collection, all drug records 
analyzed.
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    For the majority of butalbital exhibits, analytical laboratories 
only identify the active ingredient butalbital. Only a portion of the 
exhibits identifies the other secondary product ingredients. However, 
when secondary ingredients are reported, combinations of butalbital and 
acetaminophen greatly exceed the number of combination products 
containing butalbital and aspirin (or other ingredients) reported. (See 
chart below.)

                              Summary Table
------------------------------------------------------------------------
                                               Percent of     Percent of
                                                reports        reports
               Calendar year                  butalbital/    butalbital/
                                             acetaminophen     aspirin
------------------------------------------------------------------------
2010......................................             29.4          6.0
2011......................................             40.6          4.3
2012......................................             40.6          4.4
2013......................................             37.0          3.7
2014......................................             25.3          2.0
2015......................................             23.7          2.3
2016......................................             21.5          2.9
2017......................................             22.9          1.8
2018......................................             16.2          5.1
2019......................................             21.7          3.3
2020......................................             33.0          2.1
------------------------------------------------------------------------

    Therefore, DEA concludes, based on the data mentioned above, that 
the mere presence of acetaminophen or acetaminophen/caffeine in 
butalbital combination products does not serve to vitiate the potential 
for abuse.

[[Page 21591]]

State Regulatory Controls on Butalbital Products

    At least 15 states have seen a need to place additional regulatory 
requirements on the butalbital products for which DEA has granted 
exempted prescription product status. Alabama, Alaska, California, 
Georgia, Hawaii, Idaho, Illinois, Indiana, Kentucky, Maryland, 
Mississippi, New Mexico, Oklahoma, Pennsylvania, and Utah all subject 
these products to schedule III controls.

Ability To Reapply for Exempted Prescription Product Status

    Any manufacturer of a butalbital/acetaminophen or butalbital/
acetaminophen/caffeine combination product that is subject to this 
rulemaking may reapply for exempted prescription product status by 
following the application procedures specified in 21 CFR 1308.31 if 
they believe that their formulation contains unique attributes which 
demonstrate that their product meets the exemption criteria (e.g., it 
contains one or more 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). 
However, DEA wishes to clarify that the mere presence of acetaminophen 
in the formulation in quantities of greater than 70 mg per 15 mg of 
barbiturate will no longer automatically qualify a butalbital product 
for an exemption unless the applicant can further demonstrate that the 
formulation vitiates the potential for abuse.

Requirements for Handling Schedule III Controlled Substances

    If this proposed rule is adopted in final form, butalbital products 
formerly subject to automatic exemption will become subject to the 
CSA's schedule III regulatory controls and administrative, civil, and 
criminal sanctions applicable to the manufacture, distribution, reverse 
distribution, dispensing, importing, exporting, research, and conduct 
of instructional activities and chemical analysis with, and possession 
involving, schedule III substances, including the following (as of the 
date a final rule becomes effective):
    1. Registration. Any person who handles (manufactures, distributes, 
dispenses, imports, exports, engages in research, or conducts 
instructional or chemical analysis with, or possesses) butalbital 
products, or who desires to handle butalbital products, would be 
required to be registered with DEA to conduct such activities pursuant 
to 21 U.S.C. 822, 823, 957, and 958 and in accordance with 21 CFR parts 
1301 and 1312.
    2. Disposal of Stocks. Any person who does not desire or is not 
able to obtain a schedule III registration would be required to 
surrender all quantities of currently held butalbital products. 
Alternately, they may transfer all quantities of currently held 
butalbital products to a person registered with DEA in accordance with 
21 CFR part 1317, in addition to all other applicable Federal, state, 
local, and tribal laws.
    3. Security. Butalbital products would be subject to schedule III-V 
security requirements and must be handled and stored pursuant to 21 
U.S.C. 821, 823, 871(b) and in accordance with 21 CFR 1301.71-1301.93.
    4. Labeling and Packaging. All labels, labeling, and packaging for 
commercial containers of butalbital products would be required to 
comply with 21 U.S.C. 825 and 958(e) and be in accordance with 21 CFR 
part 1302.
    5. Inventory. Every DEA registrant who possesses any quantity of 
butalbital products would be required to take an inventory of 
butalbital products on hand, pursuant to 21 U.S.C. 827 and 958 and in 
accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
    Any person who becomes registered with DEA must take an initial 
inventory of all stocks of controlled substances (including butalbital 
products) on hand on the date the registrant first engages in the 
handling of controlled substances, pursuant to 21 U.S.C. 827 and 958 
and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
    After the initial inventory, every DEA registrant must take a new 
inventory of all controlled substances (including butalbital products) 
on hand at least every two years, pursuant to 21 U.S.C. 827 and 958 and 
in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
    6. Records and Reports. Every DEA registrant would be required to 
maintain records and submit reports for butalbital products, or 
products containing butalbital products, pursuant to 21 U.S.C. 827 and 
958(e), and in accordance with 21 CFR parts 1304, 1312, and 1317.
    7. Prescriptions. All prescriptions for butalbital products would 
be required to comply with 21 U.S.C. 829 and be issued in accordance 
with 21 CFR parts 1306 and 1311, subpart C.
    8. Importation and Exportation. All importation and exportation of 
butalbital products would be required to be in compliance with 21 
U.S.C. 952, 953, 957, and 958 and in accordance with 21 CFR part 1312.
    9. Liability. Any activity involving butalbital products not 
authorized by, or in violation of, the CSA or its implementing 
regulations, would be unlawful and may subject the person to 
administrative, civil, and/or criminal sanctions.

List of Butalbital Products To Be Removed From the Table of Exempted 
Prescription Products

    For reasons detailed above, DEA proposes the removal of Exempted 
Prescription Product status for all butalbital products, to include the 
products listed below:

----------------------------------------------------------------------------------------------------------------
                                                                                                         (mg or
            Company                   Trade name           NDC code       Form    Controlled substance   mg/ml)
----------------------------------------------------------------------------------------------------------------
Actavis Pharma, Inc...........  Butalbital,                  0591-2640  CA        Butalbital..........        50
                                 Acetaminophen and
                                 Caffeine Capsules USP
                                 50/300/40.
Actavis Pharma, Inc...........  Butalbital,                  0591-3369  TB        Butalbital..........        50
                                 Acetaminophen and
                                 Caffeine Tablets USP
                                 50/325/40.
Actavis Pharma, Inc...........  Fioricet (Butalbital,        52544-080  CA        Butalbital..........        50
                                 Acetaminophen and
                                 Caffeine USP 50/300/
                                 40).
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
                                 AcetaminophenTablets
                                 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.

[[Page 21592]]

 
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
                                 (25mg/325mg).
Atley Pharmaceuticals.........  Butalbital,                  59702-661  TB        Butalbital..........        50
                                 Acetaminophen and
                                 Caffeine Tablets.
Aurobindo Pharma Inc..........  Butalbital,                  13107-075  CA        Butalbital..........        50
                                 Acetaminophen and
                                 Caffeine Capsules USP
                                 50/325/40.
AvKare, Inc...................  Butalbital,                  50268-139  TB        Butalbital..........        50
                                 Acetaminophen and
                                 Caffeine Tablets USP
                                 50/325/40.
AvKare, Inc...................  Butalbital,                  42291-181  CA        Butalbital..........        50
                                 Acetaminophen and
                                 Caffeine Capsules USP
                                 50/300/40.
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,                 55154-3356  TB        Butalbital..........        50
                                 Acetaminophen and
                                 Caffeine Tablets 50mg/
                                 325mg/40mg.
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,                 55154-3356  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 325mg/        00456-0674  TB        Butalbital..........        50
                                 Butalbital 50mg.
Forest Pharmacal Inc..........  Acetaminophen 500mg/        00456-0671  TB        Butalbital..........        50
                                 Butalbital 50mg.
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.
Granules Pharmaceuticals Inc..  Butalbital,                  70010-044  CA        Butalbital..........        50
                                 Acetaminiphen and
                                 Caffeine Capsules
                                 50mg/300mg/40mg.
Granules Pharmaceuticals Inc..  Butalbital and               70010-054  CA        Butalbital..........        50
                                 Acetaminiphen
                                 Capsules 50mg/300mg.
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).

[[Page 21593]]

 
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
KVK Tech......................  Butalbital,                  10702-253  TB        Butalbital..........        50
                                 Acetaminophen &
                                 Caffeine Tablets
                                 (50mg/325mg/40mg).
Landry Pharmacal Inc..........  Febridyne Plain              05383-001  CA        Butalbital..........        50
                                 Capsules.
Lannett Company, Inc..........  Butalbital,                 00527-1695  TB        Butalbital..........        50
                                 Acetaminophen &
                                 Caffeine Tablets
                                 (50mg/325mg/40mg).
Lannett Company, Inc..........  Butalbital,                 00527-4094  CA        Butalbital..........        50
                                 Acetaminophen &
                                 Caffeine Capsules
                                 (50mg/325mg/40mg).
Lannett Company, Inc..........  Butalbital,                 00527-4095  CA        Butalbital..........        50
                                 Acetaminophen &
                                 Caffeine Capsules
                                 (50mg/300mg/40mg).
Larken Laboratories, Inc......  Allzital Butalbital          68047-752  TB        Butalbital..........        25
                                 and Acetaminophen
                                 Tablets (25mg/325mg).
Larken Laboratories, Inc......  Butalbital and               68047-722  TB        Butalbital..........        25
                                 Acetaminophen Tablets
                                 (25mg/325mg).
Larken Laboratories, Inc......  Butalbital and               68047-721  TB        Butalbital..........        50
                                 Acetaminophen Tablets
                                 (50mg/325mg).
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,                 79739-7320  TB        Butalbital..........        50
                                 Acetaminophen and
                                 Caffeine Tablets (50/
                                 325/40mg).
LGM Pharma Solutions, LLC.....  Butalbital,                 79739-7029  CA        Butalbital..........        50
                                 Acetaminophen and
                                 Caffeine Capsules (50/
                                 300/40mg).
LGM Pharma Solutions, LLC.....  Butalbital and              79739-7075  TB        Butalbital..........        50
                                 Acetaminophen Tablets
                                 (50/300mg).
Libertas Pharma, Inc..........  Butalbital,                  51862-179  CA        Butalbital..........        50
                                 Acetaminophen and
                                 Caffeine Capsules USP.
Lunsco Inc....................  Pacaps Capsules.......      10892-0116  CA        Butalbital..........        50
Major Pharmaceuticals.........  Butalbital,                  0904-6938  TB        Butalbital..........        50
                                 Acetaminophen and
                                 Caffeine Tablets (50/
                                 325/40mg).
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
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,                 46672-0053  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.

[[Page 21594]]

 
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...................  Tencon (Butalbital and      11584-0030  TB        Butalbital..........        50
                                 Acetaminophen 50mg/
                                 325mg).
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
NorthStar.....................  Butalbital,                  16714-170  CA        Butalbital..........        50
                                 Acetaminophen and
                                 Caffeine Capsules
                                 (50mg/300mg/40mg).
Oceanside Pharmaceuticals       Butalbital and               68682-306  TB        Butalbital..........        50
 (Manufactured by Nexgen).       Acetaminophen Tablets
                                 (50mg/300mg).
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         63187-933  TB        Butalbital..........        50
                                 50mg/325mg/40mg.
ProficientRx..................  Butalb/Acet/Caffeine         71205-962  CA        Butalbital..........        50
                                 50mg/300mg/40mg.
ProficientRx..................  Butalb/Acet/Caffeine         71205-981  TB        Butalbital..........        50
                                 50mg/325mg/40mg.
ProficientRx..................  Butalb/Acet/Caffeine         71205-510  TB        Butalbital..........        50
                                 50mg/325mg/40mg.
Qualitest Pharmaceuticals, Inc  Butalbital and               0603-2540  TB        Butalbital..........        50
                                 Acetaminophen Tablets.
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
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) (25mg/325mg).
Skylar Laboratories, LLC......  Butalbital and               70362-721  TB        Butalbital..........        50
                                 Acetaminophen Tablets
                                 (50mg/325mg).
Solubiomix....................  Butalbital and               69499-302  TB        Butalbital..........        50
                                 Acetaminophen Tablets
                                 (50mg/325mg).
Solubiomix....................  Butalbital and               69499-342  CA        Butalbital..........        50
                                 Acetaminophen
                                 Capsules (50mg/300mg).
Stewart Jackson Pharmacal, Inc  Ezol..................      45985-0578  CA        Butalbital..........        50
STI Pharma, LLC...............  Butalbital and               54879-026  TB        Butalbital..........        50
                                 Acetaminophen Tablets
                                 (50mg/325mg).
Sunrise Pharmaceuticals, Inc..  Butalbital,                  11534-187  CA        Butalbital..........        50
                                 Acetaminophen,
                                 Caffeine Capsules
                                 (50mg/300mg/40mg).
Taro Pharmaceuticals U.S.A.,    Butalbital,                 51672-4222  CA        Butalbital..........        50
 Inc.                            Acetaminophen and
                                 Caffeine Caps (50mg/
                                 300mg/40mg).
Tedor Pharma, Inc.............  Butalbital and               47781-534  TB        Butalbital..........        50
                                 Acetaminophen Tablets
                                 (50mg/300mg).
Tedor Pharma, Inc.............  Butalbital and               43199-053  TB        Butalbital..........        50
                                 Acetaminophen Tablets
                                 (50mg/325mg).

[[Page 21595]]

 
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
Westminster Pharmaceuticals...  Butalbital,                  69367-203  TB        Butalbital..........        50
                                 Acetaminophen and
                                 Caffeine Tablets
                                 (50mg/325mg/40mg).
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 (Regulatory Planning and Review) and 13563 
(Improving Regulation and Regulatory Review)

    This proposed rule was developed in accordance with the principles 
of Executive Orders (E.O.) 12866 and 13563. E.O. 12866 directs agencies 
to assess all costs and benefits of available regulatory alternatives 
and, if regulation is necessary, to select regulatory approaches that 
maximize net benefits (including potential economic, environmental, 
public health, and safety effects; distributive impacts; and equity). 
E.O. 13563 is supplemental to and reaffirms the principles, structures, 
and definitions governing regulatory review as established in E.O. 
12866. E.O. 12866 classifies a ``significant regulatory action'' 
requiring review by the Office of Management and Budget (OMB) as any 
regulatory action that is likely to result in a rule that may: (1) Have 
an annual effect on the economy of $100 million or more or adversely 
affect in a material way the economy, a sector of the economy, 
productivity, competition, jobs, the environment, public health or 
safety, or State, local, or tribal governments or communities; (2) 
create a serious inconsistency or otherwise interfere with an action 
taken or planned by another agency; (3) materially alter the budgetary 
impact of entitlements, grants, user fees, or loan programs or the 
rights and obligations of recipients thereof; or (4) raise novel legal 
or policy issues arising out of legal mandates, the President's 
priorities, or the principles set forth in the E.O.
    The economic, interagency, budgetary, legal, and policy 
implications of this proposed rule have been examined, and it has been 
determined that it is a significant regulatory action under E.O. 12866.

Benefits

    The removal of exempted prescription product status for butalbital 
products previously granted exemption would impose the regulatory 
controls and administrative, civil, and criminal sanctions of schedule 
III controlled substances on any person who handles or proposes to 
handle butalbital products that were previously exempted from control 
under 21 CFR 1308.31 and 1308.32. Controlling previously exempt 
butalbital prescription products as schedule III controlled substances 
is expected to prevent, curtail, and limit the questionable 
distribution and dispensing of these products, including the 
distribution and dispensing via the internet. One of DEA's primary 
concerns is the prevalence of questionable online websites that promote 
the sale of exempted butalbital products ``without a prescription.'' 
Such questionable sales practices exploit the current regulatory status 
of these exempted prescription products. These questionable websites 
are not to be equated with ``mail order pharmacies,'' which serve a 
valuable role in legitimate U.S. health care. This proposal is directed 
in particular to such questionable websites and is not intended to 
adversely affect legitimate mail order or retail pharmacies. This 
proposed rule is expected to impact these online sales practices, 
resulting in fewer individuals abusing these products and potentially 
becoming addicted to these or similar products.
    Additionally, DEA anticipates benefits from reduced societal costs 
(i.e., health care costs, criminal justice system costs, opportunity 
costs, etc.) due to abuse and addiction. While this proposed rule is 
expected to lower the abuse of currently exempt butalbital products, 
DEA has no basis to quantify the amount of abuse that will be 
prevented, and the societal cost savings result of this rule. However, 
DEA anticipates that removal of exempted prescription product status 
for butalbital products will reduce the amount of abuse of these 
products, and lead to societal cost savings.

Costs

    Below is an Economic Impact Analysis which summarizes the costs 
associated with this proposed rule.
Affected Persons
    The removal of exempted prescription product status for previously 
exempted butalbital products will affect all persons who handle 
(manufacture, distribute, dispense, engage in research, conduct 
instructional activities, or possess) or propose to handle these 
products. The exempt butalbital products are prescription drug products

[[Page 21596]]

used for the treatment of tension headaches. While some hospitals or 
clinics may hold some exempt butalbital products in inventory, 
quantities are expected to be minimal and the economic impact on 
hospitals is expected to be minimal. Therefore, DEA does not anticipate 
this proposed rule will affect hospitals. Additionally, while 
prescribers would need a DEA registration to prescribe these products, 
nearly all individual practitioners are expected to be registered with 
DEA already or otherwise have authority to prescribe controlled 
substances but are exempt from registration. Therefore, for the 
purposes of this analysis, DEA assumes this proposed rule primarily 
affects manufacturers, distributors, and pharmacies.
    The ``Table of Exempted Prescription Products'' includes the 
National Drug Code (NDC), which serves as a universal product 
identifier for the exempt prescription products, among other 
information. While the list of products that have been granted exempted 
prescription product status contains 189 prescription products 
containing butalbital (as of February 11, 2022), not all are actively 
marketed in the United States. By comparing the NDC of the 189 products 
that were granted exempt status to the current NDC Directory,\4\ 
coupled with recent exemption approvals, DEA estimates 49 exempt 
butalbital products are actively marketed in the United States. DEA 
believes many of the remainder of these 189 products have been 
discontinued; there is no requirement to inform DEA of discontinuation 
of products that have been granted exempt prescription product status. 
From review of applicant information in the application for exempt 
prescription product status and NDC labeler information from the NDC 
Directory, DEA estimates the 49 exempt butalbital products are 
manufactured by 30 manufacturers.
---------------------------------------------------------------------------

    \4\ ``The Drug Listing Act of 1972 requires registered drug 
establishments to provide FDA with a current list of all drugs 
manufactured, prepared, propagated, compounded, or processed by it 
for commercial distribution. (See Section 510 of the Federal Food, 
Drug, and Cosmetic Act (Act) (21 U.S.C. 360)). Drug products are 
identified and reported using a unique, three-segment number, called 
the National Drug Code (NDC), which serves as a universal product 
identifier for drugs. FDA publishes the listed NDC numbers and the 
information submitted as part of the listing information in the NDC 
Directory which is updated daily.'' https://www.fda.gov/Drugs/InformationOnDrugs/ucm142438.htm. (accessed March 18, 2020)
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    The number of DEA registrations forms the basis of the number of 
distributors and pharmacies. Because exempted butalbital products are 
widely prescribed, DEA assumes that all DEA-registered distributors and 
pharmacies are exempted butalbital product handlers. Also, for the 
purposes of this analysis, DEA assumes all legally operating 
distributors and pharmacies that handle exempted butalbital products 
are registered with DEA. Based on DEA records, as of June 5, 2020, 
there are 627 distributor registrations and 70,672 pharmacies 
authorized to handle schedule III controlled substances.
    In summary, DEA estimates 71,329 establishments (30 manufacturers, 
627 distributors, and 70,672 pharmacies) are affected by this proposed 
rule.
Costs Associated With Requirements
    DEA considered various costs associated with handling exempt 
butalbital products as a schedule III controlled substance for each of 
the business activities (manufacturer, distributor, prescriber, and 
pharmacy) anticipated to handle butalbital and be impacted by this 
proposed rule. The costs include costs associated with various 
requirements, such as: Registration, physical security, labeling and 
packaging, inventory and recordkeeping, and disposal.
    The registration requirements impact all manufacturers that do not 
hold a DEA manufacturer registration. DEA conducted a search of its 
registration records for the 30 manufacturer establishments identified 
as handling exempt butalbital. DEA estimates there are 19 manufacturers 
that would need DEA registrations if this proposed rule were 
promulgated. The 19 non-registered manufacturers would incur an initial 
registration and an annual renewal fee of $3,699 for the manufacturer 
registration for a total of $70,281 per year. DEA assumes all legally 
operating distributors and pharmacies that handle exempted butalbital 
products are already registered with DEA. Therefore, DEA estimates 
distributors and pharmacies would not incur additional registration-
related costs if this proposed rule were promulgated. In summary, the 
estimated cost of the registration requirements associated with this 
proposed rule is the cost of the initial registration and annual 
renewal registration fees for the 19 manufacturers, $70,281 per year.
    DEA estimated the costs associated with physical security 
requirements for manufacturers and distributors. Many states already 
control butalbital as a schedule III controlled substance under state 
law. As state requirements for schedule III controlled substances 
generally meet or exceed DEA requirements, only the establishments 
located in states where the exempt butalbital products are not 
controlled as schedule III controlled substances under state law are 
estimated to incur costs associated with physical security. Based on 
review of publicly available information regarding the locations of the 
manufacturers and registered locations of distributors, DEA estimates 
17 manufacturer establishments and 399 distributors are located in 
states where exempt butalbital products are not already subject to 
controls equivalent to Federal schedule III handling requirements under 
state law. Based on a review of manufacturing data of a largely 
prescribed controlled substance and review of commercially available 
industry reports of exempt butalbital products, DEA estimates 3 of the 
17 manufacturers (located in states where the exempt butalbital 
products are not controlled as schedule III controlled substances under 
state law) will need a large secure area and 14 of 17 will require a 
small secure area. DEA estimates the three large manufacturers would 
each need to secure 20,000 square feet (sq. ft.) of space and 14 small 
manufacturers would each need to secure 10,000 sq. ft. of space, at a 
cost of $112,000 and $79,196 for a large and small manufacturer, 
respectively, for a total of $1,444,744.
    As with manufacturers, DEA anticipates a concentration of market 
share with a small number of large distributors distributing the 
majority of exempt butalbital products in the U.S. DEA estimates the 
market distribution of exempt butalbital products is similar to that of 
a largely prescribed controlled substance. Based on estimates that 20 
large, 60 medium, and 319 small distributors would need to secure 4,000 
sq. ft., 250 sq. ft., and 16 sq. ft. of space, respectively, DEA 
estimates a cost of $35,418, $8,854, and $2,217 for large, medium, and 
small distributors, respectively, for a total of $1,946,823. In 
summary, DEA estimates the requirements associated with physical 
security controls will have a one-time cost of $1,444,744 for all 
manufacturers combined and a one-time cost of $1,946,823 for all 
distributors combined, for a grand total of $3,391,567.
    DEA estimates pharmacies are already handling other schedule III 
controlled substances and have the controls and procedures in place to 
store exempt butalbital products in a secure area at a minimal cost. 
Pharmacies and institutional practitioners may disperse such substances 
throughout the stock of non-controlled substances in such a manner as 
to obstruct the theft or diversion of controlled substances. 21 CFR 
1301.75(b). DEA believes these

[[Page 21597]]

facilities possess adequate physical security controls and any cost 
associated with physical security requirements as a result of this rule 
is minimal.
    In accordance with the CSA, every DEA registrant must maintain, on 
a current basis, a complete and accurate record of each controlled 
substance manufactured, received, sold, delivered, or otherwise 
disposed of. 21 U.S.C. 827(a). These records must be maintained 
separately from all other records of the registrant, or alternatively, 
in the case of non-narcotic controlled substances, be in such a form 
that required information is readily retrievable from the ordinary 
business records of the registrant. 21 U.S.C. 827(b)(2). The records 
must be kept and be available for at least two years for inspection and 
copying by officers or employees of the Attorney General. 21 U.S.C. 
827(b)(3). To fulfill its regulatory responsibilities, DEA assumes for 
the purpose of this analysis that exempt butalbital product handlers 
already maintain detailed records of exempt butalbital product 
transactions and those records can be maintained separately or readily 
retrievable at minimal cost. DEA estimates that there will be no 
economic impact beyond the inventory of exempted prescription status 
butalbital product stock pursuant to the initial and biennial inventory 
requirements in 21 CFR 1304.11.
    Following the finalization of this scheduling action, registrants 
would be required to take an inventory of all stocks of exempted 
prescription status butalbital products on hand and continue to conduct 
inventories biennially. DEA estimates the inventories for manufacturers 
and distributors will be conducted by a warehouse first-line supervisor 
and administrative personnel and will take one-half hour to complete. 
Additionally, DEA estimates inventories for pharmacies will be 
conducted by a pharmacist and a pharmacy technician and will take 6 
minutes (0.1 hour) to complete. Based on U.S. Bureau of Labor 
Statistics hourly wage data and load for benefits, DEA estimates the 
cost of initial and biennial inventory for manufacturers, distributors, 
and pharmacies is $33.03, $33.03, and $11.12 per occurrence, 
respectively.\5\ Total inventory cost for 30 manufacturers, 627 
distributors and 70,672 pharmacies is $807,573 initially, in the first 
year, and biennially, thereafter.
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    \5\ Bureau of Labor Statistics, Occupational and Employment and 
Wages, May 2019, https://www.bls.gov/oes/current/oes_nat.htm. Bureau 
of Labor Statistics, ``Employer Costs for Employee Compensation--
December 2019'' reports that benefits for private industry is 29.9 
percent of total compensation. The 29.9 percent of total 
compensation equates to a 42.7 percent (29.9/70.1) load on wages and 
salaries. https://www.bls.gov/news.release/pdf/ecec.pdf. 0.5 hour x 
[$26.47 per hour + $19.82 per hour] x 1.427 load = $33.03. 0.1 hour 
x [$61.58 per hour + $16.32 per hour] x 1.427 load = 11.12.
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    If this rule is finalized, labeling and packaging requirements 
pursuant to 21 CFR part 1302 would apply to currently exempted 
prescription status butalbital products. Printed labels would need to 
indicate their status as a schedule III controlled substance. For 
example, the printed label would need to include ``CIII'' or ``C-III.'' 
DEA assumes that the activity of manufacturers making labeling changes 
is routine and in their normal course of business. Therefore, DEA 
assumes that the cost of making this change is minimal. Accordingly, 
DEA estimates that the cost of the labeling and packaging requirements 
of this proposed rule is minimal.
    A reverse distributor generally performs the disposal of controlled 
substances by registrants. DEA recognizes that removing the exempt 
status for previously exempt butalbital products may increase the 
volume of material that registrants will need to dispose through a 
reverse distributor. However, as exempted prescription status 
butalbital products are currently not controlled, DEA does not have 
information on the volume of exempt butalbital products currently 
disposed of, and thus cannot determine what the increase in schedule 
III controlled substance disposal will be or how it will affect the 
fees charged by reversed distributors. Therefore, DEA is unable to 
quantify the costs associated with the disposal of exempt butalbital 
products. However, since DEA assumes the affected establishments are 
already disposing of controlled substances, the disposal of previously 
exempted prescription status butalbital products will be incorporated 
into existing business processes. DEA believes that any cost increase, 
if one exists, will be minimal.
    In summary, DEA estimates the economic impact of this proposed rule 
is due to the costs associated with registration requirements, the 
costs associated with storage requirements, and the costs associated 
with inventory requirements. The registration cost is an initial 
registration fee and an annual renewal fee of $70,281 (for the 19 non-
registered manufacturer establishments). The cost associated with 
storage requirements is a one-time cost of $3,391,567 for all affected 
establishments combined (17 manufacturers and 399 distributors located 
in states where exempted prescription status butalbital products are 
not controlled under State law). The costs associated with inventory 
and recordkeeping are an initial inventory cost of $807,573 and a 
biennially recurring inventory cost of $807,573 for all manufacturer, 
distributor, and pharmacy establishments combined.
    DEA determined the annualized cost of the proposed rule by 
calculating the present value of the costs utilizing the discounted 
cash flow method at 3 percent and 7 percent and converting the present 
value into equal annual payments over 20 years at the 3 percent and 7 
percent discount rates.\6\ The present value of the costs associated 
with the proposed rule is $10,434,492 and $8,336,626 at 3 percent and 7 
percent discount rates, respectively. The annualized costs are $701,362 
and $786,918 at 3 percent and 7 percent discount rates, respectively. 
Conservatively, using the 7 percent rate, the estimated annualized cost 
of the proposed rule is $786,918 per year. The estimated highest cost 
in any given year is $4,269,421, which represents the year of 
implementation of the rule (Year 1). Although DEA currently is unable 
to quantify the societal cost savings resulting from the placement of 
butalbital products in schedule III, DEA believes such savings will 
exceed the costs associated with this proposed rule.
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    \6\ The use of 7 percent and 3 percent rates for present value 
calculation, annual payment calculation, and analysis time horizon 
is based on OMB Circular A-4, September 17, 2003. See also 
``Regulatory Impact Analysis: A Primer'' and ``Regulatory Impact 
Analysis: Frequently Asked Questions (FAQ)'' February 7, 2011, 
Office of Information and Regulatory Affairs (OIRA). DEA used a 20-
year time horizon for this analysis as there is no predetermined end 
to this rule.
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Discussion of Uncertainties
    This analysis evaluates the economic impact of controlling 
pharmaceuticals that are currently exempt from control. Therefore, DEA 
does not have a strong basis to estimate some of the costs or other 
impacts to affected persons. DEA welcomes all comments that would 
narrow the uncertainties in the presented analysis, and specifically 
asks potentially affected persons the following questions (specific and 
quantified responses are more helpful):
    1. DEA does not have data on (a) the volume of butalbital products 
dispensed via online pharmacies and websites; (b) the number of 
physicians impacted that do not have DEA registrations; (c) the number 
of pharmacies impacted that do not have DEA registrations; and (d) the 
impact on patients that are unable to

[[Page 21598]]

seek face-to-face guidance from a provider. DEA requests comments that 
help to identify the extent of the impact this rulemaking may impose.
    2. DEA estimates that hospitals and clinics would be minimally 
affected by this proposed rule because most hospitals and clinics are 
expected to hold minimal inventory. Distributions of exempt butalbital 
products to hospitals and clinics are expected to be minimal, while a 
large majority of distributions are to pharmacies. Will hospitals and 
clinics be materially affected by this proposed rule? If so, please 
explain with specific and quantified information as possible.
    3. DEA estimates 19 manufacturers would need to obtain a DEA 
registration to continue manufacturing exempt butalbital products. Is 
this a reasonable estimate? Would any manufacturer cease manufacturing 
exempt butalbital products rather than obtaining a DEA registration to 
continue manufacturing of exempt butalbital products?
    4. How much time would be required to conduct an inventory of 
exempt butalbital products for a typical manufacturer, distributor, and 
pharmacy? Who (what occupation) usually conducts the inventory?
    5. If this rule is finalized, commercial packaging would require, 
with some exceptions, a printed label a symbol designating the 
schedule, i.e., ``CIII'' or ``C-III.'' DEA assumes that the activity of 
manufacturers making labeling changes is routine and in their normal 
course of business. What is the cost of adding the required symbol to 
the commercial packaging?

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 (RFA) (5 U.S.C. 601-612), has reviewed this proposed rule and by 
approving it, certifies that the proposed rule, if promulgated, will 
not have a significant economic impact on a substantial number of small 
entities.
    Below is a summary of the threshold analyses conducted by the DEA 
to support the certification statement above.
    In accordance with the RFA, DEA evaluated the impact of this 
proposed rule on small entities. DEA estimates that this proposed rule 
will affect 31,187 entities, of which 30,593 are small entities (17 
manufacturers, 406 distributors, and 30,170 pharmacies). The number of 
affected small entities for each business activity is compared to the 
number of small entities in each corresponding North American Industry 
Classification System (NAICS) code to determine whether a substantial 
number of small entities are affected. Additionally, the annualized 
cost of the proposed rule for each affected entity is compared to its 
estimated annual revenue to determine whether this proposed rule will 
have a significant economic impact on small entities. Since DEA does 
not collect revenue information on its registrants, to estimate the 
number of entities ``significantly'' impacted by the proposed rule, DEA 
relied on publicly available information. Combining the two criteria, 
substantial number and significant economic impact, DEA determined that 
this proposed rule will not have a significant economic impact on a 
substantial number of small entities.
    Specifically, DEA examined the registration, physical security, 
labeling and packaging, inventory and recordkeeping, and disposal 
requirements for the small entities estimated to be affected by the 
proposed rule. Based on DEA's understanding of its registrants' 
operations and facilities, and research of publicly available 
information regarding size and location, DEA estimates that the 
annualized cost of this proposed rule would vary. Entities already 
registered to handle schedule III controlled substances would not incur 
any additional registration costs, and manufacturers and distributors 
located in the states that control exempt butalbital products as a 
schedule III controlled substance under state law would not incur any 
additional costs associated with physical security as state 
requirements for schedule III controlled substances generally meet or 
exceed Federal requirements. DEA estimates the following annualized 
costs:
     $10,703 per establishment for costs associated with 
registration, physical security, and inventory requirements: Non-
registered manufacturers located in a state where exempt butalbital 
products are not already subject to controls equivalent to Federal 
schedule III handling requirements under state law.
     $7,004 per establishment for costs associated with 
physical security and inventory requirements: Registered manufacturers 
located in a state where exempt butalbital products are not already 
subject to controls equivalent to Federal schedule III handling 
requirements under state law.
     $3,716 per establishment for costs associated with 
registration and inventory requirements: Non-registered manufacturers 
located in a state where exempt butalbital products are already subject 
to controls equivalent to Federal schedule III handling requirements 
under state law.
     $17 per establishment for costs associated with inventory 
requirements: Registered manufacturers located in a state where exempt 
butalbital products are already subject to controls equivalent to 
Federal schedule III handling requirements under state law.
     $213 per establishment for costs associated with physical 
security and inventory requirements: Distributors located in a state 
where exempt butalbital products are not already subject to controls 
equivalent to Federal schedule III handling requirements under state 
law.
     $17 per establishment for costs associated with inventory 
requirements: Distributors located in a state where exempt butalbital 
products are already subject to controls equivalent to Federal schedule 
III handling requirements under state law.
     $6 per establishment for costs associated with inventory 
requirements: All pharmacies.
    DEA estimates manufacturer, distributor, and pharmacy business 
activities best correspond to the following NAICS codes:


[[Page 21599]]


 Manufacturer: 325412--Pharmaceutical Preparation Manufacturing
 Distributor: 424210--Drugs and Druggists' Sundries Merchant 
Wholesalers
 Pharmacy: 446110--Pharmacies and Drug Stores

    DEA researched publicly available information for each of the 17 
affected manufacturer small entities and estimated each of their annual 
revenues. The annualized cost corresponding to their registration and 
location were compared with the estimated annual revenue for each of 
the 17 manufacturer small entities. DEA considers the economic impact 
is ``significant'' if the annual impact is greater than 3 percent of 
annual revenue. The economic impact is estimated to be significant for 
one of the small manufacturers. In conclusion, DEA estimates there are 
930 small firms in NAICS code 325412--Pharmaceutical Preparation 
Manufacturing, of which 17 small entities are affected by this proposed 
rule, and one small entity in NAICS code 325412 will have a significant 
economic impact.
    Regarding physical security and inventory costs to distributors, 
the U.S. Census Bureau's Statistics on U.S. Businesses (SUSB) data 
contains estimated annual revenue, the number of establishments, and 
the number of firms for each NAICS code at various revenue ranges, 
i.e., less than $100,000, $100,000-499,000, $500,000-999,999, etc. The 
estimated annualized cost of $213 and $17 per distributor establishment 
was compared to the average annual revenue of the smallest of small 
firms in NAICS code 424210--Drugs and Druggists' Sundries Merchant 
Wholesalers. From SUSB data, there are 585 firms in the smallest firm 
size category, ``Less than $100,000,'' for a combined estimated annual 
receipts of $31,248,000, or an average of $53,415 per firm.\7\ The 
annualized cost of $213 and $17 are 0.4 percent and 0.03 percent of the 
average annual receipt of $53,415 per firm. Because DEA does not expect 
this proposed rule to have a significant economic impact on the 
smallest of small entities, DEA does not expect it to have a 
significant economic impact on any small entity. DEA estimates there 
are 6,663 small firms in NAICS code 424210--Drugs and Druggists' 
Sundries Merchant Wholesalers, of which 406 distributor small entities 
are affected by this proposed rule, and no small entities in NAICS code 
424210 will have a significant economic impact.
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    \7\ https://www2.census.gov/programs-surveys/susb/tables/2012/us_6digitnaics_r_2012.xlsx. (accessed June 3, 2020).
---------------------------------------------------------------------------

    Regarding inventory requirement costs for pharmacies, the estimated 
annualized cost of $6 per pharmacy establishment was compared to the 
average annual revenue of the smallest of small firms in NAICS code 
446110--Pharmacies and Drug Stores. From SUSB data, there are 751 firms 
in the smallest firm size category, ``Less than $100,000,'' for a 
combined estimated annual receipts of $36,066,000 or an average of 
$48,024 per firm.\8\ The annualized cost of $6 is approximately 0.01 
percent of the average annual receipt of $48,024 per firm. Because DEA 
does not expect this proposed rule to have a significant economic 
impact on the smallest of small entities, DEA does not expect it to 
have a significant economic impact on any small entity. While DEA 
estimates this proposed rule to affect a substantial number of pharmacy 
small entities in NAICS code 446110--Pharmacies and Drug Stores, the 
proposed rule is not expected to have a significant economic impact on 
any pharmacy small entity.
---------------------------------------------------------------------------

    \8\ Ibid.
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    In conclusion, DEA's assessment of economic impact by size category 
indicates that the proposed rule, if promulgated, will not have a 
significant economic impact on a substantial number of small entities.

Unfunded Mandates Reform Act of 1995

    The estimated highest cost in any given year is $4,269,421; thus, 
DEA has determined in accordance with the Unfunded Mandates Reform Act 
of 1995 (UMRA), 2 U.S.C. 1501 et seq., 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 for inflation) in any 
one year. Therefore, neither a Small Government Agency Plan nor any 
other action is required under provisions of UMRA.

Paperwork Reduction Act of 1995

    This action does not impose a new collection of information under 
the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-3521. This action 
would not impose recordkeeping or reporting requirements on state or 
local governments, individuals, businesses, or organizations. An agency 
may not conduct or sponsor, and a person is not required to respond to, 
a collection of information unless it displays a currently valid OMB 
control number.

List of Subjects 21 CFR Part 1308

    Administrative practice and procedure, Drug traffic control, 
Exports, Imports, Reporting and recordkeeping requirements.

    Accordingly, for the reasons set forth in the preamble, DEA 
proposes to amend 21 CFR part 1308 as follows:

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

0
1. The authority citation for part 1308 continues to read as follows:

    Authority:  21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise 
noted.

0
2. In Sec.  1308.31, revise paragraph (d) and add paragraph (e) to read 
as follows:


Sec.  1308.31   Application for exemption of nonnarcotic prescription 
product.

* * * * *
    (d) The Administrator may revoke (either individually or 
categorically) any exemption granted pursuant to section 201(g)(3)(A) 
of the Act (21 U.S.C. 811(g)(3)(A)) by following the procedures set 
forth in paragraph (c) of this section for handling an application for 
an exemption which has been accepted for filing. The Administrator has 
categorically revoked exemptions for the following products:
    (1) Effective as of [effective date of final rule], the previous 
exemptions approved for butalbital products are revoked and such 
products become subject to the statutory and regulatory restrictions 
applicable to schedule III controlled substances.
    (2) [Reserved]
    (e) The compounds, mixtures, or preparations that the Administrator 
has exempted from application of all or any part of the Act pursuant to 
section 201(g)(3)(A), of the Act (21 U.S.C. 811(g)(3)(A)) are listed in 
the Table of Exempted Prescription Products available on the DEA 
Diversion Control website at www.deadiversion.usdoj.gov/schedules.

Anne Milgram,
Administrator.
[FR Doc. 2022-07572 Filed 4-11-22; 8:45 am]
BILLING CODE 4410-09-P