21588 Federal Register / Vol. 87, No. 70 / Tuesday, April 12, 2022 / Proposed Rules 

Regulatory Policies and Procedures (44 

FR 11034; February 26, 1979); and (3) 

does not warrant preparation of a 

regulatory evaluation as the anticipated 

impact is so minimal. Since this is a 

routine matter that will only affect air 

traffic procedures and air navigation, it 

is certified that this rule, when 

promulgated, would not have a 

significant economic impact on a 

substantial number of small entities 

under the criteria of the Regulatory 

Flexibility Act. 

Environmental Review 

This proposal will be subject to an 

environmental analysis in accordance 

with FAA Order 1050.1F, 

‘‘Environmental Impacts: Policies and 

Procedures’’ prior to any FAA final 

regulatory action. 

List of Subjects in 14 CFR Part 71 

Airspace, Incorporation by reference, 

Navigation (air). 

The Proposed Amendment 

Accordingly, pursuant to the 

authority delegated to me, the Federal 

Aviation Administration proposes to 

amend 14 CFR part 71 as follows: 

PART 71—DESIGNATION OF CLASS A, 

B, C, D, AND E AIRSPACE AREAS; AIR 

TRAFFIC SERVICE ROUTES; AND 

REPORTING POINTS 

■ 1. The authority citation for 14 CFR 

part 71 continues to read as follows: 

Authority: 49 U.S.C. 106(f), 106(g), 40103, 

40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 

1959–1963 Comp., p. 389. 

§ 71.1 [Amended] 

■ 2. The incorporation by reference in 

14 CFR 71.1 of FAA Order JO 7400.11F, 

Airspace Designations and Reporting 

Points, dated August 10, 2021, and 

effective September 15, 2021, is 

amended as follows: 

Paragraph 6002 Class E Airspace 

Designated as Surface Areas. 

* * * * * 

ANM ID E2 Coeur D’Alene, ID [Amended] 

Coeur D’Alene—Pappy Boyington Field 

(Lat. 47°46′28′′ N, long. 116°49′11′′ W) 

That airspace within a 4.4-mile radius of 

the Coeur D’Alene—Pappy Boyington Field, 

and within 1 mile each side of the 193° 

bearing extending from the 4.4-mile radius to 

5.5 miles south of the airport, and that 

airspace 1.5 miles west and 3.5 miles east of 

the 019° bearing extending from the 4.4-mile 

radius to 5.2 miles northeast of the airport. 

This Class E airspace is effective during the 

specific dates and times established in 

advance by a Notice to Air Missions. The 

effective date and time will thereafter be 

continuously published in the Chart 

Supplement. 

Paragraph 6005 Class E Airspace Areas 

Extending Upward From 700 Feet or More 

Above the Surface of the Earth. 

* * * * * 

ANM ID E5 Coeur D’Alene, ID [Amended] 

Coeur D’Alene—Pappy Boyington Field 

(Lat. 47°46′28′′ N, long. 116°49′11′′ W) 

That airspace within a 4.4-mile radius of 

the Coeur D’Alene—Pappy Boyington Field, 

and within 2.2 miles each side of the 193° 

bearing from the airport extending from the 

4.4-mile radius to 9 miles south of the 

airport, and that airspace 4.4 miles each side 

of the 251° bearing from the Coeur D’Alene— 

Pappy Boyington Field extending from the 

4.4-mile radius to 16 miles west of the airport 

and that airspace 1.8 miles west and 4 miles 

east of the 013° bearing from the Coeur 

D’Alene—Pappy Boyington Field extending 

from the 4.4-mile radius to 8.5 miles 

northeast from the airport. 

Issued in Des Moines, Washington, on 

April 5, 2022. 

B.G. Chew, 

Acting Group Manager, Operations Support 

Group, Western Service Center. 

[FR Doc. 2022–07745 Filed 4–11–22; 8:45 am] 

BILLING CODE 4910–13–P 

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. 

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 


khammond on DSKJM1Z7X2PROD with PROPOSALS
Federal Register / Vol. 87, No. 70 / Tuesday, April 12, 2022 / Proposed Rules 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 § 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 


khammond on DSKJM1Z7X2PROD with PROPOSALS
21590 Federal Register / Vol. 87, No. 70 / Tuesday, April 12, 2022 / Proposed Rules 

1NFLIS 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. 

2STRIDE 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. 

3NFLIS 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. 

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. 

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

Calendar 

year 

Percent of 

reports 

butalbital/ 

acetaminophen 

Percent of 

reports 

butalbital/ 

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. 


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Federal Register / Vol. 87, No. 70 / Tuesday, April 12, 2022 / Proposed Rules 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: 

Company Trade name NDC code Form Controlled 

substance 

(mg or 

mg/ml) 

Actavis Pharma, Inc .............. Butalbital, Acetaminophen and Caffeine Capsules USP 50/ 

300/40.

0591–2640 CA Butalbital ........ 50 

Actavis Pharma, Inc .............. Butalbital, Acetaminophen and Caffeine Tablets USP 50/ 

325/40.

0591–3369 TB Butalbital ........ 50 

Actavis Pharma, Inc .............. Fioricet (Butalbital, Acetaminophen and Caffeine USP 50/ 

300/40).

52544–080 CA Butalbital ........ 50 

Alpha Scriptics Inc ................. Butacet Capsules ................................................................. 53121–0133 CA Butalbital ........ 50 

Alphagen Laboratories, Inc ... Butalbital and Acetaminophen Capsules 50mg/650mg ....... 00603–2542 CA Butalbital ........ 50 

Alphagen Laboratories, Inc ... Geone Capsules ................................................................... 59743–0004 CA Butalbital ........ 50 

Altana, Inc ............................. Axocet (Butalbital and Acetaminophen) ............................... 0281–0389 TB Butalbital ........ 50 

Althon Pharmaceuticals, Inc .. Butalbital, Acetaminophen and Caffeine Tablets USP ........ 66813–074 TB Butalbital ........ 50 

Alvogen, Inc ........................... Butalbital and AcetaminophenTablets USP 50/325 ............. 47781–0535 TB Butalbital ........ 50 

Alvogen, Inc ........................... Butalbital, Acetaminophen and Caffeine Tablets USP 50/ 

325/40.

47781–0536 TB Butalbital ........ 50 

Alvogen, Inc ........................... Butalbital and Acetaminophen Tablets 50/325 .................... 47781–0628 TB Butalbital ........ 50 


khammond on DSKJM1Z7X2PROD with PROPOSALS
21592 Federal Register / Vol. 87, No. 70 / Tuesday, April 12, 2022 / Proposed Rules 

Company Trade name NDC code Form Controlled 

substance 

(mg or 

mg/ml) 

Alvogen, Inc ........................... Butalbital, Acetaminophen and Caffeine Tablets (50/325/ 

40).

47781–0625 TB Butalbital ........ 50 

Alvogen, Inc ........................... Butalbital and Acetaminophen Tablets (50/300) .................. 47781–0644 TB Butalbital ........ 50 

American Pharmaceuticals, 

Inc.

AMERICET Tablets .............................................................. 58605–0501 TB Butalbital ........ 50 

American Urologicals Inc ...... Butace ................................................................................... 00539–0906 CA Butalbital ........ 50 

Amerisource Health Services 

Corporation.

Butalbital, Acetaminophen and Caffeine Tablets 50/325/ 

40mg.

68084–0396 TB Butalbital ........ 50 

Aphena Pharma Solutions .... Butalbital, Acetaminophen and Caffeine Tablets (50/325/ 

40mg.

71610–0042 TB Butalbital ........ 50 

Atland Pharmaceuticals ......... Butalbital and Acetaminophen Tablets (25mg/325mg) ........ 71993–301 TB Butalbital ........ 25 

Atley Pharmaceuticals ........... Butalbital, Acetaminophen and Caffeine Tablets ................. 59702–661 TB Butalbital ........ 50 

Aurobindo Pharma Inc .......... Butalbital, Acetaminophen and Caffeine Capsules USP 50/ 

325/40.

13107–075 CA Butalbital ........ 50 

AvKare, Inc ............................ Butalbital, Acetaminophen and Caffeine Tablets USP 50/ 

325/40.

50268–139 TB Butalbital ........ 50 

AvKare, Inc ............................ Butalbital, Acetaminophen and Caffeine Capsules USP 50/ 

300/40.

42291–181 CA Butalbital ........ 50 

Baucum Laboratories Inc ...... Butalbital, Acetaminophen and Caffeine Tablets ................. 54696–0513 TB Butalbital ........ 50 

Blansett Pharm Co ................ Anolor 300 Capsules ............................................................ 51674–0009 CA Butalbital ........ 50 

Cardinal Health ...................... Butalbital, Acetaminophen and Caffeine Tablets 50mg/ 

325mg/40mg.

55154–3356 TB Butalbital ........ 50 

Cardinal Health ...................... Butalbital, Acetaminophen and Caffeine Tablets 50mg/ 

325mg/40mg.

55154–7988 TB Butalbital ........ 50 

Cardinal Health ...................... Butalbital, Acetaminophen and Caffeine Tablets 50mg/ 

325mg/40mg.

55154–7147 TB Butalbital ........ 50 

Cardinal Health ...................... Butalbital, Acetaminophen and Caffeine Tablets 50mg/ 

325mg/40mg.

55154–3356 TB Butalbital ........ 50 

Cardinal Health ...................... Butalbital, Acetaminophen and Caffeine Tablets 50mg/ 

325mg/40mg.

0904–6538 TB Butalbital ........ 50 

Carnrick Labs Inc .................. Phrenilin ................................................................................ 00086–0050 TB Butalbital ........ 50 

Carpenter Pharmacal Co ...... ALAGESIC Tablets ............................................................... 55726–0300 TB Butalbital ........ 50 

Cody Laboratories, Inc .......... BU–TAB AC .......................................................................... 65893–100 TB Butalbital ........ 50 

Columbia Drug Co ................. Isopap Capsules ................................................................... 11735–0400 CA Butalbital ........ 50 

CTEX Pharmaceuticals, Inc .. Butex Forte Capsules ........................................................... 62022–0070 CA Butalbital ........ 50 

CTEX Pharmaceuticals, Inc .. Butex Forte Capsules ........................................................... 62022–0074 CA Butalbital ........ 50 

D.M. Graham Laboratories, 

Inc.

Butalbital, Acetaminophen and Caffeine Tablets ................. 00756–0111 TB Butalbital ........ 50 

Diversified Health Care Services.Geone Capsules ................................................................... 59743–004 CA Butalbital ........ 50 

Dunhall Pharmacal Inc .......... Triaprin .................................................................................. 00217–2811 CA Butalbital ........ 50 

Duramed Pharmaceuticals .... Butalbital, Acetaminophen and Caffeine Tablets ................. 51285–0849 TB Butalbital ........ 50 

EconoMed Pharmaceuticals, 

Inc.

ARCET Capsules ................................................................. 38130–0325 CA Butalbital ........ 50 

EconoMed Pharmaceuticals, 

Inc.

ARCET Compound Tablets .................................................. 38130–0111 TB Butalbital ........ 50 

Equipharm Corp .................... EQUI–CET Tablets ............................................................... 57779–0111 TB Butalbital ........ 50 

Everett Laboratories, Inc ....... Repan Capsules ................................................................... 00642–0164 CA Butalbital ........ 50 

Everett Laboratories, Inc ....... Repan Capsules ................................................................... 00642–0163 CA Butalbital ........ 50 

Everett Laboratories, Inc ....... Repan Tablets ...................................................................... 00642–0162– 

10 

TB Butalbital ........ 50 

Forest Pharmacal Inc ............ Acetaminophen 325mg/Butalbital 50mg ............................... 00456–0674 TB Butalbital ........ 50 

Forest Pharmacal Inc ............ Acetaminophen 500mg/Butalbital 50mg ............................... 00456–0671 TB Butalbital ........ 50 

Forest Pharmacal Inc ............ Bancap .................................................................................. 00456–0546 CA Butalbital ........ 50 

Forest Pharmacal Inc ............ Esgic Capsules ..................................................................... 00456–0631 CA Butalbital ........ 50 

Forest Pharmacal Inc ............ ESGIC PLUS Capsules ........................................................ 00456–0679 CA Butalbital ........ 50 

Forest Pharmacal Inc ............ Esgic Tablets ........................................................................ 00456–0630 TB Butalbital ........ 50 

Forest Pharmacal Inc ............ ESGIC–PLUS ....................................................................... 00456–0678 TB Butalbital ........ 50 

Genetco Inc ........................... Butalbital, Apap and Caffeine ............................................... 00302–0490 TB Butalbital ........ 50 

Geneva Pharmaceuticals, Inc Butalbital, Acetaminophen and Caffeine Tablets ................. 00781–1901 TB Butalbital ........ 50 

GM Pharmaceuticals (Manufactured by Mikart, Inc.).Vanatol S (Butalbital, Acetaminophen, & Caffeine Soln 50/ 

325/40.

58809–359 LQ Butalbital ........ 50 

GM Pharmaceuticals (Manufactured by Mikart, Inc.).Vanatol LQ (Butalbital, Acetaminophen, & Caffeine Soln 

50/325/40.

58809–820 LQ Butalbital ........ 50 

Goldline Laboratories ............ Butalbital, APAP and Caffeine Tablets ................................ 00182–1274 TB Butalbital ........ 50 

Granules Pharmaceuticals 

Inc.

Butalbital, Acetaminiphen and Caffeine Capsules 50mg/ 

300mg/40mg.

70010–044 CA Butalbital ........ 50 

Granules Pharmaceuticals 

Inc.

Butalbital and Acetaminiphen Capsules 50mg/300mg ........ 70010–054 CA Butalbital ........ 50 

GSMS Incorporated ............... Butalbital, Acetaminophen and Caffeine Tablets USP (50/ 

325/40).

60429–589 TB Butalbital ........ 50 

GSMS Incorporated ............... Butalbital, Acetaminophen and Caffeine Capsules USP 

(50/300/40).

51407–200 CA Butalbital ........ 50 


khammond on DSKJM1Z7X2PROD with PROPOSALS
Federal Register / Vol. 87, No. 70 / Tuesday, April 12, 2022 / Proposed Rules 21593 

Company Trade name NDC code Form Controlled 

substance 

(mg or 

mg/ml) 

Halsey Drug Co Inc ............... Blue Cross Butalbital, APAP and Caffeine Tablets ............. 00879–0567 TB Butalbital ........ 50 

Halsey Drug Co Inc ............... Butalbital and Acetaminophen Tablets ................................. 00879–0543 TB Butalbital ........ 50 

Hyrex Pharmaceutical ........... Two-Dyne Revised ............................................................... 00314–2229 TB Butalbital ........ 50 

International Ethical Laboratories, Inc.Tencon Tablets ..................................................................... 11584–029–01 TB Butalbital ........ 50 

Interstate Drug Exchange ..... IDE–Cet Tablets ................................................................... 00814–3820 TB Butalbital ........ 50 

Intetlab ................................... CON–TEN ............................................................................. 11584–1029 CA Butalbital ........ 50 

Inwood Laboratories, Inc ....... Butalbital, Acetaminophen and Caffeine Tablets, USP ....... 0258–3657 TB Butalbital ........ 50 

Keene Pharmacal Inc ............ Endolar ................................................................................. 00588–7777 CA Butalbital ........ 50 

Kenco .................................... Axotal .................................................................................... 00013–1301 TB Butalbital ........ 50 

KVK Tech .............................. Butalbital, Acetaminophen & Caffeine Tablets (50mg/ 

325mg/40mg).

10702–253 TB Butalbital ........ 50 

Landry Pharmacal Inc ........... Febridyne Plain Capsules .................................................... 05383–001 CA Butalbital ........ 50 

Lannett Company, Inc ........... Butalbital, Acetaminophen & Caffeine Tablets (50mg/ 

325mg/40mg).

00527–1695 TB Butalbital ........ 50 

Lannett Company, Inc ........... Butalbital, Acetaminophen & Caffeine Capsules (50mg/ 

325mg/40mg).

00527–4094 CA Butalbital ........ 50 

Lannett Company, Inc ........... Butalbital, Acetaminophen & Caffeine Capsules (50mg/ 

300mg/40mg).

00527–4095 CA Butalbital ........ 50 

Larken Laboratories, Inc ....... Allzital Butalbital and Acetaminophen Tablets (25mg/ 

325mg).

68047–752 TB Butalbital ........ 25 

Larken Laboratories, Inc ....... Butalbital and Acetaminophen Tablets (25mg/325mg) ........ 68047–722 TB Butalbital ........ 25 

Larken Laboratories, Inc ....... Butalbital and Acetaminophen Tablets (50mg/325mg) ........ 68047–721 TB Butalbital ........ 50 

Lasalle Laboratories .............. Pacaps Modified Formula ..................................................... 48534–0884 CA Butalbital ........ 50 

Lemmon Company ................ Acetaminophen/Butalbital/Caffeine Tablets .......................... 00093–0854 TB Butalbital ........ 50 

LGM Pharma Solutions, LLC Butalbital, Acetaminophen and Caffeine Tablets (50/325/ 

40mg).

79739–7320 TB Butalbital ........ 50 

LGM Pharma Solutions, LLC Butalbital, Acetaminophen and Caffeine Capsules (50/300/ 

40mg).

79739–7029 CA Butalbital ........ 50 

LGM Pharma Solutions, LLC Butalbital and Acetaminophen Tablets (50/300mg) ............. 79739–7075 TB Butalbital ........ 50 

Libertas Pharma, Inc ............. Butalbital, Acetaminophen and Caffeine Capsules USP ..... 51862–179 CA Butalbital ........ 50 

Lunsco Inc ............................. Pacaps Capsules .................................................................. 10892–0116 CA Butalbital ........ 50 

Major Pharmaceuticals .......... Butalbital, Acetaminophen and Caffeine Tablets (50/325/ 

40mg).

0904–6938 TB Butalbital ........ 50 

Major Pharmaceuticals .......... Fabophen Tablets ................................................................. 00904–3280 TB Butalbital ........ 50 

Mallard Consumer Products .. Anaquan Tablets .................................................................. 59441–0343 TB Butalbital ........ 50 

Mallard Inc ............................. Anoquan Modified Formula .................................................. 00166–0881 CA Butalbital ........ 50 

Mallinckrodt Inc ..................... Butalbital, Acetaminophen, and Caffeine (‘‘BAC’’) Tablets 

USP.

00406–0970 TB Butalbital ........ 50 

Marlop Pharmacal Inc ........... Dolmar .................................................................................. 12939–0812 CA Butalbital ........ 50 

Marnel Pharmaceuticals ........ Margesic Capsules ............................................................... 00682–0804 CA Butalbital ........ 50 

Marnel Pharmaceuticals ........ Marten-Tab Tablets .............................................................. 00682–1400 TB Butalbital ........ 50 

Martec Pharmacal Inc ........... Butalbital, Acetaminophen and Caffeine Tablets ................. 52555–0079 TB Butalbital ........ 50 

Mayne Pharma ...................... Butalbital, Acetaminophen, & Caffeine Capsules 50/300/40 51862–542 CA Butalbital ........ 50 

Mayrand Pharmaceuticals, 

Inc.

Sedapap-10 Tablets ............................................................. 00259–1278 TB Butalbital ........ 50 

Midlothian Laboratories (Manufactured by Mikart, Inc.).Esgic (Butalbital, Acetaminophen, & Caffeine Capsules 50/ 

325/40.

68308–219 CA Butalbital ........ 50 

Midlothian Laboratories (Manufactured by Mikart, Inc.).Esgic (Butalbital, Acetaminophen, & Caffeine Tablets 50/ 

325/40.

68308–220 TB Butalbital ........ 50 

Midlothian Laboratories (Manufactured by Mikart, Inc.).Zebutal (Butalbital, Acetaminophen, & Caffeine Capsules 

50/325/40.

68308–554 CA Butalbital ........ 50 

Mikart, Inc .............................. Alagesic Capsules ................................................................ 50991–302 CA Butalbital ........ 50 

Mikart, Inc .............................. Bupap ................................................................................... 00095–0240 TB Butalbital ........ 50 

Mikart, Inc .............................. Butalbital and Acetaminophen Tablets 50/325 .................... 46672–0099 TB Butalbital ........ 50 

Mikart, Inc .............................. Butalbital and Acetaminophen Tablets 50/650 .................... 11584–0029 TB Butalbital ........ 50 

Mikart, Inc .............................. Butalbital and Acetaminophen Tablets 50/650 .................... 46672–0098 TB Butalbital ........ 50 

Mikart, Inc .............................. Butalbital, Acetaminophen and Caffeine Capsules .............. 46672–0228 CA Butalbital ........ 50 

Mikart, Inc .............................. Butalbital, Acetaminophen and Caffeine Capsules .............. 00588–7788 CA Butalbital ........ 50 

Mikart, Inc .............................. Butalbital, Acetaminophen and Caffeine Eilixer ................... 46672–0633 EL Butalbital ........ 50 

Mikart, Inc .............................. Butalbital, Acetaminophen and Caffeine Tablets ................. 52555–0647 TB Butalbital ........ 50 

Mikart, Inc .............................. Butalbital, Acetaminophen and Caffeine Tablets ................. 46672–0053 TB Butalbital ........ 50 

Mikart, Inc .............................. Butalbital, Acetaminophen and Caffeine Tablets USP ........ 49884–0811 TB Butalbital ........ 50 

Mikart, Inc .............................. Butalbital, Acetaminophen and Caffeine Tablets USP ........ 00258–3665 TB Butalbital ........ 50 

Mikart, Inc .............................. Butalbital, Acetaminophen and Caffeine Tablets USP (50/ 

325/40).

51862–540 TB Butalbital ........ 50 

Mikart, Inc .............................. Butalbital, Acetaminophen and Caffeine Tablets, USP ....... 0591–3416 TB Butalbital ........ 50 

Mikart, Inc .............................. Butalbital and Acetaminophen Capsules 50/300 ................. 46672–286 CA Butalbital ........ 50 

Mikart, Inc .............................. Butalbital and Acetaminophen Tablets 50/300 .................... 46672–856 TB Butalbital ........ 50 

Mikart, Inc .............................. Butalbital, Acetaminophen and Caffeine Tablets, USP ....... 46672–184 TB Butalbital ........ 50 

Mikart, Inc .............................. Butalbital, Acetaminophen, and Caffeine Oral Solution ....... 66813–073 LQ Butalbital ........ 50 

Mikart, Inc .............................. Butalbital, Acetaminophen, and Caffeine Tablets ................ 51432–0034 TB Butalbital ........ 50 

Mikart, Inc .............................. Butalbital, Acetaminophen, and Caffeine Tablets ................ 46672–0059 TB Butalbital ........ 50 


khammond on DSKJM1Z7X2PROD with PROPOSALS
21594 Federal Register / Vol. 87, No. 70 / Tuesday, April 12, 2022 / Proposed Rules 

Company Trade name NDC code Form Controlled 

substance 

(mg or 

mg/ml) 

Mikart, Inc .............................. Capacet (Butalbital, Acetaminophen, and Caffeine 50/325/ 

40).

58407–534 CA Butalbital ........ 50 

Mikart, Inc .............................. Cephadyn Tablets ................................................................ 59702–0650 TB Butalbital ........ 50 

Mikart, Inc .............................. Dolgic Plus Tablets ............................................................... 68453–074 TB Butalbital ........ 50 

Mikart, Inc .............................. Dolgic Tablets ....................................................................... 62022–0073 TB Butalbital ........ 50 

Mikart, Inc .............................. DOLMAR Tablets ................................................................. 12939–0811 TB Butalbital ........ 50 

Mikart, Inc .............................. Esgic Capsules ..................................................................... 00535–0012 CA Butalbital ........ 50 

Mikart, Inc .............................. Esgic Tablets ........................................................................ 00535–0011 TB Butalbital ........ 50 

Mikart, Inc .............................. Promacet .............................................................................. 58605–524 TB Butalbital ........ 50 

Mikart, Inc .............................. Sedapap Tablets .................................................................. 00259–0392 TB Butalbital ........ 50 

Mikart, Inc. (on behalf of 

Mayne Pharma).

Butalbital and Acetaminophen Capsules 50/300 ................. 51862–544 CA Butalbital ........ 50 

Mikart, Inc. (on behalf of 

Mayne Pharma).

Butalbital and Acetaminophen Tablets 50/300 .................... 51862–538 TB Butalbital ........ 50 

Mikart, Inc. (on behalf of 

Monarch PCM, LLC).

Vtol LQ (Butalbital, Acetaminophen, Caffeine Oral Solution) 70154–111 LQ Butalbital ........ 50 

Mikart, Inc .............................. Tencon (Butalbital and Acetaminophen 50mg/325mg) ........ 11584–0030 TB Butalbital ........ 50 

Mikart, Inc./Shionogi, Inc ....... Dolgic Plus Tablets ............................................................... 59630–074 TB Butalbital ........ 50 

Moore Medical Corporation ... Butalbital, Acetaminophen and Caffeine Tablets ................. 00839–7831 TB Butalbital ........ 50 

Nexgen Pharma .................... BUPAP (Butalbital and Acetaminophen 50mg/300mg) ........ 0095–3000 TB Butalbital ........ 50 

Nexgen Pharma .................... Butalbital with Acetaminophen and Caffeine Tablets .......... 0722–7029 TB Butalbital ........ 50 

Nexgen Pharma .................... Butalbital, Acetaminophen and Caffeine Tablets (50mg/ 

325mg/40mg).

0722–7320 TB Butalbital ........ 50 

Northampton Medical, Inc ..... FEMCET ............................................................................... 58436–0703 TB Butalbital ........ 50 

NorthStar ............................... Butalbital, Acetaminophen and Caffeine Capsules (50mg/ 

300mg/40mg).

16714–170 CA Butalbital ........ 50 

Oceanside Pharmaceuticals 

(Manufactured by Nexgen).

Butalbital and Acetaminophen Tablets (50mg/300mg) ........ 68682–306 TB Butalbital ........ 50 

PD-Rx Pharmaceuticals, Inc Butalbital/APAP/Caffeine Tablets (50mg/325mg/40mg) ...... 55289–0879 TB Butalbital ........ 50 

Pharmaceutical Basics Inc .... Butalbital, Acetaminophen and Caffeine Tablets ................. 00832–1102 TB Butalbital ........ 50 

Phlight Pharma, LLC ............. Allzital (Butalbital and Acetaminophen Tablets (25 mg/325 

mg)).

70569–150 TB Butalbital ........ 25 

Poly Pharmaceuticals, Inc ..... Alagesic ................................................................................ 50991–0302 CA Butalbital ........ 50 

Private Formula Inc ............... Sangesic ............................................................................... 00511–1627 TB Butalbital ........ 30 

ProficientRx ........................... Butalb/Acet/Caffeine 50mg/325mg/40mg ............................. 63187–933 TB Butalbital ........ 50 

ProficientRx ........................... Butalb/Acet/Caffeine 50mg/300mg/40mg ............................. 71205–962 CA Butalbital ........ 50 

ProficientRx ........................... Butalb/Acet/Caffeine 50mg/325mg/40mg ............................. 71205–981 TB Butalbital ........ 50 

ProficientRx ........................... Butalb/Acet/Caffeine 50mg/325mg/40mg ............................. 71205–510 TB Butalbital ........ 50 

Qualitest Pharmaceuticals, 

Inc.

Butalbital and Acetaminophen Tablets ................................. 0603–2540 TB Butalbital ........ 50 

Qualitest Pharmaceuticals, 

Inc.

Butalbital, Acetaminophen and Caffeine Tablets 50/325/ 

40mg.

0603–2544 TB Butalbital ........ 50 

Qualitest Pharmaceuticals, 

Inc.

Butalbital, Acetaminophen and Caffeine Tablets USP ........ 0603–2547 TB Butalbital ........ 50 

Qualitest Pharmaceuticals, 

Inc.

Butalbital, Acetaminophen and Caffeine Tablets, USP ....... 0603–2551 TB Butalbital ........ 50 

Qualitest Products Inc ........... Butalbital, Acetaminophen and Caffeine Tablets ................. 52446–0544 TB Butalbital ........ 50 

Redi-Med ............................... Butalbital Compound Capsules ............................................ 53506–0103 CA Butalbital ........ 50 

Roberts Pharmaceutical Corporation.Anoquan ............................................................................... 54092–0178 TB Butalbital ........ 50 

Roberts Pharmaceutical Corporation.Tencet Tablets ...................................................................... 59441–0153 TB Butalbital ........ 50 

Rotex Pharmaceuticals, Inc .. Rogesic Capsules ................................................................. 31190–0008 CA Butalbital ........ 50 

Rugby Laboratories Inc ......... Butalbital, Acetaminophen and Caffeine Tablets, USP ....... 0536–5567 TB Butalbital ........ 50 

Rugby Laboratories Inc ......... ISOCET Tablets ................................................................... 00536–3951 TB Butalbital ........ 50 

Russ Pharmaceuticals, Inc .... FEMCET Capsules ............................................................... 50474–0703 CA Butalbital ........ 50 

Savage Laboratories ............. AXOTAL ................................................................................ 00281–1301 TB Butalbital ........ 50 

Shoals Pharmaceuticals, Inc Tencet ................................................................................... 47649–0370 TB Butalbital ........ 50 

Shoals Pharmaceuticals, Inc Tencet Capsules ................................................................... 47649–0560 CA Butalbital ........ 50 

Skylar Laboratories, LLC ....... Allzital (Butalbital and Acetaminophen Tablets) (25mg/ 

325mg).

70362–722 TB Butalbital ........ 25 

Skylar Laboratories, LLC ....... Butalbital and Acetaminophen Tablets (50mg/325mg) ........ 70362–721 TB Butalbital ........ 50 

Solubiomix ............................. Butalbital and Acetaminophen Tablets (50mg/325mg) ........ 69499–302 TB Butalbital ........ 50 

Solubiomix ............................. Butalbital and Acetaminophen Capsules (50mg/300mg) ..... 69499–342 CA Butalbital ........ 50

Stewart Jackson Pharmacal, 

Inc.

Ezol ....................................................................................... 45985–0578 CA Butalbital ........ 50 

STI Pharma, LLC .................. Butalbital and Acetaminophen Tablets (50mg/325mg) ........ 54879–026 TB Butalbital ........ 50 

Sunrise Pharmaceuticals, Inc Butalbital, Acetaminophen, Caffeine Capsules (50mg/ 

300mg/40mg).

11534–187 CA Butalbital ........ 50 

Taro Pharmaceuticals U.S.A., 

Inc.

Butalbital, Acetaminophen and Caffeine Caps (50mg/ 

300mg/40mg).

51672–4222 CA Butalbital ........ 50 

Tedor Pharma, Inc ................ Butalbital and Acetaminophen Tablets (50mg/300mg) ........ 47781–534 TB Butalbital ........ 50 

Tedor Pharma, Inc ................ Butalbital and Acetaminophen Tablets (50mg/325mg) ........ 43199–053 TB Butalbital ........ 50 


khammond on DSKJM1Z7X2PROD with PROPOSALS
Federal Register / Vol. 87, No. 70 / Tuesday, April 12, 2022 / Proposed Rules 21595 

Company Trade name NDC code Form Controlled 

substance 

(mg or 

mg/ml) 

Tedor Pharma, Inc. (Manufactured for Xspire 

Pharma).

Butalbital, Acetaminophen and Caffeine Caps (50mg/ 

300mg/40mg).

42195–955 CA Butalbital ........ 50 

Trimen Labs .......................... Amaphen Capsules (reformulated) ...................................... 11311–0954 CA Butalbital ........ 50 

U.S. Pharmaceuticals ............ Medigesic Capsules ............................................................. 52747–0600 CA Butalbital ........ 50 

UAD Laboratories Inc ............ Bucet Capsules .................................................................... 00785–2307 CA Butalbital ........ 50 

US Pharmaceuticals Inc ........ Medigesic Tablets ................................................................. 52747–0311 TB Butalbital ........ 50 

Valeant Pharmaceuticals ....... Phrenilin Forte ...................................................................... 0187–0844 CA Butalbital ........ 50 

Victory Pharma Inc. (Manuf. 

by West-Ward Pharmaceutical).

Zebutal Brand Butalbital, Acetaminophen, and Caffeine 

Capsules.

68453–170 CA Butalbital ........ 50 

WE Hauck Inc ....................... G–1 Capsules ....................................................................... 43797–0244 CA Butalbital ........ 50 

Westminster Pharmaceuticals Butalbital, Acetaminophen and Caffeine Tablets (50mg/ 

325mg/40mg).

69367–203 TB Butalbital ........ 50 

West-Ward Pharmaceutical 

Corp.

Butalbital with Acetaminophen and Caffeine Tablets .......... 00143–1787 TB Butalbital ........ 50 

West-Ward Pharmaceutical 

Corp.

Butalbital, Acetaminophen and Caffein Capsules ................ 00143–3001 CA Butalbital ........ 50 

West-Ward Pharmaceutical 

Corp.

Butalbital, Acetaminophen, and Caffeine Tablets, USP ...... 00143–1115 TB Butalbital ........ 50 

West-Ward Pharmaceutical 

Corp.

Zebutal Brand Butalbital, Acetaminophen, and Caffeine 

Capsules.

59630–0170 CA Butalbital ........ 50 

Wraser Pharmaceuticals ....... Phrenilin Forte (Butalbital, Acetaminophen and Caffeine) 

50/300/40.

66992–955 CA Butalbital ........ 50 

Zenith Goldline Pharmaceuticals.Butalbital, Acetaminophen and Caffeine Tablets ................. 00182–2659 TB Butalbital ........ 50 

Regulatory Analyses 

Executive Orders 12866 (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 


khammond on DSKJM1Z7X2PROD with PROPOSALS
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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/Information

OnDrugs/ucm142438.htm. (accessed March 18, 

2020) 

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. 

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 DEAregistered 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 nonregistered 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 registrationrelated 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 


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5Bureau 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 × [$26.47 per 

hour + $19.82 per hour] × 1.427 load = $33.03. 0.1 

hour × [$61.58 per hour + $16.32 per hour] × 1.427 

load = 11.12. 

6The 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. 

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. 

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 nonregistered 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. 

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 


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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: 


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7https://www2.census.gov/programs-surveys/ 

susb/tables/2012/us_6digitnaics_r_2012.xlsx. 

(accessed June 3, 2020). 8 Ibid. 

• 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. 

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. 

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 

■ 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. 

■ 2. In § 1308.31, revise paragraph (d) 

and add paragraph (e) to read as follows: 

§ 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 


khammond on DSKJM1Z7X2PROD with PROPOSALS