ECONOMIC IMPACT ANALYSIS 

of

Final Rule on Schedules of Controlled Substances: 

Placement of Tramadol into Schedule IV

DEA-351

Drug Enforcement Administration

U.S. Department of Justice

June 2014
Table of Contents

1. INTRODUCTION....................................................................................... 3

2. REGULATORY ANALYSES INVESTIGATED.................................................. 4

2.1. EXECUTIVE ORDERS 12866 AND 13563......................................................... 4

2.2. REGULATORY FLEXIBILITY ACT.................................................................. 6

2.3. UNFUNDED MANDATES REFORM ACT OF 1995...................................................... 7

2.4. CONGRESSIONAL REVIEW ACT OF 1996.............................................................. 8

3. ANTICIPATED ECONOMIC IMPACT OF REGULATORY ACTION....................... 8

3.1 GENERAL RELATIONSHIP BETWEEN REGISTRATIONS, ENTITIES, AND SMALL

ENTITIES....................................................................................... 8

3.2 AFFECTED ENTITIES............................................................................... 10

3.2.1 Number of Tramadol Handlers (Registration Requirements)......................... 10

3.2.2 Number of Entities and Small Entities Handling Tramadol........................... 13

3.3 ANNUAL COST OF THE RULE..................................................................... 17

3.3.1. Costs Associated with Registration Requirements.................................... 17

3.3.2. Costs Associated with Security Requirements......................................... 17

3.3.3. Costs Associated with Labeling and Packaging Requirements...................... 22

3.3.4. Costs Associated with Recordkeeping and Reporting Requirements............... 25

3.3.5. Costs Associated with Prescription Requirements.................................... 28

3.3.6. Costs Associated with Disposal Requirements......................................... 29

3.3.7. Cost Summary and Annualized Cost.................................................... 29

3.4 ANNUAL ECONOMIC EFFECT ON THE ECONOMY............................................. 31

3.5 IMPACT ON SMALL ENTITIES..................................................................... 33

3.5.1. Criteria for “Significant” Economic Impact............................................. 33

3.5.2. Analysis...................................................................................... 33

3.5.3. Criteria for “Substantial Number”....................................................... 37

3.6 EXAMINATION OF INDUSTRY SEGMENTS WITH SIGNIFICANT ECONOMIC 

IMPACT....................................................................................... 38

4. ECONOMIC ANALYSIS RESULTS............................................................... 38

4.1. EXECUTIVE ORDERS 12866 AND 13563....................................................... 38

4.2. REGULATORY FLEXIBILITY ACT............................................................... 38

4.3. UNFUNDED MANDATES REFORM ACT OF 1995.............................................. 39

4.4. CONGRESSIONAL REVIEW ACT................................................................. 40

5. APPENDIX A: REGISTRANT LANDSCAPE................................................... 41

6. APPENDIX B: BUSINESS WITH IMPACT 1% OR MORE OF ANNUAL

REVENUE................................................................................. 51
1. INTRODUCTION

This document describes the economic analysis conducted by the Drug Enforcement 

Administration (DEA) in support of the regulatory analyses statements published with the 

final rule to schedule 2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol

(tramadol), including its salts, isomers, and salts of isomers, as a schedule IV controlled 

substance under the Controlled Substances Act (CSA) [Docket No. DEA-351]. This 

action was initiated by four petitions to schedule tramadol under the CSA, and is 

supported by, inter alia, a recommendation from the Assistant Secretary of the HHS and 

an evaluation of all other relevant data by the DEA. This action imposes the regulatory 

controls and administrative, civil, and criminal sanctions applicable to schedule IV

controlled substances on persons who handle or propose to handle tramadol. 

On September 16, 2010, the Assistant Secretary of the HHS provided to the DEA a 

scientific and medical evaluation and scheduling recommendation entitled “Basis for the 

Recommendation to Schedule Tramadol in Schedule IV of the Controlled Substances 

Act.” After considering the eight factors in 21 U.S.C. 811(c), including consideration of 

the substance’s abuse potential, legitimate medical use, and dependence liability, the 

Assistant Secretary of the HHS recommended that tramadol be controlled in schedule IV 

of the CSA under 21 U.S.C. 812(b). The DEA conducted its own eight-factor analysis of 

tramadol pursuant to 21 U.S.C. 811(c). After a review of the available data, including the 

scientific and medical evaluation and the scheduling recommendation from the HHS, the 

Deputy Administrator of the DEA published in the Federal Register a notice of proposed 

rulemaking (NPRM) entitled “Schedules of Controlled Substances: Placement of 

3
Tramadol into Schedule IV” which proposed placement of tramadol in schedule IV of the 

CSA. 78 FR 65923, Nov. 4, 2013. 

Tramadol is an opioid analgesic that produces its primary opioid-like action through 

an active metabolite, referred to as the “M1” metabolite (O-desmethyltramadol). Since 

its approval by the Food and Drug Administration (FDA) in March 1995, tramadol has 

been available in the United States as a non-controlled and centrally acting opioid 

analgesic under the trade name ULTRAM®. Subsequently, the FDA approved for 

marketing generic, combination, and extended release tramadol products.

Because of its chemical structure, 2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)

cyclohexanol can exist as different isomeric forms. Thus, various prefixes can be 

associated with the name. Some examples of these prefixes include dextro, levo, d, l, R, 

S, cis, trans, erythro, threo, (+), (-), racemic, and may include combinations of these 

prefixes sometimes with numerical designations. Any such isomer is, in fact, 

2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol. Tramadol is typically 

formulated as a racemic mixture identified as (±)-cis-2-[(dimethylamino)methyl]-1-(3-

methoxyphenyl)cyclohexanol hydrochloride.1

2. REGULATORY ANALYSES INVESTIGATED

2.1 EXECUTIVE ORDERS 12866 AND 13563

Pursuant to Executive Order 12866 of September 30, 1993 (58 FR 51735), an agency 

must submit to the Office of Management and Budget (OMB), Office of Information and 

1 For simplicity’s sake, from this point forward in the document, “tramadol” is used to refer to 

2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol, its salts, isomers, salts of isomers, and all 

isomeric configurations of possible forms.

4

 
Regulatory Affairs (OIRA) a regulatory impact analysis for “significant regulatory 

actions.”

[A] “significant regulatory action” [is] any regulatory 

action that is likely to result in a rulemaking 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 [Executive Order 12866].2

 

For purposes of Executive Order 12866, “regulatory action” “means any substantive 

action by an agency (normally published in the Federal Register) that promulgates or is 

expected to lead to the promulgation of a final rule or regulation, including notices of 

inquiry, advance notices of proposed rulemaking, and notices of proposed rulemaking.”3

 

Of note, however, in the context of CSA scheduling actions is the fact that Executive 

Order 12866 excepts from the meaning of a “regulation” or “rule”: (1) “regulations or 

rules issued in accordance with the formal rulemaking provisions of 5 U.S.C. 556, 557;” 

and (2) “any other category of regulations exempted by the Administrator of OIRA.”4

 

Pursuant to these categorical exemptions, DEA actions concerning the scheduling of 

controlled substances are exempt from the centralized review requirements of Executive 

2 Executive Order 12866, sec. 3(f). 3 Id., sec. 3(e). 4 Id. sec. 3(d). (Sec. 3(d) also exempts from the definition of regulation or rule regulations or rules that 

pertain to military or foreign affairs function of the United States, other than procurement regulations and 

regulations involving the import or export of non-defense articles and services; and regulations or rules that 

are limited to agency organization, management, or personnel matters.).

5

 
Order 12866.5

 Executive Order 13563 (76 FR 3821, Jan. 21, 2011) affirms and 

supplements Executive Order 12866.

2.2 REGULATORY FLEXIBILITY ACT

The Regulatory Flexibility Act (RFA) requires agencies to consider the impact of 

their regulatory proposals on small entities, analyze effective alternatives that minimize 

small entity impacts, and make their analyses available for public comment.6 “The RFA 

does not seek preferential treatment for small entities, require agencies to adopt 

regulations that impose the least burden on small entities, or mandate exemptions for 

small entities. Rather, it requires agencies to examine public policy issues using an 

analytical process that identifies, among other things, barriers to small business 

competiveness and seeks a level playing field for small entities, not an unfair 

advantage.”7 

The RFA applies to any rule requiring publication of a general notice of proposed 

rulemaking under section 5 U.S.C. 553(b) of the Administrative Procedure Act or any 

other law. Three types of small entities are defined in the RFA: small businesses, small 

organizations, and small governmental jurisdictions. Pursuant to section 601(3) of the 

RFA, the term “small business” has the same meaning as the term “small business 

concern” under section 3 of the Small Business Act. A small business concern is an 

enterprise that is “independently owned and operated” and “not dominant in its field of 

5 21 U.S.C. 811(a) (“Rules of the Attorney General under this subsection shall be made on the record after 

opportunity for a hearing pursuant to the rulemaking procedures prescribed by subchapter II of chapter 5 of 

Title 5.”); see also letter from Sally Katzen, Administrator, OIRA, OMB to Eleanor D. Acheson, Assistant 

Attorney General, OPD, USDOJ (Feb. 4, 1994) (exempting from OMB review requirements of EO 12866 

DEA rulemaking actions concerning the scheduling of controlled substances which are made on the record

after opportunity for a hearing pursuant to the Administrative Procedure Act).

6 Pub. L. 96-354, 94 Stat. 1164 (1980) (codified at 5 U.S.C. 601). 7 SBA OFFICE OF ADVOCACY, A GUIDE FOR GOVERNMENT AGENCIES: HOW TO COMPLY WITH THE 

REGULATORY FLEXIBILITY ACT 1 (May 2012).

6

 
operation.”8

 Under the authority of the Small Business Act, the Small Business 

Administration (SBA) Administrator has established standards to be used in the 

determination of a small business concern.9 SBA size standards have been established 

for the types of economic activity or industry utilizing the North American Industry 

Classification System (NAICS) classifications. The SBA sets the maximum size 

standards—in millions of dollars or number of employees—allowed for concerns 

(including their affiliates) to be designated as small.10 Section 601(4) of the RFA defines 

a small organization as any not-for-profit enterprise that is independently owned and 

operated and not dominant in its field. Section 601(5) of the RFA defines small 

governmental jurisdictions as governments of cities, counties, towns, townships, villages, 

school districts, or special districts with a population of less than 50,000. Most DEA 

registrants are small businesses or employed by small businesses as defined under the 

RFA; therefore, for the purposes of this analysis, the terms “business” and “entity” are 

used interchangeably.

2.3 UNFUNDED MANDATES REFORM ACT OF 1995

The Unfunded Mandates Reform Act (UMRA)11 was enacted to avoid imposing 

unfunded Federal mandates on State, local, and tribal governments (SLTGs), or the 

private sector. Most of UMRA’s provisions apply to proposed and final rules:

8 15 U.S.C. 632.

9 Id.; See also SIZE STANDARDS DIVISION, OFFICE OF GOV’T CONTRACTING &BUSINESS DEVELOPMENT,

SBA SIZE STANDARDS METHODOLOGY (April 2009) (available at 

http://www.sba.gov/site/default/files/size_standards/methdology.pdf) (describing SBA methodology for 

establishing and adjusting its small business size standards pursuant to the Small Business Act and related 

legislative guidelines). 

10 13 CFR 121.201. 11 Pub. L. 104-4, 109 Stat. 48 (1995) (codified at 2 U.S.C. 1501 et seq.).

7

 
• for which a general notice of proposed rulemaking was published, and

• that include a Federal mandate that may result in the expenditure of funds by 

SLTGs, in the aggregate, or by the private sector of $100 million or more in 

any one year, adjusted for inflation.

2.4 CONGRESSIONAL REVIEW ACT OF 1996

Under the Congressional Review Act (CRA), a rule generally cannot take effect until 

the agency submits a rule report to each House of Congress and to the Comptroller 

General of the United States (head of the United States Government Accountability 

Office).12 Rules not considered “major” under the CRA may take effect as they 

otherwise would under other applicable law once a rule report is submitted. A rule is 

“major” if it results in an annual effect on the economy of $100 million or more; a major 

increase in costs or prices; or significant adverse effects on competition, employment, 

investment, productivity, or the ability of United States companies to compete with 

foreign companies.

3. ANTICIPATED ECONOMIC IMPACT OF REGULATORY ACTION

3.1 GENERAL RELATIONSHIP BETWEEN REGISTRATIONS, ENTITIES, AND SMALL 

ENTITIES

DEA registrations are held by a variety of persons, including businesses such as 

manufacturers, distributors, and pharmacies, as well as individuals such as practitioners

and mid-level practitioners.13 14 It is very common for businesses and individuals to hold 

12 Pub.L. 104-121, sec. 251, 110 Stat. 847 (1996) (codified at 5 U.S.C. 801–808). 13 For the purposes of this Economic Impact Analysis, “practitioner” means an individual registered with 

the DEA as a “practitioner” (physicians, veterinarians, podiatrists, dentists) but does not include 

hospitals/clinics, pharmacists, pharmacies, or mid-level practitioners as defined below. 

8

 
more than one registration, such as where a registrant handles controlled substances at 

multiple locations or engages in multiple types of DEA registered activities. However, 

RFA requirements and SBA size standards are applicable to entities and businesses. 

Because the DEA does not, in the general course of business, collect or otherwise 

maintain information regarding associated or parent organizations holding multiple 

registrations, the DEA needs some way of correlating and applying the parameters of the 

RFA and corresponding SBA size standards to DEA registrations (i.e., develop a 

relationship between the number of registrations and the number of entities). 

The DEA estimates the number of entities represented by the number of DEA 

controlled substance registrations by relating NAICS classification data to the various 

DEA business activity registration types. Utilizing this information, the DEA broadly 

classifies registrations into two categories: (1) registrations associated with industries 

where very few businesses in the industry are DEA registrants; and (2) registrations 

associated with industries where most businesses in the industry are DEA registrants. 

The first category includes manufacturers, distributors, importers and exporters. Only a 

small fraction of all businesses engaged in these activities across the United States are 

DEA registrants. The second category includes pharmacies, hospitals/clinics, offices of 

physicians, etc. In contrast to the first category, nearly all the businesses engaged in 

these activities across the United States are DEA registrants, employ registrants, or 

represent multiple registrations. Based on this information, the DEA utilizes certain 

assumptions unless more specific business information is readily available.

14 For the purposes of this Economic Impact Analysis, “mid-level practitioner” means an individual 

registered with the DEA as a “mid-level practitioner” but does not include practitioners as defined above. 

Examples of mid-level practitioners include, but are not limited to, health care providers such as nurse 

practitioners, nurse midwives, nurse anesthetists, clinical nurse specialists, and physician assistants.

9

 
• The DEA estimates a 1-to-1 entity-to-registration ratio for manufacturers, 

distributors, and importers/exporters (“category 1”). 

• The DEA utilizes the number of entities in the NAICS codes as an estimate 

for the number of entities for pharmacies, hospitals/clinics, offices of 

physicians, etc. (“category 2”). Specifically, the DEA estimates:

o A 0.74-to-1 entity-to-registration ratio for pharmacies; and

o A 0.23-to-1 entity-to-registration ratio for practitioners, mid-level 

practitioners, and hospitals/clinics (combined). 

More in-depth information on this topic is found in appendix A, which details the specific 

methodology used by the DEA to determine the entity-to-registration ratios and the 

percentages of entities that are small entities.

3.2 AFFECTED ENTITIES

3.2.1 Number of Tramadol Handlers (Registrations)

The placement of tramadol into schedule IV of the CSA will affect all persons who 

handle, or propose to handle, tramadol. Tramadol is a widely prescribed drug for the 

treatment of pain. Commercially available data shows that in 2012 nearly 40 million 

prescriptions for tramadol were written.

15 Tramadol handlers primarily include: 

manufacturers, distributors, importers, exporters, pharmacies, practitioners, mid-level 

practitioners, and hospitals/clinics. For the purposes of this analysis the DEA assumes all 

legally operating manufacturers, distributors, importers/exporters, pharmacies, 

practitioners, mid-level practitioners, and hospitals/clinics that handle tramadol are 

registered with the DEA and all distributors, importers/exporters, pharmacies, 

practitioners, mid-level practitioners, and hospitals/clinics registered with the DEA are 

tramadol handlers. While the number of DEA registrations forms the basis of the number 

15 IMS Health, National Sales PerspectiveTM (NSP).

10

 
of businesses affected by this rule, the number of manufacturers affected by this rule is 

based on industry data.

The estimated 63 manufacturers are based on IMS Health, National Sales 

PerspectiveTM (NSP) data for tramadol manufacturers. As stated in the economic analysis 

that accompanied the published NPRM, all 63 manufacturers are estimated to be DEA 

registrants for purposes of this economic analysis. The DEA was unable to confirm with 

100% certainty the current DEA registration status for each manufacturer listed on the 

IMS Health report due to possible discrepancies between legal names and doingbusiness-as names. The DEA additionally notes that the list of manufacturers obtained 

using IMS Health data varies from the list of approved tramadol applications posted on 

the FDA’s website. However, such discrepancies, are understood as resulting from a 

combination of the above factors combined with those associated with industry practices 

of contract manufacturing of drugs and corporate affiliations, and the DEA believes such 

discrepancies do not result in any material consideration that would affect the analysis. 

The DEA’s stated assumption in the analysis accompanying the NPRM that all 

manufacturers of tramadol are currently registered with the DEA was not contradicted by 

commenters. Therefore, the DEA concludes that its working model proposed in the 

NPRM that all tramadol manufacturers are currently registered, did not need 

modification.

The DEA considers non-registered pharmacies as being outside the scope of this 

analysis. The DEA is aware of Web sites currently offering “free online physician 

consultation and prescriptions” that are filled by “affiliate pharmacies” for shipment of 

tramadol. However, many, if not all, of these “pharmacies” are operating from outside 

11
the United States and the DEA did not receive comments from any Internet pharmacies, 

or pharmacies asserting affiliations with such Web sites, in response to the published 

NPRM or posted supporting materials. In addition, as of May 1, 2014, there are no 

pharmacies registered with the DEA to dispense controlled substances by means of the 

Internet pursuant to 21 U.S.C. 823(f). Without additional information or considerations

provided by research or commenters to the contrary, the DEA concludes these businesses 

will not be significantly impacted by the rule. All pharmacies desiring to offer, or to 

continue to offer, tramadol for sale, delivery, distribution, or dispensing by means of the 

Internet upon implementation of the final rule must register with the DEA, and provide 

the notifications required by 21 CFR 1304.40. They must comply with applicable Web

site disclosure requirements of 21 CFR 1304.45 and 1304.50 and reporting requirements 

specific to online pharmacies offering controlled substances for sale, delivery, 

distribution, or dispensing by means of the Internet, 21 CFR 1304.55, in addition to 

compliance with general handling requirements for pharmacies and/or distributors.

While 1,469,063 DEA registrations are estimated to be affected by this rule, 273,485

of those registrations are in the 10 States that already control tramadol as a schedule IV

controlled substance under State law with requirements that meet or exceed the DEA’s

requirements for schedule IV controlled substances. These States include Arkansas,

Illinois, Kentucky, Mississippi, New Mexico, New York, North Dakota, Oklahoma, 

Tennessee, and Wyoming.

16 Therefore, only 1,195,578 registrations are estimated to be 

economically impacted by this rule.

16 ARK. CODE ANN. § 5-64-210; 720 ILL.COMP.STAT. 570/210; 902 KY.ADMIN.REGS. 55:030; MISS. CODE 

ANN. § 41-29-119; N.M. ADMIN. CODE § 16.19.20; N.Y. Public Health Law §3306 (McKinney (2013)); 

12

 
Table 1 provides the estimated breakdown of number of tramadol handlers by DEA 

registrations, business activity, and control by State law.

Table 1. No. of Tramadol Handlers by Registered DEA Business Activity and Control by State Law

Business Activity

Number of 

Registrations in States 

where Tramadol 

Controlled w/ Federal 

schedule-IV 

requirements

Number of Registrations

in States where 

Tramadol Not 

Controlled w/ Federal 

schedule-IV 

requirements

Total

Manufacturer 12 51 63 

Distributor/Importer/Exporter 291 1,175 1,466 

Pharmacy 13,487 55,251 68,738 

Practitioner 209,182 947,103 1,156,285 

Mid-level Practitioner 48,265 178,422 226,687 

Hospital/Clinic 2,248 13,576 15,824 

Total 273,485 1,195,578 1,469,063 

Source: DEA, June 2013.

3.2.2 Number of Entities and Small Entities Handling Tramadol

As previously summarized, and as explained in detail in appendix A, the DEA utilizes 

an entity-to-registration ratio to estimate the number of businesses represented by the 

number of DEA registrations where specific data is not readily available. For 

manufacturers, distributors, importers, and exporters, the DEA assumes a 1-to-1 entity-toregistration ratio. For pharmacies and “other”17 registrants, where businesses are more 

likely to hold multiple registrations, employ multiple registrants, or engage in controlled 

substance activities at multiple locations, the DEA utilizes the number of businesses 

reported under the potentially impacted NAICS classification codes in the most recent 

United States Economic Census (currently the 2007 Economic Census) to represent the 

N.D. ADMIN. CODE 19-03.1-11; OKLA. STAT. ANN. tit. 63, § 2-210; TENN. CODE ANN. § 39-17-412; WYO.

STAT. ANN. § 35-7-1020. 17 Because individual practitioners and mid-level practitioners primarily work in various physician and 

health care specialist offices as well as hospitals and clinics, the analysis in appendix A groups individual 

practitioners, mid-level practitioners, and hospitals/clinics, as “other.” 

13

 
number of businesses represented by DEA registrations. Comparing economic census 

data for the number of employees and annual revenue with SBA size standards for each 

potentially impacted NAICS code, the DEA estimated the percentage of businesses 

(represented by DEA registrations) that are small businesses. Table A1 in appendix A 

summarizes the relationship among controlled substance registrations, entities, and small 

entities. The number of DEA registrations changes daily and the number of registrations 

in table 1 above can vary from the number of registrations in table A1 used to determine 

the entity-to-registration ratio. However, the analysis contained in appendix A is updated 

at least annually and any difference in the number of registrations between table 1 above 

and table A1 has negligible impact on the entity-to-registration ratio.

To estimate the number of entities that are affected by the action to schedule 

tramadol, the DEA applied the entity-to-registration ratio for that registration category 

(other than manufacturers). Applying the 1-to-1 entity-to-registration ratio for 

distributors, importers, and exporters, the DEA estimates that the 1,466 registrations 

correspond to 1,466 entities. Applying the 0.74 ratio for pharmacies, the DEA estimates 

that 68,738 registrations correspond to 50,756 entities. Applying the 0.23 ratio for 

practitioners, mid-level practitioners, and hospitals/clinics (combined), the DEA 

estimates that the 1,398,796 (1,156,285 practitioner + 226,687 mid-level practitioner + 

15,824 hospital/clinic) registrations correspond to 324,619 entities that employ 

individuals holding individual practitioner, mid-level practitioner, or hold hospital/clinic 

registrations. Based on research of DEA records and multiple subscription-based and 

public data sources, the DEA estimates that the 63 manufacturer registrations correspond 

to 63 entities. In total, the DEA estimates that 1,469,063 registrations will be affected by 

14
the rule, corresponding to 376,904 entities affected by the scheduling of tramadol as a 

schedule IV controlled substance under the CSA. Tables 2 and 3 contain the analysis, by 

the DEA business activity, of the estimated number of affected entities and affected small 

entities utilizing the applicable entity-to-registration ratios. 

To determine the number of small manufacturer entities, the DEA estimated the 

number of employees and annual revenue and noted the NAICS code for each of the 63

affected manufacturer entities based on research of DEA records and multiple 

subscription-based and public data sources. Using the SBA size standard for the 

respective NAICS codes, the DEA estimates that 55 of the 63 affected manufacturers are 

small entities.18

For the remaining affected business activities, the DEA used the percentage of 

businesses below SBA size standards, as explained in appendix A, to determine the 

number of affected businesses below SBA size standards (i.e., the number of businesses 

represented by DEA registrations that are small businesses). Applying the percentage 

(96.7%) of small entities to distributors, importers, and exporters, the DEA estimates that 

1,418 of the 1,466 affected distributors, importers, and exporters are small entities. 

Applying the percentages of 98.6% for pharmacies and 97.2% for practitioners, mid-level 

practitioners and hospitals/clinics, the DEA estimates that 50,032 of 50,756 pharmacies 

and 315,541 of 324,619 entities that employ practitioners, mid-level practitioners, or hold 

hospital/clinic registrations are small entities. In total, the DEA estimates that 367,046

(97%) of 376,904 affected entities are small entities. 

18 Relevant data was not found for nine of 63 manufacturers. All nine were assumed to be small 

businesses.

15

 
In States19 where tramadol is not already subject to controls equivalent to Federal 

schedule IV handling requirements under State law, the DEA estimates 306,375

businesses are economically affected by the rule, and 298,354 of these businesses are 

estimated to be small businesses. As State requirements for schedule IV controlled 

substances meet or exceed DEA requirements, businesses in these States are estimated to 

incur negligible economic impact as a result of this rule. Therefore, the DEA estimates 

that 298,354 small businesses would be economically impacted by this rule. Table 2 lists 

the estimated number of affected small entities by business activity for all States. Table 3 

lists the estimated number of affected small entities by business activity for States where 

tramadol is not already subject to Federal schedule IV handling requirements.

Table 2. Number of Affected Entities and Small Entities (all States)

Business Activity Number of 

Registrations

Entity-toRegistration

Ratio

Number of 

Entities

Percent of 

Small 

Entities

Number of 

Small 

Entities

Manufacturer 63 N/A 63 N/A 55

Distributor/Importer/Exporter 1,466 1.00 1,466 96.7 1,418

Pharmacy 68,738 0.74 50,756 98.6 50,032

Practitioner 1,156,285

Mid-level Practitioner 226,687 0.23 324,619 97.2 315,541

Hospital/Clinic 15,824

Total 1,469,063 376,904 367,046

Table 3. Number of Affected Entities and Small Entities (Tramadol not Controlled as Federal 

Schedule IV Equivalent under State Law)

Business Activity Number of 

Registrations

Entity-toRegistration

Ratio

Number of 

Entities

Percent of 

Small 

Entities

Number of 

Small 

Entities

Manufacturer 51 N/A 51 84.3 43

Distributor/Importer/Exporter 1,175 1.00 1,175 96.7 1,137

Pharmacy 55,251 0.74 40,797 98.6 40,215

Practitioner 947,103

Mid-level Practitioner 178,422 0.23 264,352 97.2 256,959

Hospital/Clinic 13,576

Total 1,195,578 306,375 298,354

19 The term “States” includes the District of Columbia and territories under United States jurisdiction. 

16

 
3.3 ANNUAL COST OF THE RULE

Upon implementation of this final rule, all persons who handle or propose to handle 

tramadol will be subject to the CSA’s regulatory controls applicable to schedule IV 

controlled substances and may be subject to administrative, civil, and/or criminal action.

3.3.1 Costs Associated with Registration Requirements 

As stated previously in section 3.2.1, for the purposes of this analysis, the DEA 

assumes that any entity currently handling tramadol also handles schedule IV controlled 

substances in the normal course of business and thus is already a DEA registrant. Since

no entity would be required to apply for a DEA registration, the DEA estimates there will 

be no registration costs as a result of this rule.

3.3.2 Costs Associated with Security Requirements

In accordance with 21 CFR 1301.71(a): “All applicants and registrants shall provide 

effective controls and procedures to guard against theft and diversion of controlled 

substances. In order to determine whether a registrant has provided effective controls 

against diversion, the Administrator shall use the security requirements set forth in 

§§ 1301.72–1301.76 as standards for the physical security controls and operating 

procedures necessary to prevent diversion.” The DEA’s estimated costs associated with 

such physical security controls are outlined in the following subsections. 

Manufacturers

The DEA assumes current manufacturers of tramadol are DEA registrants and 

therefore already have facilities that meet or exceed the security controls required by 21 

CFR part 1301 for schedule IV controlled substances. Many of these manufacturers are 

likely to have sufficient space in their existing vaults and/or cages to accommodate the 

17
addition of tramadol. However, the DEA understands that some current manufacturers 

may need to make modifications to manufacturing and storage facilities. Due to the 

uniqueness of each business, the DEA cannot specifically account for potential 

modifications that may be required. However, based on its understanding of 

manufacturer operations, facilities, and existing security controls and procedures,

including those related to suspicious orders and reporting of theft and losses, the DEA 

assumes any costs associated with such modifications, if needed, are nominal. While the 

DEA recognizes that other steps may be involved, the DEA understands costs associated 

with such modifications will be primarily limited to one-time expenditures for reorganizing existing stock in the vaults and cages to make room for tramadol and costs 

associated with actually moving the product. Due to costs directly associated with the 

manufacturing of pharmaceuticals as well as indirect costs associated with security and 

general overhead, the DEA assumes that manufacturers, traditionally for-profit 

businesses, seek to maximize profits, in part by limiting excess stock of pharmaceuticals, 

including tramadol, to that which they can readily sell. Not only does this prevent the 

necessity of increased costs associated with storage, but will also decrease the amount of 

available product that is potentially available for theft and diversion in accordance with 

21 CFR 1301.71(a). Costs associated with self-initiated, contemporaneous evaluation of 

storage and security for other products and equipment that do not directly result from the 

scheduling of tramadol is outside the scope of this rulemaking and are not factored into 

the economic costs associated with this rulemaking.

18
Distributors, Importers, and Exporters

As previously stated, the DEA assumes distributors, importers, and exporters of 

tramadol are current DEA registrants with existing controlled substance storage that 

complies with DEA regulations. For purposes of this analysis, the DEA assumes that 

50% of distributors, importers, and exporters have existing controlled substance storage 

areas to store tramadol at negligible cost. While the DEA believes this requirement 

affects far less than half of distributors, importers, and exporters, the DEA utilizes the top 

half of the likely range to be conservative. The DEA’s understanding that far fewer than 

50% of distributors, importers, and exporters will actually be affected by physical 

security requirements is supported by comments from industry, with a leading national 

association representing distributors stating in response to the published NPRM that most 

of their members “believe that currently, there is adequate space within their warehouse 

cages to store the anticipated volume of tramadol products that will be subject to the 

physical security requirements. Thus, for [association] members, construction or 

expansion of cage space is unlikely to result from a tramadol scheduling decision.” The 

DEA has estimated the cost of additional secure storage space for the remaining 50% that 

may require expansion.

Based on research of publicly available cost information, the DEA estimates that, 

depending on size, the addition of an enclosure with self-closing and self-locking hinged 

doors will cost $2,000 to $6,000. The $6,000 estimate is based on a cage size of 10’ high 

by 20’ long and 20’ wide. Including the estimated taxes, delivery, and installation, the 

DEA estimates a one-time cost of $10,000 per distributor, importer, or exporter that 

19
requires additional secure storage space in order to continue to handle tramadol as a result 

of the scheduling action.

The DEA recognizes that businesses that handle larger volumes may require more 

space and incur higher cost, while businesses that handle smaller volumes may require 

less space and incur lower cost. However, the DEA has no basis for further 

differentiating storage space requirements or costs. For the purposes of this analysis, the 

DEA assumes the cost of additional secure storage space is the same for all distributors, 

importers, and exporters.

Hospitals/Clinics

The DEA assumes all hospitals and clinics which hold a DEA registration already 

maintain an inventory of schedule IV controlled substances and have existing controls 

against diversion that meet DEA regulatory requirements. If the inventory of tramadol is 

not already stored in a secured area appropriate to schedule IV controlled substances at 

these locations in accordance with the physical security controls for practitioners in 21 

CFR 1301.75(b), the DEA assumes, based on its understanding of hospital/clinic 

operations and facilities, transferring the tramadol inventory to a secure storage area may 

be accomplished at negligible cost. In accordance with 21 CFR 1301.75(b), institutional 

practitioners may disperse controlled substances, including tramadol, throughout the 

stock of noncontrolled substances in such a manner as to obstruct the theft or diversion of 

the controlled substances as an alternative to being stored in a substantially constructed 

cabinet. Depending on the individual stocks carried by a particular hospital/clinic of 

tramadol and other pharmaceuticals, as well as their local security practices, in many 

cases this will mean that no changes will be required at all. However, if a hospital/clinic 

20
carries larger stocks of tramadol than have been used as non-controlled stock into which 

controlled substances are dispersed in accordance with 21 CFR 1301.75(b), it may 

require a slight rearrangement so that disbursement of tramadol and other controlled 

substances meet the requirements of the regulation.

Pharmacies

The DEA assumes all registered pharmacies currently handle schedule IV controlled 

substances and maintain secure storage areas for schedule IV controlled substances, in 

accordance with the physical security controls for practitioners in 21 CFR 1301.75(b). 

The DEA assumes based on its understanding of pharmacy operations and facilities, costs 

for pharmacies to comply with the security requirements for tramadol will be negligible. 

In accordance with 21 CFR 1301.75(b), pharmacies may disperse controlled substances, 

including tramadol, throughout the stock of noncontrolled substances in such a manner as 

to obstruct the theft or diversion of the controlled substances as an alternative to being 

stored in a substantially constructed cabinet. Depending on the individual stocks carried 

by a particular pharmacy of tramadol and other pharmaceuticals, as well as their local 

security practices, in many cases this will mean that no changes will be required at all. 

However, if a pharmacy carries larger stocks of tramadol than have been used as noncontrolled stock into which controlled substances are dispersed in accordance with 21 

CFR 1301.75(b), it may require a slight rearrangement so that disbursement of tramadol 

and other controlled substances meet the requirements of the regulation.

Practitioners and Mid-level Practitioners

The DEA assumes all registered practitioners currently handle schedule IV controlled 

substances and maintain secure storage areas for schedule IV controlled substances at a 

21
registered location, such as a physician’s office or other health care facilities. Because 

practitioners are estimated to maintain smaller quantities of tramadol, the DEA believes 

such inventory of tramadol may be secured at the current location within DEA regulatory 

requirements at negligible cost. The DEA believes that a registrant may incur a one-time 

cost for the placement of a lock, but that this or any other such costs for practitioners to 

comply with the additional physical security requirements for tramadol will be negligible.

3.3.3 Costs Associated with Labeling and Packaging Requirements

As of the effective date of the final rule, pursuant to 21 U.S.C. 821, 825, 871(b), and 

958(e) and in accordance with 21 CFR 1302.03, manufacturers are required to print upon 

the labeling of each commercial container of tramadol distributed by him the designation 

of tramadol as “C-IV.” It shall be unlawful for commercial containers of tramadol not 

bearing the labeling requirements properly identifying it as a schedule IV controlled 

substance in accordance with 21 CFR part 1302 to be distributed. As clearly stated in 21 

CFR 1302.05, “[a]ll labels on commercial containers of, and all labeling of, a controlled 

substance which either is transferred to another schedule or is added to any schedule shall 

comply with the requirements of § 1302.03, on or before the effective date established in 

the final order for the transfer or addition.” Accordingly, the DEA is requiring that 

commercial containers of tramadol distributed on or after 45 days from the date of 

publication of the final rule be labeled as “C-IV” and be packaged in accordance with 21 

CFR part 1302.

Manufacturers

The DEA assumes that the activity of manufacturers making labeling changes is 

routine and in their normal course of business. The DEA additionally notes the 

22
promotion and use of digital/print on-demand technology by industry enabling just intime printing that allows for small lead times and reducing or eliminating “over-runs” and 

excess pre-printed label stock. The DEA therefore assumes that the cost of making this 

change is nominal. Additionally, as discussed in the final rule, the DEA assumes that 45 

days is a reasonable amount of time for the products with pre-control labeling to be 

distributed without supply disruption. Correspondingly, the DEA estimates that the cost 

of the labeling and packaging requirements of this rule for manufacturers is nominal.

Distributors

The DEA believes 45 days will be a reasonable amount of time for distributors to sell 

existing stock with pre-control labeling and packaging and to restock inventory with postcontrol labeling and packaging. From the 2007 Economic Census, the DEA estimates 

that the inventory turnover ratio for the pharmaceutical distribution industry20 is 

approximately 11.3. From the census, the inventory turnover ratio of 11.3 was calculated 

by dividing the 2007 “cost of goods sold” for the industry of $280,481,051,000 by the 

average end-of-year 2006 total inventories of $24,426,676,000 and 2007 total inventories 

of $25,138,994,000 (average $24,782,835,000). The 11.3 inventory turnover ratio 

equates to an average of 32 days to sell inventory.21 The 11.3 turnover ratio is consistent 

with that of large distributors where financial information was publicly available and 

reviewed. This inventory turnover ratio is a reasonable estimate for the entire industry 

and all products under the circumstances. Publically reviewed data report that about 85% 

of all revenues (an indirect indicator of dosage units moved) from drug distribution in the 

20 2007 Economic Census, NAICS 424210 - Drugs and druggists' sundries merchant wholesalers, Merchant 

wholesalers, except manufacturers' sales branches and offices.

21 Inventory turnover is a measure of how many times inventory is sold or used in a year. Average days to 

sell inventory = 365 days/Inventory Turnover Ratio.

23

 
United States come from three public wholesalers, each with annual revenue in the 

billions. The DEA additionally notes that many regional and specialty pharmaceutical 

wholesalers have been acquired by the largest three distribution companies. Because the 

32 days to sell inventory is an average based on industry-wide census data, it is possible 

for an individual company and/or product line to have shorter or longer time to sell. The 

DEA believes 45 days will be a reasonable amount of time for distributors to sell existing 

stock with pre-control labeling and packaging and to restock inventory with post-control 

labeling and packaging. Additionally, the DEA believes that any distributor that requires 

more than 45 days to sell tramadol inventory under normal circumstances can make 

minor modifications to ordering and stocking procedure for a transitional period to meet 

the established effective date at nominal cost.

Although the DEA considers this will likely be uncommon, in the event that a 

distributor does find themselves with pre-control labeled tramadol product after the 

effective date of the final rule, the DEA notes that distributors do have the option of 

returning excess stock of pre-control labeled tramadol product to the manufacturer, as 

authorized by 21 CFR 1307.12. The DEA assumes that the activity of manufacturers 

receiving returned products stock for possible repackaging and/or relabeling is routine 

and in their normal course of business. The DEA therefore assumes that the cost of 

making this change is nominal. 

Pharmacies

Labeling requirements for commercial containers do not apply to commercial 

containers that are not being distributed (e.g., that are in pharmacies for dispensing only). 

21 CFR 1302.03 requires that the manufacturer print the required symbol on the labeling 

24
of only those products that the manufacturer packages after the established effective date. 

It does not require pharmacies to return stocks to the manufacturer for relabeling. 

Accordingly, the cost of the labeling and packaging requirements of this rule for 

pharmacies is nominal. 

3.3.4 Costs Associated with Recordkeeping and Reporting Requirements

Initial and biennial inventories are required for all schedule II-V controlled 

substances pursuant to 21 U.S.C. 827, 958 and in accordance with 21 CFR 1304.03, 

1304.04, and 1304.11. 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, be in such a form that required information is readily retrievable from the 

ordinary business records of the registrant. 21 CFR 1304.04 (f)(2) and (h)(3). 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). The DEA assumes 

for the purpose of this analysis that registrants already maintain detailed records of 

controlled substance transactions, in furtherance of their regulatory responsibilities.

This scheduling action adds one controlled substance to the existing recordkeeping 

systems of registrants. Because this would be a minor addition to the existing business 

practices of recordkeeping for most registrants, the DEA estimates that there will be no 

economic impact beyond the addition and initial and biennial inventory of registrants’ 

25
tramadol stock pursuant to the inventory requirements in 21 CFR 1304.11. The costs 

associated with inventory and recordkeeping requirements of the rule are estimated 

below.

Inventory Management System Modification

The DEA estimates that a one-time modification will be required to add tramadol to a 

registrant’s existing controlled substance inventory management system. Varying 

degrees of automation are expected among the affected entities. “Inventory management 

system” is used generically to refer to a mix of automated and manual processes used to 

manage inventory. For some registrants, the one-time modification may be changes to

paper forms. For some registrants, the one-time modification will require technical 

personnel to make changes to a computerized system. For the purposes of this analysis, 

the DEA estimates that the cost of the one-time change is the same regardless of the 

registrant’s business activity and regardless of the existing inventory management 

system.

The DEA estimates that in order to add one substance to the existing controlled 

substance inventory management system, the registrant may incur a one-time cost of a 

computer programmer to update the existing inventory management system. The DEA 

used Bureau of Labor Statistics, Occupational Employment and Wages, May 2012, data 

to determine that the median wage of a Computer Programmer in the United States is 

$35.71 per hour22 and an additional 42.25% load23 on the labor rate to account for 

benefits. The DEA estimates that modifying an existing system to accommodate the 

22 Bureau of Labor Statistics, http://www.bls.gov/oes/current/oes_nat.htm. 23 Bureau of Labor Statistics, “Employer Costs for Employee Compensation – September 2013” reports 

that benefits for private industry is 29.7% of total compensation. The 29.7% of total compensation equates 

to 42.25% (29.3% / 70.3%) load on wages and salaries. 

26

 
integration of tramadol into a current inventory management system would be 

accomplished in four hours for a total one-time cost of $203.19 (4 hours x [$35.71 per 

hour + $35.71 x 0.4225 load]) for each affected entity.

Initial Inventory

Inventory requirements in 21 CFR 1304.11 include an inventory of newly controlled 

substances as well as biennial inventories. Following this scheduling action, registrants 

will be required to take an inventory of all stocks of tramadol on hand. The DEA 

estimates an initial inventory will be conducted by two employees, a bookkeeping clerk 

and an information clerk, and will take one hour to complete. The DEA used Bureau of 

Labor Statistics, Occupational Employment and Wages, May 2012, data for median 

hourly wage for “Bookkeeping, Accounting, and Auditing Clerks” and “Receptionists 

and Information Clerks” which are $16.91 and $12.49,24 respectively. The combined 

hourly rate of $29.40, plus an additional 42.25% load on the labor rate to account for 

benefits25 for a period of one hour is $41.82 (1 hour x [$29.40 per hour + $29.40 per hour 

x 0.4225 load]). Therefore, for the purposes of this analysis, the DEA estimates that the 

cost of the required initial inventory will be a one-time cost of $41.82 for each affected 

entity.

Biennial Inventory

As discussed above, inventory requirements in 21 CFR 1304.11 also include biennial 

inventories. The DEA estimates that the cost of conducting a biennial inventory of 

tramadol will be the same as the initial inventory, $41.82 every two years. 

24 Bureau of Labor Statistics, http://www.bls.gov/oes/current/oes_nat.htm. 25 See note 24. 

27

 
3.3.5 Costs Associated with Prescription Requirements

The prescribing practitioner or mid-level practitioner must be authorized by the 

jurisdiction in which they practice and registered with the DEA to prescribe schedule IV 

controlled substances. A prescription for a controlled substance to be effective must be 

issued for a legitimate medical purpose by an individual practitioner acting in the usual 

course of professional practice. 21 CFR 1306.04. As tramadol currently requires a 

prescription, many States have limits on refills based on State law that may exceed that 

allowed under federal law for schedule IV controlled substances. 21 CFR 1306.22(a)

states that no prescription for a controlled substance listed in schedule III or IV shall be 

filled or refilled more than six months after the date on which such prescription was 

issued; and no prescription for a controlled substance listed in schedule III or IV 

authorized to be refilled may be refilled more than five times. Although there may be 

differences in the pre and post-control refill requirements for tramadol, the DEA 

estimates that any limitation in the number of refills can be overcome with new 

prescriptions so long as there exists a doctor-patient relationship and the new prescription 

is issued for a legitimate medical purpose by a practitioner acting in the usual course of 

his professional practice. Any additional prescription-related recordkeeping and/or 

administrative responsibilities imposed on pharmacists and/or prescribers as a result of 

scheduling tramadol should be minimal given that all affected pharmacists and providers 

are already DEA registrants and are knowledgeable about schedule IV handling 

requirements—including those associated with prescribing schedule IV controlled 

substances. Therefore, any cost associated with prescription requirements is nominal.

28
3.3.6 Costs associated with Disposal Requirements

The disposal of controlled substances by registrants is generally performed by 

procuring the services of a reverse distributor. The DEA recognizes that placing 

tramadol into schedule IV of the CSA may increase the volume of material that 

registrants will need to dispose of through a reverse distributor. However, as tramadol is 

not currently a controlled substance, the DEA does not have information on the volume 

of tramadol currently disposed of, thus cannot determine what the increase in schedule IV

controlled substance disposal will be or how it will affect the fees charged by reversed 

distributors. Therefore, the DEA is unable to quantify the costs associated with the 

disposal of tramadol. However, since the affected entities are assumed to be already 

disposing controlled substances, the disposal of tramadol will be incorporated into 

existing business processes. The DEA believes that any cost increase, if one exists, will 

be negligible.

3.3.7 Cost Summary and Annualized Cost

In summary, the DEA estimates there will be one-time and on-going costs to 

businesses that are affected by the control of tramadol as a schedule IV controlled 

substance. These economic impacts would be associated with storage and inventory and 

recordkeeping requirements.

The DEA estimates that the 306,375 economically affected businesses will incur nonrecurring costs totaling $245.01 and biennially recurring costs of $41.48. (The $41.48

cost of the biennial inventory does not occur until two years after implementation of the 

rule.) Furthermore, 50% of distributors, importers, and exporters are estimated to incur 

29
an additional non-recurring cost of $10,000 for storage requirements. Table 4

summarizes the non-recurring costs.

Table 4. Non-recurring costs associated with controlling tramadol under schedule IV of the CSA

Cost Category Manufacturer, Pharmacy, 

Practitioner, Mid-level 

Practitioner, Hospital, 

Clinic, and 50% of 

Distributor, Importer, 

and Exporter*

($)

50% of Distributor, 

Importer, and 

Exporter*

($)

Registration - -

Storage - 10,000.00

Inventory and Recordkeeping

System Modification 203.19 203.19

Initial Inventory 41.82 41.82

Disposal - -

Total 245.01 10,245.01

* 50% of distributors/importers/exporters are assumed to have enough storage and will not incur 

additional cost of storage.

The annual cost of the final rule is determined by determining the net present value

(NPV) of the estimated cash flows over 20 years at 7% and 3% discount rates, then 

determining the equal annual payments for the determined NPV at 7% and 3% interest 

rates.

26 For the distributors, importers, and exporters that need additional storage space, 

the DEA estimates the present value of cost of the final rule to be $10,459.05 and 

$10,551.51 at 7% and 3% discount rates, respectively. Annual cost is estimated to be 

$987.26 for $10,459.05 total present value of cost in equal annual payments at 7% rate 

for 20 years, and $709.23 for $10,551.51 total present value of cost in equal annual 

payments at 3% rate for 20 years.

26 The use of 7% and 3% discount rates for present value calculation, annual payment calculation, and 

analysis time horizon is based on OMB Circular A-4, Sept. 17, 2003. Also “Regulatory Impact Analysis: 

A Primer” (no date) and “Regulatory Impact Analysis: Frequently Asked Questions (FAQ)” Feb. 7, 2011, 

Office of Information and Regulatory Affairs (OIRA). The DEA used a 20 year time horizon for this 

analysis as there is no predetermined end to this rule.

30

 
For all other affected businesses and distributors, importers, and exporters that do not 

need additional storage space, the DEA estimates the present value of cost of the rule to 

be $459.05 and $551.51 at 7% and 3% discount rates, respectively. Annual cost is 

estimated to be $43.33 for $459.05 total present value of cost in equal annual payments at 

7% rate for 20 years, and $37.07 for $551.51 total present value of cost in equal annual 

payments at 3% rate for 20 years. Table 5 summarizes annualized cost results.

Table 5. Annualized Cost

* 50% of distributors/importers/exporters are assumed to have enough storage and will not incur additional 

cost of storage.

3.4 ANNUAL ECONOMIC EFFECT ON THE ECONOMY 

The annual economic effect on the economy is the annual cost per business times the 

number of affected businesses. In section 3.2.2, the DEA estimated that 306,375

businesses, in States where tramadol is not controlled, were economically affected by the 

rule. The annual cost of $987.26 is applied to the assumed 50% (588) of 1,175

distributors/importers/exporters affected by the rule. Annual cost of $43.33 is applied to 

remaining businesses affected by the rule: 51 manufacturers; 587 

distributors/importers/exporters; 40,797 pharmacies; and 264,352 businesses that employ 

50% of Distributor, Importer, and 

Exporter* Year 0 Year 1 Year 2 Year 3 Year 4 ... Year 19 Year 20

Storage $10,000.00

System Modification $ 203.19 $ - $ - $ - $ - ... $ - $ -

Initial/Biennial Inventory $ 41.82 $ - $ 41.82 $ - $ 41.82 ... $ - $ 41.82

Total $10,245.01 $ - $ 41.82 $ - $ 41.82 ... $ - $ 41.82

Net Present Value (7% discount rate) $10,459.05 Net Present Value (3% discount rate) $10,551.51

Annual Cost (7% rate, 20 years) $987.26 Annual Cost (3% rate, 20 years) $709.23

All Other & 50% of Distibutor, Importer, 

and Exporter* Year 0 Year 1 Year 2 Year 3 Year 4 ... Year 19 Year 20

System Modification $ 203.19 $ - $ - $ - $ - ... $ - $ -

Initial/Biennial Inventory $ 41.82 $ - $ 41.82 $ - $ 41.82 ... $ - $ 41.82

Total $ 245.01 $ - $ 41.82 $ - $ 41.82 ... $ - $ 41.82

Net Present Value (7% discount rate) $ 459.05 Net Present Value (3% discount rate) $ 551.51

Annual Cost (7% rate, 20 years) $ 43.33 Annual Cost (3% rate, 20 years) $ 37.07

31
or hold practitioner, mid-level practitioner, and/or hospital/clinic registrations. To be 

conservative in analysis, the higher values for annual costs of $987.26 and $43.33 at 7% 

discount rate is used rather than the annual costs of $709.23 and $37.07 at 3% discount 

rate. The total annual cost is estimated to be $13,830,260. Table 6 details the total 

annual cost calculation.

Table 6. Total Annual Cost

Business Activity Number of 

Registrations

Entity-toRegistration

Ratio

Number 

of 

Entities

Number of 

Entities 

with 

Economic 

Impact

Annual 

Cost per 

Entity

($)

Total Annual

Cost 

($)

Manufacturer 51 1.0 51 51 43.33 2,210

Distributor/

Importer/ Exporter 1,175 1.0 1,175

588 987.26 580,509

587 43.33 25,435

Pharmacy 55,251 0.74 40,797 40,797 43.33 1,767,734

Practitioner 947,103

0.23 264,352 264,352 43.33 11,454,372

Mid-level 

Practitioner 178,422

Hospital/Clinic 13,576

Total 1,195,578 306,375 306,375 13,830,260

The DEA does not anticipate that this rulemaking will 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.

32
3.5 IMPACT ON SMALL ENTITIES

To comply with the RFA, the DEA conducted a preliminary analysis to determine 

whether, if promulgated, the rule will have a significant economic impact on a substantial 

number of small entities.

3.5.1 Criteria for “Significant” Economic Impact

When there are no special considerations for “significant economic impact” or criteria 

prescribed by external sources, the DEA uses the revenue-based criterion for “significant 

economic impact” evaluation. Table 7 summarizes the general criteria for “significant” 

economic impact. 

Table 7. General Criteria for "Significant" Economic Impact

Criteria Basis Criteria Result

Revenue-based

<1% of annual revenue Not significant economic impact

1% to 3% of annual revenue Possible significant economic impact

>3% of annual revenue Significant economic impact

3.5.2 Analysis

To estimate the number of businesses “significantly” impacted by the rule, the DEA 

first determined the revenue level associated with the 1% criteria for each North 

American Industry Classification System (NAICS) code associated with the affected 

entities. Then, using the revenue profile from the 2007 Economic Census, estimated the 

number of businesses where the cost of the rule is 1% or more than the revenue. 

For example, NAICS code “621111–Office of physicians (except mental health 

specialists)” would incur an annual cost of $43.33. The revenue level that corresponds to 

$43.33 as 1% of revenue is $4,333. Using the revenue profile for NAICS code 621111 

from the 2007 Economic Census, the number of businesses with revenue less than $4,333

33
is estimated (See table 8). The 2007 Economic Census uses the term, “firm” 27 to 

describe businesses. There are technical differences in the definition; however, any 

difference is expected to have no impact on the analysis. For the purposes of this 

analysis, “firm,” “business,” and “entity” are used synonymously.

Table 8: Revenue Profile for NAICS Code 621111 (Example)

The revenue profile indicates that there are 7,415 firms with revenue less than 

$100,000. Using linear interpolation for revenue range of $0 to $100,000 ([$4,333 / 

$100,000] x 7,415), the cost of the rule is estimated to be 1% or more for 321 (4.3%) of 

7,415 firms with revenue less than $100,000, or (0.2%) of 160,034 total firms operated 

for the entire year. Use of linear interpolation, implicitly assumes that the 7,415 firms 

with revenue less than $100,000 are evenly distributed across $0 to $100,000 revenue 

range. One may argue that it is likely that there are more firms in the upper ranges of 

27 Firm—A firm is a business organization consisting of one or more domestic establishments in the same 

State and industry that were specified under common ownership or control. The firm and the establishment 

are the same for single-establishment firms. For each multi-establishment firm, establishments in the same 

industry within a State will be counted as one firm- the firm employment and annual payroll are summed 

from the associated establishments. http://www.census.gov/econ/susb/definitions.html.

2007 

NAICS 

code 2007 NAICS code description Revenue size of firms operated entire year

Number 

of firms

621111 Offices of physicians (except mental health specialists) Firms operated for the entire year 160,034

621111 Offices of physicians (except mental health specialists) Firms operated entire year with sales/receipts/revenue less than $100,000 7,415

621111 Offices of physicians (except mental health specialists) Firms operated entire year with sales/receipts/revenue of $100,000 to $249,999 19,674

621111 Offices of physicians (except mental health specialists) Firms operated entire year with sales/receipts/revenue of $250,000 to $499,999 38,179

621111 Offices of physicians (except mental health specialists) Firms operated entire year with sales/receipts/revenue of $500,000 to $999,999 41,770

621111 Offices of physicians (except mental health specialists) Firms operated entire year with sales/receipts/revenue of $1,000,000 to $2,499,999 31,857

621111 Offices of physicians (except mental health specialists) Firms operated entire year with sales/receipts/revenue of $2,500,000 to $4,999,999 11,486

621111 Offices of physicians (except mental health specialists) Firms operated entire year with sales/receipts/revenue of $5,000,000 to $9,999,999 5,527

621111 Offices of physicians (except mental health specialists) Firms operated entire year with sales/receipts/revenue of $10,000,000 to $24,999,999 2,850

621111 Offices of physicians (except mental health specialists) Firms operated entire year with sales/receipts/revenue of $25,000,000 to $49,999,999 768

621111 Offices of physicians (except mental health specialists) Firms operated entire year with sales/receipts/revenue of $50,000,000 to $99,999,999 299

621111 Offices of physicians (except mental health specialists) Firms operated entire year with sales/receipts/revenue of $100,000,000 or more 209

34

 
annual revenue, such as $90,000 to $100,000, than at a lower range, such as $0 to 

$10,000. Additionally, one can argue that there are no economically viable firms with 

annual revenue below $4,333, suggesting that only the 50% of distributor/exporter that 

need additional storage be examined for significant economic impact. Although there is 

merit to these arguments, the DEA used linear interpolation to be conservative and to 

account for possibility that some firms may not be operating year-round and have annual 

revenue in the low range of $0 to $100,000.

This methodology was applied to all NAICS codes, except manufacturers. The 

estimate of zero small business manufacturers with significant economic impact is based 

on multiple publically available data for annual sales data. The analysis combined the 

NAICS codes for each registrant business activity to determine the percentage of small 

businesses with revenue below the 1% threshold: 4.4% for distributor/importer/exporter, 

0.3% for pharmacy, and 0.3% for practitioner/mid-level practitioner/hospital/clinic 

business activities. The percentages were applied to the number of small businesses 

located in States where tramadol is not controlled as a Federal schedule IV equivalent 

under State law. The DEA estimates that the rule may have a significant economic 

impact on 818 small businesses: 0 manufacturers; 50 distributors/ importers/exporters; 

107 pharmacies; and 661 small practitioners/mid-level practitioners/hospitals/clinics

(“other”). See “Appendix B: Number of Businesses Whose Cost Is 1% or More of 

Revenue” for the detailed analysis. Table 9 summarizes the estimated number of affected 

small businesses with significant economic impact.

35
Table 9. Number of Affected Small Entities with Significant Economic Impact in States Where 

Tramadol is not Currently Controlled as a Schedule IV Controlled Substance under State law

Business 

Activity

Number of 

Registrations

Entity-toRegistration RatioNumber

of 

Entities

Percent of 

Entities 

Below SBA

size 

standard

Number

of 

Entities 

Below 

SBA size 

standard

Percent

of Small 

Entities 

Significantly 

Impacted 

Number of 

Affected 

Small 

Entities 

with 

Significant 

Economic 

Impact

Manufacturer 51 1.0 51 84.3 43 0.0 -

Distributor/

Importer/

Exporter 1,175 1.0 1,175 96.7 1,137 4.4 50

Pharmacy 55,251 0.74 40,797 98.6 40,215 0.3 107

Practitioner 947,103

0.23 264,352 97.2 256,959 0.3 661

Mid-level 

Practitioner 178,422

Hospital/

Clinic 13,576

Total 1,195,578 306,375 97.4 298,354 0.3 818

In section 3.2.2, the DEA estimated 376,904 businesses would be affected by the rule, 

and 367,046 of these businesses are estimated to be small businesses, including 

businesses located in States where tramadol is controlled as a Federal schedule IV 

equivalent under State law. Since only the businesses in States where tramadol is not 

controlled under State law are impacted economically, the number of small businesses 

with significant economic impact in these states also represents the number of small 

businesses with significant economic impact in all States. Therefore, this rule has a 

significant economic impact on 0 (0.0%) of 55 affected manufacturers, 50 (3.5%) of 

1,418 affected distributors/importers/exporters, 107 (0.2%) of 50,032 affected 

pharmacies, and 661 (0.2%) of 315,541 affected practitioners/mid-level 

practitioners/hospitals/clinics, totaling 818 (0.2%) of 367,046 small businesses. Table 10 

summarizes the percentage of small businesses significantly impacted by the final rule for 

all States.

36
Table 10. Percentage of Small Businesses Significantly Impacted by Control of Tramadol in 

Schedule IV across all of the United States

The DEA also examined the disproportionality of the economic impact. The DEA 

did not have a basis for differentiating costs for different business sizes, thus one cost 

estimate was made for each registrant business activity. This estimate suggests 

disproportionality, where smaller (of the small) businesses will bear a larger economic 

impact as a percentage of revenue. However, the DEA believes the disproportionality 

will be mitigated by business volume. A smaller business will handle a lower volume of 

tramadol, thus require less secure storage.

3.5.3 Criteria for “Substantial Number”

When there are no special considerations for “substantial number” or criteria 

prescribed by external sources, the DEA uses a general criterion based on percentage of 

affected entities. Table 11 summarizes the general criteria for “substantial” number.

For the purposes of this analysis, a “substantial number” is defined as greater than 

30%.

Business 

Activity

Number of 

Registrations

Entity-toRegistration RatioNumber

of 

Entities

Percent

of 

Entities 

Below 

SBA size 

standard

Number

of 

Entities 

Below 

SBA size 

standard

Number of 

Affected 

Small 

Entities w/ 

Significant

Economic 

Impact

Percent of 

Small 

Entities 

Significantly 

Impacted

Manufacturer 63 1.0 63 87.3 55 - 0.0

Distributor/

Importer/

Exporter 1,466 1.0 1,466 96.7 1,418 50 3.5

Pharmacy 68,738 0.74 50,756 98.6 50,032 107 0.2

Practitioner 1,156,285

0.23 324,619 97.2 315,541 661 0.2

Mid-level 

Practitioner 226,687

Hospital/

Clinic 15,824

Total 1,469,063 376,904 97.4 367,046 818 0.2

37
Table 11. General Criteria for "Substantial" Number

Criteria Result

<10% of small businesses Not substantial number

10% to 30% of small businesses Possible substantial number

>30% of small businesses Substantial number

As estimated in section 3.5.2, 818 or 0.2% of 367,046 affected small businesses are 

expected to experience significant economic impact by the finalized rule, far below the 

30% criteria for all registrant categories.

3.6. EXAMINATION OF INDUSTRY SEGMENTS WITH SIGNIFICANT ECONOMIC IMPACT

No industry segment is estimated to experience significant economic impact. The 

number of small businesses that are estimated to experience significant economic impact 

is less than the criteria for a “substantial number.”

4. ECONOMIC ANALYSIS RESULTS

4.1 EXECUTIVE ORDERS 12866 AND 13563

The estimated annual impact of this rule is $13,830,260; thus, this rule will not have 

an annual effect on the economy of $100 million or more and is therefore not 

economically significant.

4.2 REGULATORY FLEXIBILITY ACT

In accordance with the RFA, the DEA evaluated the impact of this rule on small 

entities. Specifically, the DEA examined the registration, storage, labeling and 

packaging, record keeping and reporting, prescriptions, and disposal requirements for the 

367,046 small businesses estimated to be affected by the rule: 55 manufacturers, 1,418

distributors/importers/exporters, 50,032 pharmacies, and 315,541 practitioners/mid-level 

38
practitioners/hospitals/clinics.

28 All legally operating businesses that currently handle 

tramadol are assumed to be DEA registrants. Based on the DEA’s understanding of its 

registrants’ operations and facilities, the DEA estimates a non-recurring expense for 

system modification and initial inventory of $245.01 for all businesses and an additional 

$10,000 for secure storage for 50% of distributors, importers, and exporters. 

Manufacturers, pharmacies, physician offices/hospitals/ clinics/other health care 

facilities, and 50% of distributors, importers, and exporters are assumed to meet the 

requirements of the rule without the need to expand secure storage area. The DEA 

estimates these costs will have significant economic impact on 0 of 55 (0%) of small 

business manufacturers; 50 of 1,418 (3.5%) of small business distributors; 107 of 50,032 

(0.2%) small business pharmacies; and 661 of 315,541 (0.2%) of practitioners/mid-level 

practitioners/hospitals/clinics, totaling 818 of 367,046 (0.2%) of all small businesses. 

The percentage of small businesses with significant economic impact is below the 30% 

threshold for all registrant categories. The DEA’s assessment of economic impact by size 

category indicates that the rule will not have a significant effect on a substantial number 

of these small business entities.

4.3 UNFUNDED MANDATES REFORM ACT OF 1995

The estimated annual impact of this rule is $13,830,260; thus will not have an annual 

effect on the economy of $100 million or more.

28 The practitioners and mid-level practitioners primarily work in various physician and health care 

specialist offices as well as hospitals and clinics. The numbers represent the estimated number of 

businesses for which the registrants work.

39

 
4.4 CONGRESSIONAL REVIEW ACT OF 1996

The estimated annual impact of this rule is $13,830,260; thus, the rule will not have 

an annual effect on the economy of $100 million (adjusted for inflation) or more.

40
APPENDIX A: REGISTRANT LANDSCAPE

The results of the analysis are summarized in the table A1 and detailed in the 

following sections. 

Table A1. DEA registrants who are Small Entities

Registrant Business Activity Number of 

Registrations

Est. Number of 

Entities 

Represented by 

DEA 

Registrants

Entity-toRegistration 

Ratio

Number of 

Entities Below 

SBA size 

standard

Percent

Small 

Entities

Manufacturer 544 544 1.00 533 97.9

Distributor/Importer/Exporter 1,481 1,481 1.00 1,433 96.7

Pharmacy 69,404 51,248 0.74 50,517 98.6

Other* 1,414,596 328,286 0.23 319,105 97.2

Total 1,486,025 381,559 371,588 97.4

Note: The number of DEA registrations changes daily and the number of registrations in table 1 in the main body of 

the document can vary from the number of registrations in table A1 used to determine the entity-to-registration ratio. 

However, the analysis contained in appendix A is updated at least annually and any difference in the number of 

registrations between table 1 and table A1 has nominal impact on the entity-to-registration ratio.

* Because individual practitioners and mid-level practitioners primarily work in various physician and health care 

specialist offices as well as hospitals and clinics, this analysis groups individual practitioners, mid-level practitioners, 

and hospitals/clinics, as “other.” 

DEA Registrant Population by Business Activity

As of June 2013, the date of the current update of the entity-to-registration ratio, there 

were 1,486,025 controlled substances registrants as shown in table A2.

Table A2. Number of Registrants by Business Activity

Registrant Business Activity Controlled Substances

Pharmacy 69,404

Hospital/Clinic 15,899

Individual Practitioner 1,156,879

Teaching Institution 318

Mid-Level Practitioner 22,826

Researcher/Canine Handler 9,739

Analytical Lab 1,518

Narcotic Treatment Program 1,317

Distributor 954

Reverse Distributor 60

Importer 223

Exporter 244

Manufacturer 544

Total 1,486,025

Source: DEA, June 2013.

Note: The number of DEA registrations fluctuates daily and the number of DEA registrations at the time of the 

analysis can vary slightly from the number of DEA registrations contained in this table. However, the base analysis 

contained in this section is updated at least annually and any difference in the number of DEA registrations between the 

time of the analysis and the number of DEA registrations contained in this table has minimal impact on the overall 

results.

41
Corresponding Number of Businesses

Most DEA registrants are small entities or employed by small entities as defined by 

the RFA. The RFA defines a “small entity” as a “small business” (5 U.S.C. 601(3)), a 

“small organization” (5 U.S.C. 601(4)), or a “small governmental jurisdiction” (5 U.S.C. 

601(5)). Pursuant to the RFA, the term “small business” has the same meaning as the 

term “small business concern” under section 3 of the Small Business Act (SBA). The 

SBA designates a “small-business concern,” as one which is independently owned and 

operated and is not dominant in its field of operation. 15 U.S.C. 632(a)(1). Furthermore, 

the SBA defines whether a business entity is small by size standards. These size 

standards have been established based on the types of economic activity or industry under 

NAICS. The SBA sets the maximum size standards—in millions of dollars or number of 

employees—allowed for concerns and their affiliates to be designated small.

The RFA requirements and SBA size standards apply to entities and businesses. 

Because the DEA does not, in the general course of business, collect information 

regarding associated or parent organizations holding multiple registrations, the DEA has 

associated the number of registrants to a corresponding number of businesses. The DEA 

registrations are held by businesses such as manufacturers, distributors, and pharmacies 

as well as individuals such as practitioners and mid-level practitioners. Additionally, 

many businesses hold more than one registration in situations where a single business has 

more than one location or more than one business activity. Therefore, the DEA related 

the approximately 1.5 million DEA registrations to the number of businesses, as 

described below. First, since the SBA size standards are organized by NAICS codes, the 

approximately 1.5 million affected registrations are organized by NAICS codes. Because 

the DEA does not collect NAICS code information from its registrants, the DEA 

42
reviewed all NAICS codes29 and developed a table that relates various registrant groups 

to NAICS codes. Table A3 lists the DEA registrant categories with NAICS titles and 

codes. Second, using 2007 Economic Census data, the DEA determined the number of 

businesses for each NAICS code. See table A4.

29 http://www.census.gov/eos/www/naics/.

43

 
Table A3. DEA Registrant Categories and Corresponding Estimated NAICS Codes

Registrant Categories and NAICS Code Titles

Titles

Number of 

DEA 

Registrations

NAICS Codes Represented 

by DEA Registrations

Manufacturers

544

Petrochemical Manufacturing 325110

Medicinal and Botanical Manufacturing 325411

Pharmaceutical Preparation Manufacturing 325412

Adhesive Manufacturing 325520

Toilet Preparation Manufacturing 325620

All Other Msc. Chemical Product and Preparation 

Manufacturing 325998

Distributors/Importers/Exporters

1,481

424210

Drugs and Druggists’ Sundries Merchant Wholesalers 424410

General Line Grocery Merchant Wholesalers 424450

Confectionary Merchant Wholesalers 424690

Tobacco and Tobacco Product Merchant Wholesalers 424940

Other Msc. Nondurable Goods Merchant Wholesalers 424990

Packaging and Labeling Services 651910

Pharmacies

69,404

Supermarkets and Other Grocery (except Convenience) 

Stores 445110

Pharmacies and Drug Stores 446110

Discount Department Stores 452112

Warehouse Clubs and Superstores 452910

Others

1,414,596

Colleges, Universities and Professional Schools 611310

Offices of Physicians (except Mental Health Specialists) 621111

Offices of Physicians, Mental Health Specialists 621112

Offices of Dentists 621210

Offices of Optometrists 621320

Offices of Podiatrists 621391

Offices of All Other Msc. Health Practitioners 621399

Outpatient Mental Health and Substance Abuse Centers 621420

HMO Medical Centers 621491

General Medical and Surgical Hsps. 622110

Psychiatric and Substance Abuse Hsps. 622210

Specialty (except Psychiatric and Substance Abuse) Hsps. 622310

Testing Laboratories 541380

Total Controlled Substance Registrants 1,486,025

44
Table A4. Number of Businesses by NAICS Codes

Source: 2007 Economic Census, http://www.census.gov/econ/census07.

* Manufacturer data is in number of establishments while all other sectors are in number of firms. A firm 

may have more than one establishment. Based on sectors with both firm and establishment data, the number 

of establishments are similar to the number of firms. The term “firm” used in the source data is used 

synonymously with “business” for the purposes of this analysis.

Registrant Categories and NAICS Code 

Titles

Number of 

DEA 

Registrations

NAICS Codes 

Represented 

by DEA 

Registrants

Total 

Number of 

Businesses 

by NAICS 

Code* 

Manufacturers 544 

Petrochemical Manufacturing 325110 56

Medicinal and Botanical Manufacturing 325411 410

Pharmaceutical Preparation Manufacturing 325412 991

Adhesive Manufacturing 325520 600

Toilet Preparation Manufacturing 325620 854

All Other Miscellaneous Chemical Product 

and Preparation Manufacturing 325998 1,261

Manufacturer Summary 4,172

Distributors/Importers/Exporters 1,481 

Drugs and Druggists’ Sundries Merchant 

Wholesalers 424210 5,430

General Line Grocery Merchant 

Wholesalers 424410 1,842

Confectionery Merchant Wholesalers 424450 1,544

Other Chemical and Allied Products 

Merchant Wholesalers 424690 5,948

Tobacco and Tobacco Product Merchant 

Wholesalers 424940 1,053

Other Miscellaneous Nondurable Goods 

Merchant Wholesalers 424990 10,043

Packaging and Labeling Services 561910 1,541

Distributors/Importers/Exporters 

Summary 27,401

Pharmacies 69,404

Supermarkets and Other Grocery (except 

Convenience) Stores 445110 34,009

Pharmacies and Drug Stores 446110 17,217

Discount Department Stores 452112 11

Warehouse Clubs and Superstores 452910 11

Pharmacies Summary 51,248

Others 1,414,596 

Colleges, Universities and Professional 

Schools 611310 2,149

Offices of Physicians (except Mental Health 

Specialists) 621111 160,034

Offices of Physicians, Mental Health 

Specialists 621112 9,075

Offices of Dentists 621210 111,013

Offices of Optometrists 621320 16,659

Offices of Podiatrists 621391 7,566

Offices of All Other Miscellaneous Health 

Practitioners

621399 9,094

Outpatient Mental Health and Substance 

Abuse Centers 621420 4,113

HMO Medical Centers 621491 30

General Medical and Surgical Hospitals 622110 3,051

Psychiatric and Substance Abuse Hospitals 622210 423

Specialty (except Psychiatric and Substance 

Abuse) Hospitals 622310 352

Testing Laboratories 541380 4,727

Others Summary 328,286

Total Controlled Substance Registrants 1,486,025 

Category 1 Category 2

45
There are many more businesses under the manufacturers and distributors/importers/

exporters NAICS codes than the number of DEA registrations that fall within these 

NAICS codes. There are 544 and 1,481 manufacturer and distributor/importer/exporter 

registrants, respectively, while the numbers of businesses for these NAICS codes are 

4,172 and 27,401, respectively. Meanwhile, the number of businesses under pharmacies 

and other (remaining) NAICS codes are far fewer than the number of DEA registrants 

that fall within these business activities. There are 69,404 and 1,414,596 pharmacies and 

other registrants, respectively, while the numbers of establishments for the corresponding 

NAICS codes are only 51,248 and 328,286, respectively. Therefore, the DEA broadly 

classified registrants in two categories: 

• Category 1: Registrants in industries where very few businesses in the 

industry are registrants; and

• Category 2: Registrants in industries where most businesses in the industry 

are registrants. 

As shown in table A4, only a small fraction of manufacturers, distributors, and 

importers/exporters are DEA registrants—2,025 (544 + 1,481) of 31,573 (4,172 + 

27,401), while nearly all pharmacies, hospitals/clinics, offices of physicians, etc., are 

registrants, employ registrants, or may represent multiple registrations, such as several 

individual practitioners and/or mid-level practitioners working in the same office or 

hospital. Therefore, while recognizing that DEA registrants with manufacturer, 

distributor, or importer/exporter registrations can also have more than one registration, 

the DEA estimates a 1-to-1 ratio and that 544 manufacturer and 1,481 distributor, 

importer/ exporter registrations roughly equate to 544 and 1,481 businesses, respectively, 

for registrants in category 1. 

46
For registrants in category 2 (pharmacies, hospitals/clinics, offices of physicians, 

etc.), nearly all businesses counted by the NAICS codes are expected to be or to hire 

DEA registrants. Therefore, the number of businesses in these NAICS codes is used as 

an estimate for the number of businesses that are in the pharmacies and other registrant 

categories. The DEA estimates that 69,404 pharmacy registrations roughly equate to 

51,248 businesses resulting in a 0.74-to-1 business-to-registration ratio, and 1,414,596 

remaining other registrations roughly equate to 328,286 businesses resulting in a 0.23-to1 business-to-registration ratio. In total, the DEA estimates that the nearly 1.5 million 

DEA registrants represent approximately 381,559 businesses. See table A5. The DEA 

recognizes that this estimate is not precise, but instead provides understanding of orders 

of magnitude.

Number of Affected Businesses that Are Small Businesses

After estimating that approximately 1.5 million DEA registrants represent 381,559 

businesses, the DEA then determined how many of the estimated 381,559 businesses 

represented by DEA registrants are small businesses based on the SBA size standards. 

Because the DEA does not collect data on company size of its registrants, it used 2007 

Economic Census data to make this determination. The Economic Census provides the 

number of businesses by annual revenue ranges as well as the number of businesses by 

number of employee ranges by NAICS codes. This data was compared to the SBA size 

standards for each NAICS code to determine the number of businesses that are small 

businesses for each NAICS code. See table A6. 

The DEA determined that 97.9% of manufacturers and 96.7% of 

distributors/importers/exporters by NAICSs are small businesses. These percentages 

47
were applied to the total affected businesses (544 manufacturers and 1,481 distributors), 

resulting in number of businesses (533 manufacturers and 1,433 distributors) estimated to 

be small businesses. The estimate for category 2 registrants/businesses that are small 

businesses is derived directly from the 2007 Economic Census. 98.6% (50,517 of 

51,248) of pharmacies and 97.2% (319,105 of 328,286) of other businesses are estimated 

to be small businesses. Combining the results of manufacturers, distributors/importers/

exporters, pharmacies, and other, the DEA estimates 371,588 of the 381,559 (97.4%) 

businesses that represent the registrant population are considered “small entities” in 

accordance with the RFA and SBA standards, 5 U.S.C. 601(6) and 15 U.S.C. 632. 

Again, the DEA recognizes that its estimate is not precise, but instead provides 

understanding of orders of magnitude, so that the DEA can assess whether or not the 

number of significantly impacted businesses constitute a substantial number of small 

businesses.

48
 Table A5: Number of Businesses Represented by DEA Controlled Substances Registrants

Registrant Categories and NAICS Code 

Titles

Number of 

DEA 

Registrations

NAICS 

Codes 

Represented 

by DEA 

Registrants

Total 

Number of 

Businesses 

by NAICS 

Code* 

Estimated 

Number of 

Businesses 

Represented 

by DEA 

Registrants

Manufacturers 544 544

Petrochemical Manufacturing 325110 56

Medicinal and Botanical Manufacturing 325411 410

Pharmaceutical Preparation Manufacturing 325412 991

Adhesive Manufacturing 325520 600

Toilet Preparation Manufacturing 325620 854

All Other Miscellaneous Chemical Product and 

Preparation Manufacturing 325998 1,261

Manufacturers Summary 4,172

Distributors/Importers/Exporters 1,481 1,481

Drugs and Druggists’ Sundries Merchant 

Wholesalers 424210 5,430

General Line Grocery Merchant Wholesalers 424410 1,842

Confectionery Merchant Wholesalers 424450 1,544

Other Chemical and Allied Products Merchant 

Wholesalers 424690 5,948

Tobacco and Tobacco Product Merchant 

Wholesalers 424940 1,053

Other Miscellaneous Nondurable Goods 

Merchant Wholesalers 424990 10,043

Packaging and Labeling Services 561910 1,541

Distributors/Importers/Exporters Summary 27,401

Pharmacies 69,404 51,248

Supermarkets and Other Grocery (except 

Convenience) Stores 445110 34,009

Pharmacies and Drug Stores 446110 17,217

Discount Department Stores 452112 11

Warehouse Clubs and Superstores 452910 11

Pharmacies Summary 51,248

Others 1,414,596 328,286

Colleges, Universities and Professional Schools 611310 2,149

Offices of Physicians (except Mental Health 

Specialists) 621111 160,034

Offices of Physicians, Mental Health Specialists 621112 9,075

Offices of Dentists 621210 111,013

Offices of Optometrists 621320 16,659

Offices of Podiatrists 621391 7,566

Offices of All Other Miscellaneous Health 

Practitioners 621399 9,094

Outpatient Mental Health and Substance Abuse 

Centers 621420 4,113

HMO Medical Centers 621491 30

General Medical and Surgical Hospitals 622110 3,051

Psychiatric and Substance Abuse Hospitals 622210 423

Specialty (except Psychiatric and Substance 

Abuse) Hospitals 622310 352

Testing Laboratories 541380 4,727

Others Summary 328,286

Total Controlled Substance Registrants 1,486,025 381,559 

Category 1 Category 2

49
Table A6. Number of Affected Businesses that Are Small Businesses

Source: 2007 Economic Census, http://www.census.gov/econ/census07; and 13 CFR 121.201.

* Manufacturer data is in number of establishments while all other sectors are in number of firms. A firm may have 

more than one establishment. The term “firm” used in the source data is used synonymously with “business” for the 

purposes of this analysis. 

**SBA size standards for manufacturers and distributors/reverse distributors are by number of employees, while size

standards for pharmacies and others (practitioners/hospitals/clinics) are by dollar amount of annual revenue.

*** Number of establishments/firms data by number of employees/annual revenue is available in specific increments. 

When the SBA size standard/threshold is between increments, half of the number in the increment was used to estimate 

the number below the threshold. For example, the number of offices of dentists was available for various increments;

$4,999,999 and below is 110,410 and increment $5,000,000-$9,999,999 is 448. Because the size standard is $7M, half 

of 448 (224) was estimated for $5,000,000-$7,000,000 resulting in a total of 110,634.

Registrant Categories and NAICS Code 

Titles

Number of 

DEA 

Registrations

NAICS 

Codes 

Represented 

by DEA 

Registrants

Total 

Number of 

Businesses 

by NAICS 

Code* 

Estimated 

Number of 

Businesses 

Represented 

by DEA 

Registrants

SBA Size 

Standards: 

Number of 

Employees or 

Millions of 

Dollars**

Number of 

Businesses 

Below SBA 

Size 

Standard

% of 

Businesses 

Below SBA 

Size 

Standard Note

Manufacturers 544 544 533

Petrochemical Manufacturing 325110 56 1,000 56

Medicinal and Botanical Manufacturing 325411 410 750 406 ***

Pharmaceutical Preparation Manufacturing 325412 991 750 943 ***

Adhesive Manufacturing 325520 600 500 600

Toilet Preparation Manufacturing 325620 854 500 828

All Other Miscellaneous Chemical Product and 

Preparation Manufacturing 325998 1,261 500 1,253

Manufacturers Summary 4,172 4,086 97.9%

Distributors/Importers/Exporters 1,481 1,481 1,433

Drugs and Druggists’ Sundries Merchant 

Wholesalers 424210 5,430 100 5,155

General Line Grocery Merchant Wholesalers 424410 1,842 100 1,739

Confectionery Merchant Wholesalers 424450 1,544 100 1,506

Other Chemical and Allied Products Merchant 

Wholesalers 424690 5,948 100 5,824

Tobacco and Tobacco Product Merchant 

Wholesalers 424940 1,053 100 978

Other Miscellaneous Nondurable Goods 

Merchant Wholesalers 424990 10,043 100 9,926

Packaging and Labeling Services 561910 1,541 $7.0 1,381 ***

Distributors/Importers/Exporters Summary 27,401 26,509 96.7%

Pharmacies 69,404 51,248 50,517

Supermarkets and Other Grocery (except 

Convenience) Stores 445110 34,009 $30.0 33,444 ***

Pharmacies and Drug Stores 446110 17,217 $25.5 17,069 ***

Discount Department Stores 452112 11 $27.0 3 ***

Warehouse Clubs and Superstores 452910 11 $27.0 1 ***

Pharmacies Summary 51,248 50,517 98.6%

Others 1,414,596 328,286 319,105

Colleges, Universities and Professional Schools 611310 2,149 $7.0 

 Not 

Available 

Offices of Physicians (except Mental Health 

Specialists) 621111 160,034 $10.0 155,908

Offices of Physicians, Mental Health Specialists 621112 9,075 $10.0 9,056

Offices of Dentists 621210 111,013 $7.0 110,634 ***

Offices of Optometrists 621320 16,659 $7.0 16,611 ***

Offices of Podiatrists 621391 7,566 $7.0 7,556 ***

Offices of All Other Miscellaneous Health 

Practitioners 621399 9,094 $7.0 9,070 ***

Outpatient Mental Health and Substance Abuse 

Centers 621420 4,113 $10.0 3,826

HMO Medical Centers 621491 30 $10.0 17

General Medical and Surgical Hospitals 622110 3,051 $34.5 1,285 ***

Psychiatric and Substance Abuse Hospitals 622210 423 $34.5 334 ***

Specialty (except Psychiatric and Substance 

Abuse) Hospitals 622310 352 $34.5 200 ***

Testing Laboratories 541380 4,727 $12.0 4,608 ***

Others Summary 328,286 319,105 97.2%

Total Controlled Substance Registrants 1,486,025 381,559 371,588

Category 1 Category 2

50
APPENDIX B: BUSINESSES WITH IMPACT 1% OR MORE OF ANNUAL 

REVENUE

Table B1 contains the complete revenue profile for distributors as well as the 

summary of analysis conducted. Table B2 contains the summary results for percentage 

of small businesses whose cost is greater than 1% of revenue.

Table B1. Complete Revenue Profile for Distributors Based On 2007 NAICS Codes and Summary of Analysis 

Conducted

NAICS 

code

NAICS

code 

description

Revenue size of firms operated entire year Number

of firms

Adjusted 

Number of 

firms for 

50% 

Distributor, 

Importer, 

Exporter

Revenue 

where cost is 

1%

($)

Number of 

Firms with 

Revenue 

below 1% 

Threshold

424210

Drugs and 

druggists' 

sundries 

merchant 

wholesalers

All firms 6,261 3,131 98,726 

Firms operated for the entire year 5,430 2,715 98,726 

Firms operated entire year with 

sales/receipts/revenue less than $250,000 909 455 98,726 179 

Firms operated entire year with

sales/receipts/revenue of $250,000 to $499,999 626 313 98,726 0

Firms operated entire year with 

sales/receipts/revenue of $500,000 to $999,999 744 372 98,726 0

Firms operated entire year with 

sales/receipts/revenue of $1,000,000 to 

$2,499,999 1,059 530 98,726 0

Firms operated entire year with 

sales/receipts/revenue of $2,500,000 to 

$4,999,999 651 326 98,726 0

Firms operated entire year with 

sales/receipts/revenue of $5,000,000 to 

$9,999,999 505 253 98,726 0

Firms operated entire year with 

sales/receipts/revenue of $10,000,000 to 

$24,999,999 425 213 98,726 0

Firms operated entire year with 

sales/receipts/revenue of $25,000,000 to 

$49,999,999 193 97 98,726 0

Firms operated entire year with 

sales/receipts/revenue of $50,000,000 to 

$99,999,999 114 57 98,726 0

Firms operated entire year with 

sales/receipts/revenue of $100,000,000 or more 204 102 98,726 0

Firms not operated for the entire year 831 416 98,726 

424410

General line 

grocery 

merchant 

wholesalers

All firms 2,208 1,104 98,726 

Firms operated for the entire year 1,842 921 98,726 

Firms operated entire year with 

sales/receipts/revenue less than $250,000 195 98 98,726 39 

Firms operated entire year with 

sales/receipts/revenue of $250,000 to $499,999 187 94 98,726 0

Firms operated entire year with 

sales/receipts/revenue of $500,000 to $999,999 243 122 98,726 0

Firms operated entire year with 

sales/receipts/revenue of $1,000,000 to 

$2,499,999 365 183 98,726 0

Firms operated entire year with 

sales/receipts/revenue of $2,500,000 to 

$4,999,999 273 137 98,726 0

51
NAICS 

code

NAICS

code 

description

Revenue size of firms operated entire year Number

of firms

Adjusted 

Number of 

firms for 

50% 

Distributor, 

Importer, 

Exporter

Revenue 

where cost is 

1%

($)

Number of 

Firms with 

Revenue 

below 1% 

Threshold

Firms operated entire year with 

sales/receipts/revenue of $5,000,000 to 

$9,999,999 188 94 98,726 0

Firms operated entire year with 

sales/receipts/revenue of $10,000,000 to 

$24,999,999 193 97 98,726 0

Firms operated entire year with 

sales/receipts/revenue of $25,000,000 to 

$49,999,999 75 38 98,726 0

Firms operated entire year with 

sales/receipts/revenue of $50,000,000 to 

$99,999,999 42 21 98,726 0

Firms operated entire year with 

sales/receipts/revenue of $100,000,000 or more 81 41 98,726 0

Firms not operated for the entire year 366 183 98,726 

424450

Confectionery 

merchant 

wholesalers

All firms 1,798 899 98,726 

Firms operated for the entire year 1,544 772 98,726 

Firms operated entire year with 

sales/receipts/revenue less than $250,000 287 144 98,726 57 

Firms operated entire year with 

sales/receipts/revenue of $250,000 to $499,999 238 119 98,726 0

Firms operated entire year with 

sales/receipts/revenue of $500,000 to $999,999 238 119 98,726 0

Firms operated entire year with 

sales/receipts/revenue of $1,000,000 to 

$2,499,999 291 146 98,726 0

Firms operated entire year with 

sales/receipts/revenue of $2,500,000 to 

$4,999,999 163 82 98,726 0

Firms operated entire year with 

sales/receipts/revenue of $5,000,000 to 

$9,999,999 132 66 98,726 0

Firms operated entire year with 

sales/receipts/revenue of $10,000,000 to 

$24,999,999 91 46 98,726 0

Firms operated entire year with 

sales/receipts/revenue of $25,000,000 to 

$49,999,999 46 23 98,726 0

Firms operated entire year with

sales/receipts/revenue of $50,000,000 to 

$99,999,999 28 14 98,726 0

Firms operated entire year with 

sales/receipts/revenue of $100,000,000 or more 30 15 98,726 0

Firms not operated for the entire year 254 127 98,726 

All firms 6,527 3,264 98,726 

424690

Other 

chemical and 

allied 

products 

merchant 

wholesalers

Firms operated for the entire year 5,948 2,974 98,726 

Firms operated entire year with 

sales/receipts/revenue less than $250,000 886 443 98,726 175 

Firms operated entire year with 

sales/receipts/revenue of $250,000 to $499,999 706 353 98,726 0

Firms operated entire year with 

sales/receipts/revenue of $500,000 to $999,999 894 447 98,726 0

Firms operated entire year with 

sales/receipts/revenue of $1,000,000 to 

$2,499,999 1,164 582 98,726 0

Firms operated entire year with 

sales/receipts/revenue of $2,500,000 to 

$4,999,999 771 386 98,726 0

Firms operated entire year with 

sales/receipts/revenue of $5,000,000 to 

$9,999,999 562 281 98,726 0

Firms operated entire year with 

sales/receipts/revenue of $10,000,000 to 

$24,999,999 494 247 98,726 0

52
NAICS 

code

NAICS

code 

description

Revenue size of firms operated entire year Number

of firms

Adjusted 

Number of 

firms for 

50% 

Distributor, 

Importer, 

Exporter

Revenue 

where cost is 

1%

($)

Number of 

Firms with 

Revenue 

below 1% 

Threshold

Firms operated entire year with 

sales/receipts/revenue of $25,000,000 to 

$49,999,999 220 110 98,726 0

Firms operated entire year with 

sales/receipts/revenue of $50,000,000 to 

$99,999,999 101 51 98,726 0

Firms operated entire year with 

sales/receipts/revenue of $100,000,000 or more 150 75 98,726 0

Firms not operated for the entire year 579 290 98,726 

424940

Tobacco and 

tobacco 

product 

merchant 

wholesalers

All firms 1,135 568 98,726 

Firms operated for the entire year 1,053 527 98,726 

Firms operated entire year with 

sales/receipts/revenue less than $250,000 56 28 98,726 11 

Firms operated entire year with 

sales/receipts/revenue of $250,000 to $499,999 55 28 98,726 0

Firms operated entire year with 

sales/receipts/revenue of $500,000 to $999,999 74 37 98,726 0

Firms operated entire year with 

sales/receipts/revenue of $1,000,000 to 

$2,499,999 139 70 98,726 0

Firms operated entire year with 

sales/receipts/revenue of $2,500,000 to 

$4,999,999 118 59 98,726 0

Firms operated entire year with 

sales/receipts/revenue of $5,000,000 to 

$9,999,999 159 80 98,726 0

Firms operated entire year with 

sales/receipts/revenue of $10,000,000 to 

$24,999,999 181 91 98,726 0

Firms operated entire year with 

sales/receipts/revenue of $25,000,000 to 

$49,999,999 99 50 98,726 0

Firms operated entire year with 

sales/receipts/revenue of $50,000,000 to 

$99,999,999 81 41 98,726 0

Firms operated entire year with 

sales/receipts/revenue of $100,000,000 or more 91 46 98,726 0

Firms not operated for the entire year 82 41 98,726 

424990

Other 

miscellaneous 

nondurable 

goods 

merchant 

wholesalers

All firms 12,118 6,059 98,726 

Firms operated for the entire year 10,043 5,022 98,726 

Firms operated entire year with 

sales/receipts/revenue less than $250,000 2,941 1,471 98,726 581 

Firms operated entire year with 

sales/receipts/revenue of $250,000 to $499,999 1,807 904 98,726 0

Firms operated entire year with 

sales/receipts/revenue of $500,000 to $999,999 1,736 868 98,726 0

Firms operated entire year with 

sales/receipts/revenue of $1,000,000 to 

$2,499,999 1,732 866 98,726 0

Firms operated entire year with 

sales/receipts/revenue of $2,500,000 to 

$4,999,999 827 414 98,726 0

Firms operated entire year with 

sales/receipts/revenue of $5,000,000 to 

$9,999,999 447 224 98,726 0

Firms operated entire year with 

sales/receipts/revenue of $10,000,000 to 

$24,999,999 348 174 98,726 0

Firms operated entire year with 

sales/receipts/revenue of $25,000,000 to 

$49,999,999 112 56 98,726 0

Firms operated entire year with 

sales/receipts/revenue of $50,000,000 to 

$99,999,999 54 27 98,726 0

53
NAICS 

code

NAICS

code 

description

Revenue size of firms operated entire year Number

of firms

Adjusted 

Number of 

firms for 

50% 

Distributor, 

Importer, 

Exporter

Revenue 

where cost is 

1%

($)

Number of 

Firms with 

Revenue 

below 1% 

Threshold

Firms operated entire year with 

sales/receipts/revenue of $100,000,000 or more 39 20 98,726 0

Firms not operated for the entire year 2,075 1,038 98,726 

561910

Packaging 

and labeling 

services

All firms 1,809 904.5 98,726 

Firms operated for the entire year 1,541 770.5 98,726 

Firms operated entire year with 

sales/receipts/revenue less than $100,000 164 82 98,726 81 

Firms operated entire year with 

sales/receipts/revenue of $100,000 to $249,999 221 110.5 98,726 0

Firms operated entire year with 

sales/receipts/revenue of $250,000 to $499,999 278 139 98,726 0

Firms operated entire year with 

sales/receipts/revenue of $500,000 to $999,999 247 123.5 98,726 0

Firms operated entire year with 

sales/receipts/revenue of $1,000,000 to 

$2,499,999 257 128.5 98,726 0

Firms operated entire year with 

sales/receipts/revenue of $2,500,000 to 

$4,999,999 161 80.5 98,726 0

Firms operated entire year with 

sales/receipts/revenue of $5,000,000 to 

$9,999,999 105 52.5 98,726 0

Firms operated entire year with 

sales/receipts/revenue of $10,000,000 to 

$24,999,999 74 37 98,726 0

Firms operated entire year with 

sales/receipts/revenue of $25,000,000 to 

$49,999,999 25 12.5 98,726 0

Firms operated entire year with 

sales/receipts/revenue of $50,000,000 to 

$99,999,999 6 3 98,726 0

Firms operated entire year with 

sales/receipts/revenue of $100,000,000 or more 3 1.5 98,726 0

Firms not operated for the entire year 268 134 98,726 

424210

Drugs and 

druggists' 

sundries 

merchant 

wholesalers

All firms 6,261 3,131 4,333 

Firms operated for the entire year 5,430 2,715 4,333 

Firms operated entire year with 

sales/receipts/revenue less than $250,000 909 455 4,333 8 

Firms operated entire year with 

sales/receipts/revenue of $250,000 to $499,999 626 313 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $500,000 to $999,999 744 372 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $1,000,000 to 

$2,499,999 1,059 530 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $2,500,000 to 

$4,999,999 651 326 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $5,000,000 to 

$9,999,999 505 253 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $10,000,000 to 

$24,999,999 425 213 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $25,000,000 to 

$49,999,999 193 97 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $50,000,000 to 

$99,999,999 114 57 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $100,000,000 or more 204 102 4,333 0

54
NAICS 

code

NAICS

code 

description

Revenue size of firms operated entire year Number

of firms

Adjusted 

Number of 

firms for 

50% 

Distributor, 

Importer, 

Exporter

Revenue 

where cost is 

1%

($)

Number of 

Firms with 

Revenue 

below 1% 

Threshold

Firms not operated for the entire year 831 416 4,333 

424410

General line 

grocery 

merchant 

wholesalers

All firms 2,208 1,104 4,333 

Firms operated for the entire year 1,842 921 4,333 

Firms operated entire year with 

sales/receipts/revenue less than $250,000 195 98 4,333 2 

Firms operated entire year with 

sales/receipts/revenue of $250,000 to $499,999 187 94 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $500,000 to $999,999 243 122 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $1,000,000 to 

$2,499,999 365 183 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $2,500,000 to 

$4,999,999 273 137 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $5,000,000 to 

$9,999,999 188 94 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $10,000,000 to 

$24,999,999 193 97 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $25,000,000 to 

$49,999,999 75 38 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $50,000,000 to 

$99,999,999 42 21 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $100,000,000 or more 81 41 4,333 0

Firms not operated for the entire year 366 183 4,333 

424450

Confectionery 

merchant 

wholesalers

All firms 1,798 899 4,333 

Firms operated for the entire year 1,544 772 4,333 

Firms operated entire year with 

sales/receipts/revenue less than $250,000 287 144 4,333 2 

Firms operated entire year with 

sales/receipts/revenue of $250,000 to $499,999 238 119 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $500,000 to $999,999 238 119 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $1,000,000 to 

$2,499,999 291 146 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $2,500,000 to 

$4,999,999 163 82 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $5,000,000 to 

$9,999,999 132 66 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $10,000,000 to 

$24,999,999 91 46 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $25,000,000 to 

$49,999,999 46 23 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $50,000,000 to 

$99,999,999 28 14 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $100,000,000 or more 30 15 4,333 0

55
NAICS 

code

NAICS

code 

description

Revenue size of firms operated entire year Number

of firms

Adjusted 

Number of 

firms for 

50% 

Distributor, 

Importer, 

Exporter

Revenue 

where cost is 

1%

($)

Number of 

Firms with 

Revenue 

below 1% 

Threshold

Firms not operated for the entire year 254 127 4,333 

424690

Other 

chemical and 

allied 

products 

merchant 

wholesalers

All firms 6,527 3,264 4,333 

Firms operated for the entire year 5,948 2,974 4,333 

Firms operated entire year with 

sales/receipts/revenue less than $250,000 886 443 4,333 8 

Firms operated entire year with 

sales/receipts/revenue of $250,000 to $499,999 706 353 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $500,000 to $999,999 894 447 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $1,000,000 to 

$2,499,999 1,164 582 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $2,500,000 to 

$4,999,999 771 386 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $5,000,000 to 

$9,999,999 562 281 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $10,000,000 to 

$24,999,999 494 247 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $25,000,000 to 

$49,999,999 220 110 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $50,000,000 to 

$99,999,999 101 51 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $100,000,000 or more 150 75 4,333 0

Firms not operated for the entire year 579 290 4,333 

424940

Tobacco and 

tobacco 

product 

merchant 

wholesalers

All firms 1,135 568 4,333 

Firms operated for the entire year 1,053 527 4,333 

Firms operated entire year with 

sales/receipts/revenue less than $250,000 56 28 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $250,000 to $499,999 55 28 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $500,000 to $999,999 74 37 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $1,000,000 to 

$2,499,999 139 70 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $2,500,000 to 

$4,999,999 118 59 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $5,000,000 to 

$9,999,999 159 80 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $10,000,000 to 

$24,999,999 181 91 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $25,000,000 to 

$49,999,999 99 50 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $50,000,000 to 

$99,999,999 81 41 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $100,000,000 or more 91 46 4,333 0

56
NAICS 

code

NAICS

code 

description

Revenue size of firms operated entire year Number

of firms

Adjusted 

Number of 

firms for 

50% 

Distributor, 

Importer, 

Exporter

Revenue 

where cost is 

1%

($)

Number of 

Firms with 

Revenue 

below 1% 

Threshold

Firms not operated for the entire year 82 41 4,333 

424990

Other 

miscellaneous 

nondurable 

goods 

merchant 

wholesalers

All firms 12,118 6,059 4,333 

Firms operated for the entire year 10,043 5,022 4,333 

Firms operated entire year with 

sales/receipts/revenue less than $250,000 2,941 1,471 4,333 25 

Firms operated entire year with 

sales/receipts/revenue of $250,000 to $499,999 1,807 904 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $500,000 to $999,999 1,736 868 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $1,000,000 to 

$2,499,999 1,732 866 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $2,500,000 to 

$4,999,999 827 414 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $5,000,000 to 

$9,999,999 447 224 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $10,000,000 to 

$24,999,999 348 174 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $25,000,000 to 

$49,999,999 112 56 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $50,000,000 to 

$99,999,999 54 27 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $100,000,000 or more 39 20 4,333 0

Firms not operated for the entire year 2,075 1,038 4,333 

561910

Packaging 

and labeling 

services

All firms 1,809 904.5 4,333 

Firms operated for the entire year 1,541 770.5 4,333 

Firms operated entire year with 

sales/receipts/revenue less than $100,000 164 82 4,333 4 

Firms operated entire year with 

sales/receipts/revenue of $100,000 to $249,999 221 110.5 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $250,000 to $499,999 278 139 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $500,000 to $999,999 247 123.5 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $1,000,000 to 

$2,499,999 257 128.5 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $2,500,000 to 

$4,999,999 161 80.5 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $5,000,000 to 

$9,999,999 105 52.5 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $10,000,000 to 

$24,999,999 74 37 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $25,000,000 to 

$49,999,999 25 12.5 4,333 0

57
NAICS 

code

NAICS

code 

description

Revenue size of firms operated entire year Number

of firms

Adjusted 

Number of 

firms for 

50% 

Distributor, 

Importer, 

Exporter

Revenue 

where cost is 

1%

($)

Number of 

Firms with 

Revenue 

below 1% 

Threshold

Firms operated entire year with 

sales/receipts/revenue of $50,000,000 to 

$99,999,999 6 3 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $100,000,000 or more 3 1.5 4,333 0

Firms not operated for the entire year 268 134 4,333 

445110

Supermarkets 

and other 

grocery 

(except 

convenience) 

stores

All firms 41,885 4,333 

Firms operated for the entire year 34,009 4,333 

Firms operated entire year with 

sales/receipts/revenue less than $250,000 6,836 4,333 118 

Firms operated entire year with 

sales/receipts/revenue of $250,000 to $499,999 6,473 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $500,000 to $999,999 6,327 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $1,000,000 to 

$2,499,999 6,290 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $2,500,000 to 

$4,999,999 3,598 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $5,000,000 to 

$9,999,999 2,360 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $10,000,000 to 

$24,999,999 1,373 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $25,000,000 to 

$49,999,999 373 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $50,000,000 to 

$99,999,999 162 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $100,000,000 to 

$249,999,999 109 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $250,000,000 or more 108 4,333 0

Firms not operated for the entire year 7,876 4,333 

446110

Pharmacies 

and drug 

stores

All firms 19,067 4,333 

Firms operated for the entire year 17,217 4,333 

Firms operated entire year with 

sales/receipts/revenue less than $250,000 943 4,333 16 

Firms operated entire year with 

sales/receipts/revenue of $250,000 to $499,999 769 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $500,000 to $999,999 1,486 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $1,000,000 to 

$2,499,999 5,674 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $2,500,000 to 

$4,999,999 5,264 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $5,000,000 to 

$9,999,999 2,311 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $10,000,000 to 

$24,999,999 622 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $25,000,000 to 

$49,999,999 89 4,333 0

58
NAICS 

code

NAICS

code 

description

Revenue size of firms operated entire year Number

of firms

Adjusted 

Number of 

firms for 

50% 

Distributor, 

Importer, 

Exporter

Revenue 

where cost is 

1%

($)

Number of 

Firms with 

Revenue 

below 1% 

Threshold

Firms operated entire year with 

sales/receipts/revenue of $50,000,000 to 

$99,999,999 27 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $100,000,000 to 

$249,999,999 8 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $250,000,000 or more 24 4,333 0

Firms not operated for the entire year 1,850 4,333 

452112

Discount 

department 

stores

All firms 14 4,333 

Firms operated for the entire year 11 4,333 

Firms operated entire year with 

sales/receipts/revenue less than $250,000 0 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $250,000 to $499,999 0 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $500,000 to $999,999 0 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $1,000,000 to 

$2,499,999 0 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $2,500,000 to 

$4,999,999 0 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $5,000,000 to 

$9,999,999 0 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $10,000,000 to 

$24,999,999 1 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $25,000,000 to 

$49,999,999 3 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $50,000,000 to 

$99,999,999 0 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $100,000,000 to 

$249,999,999 0 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $250,000,000 or more 7 4,333 0

Firms not operated for the entire year 3 4,333 

452910

Warehouse 

clubs and 

supercenters

All firms 12 4,333 

Firms operated for the entire year 11 4,333 

Firms operated entire year with 

sales/receipts/revenue less than $250,000 0 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $250,000 to $499,999 0 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $500,000 to $999,999 0 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $1,000,000 to 

$2,499,999 0 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $2,500,000 to 

$4,999,999 0 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $5,000,000 to 

$9,999,999 0 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $10,000,000 to 

$24,999,999 0 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $25,000,000 to 

$49,999,999 1 4,333 0

59
NAICS 

code

NAICS

code 

description

Revenue size of firms operated entire year Number

of firms

Adjusted 

Number of 

firms for 

50% 

Distributor, 

Importer, 

Exporter

Revenue 

where cost is 

1%

($)

Number of 

Firms with 

Revenue 

below 1% 

Threshold

Firms operated entire year with 

sales/receipts/revenue of $50,000,000 to 

$99,999,999 1 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $100,000,000 to 

$249,999,999 1 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $250,000,000 or more 8 4,333 0

Firms not operated for the entire year 1 4,333 

621111

Offices of 

physicians 

(except 

mental health 

specialists)

All firms 182,287 4,333 

Firms operated for the entire year 160,034 4,333 

Firms operated entire year with 

sales/receipts/revenue less than $100,000 7,415 4,333 321 

Firms operated entire year with 

sales/receipts/revenue of $100,000 to $249,999 19,674 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $250,000 to $499,999 38,179 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $500,000 to $999,999 41,770 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $1,000,000 to 

$2,499,999 31,857 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $2,500,000 to 

$4,999,999 11,486 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $5,000,000 to 

$9,999,999 5,527 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $10,000,000 to 

$24,999,999 2,850 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $25,000,000 to 

$49,999,999 768 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $50,000,000 to 

$99,999,999 299 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $100,000,000 or more 209 4,333 0

Firms not operated for the entire year 22,253 4,333 

621112

Offices of 

physicians, 

mental health 

specialists

All firms 10,714 4,333 

Firms operated for the entire year 9,075 4,333 

Firms operated entire year with 

sales/receipts/revenue less than $100,000 1,705 4,333 74 

Firms operated entire year with 

sales/receipts/revenue of $100,000 to $249,999 2,905 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $250,000 to $499,999 2,558 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $500,000 to $999,999 1,192 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $1,000,000 to 

$2,499,999 528 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $2,500,000 to 

$4,999,999 134 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $5,000,000 to 

$9,999,999 34 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $10,000,000 to 

$24,999,999 15 4,333 0

60
NAICS 

code

NAICS

code 

description

Revenue size of firms operated entire year Number

of firms

Adjusted 

Number of 

firms for 

50% 

Distributor, 

Importer, 

Exporter

Revenue 

where cost is 

1%

($)

Number of 

Firms with 

Revenue 

below 1% 

Threshold

Firms operated entire year with 

sales/receipts/revenue of $25,000,000 to 

$49,999,999 4 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $50,000,000 to 

$99,999,999 0 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $100,000,000 or more 0 4,333 0

Firms not operated for the entire year 1,639 4,333 

621210 Offices of 

dentists

All firms 121,048 4,333 

Firms operated for the entire year 111,013 4,333 

Firms operated entire year with 

sales/receipts/revenue less than $100,000 3,827 4,333 166 

Firms operated entire year with 

sales/receipts/revenue of $100,000 to $249,999 12,634 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $250,000 to $499,999 27,715 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $500,000 to $999,999 40,599 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $1,000,000 to 

$2,499,999 22,949 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $2,500,000 to 

$4,999,999 2,686 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $5,000,000 to 

$9,999,999 448 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $10,000,000 to 

$24,999,999 116 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $25,000,000 to 

$49,999,999 13 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $50,000,000 to 

$99,999,999 13 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $100,000,000 or more 13 4,333 0

Firms not operated for the entire year 10,035 4,333 

621320 Offices of 

optometrists

All firms 18,407 4,333 

Firms operated for the entire year 16,659 4,333 

Firms operated entire year with 

sales/receipts/revenue less than $100,000 1,296 4,333 56 

Firms operated entire year with 

sales/receipts/revenue of $100,000 to $249,999 3,493 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $250,000 to $499,999 5,163 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $500,000 to $999,999 4,450 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $1,000,000 to 

$2,499,999 1,950 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $2,500,000 to 

$4,999,999 233 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $5,000,000 to 

$9,999,999 51 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $10,000,000 to 

$24,999,999 20 4,333 0

61
NAICS 

code

NAICS

code 

description

Revenue size of firms operated entire year Number

of firms

Adjusted 

Number of 

firms for 

50% 

Distributor, 

Importer, 

Exporter

Revenue 

where cost is 

1%

($)

Number of 

Firms with 

Revenue 

below 1% 

Threshold

Firms operated entire year with 

sales/receipts/revenue of $25,000,000 to 

$49,999,999 1 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $50,000,000 to 

$99,999,999 2 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $100,000,000 or more 0 4,333 0

Firms not operated for the entire year 1,748 4,333 

621391 Offices of 

podiatrists

All firms 8,211 4,333 

Firms operated for the entire year 7,566 4,333 

Firms operated entire year with 

sales/receipts/revenue less than $100,000 636 4,333 28 

Firms operated entire year with 

sales/receipts/revenue of $100,000 to $249,999 2,041 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $250,000 to $499,999 2,564 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $500,000 to $999,999 1,594 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $1,000,000 to 

$2,499,999 623 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $2,500,000 to 

$4,999,999 88 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $5,000,000 to 

$9,999,999 20 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $10,000,000 to 

$24,999,999 0 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $25,000,000 to 

$49,999,999 0 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $50,000,000 to 

$99,999,999 0 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $100,000,000 or more 0 4,333 0

Firms not operated for the entire year 645 4,333 

621399

Offices of all 

other 

miscellaneous 

health 

practitioners

All firms 11,734 4,333 

Firms operated for the entire year 9,094 4,333 

Firms operated entire year with 

sales/receipts/revenue less than $100,000 3,061 4,333 133 

Firms operated entire year with 

sales/receipts/revenue of $100,000 to $249,999 3,054 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $250,000 to $499,999 1,646 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $500,000 to $999,999 767 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $1,000,000 to 

$2,499,999 443 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $2,500,000 to 

$4,999,999 83 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $5,000,000 to 

$9,999,999 31 4,333 0

62
NAICS 

code

NAICS

code 

description

Revenue size of firms operated entire year Number

of firms

Adjusted 

Number of 

firms for 

50% 

Distributor, 

Importer, 

Exporter

Revenue 

where cost is 

1%

($)

Number of 

Firms with 

Revenue 

below 1% 

Threshold

Firms operated entire year with 

sales/receipts/revenue of $10,000,000 to 

$24,999,999 8 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $25,000,000 to 

$49,999,999 1 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $50,000,000 to 

$99,999,999 0 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $100,000,000 or more 0 4,333 0

Firms not operated for the entire year 2,640 4,333 

621420

Outpatient 

mental health 

and substance 

abuse centers

All firms 4,555 4,333 

Firms operated for the entire year 4,113 4,333 

Firms operated entire year with 

sales/receipts/revenue less than $100,000 518 4,333 22 

Firms operated entire year with 

sales/receipts/revenue of $100,000 to $249,999 641 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $250,000 to $499,999 487 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $500,000 to $999,999 594 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $1,000,000 to 

$2,499,999 761 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $2,500,000 to 

$4,999,999 447 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $5,000,000 to 

$9,999,999 378 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $10,000,000 to 

$24,999,999 234 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $25,000,000 to 

$49,999,999 45 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $50,000,000 to 

$99,999,999 6 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $100,000,000 or more 2 4,333 0

Firms not operated for the entire year 442 4,333 

621491

HMO 

medical 

centers

All firms 35 4,333 

Firms operated for the entire year 30 4,333 

Firms operated entire year with 

sales/receipts/revenue less than $100,000 0 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $100,000 to $249,999 5 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $250,000 to $499,999 4 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $500,000 to $999,999 3 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $1,000,000 to 

$2,499,999 2 4,333 0

63
NAICS 

code

NAICS

code 

description

Revenue size of firms operated entire year Number

of firms

Adjusted 

Number of 

firms for 

50% 

Distributor, 

Importer, 

Exporter

Revenue 

where cost is 

1%

($)

Number of 

Firms with 

Revenue 

below 1% 

Threshold

Firms operated entire year with 

sales/receipts/revenue of $2,500,000 to 

$4,999,999 2 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $5,000,000 to 

$9,999,999 1 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $10,000,000 to 

$24,999,999 2 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $25,000,000 to 

$49,999,999 4 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $50,000,000 to 

$99,999,999 0 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $100,000,000 or more 7 4,333 0

Firms not operated for the entire year 5 4,333 

622110

General 

medical and 

surgical 

hospitals

All firms 3,076 4,333 

Firms operated for the entire year 3,051 4,333 

Firms operated entire year with 

sales/receipts/revenue less than $100,000 0 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $100,000 to $249,999 2 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $250,000 to $499,999 1 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $500,000 to $999,999 0 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $1,000,000 to 

$2,499,999 18 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $2,500,000 to 

$4,999,999 117 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $5,000,000 to 

$9,999,999 316 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $10,000,000 to 

$24,999,999 613 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $25,000,000 to 

$49,999,999 436 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $50,000,000 to 

$99,999,999 416 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $100,000,000 or more 1,132 4,333 0

Firms not operated for the entire year 25 4,333 

622210

Psychiatric 

and substance 

abuse 

hospitals

All firms 429 4,333 

Firms operated for the entire year 423 4,333 

Firms operated entire year with 

sales/receipts/revenue less than $100,000 0 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $100,000 to $249,999 0 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $250,000 to $499,999 0 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $500,000 to $999,999 0 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $1,000,000 to 

$2,499,999 1 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $2,500,000 to 

$4,999,999 22 4,333 0

64
NAICS 

code

NAICS

code 

description

Revenue size of firms operated entire year Number

of firms

Adjusted 

Number of 

firms for 

50% 

Distributor, 

Importer, 

Exporter

Revenue 

where cost is 

1%

($)

Number of 

Firms with 

Revenue 

below 1% 

Threshold

Firms operated entire year with 

sales/receipts/revenue of $5,000,000 to 

$9,999,999 55 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $10,000,000 to 

$24,999,999 140 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $25,000,000 to 

$49,999,999 115 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $50,000,000 to 

$99,999,999 63 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $100,000,000 or more 27 4,333 0

Firms not operated for the entire year 6 4,333 

622310

Specialty 

(except 

psychiatric 

and substance 

abuse) 

hospitals

All firms 375 4,333 

Firms operated for the entire year 352 4,333 

Firms operated entire year with 

sales/receipts/revenue less than $100,000 0 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $100,000 to $249,999 0 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $250,000 to $499,999 0 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $500,000 to $999,999 1 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $1,000,000 to 

$2,499,999 7 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $2,500,000 to 

$4,999,999 27 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $5,000,000 to 

$9,999,999 49 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $10,000,000 to 

$24,999,999 73 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $25,000,000 to 

$49,999,999 86 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $50,000,000 to 

$99,999,999 55 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $100,000,000 or more 54 4,333 0

Firms not operated for the entire year 23 4,333 

541380 Testing 

laboratories

All firms 5,288 4,333 

Firms operated for the entire year 4,727 4,333 

Firms operated entire year with 

sales/receipts/revenue less than $100,000 493 4,333 21 

Firms operated entire year with 

sales/receipts/revenue of $100,000 to $249,999 771 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $250,000 to $499,999 817 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $500,000 to $999,999 872 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $1,000,000 to 

$2,499,999 934 4,333 0

65
NAICS 

code

NAICS

code 

description

Revenue size of firms operated entire year Number

of firms

Adjusted 

Number of 

firms for 

50% 

Distributor, 

Importer, 

Exporter

Revenue 

where cost is 

1%

($)

Number of 

Firms with 

Revenue 

below 1% 

Threshold

Firms operated entire year with 

sales/receipts/revenue of $2,500,000 to 

$4,999,999 413 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $5,000,000 to 

$9,999,999 247 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $10,000,000 to 

$24,999,999 123 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $25,000,000 to 

$49,999,999 31 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $50,000,000 to 

$99,999,999 16 4,333 0

Firms operated entire year with 

sales/receipts/revenue of $100,000,000 or more 10 4,333 0

Firms not operated for the entire year 561 4,333 

Total with impact greater than 1% of 

revenue 2,127

66
Table B2. Summary of percentage of small businesses whose cost is greater than 1% of revenue (or “below 

threshold”)

Registrant Categories and NAICS Code Titles

NAICS Codes 

Represented 

by DEA 

Registrants

Number of 

Businesses 

Below SBA 

Size 

Standard

Revenue at 

threshold 

(1%)

Sum of Firms 

operated for 

the entire 

year

Number of 

Firms 

w/Revenue 

below 

Threshold

Percentage 

of Small 

Businesss 

below 

threshold

Manufacturers 533

Petrochemical Manufacturing 325110 56 $ 4,333 56 -

Medicinal and Botanical Manufacturing 325411 406 $ 4,333 410 -

Pharmaceutical Preparation Manufacturing 325412 943 $ 4,333 991 -

Adhesive Manufacturing 325520 600 $ 4,333 600 -

Toilet Preparation Manufacturing 325620 828 $ 4,333 854 -

All Other Miscellaneous Chemical Product and 

Preparation Manufacturing 325998 1,253 $ 4,333 1,261 -

Manufacturer Summary 4,086 4,172 - 0.0%

Distributors/Importer/Exporter 1,433

Drugs and Druggists’ Sundries Merchant 

Wholesalers

424210 5,155 $ 98,726 5,430 187

General Line Grocery Merchant Wholesalers 424410 1,739 $ 98,726 1,842 41

Confectionery Merchant Wholesalers 424450 1,506 $ 98,726 1,544 59

Other Chemical and Allied Products Merchant 

Wholesalers

424690 5,824 $ 98,726 5,948 183

Tobacco and Tobacco Product Merchant 

Wholesalers

424940 978 $ 98,726 1,053 11

Other Miscellaneous Nondurable Goods Merchant 

Wholesalers

424990 9,926 $ 98,726 10,043 606

Packaging and Labeling Services 561910 1,381 $ 98,726 1,541 85

Distributors/Importers/Exporters Summary 26,509 27,401 1,172 4.4%

Pharmacies 50,517

Supermarkets and Other Grocery (except 

Convenience) Stores 445110 33,444 $ 4,333 34,009 118

Pharmacies and Drug Stores 446110 17,069 $ 4,333 17,217 16

Discount Department Stores 452112 3 $ 4,333 11 -

Warehouse Clubs and Superstores 452910 1 $ 4,333 11 -

Pharmacies Summary 50,517 51,248 134 0.3%

Others 319,105

Colleges, Universities and Professional Schools** 611310 Not 

Available $ 4,333 2,149

 Not 

Available 

Offices of Physicians (except Mental Health 

Specialists) 621111 155,908 $ 4,333 160,034 321

Offices of Physicians, Mental Health Specialists 621112 9,056 $ 4,333 9,075 74

Offices of Dentists 621210 110,634 $ 4,333 111,013 166

Offices of Optometrists 621320 16,611 $ 4,333 16,659 56

Offices of Podiatrists 621391 7,556 $ 4,333 7,566 28

Offices of All Other Miscellaneous Health 

Practitioners

621399 9,070 $ 4,333 9,094 133

Outpatient Mental Health and Substance Abuse 

Centers

621420 3,826 $ 4,333 4,113 22

HMO Medical Centers 621491 17 $ 4,333 30 -

General Medical and Surgical Hospitals 622110 1,285 $ 4,333 3,051 -

Psychiatric and Substance Abuse Hospitals 622210 334 $ 4,333 423 -

Specialty (except Psychiatric and Substance Abuse) 

Hospitals

622310 200 $ 4,333 352 -

Testing Laboratories 541380 4,608 $ 4,333 4,727 21

Others Summary 319,105 328,286 821 0.3%

Total Controlled Substance Registrants 371,588 2,127

Category 1 Category 2

67