Federal Register / Vol. 87, No. 24 / Friday, February 4, 2022 / Proposed Rules 6443 

from the FT–895 in constructing reliable 

and consistent economic statistics, 

including GDP for U.S. territories. Such 

statistics provide key insight into the 

territorial economies, and meaningful 

information to businesses and decision 

makers alike. Territorial GDP are highly 

reliant on export and import data 

provided from the Census Bureau’s FT– 

895. The direct concern is that an 

elimination of EEI reporting 

requirements could directly impact the 

availability of import data used in the 

USVI GDP statistics. To illustrate the 

significance of this information loss, in 

2018 exports reported in the FT–895 

accounted for 59-percent and 9-percent 

of American Samoa and the USVI GDP, 

respectively. The direct and indirect 

impact associated to the elimination of 

the EEI reporting requirements could 

severely affect the usefulness of 

American Samoa, Northern Mariana 

Islands, Guam and USVI GDP as time 

series statistics. Should the reporting 

requirement be eliminated, it remains 

unclear if the Census Bureau will 

continue to make non-EEI-sourced trade 

data available for these territories. Other 

commenters stated that the lack of data 

with no other avenue for gathering the 

information would be harmful and 

unfortunate if such a longtime source of 

information were to disappear. 

Similarly, a commenter noted that the 

FT–895 constitutes an excellent and 

unique tool benefitting individuals, 

businesses, academia, etc. and for which 

there is no viable substitute available. 

Robert L. Santos, Director, Census 

Bureau, approved the publication of this 

notice of proposed rulemaking in the 

Federal Register. 

Dated: January 31, 2022. 

Sheleen Dumas, 

Department PRA Clearance Officer, Office of 

the Chief Information Officer, Commerce 

Department. 

[FR Doc. 2022–02341 Filed 2–3–22; 8:45 am] 

BILLING CODE 3510–07–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 203 

[Docket No. FDA–2020–N–1819] 

RIN 0910–AH56 

Certain Requirements Regarding 

Prescription Drug Marketing 

AGENCY: Food and Drug Administration, 

Department of Health and Human 

Services (HHS). 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is proposing to amend certain 

prescription drug marketing regulations 

to reflect changes to affected provisions 

of the Federal Food, Drug, and Cosmetic 

Act (FD&C Act) resulting from 

enactment of the Drug Supply Chain 

Security Act (DSCSA), Title II of the 

Drug Quality and Security Act (DQSA). 

This action, if finalized, will remove or 

revise outdated and conflicting 

regulatory requirements to align with 

changes to affected provisions of the 

FD&C Act following enactment of the 

DSCSA. 

DATES: Submit either electronic or 

written comments on the proposed rule 

by April 5, 2022. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

April 5, 2022. Electronic comments 

must be submitted on or before that 

date. Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2020–N–1819 for ‘‘Certain Requirements 

Regarding Prescription Drug 

Marketing.’’ Received comments, those 

filed in a timely manner (see 

ADDRESSES), will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

available at https://

www.regulations.gov, or at the Dockets 

Management Staff between 9 a.m. and 4 

p.m., Monday through Friday, 240–402– 

7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 


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6444 Federal Register / Vol. 87, No. 24 / Friday, February 4, 2022 / Proposed Rules 

1This function has been delegated to FDA. 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Aaron Weisbuch, Center for Drug 

Evaluation and Research, Office of 

Compliance, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993, 301– 

796–3130, WDD3PLrequirements@

fda.hhs.gov. 

With regard to biologics: Stephen 

Ripley, Center for Biologics Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 71, Rm. 7301, Silver Spring, 

MD 20993–0002, 240–402–7911. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Executive Summary 

A. Purpose of the Proposed Rule 

B. Summary of the Major Provisions of the 

Proposed Rule 

C. Legal Authority 

D. Costs and Benefits 

II. Table of Abbreviations/Commonly Used 

Acronyms in This Document 

III. Background 

A. Introduction 

B. Need for the Regulation 

IV. Legal Authority 

V. Description of the Proposed Rule 

VI. Proposed Effective Dates 

VII. Preliminary Economic Analysis of 

Impacts 

VIII. Analysis of Environmental Impact 

IX. Paperwork Reduction Act of 1995 

X. Federalism 

XI. Consultation and Coordination With 

Indian Tribal Governments 

XII. Reference 

I. Executive Summary 

A. Purpose of the Proposed Rule 

FDA is proposing to amend part 203 

(21 CFR part 203) to reflect changes to 

affected provisions of the FD&C Act 

following enactment of the DSCSA, 

Title II of the DQSA (Pub. L. 113–54). 

In this proposed rulemaking, we are 

proposing to amend certain provisions 

of part 203 to avoid potential confusion 

with the new standards and 

requirements for wholesale distributors 

applicable under the FD&C Act (as 

amended by the DSCSA), and to make 

certain related, conforming changes. 

B. Summary of the Major Provisions of 

the Proposed Rule 

The proposed rule would: (1) Modify 

the ‘‘scope’’ and ‘‘purpose’’ sections of 

the regulations in part 203 to eliminate 

references to wholesale distribution, (2) 

delete Subpart E—Wholesale 

Distribution in its entirety, (3) delete 

from § 203.3 the definitions for terms 

that only appeared in subpart E, and (4) 

modify other provisions of part 203 to 

eliminate references to wholesale 

distribution to conform to the changes 

described above. 

C. Legal Authority 

We are issuing this proposed rule 

under sections 503(c), 503(e), 582, 583 

and 701(a) of the FD&C Act (21 U.S.C. 

353(c), 353(e), 360eee-1, 360eee-2, and 

371(a)). 

D. Costs and Benefits 

This proposed rule is a companion to 

the proposed rule ‘‘National Standards 

for the Licensure of Wholesale Drug 

Distributors and Third-Party Logistics 

Providers’’ (licensing standards 

proposed rule) which implements the 

national licensing standards 

requirements of DSCSA. The licensing 

standards proposed rule, which would 

amend part 205, is published elsewhere 

in this issue of the Federal Register. We 

analyze the effects of the two rules 

together; thus, we include the benefits 

and costs of this proposed rule in the 

regulatory impact analysis of the 

licensing standards proposed rule. 

II. Table of Abbreviations/Commonly 

Used Acronyms in This Document 

Abbreviation/ 

acronym What it means 

CFR ............... Code of Federal Regulations. 

DSCSA .......... Drug Supply Chain Security 

Act. 

DQSA ............ Drug Quality and Security 

Act. 

FDA or the 

Agency.

U.S. Food and Drug Administration. 

FD&C Act ...... Federal Food, Drug, and 

Cosmetic Act. 

U.S.C. ............ United States Code. 

III. Background 

A. Introduction 

The DQSA was enacted on November 

27, 2013. The DQSA contains two titles: 

Title I, the Compounding Quality Act 

and Title II, the DSCSA. The DSCSA 

amended Chapter V of the FD&C Act by 

adding Subchapter H (Pharmaceutical 

Distribution Supply Chain), which 

includes new sections 581 through 585 

(21 U.S.C. 360eee through 360eee–4), 

and by amending section 503(e) of the 

FD&C Act. As amended, section 503(e) 

of the FD&C Act, together with new 

section 583 of the FD&C Act, require the 

Secretary of Health and Human Services 

(Secretary) 1 to establish national 

prescription drug wholesale distributor 

licensure standards. In addition, section 

582 of the FD&C Act establishes 

prescription drug product tracing 

requirements for wholesale distributors 

and their trading partners. FDA is 

proposing to revise the regulations in 

part 203 by removing or amending those 

sections of the regulations that have 

been affected by the changes to the 

FD&C Act through the enactment of the 

DSCSA. 

B. Need for the Regulation 

This rulemaking, when finalized, 

would: (1) Remove existing regulations 

regarding wholesale distribution of 

prescription drugs that conflict with or 

were superseded by new requirements 

established under the DSCSA; (2) 

modify other existing regulations for 

consistency with the regulations on 

standards for licensure of wholesale 

distributors that FDA is proposing 

pursuant to section 583 of the FD&C 

Act; and (3) make certain related, 

conforming changes. This rulemaking is 

needed to remove outdated regulations 

and to prevent confusion about 

requirements for wholesale distributors 

under the FD&C Act. 

IV. Legal Authority 

The Agency is proposing this rule 

under the authority to impose 

requirements regarding prescription 

drug marketing and wholesale drug 

distribution granted to it under various 

sections of the FD&C Act, including 

sections 503(c), 503(e), 582, 583, and 

701(a). Section 503(c) describes certain 

restrictions on prescription drug 

marketing, including relating to the sale 

of drug samples and of drugs that have 

been purchased by hospitals or other 

healthcare entities. Section 503(e), 

together with section 583 of the FD&C 

Act, require the Secretary to establish 

national prescription drug wholesale 

distributor licensure standards, while 

section 582 describes requirements 

applicable to wholesale distributors and 

other entities related to product tracing. 

Section 701(a) provides general 

authority to issue regulations for the 

efficient enforcement of the FD&C Act. 

By clarifying provisions related to 

prescription drug marketing and by 

removing provisions relating to 

wholesale distribution, this rule, when 

finalized, is expected to aid in the 

efficient enforcement of the FD&C Act. 

V. Description of the Proposed Rule 

This proposed rule would make the 

deletions and changes to the existing 

regulations in part 203 discussed below 

as well as technical changes for clarity. 


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1. Scope and Purpose (§§ 203.1 and 

203.2) 

Existing §§ 203.1 and 203.2 describe 

the scope and purpose of the regulations 

in part 203, respectively. The proposed 

revisions would narrow the scope and 

purpose descriptions in light of the 

proposed elimination of requirements 

relating to wholesale distributors from 

part 203. We plan to address the 

standards and requirements related to 

wholesale distributor licensing 

elsewhere in our regulations, in 

accordance with the applicable 

provisions of the FD&C Act (as amended 

by the DSCSA). 

2. Definitions (§ 203.3) 

Certain definitions that currently 

appear in this section would be 

modified or eliminated. 

a. Authorized distributor of record. 

The amendments to section 503(e) 

effectuated by the DSCSA eliminated 

the definition of ‘‘authorized 

distributors of record’’ from section 

503(e) of the FD&C Act, which 

previously provided that the definition 

applied for the purposes of section 

503(d) and 503(e). However, the DSCSA 

added a definition of the same term in 

section 503(d) of the FD&C Act, which 

relates to drug sample distribution, in 

section 503(d)(4). The ‘‘authorized 

distributor of record’’ definition in 

§ 203.3 would be revised to reflect the 

fact that, as used in the amended part 

203, the phrase would relate solely to 

distribution of drug samples. The 

revised ‘‘authorized distributor of 

record’’ definition would be found in 

the new § 203.3(a). In addition, as 

further discussed below, references to 

distribution of products by authorized 

distributors of record would be 

amended throughout the text of part 

203, where appropriate, to clarify that 

these references relate only to 

distribution of drug samples. 

b. Emergency medical reasons. The 

proposed rule would amend the 

definition of ‘‘emergency medical 

reasons’’ in the new § 203.3(l). Section 

203.22, which sets forth exemptions 

from the sales restrictions described in 

§ 203.20, generally provides an 

exemption from those restrictions for 

sales, purchases, or trades of a drug for 

emergency medical reasons 

(§ 203.22(d)). Section 203.3(m) currently 

states, in part, that ‘‘emergency medical 

reasons’’ include, but are not limited to, 

transfers of a prescription drug between 

healthcare entities or from a healthcare 

entity to a retail pharmacy to alleviate 

a temporary shortage of a prescription 

drug arising from delays in or 

interruption of regular distribution 

schedules, as well as transfers of 

prescription drugs by a retail pharmacy 

to another retail pharmacy to alleviate a 

temporary shortage. As a result, under 

§ 203.22(d) such transfers to alleviate 

temporary shortages are exempt from 

the sales restrictions set forth in 

§ 203.20. Certain of those transfers may, 

however, constitute ‘‘wholesale 

distribution’’ as defined in the DSCSA 

(section 503(e)(4) of the FD&C Act) 

because, while the ‘‘wholesale 

distribution’’ definition generally 

excludes distributions for ‘‘emergency 

medical reasons,’’ it states that a drug 

shortage not caused by a public health 

emergency shall not constitute an 

emergency medical reason. With certain 

exceptions, a person cannot 

simultaneously be a healthcare entity 

and a wholesale distributor (see 

§ 203.3(p)). Because of this, FDA 

proposes to amend relevant language in 

the ‘‘emergency medical reasons’’ 

definition to clarify the relationship 

between it and the definition of 

‘‘wholesale distribution’’ in section 

503(e)(4) of the FD&C Act. In particular, 

we would add text to § 203.3(l) to make 

clear that a transfer made to alleviate a 

temporary shortage would generally be 

considered to be for ‘‘emergency 

medical reasons’’ for purposes of part 

203 only where the transfer was either 

to fulfill a specific patient need or 

where the shortage was caused by a 

public health emergency (that is, where 

such transfers would not constitute 

‘‘wholesale distribution’’ as defined in 

section 503(e)(4) of the FD&C Act). As 

explained in our companion proposed 

rulemaking for part 205 (21 CFR part 

205), the Agency considers the transfer 

or sale of a drug from one dispenser to 

another dispenser made to fulfill a 

specific patient need to be outside the 

scope of the ‘‘wholesale distribution’’ 

definition in section 503(e)(4) of the 

FD&C Act. 

c. Unauthorized distributor and 

wholesale distribution. The definitions 

of ‘‘unauthorized distributor’’ and 

‘‘wholesale distribution,’’ currently 

codified in § 203.3(bb) and (cc), 

respectively, would be eliminated from 

part 203, because these terms would no 

longer appear in part 203, as amended. 

The definition of the term ‘‘wholesale 

distributor’’ would be modified to 

indicate that the term would have the 

meaning set forth in section 581(29) of 

the FD&C Act. 

3. Exclusions (§ 203.22(h) and (i)) 

Paragraphs (h) and (i) of § 203.22, 

which set forth exemptions from the 

sales restrictions in § 203.20, would be 

modified to eliminate the phrase 

indicating that the applicable 

requirements for a wholesale distributor 

or retail pharmacy are contained in part 

203, because FDA is proposing to 

remove § 203.50, as discussed in section 

V.5. 

4. Subpart D—Samples 

FDA would replace the term 

‘‘distributor’’ where it appears in 

subpart D with the phrase ‘‘authorized 

distributor of record’’ where that phrase 

is not already used (§§ 203.30, 203.31, 

203.34, 203.36, and 203.37). As noted 

above, the DSCSA added a definition of 

‘‘authorized distributors of record’’ in 

section 503(d) of the FD&C Act, which 

relates to drug sample distribution. 

5. Subpart E—Wholesale Distribution 

FDA proposes to remove § 203.50 

(Subpart E—Wholesale Distribution) in 

its entirety. On July 14, 2011, FDA 

proposed to remove § 203.50(a) (76 FR 

41434). Before that rulemaking was 

finalized, the DSCSA was enacted. The 

DSCSA replaced section 503(e)(1)–(3) of 

the FD&C Act and added additional and 

different requirements for wholesale 

distributors. The DSCSA also added 

new requirements for wholesale 

distributors, including phased-in 

prescription drug tracing requirements 

in section 582(c) of the FD&C Act. FDA 

is withdrawing the above referenced 

July 14, 2011, proposed rule in a 

document published elsewhere in this 

issue of the Federal Register. In 

accordance with the changes in 

statutory authorities, FDA proposes to 

remove § 203.50 in its entirety. FDA is 

proposing new requirements for 

wholesale distributors and wholesale 

distribution consistent with the relevant 

provisions of the DSCSA in a separate 

proposed rulemaking for part 205, also 

published in this issue of the Federal 

Register. 

VI. Proposed Effective Date 

This regulation, if finalized as 

proposed, will be effective 30 calendar 

days after the date the final rule 

publishes in the Federal Register. 

VII. Preliminary Economic Analysis of 

Impacts 

We have examined the impacts of the 

proposed rule under Executive Order 

12866, Executive Order 13563, the 

Regulatory Flexibility Act (5 U.S.C. 

601–612), and the Unfunded Mandates 

Reform Act of 1995 (Pub. L. 104–4). 

Executive Orders 12866 and 13563 

direct us to assess all costs and benefits 

of available regulatory alternatives and, 

when regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 


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6446 Federal Register / Vol. 87, No. 24 / Friday, February 4, 2022 / Proposed Rules 

and safety, and other advantages; 

distributive impacts; and equity). We 

believe that this proposed rule is not a 

significant regulatory action as defined 

by Executive Order 12866. 

The Regulatory Flexibility Act 

requires us to analyze regulatory options 

that would minimize any significant 

impact of a rule on small entities. 

Because the proposed rule imposes only 

minimal one-time costs of less than 

$100 per entity to read and understand 

the rule on small entities, we propose to 

certify that the proposed rule will not 

have a significant economic impact on 

a substantial number of small entities. 

The Unfunded Mandates Reform Act 

of 1995 (section 202(a)) requires us to 

prepare a written statement, which 

includes an assessment of anticipated 

costs and benefits, before proposing 

‘‘any rule that includes any Federal 

mandate that may result in the 

expenditure by State, local, and tribal 

governments, in the aggregate, or by the 

private sector, of $100,000,000 or more 

(adjusted annually for inflation) in any 

one year.’’ The current threshold after 

adjustment for inflation is $158 million, 

using the most current (2020) Implicit 

Price Deflator for the Gross Domestic 

Product. This proposed rule would not 

result in an expenditure in any year that 

meets or exceeds this amount. 

We include the costs to read and 

understand this proposed rule in the 

regulatory impact analysis of the 

companion licensing standards 

proposed rule. The full preliminary 

analysis of economic impacts of both 

rules is available at https://

www.fda.gov/AboutFDA/Reports

ManualsForms/Reports/Economic

Analyses/default.htm under ‘‘National 

Standards for Licensing of Prescription 

Drug Wholesale Distributor and Third 

Party Logistics Providers’’ (Ref. 1). 

VIII. Analysis of Environmental Impact 

We have determined under 21 CFR 

25.30 that this action is of the type that 

does not individually or cumulatively 

have a significant effect on the human 

environment. Therefore, neither an 

environmental assessment nor an 

environmental impact statement is 

required. 

IX. Paperwork Reduction Act of 1995 

FDA tentatively concludes that this 

proposed rule contains no collection of 

information. Therefore clearance by the 

Office of Management and Budget under 

the Paperwork Reduction Act of 1995 is 

not required. 

X. Federalism 

We have analyzed this proposed rule 

in accordance with the principles set 

forth in Executive Order 13132. We 

have determined that this proposed rule 

does not contain policies that have 

substantial direct effects on the States, 

on the relationship between the 

National Government and the States, or 

on the distribution of power and 

responsibilities among the various 

levels of government. Accordingly, we 

conclude that the rule does not contain 

policies that have federalism 

implications as defined in the Executive 

order and, consequently, a federalism 

summary impact statement is not 

required. 

XI. Consultation and Coordination With 

Indian Tribal Governments 

We have analyzed this proposed rule 

in accordance with the principles set 

forth in Executive Order 13175. We 

have tentatively determined that the 

rule does not contain policies that 

would have a substantial direct effect on 

one or more Indian Tribes, on the 

relationship between the Federal 

Government and Indian Tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian Tribes. The 

Agency solicits comments from tribal 

officials on any potential impact on 

Indian Tribes from this proposed action. 

XII. Reference 

The following reference is on display 

in the Dockets Management Staff (see 

ADDRESSES) and is available for viewing 

by interested persons between 9 a.m. 

and 4 p.m., Monday through Friday; it 

is also available electronically at https:// 

www.regulations.gov. FDA has verified 

the website address, as of the date this 

document publishes in the Federal 

Register, but websites are subject to 

change over time. 

1. Preliminary Regulatory Impact Analysis, 

Initial Regulatory Flexibility Analysis, and 

Unfunded Mandates Reform Act Analysis for 

Certain Requirements Regarding Prescription 

Drug Marketing; Proposed Rule, available at 

https://www.fda.gov/AboutFDA/Reports

ManualsForms/Reports/EconomicAnalyses/ 

default.htm. 

List of Subjects in 21 CFR Part 203 

Labeling, Prescription drugs, 

Reporting and recordkeeping 

requirements, Warehouses. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, we propose that 21 

CFR part 203 be amended as follows: 

PART 203—PRESCRIPTION DRUG 

MARKETING 

■ 1. The authority citation for part 203 

continues to read as follows: 

Authority: 21 U.S.C. 331, 333, 351, 352, 

353, 360, 371, 374, 381. 

■ 2. In part 203, remove the words ‘‘the 

act’’ wherever they appear and add in 

their place ‘‘the Federal Food, Drug, and 

Cosmetic Act’’. 

■ 3. Revise § 203.1 to read as follows: 

§ 203.1 Scope. 

This part sets forth procedures and 

requirements pertaining to the 

reimportation of prescription drugs, 

including both bulk drug substances 

and finished dosage forms; the sale, 

purchase, or trade of (or the offer to sell, 

purchase, or trade) prescription drugs, 

including bulk drug substances, that 

were purchased by hospitals or 

healthcare entities, or donated to 

charitable organizations; and the 

distribution of prescription drug 

samples. For purposes of this part, the 

term ‘‘prescription drug’’ has the 

meaning set forth in § 203.3(x). 

■ 4. Revise § 203.2 to read as follows: 

§ 203.2 Purpose. 

The purpose of this part is to protect 

the public against drug diversion and 

enhance the security of the drug supply 

chain by establishing procedures and 

requirements relating to the 

reimportation of prescription drugs, the 

distribution of prescription drug 

samples, and the sale, purchase, or trade 

of prescription drugs purchased by 

hospitals or healthcare entities or 

donated to charitable organizations. 

■ 5. Revise § 203.3 to read as follows: 

§ 203.3 Definitions. 

(a) Authorized distributor of record 

means a distributor with whom a 

manufacturer has established an 

ongoing relationship to distribute such 

manufacturer’s drug samples. 

(b) Blood means whole blood 

collected from a single donor and 

processed either for transfusion or 

further manufacturing. 

(c) Blood component means that part 

of a single-donor unit of blood separated 

by physical or mechanical means. 

(d) Bulk drug substance means any 

substance that is represented for use in 

a drug and that, when used in the 

manufacturing, processing, or packaging 

of a drug, becomes an active ingredient 

or a finished dosage form of the drug, 

but the term does not include 

intermediates used in the synthesis of 

such substances. 

(e) Charitable institution or charitable 

organization means a nonprofit hospital, 

healthcare entity, organization, 

institution, foundation, association, or 

corporation that has been granted an 

exemption under section 501(c)(3) of the 

Internal Revenue Code of 1954, as 

amended. 


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(f) Common control means the power 

to direct or cause the direction of the 

management and policies of a person or 

an organization, whether by ownership 

of stock, voting rights, by contract, or 

otherwise. 

(g) Distribute means to sell, offer to 

sell, deliver, or offer to deliver a drug to 

a recipient, except that the term 

‘‘distribute’’ does not include: 

(1) Delivering or offering to deliver a 

drug by a common carrier in the usual 

course of business as a common carrier; 

or 

(2) Providing of a drug sample to a 

patient by: 

(i) A practitioner licensed to prescribe 

such drug; 

(ii) A healthcare professional acting at 

the direction and under the supervision 

of such a practitioner; or 

(iii) The pharmacy of a hospital or of 

another healthcare entity that is acting 

at the direction of such a practitioner 

and that received such sample in 

accordance with the Federal Food, Drug, 

and Cosmetic Act and the regulations in 

this part. 

(h) Drug sample means a unit of a 

prescription drug that is not intended to 

be sold and is intended to promote the 

sale of the drug. 

(i) Drug coupon means a form that 

may be redeemed, at no cost or at 

reduced cost, for a drug that is 

prescribed in accordance with section 

503(b) of the Federal Food, Drug, and 

Cosmetic Act. 

(j) Electronic record means any 

combination of text, graphics, data, 

audio, pictorial, or other information 

representation in digital form that is 

created, modified, maintained, archived, 

retrieved, or distributed by a computer 

system. 

(k) Electronic signature means any 

computer data compilation of any 

symbol or series of symbols executed, 

adopted, or authorized by an individual 

to be the legally binding equivalent of 

the individual’s handwritten signature. 

(l) Emergency medical reasons 

include, but are not limited to: 

(1) Transfers of a prescription drug 

between healthcare entities or from a 

healthcare entity to a retail pharmacy to 

alleviate a temporary shortage of a 

prescription drug arising from delays in 

or interruption of regular distribution 

schedules, provided that such transfers 

are made in order to fulfill a specific 

patient need or respond to a public 

health emergency; 

(2) Sales to nearby emergency medical 

services, i.e., ambulance companies, 

police, and fire-fighting organizations in 

the same State or same marketing or 

service area, or nearby licensed 

practitioners, of drugs for use in the 

treatment of acutely ill or injured 

persons; 

(3) Provision of minimal emergency 

supplies of drugs to nearby nursing 

homes for use in emergencies or during 

hours of the day when necessary drugs 

cannot be obtained; and 

(4) Transfers of prescription drugs by 

a retail pharmacy to another retail 

pharmacy to alleviate a temporary 

shortage, provided that such transfers 

are made in order to fulfill a specific 

patient need or respond to a public 

health emergency but do not include 

regular and systematic sales to licensed 

practitioners of prescription drugs that 

will be used for routine office 

procedures. 

(m) FDA means the U.S. Food and 

Drug Administration. 

(n) Group purchasing organization 

means any entity established, 

maintained, and operated for the 

purchase of prescription drugs for 

distribution exclusively to its members 

with such membership consisting solely 

of hospitals and healthcare entities 

bound by written contract with the 

entity. 

(o) Handwritten signature means the 

scripted name or legal mark of an 

individual handwritten by that 

individual and executed or adopted 

with the present intention to 

authenticate a writing in a permanent 

form. The act of signing with a writing 

or marking instrument such as a pen or 

stylus is preserved. The scripted name 

or legal mark, while conventionally 

applied to paper, may also be applied to 

other devices that capture the name or 

mark. 

(p) Healthcare entity means any 

person that provides diagnostic, 

medical, surgical, or dental treatment, or 

chronic or rehabilitative care, but does 

not include any retail pharmacy or any 

wholesale distributor. Except as 

provided in § 203.22(h) and (i), a person 

cannot simultaneously be a ‘‘healthcare 

entity’’ and a retail pharmacy or 

wholesale distributor. 

(q) Licensed practitioner means any 

person licensed or authorized by State 

law to prescribe drugs. 

(r) Manufacturer means any person 

who is a manufacturer as defined by 

§ 201.1 of this chapter. 

(s) Nonprofit affiliate means any notfor-profit organization that is either 

associated with or a subsidiary of a 

charitable organization as defined in 

section 501(c)(3) of the Internal Revenue 

Code of 1954. 

(t) Ongoing relationship means an 

association that exists when a 

manufacturer and a distributor enter 

into a written agreement under which 

the distributor is authorized to 

distribute the manufacturer’s drug 

samples for a period of time or for a 

number of shipments. If the distributor 

is not authorized to distribute a 

manufacturer’s entire drug sample line, 

the agreement must identify the specific 

drug samples that the distributor is 

authorized to distribute. 

(u) PDA means the Prescription Drug 

Amendments of 1992. 

(v) PDMA means the Prescription 

Drug Marketing Act of 1987. 

(w) Person includes any individual, 

partnership, corporation, or association. 

(x) Prescription drug means any drug 

(including any biological product, 

except for blood and blood components 

intended for transfusion or biological 

products that are also medical devices) 

required by Federal law (including 

Federal regulation) to be dispensed only 

by a prescription, including finished 

dosage forms and bulk drug substances 

subject to section 503(b) of the Federal 

Food, Drug, and Cosmetic Act. 

(y) Representative means an employee 

or agent of a drug manufacturer or 

authorized distributor of record who 

promotes the sale of prescription drugs 

to licensed practitioners and who may 

solicit or receive written requests for the 

delivery of drug samples. A detailer is 

a representative. 

(z) Sample unit means a packet, card, 

blister pack, bottle, container, or other 

single package comprised of one or 

more dosage units of a prescription drug 

sample, intended by the manufacturer 

or authorized distributor of record to be 

provided by a licensed practitioner to a 

patient in an unbroken or unopened 

condition. 

(aa) Wholesale distributor has the 

meaning set forth in section 581(29) of 

the Federal Food, Drug, and Cosmetic 

Act. 

■ 6. In § 203.22, revise paragraphs (h) 

and (i) to read as follows: 

§ 203.22 Exclusions. 

* * * * * 

(h) The sale, purchase, or trade of, or 

the offer to sell, purchase, or trade, by 

a registered blood establishment that 

qualifies as a healthcare entity, any: 

(1) Drug indicated for a bleeding or 

clotting disorder, or anemia; 

(2) Blood collection container 

approved under section 505 of the 

Federal Food, Drug, and Cosmetic Act; 

or 

(3) Drug that is a blood derivative (or 

a recombinant or synthetic form of a 

blood derivative); as long as all of the 

healthcare services that the 

establishment provides are related to its 

activities as a registered blood 

establishment or the healthcare services 

consist of collecting, processing, storing, 


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or administering human hematopoietic 

stem/progenitor cells or performing 

diagnostic testing of specimens 

provided that these specimens are tested 

together with specimens undergoing 

routine donor testing. Blood 

establishments relying on the exclusion 

in this paragraph (h)(3) must satisfy all 

other applicable requirements of the 

Federal Food, Drug, and Cosmetic Act 

and the regulations in this part 

promulgated thereunder. 

(i) The sale, purchase, or trade of, or 

the offer to sell, purchase, or trade, by 

a comprehensive hemophilia diagnostic 

treatment center that is receiving a grant 

under section 501(a)(2) of the Social 

Security Act and that qualifies as a 

healthcare entity, any drug indicated for 

a bleeding or clotting disorder, or 

anemia, or any drug that is a blood 

derivative (or a recombinant or 

synthetic form of a blood derivative). 

Comprehensive hemophilia diagnostic 

treatment centers relying on the 

exclusion in this paragraph (i) must 

satisfy all other applicable requirements 

of the Social Security Act and the 

regulations in this part promulgated 

thereunder. 

■ 7. In § 203.30, revise paragraphs (a)(4) 

and (c) to read as follows: 

§ 203.30 Sample distribution by mail or 

common carrier. 

(a) * * * 

(4) The receipt is returned to the 

manufacturer or authorized distributor 

of record from which the drug sample 

was received. 

* * * * * 

(c) Contents of the receipt to be 

completed upon delivery of a drug 

sample. The receipt is to be on a form 

designated by the manufacturer or 

authorized distributor of record, and is 

required to contain the following: 

(1) If the drug sample is delivered to 

the licensed practitioner who requested 

it, the receipt is required to contain the 

name, address, professional title, and 

signature of the practitioner or the 

practitioner’s designee who 

acknowledges delivery of the drug 

sample; the proprietary or established 

name and strength of the drug sample; 

the quantity of the drug sample 

delivered; and the date of the delivery. 

(2) If the drug sample is delivered to 

the pharmacy of a hospital or other 

healthcare entity at the request of a 

licensed practitioner, the receipt is 

required to contain the name and 

address of the requesting licensed 

practitioner; the name and address of 

the hospital or healthcare entity 

pharmacy designated to receive the drug 

sample; the name, address, professional 

title, and signature of the person 

acknowledging delivery of the drug 

sample; the proprietary or established 

name and strength of the drug sample; 

the quantity of the drug sample 

delivered; and the date of the delivery. 

■ 8. In § 203.31, revise paragraphs (a)(4), 

(c), (d) introductory text, (d)(2)(iii), and 

(e) to read as follows: 

§ 203.31 Sample distribution by means 

other than mail or common carrier (direct 

delivery by a representative or detailer). 

(a) * * * 

(4) The receipt is returned to the 

manufacturer or authorized distributor 

of record; and 

* * * * * 

(c) Contents of the receipt to be 

completed upon delivery of a drug 

sample. The receipt is to be on a form 

designated by the manufacturer or 

authorized distributor of record, and is 

required to contain the following: 

(1) If the drug sample is received at 

the address of the licensed practitioner 

who requested it, the receipt is required 

to contain the name, address, 

professional title, and signature of the 

practitioner or the practitioner’s 

designee who acknowledges delivery of 

the drug sample; the proprietary or 

established name and strength of the 

drug sample; the quantity of the drug 

sample delivered; and the date of the 

delivery. 

(2) If the drug sample is received by 

the pharmacy of a hospital or other 

healthcare entity at the request of a 

licensed practitioner, the receipt is 

required to contain the name and 

address of the requesting licensed 

practitioner; the name and address of 

the hospital or healthcare entity 

pharmacy designated to receive the drug 

sample; the name, address, professional 

title, and signature of the person 

acknowledging delivery of the drug 

sample; the proprietary or established 

name and strength of the drug sample; 

the quantity of the drug sample 

delivered; and the date of the delivery. 

(d) Inventory and reconciliation of 

drug samples of manufacturers’ and 

authorized distributors’ representatives. 

Each drug manufacturer or authorized 

distributor of record that distributes 

drug samples by means of 

representatives shall conduct, at least 

annually, a complete and accurate 

physical inventory of all drug samples. 

All drug samples in the possession or 

control of each manufacturer’s and 

authorized distributor’s representatives 

are required to be inventoried and the 

results of the inventory are required to 

be recorded in an inventory record, as 

specified in paragraph (d)(1) of this 

section. In addition, manufacturers and 

authorized distributors of record shall 

reconcile the results of the physical 

inventory with the most recently 

completed prior physical inventory and 

create a report documenting the 

reconciliation process, as specified in 

paragraph (d)(2) of this section. 

* * * * * 

(2) * * * 

(iii) A record of drug sample 

distributions since the most recently 

completed inventory showing the name 

and address of each recipient of each 

sample unit shipped, the date of the 

shipment, and the proprietary or 

established name, dosage strength, and 

number of sample units shipped. For 

the purposes of this paragraph (d)(2)(iii) 

and paragraph (d)(2)(v) of this section, 

‘‘distributions’’ includes distributions to 

healthcare practitioners or designated 

hospital or healthcare entity 

pharmacies, transfers or exchanges with 

other firm representatives, returns to the 

manufacturer or authorized distributor 

of record, destruction of drug samples 

by a sales representative, and other 

types of drug sample dispositions. The 

specific type of distribution must be 

specified in the record; 

* * * * * 

(e) Lists of manufacturers’ and 

authorized distributors’ representatives. 

Each drug manufacturer or authorized 

distributor of record who distributes 

drug samples by means of 

representatives shall maintain a list of 

the names and addresses of its 

representatives who distribute drug 

samples and of the sites where drug 

samples are stored. 

■ 9. In § 203.34, revise paragraph (b)(1) 

to read as follows: 

§ 203.34 Policies and procedures; 

administrative systems. 

* * * * * 

(b) * * * 

(1) Reconciling requests and receipts, 

identifying patterns of nonresponse, and 

the manufacturer’s or authorized 

distributor of record’s response when 

such patterns are found; 

* * * * * 

■ 10. In § 203.36, revise paragraph (a) to 

read as follows: 

§ 203.36 Fulfillment houses, shipping and 

mailing services, comarketing agreements, 

and third-party recordkeeping. 

(a) Responsibility for creating and 

maintaining forms, reports, and records. 

Any manufacturer or authorized 

distributor of record that uses a 

fulfillment house, shipping or mailing 

service, or other third party, or engages 

in a comarketing agreement with 

another manufacturer or authorized 

distributor of record to distribute drug 

samples or to meet any of the 


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requirements of PDMA, PDA, or this 

part, remains responsible for creating 

and maintaining all requests, receipts, 

forms, reports, and records required 

under PDMA, PDA, and this part. 

* * * * * 

■ 11. In § 203.37, revise paragraph (e) to 

read as follows: 

§ 203.37 Investigation and notification 

requirements. 

* * * * * 

(e) Whom to notify at FDA. 

Notifications and reports concerning 

samples of human prescription drugs or 

biological products that are regulated by 

the Center for Drug Evaluation and 

Research shall be made via email to 

PDMAREPORTS@fda.hhs.gov. 

Alternatively, reports and 

correspondence concerning such 

samples may be made via regular mail 

to the Office of Drug Security, Integrity, 

and Response, Office of Compliance, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Silver Spring, MD 

20993–0002, ATTN: PDMA Reports. 

Notifications and reports concerning 

samples of human prescription 

biological products regulated by the 

Center for Biologics Evaluation and 

Research shall be made to the Food and 

Drug Administration, Center for 

Biologics Evaluation and Research, 

Document Control Center, 10903 New 

Hampshire Ave., Bldg. 71, Rm. G112, 

Silver Spring, MD 20993–0002. 

Subpart E [Removed and Reserved] 

■ 12. Remove and reserve subpart E, 

consisting of § 203.50. 

Dated: January 24, 2022. 

Janet Woodcock, 

Acting Commissioner of Food and Drugs. 

[FR Doc. 2022–01927 Filed 2–3–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 203 

[Docket No. FDA–2011–N–0446] 

Removal of Certain Requirements 

Related to the Prescription Drug 

Marketing Act; Opportunity for Public 

Comment; Withdrawal 

AGENCY: Food and Drug Administration, 

Department of Health and Human 

Services (HHS). 

ACTION: Proposed rule; withdrawal. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing the withdrawal of the 

proposed rule ‘‘Removal of Certain 

Requirements Related to the 

Prescription Drug Marketing Act; 

Opportunity for Public Comment,’’ 

published in the Federal Register on 

July 14, 2011. FDA is taking this action 

because the proposed changes are 

duplicative of another FDA proposed 

rulemaking, which is also being 

published in this issue of the Federal 

Register, that is intended to conform 

with newly established definitions and 

requirements set out by the Drug Supply 

Chain Security Act of 2013 (DSCSA). 

DATES: The proposed rule published 

July 14, 2011 (76 FR 41434), is 

withdrawn as of February 4, 2022. 

ADDRESSES: For access to the docket, go 

to https://www.regulations.gov and 

insert the docket number found in 

brackets in the heading of this 

document into the ‘‘Search’’ box and 

follow the prompts, and/or go to the 

Dockets Management Staff, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Aaron Weisbuch, Center for Drug 

Evaluation and Research, Office of 

Compliance, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993, 301– 

796–9362, AaronWeisbuch@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Drug Quality and Security Act 

(DQSA) was enacted on November 27, 

2013. The DQSA contains two titles: 

Title I, the Compounding Quality Act, 

and Title II, the DSCSA (Pub. L. 113– 

54). The DSCSA amended Chapter V of 

the Federal Food, Drug, and Cosmetic 

Act (FD&C Act) by adding Subchapter H 

(Pharmaceutical Distribution Supply 

Chain), sections 581 through 585 (21 

U.S.C. 360eee through 360eee–4), and 

by amending section 503(e) of the FD&C 

Act (21 U.S.C. 353(e)). As amended, 

sections 503(e) and 583 of the FD&C Act 

require the Secretary to establish 

national prescription drug wholesale 

distributor licensure standards. In 

addition, section 582 of the FD&C Act 

establishes prescription drug product 

tracing requirements for wholesale 

distributors and their trading partners. 

On July 14, 2011, FDA proposed to 

remove § 203.50(a) (21 CFR 203.50(a)). 

Before that rulemaking was finalized, 

the DSCSA was enacted. Section 204 of 

the DSCSA amended section 503(e)(1) 

through (3) of the FD&C Act with 

additional and different requirements 

for wholesale distributors. The DSCSA 

also added new requirements for 

wholesale distributors, including 

phased-in prescription drug tracing 

requirements in section 582(c) of the 

FD&C Act. Because of the changes to 

requirements for wholesale distributors 

under the DSCSA, the Agency’s 

proposed rule published on July 14, 

2011, to remove § 203.50(a), was never 

finalized. 

In its proposed rulemaking entitled 

‘‘Certain Requirements Regarding 

Prescription Drug Marketing,’’ 

published elsewhere in this issue of the 

Federal Register, FDA will propose a 

rule that will seek to amend part 203 (21 

CFR part 203) to remove provisions no 

longer in effect and incorporate 

conforming changes following 

enactment of the DSCSA. In the 

proposed rulemaking, the Agency will 

clarify provisions to avoid potential 

confusion with the new standards for 

wholesale distribution established by 

the DSCSA. The amendments to part 

203 in the proposed rule will include 

the removal of § 203.50 in its entirety, 

rendering the proposed rule published 

July 14, 2011, removing § 203.50(a), 

obsolete. 

II. Withdrawal of the Proposed Rule 

As result of these efforts, FDA is 

withdrawing the proposed rule 

‘‘Removal of Certain Requirements 

Related to the Prescription Drug 

Marketing Act; Opportunity for Public 

Comment,’’ published in the Federal 

Register of July 14, 2011. 

The withdrawal of this proposed rule 

does not preclude the Agency from 

reinstituting rulemaking concerning the 

issues addressed in the proposal. 

Should we decide to undertake such 

rulemakings in the future, we will repropose the actions and provide new 

opportunities for comment. 

Furthermore, this proposed rule is only 

intended to address the withdrawal of 

the proposed rule on ‘‘Removal of 

Certain Requirements Related to the 

Prescription Drug Marketing Act; 

Opportunity for Public Comment,’’ 

published in the Federal Register of 

July 14, 2011, and not any other 

pending proposals that the Agency has 

issued or is considering. If you need 

additional information about the subject 

matter of the withdrawn proposed rule, 

visit the Agency’s website at https://

www.fda.gov for any current 

information on the matter. 

Dated: January 24, 2022. 

Janet Woodcock, 

Acting Commissioner of Food and Drugs. 

[FR Doc. 2022–01928 Filed 2–3–22; 8:45 am] 

BILLING CODE 4164–01–P 


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