Manufacture amounts and exemption from reporting - drug shortage determinations

Reporting Amount of Listed
Drugs and Biological
Products Under Section
510(j)(3) of the FD&C Act
Guidance for Industry

For questions regarding this document, contact (CDER) DrugAmountReporting@fda.hhs.gov,
(CBER) Office of Communication, Outreach and Development, 800-835-4709 or 240-402-8010,
or (CVM) Office of Surveillance and Compliance, 240-402-7002 or AskOSC@fda.hhs.gov.

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
Center for Veterinary Medicine (CVM)
February 2024
Procedural
Revision 1

Contains Nonbinding Recommendations

Reporting Amount of Listed
Drugs and Biological Products
Under Section 510(j)(3) of the
FD&C Act
Guidance for Industry
Additional copies are available from:
Office of Communications, Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration
10001 New Hampshire Ave., Hillandale Bldg., 4th Floor
Silver Spring, MD 20993-0002
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353
Email: druginfo@fda.hhs.gov
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs

and/or
Office of Communication, Outreach and Development
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave., Bldg. 71, Room 3128
Silver Spring, MD 20993-0002
Phone: 800-835-4709 or 240-402-8010
Email: ocod@fda.hhs.gov
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances

and/or
Policy and Regulations Staff, HFV-6
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Place, Rockville, MD 20855

https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry 

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
Center for Veterinary Medicine (CVM)
February 2024
Procedural
Revision 1

Contains Nonbinding Recommendations
TABLE OF CONTENTS

I. 

INTRODUCTION............................................................................................................. 1 

II. 

BACKGROUND ............................................................................................................... 2 

III. 

DISCUSSION .................................................................................................................... 4 

A.  Who Must Report .......................................................................................................................... 4 
B. 

What to Report............................................................................................................................... 4 

C.  Timing of Reports ........................................................................................................................ 13 
D.  Process for Report Submission ................................................................................................... 13 

IV. 

QUESTIONS AND ANSWERS..................................................................................... 14 

Contains Nonbinding Recommendations

Reporting Amount of Listed Drugs and Biological Products Under
Section 510(j)(3) of the FD&C Act
Guidance for Industry1
This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on
this topic. It does not establish any rights for any person and is not binding on FDA or the public. You
can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the
title page.

I.

INTRODUCTION

The Food and Drug Administration (FDA) is issuing this guidance to assist registrants of drug
establishments2 in submitting reports to FDA on the amount of each listed drug manufactured,3
prepared, propagated, compounded, or processed for commercial distribution, as required by
section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.
360(j)(3)), as added by section 3112(e) of the Coronavirus Aid, Relief, and Economic Security
Act (CARES Act).
This guidance describes the process that should be used for reporting information under section
510(j)(3) by each person who registers with FDA under section 510 of the FD&C Act with
regard to a listed drug (including a drug product that is in finished package form, a drug product
that is not in finished package form, an active pharmaceutical ingredient (API), and other types
of listed drugs, except for biological products or categories thereof exempted by an order under
section 510(j)(3)(B)).4 Listed drugs subject to reporting include human drug products (including
non-exempt biological products) marketed under an approved application, animal drug products
marketed under an approved application, medical gases,5 homeopathic products, products
1

This guidance has been prepared by the Office of Regulatory Policy and the Office of Pharmaceutical Quality in
the Center for Drug Evaluation and Research, in cooperation with the Center for Biologics Evaluation and Research
and the Center for Veterinary Medicine, at the Food and Drug Administration.
2
For the purposes of this guidance, the terms “establishment” and “facility” are used interchangeably.
3
For the purposes of this guidance, “manufacture” means the manufacture, preparation, propagation, compounding,
and processing of a drug. “Manufacture, preparation, propagation, compounding, or processing” also includes
repackaging and relabeling. See section 510(a) of the FD&C Act; § 207.1 (21 CFR 207.1) (definitions of
manufacture and manufacturer).
4
Under section 510(j)(3)(B) of the FD&C Act, FDA may issue an order to exempt certain biological products or
categories of biological products regulated under section 351 of the Public Health Service Act from some or all of
the reporting requirements under section 510(j)(3)(A) of the FD&C Act, if FDA determines that applying such
reporting requirements is not necessary to protect the public health. FDA has issued an order that exempts from
section 510(j)(3)(A) reporting requirements the following categories of biological products: (i) blood and blood
components for transfusion; and (ii) cell and gene therapy products, where one lot treats a single patient. See 88 FR
22454 (Apr. 13, 2023). See also Question & Answer IV.J.
5
For purposes of this guidance, “medical gas” and “designated medical gas” have the meanings set forth in section
575 of the FD&C Act.

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marketed in accordance with requirements under section 505G of the FD&C Act (21 U.S.C.
355h),6 often referred to as over-the-counter monograph drugs, and animal drug products that are
not approved, conditionally approved, or indexed under sections 512, 571, and 572 of the FD&C
Act.
In general, FDA’s guidance documents do not establish legally enforceable responsibilities.
Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only
as recommendations, unless specific regulatory or statutory requirements are cited. The use of
the word should in Agency guidances means that something is suggested or recommended, but
not required.
II.

BACKGROUND

An establishment engaged in the manufacture of a drug in the United States is required to be
registered with FDA.7 Likewise, any establishment within a foreign country engaged in the
manufacture of a drug that is imported or offered for import into the United States is also
required to be registered with the FDA.8, 9 Further, domestic and foreign registrants are required
to list with FDA all the drugs being manufactured by their registered establishments for
commercial distribution.10 Each registrant must provide certain information11 for each listed
drug it manufactures for commercial distribution,12 including unfinished drugs13 and APIs.
These obligations pertain to the registrant (e.g., manufacturers, including contract
manufacturers14).15 Unless the application holder is also the registrant, these obligations do not
pertain to the application holder of an approved drug.
On March 27, 2020, the CARES Act16 was enacted to aid response efforts and ease the economic
impact of the Coronavirus Disease 2019 (COVID-19). In addition, the CARES Act included
authorities to enhance FDA’s ability to assess, prevent, and mitigate possible drug shortages by,
6

Under section 505G of the FD&C Act, certain nonprescription drug products may be lawfully marketed without an
approved application under section 505 of the FD&C Act if applicable requirements are met. Other listed
unapproved drugs are also subject to reporting under section 510(j)(3) of the FD&C Act.
7
Section 510(b), (c) and (d) of the FD&C Act; § 207.17 (21 CFR 207.17).
8
Section 510(i) of the FD&C Act; § 207.17.
9
Registration and listing information helps the FDA maintain a catalog of all drugs in commercial distribution in the
United States.
10
Section 510(j)(1) of the FD&C Act; § 207.41 (21 CFR 207.41). Manufacturers, repackers, relabelers or salvagers
of Type B or Type C medicated feed are exempt from drug listing (section 510(g)(5) of the FD&C Act; 21 CFR
207.13(g)).
11
Section 510(j) of the FD&C Act; 21 CFR 207.49(a) (e.g., § 207.49(a)(4); § 207.49(a)(8)); 21 CFR 207.53.
12
See §207.1 (21 CFR 207.1) (defining “manufacture” and “commercial distribution”). Donated drugs and drug
samples are considered to be in commercial distribution.
13
Unfinished drug means an active pharmaceutical ingredient either alone or together with one or more other
ingredients but does not include finished drug products (§ 207.1).
14
See § 207.41(a) and (c). While contract manufacturer registrants are included in the scope of registrants for which
a report is required, note that a person (e.g., holder of a drug application) that has been authorized as an agent on
behalf of a contract manufacturer registrant may submit the section 510(j)(3) report. See Question and Answer IV.D
for further information.
15
See footnote 10.
16
Public Law 116-136.

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among other things, improving FDA’s visibility into drug supply chains. Section 3112(e) of the
CARES Act added section 510(j)(3) of the FD&C Act, which requires that each person
(including repackers and relabelers) who registers with FDA under section 510 of the FD&C Act
with regard to a drug must report to FDA annually on the amount of each listed drug that was
manufactured by such person for commercial distribution.
Section 510(j)(3) of the FD&C Act applies to each registrant of listed drugs in the drug supply
chain (e.g., registrants that manufacture for commercial distribution a package form suitable for
distribution to pharmacies, hospitals, or other dispensers or sellers of the drug product to patients
or consumers, as well as registrants that manufacture drugs for commercial distribution that are
not in such package forms). Data reported from registrants along the supply chain on the amount
of listed drugs17 that they manufacture (including data from registrants that manufacture a drug
before it is in finished package form) provide FDA with a more comprehensive picture of the
drug supply chain, which can inform operational decisions.18,19
These data support the Agency’s efforts to reduce drug shortage risk. When FDA is notified of
an impending interruption in manufacturing that is likely to lead to a supply disruption,20 these
data can provide insight into how much manufacturing typically occurs at the affected
establishment and whether the interruption may lead to a drug shortage. Furthermore, these data
can help the Agency identify and assess supply chain vulnerabilities that could be long term risk
factors for drug shortages. With earlier awareness of persistent or emerging supply chain
challenges, FDA is better informed and able to take more targeted and timely actions to promote
stronger supply chains and reduce drug shortage risks.
In addition to supporting FDA’s response to drug shortages, section 510(j)(3) of the FD&C Act
also facilitates FDA’s access to information useful in making decisions regarding the appropriate
level of drug facility surveillance. FDA can use reported drug amount information in concert
with other information about a particular facility (e.g., inspection history, hazard signals,
inherent product risk) as part of FDA’s quality surveillance oversight and risk-based approach to
surveillance actions. Because drug amount data assist in the Agency’s understanding of how
much of a drug is typically manufactured at each facility, it may allow for a better estimate of
potential public exposure to a particular drug manufactured at a particular facility. Additionally,
information reported from repackers and relabelers on the amount of listed drugs they process21
for commercial distribution provides FDA with information useful in making surveillance
decisions. For example, assuming all other factors are the same, a facility that has a higher
production volume may have a higher risk than one that has a lower production volume due to
17

Listed drugs include drug product in finished package form, drug product not in finished package form, APIs, and
other types of listed drugs, except for biological products or categories thereof exempted by an order under section
510(j)(3)(B) of the FD&C Act.
18
Accordingly, data reported from different registrants along the supply chain for a particular drug are not
considered duplicative.
19
In assessing data received in section 510(j)(3) reports, the Agency intends to review for general trends, and does
not intend to focus on minor data discrepancies.
20
See, e.g., section 506C(a) of the FD&C Act (notifications of discontinuance or interruption in the production of
life-saving drugs). See also 21 CFR 310.306, 314.81(b)(3)(iii), and 600.82.
21
As noted above, repackagers and relabelers are considered drug manufacturers under the definitions of
“manufacture” and “manufacturer” in 21 CFR § 207.1. See footnote 3.

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the relative levels of potential public exposure. Amount reporting data submitted by repackers
and relabelers under section 510(j)(3) of the FD&C Act helps FDA to gain visibility to make
such an assessment.
Regarding confidentiality of data, information submitted to the Agency in a section 510(j)(3)
report with respect to the amount of each listed drug manufactured at a specific establishment is
generally considered confidential commercial information (CCI) under FDA regulations.22 CCI
is valuable data or information which is used in one’s business and is of a type that is
customarily held in confidence and not disclosed to the public by the person to whom it
belongs.23 When a firm submits confidential business or financial information to FDA, the
Agency is required to follow applicable federal disclosure laws and regulations that generally
prohibit public disclosure of that information. CCI is exempt from disclosure under FDA’s
disclosure regulations and the Freedom of Information Act.24
III.

DISCUSSION
A.

Who Must Report

Each registrant that lists a drug must report to FDA annually on the amount of such drug that it
manufactured for commercial distribution.25 While contract manufacturer registrants are
included in the scope of registrants for which a report is required,26 note that a person, including
an application holder, that has been authorized as an agent on behalf of a contract manufacturer
may submit the section 510(j)(3) report. See Question and Answer IV.D for further information.
B.

What To Report

The section 510(j)(3) report should provide the amount of each listed drug, identified by the
National Drug Code (NDC), that was manufactured by each registered establishment during the
reported calendar year, organized by the amount of drug manufactured for commercial
distribution in each month. Having data organized by month facilitates the Agency’s ability to
review for trends (e.g., trends associated with hurricane or typhoon seasons, or seasonal drug
manufacturing campaigns), and assess whether such trends may be associated with drug supply
disruptions.
When reporting, registrants should first consider (1) when their drugs were manufactured,27 and
(2) whether they were manufactured for commercial distribution. When reporting the amount of
listed drugs, registrants should identify the drug by its NDC and the single business operation
that best describes the activities that the registrant performs at the establishment with respect to
such drug (see part III.B.4 below). In structuring the report, registrants should take into account
22

See § 20.61 (21 CFR 20.61).
See § 20.61.
24
5 U.S.C § 552(b)(4).
25
See section 510(j)(3)(A) of the FD&C Act.
26
See id. Additionally, as described in II. Background, reporting from contract manufacturers provides FDA with
information useful in FDA’s understanding of potential vulnerabilities for supply disruptions in registered drug
establishments.
27
See footnote 3.
23

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the type of drug and its packaging (see part III.B.5 below). Further, a report from a contract
manufacturer registrant should provide the amount of drug that the contract manufacturer
registrant themselves manufactured, rather than what other registrants further downstream in that
drug supply chain manufactured. Further details on reporting recommendations are below.
1. Determining When a Drug Is Manufactured
To determine which month a drug is manufactured, it is suggested that registrants (or their
authorized agents) use the month in which the drug is released. For the purposes of this
guidance, released means that the batch or lot has been determined to conform to final
specifications.28, 29
2. Manufactured for Commercial Distribution
Registrants are required to list with FDA each drug they manufacture for commercial
distribution.30 Under section 510(j)(3) of the FD&C Act, each registrant must report to FDA
annually on the amount of each such listed drug that it manufactured for commercial distribution.
The term “commercial distribution” is defined in 21 CFR 207.1 to mean “any distribution” of a
drug, subject to certain limited exceptions.31 The reference in this guidance to commercial
distribution is intended to capture the concept described in § 207.1.
For purposes of section 510(j)(3) reports by domestic registrants, the annual amount of each
listed drug manufactured for commercial distribution includes any amount manufactured for
commercial distribution within the U.S. and any amount manufactured for commercial
distribution outside the U.S. If all of the drug manufactured by the domestic establishment is
intended to be exported, that amount should be reported, unless it is being exported for
investigational use under 21 CFR part 312 or part 511, or if the exporting of the drug is an
interplant transfer as described in the definition of “commercial distribution” in § 207.1.

28

See 21 CFR 211.165 regarding testing and release for distribution; see also the FDA guidance for industry ICH
Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (ICH Q7 (September 2016),
section 11.2). In addition, the production and control records have been reviewed and approved by the quality
control unit (see 21 CFR 211.192; see also ICH Q7 section 6.7). We update guidances periodically. To make sure
you have the most recent version of a guidance, check the FDA Guidance web page at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents.
29
Additional information regarding how to report the amount of each listed drug under section 510(j)(3) is available
in FDA’s guidance for industry Reporting Amount of Listed Drugs and Biological Products Technical Conformance
Guide (February 2024).
30
Section 510(j)(1) of the FD&C Act; 21 C.F.R. 207.41(a).
31
Under § 207.1, commercial distribution “means any distribution of a human drug, except for investigational use
under [21 C.F.R part 312]…and any distribution of an animal drug or an animal feed bearing or containing an
animal drug, except for investigational use under [21 C.F.R. part 511]...The term does not include internal or
interplant transfer between registered establishments under common ownership and control, including a parent,
subsidiary, or affiliate company. For foreign establishments that manufacture, repack, relabel, or salvage, or for
foreign private label distributors, the term ‘commercial distribution’ has the same meaning except the term does not
include distribution of any drug that is neither imported nor offered for import into the United States”.

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For foreign establishments, the annual amount of each listed drug manufactured for commercial
distribution should be determined based on the amount that was manufactured for importation
(or to be offered for importation) into the U.S. This determination does not always solely rely on
whether the drug was actually imported into the U.S. For example, if a registrant manufactures
an amount of a drug based on compliance with multiple different countries’ standards (including
U.S. standards) and some or all of that amount of the drug will be available to be imported into
the U.S., then the foreign registrant should report the amount of that listed drug that will be
offered to be imported into the U.S., even if it is not ultimately distributed to the U.S. market.
The determination of commercial distribution also does not depend on whether the registrant is
manufacturing a drug that is in finished package form. Registrants of a listed drug32 (including
but not limited to API and contract manufacturers) that is not in finished package form are not
excluded from being considered engaged in manufacture of a drug for commercial distribution.33
Even if such registrants are unsure of which market(s) a drug may move into further down the
supply chain, registrants should still apply the above principles to their own activities and
information available to them to determine whether, and what amount, they are manufacturing
for commercial distribution.
3. National Drug Codes
The section 510(j)(3) report should provide the amount of each listed drug, identified by the
NDC, that was manufactured by each registered establishment during the reported calendar year,
organized by the amount of drug manufactured for commercial distribution in each month.
Reports from contract manufacturer registrants should provide the amount of drug that the
contract manufacturer registrant themselves manufactured, rather than the amount that other
registrants further downstream in the drug supply chain manufactured.
Registrants of human and animal drugs should report using the NDC assigned to the drug that
they manufactured, even if the drug they manufactured is not in finished package form.
Repackers and relabelers should also include in their reports the source NDC (i.e., the full threesegment NDC assigned to the drug received by the repacker/relabeler for repacking or
relabeling), if available.
For human drugs that are manufactured by a registrant for commercial distribution under the
trade name or label of a private label distributor, the drug must be listed under an NDC
associated with the registrant’s labeler code and listed under an NDC associated with the private

32

Drugs not required to be listed are not required to be included in a section 510(j)(3) report. For example, if the
same establishment manufactures both API and the finished dosage form that includes that API, and no remaining
portion of the API is commercially distributed, the API is not required to be listed. Because in this example the API
itself is not required to be listed, the API is not required to be included in a section 510(j)(3) report. See § 207.41
(“Who must list drugs and what drugs must they list?”) and § 207.1 (definition of commercial distribution).
33
See § 207.1 (the definition of “commercial distribution” does not exclude drug distribution by a registrant that is
not the last registrant in the drug supply chain).

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label distributor’s labeler code.34 Accordingly, the drug amounts should be reported separately
under each NDC.35
For animal drugs that are manufactured by a registrant for commercial distribution under the
trade name or label of a private label distributor, the drug must be listed only under an NDC
associated with the private label distributor’s labeler code.36 Accordingly, the data should be
organized by the NDC associated with the private label distributor’s labeler code. Registrants
manufacturing animal drugs who only perform early manufacturing steps and who are unaware
of the volume ultimately associated with each private label NDC should attempt to obtain that
information from their customers and report accordingly. If a registrant manufacturing an animal
drug is unable to obtain NDC-specific volume for each package size and type distributed of any
individual drug, they should allocate the known total volume for which it does not have NDCspecific volume information and divide equally across all applicable NDCs to provide an NDCspecific volume.37
While each registrant is ultimately responsible for ensuring that an accurate and timely report
under section 510(j)(3) is submitted, note that a person, including a private label distributor that
has been authorized as an agent on behalf of a registrant, may submit the section 510(j)(3) report.
See Question and Answer IV.D for further information.
4. Business Operations
Registrants should also identify in their section 510(j)(3) reports the business operation that best
describes the manufacturing activity performed at the establishment for the listed drug. This
business operation should generally match the business operation for that establishment that was
included in the drug listing. If the drug listing includes only a single business operation for that
establishment, the registrant should identify that business operation in its section 510(j)(3) report.
If the drug listing includes multiple business operations for that establishment, the registrant
should identify the single business operation from the drug listing that best describes the
activities performed at the registered establishment in that year for the listed drug.38 Note that if
the business operation from the drug listing file that best describes the activities performed for
34

§ 207.41(c)(1)-(2).
Additionally, we are requesting that this information be reported under both NDCs to facilitate the Agency’s
reconciliation of data. Reconciliation of data is important due to inconsistencies in drug listing data and section
510(j)(3) reports received by the Agency for drugs that are manufactured by a registrant for commercial distribution
under the trade name or label of a private label distributor.
36
§ 207.41(c)(1).
37
For example, an animal drug registrant releases 100 identical units in a reporting period and distributes 90 of those
units to 3 customers. Ten reportable units remain in inventory. Customer A receives 10 units and has a single
applicable NDC (NDC1), customer B receives 30 units and has two applicable NDCs (NDC2 and NDC3), and
customer C receives 50 units and has two applicable NDCs (NDC4 and NDC5). The registrant requests NDCspecific volume information from all three customers. Only customer B responds and tells the registrant customer
B’s volume was 30 units for NDC2. The registrant, taking into account the amount shipped to each customer and
the possible applicable NDCs for each customer should therefore report: 12 units NDC1, 32 units NDC2, 2 units
NDC3, 27 units NDC4, 27 units NDC5. (The 10 units remaining in inventory were divided among all 5 NDCs
equally, adding 2 to each.)
38
Additional information regarding the business operation to include in a section 510(j)(3) report is available in
FDA’s Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide.
35

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the listed drug, or the single business operation for the listed drug, for that establishment is
“pack” or “label,” then the registrant should, for the purposes of a section 510(j)(3) report,
identify “manufacture” as the single business operation that best describes the activities
performed for the listed drug.
5. Content of Report Based on Type of Drug and its Packaging
In structuring a section 510(j)(3) report, registrants should consider the type of drug39 and its
packaging. Below is a summary diagram, followed by the details of the recommended reporting
structures.

1

For the purposes of this guidance, drug product means a finished dosage form, for example, tablet, capsule,
solution, etc., that contains an active drug ingredient generally, but not necessarily, in association with inactive
ingredients (see 21 CFR 210.3(b)(4)).
2
For the purposes of this guidance, finished package form means a form suitable for distribution to pharmacies,
hospitals, or other dispensers or sellers of the drug product to patients or consumers.

39

For the purposes of this guidance, “type of drug” refers to the following categories: (i) drug that consists of API
alone; (ii) drug that consists of API with other ingredient(s) but that is not in finished dosage form; (iii) drug product
that is not in finished package form; and (iv) drug product that is in finished package form.

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a. Drug Products
Each registrant that lists a drug, including a drug that is a drug product, must annually report to
FDA the amount of such drug that it manufactured for commercial distribution.40 For the
purposes of this guidance, drug product means a finished dosage form, for example, tablet,
capsule, solution, etc., that contains an API, generally, but not necessarily, in association with
inactive ingredients.41 A drug product may, but not necessarily, be in finished package form.
For the purposes of this guidance, finished package form means a form suitable for distribution
to pharmacies, hospitals, or other dispensers or sellers of the drug product to patients or
consumers.
i. Drug Products in Finished Package Form
If the drug product is in finished package form and is listed with FDA as having a single level of
packaging, the amount reported should correspond only to the quantity of that package type
associated with the NDC assigned to the manufactured product. For example, if the NDC is for a
drug packaged in a bottle containing 500 film-coated tablets, the registrant should report the
number of bottles, not the number of tablets. Table 1 provides an illustration of the relationship
between the NDC, the package description, and the quantity reported for a drug product with a
single level of packaging.42
Table 1: Relationship Between the NDC, Package Description, and Quantity Reported for
Products with a Single Level of Packaging
NDC 

Package Description 

Quantity of Bottles  

00000‐000‐00 

500 TABLET, FILM 
COATED in 1 BOTTLE 

10,000 

Package Type 
Quantity To be 
Reported 
10,000 

If the drug product is in finished package form, and listed with FDA as having multiple levels of
packaging, and the product is not listed as a kit, then the product should be reported using the
NDC assigned to the outermost layer of packaging, and the amounts reported should correspond
to the package types associated with both the outermost layer of packaging and the innermost
layer of packaging. The outermost layer of packaging is the package type associated with the
NDC assigned to the manufactured drug. The innermost layer of packaging is the package type
directly enclosing the product. For example, a case (outermost layer of packaging) of 48 cartons,
each carton containing one bottle (innermost layer of packaging) of 30 tablets, should be
reported by the NDC assigned to the case, with the amounts reported using both the number of

40

See section 510(j)(3)(A) of the FD&C Act.
See 21 CFR 210.3(b)(4).
42
For information about how to submit the amount of each listed drug in a section 510(j)(3) report, refer to FDA’s
Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide.
41

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cases and the number of bottles.43 Table 2 provides an illustration of the relationship between
the NDC, the package description, and the quantity reported for a drug product with multiple
levels of packaging.44
Table 2: Relationship Between the NDC, Package Description, and Quantity Reported for
Products With Multiple Levels of Packaging
NDC 

11111-11111 

Package Description  Quantity  Quantity of  Outermost 
Innermost 
(Inclusive of all levels)  of Cases   Bottles  
Package  Package Type 
Type 
Quantity To 
Quantity 
be Reported 
To be 
Reported 
48 CARTONS in 1 CASE  20,000 
960,000 
20,000 
960,000 
(11111‐1111‐1); 1 
BOTTLE in 1 CARTON; 
30 TABLETS in 1 
BOTTLE 

If the product is listed as a kit,45 the amount reported should be based on the outermost layer of
packaging associated with the NDC assigned to the manufactured kit.
In some instances, a product that has been assigned an NDC (NDC #1) may be both
commercially distributed on its own and commercially distributed (and listed) as a part of a kit or
as an inner packaging layer for another product that is assigned a separate NDC (NDC #2).
Reports submitted under NDC #1 should only include amounts intended to be commercially
distributed on their own and should not include amounts of the product that are a part of the kit
or an inner packaging layer for the other product assigned NDC #2, as those would be accounted
for in the amount reported for NDC #2.

43

We are requesting that this information be reported at both of these packaging levels for multiple reasons. First,
having this information, combined with the information in the self-reported drug listing files, will help us validate
the data submitted and identify certain possible reporting errors. Second, having this volume information at multiple
reporting levels will increase the utility of the data. Although the Agency may have the capability to use some of
the data from the drug listing files to convert from one packaging level to the other, the Agency has identified
discrepancies between the package descriptions included in self-reported drug listing files and packaging
descriptions included in product labeling. These discrepancies could impact the validity of the data if the Agency
were to try to convert amounts from one packaging level to the other. Accordingly, the Agency currently believes
that, with respect to drug products listed as having multi-level packaging, reporting of drug amount information by
both the outermost layer of packaging and the innermost layer of packaging would ensure the data is provided in the
most useful way to the Agency.
44
For information about how to submit the amount of each listed drug in a section 510(j)(3) report, including drugs
in partially-filled packages, refer to FDA’s Reporting Amount of Listed Drugs and Biological Products Technical
Conformance Guide.
45
For purposes of this guidance, a kit is a co-packaged product that includes at least one or more drug items.

10

Contains Nonbinding Recommendations
For drug products that are in finished package form, registrants should not submit section
510(j)(3) reports to FDA based on the number of tablets, volume, or mass of the product.46
ii. Drug Products Not in Finished Package Form
If the drug is a drug product (as defined in part III.B.5.a) but is not in finished package form
(e.g., not in a package form suitable for distribution to pharmacies, hospitals, or other dispensers
or sellers of the drug product to patients or consumers), the amount reported should correspond
only to the dosage form associated with the NDC assigned to the manufactured product.47 For
example, if the NDC is for a drug packaged in a drum containing 50,000 film-coated tablets, the
registrant should report the number of tablets manufactured per drum (adjusting for any partiallyfilled drums, as appropriate). Table 3 provides an illustration of the relationship between the
NDC, the dosage form, and the quantity reported.48

46

Medical gas manufacturers should report to the Agency each year the number of units (e.g., cylinder, dewar, tank)
of each medical gas manufactured at each registered establishment. FDA recognizes that, during normal
manufacturing, storage, and filling operations for medical gases, venting may result in some product loss, and that
manufacturers reuse containers that may contain residual gas from previous use. Registrants that list a medical gas
need not, in preparing a report under section 510(j)(3), determine what amount has vented during normal operations
or what amount of manufactured gas consisted of residual gas from previous use.
Additionally, FDA recognizes that some designated medical gas manufacturers produce and distribute the same gas
for both medical and non-medical (e.g., industrial) purposes and may not be able to determine how much of the gas
will be used for medical purposes. Registrants that list a designated medical gas need not, in preparing a report
under section 510(j)(3), determine whether the gas will be ultimately used for a medical or non-medical purpose;
rather, they should report to the Agency each year the number of units of each designated medical gas manufactured
at each registered establishment, regardless of its ultimate use.
47
The amount reported should correspond only to the dosage form associated with the NDC assigned to the
manufactured product, regardless of whether the product is in single or multi-level packaging.
48
For information about how to submit the amount of each listed drug in a section 510(j)(3) report, refer to FDA’s
Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide.

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Contains Nonbinding Recommendations
Table 3: Relationship Between the NDC, Dosage Form, and Quantity Reported for
Products With a Single Level of Packaging
NDC 

Package 
Description 

Quantity of 
Drums  

22222‐222‐22 

50,000 TABLET, 
FILM COATED in 1 
DRUM 
50,000 TABLET, 
FILM COATED in 1 
DRUM 

25 

33333‐333‐33 

b.

25 

Dosage Form 
Quantity of 
Drug Product  Type Quantity To 
per Drum 
be Reported 
50,000 tablets 
1,250,000 
in each drum 
50,000 tablets 
in 23 drums  

25,245 tablets 
in 1 drum 

24,942 tablets 
in 1 drum 

1,200,187 

Drugs That Are Not Drug Products

Each registrant that lists a drug, including a drug that is not a drug product, must report to FDA
annually the amount of such drug that it manufactured for commercial distribution.49 Drugs that
are not drug products include:
 Drugs that consist of API alone; and
 Drugs that consist of API with other ingredient(s) but that are not in finished dosage
form.
For the purposes of this guidance, active pharmaceutical ingredient (API) means any substance
that is intended for incorporation into a finished drug product and is intended to furnish
pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or
prevention of disease, or to affect the structure or any function of the body.50
If the drug is not a drug product (as defined in part III.B.5.a), the amount should be reported in
terms of the mass or volume of the contents of the drug container, using the appropriate unit as
reported in the drug listing (e.g., kilograms, liters).51

49

See section 510(j)(3)(A) of the FD&C Act.
API does not include intermediates used in the synthesis of the substance (§ 207.1). Additionally, for the
purposes of this guidance, API includes drug substance as defined by FDA’s guidance for industry: Q6B,
Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products (ICH Q6B)
(August 1999).
51
The amount reported should correspond only to the mass or volume of the listed drug within the container,
regardless of whether the product is in single or multi-level packaging.
50

12

Contains Nonbinding Recommendations
For drugs that are formulated by activity (e.g., heparin), API registrants should also provide the
activity. API amounts are typically measured by mass or volume. However, for certain APIs
such as hormones or antibiotics, dosing may be expressed in terms of biological effect or
activity. The biological effect of a drug may be expressed in Units (U) or International Units
(IU), which are standard units that define the amount of API that causes a certain biological
effect. The volume or mass of API that corresponds to one unit may vary from drug to drug and
from batch to batch. Therefore, it is recommended that registrants of drugs formulated by
activity report how a unit is defined in terms of biological effect and how it corresponds to a
mass or volume.52
C.

Timing of Reports

Reports on the amount of each registrant’s listed drugs must be submitted annually.53 Such
reports should include information regarding the amount of drug manufactured54 for the
respective calendar year (January 1 – December 31).
Reports for calendar year 2023 should be submitted no later than July 31, 2024. Reports for
subsequent calendar years should be submitted no later than March 31 of the following calendar
year. For instance, registrants that manufactured listed drugs for commercial distribution at any
time in calendar year 2024 should submit reports to FDA reporting the drug amounts for
calendar year 2024 no later than March 31, 2025.55
Reports for calendar years 2020, 2021, and 2022 that have yet to be submitted as of the date of
issuance of this final guidance are still required under the statute and should be submitted to the
Agency as soon as possible.56 The Agency uses historical data from prior year reports under
FD&C Act section 510(j)(3) to better understand the patterns that preceded specific supply chain
issues, such as shifts in manufacturing for products involved, alongside changes in other
potential risk factors such as market and product characteristics.
D.

Process for Report Submission

Registrants should submit reports via the NextGen Portal, available at edm.fda.gov.57 Additional
information regarding technical specifications for submissions is available on FDA’s website.58
52

Additional information regarding the activity information to include in a section 510(j)(3) report is available in
FDA’s Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide.
53
Section 510(j)(3)(A) of the FD&C Act.
54
See part III.B.1.
55
In addition to annual reporting requirements, FDA is authorized under section 510(j)(3)(A) of the FD&C Act to
require registrants to submit reports on the amount of listed drugs manufactured for commercial distribution at the
time a public health emergency is declared by the Secretary under section 319 of the Public Health Service Act.
Report submissions related to a public health emergency under section 510(j)(3)(A) of the FD&C Act do not satisfy
the requirement to submit a separate annual report under such section.
56
The effective date of section 510(j)(3) of the FD&C Act, as added by section 3112(e) of the CARES Act, was
September 23, 2020.
57
Under section 510(j)(3)(A) of the FD&C Act, FDA is authorized to require submission of section 510(j)(3) reports
in an electronic format as determined by the Agency. Use of the NextGen Portal facilitates accurate submission of
report data.
58
See FDA’s Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide.

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Contains Nonbinding Recommendations
Technical questions regarding the submission process should be sent to
EDMSupport@fda.hhs.gov (For questions regarding the content to be submitted in a section
510(j)(3) report, please contact (CDER) DrugAmountReporting@fda.hhs.gov, (CBER) Office of
Communication, Outreach and Development, 800-835-4709 or 240-402-8010, or (CVM) Office
of Surveillance and Compliance, 240-402-7002 or AskOSC@fda.hhs.gov, as applicable).
IV.

QUESTIONS AND ANSWERS
A.

What type of drug reporting is the subject of this guidance?
This guidance describes the process that registrants should use for annually
reporting the amount of each listed drug that was manufactured, prepared,
propagated, compounded, or processed for commercial distribution. Under
section 510(j)(3) of the FD&C Act, such information must be reported by each
person who registers with FDA under section 510 of the FD&C Act with regard to
a listed drug (including a drug product in finished package form, a drug product
not in finished package form, an API, and other listed drugs, except for biological
products or categories thereof exempted by an order under section 510(j)(3)(B)).59
Listed drugs subject to reporting include human drug products (including nonexempt biological products) marketed under an approved application, animal drug
products marketed under an approved application, medical gases, homeopathic
products, products marketed in accordance with requirements under section 505G
of the FD&C Act (21 U.S.C. 355h),60 often referred to as over-the-counter
monograph drugs, and animal drug products that are not approved, conditionally
approved, or indexed under sections 512, 571, and 572 of the FD&C Act.

B.

If an applicant submits a report containing distribution data under 21 CFR
314.81(b)(2)(ii)(a) or 21 CFR 600.81(a) for human drugs or biological
products, respectively, does the registrant of an establishment(s) identified in
the application also need to annually submit a separate report under section
510(j)(3) of the FD&C Act containing the amount of the listed drug that was
manufactured, prepared, propagated, compounded, or processed at the
establishment for commercial distribution?
In this situation, a registrant61 of a listed drug still must submit a report as
required under section 510(j)(3) of the FD&C Act.62 FDA acknowledges that

59

See footnote 4 and Question & Answer IV.J.
Under section 505G of the FD&C Act, certain nonprescription drug products may be lawfully marketed without
an approved application under section 505 of the FD&C Act if applicable requirements are met. Other listed
unapproved drugs are also subject to reporting under section 510(j)(3) of the FD&C Act.
61
Registrant means any person that owns or operates an establishment that manufactures, repacks, relabels, or
salvages a drug, and is not otherwise exempt from establishment registration requirements under section 510 of the
FD&C Act or 21 CFR part 207. See § 207.1.
62
See section 510(j)(3)(A) of the FD&C Act.
60

14

Contains Nonbinding Recommendations
applicants with approved applications63 provide to FDA certain drug product
distribution data in reports under § 314.81 (21 CFR 314.81) and § 600.81 (21
CFR 600.81); however, such data is aggregated and reflects the total amount
distributed by an applicant, and does not include reporting specific to each
establishment for the listed drug. If an application includes multiple
establishments, the information reported under § 314.81 and § 600.81 would not
be specific to each establishment, which can introduce challenges for the Agency
in accessing information that could be used to make drug facility surveillance
decisions and for assessing or mitigating drug shortages. In contrast, reports
submitted under section 510(j)(3) of the FD&C Act should be submitted for each
establishment. Additionally, reports that the Agency receives under §
314.81(b)(2)(ii)(a) and § 600.81(a) are limited to the finished drug product and do
not include information about the API, drug substance, or unfinished drug
product. Moreover, these reports arrive at the Agency at different times
throughout the year and cover different time periods, which makes it challenging
for the Agency to assess data received across different approved applications. In
contrast, under FDA’s recommendations for reports submitted under section
510(j)(3) of the FD&C Act, the data from all applicable registrants should arrive
at the Agency during the same timeframe and cover the previous calendar year
(see section III.B). This will enhance the Agency’s ability to combine the data
across establishments and drugs to provide a more comprehensive picture of the
drug supply chain during a specific time period.
FDA does not intend to take action against an applicant regarding the requirement
to submit distribution data in annual reports64,65 submitted under
§314.81(b)(2)(ii)(a), if:
(1) Each registrant of establishments identified in the application submits a timely
and complete report under section 510(j)(3) of the FD&C Act;

63

For the purposes of this Question & Answer IV.B, applicant includes (i) any person who submits a new drug
application (NDA) under section 505(b) of the FD&C Act, abbreviated new drug application (ANDA) under section
505(j) of the FD&C Act, or a biologics license application (BLA) under section 351 of the PHS Act (or an
amendment or supplement to any such NDA, ANDA, or BLA), and (ii) any person who owns an approved NDA,
ANDA, or BLA. See 21 CFR 314.3, 21 CFR 601.2(a).
64
For the purposes of this enforcement policy, the § 314.81(b)(2) annual report would be submitted no later than 1
year after the submission of the section 510(j)(3) report(s) by each registrant of establishments identified in the
application. To the extent that the reporting periods for the § 314.81(b)(2) annual report and the section 510(j)(3)
report are not aligned, 510(j)(3) report data covering the reporting period of a single § 314.81(b)(2) annual report
may be submitted over the course of two consecutive section 510(j)(3) reports. For instance, if the reporting period
for a § 314.81(b)(2) annual report is July – June, the corresponding section 510(j)(3) report data would include JulyDecember of one calendar year and January-June of the following calendar year.
65
Additionally, annual reports submitted under § 314.81(b)(2) are required to provide as applicable, among other
information, a brief summary of significant new information from the previous year that might affect the safety,
effectiveness, or labeling of the drug product; labeling information; chemistry, manufacturing, and control change
information, nonclinical laboratory studies, clinical data; and status reports of postmarketing study commitments.

15

Contains Nonbinding Recommendations
(2) Each registrant of establishments identified in the application adds to its
section 510(j)(3) report the amount of listed drug product (organized by NDC
number) that was distributed for foreign use during the reporting period;66 and
(3) The applicant’s annual report submitted under § 314.81(b)(2) provides:
 The NDC number(s) and strength(s) of drug product for which each
registrant submitted or will submit its report(s) under section 510(j)(3)
of the FD&C Act;67 and
 The date(s) of the report(s) submitted under section 510(j)(3) of the
FD&C Act.
FDA believes that this enforcement policy would maintain the Agency’s access to
information that would be useful in making drug surveillance decisions, would
enhance the Agency’s ability to reduce drug shortage risks, and would also
address the potential reporting burden for applicants that are subject to both §
314.81(b)(2)(ii)(a) and section 510(j)(3) of the FD&C Act.68
C.

If an applicant submits a report containing distribution data for animal
drugs under 21 CFR 514.80(b)(4)(i), and/or 21 CFR 514.87(b)(4)-(5), does the
registrant of an establishment(s) in the application also need to submit a
separate report under section 510(j)(3) of the FD&C Act containing the
amount of the listed drug that was manufactured, prepared, propagated,
compounded, or processed at the establishment for commercial distribution?
Yes, a registrant of a listed animal drug must submit a separate report under
section 510(j)(3) of the FD&C Act containing the amount of the listed drug that
was manufactured, prepared, propagated, compounded, or processed by such
person for commercial distribution. This is in addition to the reporting
requirements of applicants69 under § 514.80(b)(4)(i) (21 CFR 514.80(b)(4)(i)) and
§ 514.87(b)(4)-(5) (21 CFR 514.87(b)(4)-(5)).70

66

§ 314.81(b)(2)(ii)(a) requires applicants to provide to the Agency information about the quantities of drug product
distributed for foreign use.
67
See also footnote 64.
68
The Agency does not intend to extend this enforcement policy to the submission of distribution reports under §
600.81. Distribution reports submitted under § 600.81 contain certain information relating to the quantity of
biological product distributed by the applicant by lot, which is not required for reports submitted under section
510(j)(3) of the FD&C Act. For example, distribution reports submitted under § 600.81 include the fill lot numbers
for the total number of dosage units of each strength or potency distributed, the label lot number (if different from
fill lot number), the number of doses in fill lot/label lot, and the date of release of fill lot/label lot for distribution.
See § 600.81(a). Additionally, distribution reports under § 600.81 are generally submitted once every 6 months,
while reports under section 510(j)(3) of the FD&C Act are submitted annually.
69
For the purposes of this Question & Answer IV.C, applicant is a person or entity who owns or holds on behalf of
the owner the approval for a new animal drug application (NADA) or an abbreviated new animal drug application
(ANADA), and is responsible for compliance with the applicable provisions of the FD&C Act and regulations. See
21 CFR 514.3.
70
The Agency does not intend to extend a policy similar to that described for § 314.81(b)(2)(ii)(a) (see Question &
Answer IV.B), with respect to reports containing distribution data submitted under § 514.80(b)(4)(i) or §
514.87(b)(4)-(5). In contrast to annual reports submitted under § 314.81, distribution reports submitted under §
514.80(b)(4)(i) are generally submitted once every 6 months for the first 2 years following approval of an NADA or

16

Contains Nonbinding Recommendations

FDA understands that applicants provide to FDA certain distribution data in
reports under § 514.80(b)(4)(i) and § 514.87(b)(4)-(5); however, such data is
limited to the applicants, and it does not include reporting specific to each
establishment of the listed drug. If an application includes multiple
establishments, the information reported under § 514.80(b)(4)(i) and §
514.87(b)(4)-(5) would not be specific to each establishment, which can introduce
challenges for the Agency in accessing information that could be used to make
drug facility surveillance decisions and assessing and mitigating drug shortages.
In contrast, for reports submitted under section 510(j)(3) of the FD&C Act,
reports should be submitted for each establishment, which would enhance the
Agency’s access to information used to make drug surveillance decisions, as well
as the Agency’s ability to assess and mitigate possible drug shortages.71
D.

Can an authorized agent of a registrant submit a report under section
510(j)(3) of the FD&C Act on behalf of a registrant (including a contract
manufacturer registrant)?
An agent that has knowledge regarding the amount of drug manufactured for
commercial distribution and who has been authorized by the registrant to submit
the registrant’s report under section 510(j)(3) of the FD&C Act may submit such
a report on the registrant’s behalf to the Agency. Accordingly, a private label
distributor with knowledge of the amount of drug released and who has been
authorized as an agent72 to submit a report under section 510(j)(3) on the
registrant’s behalf may do so. Additionally, an application holder (e.g., holder of
an NDA, ANDA, BLA, NADA, or ANADA) that has been authorized as an agent
on behalf of a contract manufacturer (registrant) to submit a report under section
510(j)(3) on the contract manufacturer’s behalf may do so.73 However, each
registrant is ultimately responsible for ensuring that an accurate and timely report
under section 510(j)(3) is submitted on its behalf.

ANADA. Further, FDA is required to publish annual summary reports of data and information it receives under §
514.87, and these published reports are required to include a summary of distribution data received under § 514.87.
See § 514.87(f); see also section 512(l)(3)(E) of the FD&C Act.).
71
Additionally, reports that the Agency receives under § 514.80(b)(4)(i) and § 514.87(b)(4)-(5) are limited to the
finished drug product and do not include information about the API or unfinished drug product. Moreover, these
reports arrive at the Agency from numerous applicants at different times throughout the year, which makes it
challenging for the Agency to assess, and mitigate drug shortages at any particular point in time. In contrast, under
FDA’s recommendations for reports submitted under section 510(j)(3) of the FD&C Act, the data from all
applicable registrants would arrive at the Agency during the same time frame, which would enhance the Agency’s
ability to assess and mitigate possible drug shortages.
72
The reference in this guidance to authorized agent is intended to capture the concept described in § 207.17(b) with
respect to an authorized agent. Note that the authorized agent for the purposes of submitting a registrant’s report
under section 510(j)(3) of the FD&C Act need not be the same agent that is authorized to submit information to
FDA that is outside the scope of a section 510(j)(3) report. For example, the agent that is authorized to submit a
section 510(j)(3) report does not necessarily have to be the same agent that submitted registration information on
behalf of a registrant.
73
Contract facilities should consider outlining the reporting arrangements in a written quality agreement or other
written contract.

17

Contains Nonbinding Recommendations

E.

Should the registrant report the amount of listed drug manufactured based
on theoretical yield?
Registrants should report the actual amount of drug that is manufactured during
the reporting period (This value would equate to the actual yield, if calculated).
Percent yield is the percent ratio of actual yield to theoretical or predicted yield
and can only be 100% if there are no losses or errors during actual production.
Registrants should not report the amount of listed drug available for commercial
distribution based on a theoretical assumption of 100% yield.

F.

In determining the amount of drug to report in a section 510(j)(3) report,
should a registrant include amounts of drug that were returned and/or
recalled?
Registrants are required to report “on the amount” of listed drugs manufactured,
prepared, propagated, compounded, or processed for commercial distribution.74
There is no exemption for drugs that have been returned or recalled. For that
reason, the report must not subtract amounts that have been returned75 or
recalled.76

G.

If a registrant manufactured, prepared, propagated, compounded, or
processed an applicable drug for commercial distribution during only part of
the calendar year, does the registrant still need to submit an annual drug
amount report under section 510(j)(3) of the FD&C Act?
Yes, the registrant should submit a report to FDA no later than the recommended
date each year (see section III.C). The registrant is responsible for reporting
annually the amount of listed drug that was manufactured by the registrant for
commercial distribution.
If there is an ownership change with respect to a registered establishment during
the reporting period, the new owner should ensure the submission of data for the
entire reporting period.

H.

If a registrant had a drug listed with FDA during the calendar year, but did
not ultimately manufacture, prepare, propagate, compound, or process any
of the drug for commercial distribution during that calendar year, does the
registrant need to submit a report under section 510(j)(3) of the FD&C Act?
Registrants are required to report “on the amount” of listed drugs manufactured,
prepared, propagated, compounded, or processed for commercial distribution.77 If

74

Section 510(j)(3)(A) of the FD&C Act.
See 21 CFR 211.204.
76
See 21 CFR part 7, subpart C.
77
See section 510(j)(3)(A) of the FD&C Act.
75

18

Contains Nonbinding Recommendations
such amount for an individual registrant is zero, the registrant still must submit a
report under section 510(j)(3) of the FD&C Act. The drug listing data submitted
to FDA must also be updated accordingly.78
I.

What amount should a registrant of a foreign establishment report if some,
but not all, of the listed drug it manufactures is imported or offered for
import into the United States?
In the case of a listed drug manufactured, prepared, propagated, compounded, or
processed in a foreign establishment for commercial distribution and the registrant
of the foreign establishment knows how much of the listed drug was imported or
offered for import into the United States, then the registrant should report that
amount. However, if the registrant does not know how much of the listed drug
was imported or offered for import into the United States, then the registrant
should report the total amount of the listed drug that it manufactured, prepared,
propagated, compounded, or processed (including repacked or relabeled) during
the reporting period.79

J.

Should a registrant of a listed biological product submit a section 510(j)(3)
report to FDA, if the biological product falls within a category of biological
products identified in FDA’s order as exempt from section 510(j)(3)(A)
reporting requirements?
Under section 510(j)(3)(B) of the FD&C Act, FDA may issue an order to exempt
certain biological products or categories of biological products regulated under
section 351 of the Public Health Service Act from some or all of the reporting
requirements under section 510(j)(3)(A) of the FD&C Act, if FDA determines
that applying such reporting requirements is not necessary to protect the public
health. FDA has issued an order that exempts from section 510(j)(3)(A) reporting
requirements the following categories of biological products: (i) blood and blood
components for transfusion; and (ii) cell and gene therapy products, where one lot
treats a single patient.80 Therefore, registrants of such biological products need
not submit section 510(j)(3) reports to FDA for these products.

78

See 21 CFR 207.57(b)(1).
The amount reported should be for drugs that comply with applicable U.S. standards (e.g., the approved
application, final order issued under section 505G of the FD&C Act). Even in instances where the registrant of a
foreign facility does not know how much of the listed drug was imported or offered for import into the U.S., the
reported data still will be of value to the Agency in carrying out its public health mission (see part II, supra). In
such instances, the Agency will interpret these amounts as an upper estimate of how much was intended for the U.S.
market.
80
See 88 FR 22454 (Apr. 13, 2023). Such cell and gene therapy products, where one lot treats a single patient, are a
subset of all cell and gene therapy products.
79

19

Contains Nonbinding Recommendations
K.

Should a registrant of a listed drug submit a section 510(j)(3) report to FDA,
if the registrant’s only business operation in the drug listing file is “sterilize,”
“analysis,” “particle size reduction,” and/or “salvage”?
FDA does not intend to take action if registrants whose only business operation in
the drug listing file is “sterilize,” “analysis,” “particle size reduction,” and/or
“salvage” do not submit reports under section 510(j)(3) of the FD&C Act. FDA
believes the data reported by other registrants (e.g., registrants with business
operations of manufacture, repack, or relabel in the drug listing file) will be
sufficient.

20