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.    
  1  Contains Nonbinding Recommendations 
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, FDAs guidance documents do not establish legally enforceable responsibilities.  
Instead, guidances describe the Agencys 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 FDAs 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.  
  2  Contains Nonbinding Recommendations 
among other things, improving FDAs 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 Agencys 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 FDAs response to drug shortages, section 510(j)(3) of the FD&C Act 
also facilitates FDAs 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 FDAs quality surveillance oversight and risk-based approach to 
surveillance actions.  Because drug amount data assist in the Agencys 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.  
  3  Contains Nonbinding Recommendations 
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 ones 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 FDAs 
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 Agencys 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).  
23  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 FDAs understanding  of potential vulnerabilities for supply  disruptions in registered  drug  
establishments. 
27  See footnote 3. 
  4  Contains Nonbinding Recommendations 
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 FDAs 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.  
  5  Contains Nonbinding Recommendations 
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 three-
segment 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 registrants 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).  
  6  Contains Nonbinding Recommendations 
label distributors 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 distributors labeler code.36  Accordingly, the data should be 
organized by the NDC associated with the private label distributors 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 NDC-
specific volume information and divide equally across all applicable NDCs to provide an NDC-
specific 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). 
35 Additionally, we are requesting that this information be reported under both  NDCs to facilitate the Agencys 
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 NDC-
specific volume information from all three customers.   Only customer B responds and tells the registrant customer  
Bs 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  
FDAs  Reporting Amount of  Listed Drugs and Biological  Products Technical Conformance Guide. 
  7  Contains Nonbinding Recommendations 
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.  
  8  Contains Nonbinding Recommendations 
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    Package  Type  
Quantity  To  be  
Reported  
0000000000   500  TABLET,  FILM   10,000   10,000  
COATED  in  1  BOTTLE  
 
 
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.   
41 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 FDAs  
Reporting  Amount of  Listed Drugs and Biological  Products Technical  Conformance Guide. 
  9  Contains Nonbinding Recommendations 
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   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  
11111-1111- 48  CARTONS  in  1  CASE   20,000   960,000   20,000   960,000  
1   (1111111111);  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 FDAs 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 partially-
filled 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 FDAs  
Reporting  Amount of  Listed Drugs and Biological  Products Technical  Conformance Guide. 
  11   Contains Nonbinding Recommendations 
Table 3: Relationship Between the NDC, Dosage Form, and Quantity Reported for 
Products With a Single Level of Packaging 
 
NDC   Package   Quantity  of   Quantity  of   Dosage  Form  
Description   Drums    Drug  Product   Type  Quantity  To  
per  Drum   be  Reported  
2222222222   50,000  TABLET,   25   50,000  tablets   1,250,000  
FILM  COATED  in  1   in  each  drum  
DRUM  
3333333333   50,000  TABLET,   25   50,000  tablets   1,200,187  
FILM  COATED  in  1   in  23  drums   
DRUM    
25,245  tablets  
in  1  drum  
 
24,942  tablets  
in  1  drum  
 
 
b.   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.   
50 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 FDAs 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.  
  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 registrants 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 FDAs website.58   
 
52 Additional information regarding the activity information to include in a section  510(j)(3) report is available in  
FDAs  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 FDAs  Reporting Amount of Listed Drugs and Biological Products  Technical Conformance Guide. 
  13   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 non-
exempt 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. 
60 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. 
  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 FDAs 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 Agencys 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 July-
December 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 applicants 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 Agencys access to 
information that would be useful in making drug surveillance decisions, would 
enhance the Agencys 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 
Agencys access to information used to make drug surveillance decisions, as well 
as the Agencys 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 registrants report under section 510(j)(3) of the FD&C Act may submit such 
a report on the registrants 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 
registrants 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 manufacturers 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 
FDAs 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 Agencys  
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 registrants 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. 
75 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.  
  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 FDAs 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). 
79 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.   
  19   Contains Nonbinding Recommendations 
K.   Should a registrant of a listed drug submit a section 510(j)(3) report to FDA, 
if the registrants 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