Reporting Amount of Listed 

Drugs and Biological 

Products Under Section

510(j)(3) of the FD&C Act

Guidance for Industry

DRAFT GUIDANCE

This guidance document is being distributed for comment purposes only.

Comments and suggestions regarding this draft document should be submitted within 60 days of 

publication in the Federal Register of the notice announcing the availability of the draft 

guidance. Submit electronic comments to https://www.regulations.gov. Submit written 

comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 

Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the 

docket number listed in the notice of availability that publishes in the Federal Register.

For questions regarding this draft document, contact (CDER) 

DrugVolumeReporting@fda.hhs.gov, (CBER) Office of Communication, Outreach and 

Development, 800-835-4709 or 240-402-8010, or (CVM) Office of Surveillance and 

Compliance, 240-402-7082 or CVMSurveillance@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)

October 2021

Procedural
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)

October 2021

Procedural
Contains Nonbinding Recommendations

Draft — Not for Implementation

TABLE OF CONTENTS

I. INTRODUCTION............................................................................................................. 1

II. BACKGROUND ............................................................................................................... 2

III. DISCUSSION.................................................................................................................... 3

A. Content of Reports.........................................................................................................................3

B. Timing of Reports..........................................................................................................................7

C. Process for Report Submission.....................................................................................................7

IV. QUESTIONS AND ANSWERS....................................................................................... 8
Contains Nonbinding Recommendations

Draft — Not for Implementation

1

1 Reporting Amount of Listed Drugs and Biological Products Under

2 Section 510(j)(3) of the FD&C Act

Guidance for Industry1 3

4

5

6 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 

7 Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not 

8 binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the 

9 applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible 

10 for this guidance as listed on the title page. 

11

12

13

14

15 I. INTRODUCTION 

16

17 The Food and Drug Administration (FDA) is issuing this draft guidance to assist registrants of 

18 drug establishments in submitting to FDA reports on the amount of each listed drug 

19 manufactured, prepared, propagated, compounded, or processed for commercial distribution, as 

20 required by section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 

21 U.S.C. 360(j)(3)), as added by section 3112(e) of the Coronavirus Aid, Relief, and Economic 

22 Security Act (CARES Act). 

23

24 This guidance describes the process that should be used for reporting such information by each 

25 person who registers with FDA under section 510 of the FD&C Act with regard to a listed drug

26 (including a finished dosage form product, an active pharmaceutical ingredient (API), and other 

27 types of listed drugs, except for biological products or categories thereof exempted by an order 

under section 510(j)(3)(B)).

2 28 The process described in this guidance applies to such reporting 

with respect to listed drugs including medical gases,3 29 homeopathic products, products marketed 

in accordance with requirements under section 505G of the FD&C Act (21 U.S.C. 355h),

4 30 often 

31 referred to as over-the-counter monograph drugs, and animal drug products that are not 

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 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 a Proposed Order that, if 

finalized, would exempt 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 86 FR 59395 (October 27, 2021). See also Question & Answer IV.J. 3 For purposes of this guidance, “medical gas” and “designated medical gas” have the meanings set forth in section 

575 of the FD&C Act. 

4 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. 
Contains Nonbinding Recommendations

Draft — Not for Implementation

2

32 approved, conditionally approved, or indexed under sections 512, 571, and 572 of the FD&C 

33 Act.

34

35 The contents of this document do not have the force and effect of law and are not meant to bind 

36 the public in any way, unless specifically incorporated into a contract. This document is 

37 intended only to provide clarity to the public regarding existing requirements under the law. 

38 FDA guidance documents, including this guidance, should be viewed only as recommendations, 

39 unless specific regulatory or statutory requirements are cited. The use of the word should in 

40 Agency guidances means that something is suggested or recommended, but not required.

41

42

43 II. BACKGROUND

44

45 An establishment engaged in the manufacture, preparation, propagation, compounding, or 

processing of a drug in the United States is required to be registered with the FDA.5 46 Likewise, 

47 any establishment within a foreign country engaged in the manufacture, preparation,

48 propagation, compounding, or processing of a drug that is imported or offered for import into the 

United States is also required to be registered with the FDA.6 49 Further, domestic and foreign 

50 registrants are required to list with FDA all the drugs being manufactured, prepared, propagated, 

compounded, or processed by their registered establishments for commercial distribution.

7 51 Each 

registrant must provide certain information8 52 for each listed drug it manufactures for commercial 

distribution,9 including unfinished drugs10 53 and APIs. This information helps the FDA maintain a 

54 catalog of all drugs in commercial distribution in the United States.

55

On March 27, 2020, the CARES Act11 56 was enacted to aid response efforts and ease the economic 

57 impact of the Coronavirus Disease 2019 (COVID-19). In addition, the CARES Act included

58 authorities to enhance FDA’s ability to identify, prevent, and mitigate possible drug shortages 

59 by, among other things, improving FDA’s visibility into drug supply chains. Section 3112(e) of 

60 the CARES Act added new section 510(j)(3) of the FD&C Act, which requires that each person

61 (including repackers and relabelers) who registers with FDA under section 510 of the FD&C Act 

62 with regard to a drug must report to FDA annually on the amount of each listed drug that was 

63 manufactured, prepared, propagated, compounded, or processed by such person for commercial 

64 distribution. 

65

66

5 Section 510(b) of the FD&C Act; § 207.17 (21 CFR 207.17).

6 Section 510(i) of the FD&C Act; § 207.17.

7 Section 510(j)(1) of the FD&C Act; 21 CFR 207.41. Manufacturers, repackers, relabelers or salvagers of Type B 

or Type C mediated feed are exempt from drug listing (section 510(g)(5) of the FD&C Act; 21 CFR 207.13(g)). 8 Section 510(j) of the FD&C Act; 21 CFR 207.49(a) (e.g., § 207.49(a)(4); § 207.49(a)(8)). 9 See 21 CFR 207.1 (21 CFR 207.1) (defining “manufacture” and “commercial distribution”).

10 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). 11 Public Law 116-136.
Contains Nonbinding Recommendations

Draft — Not for Implementation

3

67 III. DISCUSSION 

68

69 A. Content of Reports

70

71 Each registrant that lists a drug must report to FDA annually on the amount of such drug that it 

72 manufactured, prepared, propagated, compounded, or processed (including repacking and 

relabeling12) for commercial distribution.13 73 

74

75 The report should provide the amount of each listed drug, identified by National Drug Code

76 (NDC), that was released by each registered establishment during the reported year, organized by 

the amount of drug released in each month.

14 77 Repackers and relabelers should also include in 

78 their reports the source NDC (i.e., the full three-segment NDC assigned to the drug received by 

79 the repacker/relabeler for repacking or relabeling), if available. 

80

81 Registrants should also report the single business operation that is most relevant to the overall 

business operations performed for the listed drug at the registered establishment in that year.

15 82 

83 The business operation information provided in the section 510(j)(3) report may be different 

84 from the business operation(s) included in the drug listing because the drug listing file may 

85 identify multiple business operations, whereas the 510(j)(3) report should identify a single 

86 business operation. 

87

88 1. Finished Dosage Form Products

89

90 For the purposes of this guidance, a finished dosage form product is a drug that is in finished 

91 dosage form (e.g., finished tablet, capsule, or solution), whether or not it is in a package form 

92 suitable for distribution to pharmacies, hospitals, or other sellers or dispensers of the drug 

93 product to patients or consumers. 

94

95 Each registrant that lists a finished dosage form product must report to FDA annually the amount 

96 of such drug that it manufactured, prepared, propagated, compounded, or processed (including 

repacking and relabeling16) for commercial distribution.

17 97

98

12 See section 510(a)(1) of the FD&C Act. 13 See section 510(j)(3)(A) of the FD&C Act. 14 For the purposes of this guidance, “released” means that the batch or lot has been determined to conform to final 

specifications (see 21 CFR 211.165; FDA guidance for industry ICH Q7 Good Manufacturing Practice Guidance 

for Active Pharmaceutical Ingredients (ICH Q7) (September 2016), section 11.2), and the production and control 

records have been reviewed and approved by the quality control unit (see 21 CFR 211.192; ICH Q7 section 6.7). 

Additional information regarding how to report the amount of each listed drug under section 510(j)(3) is available in 

FDA’s Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide. We update

guidances periodically. To make sure you have the most recent version of a guidance, check the FDA Drugs 

guidance web page at https://www.fda.gov/regulatory-information/search-fda-guidance-documents. 15 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. 16 See section 510(a)(1) of the FD&C Act; also see definition of “manufacture” at § 207.1 (i.e., “the term 

‘manufacture, preparation, propagation, compounding, or processing,’ as used in section 510 of the Federal Food, 

Drug, and Cosmetic Act, includes relabeling, repackaging, and salvaging”). 17 See section 510(j)(3)(A) of the FD&C Act. 
Contains Nonbinding Recommendations

Draft — Not for Implementation

4

99 If the product is listed with FDA as having a single level of packaging, the amount reported 

100 should correspond only to the quantity of that package type associated with the NDC assigned to 

101 the product released. For example, if the NDC is for a drug packaged in a bottle containing 500

102 film-coated tablets, the registrant should report the number of bottles released, not the number of 

103 tablets. Table 1 provides an illustration of the relationship between the NDC, the package 

description, and the quantity reported.18 104

105

106 Table 1: Relationship Between the NDC, Package Description, and Quantity Reported for 

107 Products with a Single Level of Packaging

108

NDC Package Description Quantity of Bottles 

Released 

Package Type 

Quantity To be 

Reported

00000-000-00 500 TABLET, FILM 

COATED in 1 BOTTLE

10,000 10,000

109

110

111 If the product is listed with FDA as having multiple levels of packaging and the product is not

112 listed as a kit, then the product should be reported using the NDC assigned to the outermost layer 

113 of packaging, and the amounts reported should correspond to the package types associated with

114 both the outermost layer of packaging and the innermost layer of packaging. The outermost 

115 layer of packaging is the package type associated with the NDC assigned to the drug released. 

116 The innermost layer of packaging is the package type directly enclosing the product. For 

117 example, a case (outermost layer of packaging) of 48 cartons, each carton containing one bottle

118 (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 cases and the number of bottles released.

19 119 

120 Table 2 provides an illustration of the relationship between the NDC, the package description, 

and the quantity reported.20 121

122

18 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. 19 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. 

20 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.
Contains Nonbinding Recommendations

Draft — Not for Implementation

5

123 Table 2: Relationship Between the NDC, Package Description, and Quantity Reported for 

124 Products with Multiple Levels of Packaging

125

NDC Package Description 

(Inclusive of all levels)

Quantity 

of Cases 

Released 

Quantity of 

Bottles 

Released 

Outermost 

Package 

Type 

Quantity 

To be 

Reported

Innermost 

Package Type 

Quantity To 

be Reported

11111-1111-

1

1 CASE (11111-1111-1) 

contains 48 CARTONS; 

1 CARTON contains 1 

BOTTLE; 1 BOTTLE 

contains 30 TABLETS

20,000 960,000 20,000 960,000

126

127

If the product is listed as a kit,21 128 the amount reported should be based on the outermost layer of 

129 packaging associated with the NDC assigned to the kit released.

130

131 In some instances, a product that has been assigned an NDC (NDC #1) may be both 

132 commercially distributed on its own and commercially distributed (and listed) as a part of a kit or 

133 as an inner packaging layer for another product that is assigned a separate NDC (NDC #2). 

134 Reports submitted under NDC #1 should only include amounts released on their own and should 

135 not include amounts of the product that are a part of the kit or an inner packaging layer for the 

136 other product assigned NDC #2, as those would be accounted for in the amount reported for 

137 NDC #2. 

138

139 Registrants should not submit section 510(j)(3) reports to FDA based on the number of tablets, 

volume, or mass of the product.22 140

141

21 For purposes of this guidance, a kit is a co-packaged product that includes at least one or more drug items. 22 Medical gas manufacturers should report to the Agency each year the number of units (e.g., cylinder, dewar, tank) 

of each medical gas released from 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 gas released 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 released from 

each registered establishment, regardless of its ultimate use. 
Contains Nonbinding Recommendations

Draft — Not for Implementation

6

142 2. API

143

Each registrant that lists an API 144 23 must report to FDA annually the amount of API that it has

145 manufactured, prepared, propagated, compounded, or processed (including repacking and 

relabeling24) for commercial distribution for the reporting year.

25 146 The amount should be 

147 reported in terms of the appropriate unit containers as reported in drug listing (e.g., tanks, drums, 

cylinders, bags) rather than by weight, mass, or volume using metric or imperial system units.

26 148

149

150 3. Other Listed Drugs

151

152 Each registrant that lists a drug that consists of API with other ingredient(s) and that is not a 

finished dosage form product, 153 27 must report to FDA annually the amount of such drug 

154 manufactured, prepared, propagated, compounded, or processed (including repacking and 

relabeling28) for commercial distribution for the reporting year.

29 155 The amount should be 

156 reported in the appropriate unit containers as reported in the drug listing, rather than metric or 

imperial system units.

30 157 

158

159 4. Private Label Distribution

160

161 As noted above, the report should provide the amount of each listed drug, identified by NDC, 

162 that was released by each registered establishment during the reported year, organized by the 

163 amount of drug released in each month. For drugs that are manufactured, prepared, propagated, 

164 compounded, or processed (including repacking and relabeling) by a registrant for commercial 

165 distribution under the trade name or label of a private label distributor, the data should be 

166 submitted separately by the NDC associated with the registrant’s labeler code and the NDC 

167 associated with the private label distributor’s labeler code. 

168

23 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. 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). 24 See section 510(a)(1) of the FD&C Act. Also see the definition of “manufacture” at § 207.1 (i.e., “the term 

‘manufacture, preparation, propagation, compounding, or processing,’ as used in section 510 of the Federal Food, 

Drug, and Cosmetic Act, includes relabeling, repackaging, and salvaging”). 25 See section 510(j)(3)(A) of the FD&C Act. 26 For API that is in multi-level packaging, the principles underlying the recommendations for reporting multi-level 

packaged finished dosage form products should apply (see section III.A.1). 27 See definition of finished dosage form product in section III.A.1. 28 See section 510(a)(1) of the FD&C Act.

29 See section 510(j)(3)(A) of the FD&C Act. 30 For other listed drugs that are in multi-level packaging, the principles underlying the recommendations for 

reporting multi-level packaged finished dosage form products should apply (see section III.A.1).
Contains Nonbinding Recommendations

Draft — Not for Implementation

7

169 B. Timing of Reports

170

Reports on the amount of each registrant’s listed drugs must be submitted annually.

31 171 Such 

reports should include information regarding the amount of drug released32 172 for the respective 

173 calendar year (January 1 – December 31). 

174

Reports for calendar year 202033 should be submitted no later than February 15, 2022,34 175 and 

176 reports for calendar year 2021 should be submitted no later than May 16, 2022. Reports for 

177 subsequent calendar years should be submitted no later than February 15 of the following 

178 calendar year. For instance, registrants that manufactured, prepared, propagated, compounded, 

179 or processed listed drugs for commercial distribution at any time in calendar year 2022 should 

180 submit reports to FDA reporting the drug amounts for calendar year 2022 no later than February 

15, 2023.

35 181

182

183 C. Process for Report Submission

184

185 FDA is authorized to require registrants to submit section 510(j)(3) reports in an electronic 

format, as determined by the Agency.

36 186 Registrants should submit reports via the NextGen

187 Portal, available at edm.fda.gov. Additional information regarding technical specifications for 

submissions is available on FDA’s website.

37 188 Technical questions regarding the submission 

189 process should be sent to EDMSupport@fda.hhs.gov. (For questions regarding the content to be 

190 submitted in a section 510(j)(3) report, please contact (CDER) 

191 DrugVolumeReporting@fda.hhs.gov, (CBER) Office of Communication, Outreach and 

192 Development, 800-835-4709 or 240-402-8010, or (CVM) Office of Surveillance and 

193 Compliance, 240-402-7082 or CVMSurveillance@fda.hhs.gov, as applicable.) 

194

195

31 Section 510(j)(3)(A) of the FD&C Act. 32 See footnote 14. 33 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. 

34 Firms that were not registered with listed drugs at any point in calendar year 2020 are not required to submit a 

section 510(j)(3) report for that year. 35 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 at the time a public health emergency is declared 

by the Secretary under section 319 of the Public Health Service Act. FDA intends to continue to assess the need for 

such additional reporting during public health emergencies, including the public health emergency declared by the 

Secretary of the Department of Health and Human Services (HHS) on January 31, 2020. This includes any renewals 

made by the HHS Secretary in accordance with section 319(a) of the Public Health Service Act (42 U.S.C. 247d(a)). 

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 report for the calendar year under such section. 36 Section 510(j)(3)(A) of the FD&C Act. 37 See FDA’s Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide.
Contains Nonbinding Recommendations

Draft — Not for Implementation

8

196 IV. QUESTIONS AND ANSWERS

197

198 A. What type of drug reporting is the subject of this guidance?

199

200 This guidance describes the process that registrants should use for annually

201 reporting the amount of each listed drug that was manufactured, prepared, 

202 propagated, compounded, or processed for commercial distribution. Under 

203 section 510(j)(3) of the FD&C Act, such information must be reported by each 

204 person who registers with FDA under section 510 of the FD&C Act with regard to 

205 a listed drug (including a finished dosage form product, an API, and other listed 

206 drugs, except for biological products or categories thereof exempted by an order 

under section 510(j)(3)(B)).38 207 The process described in this guidance applies to 

208 such reporting with respect to listed drugs including medical gases, homeopathic 

209 products, products marketed in accordance with requirements under section 505G 

of the FD&C Act (21 U.S.C. 355h),

39 210 often referred to as over-the-counter 

211 monograph drugs, and animal drug products that are not approved, conditionally 

212 approved, or indexed under sections 512, 571, and 572 of the FD&C Act.

213

214 B. If an applicant submits a report containing distribution data under 21 CFR 

215 314.81(b)(2)(ii)(a) or 21 CFR 600.81(a) for human drugs or biological 

216 products, respectively, does the registrant of an establishment(s) identified in 

217 the application also need to annually submit a separate report under section 

218 510(j)(3) of the FD&C Act containing the amount of the listed drug that was 

219 manufactured, prepared, propagated, compounded, or processed at the 

220 establishment for commercial distribution?

221

A registrant40 222 of a listed drug must submit a report as required under section 

510(j)(3) of the FD&C Act.

41 223 FDA acknowledges that applicants with approved 

applications42 224 provide to FDA certain drug product distribution data in reports 

225 under § 314.81 (21 CFR 314.81) and § 600.81 (21 CFR 600.81); however, such 

226 data is aggregated and reflects the total amount distributed by an applicant but

227 does not include reporting specific to each establishment of the listed drug. If an

228 application includes multiple establishments, the information reported under §

229 314.81 and § 600.81 would not be specific to each establishment, which can

230 introduce challenges for the Agency in identifying, preventing, and mitigating

38 See footnote 2. 39 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. 

40 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.

41 See section 510(j)(3)(A) of the FD&C Act. 42 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). 
Contains Nonbinding Recommendations

Draft — Not for Implementation

9

231 drug shortages. In contrast, reports submitted under section 510(j)(3) of the 

232 FD&C Act should be submitted for each establishment, which would enhance the 

Agency’s ability to identify, prevent, and mitigate possible drug shortages.43 233

234

235 FDA does not intend to take action against an applicant regarding the requirement 

to submit distribution data in annual reports44 236 submitted under

237 §314.81(b)(2)(ii)(a), if:

238 (1) Each registrant of establishments identified in the application submits a timely 

239 and complete report under section 510(j)(3) of the FD&C Act;

240 (2) Each registrant of establishments identified in the application adds to its

241 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;

45 242 and

243 (3) The applicant’s annual report submitted under § 314.81(b)(2) provides:

244 • The NDC number(s) and strength(s) of drug product for which each

245 registrant submitted its report under section 510(j)(3) of the FD&C 

246 Act; and

247 • The date(s) of the report(s) submitted under section 510(j)(3) of the 

248 FD&C Act. 

249

250 FDA believes that this enforcement policy would maintain the Agency’s access to 

251 information that would enhance the Agency’s ability to identify, prevent, and 

252 mitigate possible drug shortages, and would also address the potential reporting 

253 burden for applicants that are subject to both § 314.81(b)(2)(ii)(a) and section 

510(j)(3) of the FD&C Act.46 254

255

43 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 from numerous applicants at different times throughout the year, which 

makes it challenging for the Agency to identify, prevent, 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 should arrive at the Agency during the same timeframe (see section III.B), which 

would enhance the Agency’s ability to identify, prevent, and mitigate possible drug shortages. 

44 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. 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.

45 § 314.81(b)(2)(ii)(a) requires applicants to provide to the Agency information about the quantities of drug product 

distributed for foreign use.

46 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.
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256 C. If an applicant submits a report containing distribution data for animal 

257 drugs under 21 CFR 514.80(b)(4)(i), and/or 21 CFR 514.87(b)(4)-(5), does the 

258 registrant of an establishment(s) in the application also need to submit a 

259 separate report under section 510(j)(3) of the FD&C Act containing the 

260 amount of the listed drug that was manufactured, prepared, propagated, 

261 compounded, or processed at the establishment for commercial distribution?

262

263 Yes, a registrant of a listed animal drug must submit a separate report under 

264 section 510(j)(3) of the FD&C Act containing the amount of the listed drug that 

265 was manufactured, prepared, propagated, compounded, or processed by such

266 person for commercial distribution. This is in addition to the reporting 

requirements of applicants47 267 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)).

48 268 

269

270 FDA understands that applicants provide to FDA certain distribution data in 

271 reports under § 514.80(b)(4)(i) and § 514.87(b)(4)-(5); however, such data is 

272 limited to the applicants and it does not include reporting specific to each 

273 establishment of the listed drug. If an application includes multiple 

274 establishments, the information reported under § 514.80(b)(4)(i) and §

275 514.87(b)(4)-(5) would not be specific to each establishment, which can introduce 

276 challenges for the Agency in identifying, preventing, and mitigating drug 

277 shortages. In contrast, for reports submitted under section 510(j)(3) of the FD&C 

278 Act, reports should be submitted for each establishment, which would enhance the 

Agency’s ability to identify, prevent, and mitigate possible drug shortages.49 279 

280

281 D. Can an authorized agent of a registrant submit a report under section 

282 510(j)(3) of the FD&C Act on the registrant’s behalf?

283

284 An agent that has knowledge regarding the amount of drug released and who has

285 been authorized by the registrant to submit the registrant’s report under section 

47 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.

48 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 21 CFR 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 

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.).

49 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 identify, prevent, 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 identify, prevent, and mitigate possible drug shortages. 
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286 510(j)(3) of the FD&C Act may submit such a report on the registrant’s behalf to 

287 the Agency. Accordingly, a private label distributor with knowledge of the 

288 amount of drug released and who has been authorized as an agent to submit a 

289 report under section 510(j)(3) on the registrant’s behalf may do so. Additionally, 

290 an applicant (e.g., holder of an NDA, ANDA, BLA, NADA, or ANADA) that has 

291 been authorized as an agent on behalf of a contract manufacturer (registrant) to 

292 submit a report under section 510(j)(3) on the contract manufacturer’s behalf may 

do so.50 293 However, each registrant is ultimately responsible for ensuring that an 

294 accurate and timely report under section 510(j)(3) is submitted on its behalf. 

295

296 E. Should the registrant report the amount of listed drug released based on 

297 theoretical yield or actual yield? 

298

299 Registrants should report the actual yield—the actual amount of drug that is 

300 released during the reporting period. Percent yield is the percent ratio of actual 

301 yield to theoretical or predicted yield and can only be 100% if there are no losses 

302 or errors during actual production. Registrants should not report the amount of 

303 listed drug available for commercial distribution based on a theoretical 

304 assumption of 100% yield. 

305

306 F. In determining the amount of drug to report in a section 510(j)(3) report, 

307 should a registrant include amounts of drug that were returned and/or 

308 recalled?

309

310 Registrants are required to report “on the amount” of listed drugs manufactured, 

prepared, propagated, compounded, or processed for commercial distribution.51 311 

312 There is no exemption for drugs that have been returned or recalled. For that 

reason, the report must not subtract amounts that have been returned52 313 or 

recalled.

53 314 

315

316 G. If a registrant manufactured, prepared, propagated, compounded, or 

317 processed an applicable drug for commercial distribution during only part of 

318 the calendar year, does the registrant still need to submit an annual volume 

319 report under section 510(j)(3) of the FD&C Act?

320

321 Yes, the registrant should submit a report to FDA no later than the recommended 

322 date each year (see section III.B). 

323

324 H. If a registrant had a drug listed with FDA during the calendar year, but did 

325 not ultimately manufacture, prepare, propagate, compound, or process any 

50 Contract facilities should consider outlining the reporting arrangements in a written quality agreement or other 

written contract.

51 Section 510(j)(3)(A) of the FD&C Act. 52 See 21 CFR 211.204. 53 See 21 CFR part 7, subpart C.
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326 of the drug for commercial distribution during that calendar year, does the 

327 registrant need to submit a report under section 510(j)(3) of the FD&C Act?

328

329 Registrants are required to report “on the amount” of listed drugs manufactured, 

prepared, propagated, compounded, or processed for commercial distribution.54 330 

331 If such amount for an individual registrant is zero, the registrant still must submit 

332 a report under section 510(j)(3) of the FD&C Act.

333

334 I. What amount should a registrant of a foreign establishment report if some, 

335 but not all, of the listed drug it manufactures is imported or offered for 

336 import into the United States?

337

338 If a listed drug was manufactured, prepared, propagated, compounded, or 

339 processed in a foreign establishment for commercial distribution (i.e., in the 

United States55 340 ) and the registrant of the foreign establishment knows how much 

341 of the listed drug was imported or offered for import into the United States, then 

the registrant must report that amount.56 342 However, if a listed drug was 

343 manufactured, prepared, propagated, compounded, or processed for commercial 

344 distribution in a foreign establishment but the registrant does not know how much

345 of the listed drug was imported or offered for import into the United States, then 

346 the registrant should report the total amount of the listed drug that it

347 manufactured, prepared propagated, compounded or processed (including 

348 repacked or relabeled) during the reporting period.

349

350 J. Should a registrant of a listed biological product submit a section 510(j)(3) 

351 report to FDA, if the biological product falls within a category of biological 

352 products identified in FDA’s Proposed Order as being proposed for 

353 exemption from section 510(j)(3)(A) reporting requirements?

354

355 Under section 510(j)(3)(B) of the FD&C Act, FDA may issue an order to exempt 

356 certain biological products or categories of biological products regulated under 

357 section 351 of the Public Health Service Act from some or all of the reporting 

358 requirements under section 510(j)(3)(A) of the FD&C Act, if FDA determines 

359 that applying such reporting requirements is not necessary to protect the public 

360 health. FDA has issued a Proposed Order that, if finalized, would exempt from 

361 section 510(j)(3)(A) reporting requirements the following categories of biological 

362 products: (i) blood and blood components for transfusion; and (ii) cell and gene 

therapy products, where one lot treats a single patient.57 363 

364

365 Until the effective date of an order finalizing the Proposed Order or the date of 

366 withdrawal of the Proposed Order, whichever comes first, FDA does not intend to 

367 take action if a registrant does not submit a report required under section 

54 See section 510(j)(3)(A) of the FD&C Act. 55 See § 207.1 (defining “commercial distribution"). 56 See section 510(j)(3)(A) of the FD&C Act. 57 See 86 FR 59395 (October 27, 2021). 
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368 510(j)(3)(A) of the FD&C Act with respect to a biological product that falls 

369 within a category of biological products identified in the Proposed Order as being 

370 proposed for exemption from section 510(j)(3)(A) reporting requirements. 

371

372 K. Should a registrant of a listed drug submit a section 510(j)(3) report to FDA, 

373 if the registrant’s only business operation in the drug listing file is sterilize,

374 analysis, particle size reduction, and/or salvage?

375

376 FDA does not intend to take action if registrants whose only business operation in 

377 the drug listing file is sterilize, analysis, particle size reduction, and/or salvage do 

378 not submit reports under section 510(j)(3) of the FD&C Act. FDA believes the 

379 data reported by other registrants (e.g., registrants with business operations of

380 manufacture, repack, or relabel in the drug listing file) will be sufficient.

381

382