Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers Guidance for Industry

Administrative draft guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.

Annual Reporting by Prescription
Drug Wholesale Distributors and
Third-Party Logistics Providers:
Questions and Answers
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DRAFT GUIDANCE
This guidance document is being distributed for comment purposes only.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publication in the Federal Register of the notice announcing the availability of the draft
guidance.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 http://www.regulations.gov. Submit written
comments to the Division of Dockets Management (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 Office of Compliance at 301-796-
3130 or wdd3plrequirements@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)
January 2017
Procedural

Annual Reporting by Prescription
Drug Wholesale Distributors and
Third-Party Logistics Providers:
Questions and Answers
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
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
and/or
Office of Communication, Outreach andDevelopment
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
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
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)
January 2017
Procedural

Contains Nonbinding Recommendations
Draft — Not for Implementation
TABLE OF CONTENTS
INTRODUCTION............................................................................................................. 1	I.
CLARIFICATION OF WHO MUST REPORT ............................................................ 2	II.
CLARIFICATION OF WHAT SHOULD BE REPORTED ........................................ 4	III.
CLAFIFICATION OF WHEN TO REPORT ............................................................... 6	IV.
CLARIFICATION OF HOW TO REPORT ................................................................. 7	V.
PUBLIC AVAILABILITY OF INFORMATION ....................................................... 10	VI.

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1
Annual Reporting by Prescription Drug Wholesale	1
Distributors and Third-Party Logistics Providers:	2
Questions and Answers	3
Guidance for Industry1
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
INTRODUCTION	I.	15
16
This guidance addresses questions and clarifies FDA’s expectations for annual reporting to FDA	17
by prescription drug wholesale distributors (wholesale distributors) and third-party logistics	18
providers (3PLs) as required under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as	19
amended by the Drug Supply Chain Security Act of 2013 (DSCSA).2
20
21
FDA previously published a draft guidance for industry entitled DSCSA Implementation: Annual	22
Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers	23
(Annual Reporting draft guidance).3 This question-and-answer guidance supplements the	24
information in the Annual Reporting draft guidance by addressing questions and comments that	25
FDA received about annual reporting since publication of the Annual Reporting draft guidance.4
26
27
In general, FDA’s guidance documents do not establish legally enforceable responsibilities.	28
Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only	29
as recommendations, unless specific regulatory or statutory requirements are cited. The use of	30
1 This guidance has been prepared by the Office of Compliance in the Center for Drug Evaluation and Research in
cooperation with the Center for Biologics Evaluation and Research and the Office of Regulatory Affairs at the Food
and Drug Administration.
2 Title II of Public Law 113-54. In particular, see sections 503(e)(2) and 584 of the FD&C Act (21 U.S.C. 353(e)(2)
and 360eee-3).
3 In December 2014, FDA issued the draft guidance entitled DSCSA Implementation: Annual Reporting by
Prescription Drug Wholesale Distributors and Third-Party Logistics Providers. When final, that guidance will
represent FDA’s current thinking on this topic. For the most recent version of a guidance, check the FDA Drugs
guidance Web page at:
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
4 More information about reporting is on the Wholesale Distributor and Third-Party logistics Providers Reporting
Web page
(http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/ucm4
23749.htm).

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the word should in Agency guidances means that something is suggested or recommended, but	31
not required.	32
33
CLARIFICATION OF WHO MUST REPORT	II.	34
35
1. 	Is a manufacturer, currently licensed by a State as a wholesale distributor,	36
required to report this license?	37
38
A manufacturer that is engaged in wholesale distribution, as defined in section 503(e)(4) of the	39
FD&C Act (21 U.S.C. 353(e)(4)), as amended by the DSCSA, is required to report information	40
related to its wholesale distributor license (see section 503(e)(2)(A) of the FD&C Act).	41
However, the distribution of a manufacturer’s own drug is exempt from the definition of	42
wholesale distribution (section 503(e)(4)(H)). As a result, if a manufacturer is only distributing	43
its own drug, it would not be engaged in wholesale distribution, and would not be required to	44
report under Federal law, even if the manufacturer has a wholesale distributor license issued by a	45
State.	46
47
2. 	Do wholesale distributors or 3PL facilities that distribute only over-the-counter	48
drugs need to report?	49
50
No. The annual reporting requirements under the DSCSA apply to wholesale distributors5 that	51
distribute and 3PL facilities6 that provide services related to human prescription drugs.7
52
53
3. 	Should wholesale distributors that only distribute bulk prescription drug	54
substances report?	55
56
Yes. The definition of wholesale distribution in section 503(e)(4) of the FD&C Act means the	57
distribution of a human prescription drug subject to section 503(b) of the FD&C Act, which FDA	58
considers to include bulk drug substances.8
59
60
4. 	Do 3PL facilities that only provide services related to bulk prescription drug	61
substances need to report?	62
63
No, unless the bulk prescription drug substance is in finished dosage form. The annual reporting	64
requirements apply to 3PL facilities that provide or coordinate warehousing, or other logistics	65
services of a product in interstate commerce on behalf of a manufacturer, wholesale distributor,	66
or dispenser of a product. Product is defined in section 581(13) of the FD&C Act to mean	67
human prescription drugs in finished dosage form. If a 3PL facility handles only bulk drug	68
substances that are free form active pharmaceutical ingredients (API) and have yet to undergo	69
5 See section 503(e)(4) of the FD&C Act.
6 See section 581(22) of the FD&C Act (21 U.S.C. 360eee(22)).
7 See section 581(12) and 581(13) of the FD&C Act (21 U.S.C. 360eee(12) and 360eee(13)).
8 Under current FDA regulations, the term bulk drug substances means any substance that is represented for use in a
drug and that, when used in the manufacturing, processing, or packaging of a drug, becomes an active ingredient or
a finished dosage form of the drug, but the term does not include intermediates used in the synthesis of such
substances (21 CFR 203.3(e)).

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manufacturing, processing, or packaging to become the finished dosage form of the drug, the	70
3PL facility does not need to report. However, if a 3PL facility handles bulk drug substances	71
that have already been manufactured into a human prescription drug in finished dosage form but	72
may need further processing for distribution (e.g., bottling, packaging, or labeling), the 3PL	73
facility must report.	74
75
5. 	Do wholesale distributors and 3PL facilities that only distribute and provide	76
services related to animal drugs need to report?	77
78
Wholesale distributors and 3PL facilities only distributing animal drugs (i.e., drugs subject to	79
section 512 of the FD&C Act (21 U.S.C. 360b)) do not need to report. 9
80
81
DSCSA requires wholesale distributors and 3PL facilities that distribute human prescription	82
drugs to comply with the annual reporting requirements regardless of whether the human	83
prescription drug is ultimately used to treat animals.	84
85
6. 	Do 3PL facilities that provide services related to only prescription drug samples	86
need to report?	87
88
Yes, 3PL facilities that provide services related to only prescription drug samples are required to	89
report. Prescription drug samples are not exempt from the definition of product in section	90
581(22) of the FD&C Act. Product is defined in section 581(13) of the FD&C Act to mean	91
human prescription drugs in finished dosage form.	92
93
7. 	I am a 3PL in a State without a licensing requirement for 3PLs. Before the	94
effective date of the Federal regulations, do I need to report to FDA?	95
96
Yes, as of November 27, 2014, 3PL facilities are required to report to FDA annually.10
97
Information about the facility should be reported even if there is no State licensing requirement	98
for 3PLs (see response 11, below).	99
100
8. 	If a pharmacy is currently also licensed in a State as a wholesale distributor, is	101
this pharmacy required to report this license?	102
103
If the pharmacy engages in wholesale distribution as defined in section 503(e)(4) of the FD&C	104
Act, as amended by the DSCSA, it is required to report information related to its wholesale	105
distributor license, regardless of other license(s) it may have based on individual State	106
requirements.	107
108
109
9 See section 581(12) (“The term ‘prescription drug’ means a drug for human use subject to section 503(b)(1)”).
10 See section 584(b) of the FD&C Act (21 U.S.C. 360eee-3(b)).

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9. 	I am a new drug application (NDA) or biologics license application (BLA) holder	110
that contracts out the manufacturing of my prescription drug products, and	111
therefore, I am not registered as an establishment under section 510 of the FD&C	112
Act (21 U.S.C. 360). Do I have to report as a wholesale distributor?	113
114
Section 581(10) of the FD&C Act defines manufacturer to include application holders such as	115
NDA11 and BLA12 holders. The wholesale distributor reporting requirement does not apply to a	116
manufacturer unless the company is engaged in wholesale distribution as defined in section	117
503(e)(4) of the FD&C Act. A manufacturer’s distribution of its own drug is exempt from the	118
definition of wholesale distribution (section 503(e)(4)(H)).	119
120
CLARIFICATION OF WHAT SHOULD BE REPORTED	III.	121
122
10. Which licenses should a wholesale distributor report, home State license or all	123
States where each facility holds a license?	124
125
Wholesale distributors should report all licenses that authorize wholesale distribution. This	126
includes licenses the wholesale distributor holds from any State that the wholesale distributor	127
ships human prescription drug from and any licenses the wholesale distributor holds from States	128
that the wholesale distributor ships into.	129
130
11. I am a 3PL in a State without a licensing requirement for 3PLs. What	131
information should I report?	132
133
If a 3PL facility has no license information to report, a 3PL facility should report the name and	134
address of the facility, as well as the facility contact information.	135
136
12. Should 3PL facilities report all State licenses, including those licenses that classify	137
the 3PL as a wholesale distributor?	138
139
The DSCSA does not permit states to license 3PLs as wholesale drug distributors.13
140
141
Third-party logistics provider facilities must report any State licenses that classify them as 3PLs.	142
Until the FDA regulations on standards for 3PL licensing go into effect, if an entity meets the	143
3PL definition in section 581(22) of the FD&C Act but is not licensed by a State as a 3PL, the	144
3PL facility should report but not submit any license information for that facility (see response	145
11, above).	146
147
13. For a wholesale distributor, what disciplinary actions must be reported?	148
149
Wholesale distributors must report any significant disciplinary actions, including suspension or	150
revocation of a wholesale distributor license, taken by a State or the Federal Government during	151
11 See section 505 of the FD&C Act (21 U.S.C. 355).
12 See section 351 of the Public Health and Service Act (42 U.S.C. 262).
13 See section 585(b)(2) of the FD&C Act (21 U.S.C. 360eee-4(b)(2)), effective November 27, 2013.

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the reporting period against the wholesale distributor. FDA considers significant disciplinary	152
actions taken by a State or Federal government to include disciplinary actions that limit the	153
ability of that entity to distribute human prescription drugs, such as actions taken against the	154
wholesale distributor’s United States Drug Enforcement Agency (DEA) registration.14
155
156
14. I am a wholesale distributor. Should we provide our DEA registration or State	157
controlled-substance license(s) information when reporting?	158
159
No. For routine annual reporting, wholesale distributors should not report DEA registration	160
numbers or State controlled-substance licenses to FDA. The only exception is when there is a	161
disciplinary action issued by the DEA or the State controlled-substance licensing authority that	162
would limit the ability of an entity to distribute human prescription drug products. In that case,	163
information about the DEA registration or State controlled-substance license should be reported	164
because the disciplinary action is reported under that specific license or registration (see response	165
13, above).	166
167
15. For 3PLs, what disciplinary actions should be submitted?	168
169
FDA is requesting that 3PL facilities report significant disciplinary actions taken by a State or	170
Federal Government that limit the ability of the 3PL to distribute human prescription drug	171
products, such as suspension or revocation of a license. Disciplinary actions taken against a	172
manufacturer, repackager, wholesale distributor, or dispenser for which the 3PL conducts	173
warehousing or other logistics services should not be reported by the 3PL facility unless the	174
disciplinary actions involved the 3PL.	175
176
16. I am a 3PL. Should we provide our DEA registration or State controlled-	177
substance license(s) information when reporting?	178
179
No. For routine annual reporting, 3PL facilities should not report DEA registration numbers or	180
State controlled-substance licenses to FDA. The only exception is when there is a significant	181
disciplinary action issued by the DEA or the State controlled-substance licensing authority that	182
would limit the ability of an entity to distribute human prescription drug products. In that case,	183
information about the DEA registration or State controlled-substance license should be reported	184
because the disciplinary action is reported under that specific license or registration.	185
186
17. Should the Unique Facility Identifier (UFI) be reported for the reporter?	187
188
Yes, the UFI is used to either obtain an account to report using the Center for Drug Evaluation	189
and Research (CDER) Direct Electronic Submissions Portal (CDER Direct or CDER Direct	190
system), or to report using an alternative mechanism such as through the FDA Electronic	191
Submissions Gateway. More information about these reporting systems is included under	192
Section V., below.	193
194
195
14 See section 503(e)(2)(A)(ii) of the FD&C Act.

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18. Does the UFI need to be reported for each facility?	196
197
The UFI is not required for each facility at this time. However, if a UFI is reported, the	198
electronic system will perform a validation of the UFI against the company name and facility	199
address that corresponds with that UFI. If the company name and address do not correspond	200
with the information associated with the UFI, the system will not accept the submission. A UFI	201
should be obtained for each separate address. The UFI can be verified by checking	202
https://www.dandb.com/dunsnumberlookup/.	203
204
19. Does every facility name need to be different?	205
206
The facility name should be the business name of the facility that corresponds with the UFI. Do	207
not include the city, doing business as (DBA) name, or other extraneous information in the field	208
for “name of the facility” unless it is included in the official business name of the facility.	209
210
20. Who should be reported as the contact person for a facility?	211
212
The facility contact person should be the facility manager or designated representative of the	213
facility manager who has authority to address inquiries about the facility and its operations with	214
FDA, the licensing authority, and other trading partners.	215
216
21. I am the contact person for a facility. What contact information should I	217
provide?	218
219
FDA considers contact information to include the email address, telephone number, and name of	220
individual (if applicable). NOTE: This information is included in the public database.	221
222
CLARIFICATION OF WHEN TO REPORT	IV.	223
224
22. Does reporting need to be performed just once a year or do wholesale distributors	225
and 3PL facilities need to report throughout the year if they have a change in	226
license expiration date or a disciplinary action?	227
228
The DSCSA requires that wholesale distributors and 3PL facilities report annually.15 FDA is	229
requesting that wholesale distributors and 3PL facilities report between January 1 st and March	230
31st of each year. If an entity chooses to update expired licenses during a time frame outside of this	231
annual reporting time period, the entity should still report during the next defined annual reporting	232
period. FDA requests that disciplinary actions be reported within 30 days of the final ruling by the	233
State or Federal licensing authority. FDA also requests that entities that go out of business or	234
voluntarily withdraw a license report this to FDA within 30 days.	235
236
237
15 See sections 503(e)(2)(A) and 584(b) of the FD&C Act.

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23. If there are no changes to the information reported the previous year, do I need	238
to report again?	239
240
Yes, the DSCSA requires that wholesale distributors and 3PL facilities report annually.16
241
242
24. If I missed the requested reporting deadline of March 31st
, do I need to wait until	243
the next reporting period (January 1st – March 31 st
)?	244
245
No, wholesale distributors and 3PL facilities should not wait until the next reporting period	246
(January 1st – March 31st ) to report under those circumstances. The DSCSA requires that	247
wholesale distributors and 3PL facilities report to FDA annually.17 If you have missed the	248
requested deadline, wholesale distributors and 3PL facilities must still report annually and should	249
do so as soon as possible. Reporting after the requested deadline, or submitting updates, can be	250
done using the CDER Direct system at any time.	251
252
25. I have been informed by the State licensing authority of a potential disciplinary	253
action, but the hearing with the State Board has not occurred. Do I have to	254
report within 30 days of the notification or within 30 days after the final ruling by	255
the State?	256
257
For wholesale distributors and 3PLs, disciplinary actions should be reported within 30 days of	258
the final ruling, along with any supporting documentation of the disciplinary action taken.	259
260
CLARIFICATION OF HOW TO REPORT	V.	261
262
26. If I reported information using CDER Direct, can I go back and enter additional	263
information to that submitted report?	264
265
It is not possible to enter additional information to a previously accepted submission. However,	266
additional information may be submitted by creating a new version by following these steps:	267
• 	Log into CDER Direct.	268
• 	Choose the last Submission Accepted and open it.	269
• 	Click on “Create New Version” (the version number should increase by 1).	270
• 	Enter or update information as necessary.	271
• 	Submit the report in Structured Product Labeling (SPL) format by clicking on “Submit	272
the SPL.”	273
274
This same process may be used to re-report annually, update license expiration dates, or report	275
disciplinary actions.	276
277
278
16 Id.
17 See sections 503(e)(2) and 584(b) of the FD&C Act.

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27. Do I need to use CDER Direct to enter the license information?	279
280
No, FDA developed reporting through CDER Direct for the convenience of wholesale	281
distributors and 3PLs and highly recommends its use. Companies using CDER Direct for entry	282
and submission will not be required to convert the information to extensible markup language	283
(XML) in SPL format; this formatting will happen automatically when using the CDER Direct	284
system. The information will be entered once and saved in the system for future review and	285
updating.	286
287
If a wholesale distributor or a 3PL facility chooses not to use CDER Direct for reporting,	288
alternative methods for reporting include either:	289
• 	Submitting a properly formatted XML file in the SPL format via an account through the	290
FDA Electronic Submissions Gateway (ESG), or	291
• 	Uploading a zipped XML file in the SPL format into CDER Direct.	292
293
The specifications for the XML in the SPL format for wholesale distributors and 3PLs can be	294
found in the SPL Implementation Guide with Validation Procedures (available on the FDA Web	295
site at	296
http://www.fda.gov/downloads/ForIndustry/DataStandards/StructuredProductLabeling/UCM321	297
876.pdf).	298
299
Wholesale distributors and 3PL facilities that use alternative methods other than CDER Direct	300
should check the SPL format before submitting because updates to the system are implemented	301
from time to time and the SPL format may change.	302
303
28. How do I report annually in CDER Direct if I have no new information?	304
305
To satisfy the reporting requirement, if CDER Direct is used:	306
• 	Log into CDER Direct.	307
• 	Choose the last Submission Accepted and open it.	308
• 	Click on “Create New Version” (the version number should increase by 1).	309
• 	Submit the SPL.	310
311
29. How do I update a previously reported disciplinary action that has been resolved	312
satisfactorily?	313
314
• 	Log into CDER Direct.	315
• 	Choose the last Submission Accepted and open it.	316
• 	Click on “Create New Version” (the version number should increase by 1).	317
• 	Add a new disciplinary action and choose “resolved” from the drop-down menu.	318
• 	Upload the document that corresponds to the action. Do not delete or edit the previously	319
reported action.	320
• 	Submit the SPL.	321
322
323

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30. Can a third party report on behalf of a wholesale distributor or 3PL?	324
325
Yes, a wholesale distributor or 3PL may designate a third party to enter the facility information	326
into CDER Direct or create the XML file in the SPL format if direct data entry in CDER Direct	327
is not used. The third party should identify itself as the contact for the “reporter contact name”;	328
however, the UFI and reporter name should be the company for which the reporter is reporting.	329
If this is not done, then all companies that the third party is reporting on behalf of would be in	330
the same SPL record. In addition, the contact information for each facility should reflect the	331
appropriate facility representative who will interact with FDA (see response 19, above).	332
333
31. If I reported in error (I am not a 3PL facility or a wholesale distributor), how do	334
I eliminate my entire entry?	335
336
To withdraw a report, do the following steps:	337
• 	Log into CDER Direct.	338
• 	Choose the last Submission Accepted and open it.	339
• 	Click on “Create New Version” (the version number should increase by 1).	340
• 	Under “Document Type” at the top under “Header Details,” select “Withdrawal of	341
wholesale drug distributor and third-party logistics facility report” from the drop-down	342
menu.	343
• 	Submit the SPL.	344
345
32. If I go out of business, what should I report?	346
347
To report going out of business, a wholesale distributor or 3PL facility should perform the	348
following steps within 30 days of going out of business:	349
• 	Log into CDER Direct.	350
• 	Choose the last Submission Accepted and open it.	351
• 	Click on “Create New Version” (the version number should increase by 1).	352
• 	Under “Document Type” at the top under “Header Details,” select “Out of Business	353
Notification” from the drop-down menu.	354
• 	Submit the SPL.	355
356
33. If I sell a facility, how do I delete that facility from my report?	357
358
To delete one facility in a report that contains more than one facility, follow these steps:	359
• 	Log into CDER Direct.	360
• 	Choose the last Submission Accepted and open it.	361
• 	Click on “Create New Version” (the version number should increase by 1).	362
• 	Click on the edit pencil next to the facility to be deleted.	363
• 	A separate page will open and click “delete facility” from the top bar. This will delete	364
the facility and all information, including licenses associated with that facility.	365
• 	Submit the SPL.	366
367

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34. If my company has a change of ownership, what should I do with the current	368
report? Do I need to report the new company?	369
370
Following the company change of ownership, a wholesale distributor or 3PL should follow State	371
licensing laws to obtain new licenses if required. Wholesale distributor and 3PL facilities that	372
are newly licensed should initially report within 30 days of obtaining a State or Federal license.	373
After the change is complete and new licenses (if applicable) are obtained, CDER Direct has a	374
mechanism for withdrawing the current report (see process in response 30, above). After	375
withdrawing the current report, you should then report the information for the new company,	376
including all applicable wholesale distributor or 3PL licenses issued by States to the new	377
company. Trading partners will be able to access the information about the new company in the	378
FDA public database.	379
380
PUBLIC AVAILABILITY OF INFORMATION	VI.	381
382
35. Why are some facility addresses not available in the public database?	383
384
The DSCSA does not require facility address to be available in the publicly available database.18
385
FDA received comments indicating that making addresses or UFIs publicly available for certain	386
facilities could be a safety risk. FDA has added a field in CDER Direct where a reporter can	387
indicate if a facility address should remain confidential. If the field is selected, FDA will not	388
publish the street address on the public Web site. However, pursuant to a Freedom of	389
Information Act request or FDA’s regulations, FDA may ultimately make determinations as to	390
whether the street address can be disclosed to the public under the Trade Secrets Act, the	391
Freedom of Information Act, and other applicable law.	392
393
36. How long does it take to see updates in the public database?	394
395
The public database is updated the next business day, usually by 12:00 pm (EST).	396
397
37. Why are some companies listed both in FDA’s eDrug Registration and Listing	398
System (eDRLS) and in the wholesale distributor and 3PL public database?	399
400
The DSCSA requires annual reporting to FDA of licensure and other information by wholesale	401
distributors and 3PL facilities.19 Section 510 of the FD&C Act requires any person who owns or	402
operates any establishment that manufactures, prepares, propagates, compounds, or processes	403
drugs in the United States, or that are offered for import into the United States, to register with	404
FDA. If a firm meets the requirements under DSCSA and under section 510, it would be	405
required to report to both systems. Also, in some cases, firms may have mistakenly registered	406
under one system or the other.	407
408
18 See section 503(e)(2)(B) of the FD&C Act.
19 See sections 503(e)(2)(A) and 584(b) of the FD&C Act.

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38. Why are disciplinary actions not listed in the public database?	409
410
Although the DSCSA requires that certain types of disciplinary actions be reported to FDA, the	411
statute does not require that the public database contain disciplinary actions. Currently, FDA’s	412
public database does not list disciplinary actions submitted to FDA. However, pursuant to a	413
Freedom of Information Act request or FDA’s regulations, FDA may ultimately make	414
determinations as to whether a disciplinary action can be disclosed to the public under the Trade	415
Secrets Act, the Freedom of Information Act, and other applicable law.	416
417
39. Why isn’t “doing business as” a field in the public database?	418
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Although you may not be able to see the “doing business as” name in the public database, FDA	420
has linked the “doing business as” name to the facility name field in the CDER Direct system. If	421
you search for a “doing business as” name, the facility name will appear in the generated table.	422