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DRAFT GUIDANCE 
 
  This guidance document is being distributed for comment purposes only.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publication in the Federal Register of the notice announcing the availability of the draft 
guidance.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Draft  Not for Implementation 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 
 
 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  CLARIFICATION OF WHO MUST REPORT ............................................................ 2 
III.  CLARIFICATION OF WHAT SHOULD BE REPORTED ........................................ 4 
IV.  CLAFIFICATION OF WHEN TO REPORT ............................................................... 6 
V.  CLARIFICATION OF HOW TO REPORT ................................................................. 7 
VI.  PUBLIC AVAILABILITY OF INFORMATION ....................................................... 10 
 
 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
1  Annual Reporting by Prescription Drug Wholesale  
2  Distributors and Third-Party Logistics Providers: 
3  Questions and Answers   
4  Guidance for Industry1 
5   
6   
7  This draft guidance, when finalized, will represent the current thinking of the Food and Drug 
8  Administration (FDA or Agency) on this topic.  It does not establish any rights for any person and is not 
9  binding on FDA or the public.  You can use an alternative approach if it satisfies the requirements of the 
10  applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff responsible 
11  for this guidance as listed on the title page.   
12   
13   
14   
15  I.  INTRODUCTION  
16   
17  This guidance addresses questions and clarifies FDAs expectations for annual reporting to FDA 
18  by prescription drug wholesale distributors (wholesale distributors) and third-party logistics 
19  providers (3PLs) as required under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as 
20  amended by the Drug Supply Chain Security Act of 2013 (DSCSA).2   
21   
22  FDA previously published a draft guidance for industry entitled DSCSA Implementation: Annual 
23  Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers 
24  (Annual Reporting draft guidance).3  This question-and-answer guidance supplements the 
25  information in the Annual Reporting draft guidance by addressing questions and comments that 
26  FDA received about annual reporting since publication of the Annual Reporting draft guidance.4  
27   
28  In general, FDAs guidance documents do not establish legally enforceable responsibilities.  
29  Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
30  as recommendations, unless specific regulatory or statutory requirements are cited.  The use of 
                                                 
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 FDAs 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). 
  1  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
31  the word should in Agency guidances means that something is suggested or recommended, but 
32  not required. 
33     
34  II.  CLARIFICATION OF WHO MUST REPORT 
35   
36  1.  Is a manufacturer, currently licensed by a State as a wholesale distributor, 
37  required to report this license? 
38   
39  A manufacturer that is engaged in wholesale distribution, as defined in section 503(e)(4) of the 
40  FD&C Act (21 U.S.C. 353(e)(4)), as amended by the DSCSA, is required to report information 
41  related to its wholesale distributor license (see section 503(e)(2)(A) of the FD&C Act).  
42  However, the distribution of a manufacturers own drug is exempt from the definition of 
43  wholesale distribution (section 503(e)(4)(H)).  As a result, if a manufacturer is only distributing 
44  its own drug, it would not be engaged in wholesale distribution, and would not be required to 
45  report under Federal law, even if the manufacturer has a wholesale distributor license issued by a 
46  State. 
47   
48  2.  Do wholesale distributors or 3PL facilities that distribute only over-the-counter 
49  drugs need to report?   
50   
51  No.  The annual reporting requirements under the DSCSA apply to wholesale distributors5 that 
52  distribute and 3PL facilities6 that provide services related to human prescription drugs.7 
53   
54  3.  Should wholesale distributors that only distribute bulk prescription drug 
55  substances report? 
56   
57  Yes.  The definition of wholesale distribution in section 503(e)(4) of the FD&C Act means the 
58  distribution of a human prescription drug subject to section 503(b) of the FD&C Act, which FDA 
59  considers to include bulk drug substances.8 
60   
61  4.  Do 3PL facilities that only provide services related to bulk prescription drug 
62  substances need to report? 
63   
64  No, unless the bulk prescription drug substance is in finished dosage form.  The annual reporting 
65  requirements apply to 3PL facilities that provide or coordinate warehousing, or other logistics 
66  services of a product in interstate commerce on behalf of a manufacturer, wholesale distributor, 
67  or dispenser of a product.  Product is defined in section 581(13) of the FD&C Act to mean 
68  human prescription drugs in finished dosage form.  If a 3PL facility handles only bulk drug 
69  substances that are free form active pharmaceutical ingredients (API) and have yet to undergo 
                                                 
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)). 
  2  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
70  manufacturing, processing, or packaging to become the finished dosage form of the drug, the 
71  3PL facility does not need to report.  However, if a 3PL facility handles bulk drug substances 
72  that have already been manufactured into a human prescription drug in finished dosage form but 
73  may need further processing for distribution (e.g., bottling, packaging, or labeling), the 3PL 
74  facility must report. 
75   
76  5.  Do wholesale distributors and 3PL facilities that only distribute and provide 
77  services related to animal drugs need to report? 
78   
79  Wholesale distributors and 3PL facilities only distributing animal drugs (i.e., drugs subject to 
80  section 512 of the FD&C Act (21 U.S.C. 360b)) do not need to report. 9 
81   
82  DSCSA requires wholesale distributors and 3PL facilities that distribute human prescription 
83  drugs to comply with the annual reporting requirements regardless of whether the human 
84  prescription drug is ultimately used to treat animals.  
85   
86  6.  Do 3PL facilities that provide services related to only prescription drug samples 
87  need to report? 
88   
89  Yes, 3PL facilities that provide services related to only prescription drug samples are required to 
90  report.  Prescription drug samples are not exempt from the definition of product in section 
91  581(22) of the FD&C Act.  Product is defined in section 581(13) of the FD&C Act to mean 
92  human prescription drugs in finished dosage form. 
93   
94  7.  I am a 3PL in a State without a licensing requirement for 3PLs.  Before the 
95  effective date of the Federal regulations, do I need to report to FDA? 
96   
97  Yes, as of November 27, 2014, 3PL facilities are required to report to FDA annually.10  
98  Information about the facility should be reported even if there is no State licensing requirement 
99  for 3PLs (see response 11, below). 
100   
101  8.  If a pharmacy is currently also licensed in a State as a wholesale distributor, is 
102  this pharmacy required to report this license? 
103   
104  If the pharmacy engages in wholesale distribution as defined in section 503(e)(4) of the FD&C  
105  Act, as amended by the DSCSA, it is required to report information related to its wholesale 
106  distributor license, regardless of other license(s) it may have based on individual State 
107  requirements.    
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)). 
  3  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
110  9.  I am a new drug application (NDA) or biologics license application (BLA) holder 
111  that contracts out the manufacturing of my prescription drug products, and 
112  therefore, I am not registered as an establishment under section 510 of the FD&C 
113  Act (21 U.S.C. 360).  Do I have to report as a wholesale distributor? 
114   
115  Section 581(10) of the FD&C Act defines manufacturer to include application holders such as 
116  NDA11 and BLA12 holders.  The wholesale distributor reporting requirement does not apply to a 
117  manufacturer unless the company is engaged in wholesale distribution as defined in section 
118  503(e)(4) of the FD&C Act.  A manufacturers distribution of its own drug is exempt from the 
119  definition of wholesale distribution (section 503(e)(4)(H)). 
120   
121  III.  CLARIFICATION OF WHAT SHOULD BE REPORTED 
122   
123  10. Which licenses should a wholesale distributor report, home State license or all 
124  States where each facility holds a license? 
125     
126  Wholesale distributors should report all licenses that authorize wholesale distribution.  This 
127  includes licenses the wholesale distributor holds from any State that the wholesale distributor 
128  ships human prescription drug from and any licenses the wholesale distributor holds from States 
129  that the wholesale distributor ships into.   
130   
131  11.  I am a 3PL in a State without a licensing requirement for 3PLs.  What 
132  information should I report? 
133   
134  If a 3PL facility has no license information to report, a 3PL facility should report the name and 
135  address of the facility, as well as the facility contact information.   
136    
137  12. Should 3PL facilities report all State licenses, including those licenses that classify 
138  the 3PL as a wholesale distributor? 
139   
140  The DSCSA does not permit states to license 3PLs as wholesale drug distributors.13   
141   
142  Third-party logistics provider facilities must report any State licenses that classify them as 3PLs.  
143  Until the FDA regulations on standards for 3PL licensing go into effect, if an entity meets the 
144  3PL definition in section 581(22) of the FD&C Act but is not licensed by a State as a 3PL, the 
145  3PL facility should report but not submit any license information for that facility (see response 
146  11, above).  
147   
148  13. For a wholesale distributor, what disciplinary actions must be reported? 
149   
150  Wholesale distributors must report any significant disciplinary actions, including suspension or 
151  revocation of a wholesale distributor license, taken by a State or the Federal Government during 
                                                 
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.  
  4  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
152  the reporting period against the wholesale distributor.  FDA considers significant disciplinary 
153  actions taken by a State or Federal government to include disciplinary actions that limit the 
154  ability of that entity to distribute human prescription drugs, such as actions taken against the 
155  wholesale distributors United States Drug Enforcement Agency (DEA) registration.14    
156   
157  14. I am a wholesale distributor.  Should we provide our DEA registration or State 
158  controlled-substance license(s) information when reporting? 
159   
160  No.  For routine annual reporting, wholesale distributors should not report DEA registration 
161  numbers or State controlled-substance licenses to FDA.  The only exception is when there is a 
162  disciplinary action issued by the DEA or the State controlled-substance licensing authority that 
163  would limit the ability of an entity to distribute human prescription drug products.  In that case, 
164  information about the DEA registration or State controlled-substance license should be reported 
165  because the disciplinary action is reported under that specific license or registration (see response 
166  13, above).  
167   
168  15. For 3PLs, what disciplinary actions should be submitted? 
169   
170  FDA is requesting that 3PL facilities report significant disciplinary actions taken by a State or 
171  Federal Government that limit the ability of the 3PL to distribute human prescription drug 
172  products, such as suspension or revocation of a license.  Disciplinary actions taken against a 
173  manufacturer, repackager, wholesale distributor, or dispenser for which the 3PL conducts 
174  warehousing or other logistics services should not be reported by the 3PL facility unless the 
175  disciplinary actions involved the 3PL.  
176   
177  16. I am a 3PL.  Should we provide our DEA registration or State controlled-
178  substance license(s) information when reporting? 
179   
180  No.  For routine annual reporting, 3PL facilities should not report DEA registration numbers or 
181  State controlled-substance licenses to FDA.  The only exception is when there is a significant 
182  disciplinary action issued by the DEA or the State controlled-substance licensing authority that 
183  would limit the ability of an entity to distribute human prescription drug products.  In that case, 
184  information about the DEA registration or State controlled-substance license should be reported 
185  because the disciplinary action is reported under that specific license or registration.  
186   
187  17. Should the Unique Facility Identifier (UFI) be reported for the reporter? 
188   
189  Yes, the UFI is used to either obtain an account to report using the Center for Drug Evaluation 
190  and Research (CDER) Direct Electronic Submissions Portal (CDER Direct or CDER Direct 
191  system), or to report using an alternative mechanism such as through the FDA Electronic 
192  Submissions Gateway.  More information about these reporting systems is included under 
193  Section V., below. 
194   
195     
                                                 
14 See section 503(e)(2)(A)(ii) of the FD&C Act. 
  5  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
196  18. Does the UFI need to be reported for each facility? 
197   
198  The UFI is not required for each facility at this time.  However, if a UFI is reported, the 
199  electronic system will perform a validation of the UFI against the company name and facility 
200  address that corresponds with that UFI.  If the company name and address do not correspond 
201  with the information associated with the UFI, the system will not accept the submission.  A UFI 
202  should be obtained for each separate address.  The UFI can be verified by checking 
203  https://www.dandb.com/dunsnumberlookup/. 
204   
205  19. Does every facility name need to be different? 
206   
207  The facility name should be the business name of the facility that corresponds with the UFI.  Do 
208  not include the city, doing business as (DBA) name, or other extraneous information in the field 
209  for name of the facility unless it is included in the official business name of the facility.  
210   
211  20. Who should be reported as the contact person for a facility? 
212    
213  The facility contact person should be the facility manager or designated representative of the 
214  facility manager who has authority to address inquiries about the facility and its operations with 
215  FDA, the licensing authority, and other trading partners.  
216   
217  21. I am the contact person for a facility.  What contact information should I 
218  provide? 
219   
220  FDA considers contact information to include the email address, telephone number, and name of 
221  individual (if applicable).  NOTE: This information is included in the public database.  
222   
223  IV.  CLARIFICATION OF WHEN TO REPORT 
224   
225  22. Does reporting need to be performed just once a year or do wholesale distributors 
226  and 3PL facilities need to report throughout the year if they have a change in 
227  license expiration date or a disciplinary action? 
228   
229  The DSCSA requires that wholesale distributors and 3PL facilities report annually.15  FDA is 
230  requesting that wholesale distributors and 3PL facilities report between January 1st and March 
231  31st of each year.  If an entity chooses to update expired licenses during a time frame outside of this 
232  annual reporting time period, the entity should still report during the next defined annual reporting 
233  period.  FDA requests that disciplinary actions be reported within 30 days of the final ruling by the 
234  State or Federal licensing authority.  FDA also requests that entities that go out of business or 
235  voluntarily withdraw a license report this to FDA within 30 days.  
236   
237     
                                                 
15 See sections 503(e)(2)(A) and 584(b) of the FD&C Act. 
  6  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
238  23. If there are no changes to the information reported the previous year, do I need 
239  to report again? 
240   
241  Yes, the DSCSA requires that wholesale distributors and 3PL facilities report annually.16  
242   
243  24. If I missed the requested reporting deadline of March 31st, do I need to wait until 
244  the next reporting period (January 1st  March 31st)? 
245   
246  No, wholesale distributors and 3PL facilities should not wait until the next reporting period 
247  (January 1st  March 31st) to report under those circumstances.  The DSCSA requires that 
248  wholesale distributors and 3PL facilities report to FDA annually.17  If you have missed the 
249  requested deadline, wholesale distributors and 3PL facilities must still report annually and should 
250  do so as soon as possible.  Reporting after the requested deadline, or submitting updates, can be 
251  done using the CDER Direct system at any time.  
252   
253  25. I have been informed by the State licensing authority of a potential disciplinary 
254  action, but the hearing with the State Board has not occurred.  Do I have to 
255  report within 30 days of the notification or within 30 days after the final ruling by 
256  the State? 
257   
258  For wholesale distributors and 3PLs, disciplinary actions should be reported within 30 days of 
259  the final ruling, along with any supporting documentation of the disciplinary action taken.  
260   
261  V.  CLARIFICATION OF HOW TO REPORT 
262   
263  26. If I reported information using CDER Direct, can I go back and enter additional 
264  information to that submitted report? 
265   
266  It is not possible to enter additional information to a previously accepted submission.  However, 
267  additional information may be submitted by creating a new version by following these steps: 
268    Log into CDER Direct. 
269    Choose the last Submission Accepted and open it. 
270    Click on Create New Version (the version number should increase by 1). 
271    Enter or update information as necessary. 
272    Submit the report in Structured Product Labeling (SPL) format by clicking on Submit 
273  the SPL.   
274   
275  This same process may be used to re-report annually, update license expiration dates, or report 
276  disciplinary actions.  
277    
278     
                                                 
16 Id.  
17 See sections 503(e)(2) and 584(b) of the FD&C Act.  
  7  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
279  27. Do I need to use CDER Direct to enter the license information? 
280   
281  No, FDA developed reporting through CDER Direct for the convenience of wholesale 
282  distributors and 3PLs and highly recommends its use.  Companies using CDER Direct for entry 
283  and submission will not be required to convert the information to extensible markup language 
284  (XML) in SPL format; this formatting will happen automatically when using the CDER Direct 
285  system.  The information will be entered once and saved in the system for future review and 
286  updating.   
287   
288  If a wholesale distributor or a 3PL facility chooses not to use CDER Direct for reporting, 
289  alternative methods for reporting include either: 
290    Submitting a properly formatted XML file in the SPL format via an account through the 
291  FDA Electronic Submissions Gateway (ESG), or  
292    Uploading a zipped XML file in the SPL format into CDER Direct.   
293   
294  The specifications for the XML in the SPL format for wholesale distributors and 3PLs can be 
295  found in the SPL Implementation Guide with Validation Procedures (available on the FDA Web 
296  site at 
297  http://www.fda.gov/downloads/ForIndustry/DataStandards/StructuredProductLabeling/UCM321
298  876.pdf). 
299   
300  Wholesale distributors and 3PL facilities that use alternative methods other than CDER Direct 
301  should check the SPL format before submitting because updates to the system are implemented 
302  from time to time and the SPL format may change.  
303   
304  28. How do I report annually in CDER Direct if I have no new information? 
305   
306  To satisfy the reporting requirement, if CDER Direct is used: 
307    Log into CDER Direct. 
308    Choose the last Submission Accepted and open it. 
309    Click on Create New Version (the version number should increase by 1). 
310    Submit the SPL.    
311   
312  29. How do I update a previously reported disciplinary action that has been resolved 
313  satisfactorily?  
314   
315    Log into CDER Direct. 
316    Choose the last Submission Accepted and open it. 
317    Click on Create New Version (the version number should increase by 1). 
318    Add a new disciplinary action and choose resolved from the drop-down menu. 
319    Upload the document that corresponds to the action.  Do not delete or edit the previously 
320  reported action. 
321    Submit the SPL.   
322   
323     
  8  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
324  30. Can a third party report on behalf of a wholesale distributor or 3PL? 
325   
326  Yes, a wholesale distributor or 3PL may designate a third party to enter the facility information 
327  into CDER Direct or create the XML file in the SPL format if direct data entry in CDER Direct 
328  is not used.  The third party should identify itself as the contact for the reporter contact name; 
329  however, the UFI and reporter name should be the company for which the reporter is reporting.  
330  If this is not done, then all companies that the third party is reporting on behalf of would be in 
331  the same SPL record.  In addition, the contact information for each facility should reflect the 
332  appropriate facility representative who will interact with FDA (see response 19, above).  
333   
334  31. If I reported in error (I am not a 3PL facility or a wholesale distributor), how do 
335  I eliminate my entire entry? 
336   
337  To withdraw a report, do the following steps: 
338    Log into CDER Direct. 
339    Choose the last Submission Accepted and open it. 
340    Click on Create New Version (the version number should increase by 1). 
341    Under Document Type at the top under Header Details, select Withdrawal of 
342  wholesale drug distributor and third-party logistics facility report from the drop-down 
343  menu.   
344    Submit the SPL.   
345   
346  32. If I go out of business, what should I report? 
347   
348  To report going out of business, a wholesale distributor or 3PL facility should perform the 
349  following steps within 30 days of going out of business: 
350    Log into CDER Direct. 
351    Choose the last Submission Accepted and open it. 
352    Click on Create New Version (the version number should increase by 1). 
353    Under Document Type at the top under Header Details, select Out of Business 
354  Notification from the drop-down menu.   
355    Submit the SPL.  
356   
357  33. If I sell a facility, how do I delete that facility from my report? 
358   
359  To delete one facility in a report that contains more than one facility, follow these steps: 
360    Log into CDER Direct. 
361    Choose the last Submission Accepted and open it. 
362    Click on Create New Version (the version number should increase by 1). 
363    Click on the edit pencil next to the facility to be deleted. 
364    A separate page will open and click delete facility from the top bar.  This will delete 
365  the facility and all information, including licenses associated with that facility.  
366    Submit the SPL.  
367   
  9  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
368  34. If my company has a change of ownership, what should I do with the current 
369  report?  Do I need to report the new company? 
370   
371  Following the company change of ownership, a wholesale distributor or 3PL should follow State 
372  licensing laws to obtain new licenses if required.  Wholesale distributor and 3PL facilities that 
373  are newly licensed should initially report within 30 days of obtaining a State or Federal license.   
374  After the change is complete and new licenses (if applicable) are obtained, CDER Direct has a 
375  mechanism for withdrawing the current report (see process in response 30, above).  After 
376  withdrawing the current report, you should then report the information for the new company, 
377  including all applicable wholesale distributor or 3PL licenses issued by States to the new 
378  company.  Trading partners will be able to access the information about the new company in the 
379  FDA public database. 
380   
381  VI.  PUBLIC AVAILABILITY OF INFORMATION 
382   
383  35. Why are some facility addresses not available in the public database? 
384   
385  The DSCSA does not require facility address to be available in the publicly available database.18  
386  FDA received comments indicating that making addresses or UFIs publicly available for certain 
387  facilities could be a safety risk.  FDA has added a field in CDER Direct where a reporter can 
388  indicate if a facility address should remain confidential.  If the field is selected, FDA will not 
389  publish the street address on the public Web site.  However, pursuant to a Freedom of 
390  Information Act request or FDAs regulations, FDA may ultimately make determinations as to 
391  whether the street address can be disclosed to the public under the Trade Secrets Act, the 
392  Freedom of Information Act, and other applicable law. 
393   
394  36. How long does it take to see updates in the public database? 
395   
396  The public database is updated the next business day, usually by 12:00 pm (EST).  
397   
398  37. Why are some companies listed both in FDAs eDrug Registration and Listing 
399  System (eDRLS) and in the wholesale distributor and 3PL public database? 
400   
401  The DSCSA requires annual reporting to FDA of licensure and other information by wholesale 
402  distributors and 3PL facilities.19  Section 510 of the FD&C Act requires any person who owns or 
403  operates any establishment that manufactures, prepares, propagates, compounds, or processes 
404  drugs in the United States, or that are offered for import into the United States, to register with 
405  FDA.  If a firm meets the requirements under DSCSA and under section 510, it would be 
406  required to report to both systems.  Also, in some cases, firms may have mistakenly registered 
407  under one system or the other.    
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. 
  10  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
409  38. Why are disciplinary actions not listed in the public database? 
410   
411  Although the DSCSA requires that certain types of disciplinary actions be reported to FDA, the 
412  statute does not require that the public database contain disciplinary actions.  Currently, FDAs 
413  public database does not list disciplinary actions submitted to FDA.  However, pursuant to a 
414  Freedom of Information Act request or FDAs regulations, FDA may ultimately make 
415  determinations as to whether a disciplinary action can be disclosed to the public under the Trade 
416  Secrets Act, the Freedom of Information Act, and other applicable law. 
417    
418  39. Why isnt doing business as a field in the public database? 
419   
420  Although you may not be able to see the doing business as name in the public database, FDA 
421  has linked the doing business as name to the facility name field in the CDER Direct system.  If 
422  you search for a doing business as name, the facility name will appear in the generated table. 
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