DSCSA Implementation: 
Annual Reporting by 
Prescription Drug Wholesale 
Distributors and Third-Party 
  
Logistics Providers
 
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DRAFT GUIDANCE 
 
  This guidance document is being distributed for comment purposes only.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publication in the Federal Register of the notice announcing the availability of the draft 
guidance.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) 
 
December 2014 
Procedural   
DSCSA Implementation: 
Annual Reporting by 
Prescription Drug Wholesale 
Distributors and Third-Party 
Logistics Providers 
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 Avenue 
Hillandale Building, 4th Floor, 4147 
Silver Spring, MD 20993 
Phone: 301-796-3400 or 855-543-3784; Fax: 301-431-6353 
druginfo@fda.hhs.gov  
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm 
and/or 
Office of Communication, Outreach and 
Development, WO71, Room 3128 
Center for Biologics Evaluation and Research 
 Food and Drug Administration 
10903 New Hampshire Ave. 
Silver Spring, MD 20993 
Phone: 800-835-4709 or 240-402-7800 
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) 
 
December 2014 
Procedural  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
 
TABLE OF CONTENTS 
 
 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 2 
III.  WHO MUST REPORT .................................................................................................... 2 
A.  Prescription Drug Wholesale Distributors .................................................................................. 2 
B.  Third-Party Logistics Providers ................................................................................................... 2 
C.  Dual Roles ....................................................................................................................................... 3 
IV.  WHAT SHOULD BE REPORTED ................................................................................ 3 
A.  Discussion ....................................................................................................................................... 3 
B.  Initial Report .................................................................................................................................. 3 
C.  Subsequent Reports ....................................................................................................................... 6 
V.  WHEN TO REPORT ....................................................................................................... 6 
A.  Initial Report .................................................................................................................................. 6 
B.  Subsequent Annual Reports.......................................................................................................... 6 
C.  Significant Disciplinary Action Reports ...................................................................................... 6 
D.  Other Voluntary Reports .............................................................................................................. 6 
VI.  HOW TO REPORT .......................................................................................................... 7 
A.  Format ............................................................................................................................................. 7 
B.  Submission ...................................................................................................................................... 7 
VII.  PUBLIC AVAILABILITY OF INFORMATION ......................................................... 7 
 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
1  Guidance for Industry1 
2  Drug Supply Chain Security Act Implementation:   
3  Annual Reporting by Prescription Drug Wholesale Distributors and  
4  Third-Party Logistics Providers   
5   
6  This draft guidance, when finalized, will represent the Food and Drug Administrations (FDAs) current 
7  thinking on this topic. It does not create or confer any rights for or on any person and does not operate to 
8  bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of 
9  the applicable statutes and regulations. If you want to discuss an alternative approach, contact FDA staff 
10  responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the 
11  appropriate number listed on the title page of this guidance.  
12   
13   
14   
15  I.  INTRODUCTION  
16   
17  This guidance describes FDAs expectations for prescription drug wholesale distributors 
18  (wholesale distributors) and third-party logistics providers (3PLs) for the annual reporting to 
19  FDA as required under the Drug Supply Chain Security Act of 2013 (DSCSA).  Under section 
20  584(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-3(b)), 
21  beginning November 27, 2014, 3PLs must report certain information to FDA, including State 
22  licensure information for each facility and the name and address for each facility.  Under section 
23  503(e)(2)(A) (21 U.S.C. 353(e)(2)(A) (as amended by the DSCSA), beginning January 1, 2015, 
24  wholesale distributors also must report certain information to FDA, including State licensure 
25  information for each facility, contact information for each facility, and any significant 
26  disciplinary actions taken by a State or the Federal Government.  This guidance outlines the 
27  information that should be submitted to FDA, the timing of the submissions, a preferred format 
28  for the submissions, and a preferred method for reporting to FDA.   
29   
30  This guidance does not address all requirements described in the DSCSA for wholesale 
31  distributors and 3PLs pursuant to sections 503(e)(2) and 584.  The information provided in this 
32  guidance is limited to reporting of information by wholesale distributors and 3PLs. Some 
33  information outlined in the guidance is required to be reported under section 503(e)(2)(A) and 
34  section 584(b) of the FD&C Act, as amended by the DSCSA.   
35   
36  FDAs guidance documents, including this guidance, do not establish legally enforceable 
37  responsibilities.  Instead, guidances describe the Agencys current thinking on a topic and should 
38  be viewed only as recommendations, unless specific regulatory or statutory requirements are 
39  cited.  The use of the word should in Agency guidances means that something is suggested or 
40  recommended, but not required.   
41   
                                                 
1 This guidance has been prepared by the Office of Compliance in the Center for Drug Evaluation and Research 
(CDER) in cooperation with the Center for Biologics Evaluation and Research (CBER).  
  1  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
42  II.  BACKGROUND 
43   
44  On November 27, 2013, the DSCSA (Title II of Public Law 113-54) was signed into law.  The 
45  DSCSA outlines new requirements to develop and enhance drug distribution security over the 
46  next 10 years, including establishing national standards for the licensing of prescription drug 
47  wholesale distributors and 3PLs.     
48   
49  Section 204 of the DSCSA amends section 503(e) of the FD&C Act and outlines requirements 
50  for reporting by wholesale distributors.  Section 503(e)(2)(A) of the FD&C Act (as amended) 
51  requires wholesale distributors to report certain information annually, beginning on January 1, 
52  2015.  Information to be reported includes State licensure information and contact information for 
53  each facility.  Wholesale distributors must also report to FDA any significant disciplinary actions 
54  taken by the State or Federal Government, such as revocation or suspension of a license.  Section 
55  204 of the DSCSA also amends section 503(e)(2)(B) of the FD&C Act and requires FDA to 
56  make certain information about wholesale distributors licensure available to the public on 
57  FDAs Web site.  Updates to the public information are to be made on a schedule to be 
58  determined by FDA. 
59   
60  Section 205 of the DSCSA adds section 584 to the FD&C Act.  Section 584 sets forth 
61  requirements for licensure and reporting by 3PLs.  Under section 584(b) of the FD&C Act (as 
62  amended), 3PLs must report annually to FDA, beginning on November 27, 2014 (1 year after the 
63  date of enactment of the DSCSA).  Third-party logistic providers must report State licensure 
64  information, the name and address for each facility, and all trade names under which each 
65  facility conducts business. 
66   
67  III.  WHO MUST REPORT 
68   
69  A.  Prescription Drug Wholesale Distributors  
70   
71  Section 503(e)(2)(A) requires that any person who owns or operates an establishment that 
72  engages in wholesale distribution, as defined in section 503(e)(4) of the FD&C Act, as amended 
73  by the DSCSA, must report. Companies should refer to the applicable definitions in section 
74  503(e)(4) of the FD&C Act to determine if they conduct wholesale distribution and would be 
75  required to report annually to FDA.  
76   
77  B.  Third-Party Logistics Providers 
78   
79  Section 584 requires that any facility of a 3PL, as defined in section 581(22) of the FD&C Act, 
80  as amended by DSCSA, must report.   A 3PL is an entity that provides or coordinates 
81  warehousing, or other logistics services of a product2 in interstate commerce on behalf of a 
82  manufacturer, wholesale distributor, or dispenser of a product, but does not take ownership of the 
83  product, nor have responsibility to direct the sale or disposition of the product.  
84   
                                                 
2 Product as defined under section 581(13) of the FD&C Act (21 U.S.C. 360eee), as amended by the DSCSA. 
  2  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
85   
86  C.  Dual Roles 
87   
88  Any person or entity that acts as both a wholesale distributor and a 3PL is subject to the reporting 
89  requirements of both section 503(e)(2) and section 584.  The person or entity should report 
90  according to the relevant requirement for each respective facility. If a company conducts both 
91  prescription drug wholesale distribution and 3PL services from the same facility, that facility 
92  should be reported separately under each category as a wholesale distributor and a 3PL.   
93   
94  IV.  WHAT SHOULD BE REPORTED 
95   
96  A.  Discussion 
97     
98  The DSCSA requires FDA to make a database of authorized wholesale distributors available to 
99  the public on FDAs Web site.  In addition,  FDA believes it would be helpful for enforcement of 
100  the DSCSA to make information about 3PLs available on FDAs Web site, because having the 
101  license status of 3PLs in one publicly available database would be helpful for FDA, trading 
102  partners, and other stakeholders, in determining whether 3PLs are authorized or not.   Therefore, 
103  all of the information reported to the FDA may be made available to the public on the FDA Web 
104  site, to the extent allowable by law. 
105  The DSCSA requires contact information to be submitted by wholesale distributors.  FDA 
106  considers contact information to include the email address and telephone number of the person 
107  who will interact with the FDA.  In addition to the specific information required by DSCSA to be 
108  submitted to the Agency, FDA has identified additional information that will enhance 
109  efficiencies and improve accuracy in the management of the licensing and facility information 
110  submitted to the Agency.  Therefore, FDA is requesting that certain additional information be 
111  submitted to FDA on a voluntary basis.  This additional information will be useful to FDA in its 
112  enforcement of the Act and to stakeholders as they make decisions about their drug product 
113  distribution.  Furthermore, FDA is requesting the same information from wholesale distributors 
114  and 3PLs. The ultimate goal is for the public database to serve as a single repository of licensing 
115  and facility information for wholesale drug distributors and 3PLs conducting business in the 
116  United States.  
117  B.  Initial Report 
118   
119  The initial report from a wholesale distributor is the first report submitted to FDA to meet the 
120  reporting requirements under section 503(e)(2)(A) of the FD&C Act, as amended by the 
121  DSCSA.   
122  1.  For each facility, a wholesale distributor must provide:  
123   
124  a)  Identifying information for the facility 
125    Name of company (FDA recommends providing the company 
126  name in the same form as it appears on the license) 
127    Address of the facility 
  3  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
128    Contact information (FDA recommends providing the name of a 
129  contact person to interact with FDA, an email address and a 
130  telephone number) 
131    All trade names that the company does business as (i.e., any other 
132  names listed as dba) 
133   
134  b)  Licensure information for each State 
135    State  
136    State license number (identification number) 
137    Significant disciplinary actions by any State or Federal agency 
138  (FDA recommends describing any significant disciplinary action 
139  that occurred in the 12 months preceding the initial report by 
140  identifying the type of disciplinary action, the date of final 
141  disciplinary action, and the state where the disciplinary action 
142  occurred) 
143   
144   
145  2.  For each facility, a wholesale distributor should provide: 
146  a)  Unique facility identifier 
147  b)  Expiration date for the license  
148  c)  Documents associated with the disciplinary action, such as a 
149  consent decree, final State Board ruling, etc. 
150   
151  The initial report from a 3PL is the first report submitted to FDA to meet the reporting 
152  requirements under section 584(b) of the FD&C Act, as amended by the DSCSA. 
153   
154  1.  For each facility, a 3PL must provide: 
155  a)  Name of company (FDA recommends providing the company 
156  name in the same form as it appears on the license) 
157  b)  Address of the facility 
158  c)  All trade names that the company does business as (i.e., any other 
159  names listed as dba) 
160  d)  Licensure information for each State 
161    State  
162    State license number (identification number) 
163   
164  2.  For each facility, a 3PL should provide: 
165  a)  Name of contact person to interact with FDA 
166  b)  Email address 
167  c)  Telephone number 
168  d)  Unique facility identifier 
169  e)  Expiration date for the license  
170  f)  Significant disciplinary actions by any State or Federal agency that 
171  occurred in the 12 months preceding the initial report the past 1 
172  year 
173    State where disciplinary action occurred 
  4  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
174    Date of final action 
175    Type of disciplinary action 
176    Description of violation 
177    Documents associated with the disciplinary action, such as a 
178  consent decree, final State Board ruling, etc. 
179   
180  In addition to the name and address of the facility, FDA is requesting that wholesale distributors 
181  and 3PLs submit a unique facility identifier for each facility. The site-specific unique facility 
182  identifier for a facility is a useful resource for FDA in identifying and confirming certain 
183  business information for that entity.  The current unique facility identifier preferred by FDA is 
184  the D-U-N-S number.  Businesses may obtain D-U-N-S numbers for no cost directly from 
185  Dun & Bradstreet (D&B) (http://www.dnb.com).3  
186   
187  State license information must be provided for each State from which the drug products are 
188  distributed with State licensure programs and for each State that requires a license to ship 
189  product into that State.  Third-party logistics providers are considered to be licensed under 
190  section 582(a)(7) of the FD&C Act (as amended) (21 U.S.C. 360eee-1) until the effective date of 
191  the 3PL licensing regulations and may not have information to report to FDA about specific 
192  State licensure unless a State has a 3PL licensing program.  However, 3PLs are still required to 
193  report to the FDA under the DSCSA.   
194   
195  FDA is also requesting submission of the date(s) that State license(s) expires. This information is 
196  essential for determining the licensure status for each wholesale distributor and 3PL facility 
197  during the reporting period.  Pursuant to section 503(e)(1) of the FD&C Act, as amended by the 
198  DSCSA, wholesale distributors will be licensed by the State from which the drug is distributed or 
199  by FDA if the State from which the drug is distributed has not established a licensure program.  
200  Wholesale distributors will also be licensed by the State into which the drug is distributed if 
201  required by that State.  Similarly, pursuant to 584(a) of the FD&C Act, as amended by the 
202  DSCSA, 3PLs will be licensed by the State from which the drug is distributed or by FDA if the 
203  State has not established a licensure program.  And 3PLs will be licensed by the State into which 
204  the drug is distributed if that State requires the licensure of a person that distributes drugs into 
205  the State and the 3PL is not licensed by FDA. 
206   
207  Significant disciplinary actions taken against wholesale distributors must be reported to FDA, as 
208  required under section 503(e)(2)(ii) of the FD&C Act, as amended by the DSCSA.  In addition, 
209  FDA is requesting that 3PLs report significant disciplinary actions to FDA.  It is important for 
210  FDA and others to know whether a wholesale distributor or 3PL has had a license revoked or 
211  suspended or whether a wholesale distributor or 3PL has had any other significant disciplinary 
212  actions taken against them that limits the ability of a facility to conduct drug-related business.  
213  Reports of significant disciplinary actions should include any action by State or Federal 
214  government that limits or prevents a wholesale distributor or 3PL from distributing or facilitating 
                                                 
3 As explained in FDAs Guidance for Industry: Specification of the Unique Facility Identifier (UFI) System for 
Drug Establishment Registration (available at http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-
gen/documents/document/ucm367199.pdf), alternative identifiers can also be used by contacting FDA. 
  5  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
215  the distribution of prescription drugs, including for-cause revocation, termination, or suspension 
216  of a license.   
217   
218  C.  Subsequent Reports 
219   
220  To meet the continuing reporting requirements under sections 503(e)(2)(A) and 584(b) of the 
221  FD&C Act , as amended by DSCSA, any reports from a wholesale distributor or 3PL submitted 
222  to FDA after the Initial Report for a particular facility is considered a subsequent report for 
223  that facility.  The required and voluntary components of subsequent reports are the same as those 
224  for initial reports.   
225   
226  V.  WHEN TO REPORT 
227   
228  The following section describes the time frames for reporting for wholesale distributors and 
229  3PLs to FDA to meet the reporting requirements under DSCSA and provide additional 
230  information to FDA voluntarily.  If a company chooses to update expired licenses during a time 
231  frame outside of the annual reporting time period as defined below, the company should still 
232  report during the defined annual reporting period.   
233   
234  A.  Initial Report  
235   
236  1.  Wholesale distributors: January 1, 2015March 31, 2015 
237  2.  3PLs: November 27, 2014March 31, 2015 
238  3.  Wholesale distributor and 3PL facilities that are newly licensed after the 
239  dates noted above should initially report within 30 days of obtaining a 
240  State or Federal license. 
241   
242  B.  Subsequent Annual Reports 
243   
244  1.  Wholesale distributors: January 1March 31 annually 
245  2.  3PLs: January 1March 31 annually 
246   
247  C.  Significant Disciplinary Action Reports  
248   
249  Reports of significant disciplinary actions should be submitted to FDA when a final action or 
250  ruling has been made by a State or Federal licensing authority. 
251   
252  1.  Wholesale distributors: within 30 days of final action  
253  2.  3PLs: within 30 days of final action 
254   
255  D.  Other Voluntary Reports 
256   
257  A company should notify FDA if a facility goes out of business or decides to voluntarily 
258  withdraw a State or Federal license.   
259   
  6  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
260  1.  Out of business: within 30 days of business closing 
261  2.  Voluntary withdrawal of a State license: within 30 days  
262   
263  VI.  HOW TO REPORT 
264   
265  A.  Format  
266   
267  FDA prefers the use of extensible markup language (XML) files in a standard Structured Product 
268  Labeling (SPL)4 format. 
269   
270  B.  Submission 
271   
272  FDA is providing a method to enter and submit the required and voluntary reporting and 
273  significant disciplinary actions for wholesale distributors and 3PLs.  A link to the Web portal can 
274  be accessed from FDAs Web site. Wholesale distributors and 3PLs should access FDAs Web 
275  page at http://www.fda.gov/wdd3plreporting and follow the instructions to complete the required 
276  and voluntary reporting.  Companies using the FDA Web portal for entry and submission will 
277  not have to convert the information to XML in the SPL format; appropriate formatting will 
278  happen automatically via the web portal.   This portal will allow a company to act as a reporter 
279  for all of the facilities that they own without having to create a separate account for each facility. 
280  If the reporter wants to enter information for multiple facilities, contact information about the 
281  reporter, including the reporters UFI, will be needed.  An alternative method for reporting is to 
282  submit an XML file in the SPL format via an account through the FDA Electronic Submissions 
283  Gateway (ESG).  If you want to use an alternative method for your submissions, contact FDA via 
284  email at WDD3PLRequirements@fda.hhs.gov for more information. 
285   
286   
287  VII.  PUBLIC AVAILABILITY OF INFORMATION 
288   
289  FDA will make the information collected publically available on its Web site. FDA plans to 
290  make the wholesale distributor and 3PL significant disciplinary action information publicly 
291  available to the extent allowable by law.  This information will be updated on a regular basis.  
292  The public information will be available for download from FDAs Web site at 
293  http://www.fda.gov/wdd3plreporting.   
                                                 
4 SPL is a Health Level Seven, Inc., standard for the exchange of product information using XML. 
  7