Identifying  Trading Partners 
Under the Drug Supply Chain 
  
Security 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DRAFT GUIDANCE
 
 
  This guidance document is being distributed for comment purposes only.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publication  in the Federal Register of the notice announcing  the availability  of the draft 
guidance.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 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  301-796-3130 
or (CBER) Office of Communication,  Outreach and Development, 800-835-4709  or 240-402-
8010 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) 
 
August 2017 
Procedural 
   
Identifying  Trading Partners 
Under the Drug Supply Chain 
Security 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/GuidanceComplianceRegulatoryInformation/Guidances/default.htm  
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/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) 
  
 
 
 
 
 
August 2017 
Procedural 
 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
TABLE OF CONTENTS 
 
 
 
I.  INTRODUCTION ...................................................................................................... 1 
II.  BACKGROUND ........................................................................................................ 2 
A.  Definitions of Drug Supply Chain Entities Under DSCSA ................................................ 2 
B.  Authorized Trading Partners Under DSCSA .................................................................. 3 
C.  Licensure and Reporting Requirements for WDDs and 3PLs ........................................... 4 
III.   IDENTIFYING WHO IS A TRADING PARTNER .................................................. 4 
A.  Manufacturers as Trading Partners Under DSCSA ......................................................... 5 
1. Manufacturing Establishments.......................................................................................... 6 
2. NDA-, BLA-, or ANDA-Holder, or Co-Licensed Partner of a Manufacturer ............................. 6 
3. Affiliate of a Manufacturer (Section 581(10)(C)) ................................................................. 6 
B.  Repackagers as Trading Partners Under DSCSA ............................................................ 7 
C.  WDDs as Trading Partners Under DSCSA ..................................................................... 7 
D.  3PLs as Trading Partners Under DSCSA........................................................................ 8 
1. Entities That Warehouse But Do Not Own or Direct the Sale or Disposition of Product............. 9 
2. Brokers ........................................................................................................................10 
3. Solution Providers .........................................................................................................10 
4. Common Carriers ..........................................................................................................10 
5. Logistics or Administrative Services Contractors................................................................11 
6. Returns Processors and Reverse Logistics Providers...........................................................11 
E.  Dispensers as Trading Partners Under DSCSA ..............................................................11 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
1  Identifying Trading  Partners Under the Drug Supply  Chain 
2  Security Act 
1
3  Guidance for Industry  
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 or the Agency) is issuing  this guidance to assist 
18  industry and State and local governments in understanding  how to categorize the entities in the 
19  drug supply chain in accordance with the Drug Supply Chain Security Act (DSCSA).2  DSCSA 
20  establishes product tracing requirements for certain trading partners in the drug supply chain, 
21  including  manufacturers, repackagers, wholesale distributors,  and dispensers.  DSCSA also 
22  requires that trading partners of manufacturers, wholesale distributors,  dispensers, and 
23  repackagers must meet the applicable  requirements for being authorized  trading partners.3  
24  DSCSA also requires FDA to issue regulations that establish Federal standards for the licensing 
25  of wholesale drug distributors  (WDDs) and third-party logistics  providers (3PLs).  The Agency 
26  is currently drafting these regulations.   This guidance, when finalized,  will explain FDAs 
27  current thinking  on how licensing  and certain other requirements apply to entities that may be 
28  considered trading partners in the drug supply chain.      
29   
30  This guidance is intended to (1) assist industry and State and local governments in understanding 
31  the applicability  of DSCSA requirements to the various types of entities that take part in the 
32  distribution  of prescription  drugs in the United States, and (2) help clarify for industry whether 
33  they are engaged in activities that require licensure and annual reporting,  as well as other 
34  requirements related to being an authorized trading partner in the drug supply chain.  The 
35  guidance does not address all requirements described in DSCSA, but is limited  to describing  the 
36  activities that would determine what type of trading partner an entity may be and the applicable 
37  requirements under DSCSA. 
38   
                                              
1 This guidance has been prepared by the Division of Drug Supply Chain Integrity in the Center for Drug Evaluation 
and Research (CDER) in cooperation with the Center for Biologics Evaluation and Research (CBER) 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), 581, and 584 of the Food, Drug & Cosmetic Act 
(FD&C Act) (21 U.S.C. 353(e), 360eee, and 360eee-3). 
3 See sections 582(b)(3), (c)(3), (d)(3), and (e)(3) of the FD&C Act (21 U.S.C. 360eee-1). 
  1  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
39  In general, FDAs guidance documents do not establish legally  enforceable responsibilities.   
40  Instead, guidances describe the Agencys current thinking  on a topic and should be viewed only 
41  as recommendations,  unless specific regulatory or statutory requirements are cited.  The use of 
42  the word should in Agency guidances means that something  is suggested or recommended, but 
43  not required.  
44   
45   
46  II.  BACKGROUND 
47   
48  On November 27, 2013, DSCSA was signed into law.  It outlines new requirements to develop 
49  and enhance drug distribution  security by 2023.  In part, these changes include defining the types 
50  of entities in the drug supply chain (i.e., manufacturers, repackagers, wholesale distributors, 
51  3PLs, and dispensers), requiring that the trading partners of manufacturers, repackagers, 
52  wholesale distributors,  and dispensers meet the applicable  requirements to be authorized trading 
53  partners, and establishing  national standards for the licensing  of WDDs and 3PLs.  
54   
55  A.  Definitions of Drug Supply Chain Entities Under DSCSA 
56   
57  DSCSA identifies  and defines five types of entities in the prescription  drug supply chain: 
58  manufacturers, repackagers, dispensers, wholesale distributors,  and 3PLs.  DSCSA defines these 
59  entities in section 581 of the FD&C Act (21 U.S.C. 360eee).   
60   
61  A manufacturer is defined in section 581(10) of the FD&C Act to mean:  
62   
63  [W]ith respect to a product -- (A) a person that holds an application approved under 
64  section 505 or a license issued under section 351 of the Public Health Service Act for 
65  such product, or if such product is not the subject of an approved application or license, 
66  the person who manufactured the product; (B) a co-licensed partner of the person 
67  described in subparagraph (A) that obtains the product directly from a person described 
68  in this subparagraph or subparagraph (A) or (C); or (C) an affiliate of a person described 
69  in subparagraph (A) or (B) that receives the product directly from a person described in 
70  this subparagraph or subparagraph (A) or (B).  
71   
72  Section 581(16) of the FD&C Act defines a repackager to mean a person who owns or operates 
73  an establishment that repacks and relabels a product or package for  (A) further sale; or (B) 
74  distribution  without a further transaction.  
75   
76  The term dispenser, as defined in section 581(3) of the FD&C Act: 
77   
78  (A) means a retail pharmacy, hospital pharmacy, a group of chain pharmacies under 
79  common ownership and control that do not act as a wholesale distributor, or any other 
80  person authorized by law to dispense or administer prescription drugs, and the affiliated 
81  warehouses or distribution centers of such entities under common ownership and control 
82  that do not act as a wholesale distributor; and (B) does not include a person who 
83  dispenses only products to be used in animals in accordance with section 512(a)(5). 
84   
85  DSCSA defines wholesale distributor in section 581(29) of the FD&C Act to mean a person 
86  (other than a manufacturer, a manufacturers co-licensed partner, a third-party logistics  provider, 
  2  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
87  or repackager) engaged in wholesale distribution  (as defined in section 503(e)(4) of the FD&C 
88  Act, as amended by [DSCSA]).  Section 503(e)(4) of the FD&C Act (21 U.S.C. 353(e)(4)) 
89  defines wholesale distribution as distribution  of a drug subject to [section 503(b) of the FD&C 
90  Act (21 U.S.C. 353(b))] to a person other than a consumer or patient, or receipt of a drug subject 
91  to [section 503(b) of the FD&C Act (21 U.S.C. 353(b))] by a person other than the consumer or 
92  patient, but exempts several specific activities.    
93   
94  DSCSA adds third-party logistics providers (3PLs) as a new entity in the drug supply chain,4 
95  and requires 3PL facilities  to be licensed and regulated separately from wholesale distributors.5  
96  DSCSA defines a 3PL in section 581(22) of the FD&C Act to mean: 
97   
98  [A]n entity that provides or coordinates warehousing, or other logistics services of a 
99  product in interstate commerce on behalf of a manufacturer, wholesale distributor, or 
100  dispenser of a product, but does not take ownership of the product, nor has responsibility 
101  to direct the sale or disposition of the product.   
102   
103  The key distinction  between wholesale distributors  and 3PLs is that, unlike a wholesale 
104  distributor,  a 3PL does not take ownership of the product, and does not direct the sale or 
105  disposition  of the product.   
106   
107  B.  Authorized Trading Partners Under DSCSA 
108   
109  DSCSA restricts access to the distribution  system for prescription  drug products by requiring 
110  trading partners of manufacturers, wholesale distributors,  dispensers, and repackagers meet the 
111  applicable requirements for being authorized trading partners.6  DSCSA includes definitions  for 
112  authorized7 and trading partner8 with respect to each entity in the drug supply chain as follows:    
113   
114    To be considered an authorized trading partner, a manufacturer or repackager must have 
115  a valid registration in accordance with section 510 of the FD&C Act and accept or 
116  transfer direct ownership of a product from or to a manufacturer, repackager, wholesale 
117  distributor,  or dispenser.  
118   
119    To be considered an authorized trading partner, a wholesale distributor must have a valid 
120  license under State law or section 583 of the FD&C Act, in accordance with section 
121  582(a)(6) of the FD&C Act , comply with the licensure reporting requirements in section 
122  503(e) of the FD&C Act, as amended by DSCSA, and accept or transfer direct ownership 
123  of a product from or to a manufacturer, repackager, wholesale distributor,  or dispenser.  
124   
125    Similarly,  to be considered an authorized trading partner, a 3PL must have a valid license 
126  under State law or section 584(a)(1) of the FD&C Act, in accordance with section 
                                              
4 Section 581(22) of the FD&C Act.  
5 See section 585(b)(2) of the FD&C Act(21 U.S.C. 360eee-4).   
6 See sections 582(b)(3), (c)(3), (d)(3), and (e)(3) of the FD&C Act (21 U.S.C. 360eee-1). 
7 See section 581(2) of the FD&C Act. 
8 See section 581(23) of the FD&C Act. 
  3  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
127  582(a)(7) of the FD&C Act, comply with the licensure reporting requirements under 
128  section 584(b) of the FD&C Act (21 U.S.C. 360eee-3), and accept or transfer direct 
129  possession of a product from or to a manufacturer, repackager, wholesale distributor,  or 
130  dispenser.  
131   
132    A dispenser must have a valid license under State law and accept or transfer direct 
133  ownership of a product from or to a manufacturer, repackager, wholesale distributor,  or 
134  dispenser.  
135    
136  C.  Licensure and Reporting Requirements for WDDs and 3PLs 
137   
138  DSCSA also establishes new licensure and reporting requirements for wholesale distributors  and 
139  third-party logistics  providers.  
140   
141  Section 503(e) of the FD&C Act (as amended by DSCSA) establishes licensure requirements 
142  and adds reporting requirements for WDDs.  Specifically,  section 503(e)(1) prohibits  a person 
143  from engaging in wholesale distribution  of prescription drugs in any State unless such person is 
144  licensed by the State from which the drug is distributed,  or by FDA if such State from which the 
145  drug is distributed  has not established a licensure requirement.  Furthermore, under certain 
146  circumstances,9 such person must also be licensed by the State into which the drug is distributed.   
147  Section 503(e)(2) of the FD&C Act requires WDDs to report certain information  to FDA on an 
148  annual basis, including  State licensure information  for each license, the name and address of 
149  each licensed facility,  and any significant  disciplinary  actions taken by a State or the Federal 
150  government.10  
151   
152  DSCSA adds section 584 to the FD&C Act; the section sets forth requirements for licensure and 
153  reporting by 3PL facilities.  Specifically,  section 584(a) prohibits  a 3PL in any State from 
154  conducting activities in any State unless each facility  of the 3PL is licensed by the State from 
155  which the drug is distributed  by the 3PL, or by FDA if the State from which the drug is 
156  distributed  by the 3PL has not established a licensure requirement.  Furthermore, under certain 
157  circumstances,11 the 3PL must also be licensed by the State into which the drug is distributed.  
158  Section 584(b) of the FD&C Act requires 3PL facilities to report certain information  to FDA, 
159  including  State licensure information  for each facility and the name and address of each facility.  
160   
161   
162  III.   IDENTIFYING WHO IS A TRADING PARTNER 
163   
                                              
9 See section 503(e)(1)(A)(ii)  in relevant part, if the State into which the drug is distributed requires the licensure 
of a person that distributes drugs into the State. 
10 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). 
11 See section 584(a)(2)  in relevant part, if such State licenses third-party logistics providers that distribute drugs 
into the State and the third-party logistics provider is not licensed by the Secretary. 
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Draft  Not for Implementation 
164  FDA has received comments and inquiries  about which entities meet the definitions  of the 
165  various trading partners.  Whether an entity meets the statutory definition  of a particular trading 
166  partner that would trigger the applicable requirements depends on the activities in which it 
167  engages.  This may be particularly  applicable  to entities, such as private-label  distributors,12  who 
168  may have a variety of business models and may meet the definitions  of a variety of trading 
169  partners.  Please see the discussion below for each type of trading partner for more information. 
170   
171  There has also been confusion about how the definitions  of wholesale distributor and wholesale 
172  distribution changed upon enactment of the DSCSA.  Regulations enacted prior to DSCSA 
173  defined the term wholesale distributor to include manufacturers; repackers; own-label 
174  distributors;  private-label  distributors;  jobbers; brokers; warehouses, including  manufacturers' 
175  and distributors'  warehouses, chain drug warehouses, and wholesale drug warehouses; 
176  independent wholesale drug traders; and retail pharmacies that conduct wholesale distributions.13   
177  Some of these listed entities are not included as wholesale distributors  in the DSCSA.   
178   
179  In addition,  section 581 of the FD&C Act defines different types of trading partners in the drug 
180  supply chain, including  manufacturers, repackagers, WDDs, 3PLs, and dispensers.  Neither 
181  section 503(e) nor section 581 of the FD&C Act lists the other types of entities included in the 
182  regulations discussed above, at 21 CFR 203.3(dd).  Consequently,  several types of activities that 
183  may fall within the definition  of wholesale distribution under 21 CFR part 203 are not directly 
184  addressed by the statutory definition  of wholesale distribution  in section 503(e) of the FD&C 
185  Act, as amended by DSCSA.  This may leave questions regarding the status of certain entities 
186  under the DSCSA.  For example, there has been confusion as to whether DSCSA licensure and 
187  reporting requirements apply to certain types of entities, such as but not limited  to jobbers, 
188  brokers, and certain contractors and solution  providers.  To address some of the confusion 
189  expressed by industry and the States, FDA is providing  its current thinking  on each of the trading 
190  partners. 
191   
192  A.  Manufacturers as Trading Partners Under DSCSA 
193   
194  DSCSA defines a manufacturer in section 581(10) of the FD&C Act as:  
195   
196  [W]ith respect to a product -- (A) a person that holds an application approved under 
197  section 505 or a license issued under section 351 of the Public Health Service Act for 
198  such product, or if such product is not the subject of an approved application or license, 
199  the person who manufactured the product; (B) a co-licensed partner of the person 
200  described in subparagraph (A) that obtains the product directly from a person described 
201  in this subparagraph or subparagraph (A) or (C); or (C) an affiliate of a person described 
202  in subparagraph (A) or (B) that receives the product directly from a person described in 
203  this subparagraph or subparagraph (A) or (B).  
204   
205  An entity that falls within the definition  of manufacturer in section 581(10) of the FD&C Act 
206  must comply with the requirements under section 582(b) of the FD&C Act.  
                                              
12 21 CFR 207.1 (2016).   
13 21 CFR 203.3(dd) (1999).  
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207   
208  FDA has received comments and inquiries  about how to determine whether a manufacturer is an 
209  authorized trading partner.  FDA believes that most of the confusion14 is related to the inclusion 
210  of entities that hold drug approvals (aka NDA-, BLA-, or ANDA-holders15), co-licensed 
211  partners, and affiliates of such entities in the definition  of manufacturer in section 581(10) of the 
212  FD&C Act, and the interaction of this definition  with the requirement to register under section 
213  510 of the FD&C Act to be authorized according to section 581(2).   
214   
215  1.  Manufacturing Establishments  
216   
217  Under section 510 of the FD&C Act, and part 207 (21 CFR part 207), with some limited 
218  exceptions, any person who owns or operates any establishment that manufactures, prepares, 
219  propagates, compounds,  or processes drugs in the United States, or that are offered for import 
220  into the United States, must be registered with the FDA.16  Thus, under section 581(2)(A), such 
221  manufacturer establishments must be registered in accordance with section 510 of the FD&C Act 
222  to be considered an authorized trading partner.  
223   
224  2.   NDA-, BLA-, or ANDA-Holder, or Co-Licensed Partner of a Manufacturer  
225   
226  An NDA-, BLA-, or ANDA-holder or co-licensed partner of a manufacturer might not engage in 
227  the manufacturing,  preparation, propagation,  compounding,  or processing of a drug, but could  
228  still meet the definition  of manufacturer in section 581(10) in the FD&C Act.  There has been 
229  confusion as to whether such manufacturers should register under section 510 of the FD&C Act 
230  to be considered an authorized trading partner.  FDA believes such an entity would be an 
231  authorized trading partner without being registered under section 510 so long as the NDA-, 
232  BLA-, or ANDA-holder, or co-licensed partner is compliant  with its obligations  under section 
233  510 of the FD&C Act and with any other obligations  under the DSCSA.  We note, however, that 
234  any person who owns or operates any establishment manufacturing,  preparing, propagating, 
235  compounding,  or processing drugs in the United States, or that are offered for import into the 
236  United States, must have a valid registration in accordance with section 510 to comply with the 
237  FD&C Act.   
238   
239  3.  Affiliate of a Manufacturer (Section 581(10)(C))  
240   
241  Affiliate is defined in section 581(1) of the FD&C Act as: 
242   
243  [A] business entity that has a relationship with a second business entity if, directly or 
244  indirectly 
245  (A)  one business entity controls, or has the power to control, the other business 
246  entity; or 
247  (B)  a third party controls, or has the power to control, both of the business entities. 
                                              
14 Part 207 (21 CFR part 207) defines manufacturers for purposes of registration requirements under section 510 of 
the FD&C Act, while section 581(10) defines manufacturers differently for purposes of DSCSA.  
15 This refers to holders of an approved new drug application (NDA), biologics license application (BLA), or 
abbreviated new drug application (ANDA). 
16 21 U.S.C. 360(b), (c), (d), and (i). 
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248   
249  FDA considers the situation  described in paragraph (A) to be similar to a parent/subsidiary 
250  business relationship (i.e., the parent has the power to control the business of the subsidiary).  
251  FDA considers the situation  described in paragraph (B) as describing a business relationship 
252  where a third party controls the business of several entities, such as controlling  both the parent 
253  and the subsidiary.   In other words, an affiliate is a business entity that legally controls another 
254  business entity, directly or indirectly,  or is controlled  by another business entity; mere business 
255  links or relationships  are not sufficient to meet the definition  of an affiliate.17  Manufacturers and 
256  their affiliates retain responsibility  for carrying out the activities and requirements under section 
257  582(b) of the FD&C Act.  To be considered a manufacturer under DSCSA, an affiliate of a 
258  manufacturer as defined in 581(10)(A) or (B) of the FD&C Act must have received the product 
259  directly from such a manufacturer.18   
260   
261  B.  Repackagers as Trading Partners Under DSCSA  
262   
263  DSCSA defines repackager in section 581(16) of the FD&C Act as a person who owns or 
264  operates an establishment that repacks and relabels a product or package for  (A) further sale; or 
265  (B) distribution  without a further transaction.  Under section 510 of the FD&C Act, and under 
266  part 207, with some limited  exceptions, any person who owns or operates any establishment  that 
267  manufactures, prepares, propagates, compounds,  or processes drugs in the United States or that 
268  are offered for import into the United States must be registered with the FDA.19  This includes 
269  repackagers of drugs.20  Thus, such repackager establishments must be registered in accordance 
270  with section 510 to be considered authorized trading partners. 
271   
272  An entity that falls within the definition  of repackager in section 581(16) of the FD&C Act must 
273  comply with the requirements under section 582(e) of the FD&C Act.  However, FDA does not 
274  consider a dispenser, specifically  a pharmacy, that is solely engaged in packaging and labeling 
275  drug product(s) for dispensing  to an identified  individual  patient after the receipt of a valid 
276  prescription for that patient (e.g., repackaging product into unit-dose packages for administration 
277  to an identified  individual  patient), to be a repackager under DSCSA.  Therefore, the 
278  requirements in section 582(e) of the FD&C Act would not apply. 
279   
280  C.  WDDs as Trading Partners Under DSCSA  
281   
282  DSCSA defines wholesale distributor in section 581(29) of the FD&C Act to mean a person 
283  (other than a manufacturer, a manufacturers co-licensed partner, a third-party logistics  provider, 
284  or repackager) engaged in wholesale distribution  (as defined in section 503(e)(4) of the FD&C 
285  Act, as amended by [DSCSA]).  Section 503(e)(4) of the FD&C Act (21 U.S.C. 353(e)(4)) 
286  defines wholesale distribution as distribution  of a drug subject to [section 503(b) of the FD&C 
287  Act (21 U.S.C. 353(b))] to a person other than a consumer or patient, or receipt of a drug subject 
                                              
17 This interpretation is consistent with the interpretation of affiliate previously described in 66 FR 59138 at 59146 
(November 27, 2001).   
18 See section 581(10)(C) of the FD&C Act. 
19 21 U.S.C. 360(b), (c), (d), and (i). 
20 21 U.S.C. 360(a)(1). 
  7  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
288  to [section 503(b) of the FD&C Act (21 U.S.C. 353(b))] by a person other than the consumer or 
289  patient, but exempts several specific activities.  An entity that falls within  the definition  of 
290  wholesale distributor in section 581(29) of the FD&C Act must comply with the requirements 
291  under section 582(c) of the FD&C Act.   
292   
293  FDA has received comments and inquiries  about how to determine whether a WDD is an 
294  authorized trading partner.  Comments have stated that one source of confusion is that DSCSA 
295  provides a definition  of wholesale distribution in section 503(e) of the FD&C Act and a 
296  definition  for wholesale distributor in section 581 of the FD&C Act that differ from the 
297  respective definitions  in the regulations promulgated  pursuant to sections 503(c), (d), and (e) of 
298  the FD&C Act, as enacted by the Prescription Drug Marketing Act of 1987 (PDMA).21  Several 
299  types of entities are not considered to be WDDs under DSCSA that were under these regulations.  
300  Many of these entities are now considered to be 3PLs under DSCSA, and are discussed in the 
301  next section.  
302   
303  Another source of confusion stems from uncertainty as to whether a manufacturer can also be 
304  licensed as a WDD.  The definition  of wholesale distribution, as set forth in section 503(e)(4) of 
305  the FD&C Act, as amended by DSCSA, excludes the distribution  of a manufacturers own drug 
306  (section 503(e)(4)(H)).  As a result, if a manufacturer is only distributing  its own drug, it would 
307  not be engaged in wholesale distribution  under DSCSA, and would not be required to comply 
308  with the licensure and reporting requirements for WDDs under DSCSA. 
309   
310  Generally,  but with exclusions enumerated in section 503(e)(4), an entity engaged in the 
311  distribution  of a drug subject to section 503(b) of the FD&C Act (21 U.S.C. 353(b)) to someone 
312  other than a consumer or patient and that the entity did not manufacture, would be engaged in 
313  wholesale distribution  and subject to all the WDD requirements under DSCSA. 
314   
315  Jobbers: FDA considers a jobber to be a person or entity that owns or operates an establishment 
316  that engages in wholesale distribution  on a small scale, or sells product solely to retailers and 
317  institutions.   Jobbers engage in wholesale distribution because they own and direct the sale or 
318  distribution  of product to, and receive product from, a person other than a consumer or patient, 
319  and are not otherwise excluded from the definition  under section 503(e)(4) of the FD&C Act.  
320  Jobbers are thus considered WDDs and are subject to the requirements for WDDs under DSCSA. 
321   
322  D.  3PLs as Trading Partners Under DSCSA  
323   
324  DSCSA defines 3PLs broadly to include any entity that provides or coordinates warehousing, or 
325  other logistics services of a product in interstate commerce on behalf of a manufacturer, 
326  wholesale distributor,  or dispenser of a product, but does not take ownership of the product, nor 
327  have responsibility  to direct the sale or disposition  of the product.22   
328   
329  There has been confusion as to what activities would be considered other logistics  services 
330  within the definition  of 3PL.  FDAs current thinking  is that other logistics services means 
                                              
21 Public Law 100-293; codified at 21 U.S.C. 321 et seq. 
22 See section 581(22) of the FD&C Act. 
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331  services provided by entities that accept or transfer direct possession23 of products from that 
332  entitys facility within the United States and its territories on behalf of a trading partner (i.e., 
333  manufacturer, repackager, WDD, or dispenser).  FDA also considers other logistics  services to 
334  include services provided by entities that accept or transfer direct possession of products from 
335  that entitys facility within the United States and its territories on behalf of a repackager of 
336  products for further sale or a repackager acting on behalf of a manufacturer, WDD, or dispenser. 
337    
338  Trading partner, with respect to 3PLs, is defined in part as having direct possession of 
339  product.24  Those 3PLs that do not accept or transfer direct possession of product are thus not 
340  considered trading partners.  Therefore, the authorized  trading partner provisions  of section 
341  582 of the FD&C Act would not apply when manufacturers, wholesale distributors,  dispensers, 
342  and repackagers engage 3PLs who are not trading partners.25  
343   
344  Furthermore, FDA considers the section 584 requirement that each facility of such [3PL] 26 be 
345  licensed in accordance with the regulations to mean that 3PLs without a facility are not 
346  required to be licensed.  Section 584 provides that FDA will establish licensure standards that 
347  centrally include requirements relating to storage of product.  These standards address issues 
348  with access and maintenance that presuppose the existence of a physical facility wherein product 
349  is maintained.   
350   
351  Accordingly,  FDA considers a facility to be an establishment,  warehouse, structure, or structures 
352  under common ownership at one general, permanent, physical location used to store or handle 
353  prescription drug products.  FDA would not consider a truck or shipping  container used to 
354  transport product to constitute a facility for purposes of DSCSA because such trucks or 
355  containers are not consistently  located at one physical location and would not sensibly be 
356  covered by the storage requirements specific to 3PL facility licensure.  Likewise, FDA would not 
357  consider an establishment,  warehouse, or structure that is not used to store or handle prescription 
358  drug products to constitute a facility for purposes of section 584. 
359   
360  1.  Entities That Warehouse But Do Not Own or Direct the Sale or Disposition of 
361  Product  
362   
363  An entity that owns, rents, or leases a facility  where it warehouses product, but does not take 
364  ownership of, nor direct the sale or disposition  of the product, is a 3PL under DSCSA.  An entity 
365  that owns, rents, or leases a facility  under common ownership or control with another trading 
366  partner, where it warehouses product but does not take ownership of, nor direct the sale or 
367  disposition  of the product, is also a 3PL under DSCSA.  These entities could be engaged in 
368  activities that include storage of products distributed  by consignment.27 
369   
                                              
23 FDA considers direct possession to mean having physical, direct contact with the product. 
24 See section 581(23)(B) of the FD&C Act. 
25 See sections 582(b)(3), (c)(3), (d)(3), and (e)(3) of the FD&C Act (21 U.S.C. 360eee-1). 
26 FDA interprets the language in section 584(a) of the FD&C Act, facility of such third-party logistics provider, 
to mean a facility owned, rented, or leased by the 3PL.  
27 FDAs current understanding of consignment involves the sale of a product by the manufacturer directly to the 
consumer where the product is stored and shipped by an entity on behalf of the manufacturer.  
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370  2.  Brokers  
371   
372  FDA considers a broker to be a person or entity, who facilitates business transactions between 
373  two other trading partners, but does not take ownership of the product nor direct the sale or 
374  disposition  of a product.  A broker does not provide or coordinate warehousing and does not 
375  accept or transfer direct possession of the product and, therefore, is not considered a 3PL under 
376  DSCSA.  Thus, FDA generally would not consider the 3PL licensure requirements under 
377  DSCSA to cover brokers.   
378   
379  However, if a person or entity acts as a seller or buyer, or directs the sale, purchase, or trade of a 
380  product, such person or entity is a principal  party to the transaction and is considered to be 
381  involved  in directing the sale or disposition  of the product.  FDA does not consider the lack of 
382  direct possession of the product as a sufficient reason to preserve broker status because, as the 
383  seller or buyer, the person or entity is accepting or transferring ownership of the product.  A 
384  person or entity engaged in this activity would not be considered a broker, but would likely  meet 
385  the definition  of a manufacturer, WDD, repackager, or dispenser, depending on the 
386  circumstances, and would be required to meet all of the applicable  requirements under DSCSA.   
387   
388  3.  Solution Providers  
389   
390  FDA considers a solution provider to be a person or entity that provides other entities hardware, 
391  software, or systems solutions  to help achieve compliance with the requirements under DSCSA.  
392  A solution  provider does not take ownership of the product nor direct the sale or disposition  of a 
393  product.  Furthermore, a solution  provider does not provide or coordinate warehousing and does 
394  not accept or transfer direct possession of the product and, therefore, is not considered a 3PL 
395  under DSCSA.  Thus, FDA would not consider the 3PL licensure requirements under DSCSA to 
396  cover solution  providers. 
397   
398  4.  Common Carriers  
399   
400  As it relates to the distribution  of prescription drug products subject to DSCSA, FDA considers a 
401  common carrier to be an entity that solely provides transportation services,28 but does not take 
402  ownership of the product nor direct the sale or disposition  of the product.  Common carriers do 
403  not provide or coordinate warehousing for the products they transport.  Although common 
404  carriers accept and transfer direct possession of product, they do not store and handle product 
405  from a facility,  as defined above.  Therefore, FDA would not consider the services provided by 
406  common carriers to constitute other logistics  services, and FDA would not consider common 
407  carriers to be covered by the 3PL licensure requirements under DSCSA.  The owner of the 
408  product would remain responsible for compliance with any applicable  storage and handling 
409  requirements and for the products safety and integrity  during transit, and should select common 
410  carriers that can provide appropriate safeguards.   
411   
                                              
28 Such transportation services may include the transport of product from one location to another, and cross-docking 
of product en route to its destination, but does not include the warehousing of a product that lacks an identified 
consignee or delivery destination.  
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412  5.  Logistics or Administrative Services Contractors  
413   
414  FDA is also aware that some entities that solely contract with other trading partners to provide 
415  labor, logistic,  or administrative  services in the other trading partners facility,  but do not take 
416  ownership nor direct the sale or disposition  of product, have identified  themselves as 3PLs.  
417  These entities do not themselves provide or coordinate the warehousing of product; rather, the 
418  trading partner with which the entity is contracting provides or coordinates the warehousing.  
419  Although such contractors may accept and transfer direct possession of product, they do not store 
420  and maintain  product at their own facility, and thus would not meet the facility requirement of 
421  the other logistics services definition above.  Therefore, FDA would not consider such entities to 
422  be 3PLs under DSCSA.  FDA expects the trading partner with which such a contractor is 
423  contracting to be responsible for its activities.  For example, if an entity is engaged in the 
424  provision  of its services as a contractor in a wholesale distribution  facility that is not under 
425  common ownership or control of the contractor and WDD, the contractors activity would be 
426  captured by the wholesalers license and obligations  for compliance.  
427   
428  6.  Returns Processors and Reverse Logistics Providers  
429   
430  A returns processor or reverse logistics provider is defined in section 581(18) of the FD&C Act 
431  as: 
432   
433  [A] person who owns or operates an establishment that dispositions or otherwise 
434  processes saleable or nonsaleable product received from an authorized trading partner 
435  such that the product may be processed for credit to the purchaser, manufacturer, or seller 
436  or disposed of for no further distribution.   
437   
438  FDA considers returns processors and reverse logistics providers to be 3PLs because they are 
439  entities that provide other logistics services on behalf of other trading partners in a facility the 
440  returns processor or reverse logistics  provider owns, rents, or leases, and they do not take 
441  ownership of nor direct the sale or disposition  of the product.  As indicated in the definition,  such 
442  entities may execute the dispositioning  of product, whether it is as a return, recall, or for 
443  disposal,  but they are not responsible for directing  whether the product is to be sold or 
444  dispositioned.   This activity may include activity that has been referred to as reverse 
445  distribution.   However, if an entity takes ownership of the returned or dispositioned  product or 
446  is responsible for directing the sale or disposition  of the product, such entity does not meet the 
447  definition  of a returns processor or reverse logistics provider,  but rather is engaged in wholesale 
448  distribution,  subject to all the requirements for WDDs under DSCSA.  
449   
450  E.  Dispensers as Trading Partners Under DSCSA  
451   
452  Section 581(3) of the FD&C Act states that dispenser: 
453   
454  (A) means a retail pharmacy, hospital pharmacy, a group of chain pharmacies under 
455  common ownership and control that do not act as a wholesale distributor, or any other 
456  person authorized by law to dispense or administer prescription drugs, and the affiliated 
457  warehouses or distribution centers of such entities under common ownership and control 
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458  that do not act as a wholesale distributor; and (B) does not include a person who 
459  dispenses only products to be used in animals in accordance with section 512(a)(5).  
460   
461  Under this definition,  a dispenser is a pharmacy that does not act as a WDD, or any other person 
462  authorized to dispense or administer human prescription drugs.  Furthermore, this definition 
463  redefines dispenser-affiliated  warehouses and distribution  centers as dispensers (these were 
464  previously  considered to be WDDs under PDMA).  Such warehouses and distribution  centers are 
465  no longer considered WDDs, unless such facilities  are also engaged in wholesale distribution 
466  activities.  
467   
468  An entity that falls within the definition  of dispenser in section 581(3) of the FD&C Act must 
469  comply with the requirements under section 582(d) of the FD&C Act.  The statutory requirement 
470  for dispensers to exchange product tracing information  became effective on July 1, 2015.29  
471  However, dispensers are not required to provide the product tracing information  prior to, or at 
472  the time of, a transaction if the product is dispensed to a patient or if it is a sale by a dispenser to 
473  another dispenser to fulfill  a specific patient need.30,31  The term specific patient need refers to 
474  the transfer of a product from one pharmacy to another to fill a prescription  for an identified 
475  patient.  This term does not include the transfer of a product from one pharmacy to another for 
476  the purpose of increasing or replenishing  stock in anticipation  of a potential need.32  Although a 
477  dispenser that sells a product to another dispenser to fulfill  a specific patient need is not required 
478  to provide product tracing information,  other requirements of section 582(d) and the FD&C Act 
479  may apply to the transferring and receiving pharmacies.  Accordingly,  such sales or transfers 
480  should be documented by each pharmacy in a manner that would facilitate appropriate actions by 
481  the pharmacy in the event of an investigation  of suspect or illegitimate  product, recall, or 
482  notification  of illegitimate  product.  Transfers of product to another dispenser without a specific 
483  patient need may constitute wholesale distribution,  subject to the requirements for wholesale 
484  distributors  in sections 503(e), 582, and 583 of the FD&C Act.  
485   
486  To be considered an authorized trading partner, a dispenser must have a valid license under State 
487  law and accept or transfer direct ownership of a product from or to a manufacturer, repackager, 
488  wholesale distributor,  or dispenser. 
489   
                                              
29 FDA issued guidance explaining that the Agency did not intend to object to the failure to comply with certain 
requirements of section 582(d) of the FD&C Act, relating to the exchange of product tracing information before 
March 1, 2016.  See FDA guidance for industry DSCSA Implementation: Product Tracing Requirements for 
Dispensers  Compliance Policy (Revised).  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/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. 
30 See section 582(d)(1)(A)(ii) of the FD&C Act. 
31 The term specific patient need is defined in section 581(19) of the FD&C Act. 
32 Id. 
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490  Table 1.  Summary of Authorized Trading Partners* 
Entity Type  Description of Activity  Other Entities  Entities Generally Not  Entity is a Trading  Entity is 
Included  Included  Partner When It  Authorized When 
It is 
Manufacturer  Manufactured the        Registered with 
product    FDA in accordance 
  with section 510 of 
  the FD&C Act  
Approved application        Compliant  with its 
holder, or co-licensed  Accepts or transfers  obligations  under 
partner of the approved  direct ownership of a  section 510 of the 
application  holder who  product from or to a  FD&C Act  
obtained the product  manufacturer, 
directly from the  repackager, 
application  holder or  wholesale distributor, 
person who  or dispenser 
manufactured the 
product 
Affiliate1 of      Compliant  with its 
manufacturer who  obligations  under 
obtained the product  section 510 of the 
directly from the  FD&C Act 
application  holder or 
person who 
manufactured the 
product 
Repackager  Owns or operates an    A dispenser, specifically  a  Accepts or transfers  Registered with 
establishment that  pharmacy, that is solely  direct ownership of a  FDA in accordance 
repacks and relabels a  engaged in packaging and  product from or to a  with section 510 of 
product or package for  labeling  a product for  manufacturer,  the FD&C Act 
further sale or  dispensing  to an identified  repackager, 
distribution  without a  individual  patient pursuant  wholesale distributor, 
further transaction  to a valid prescription  or dispenser 
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491  Table 1 (contd).  Summary of Authorized Trading Partners* 
Entity Type  Description of Activity  Other Entities  Entities Generally Not  Entity is a Trading  Entity is 
Included  Included  Partner When It  Authorized When 
It/It is 
Wholesale  Engaged in distribution  Jobbers, i.e.,  A manufacturer  Accepts or transfers  Has a valid license 
Distributor2  of a drug to, or receipt of  those engaged in  distributing  its own drug;  direct ownership of a  under state law or 
a drug by, a person other  wholesale  a manufacturers co- product from or to a  section 583 of the 
than a consumer or  distribution  on a  licensed partner, a 3PL, a  manufacturer,  FD&C Act, in 
patient, with certain  small scale or that  repackager, entities  repackager,  accordance with 
exceptions  sell product solely  excluded from wholesale  wholesale distributor,  582(a)(6) of the 
to retailers and  distribution  pursuant to  or dispenser  FD&C Act, as 
institutions;  section 503(e)(4), a  amended by 
dispensers who  dispenser, a dispenser- DSCSA; in 
transfer product  affiliated warehouse or  compliance with 
to another  distribution  center, or a  reporting 
dispenser without  dispenser who transfers  requirements under 
a specific patient  product to another  section 503(e) 
need   dispenser for a specific 
patient need 
3PL  Provides or coordinates  Returns  Brokers,4 solution  Accepts or transfers  Has a valid license 
warehousing or other  processors or  providers,5 common  direct possession of a  under state law or 
logistics  services with  reverse logistics  carriers,6 logistics  or  product from or to a  section 584(a)(1) of 
regard to a product in  providers3 that do  administrative  services  manufacturer,  the FD&C Act, in 
interstate commerce on  not take  contractors7  repackager,  accordance with 
behalf of a manufacturer,  ownership of the  wholesale distributor,  582(a)(7) of the 
wholesale distributor,  or  product and are  or dispenser  FD&C Act, as 
dispenser of a product,  not responsible  amended by 
but does not take  for directing the  DSCSA; in 
ownership of the product,  sale or disposition  compliance with 
nor have responsibility  to  of the product  reporting 
direct the sale or  requirements under 
disposition  of the product   section 584(b) 
492   
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493  Table 1 (contd). Summary of Authorized  Trading Partners* 
Entity Type  Description of Activity  Other Entities  Entities Generally Not  Entity is a Trading  Entity is 
Included  Included  Partner When It  Authorized When 
It 
Dispenser  Retail pharmacy,         
hospital pharmacy, or       
group of chain       
pharmacies under       
common ownership and  Person who only dispenses  Accepts or transfers   
control that do not act as  products to be used in  direct ownership of a   
a wholesale distributor  animals in accordance  product from or to a   
Person authorized by  with section 512(a)(5)  manufacturer,  Has a valid license 
law to dispense or  repackager, wholesale  under state law 
administer prescription  distributor,  or 
drugs  dispenser 
Affiliated warehouses or 
distribution  centers of a 
dispenser under common 
ownership and control 
that do not act as a 
wholesale distributor 
494  * Content in merged cells applies to all the rows that run across those merged cells for each entity type. 
495  1 See 581(1) of the FD&C Act. 
496  2 See discussion in section III.C. above, pp. 7-8. 
497  3 See 581(18) of the FD&C Act, and discussion  in section III.D.6. above, p. 11. 
498  4 See discussion in section III.D.2. above, pp. 9-10. 
499  5 See discussion in section III.D.3. above, p. 10. 
500  6 See discussion in section III.D.4. above, p. 10. 
501  7 See discussion in section III.D.5. above, pp. 10-11. 
  15