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DRAFT GUIDANCE 
 
This guidance document is being distributed for comment purposes only.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publication in the Federal Register of the notice announcing the availability of the draft 
guidance.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 http://www.regulations.gov.  Submit written 
comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD  20852.  All comments should be identified with the 
docket number listed in the notice of availability that publishes in the Federal Register. 
 
For questions regarding this draft document, contact (CDER) Office of Compliance 301-796-
3130 or (CBER) Office of Communication, Outreach and Development, 800-835-4709 or 240-
402-8010.  
 
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) 
 
July 2022 
Procedural 
Revision 1 
 
   
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/guidance-compliance-regulatory-information/guidances-drugs  
and/or 
Office of Communication, Outreach and Development  
Center for Biologics Evaluation and Research 
 Food and Drug Administration 
10903 New Hampshire Ave., Bldg. 71, Room 3128 
Silver Spring, MD 20993-0002 
Phone: 800-835-4709 or 240-402-8010 
Email: ocod@fda.hhs.gov 
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances 
 
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) 
 
 
July 2022 
Procedural 
Revision 1 
 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
 
TABLE OF CONTENTS 
 
 
I.  INTRODUCTION ...................................................................................................... 1 
II.  BACKGROUND ........................................................................................................ 2 
A.  Definitions of Drug Supply Chain Entities Under the DSCSA........................................... 2 
B.  Authorized Trading Partners Under the DSCSA ............................................................. 3 
C.  Licensure and Reporting Requirements for WDDs and 3PLs ........................................... 4 
III.  IDENTIFYING WHO IS A TRADING PARTNER .................................................. 6 
A.  Manufacturers as Trading Partners Under the DSCSA ................................................... 7 
1. Manufacturing Establishments.......................................................................................... 7 
2. NDA-, BLA-, or ANDA-Holder, or Co-Licensed Partner of a Manufacturer ............................. 7 
3. Affiliate of a Manufacturer (Section 581(10)(C) of the FD&C Act)......................................... 8 
4. Private Label Distributors ............................................................................................... 9 
5. Salvagers .....................................................................................................................10 
B.  Repackagers as Trading Partners Under the DSCSA......................................................11 
C.  WDDs as Trading Partners Under the DSCSA ...............................................................11 
1. Distribution for Emergency Medical Reasons ....................................................................12 
2. Distribution for Office Use..............................................................................................13 
3. Distribution of Drugs for Non-Human Research Purposes Only............................................13 
4. Distribution of Drugs for Research Purposes in Humans Under an IND ................................14 
D.  3PLs as Trading Partners Under the DSCSA .................................................................14 
1. Entities That Warehouse But Do Not Own or Direct the Sale or Disposition of Product............15 
2. Brokers ........................................................................................................................16 
3. Solution Providers .........................................................................................................16 
4. Common Carriers ..........................................................................................................16 
5. Logistics or Administrative Services Contractors................................................................17 
6. Returns Processors and Reverse Logistics Providers...........................................................17 
E. Dispensers as Trading Partners Under the DSCSA ............................................................18 
 
 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
Identifying Trading Partners Under the Drug Supply Chain 
1 
Security Act 
2 
Guidance for Industry1
3   
4   
5  This draft guidance, when finalized, will represent the current thinking of the Food and Drug 
6  Administration (FDA or Agency) on this topic.  It does not establish any rights for any person and is not 
7  binding on FDA or the public.  You can use an alternative approach if it satisfies the requirements of the 
8  applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff responsible 
9  for this guidance as listed on the title page.   
10   
11   
12   
13   
14  I.  INTRODUCTION  
15   
16  The Food and Drug Administration (FDA or Agency) is issuing this guidance to assist industry 
17  and State and local governments in understanding how to categorize the entities in the drug 
18  supply chain in accordance with the Drug Supply Chain Security Act (DSCSA).2  This guidance 
19  revises the Agencys draft guidance for industry Identifying Trading Partners Under the Drug 
20  Supply Chain Security Act (August 2017) to address the status of some entities as trading 
21  partners (e.g., private-label distributors, salvagers, and returns processors and reverse logistics 
22  providers), provide clarification on certain drug distribution scenarios, and address the 
23  interpretation of section 582(a)(7) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 
24  which discusses third-party logistics providers (3PL) licensure status prior to the effective date of 
25  the forthcoming regulations establishing licensure standards.  The DSCSA establishes product 
26  tracing requirements for certain trading partners in the drug supply chain, including 
27  manufacturers, repackagers, wholesale distributors, and dispensers.  The DSCSA also requires 
28  that trading partners of manufacturers, wholesale distributors, dispensers, and repackagers must 
29  meet the applicable requirements for being authorized trading partners.3  Additionally, the 
30  DSCSA requires FDA to issue regulations that establish Federal standards for the licensing of 
31  wholesale drug distributors4 (WDDs) and 3PLs.  The Agency is currently drafting these 
32  regulations.  This guidance, when finalized, will explain FDAs current thinking on how certain 
33  DSCSA requirements apply to entities that are considered trading partners in the drug supply 
34  chain.   
35   
 
1 This guidance has been prepared by the Division of Drug Supply Chain Integrity in the Center for Drug Evaluation 
and Research in consultation 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), 581, and 584 of the FD&C Act (21 U.S.C. 353(e), 
360eee, and 360eee-3). 
3 See section 582(b)(3), (c)(3), (d)(3), and (e)(3) of the FD&C Act (21 U.S.C. 360eee-1(b)(3), (c)(3), (d)(3), and 
(e)(3)). 
4 For the purposes of this guidance, the terms wholesale distributor or wholesale drug distributor are considered the 
same and may be used interchangeably in the guidance. 
  1  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
36  This guidance is intended to: (1) assist industry and State and local governments in 
37  understanding the applicability of DSCSA requirements to the various types of entities that take 
38  part in the distribution of prescription drugs in the United States5; and (2) help clarify for 
39  industry whether they are engaged in activities that require licensure and annual reporting, as 
40  well as other requirements related to being an authorized trading partner in the drug supply 
41  chain.  The guidance does not address all requirements described in the DSCSA but is limited to 
42  describing the activities that would determine what type of trading partner an entity may be and 
43  the applicable requirements under the DSCSA. 
44   
45  The contents of this document do not have the force and effect of law and are not meant to bind 
46  the public in any way, unless specifically incorporated into a contract.  This document is 
47  intended only to provide clarity to the public regarding existing requirements under the law.  
48  FDA guidance documents, including this guidance, should be viewed only as recommendations, 
49  unless specific regulatory or statutory requirements are cited. The use of the word should in FDA 
50  guidance means that something is suggested or recommended, but not required.  
51   
52   
53  II.  BACKGROUND 
54   
55  On November 27, 2013, the DSCSA was signed into law.  The DSCSA outlines requirements to 
56  develop and enhance drug distribution security by 2023.  In part, these changes include defining 
57  the types of entities in the drug supply chain (i.e., manufacturers, repackagers, wholesale 
58  distributors, 3PLs, and dispensers), requiring that the trading partners of manufacturers, 
59  repackagers, wholesale distributors, and dispensers meet the applicable requirements to be 
60  authorized trading partners, and establishing national standards for the licensing of WDDs and 
61  3PLs.  
62   
63  A.  Definitions of Drug Supply Chain Entities Under the DSCSA 
64   
65  The DSCSA identifies and defines five types of entities in the prescription drug supply chain: 
66  manufacturers, repackagers, dispensers, wholesale distributors, and 3PLs.  The DSCSA defines 
67  these entities in section 581 of the FD&C Act (21 U.S.C. 360eee).   
68   
69  A manufacturer is defined in section 581(10) of the FD&C Act to mean:  
70   
71  [W]ith respect to a product -- (A) a person that holds an application approved under 
72  section 505 or a license issued under section 351 of the Public Health Service Act for 
73  such product, or if such product is not the subject of an approved application or license, 
74  the person who manufactured the product; (B) a co-licensed partner of the person 
75  described in subparagraph (A) that obtains the product directly from a person described 
76  in this subparagraph or subparagraph (A) or (C); or (C) an affiliate of a person described 
77  in subparagraph (A) or (B) that receives the product directly from a person described in 
78  this subparagraph or subparagraph (A) or (B).  
79   
 
5 Under section 201(a)(1) of the FD&C Act, the term state means any state or territory of the United States, the 
District of Columbia, and the Commonwealth of Puerto Rico.  
  2  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
80  Section 581(16) of the FD&C Act defines a repackager to mean a person who owns or operates 
81  an establishment that repacks and relabels a product or package for  (A) further sale; or (B) 
82  distribution without a further transaction.  
83   
84  The term dispenser, as defined in section 581(3) of the FD&C Act: 
85   
86  (A) means a retail pharmacy, hospital pharmacy, a group of chain pharmacies under 
87  common ownership and control that do not act as a wholesale distributor, or any other 
88  person authorized by law to dispense or administer prescription drugs, and the affiliated 
89  warehouses or distribution centers of such entities under common ownership and control 
90  that do not act as a wholesale distributor; and (B) does not include a person who 
91  dispenses only products to be used in animals in accordance with section 512(a)(5). 
92   
93  The DSCSA defines wholesale distributor in section 581(29) of the FD&C Act to mean: 
94   
95  [A] person (other than a manufacturer, a manufacturers co-licensed partner, a third-party 
96  logistics provider, or repackager) engaged in wholesale distribution (as defined in section 
97  503(e)(4), as amended by the Drug Supply Chain Security Act. 
98   
99  Section 503(e)(4) of the FD&C Act (21 U.S.C. 353(e)(4)) defines wholesale distribution as 
100  distribution of a drug subject to [section 503(b) of the FD&C Act (21 U.S.C. 353(b))] to a 
101  person other than a consumer or patient, or receipt of a drug subject to [section 503(b) of the 
102  FD&C Act (21 U.S.C. 353(b))] by a person other than the consumer or patient, but excludes 
103  several specific activities.6   
104   
105  The DSCSA adds third-party logistics providers (3PLs) as a new entity in the drug supply 
106  chain,7 and requires 3PL facilities to be regulated separately from wholesale distributors.8  The 
107  DSCSA defines a 3PL in section 581(22) of the FD&C Act to mean: 
108   
109  [A]n entity that provides or coordinates warehousing, or other logistics services of a 
110  product in interstate commerce on behalf of a manufacturer, wholesale distributor, or 
111  dispenser of a product, but does not take ownership of the product, nor has responsibility 
112  to direct the sale or disposition of the product.   
113   
114  The key distinction between wholesale distributors and 3PLs is that, unlike a wholesale 
115  distributor, a 3PL does not take ownership of the product, and does not direct the sale or 
116  disposition of the product.   
117   
118  B.  Authorized Trading Partners Under the DSCSA 
119   
120  The DSCSA restricts access to the distribution system for prescription drug products by 
121  requiring that trading partners of manufacturers, wholesale distributors, dispensers, and 
 
6 For exclusions see section 503(e)(4)(A) through (S) of the FD&C Act. 
7 Section 581(22) of the FD&C Act.  
8 See section 585(b)(2) of the FD&C Act (21 U.S.C. 360eee-4(b)(2)).   
  3  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
122  repackagers meet the applicable requirements for being authorized trading partners.9  The 
123  DSCSA includes definitions for authorized10 and trading partner11 with respect to each entity in 
124  the drug supply chain as follows:   
125   
126    To be considered an authorized trading partner, a manufacturer or repackager must have a 
127  valid registration in accordance with section 510 of the FD&C Act and accept or transfer 
128  direct ownership of a product from or to a manufacturer, repackager, wholesale 
129  distributor, or dispenser.  
130   
131    To be considered an authorized trading partner, a wholesale distributor must have a valid 
132  license under State law or section 583 of the FD&C Act, in accordance with section 
133  582(a)(6) of the FD&C Act, comply with the licensure reporting requirements in section 
134  503(e) of the FD&C Act, and accept or transfer direct ownership of a product from or to a 
135  manufacturer, repackager, wholesale distributor, or dispenser.  
136   
137    Similarly, to be considered an authorized trading partner, a 3PL must have a valid license 
138  under State law or section 584(a)(1) of the FD&C Act, in accordance with section 
139  582(a)(7) of the FD&C Act, comply with the licensure reporting requirements under 
140  section 584(b) of the FD&C Act (21 U.S.C. 360eee-3(b)), and accept or transfer direct 
141  possession of a product from or to a manufacturer, repackager, wholesale distributor, or 
142  dispenser.  
143   
144    To be considered an authorized trading partner, a dispenser must have a valid license 
145  under State law and accept or transfer direct ownership of a product from or to a 
146  manufacturer, repackager, wholesale distributor, or dispenser.  
147   
148  C.  Licensure and Reporting Requirements for WDDs and 3PLs 
149   
150  The DSCSA also establishes new licensure and reporting requirements for wholesale distributors 
151  and third-party logistics providers.  
152   
153  Section 583 of the FD&C Act requires FDA to issue regulations regarding the standards for 
154  licensure of wholesale distributors under section 503(e)(1) of the FD&C Act.  Section 503(e) of 
155  the FD&C Act establishes licensure requirements based on these standards and adds reporting 
156  requirements for WDDs.  Specifically, section 503(e)(1), subject to section 583 of the FD&C 
157  Act, prohibits an entity from engaging in wholesale distribution of prescription drugs in any 
158  State unless such entity is licensed by the State from which the drug is distributed, or by FDA if 
159  such State from which the drug is distributed has not established a licensure requirement.  
160  Furthermore, under certain circumstances,12 such wholesale distributor must also be licensed by 
161  the State into which the drug is distributed.  Section 503(e)(2) of the FD&C Act requires WDDs 
 
9 See section 582(b)(3), (c)(3), (d)(3), and (e)(3) of the FD&C Act (21 U.S.C. 360eee-1(b)(3), (c)(3), (d)(3), and 
(e)(3)). 
10 See section 581(2) of the FD&C Act. 
11 See section 581(23) of the FD&C Act. 
12 See section 503(e)(1)(A)(ii) of the FD&C Actin relevant part, if the State into which the drug is distributed 
requires the licensure of a person that distributes drugs into the State. 
  4  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
162  to report certain information to FDA on an annual basis, including State licensure information 
163  for each license, the name and address of each licensed facility, and any significant disciplinary 
164  actions taken by a State or the Federal government.13  
165   
166  The DSCSA adds section 584 to the FD&C Act, which requires FDA to issue regulations 
167  regarding the standards for licensure of 3PLs and sets forth requirements for 3PL licensure in 
168  accordance with those standards and for 3PL licensure reporting.  Specifically, section 584(a) 
169  prohibits a 3PL in any State from conducting activities in any State unless each facility of the 
170  3PL is licensed by the State from which the drug is distributed by the 3PL, or by FDA if the 
171  State from which the drug is distributed by the 3PL has not established a licensure requirement 
172  (subject to section 582(a)(7) of the FD&C Act, discussed below).  Furthermore, under certain 
173  circumstances,14 the 3PL must also be licensed by the State into which the drug is distributed.  
174  Section 584(b) of the FD&C Act requires 3PL facilities to report certain information to FDA on 
175  an annual basis, including State licensure information for each facility and the name and address 
176  of each facility.  
177   
178  The DSCSA also addresses the licensure status of wholesale distributors and 3PLs during the 
179  period before the regulations detailing licensure standards under sections 583 and 584 of the 
180  FD&C Act, respectively, are effective.  With respect to wholesale distributors, section 582(a)(6) 
181  of the FD&C Act provides that: 
182   
183  Notwithstanding section 581(9)(A), until the effective date of the wholesale distributor 
184  licensing regulations under section 583, the term licensed or authorized, as it relates to 
185  a wholesale distributor with respect to prescription drugs, shall mean a wholesale 
186  distributor with a valid license under State law.15  
187   
188  With respect to 3PLs, section 582(a)(7) of the FD&C Act provides that:  
189   
190  Until the effective date of the third-party logistics provider licensing regulations under 
191  section 584, a third-party logistics provider shall be considered licensed under section 
192  581(9)(B) unless the Secretary has made a finding that the third-party logistics provider 
193  does not utilize good handling and distribution practices and publishes notice thereof.16   
194   
195  Accordingly, until the regulations with respect to wholesale distributor licensure under section 
196  583 are effective, FDA will generally consider a wholesale distributor to be fully licensed for 
197  DSCSA purposes if the wholesale distributor holds a valid license under State law.  Similarly, 
 
13 More information about reporting is on the Annual Reporting by Prescription Drug Wholesale Distributors and 
Third-Party Logistics Providers web page, available at 
http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/ucm42
3749.htm 
14 See section 584(a)(2) of the FD&C Actin 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.  For clarity, a 
3PL does not need to obtain a license from the State(s) into which such 3PL ships product if that 3PL is licensed by 
FDA pursuant to section 584(a)(1)(B) of the FD&C Act. 
15 Under section 581(9)(A) of the FD&C Act, the term licensed means, in the case of a wholesale distributor, 
having a valid license in accordance with section 503(e) or section 582(a)(6), as applicable. 
16 Under section 581(9)(B) of the FD&C Act, the term licensed means, in the case of a third-party logistics provider, 
having a valid license in accordance with section 584(a) or section 582(a)(7), as applicable. 
  5  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
198  until the regulations with respect to 3PL licensure under section 584 are effective, FDA will 
199  generally consider a 3PL to be fully licensed for DSCSA purposes, unless FDA determines that 
200  the 3PL is not utilizing good product handling and distribution practices and publishes notice 
201  thereof. Any such determination would be posted on FDAs DSCSA webpage.17   
202   
203  FDA interprets this provision to mean that a 3PL is fully licensed for DSCSA purposes during 
204  the period prior to the effective date of Federal 3PL licensure regulations (provided that the 3PL 
205  utilizes good product handling and distribution practices), notwithstanding a situation where a 
206  State requires licensure of the 3PL during this period and the 3PL does not hold such State 
207  licensure.  This interpretation should not be construed to impact the ability of States to require 
208  licensure of 3PLs under State law or the validity of such State licensure.  Rather, the Agency's 
209  view reflects FDAs understanding that in enacting section 582(a)(7) of the FD&C Act, Congress 
210  intended 3PLs to be deemed licensed for DSCSA purposes to facilitate supply chain operations 
211  until the Federal licensing standards take effect. 
212   
213   
214  III.  IDENTIFYING WHO IS A TRADING PARTNER 
215   
216  Whether an entity meets the statutory definition of a particular trading partner that would trigger 
217  the applicable DSCSA requirements depends on the activities engaged in by the entity.  Please 
218  see the discussion below for each type of trading partner for more information. 
219   
220  There has been confusion about how the definitions of wholesale distributor and wholesale 
221  distribution changed upon enactment of the DSCSA.  Regulations enacted prior to the DSCSA 
222  defined the term wholesale distributor to include:  
223   
224   . . . manufacturers; repackers; own-label distributors; private label distributors; jobbers; 
225  brokers; warehouses, including manufacturers' and distributors' warehouses, chain drug 
226  warehouses, and wholesale drug warehouses; independent wholesale drug traders; and 
227  retail pharmacies that conduct wholesale distributions.18   
228   
229  Some of these listed entities are not considered wholesale distributors under the DSCSA.  In 
230  addition, section 581 of the FD&C Act defines different trading partners in the drug supply 
231  chain, including manufacturers, repackagers, WDDs, 3PLs, and dispensers.  Neither section 
232  503(e) nor section 581 of the FD&C Act lists the other types of entities included in the 
233  regulations discussed above, at 21 CFR 203.3(dd).  Consequently, several types of activities that 
234  may fall within the definition of wholesale distribution under 21 CFR part 203 are not directly 
235  addressed by the statutory definition of wholesale distribution in section 503(e) of the FD&C 
236  Act.  This may leave questions regarding the status of certain entities under the DSCSA.  For 
237  example, there has been confusion as to whether DSCSA licensure and reporting requirements 
238  apply to certain types of entities, such as but not limited to jobbers, brokers, and certain 
239  contractors and solution providers.  To address some of the confusion expressed by industry and 
240  the States, FDA discusses each type of trading partner. 
241   
 
17 See https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa. 
18 21 CFR 203.3(dd) (1999).  
  6  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
242  A.  Manufacturers as Trading Partners Under the DSCSA 
243   
244  The DSCSA defines a manufacturer in section 581(10) of the FD&C Act as:  
245   
246  [W]ith respect to a product -- (A) a person that holds an application approved under 
247  section 505 or a license issued under section 351 of the Public Health Service Act for 
248  such product, or if such product is not the subject of an approved application or license, 
249  the person who manufactured the product; (B) a co-licensed partner of the person 
250  described in subparagraph (A) that obtains the product directly from a person described 
251  in this subparagraph or subparagraph (A) or (C); or (C) an affiliate of a person described 
252  in subparagraph (A) or (B) that receives the product directly from a person described in 
253  this subparagraph or subparagraph (A) or (B).  
254   
255  An entity that falls within the definition of manufacturer in section 581(10) of the FD&C Act 
256  must comply with the requirements under section 582(b) of the FD&C Act.  
257   
258  FDA believes that most of the confusion19 is related to the inclusion of entities that hold drug 
259  approvals (i.e., holders of approved new drug applications (NDAs), biologics license 
260  applications (BLAs), or abbreviated new drug applications (ANDAs)), co-licensed partners, and 
261  affiliates of such entities in the definition of manufacturer in section 581(10) of the FD&C Act, 
262  and the interaction of this definition with the requirement to register under section 510 of the 
263  FD&C Act to be authorized according to section 581(2) of the FD&C Act.   
264   
265  1.  Manufacturing Establishments 
266   
267  Under section 510 of the FD&C Act, and part 207 (21 CFR part 207), with some limited 
268  exceptions, any person who owns or operates any establishment that manufactures, prepares, 
269  propagates, compounds, or processes drugs in the United States, or that are offered for import 
270  into the United States, must be registered with the FDA.20  Thus, under section 581(2)(A) of the 
271  FD&C Act, such manufacturer establishments must be registered in accordance with section 510 
272  of the FD&C Act to be considered an authorized trading partner.  
273   
274  2.  NDA-, BLA-, or ANDA-Holder, or Co-Licensed Partner of a Manufacturer  
275   
276   
277  While an NDA-, BLA-, or ANDA-holder or co-licensed partner of a manufacturer might not 
278  engage in the manufacturing, preparation, propagation, compounding, or processing of a drug, 
279  they could still meet the definition of manufacturer in section 581(10) of the FD&C Act.  There 
280  has been confusion as to whether such manufacturers should register under section 510 of the 
281  FD&C Act to be considered an authorized trading partner.  FDA believes such an entity would 
282  be an authorized trading partner without being registered under section 510 so long as the NDA-, 
283  BLA-, or ANDA-holder, or co-licensed partner is compliant with its obligations under section 
284  510 of the FD&C Act, if applicable. While these entities need not register under section 510 of 
 
19 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 the DSCSA.  
20 21 U.S.C. 360(b), (c), (d), and (i). 
  7  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
285  the FD&C Act in order to be considered authorized trading partners, they still must comply with 
286  all other relevant obligations under the DSCSA.  For example, the NDA-, BLA-, or ANDA-
287  holder, or co-licensed partner should ensure that the product it transfers to another trading 
288  partner was manufactured by an authorized21 entity that is registered under section 510 of the 
289  FD&C Act.22  We note, however, that any person who owns or operates any establishment 
290  manufacturing, preparing, propagating, compounding, or processing drugs in the United States, 
291  or that are offered for import into the United States, must have a valid registration in accordance 
292  with section 510 to comply with the FD&C Act.   
293   
294  For purposes of the DSCSA, FDA interprets the term co-licensed partner of a manufacturer, 
295  referenced in section 581(10)(B) of the FD&C Act, to mean one of two or more entities that have 
296  entered into a written agreement for the right to engage in the marketing of a prescription drug.  
297  While the term co-licensed partner is not defined in the FD&C Act, the Agency believes this 
298  interpretation is in alignment with industry practice and existing state laws.23  
299   
300   
301  3.  Affiliate of a Manufacturer (Section 581(10)(C) of the FD&C Act) 
302   
303  Affiliate is defined in section 581(1) of the FD&C Act as: 
304   
305  [A] business entity that has a relationship with a second business entity if, directly or 
306  indirectly  
307  (A) one business entity controls, or has the power to control, the other business 
308  entity; or  
309  (B) a third party controls, or has the power to control, both of the business entities. 
310   
311  FDA generally considers the situation described in paragraph (A) to be similar to a 
312  parent/subsidiary business relationship (i.e., the parent has the power to control the business of 
313  the subsidiary), and the situation described in paragraph (B) as describing a business relationship 
314  where a third party controls the business of several entities, such as controlling both the parent 
315  and the subsidiary.  In other words, an affiliate is a business entity that legally controls another 
316  business entity, directly or indirectly, or is controlled by another business entity; mere business 
317  links or relationships are not sufficient to meet the definition of an affiliate.24  Manufacturers and 
 
21 A manufacturer that is an establishment that manufactures, prepares, propagates, compounds, or processes a drug 
must have a valid registration with FDA in accordance with section 510 of the FD&C Act to be considered an 
authorized trading partner. See section 581(2)(A) of the FD&C Act. 
22 A drug is misbranded if, among other things, it is manufactured in an establishment not duly registered under 
section 510 of the FD&C Act (section 502(o) of the FD&C Act (21 U.S.C. 352(o)). 
23 While co-licensed partner is not defined in the FD&C Act, the term has been defined by various states to include 
a co-licensed marketing arrangement. See e.g.,  16.19.8.7(F) NMAC (which defines Co-licensed partner or 
product to mean an instance where two or more parties have the right to engage in the manufacturing or marketing 
of a prescription drug, consistent with FDAs implementation of the Drug Supply Chain Security Act (DSCSA) and 
Md. Health. Occ. Code  12-6c-01(d) (which defines co-licensed partner to mean a person in a relationship in 
which two or more persons have the right to engage in the manufacturing or marketing of a prescription drug, 
consistent with the U.S. Food and Drug Administration's implementation of the federal Prescription Drug Marketing 
Act. 
24 This interpretation is consistent with the interpretation of affiliate previously described in FDAs final rule 
Foreign Establishment Registration and Listing (66 FR 59138 at 59146, Nov. 27, 2001).   
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318  their affiliates retain responsibility for carrying out the activities and requirements under section 
319  582(b) of the FD&C Act.  To be considered a manufacturer under the DSCSA, an affiliate of a 
320  manufacturer as defined in 581(10)(A) or (B) of the FD&C Act must have received the product 
321  directly from such a manufacturer.25   
322   
323  4.  Private Label Distributors 
324   
325  For DSCSA purposes, FDA generally considers a private label distributor to be an entity that 
326  owns and distributes a manufactured product under its own label or trade name but does not 
327  manufacture, repack, relabel, or salvage the product itself.26   
328   
329  For purposes of the DSCSA, FDA generally considers private label distributors, who obtain a 
330  manufactured product to market under their own label or trade name from an entity that holds an 
331  approved application or license for such product, to be a co-licensed partner of the application or 
332  license holder for a given product. As noted above, FDA interprets the term co-licensed partner 
333  to mean one of two or more entities that have entered into a written agreement for the right to 
334  engage in the marketing of a prescription drug. 
335   
336  FDA generally considers the term co-licensed partner to apply to private label distributors 
337  because private label distributors are entities that enter into contractual agreements with 
338  application holders and manufacturers for the right to engage in the marketing of a drug. In this 
339  instance, the drug would be owned and marketed by the private label distributor under the label 
340  or trade name of that private label distributor.  
341   
342  A private label distributor, who obtains product directly from an application holder or an affiliate 
343  of that application holder, would generally be considered to be a manufacturer for purposes of 
344  the DSCSA.27  
345   
346  As a manufacturer for purposes of the DSCSA, a private label distributor is subject to all the 
347  requirements for manufacturers in section 582 of the FD&C Act, including the product tracing, 
348  product identifier, authorized trading partner, and verification requirements. 
349   
350  This is different from the definition of manufacturer under section 510 of the FD&C Act and 21 
351  CFR part 207, which requires establishments that manufacture, prepare, propagate, compound, or 
352  process drugs to register with the FDA.  A private label distributor that does not manufacture, 
353  repack, relabel, or salvage drugs should not register with FDA.28  However, the product that the 
 
25 See section 581(10)(C) of the FD&C Act. 
26 This interpretation is consistent with the interpretation of private label distributor in 21 CFR 207.1.   
27 See section 581(10)(B) of the FD&C Act which defines a co-licensed partner of an application holder as a 
manufacturer for DSCSA purposes if the co-licensed partner receives the product directly from the manufacturer as 
defined in sections 581(10)(A) and (C) of the FD&C Act.  
28 See 21 CFR 207.17(b).  
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354  private label distributor transfers to another trading partner must have been manufactured or 
355  repackaged by an authorized entity that is registered under section 510 of the FD&C Act.29 
356   
357  If an entity owns and distributes a manufactured product under a label or trade name that is not 
358  its own, it may be engaged in wholesale distribution and subject to all the requirements for 
359  wholesale distributors under the DSCSA unless the activity falls under one of the exclusions to 
360  the definition of wholesale distribution enumerated in section 503(e)(4) of the FD&C Act. 
361   
362  5.  Salvagers 
363   
364  FDA generally does not consider a salvager to be a manufacturer under the DSCSA.  A salvager 
365  is defined in 21 CFR 207.1 as a person who owns or operates an establishment that engages in 
366  salvaging.  Salvaging means the act of segregating out those finished drug products that may 
367  have been subjected to improper storage conditions (such as extremes in temperature, humidity, 
368  smoke, fumes, pressure, age, or radiation) for the purpose of returning the products that have 
369  been deemed acceptable for distribution to the marketplace, and includes applying manufacturing 
370  controls such as those required by current good manufacturing practice in 21 CFR parts 210 and 
371  211.30  Salvagers are required to register with FDA and report the National Drug Codes and lot 
372  numbers for product they have determined can be sold or used.31  While FDA generally does not 
373  consider salvagers to be manufacturers for the purposes of the DSCSA, other activities that a 
374  salvager conducts may subject them to DSCSA requirements.  For example: 
375   
376    If a salvager conducts repackaging activities, they are also required to register under 
377  section 510 and comply with repackager requirements under section 582(e) of the FD&C 
378  Act (see section B below). 
379   
380    If a salvager owns the drug products that have been salvaged, and sells salvaged products 
381  to another trading partner, this activity is considered wholesale distribution unless the 
382  activity falls under one of the exclusions to the definition of wholesale distribution 
383  enumerated in section 503(e)(4) of the FD&C Act.  Wholesale distributor product tracing 
384  requirements under section 582(c) and licensing and reporting requirements under 
385  sections 503(e) and 583 of the FD&C Act would apply (see section C below). 
386   
387    If a salvager does not take ownership of the drug products, but takes direct possession32 
388  of the products and conducts activities on behalf of another trading partner to determine 
389  if the products can be sold, FDA generally considers this as other logistic services and 
 
29 A manufacturer that is an establishment that manufactures, prepares, propagates, compounds, or processes a drug 
must have a valid registration with FDA in accordance with section 510 of the FD&C Act to be considered an 
authorized trading partner. See section 581(2)(A) of the FD&C Act. A repackager must have a valid registration 
with FDA in accordance with section 510 of the FD&C Act in order to be considered an authorized trading partner. 
See section 581(2)(A) of the FD&C Act. 
30 See 21 CFR 207.1. 
31 See 21 CFR 207.17(a) and 21 CFR 207.54. 
32 For the purposes of this guidance, FDA generally considers direct possession to mean having physical, direct 
contact with the product. 
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390  3PL requirements for licensure and reporting under section 584 of the FD&C Act would 
391  apply (see section D below). 
392   
393  B.  Repackagers as Trading Partners Under the DSCSA 
394   
395  The DSCSA defines repackager in section 581(16) of the FD&C Act as a person who owns or 
396  operates an establishment that repacks and relabels a product or package for  (A) further sale; or 
397  (B) distribution without a further transaction.  FDA generally considers entities engaged in 
398  relabeling activities described in 21 CFR 207.1 to be repackagers under the DSCSA.  Under 
399  section 510 of the FD&C Act and 21 CFR part 207, with some limited exceptions, any person 
400  who owns or operates any establishment that manufactures, prepares, propagates, compounds, or 
401  processes drugs in the United States or that are offered for import into the United States must be 
402  registered with the FDA.33  This includes entities that repackage or otherwise change the 
403  container, wrapper, or labeling of a drug in furtherance of the distribution of the drug.34  Thus, 
404  repackagers under the DSCSA must register in accordance with section 510 of the FD&C Act to 
405  be considered authorized trading partners. 
406   
407  An entity that falls within the definition of repackager in section 581(16)(A) of the FD&C Act 
408  who repacks and relabels a product or package for further sale must comply with all 
409  requirements under section 582(e) of the FD&C Act.  Repackagers defined under section 
410  581(16)(B) of the FD&C Act who repackage and relabel product for distribution without a 
411  further transaction must comply with only section 582(e)(1)(B)(ii) and (e)(3) of the FD&C 
412  Act.35   
413   
414  FDA generally does not consider a dispenser, specifically a pharmacy, that is solely engaged in 
415  packaging and labeling drug product(s) for dispensing to an identified individual patient after the 
416  receipt of a valid prescription for that patient (e.g., repackaging product into unit-dose packages 
417  for administration to an identified individual patient), to be a repackager under the DSCSA.  
418  Therefore, the requirements in section 582(e) of the FD&C Act would not apply. 
419   
420  C.  WDDs as Trading Partners Under the DSCSA 
421   
422  The DSCSA defines wholesale distributor in section 581(29) of the FD&C Act to mean a 
423  person (other than a manufacturer, a manufacturers co-licensed partner, a third-party logistics 
424  provider, or repackager) engaged in wholesale distribution (as defined in section 503(e)(4) of the 
425  FD&C Act,).   
426   
427  Section 503(e)(4) of the FD&C Act (21 U.S.C. 353(e)(4)) defines wholesale distribution as 
428  distribution of a drug subject to [section 503(b) of the FD&C Act (21 U.S.C. 353(b))] to a 
429  person other than a consumer or patient, or receipt of a drug subject to [section 503(b) of the 
430  FD&C Act (21 U.S.C. 353(b))] by a person other than the consumer or patient, but excludes 
 
33 21 U.S.C. 360(b), (c), (d), and (i). 
34 21 U.S.C. 360(a)(1). 
35 Section 582(e)(1) (except for 582(e)(1)(B)(ii)), (e)(2), (e)(3) and (e)(4) applies to repackagers defined under 
section 581(16)(A) of the FD&C Act, and only section 582(e)(1)(B)(ii) and (e)(3) applies to repackagers defined 
under section 581(16)(B) of the FD&C Act. 
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431  several specific activities.  An entity that falls within the definition of wholesale distributor in 
432  section 581(29) of the FD&C Act must comply with the requirements under section 582(c) of the 
433  FD&C Act.   
434   
435  One source of confusion is that the DSCSA provides a definition of wholesale distribution in 
436  section 503(e) of the FD&C Act and a definition for wholesale distributor in section 581 of the 
437  FD&C Act that differ from the respective definitions in the regulations promulgated pursuant to 
438  sections 503(c), (d), and (e) of the FD&C Act, as enacted by the Prescription Drug Marketing 
439  Act of 1987 (PDMA).36  Several types of entities are not considered WDDs under the DSCSA 
440  that were under these regulations.  Many of these entities are now considered to be 3PLs under 
441  the DSCSA and are discussed in the next section.  
442   
443  Another source of confusion stems from uncertainty as to whether a manufacturer can also be 
444  licensed as a WDD.  The definition of wholesale distribution, as set forth in section 503(e)(4) of 
445  the FD&C Act, excludes the distribution of a manufacturers own drug (section 503(e)(4)(H)).  
446  As a result, if a manufacturer is only distributing its own drug, it would not be engaged in 
447  wholesale distribution under the DSCSA and would not be required to comply with the licensure 
448  and reporting requirements for WDDs under the DSCSA. 
449   
450  Generally, but with exclusions enumerated in section 503(e)(4), an entity engaged in the 
451  distribution of a drug subject to section 503(b) of the FD&C Act (21 U.S.C. 353(b)), that the 
452  entity did not manufacture, to someone other than a consumer or patient, is conducting wholesale 
453  distribution and would be subject to all the WDD requirements under the DSCSA.  FDA is 
454  providing additional clarification on the applicability of some of the exclusions to wholesale 
455  distribution as provided below.  
456   
457  1.  Distribution for Emergency Medical Reasons 
458   
459  Section 503(e)(4)(C) of the FD&C Act states that the distribution of a drug or an offer to 
460  distribute a drug for emergency medical reasons, including a public health emergency (PHE) 
461  declaration pursuant to section 319 of the Public Health Service Act, does not constitute 
462  wholesale distribution.37  FDA generally considers this exclusion to cover distribution activities 
463  directly impacted by the PHE and distribution of products that are approved or authorized to 
464  diagnose, cure, mitigate, treat, or prevent the basis of the PHE.38  In addition, FDA generally 
465  considers the following circumstances to constitute emergency medical reasons for purposes of 
466  section 503(e)(4)(C) of the FD&C Act and therefore to be excluded from the definition of 
467  wholesale distribution: (1) the distribution of a drug to a first responder or other authorized 
468  individual administering prescription drugs to acutely ill or injured persons in an emergency 
469  situation and outside a healthcare facility; and (2) the distribution of a drug to a long-term care 
 
36 Public Law 100-293; codified at 21 U.S.C. 321 et seq. 
37 Pursuant to section 503(e)(4)(C) of the FD&C Act, this exclusion from the definition of wholesale distribution 
does not include a drug shortage unless caused by a public health emergency. 
38 During the public health emergency, if an entity is engaged in activities that meet the definition of wholesale 
distribution but such activities are not for emergency medical reasons then that entity would be a wholesale 
distributor with respect to such activities and would need to comply with sections 503(e) and 582(c) of the FD&C 
Act for the distribution of the products involved.   
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470  facility for use in emergency situations to treat acutely ill or injured persons during hours of the 
471  day when necessary drugs cannot be obtained from a dispenser.  
472   
473  Because we generally would not consider these activities to fall within the definition of 
474  wholesale distribution as defined in section 503(e)(4) of the FD&C Act, they do not subject an 
475  entity to the wholesale distributor requirements under the DSCSA.  With respect to the exclusion 
476  related to first responders mentioned above, FDA considers this to be an emergency medical 
477  reason only where the drug is to be administered to a patient who is in a current or active 
478  emergency situation.  This exclusion from the definition of wholesale distribution would not 
479  apply in normal circumstances involving the replenishment of stock drugs, as there is no active 
480  emergency in those situations.  An entity distributing drugs to a first responder in the absence of 
481  an emergency situation is subject to wholesale distributor requirements under the DSCSA.  
482   
483  2.  Distribution for Office Use 
484   
485  Section 503(e)(4)(E) of the FD&C Act excludes the distribution of minimal quantities of drug 
486  by a licensed retail pharmacy to a licensed practitioner for office use from the definition of 
487  wholesale distribution.  FDA has previously stated that it considers minimal quantities to mean 
488  the total annual dollar volume of prescription drugs sold to licensed practitioners does not exceed 
489  5 percent of the dollar volume of that retail pharmacys annual prescription drug sales.39  FDA 
490  generally intends to maintain its interpretation of what constitutes minimal quantities.  
491  Furthermore, FDA generally considers office use to mean use by a licensed practitioner in the 
492  usual course of professional practice and is not limited to use in a physicians office, where the 
493  licensed practitioner is lawfully authorized to prescribe or administer prescription drugs. 
494   
495  FDA generally does not consider a licensed retail pharmacy that sells drugs to a licensed 
496  practitioner for office use in minimal quantities at or below such 5 percent threshold to be subject 
497  to the wholesale distributor requirements under the DSCSA based on those sales alone; however, 
498  the licensed retail pharmacy may still be considered a wholesale distributor based on other 
499  activities it engages in that constitute wholesale distribution under section 503(e)(4) of the 
500  FD&C Act. 
501   
502  3.  Distribution of Drugs for Non-Human Research Purposes Only 
503   
504  For the purposes of DSCSA requirements, wholesale distribution is limited to include only 
505  distribution of prescription drugs intended for use in humans.40 Thus, the activities of the 
506  purchaser or receiver of drugs for non-human research purposes only do not fall into activities of 
507  a trading partner under the DSCSA and such purchaser or receiver would not be subject to 
508  requirements under the DSCSA for those transactions. While DSCSA product tracing does not 
509  apply, the receiver of drugs for non-human research purposes should maintain basic 
510  recordkeeping in the event of a drug recall.  Examples of non-human research include studies 
511  conducted in animals only or in vitro studies.  The seller of the drug may have DSCSA 
 
39 See the preamble to the final rule Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 
1992; Policies, Requirements, and Administrative Procedures (64 FR 67720 at 67748, Dec. 3, 1999).  
40 See section 503(e)(4) of the FD&C Act which references section 503(b) of the FD&C Act in the definition of 
wholesale distribution. 
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512  obligations if they meet the definition of a trading partner and the drug meets the definition of 
513  product under section 581 of the FD&C Act.  
514   
515  4.  Distribution of Drugs for Research Purposes in Humans Under an IND 
516   
517  Section 503(e)(4) of the FD&C Act defines wholesale distribution as a distribution to a person 
518  other than a consumer or patient.  FDA generally considers an investigator41 receiving drugs 
519  for clinical research purposes to be a consumer if the studies are either under an investigational 
520  new drug application (IND)42 or bioavailability or bioequivalence studies regulated under 21 
521  CFR part 320.43 In these situations, FDA generally would not consider the seller to be a WDD 
522  within the meaning of the DSCSA, and the investigator, considered a consumer, would not be 
523  considered a trading partner under the DSCSA.  Accordingly, such investigator also would not 
524  be subject to DSCSA requirements.44  Drugs received by an investigator for clinical research 
525  purposes should not re-enter the U.S. pharmaceutical supply chain.45  
526   
527  5.  Jobbers 
528   
529  FDA generally considers a jobber to be a person or entity that owns or operates an establishment 
530  that engages in wholesale distribution on a small scale or sells product solely to retailers and 
531  institutions.  Jobbers engage in wholesale distribution because they own and direct the sale or 
532  distribution of product to, and receive product from, a person other than a consumer or patient, 
533  and are not otherwise excluded from the definition under section 503(e)(4) of the FD&C Act.  
534  Thus, FDA generally considers jobbers to be WDDs and subject to the requirements for WDDs 
535  under the DSCSA. 
536   
537  D.  3PLs as Trading Partners Under the DSCSA 
538   
539  The DSCSA defines 3PLs broadly to include any entity that provides or coordinates 
540  warehousing, or other logistics services of a product in interstate commerce on behalf of a 
 
41 For purposes of this draft guidance, the term investigator has the definition set forth in 21 CFR 312.3(b) and 
includes a sponsor-investigator as well as individuals and entities under the supervision of the investigator.  See 
21 CFR 312.61. See also 21 CFR 312.57(a) (describing a sponsors responsibility for maintaining adequate records 
of the receipt, shipment, or other disposition of the investigational drug). 
42 See 21 CFR part 312 (setting forth the requirements for an investigational new drug application).  
43 Bioavailability and bioequivalence studies submitted to FDA in an NDA, ANDA, or supplement to those 
applications, are required to be conducted consistent with the requirements of 21 CFR part 320. While some 
bioavailability and bioequivalence studies are conducted under an IND, many such studies are exempt from IND 
requirements. See 21 CFR 320.31.  
44 Prior to this distribution from the seller to the investigator, transfers of a drug that meets the definition of product 
under section 581 of the FD&C Act between trading partners may be subject to DSCSA requirements.  
45 FDA generally considers a product to be diverted, and therefore potentially suspect or illegitimate under sections 
581(8) and 581(21) of the FD&C Act, if it is sold or dispensed to a consumer and then re-introduced into the U.S. 
pharmaceutical supply chain. See FDAs draft guidance for industry Definitions of Suspect Product and Illegitimate 
Product for Verification Obligations Under the Drug Supply Chain Security Act (June 2021), which, when finalized, 
will represent the agencys current thinking. We update guidances periodically. 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. 
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541  manufacturer, wholesale distributor, or dispenser of a product, but does not take ownership of the 
542  product, nor have responsibility to direct the sale or disposition of the product.46   
543   
544  There has been confusion as to what activities would be considered other logistics services 
545  within the definition of 3PL.  FDA generally considers other logistics services to mean services 
546  provided by an entity that accepts or transfers direct possession of products from that entitys 
547  facility within the United States and its territories on behalf of a trading partner (i.e., 
548  manufacturer, repackager, WDD, or dispenser).  FDA also generally considers other logistics 
549  services to include services provided by an entity that accepts or transfers direct possession of 
550  products from that entitys facility within the United States and its territories on behalf of a 
551  repackager of products for further sale or a repackager acting on behalf of a manufacturer, WDD, 
552  or dispenser. 
553     
554  Trading partner, with respect to 3PLs, is defined in part as having direct possession of product.47  
555  Manufacturers, wholesale distributors, dispensers, and repackagers are required to conduct 
556  transactions with authorized trading partners, therefore, 3PLs must be authorized, as defined in 
557  section 581(2) of the FD&C Act, when working on behalf of manufacturers, wholesale 
558  distributors, dispensers, and repackagers of product.48   
559   
560  Furthermore, FDA generally considers the section 584 requirement that each facility of such 
561  [3PL] 49 be licensed in accordance with the regulations to mean that 3PLs without a facility 
562  are not required to be licensed.  Section 584(d) of the FD&C Act provides that FDA will 
563  establish licensure standards that centrally include requirements relating to storage of product.  
564  These standards address issues with access and maintenance that presuppose the existence of a 
565  physical facility wherein product is maintained.   
566   
567  Accordingly, FDA generally considers a facility to be an establishment, warehouse, structure, or 
568  structures under common ownership at one general, permanent, physical location used to store or 
569  handle prescription drug products.  FDA would not generally consider a truck or shipping 
570  container used to transport product to constitute a facility for purposes of the DSCSA because 
571  such trucks or containers are not consistently located at one physical location and would not 
572  sensibly be covered by the storage requirements specific to 3PL facility licensure.  Likewise, 
573  FDA would not generally consider an establishment, warehouse, or structure that is not used to 
574  store or handle prescription drug products to constitute a facility for purposes of section 584 of 
575  the FD&C Act. 
576   
577  1.  Entities That Warehouse But Do Not Own or Direct the Sale or Disposition of 
578  Product 
579   
 
46 See section 581(22) of the FD&C Act. 
47 See section 581(23)(B) of the FD&C Act. 
48 See section 582(b)(3), (c)(3), (d)(3), and (e)(3) of the FD&C Act (21 U.S.C. 360eee-1(b)(3), (c)(3), (d)(3) and 
(e)(3)). 
49 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.  
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580  FDA generally considers an entity that owns, rents, or leases a facility where it warehouses 
581  product, but does not take ownership of, nor direct the sale or disposition of the product, to be a 
582  3PL under the DSCSA.  FDA would also generally consider an entity that owns, rents, or leases 
583  a facility under common ownership or control with another trading partner, where it warehouses 
584  product but does not take ownership of, nor direct the sale or disposition of the product, to be a 
585  3PL under the DSCSA.   
586   
587  2.  Brokers  
588   
589  FDA generally considers a broker to be a person or entity, who facilitates business transactions 
590  between two other trading partners, but does not take ownership of the product nor direct the sale 
591  or disposition of a product.  A broker does not provide or coordinate warehousing and does not 
592  accept or transfer direct possession of the product and, therefore, is not considered a 3PL under 
593  the DSCSA.  Thus, FDA generally would not consider the 3PL licensure requirements under the 
594  DSCSA to cover brokers.   
595   
596  However, if an entity acts as a seller or buyer, or directs the sale, purchase, or trade of a product, 
597  the broker becomes a principal party to the transaction and FDA generally considers such an 
598  entity to be involved in directing the sale or disposition of the product.  FDA generally does not 
599  consider the lack of direct possession of the product as a sufficient reason to preserve broker 
600  status because, as the seller or buyer, the person or entity is accepting or transferring ownership 
601  of the product.  Depending on the circumstances, FDA generally considers an entity engaged in 
602  this activity to likely meet the definition of a manufacturer, WDD, repackager, or dispenser, who 
603  would be required to meet all of the applicable requirements under the DSCSA.   
604   
605  3.  Solution Providers  
606   
607  FDA generally considers a solution provider to be a person or entity that provides other entities 
608  hardware, software, or systems solutions to help achieve compliance with the requirements under 
609  the DSCSA.  A solution provider does not take ownership of the product nor direct the sale or 
610  disposition of a product.  Furthermore, a solution provider does not provide or coordinate 
611  warehousing and does not accept or transfer direct possession of the product and, therefore, FDA 
612  generally would  not consider such person or entity to be a 3PL under the DSCSA.  Thus, FDA 
613  would not generally consider the 3PL licensure requirements under the DSCSA to cover solution 
614  providers. 
615   
616  4.  Common Carriers  
617   
618  As it relates to the distribution of prescription drug products subject to the DSCSA, FDA 
619  generally considers a common carrier to be an entity that solely provides transportation 
620  services50 but does not take ownership of the product nor direct the sale or disposition of the 
621  product.  Common carriers do not provide or coordinate warehousing for the products they 
 
50 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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622  transport.  Although common carriers accept and transfer direct possession of product, they do 
623  not store and handle product at a facility, as defined above.  Therefore, FDA would not generally 
624  consider the services provided by common carriers to constitute other logistics services, and 
625  FDA would not generally consider common carriers to be covered by the 3PL licensure 
626  requirements under the DSCSA.  The owner of the product would remain responsible for 
627  compliance with any applicable storage and handling requirements and for the products safety 
628  and integrity during transit and should select common carriers that can provide appropriate 
629  safeguards.   
630   
631  5.  Logistics or Administrative Services Contractors 
632   
633  FDA is also aware that some entities that solely contract with trading partners to provide labor, 
634  logistic, or administrative services in that trading partners facility, but do not take ownership nor 
635  direct the sale or disposition of product, have identified themselves as 3PLs.  These entities do 
636  not themselves provide or coordinate the warehousing of product; rather, the trading partner with 
637  which the entity is contracting provides or coordinates the warehousing.  Although such 
638  contractors may accept and transfer direct possession of product, they do not store and maintain 
639  product at their own facility, and thus would not meet the facility requirement of the other 
640  logistics services definition above.  Therefore, FDA would not generally consider such entities to 
641  be 3PLs under the DSCSA.  FDA expects the trading partner with which such a contractor is 
642  contracting to be responsible for its activities.  For example, if an entity is engaged in the 
643  provision of its services as a contractor in a wholesale distribution facility that is not under 
644  common ownership or control of the contractor and WDD, the contractors activity would be 
645  covered by the wholesalers license and obligations for compliance.  
646   
647  6.  Returns Processors and Reverse Logistics Providers 
648   
649  A returns processor or reverse logistics provider is defined in section 581(18) of the FD&C Act 
650  as: 
651   
652  [A] person who owns or operates an establishment that dispositions or otherwise 
653  processes saleable or nonsaleable product received from an authorized trading partner 
654  such that the product may be processed for credit to the purchaser, manufacturer, or seller 
655  or disposed of for no further distribution.   
656   
657  FDA previously considered returns processors and reverse logistics providers to be 3PLs because 
658  the definition at section 581(18) permitted these entities to handle saleable product.  FDA has 
659  received comments that some entities only handle products at the end of their lifecycle, either 
660  returning nonsaleable products to the manufacturer for credit or dispositioning products for 
661  destruction.  FDA generally does not consider such entities to be 3PLs, as under these 
662  circumstances, these products will not re-enter the supply chain.  However, if an entity is 
663  conducting activities for saleable returns that could put the product back into the pharmaceutical 
664  supply chain by way of sale or transfer to a trading partner, it generally would be considered a 
665  3PL, and 3PL requirements for licensure and reporting under section 584 of the FD&C Act 
666  would apply.  Additionally, if an entity takes ownership of the product or is responsible for 
667  directing the sale or disposition of the product, FDA generally considers such entity to be 
  17  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
668  engaged in wholesale distribution, subject to all the requirements for WDDs under the DSCSA.  
669  Therefore, a returns processor or reverse logistics provider may be considered a 3PL, a WDD, or 
670  neither depending on the activities it performs as described above. 
671   
672  E. Dispensers as Trading Partners Under the DSCSA 
673   
674  Section 581(3) of the FD&C Act states that dispenser: 
675   
676  (A) means a retail pharmacy, hospital pharmacy, a group of chain pharmacies under 
677  common ownership and control that do not act as a wholesale distributor, or any other 
678  person authorized by law to dispense or administer prescription drugs, and the affiliated 
679  warehouses or distribution centers of such entities under common ownership and control 
680  that do not act as a wholesale distributor; and (B) does not include a person who 
681  dispenses only products to be used in animals in accordance with section 512(a)(5).  
682   
683  Under this definition, a dispenser is a pharmacy that does not act as a WDD, or any other person 
684  authorized to dispense or administer human prescription drugs.  Furthermore, this definition 
685  redefines dispenser-affiliated warehouses and distribution centers as dispensers (these were 
686  previously considered to be WDDs under PDMA).  Such warehouses and distribution centers are 
687  no longer considered WDDs, unless such facilities are also engaged in wholesale distribution 
688  activities.  
689   
690  An entity that falls within the definition of dispenser in section 581(3) of the FD&C Act must 
691  comply with the requirements under section 582(d) of the FD&C Act.  The statutory requirement 
692  for dispensers to exchange product tracing information became effective on July 1, 2015.  
693  However, dispensers are not required to provide the product tracing information prior to, or at 
694  the time of, a transaction if the product is dispensed to a patient or if it is a sale by a dispenser to 
695  another dispenser to fulfill a specific patient need.51  The term specific patient need refers to 
696  the transfer of a product from one pharmacy to another to fill a prescription for an identified 
697  patient. 52  This term does not include the transfer of a product from one pharmacy to another for 
698  the purpose of increasing or replenishing stock in anticipation of a potential need.53  Although a 
699  dispenser that sells a product to another dispenser to fulfill a specific patient need is not required 
700  to provide product tracing information, other requirements of section 582(d) of the FD&C Act 
701  may apply to the transferring and receiving pharmacies.  Accordingly, such sales or transfers 
702  should be documented by each pharmacy in the normal course of business in a manner that 
703  would facilitate appropriate actions by the pharmacy in the event of an investigation of suspect 
704  or illegitimate product, recall, or notification of illegitimate product.  To reiterate, a dispenser 
705  transferring product to another dispenser for a specific patient need is not required to provide 
706  product tracing information with the transfer.  Transfers of product to another dispenser without 
707  a specific patient need may constitute wholesale distribution, and thus, the requirements for 
708  wholesale distributors in sections 582 and 583 of the FD&C Act may apply.  
709   
 
51 See section 582(d)(1)(A)(ii) of the FD&C Act. 
52 See section 581(19) of the FD&C Act. 
53 Id. 
  18  Contains Nonbinding Recommendations 
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710  To be considered an authorized trading partner, a dispenser must have a valid license under State 
711  law and accept or transfer direct ownership of a product from or to a manufacturer, repackager, 
712  wholesale distributor, or dispenser. 
  19  Contains Nonbinding Recommendations 
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713  Table 1. Summary of Authorized Trading Partners as Described in This Guidance*54 
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     Salvagers as defined in 21   Accepts or transfers   Registered with 
product    CFR 207.1  direct ownership of a  FDA in 
 Approved application  product from or to a  accordance with 
holder, or co-licensed  manufacturer,  section 510 of the 
partner of the approved  repackager,  FD&C Act  
application holder who  wholesale   Compliant with 
obtained the product  distributor, or  its obligations 
 
directly from a person  dispenser  under section 510 
 
described as a  of the FD&C Act  
manufacturer under   Compliant with 
section 581(10) of the  its obligations 
FD&C Act  under section 510 
 Affiliate of manufacturer  of the FD&C Act, 
who obtained the product  if applicable.  
directly from a person   Compliant with 
described as a  its obligations 
manufacturer under  under section 510 
section 581(10) of the  of the FD&C Act 
FD&C Act 
 Private label distributors 
who own and market a 
product under their own 
label 
continued 
 
 
54 For discussion of the entities identified in this table, see section III., above.  
  1  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
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 
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 
repacks and relabels a  engaged in packaging and  product from or to a  accordance with 
product or package for  labeling a product for  manufacturer,  section 510 of the 
further sale or  dispensing to an identified  repackager,  FD&C Act 
distribution without a  individual patient  wholesale   
further transaction  pursuant to a valid  distributor, or   
prescription  dispenser   
 
Wholesale   Engaged in distribution   Jobbers, i.e.,   A manufacturer   Accepts or transfers   Has a valid 
Distributor  of a drug to, or receipt of  those engaged in  distributing its own drug;  direct ownership of a  license under 
a drug by, a person other  wholesale  a manufacturers co- product from or to a  State law or 
than a consumer or  distribution on a  licensed partner; a 3PL; a  manufacturer,  section 583 of the 
patient, with certain  small scale or  repackager; a dispenser; a  repackager,  FD&C Act, in 
exceptions  that sell product  dispenser-affiliated  wholesale  accordance with 
solely to retailers  warehouse or distribution  distributor, or  582(a)(6) of the 
and institutions;  center; a dispenser who  dispenser  FD&C Act; in 
dispensers who  transfers product to  compliance with 
transfer product  another dispenser for a  reporting 
to another  specific patient need; and  requirements 
dispenser  other entities engaged in  under section 
without a  the distribution or receipt  503(e) of the 
specific patient  of a drug that falls under  FD&C Act 
need  an exclusion from   
wholesale distribution 
pursuant to section 
503(e)(4) of the FD&C 
Act, including but not 
limited to: emergency 
medical reasons; office 
continued 
  2    Contains Nonbinding Recommendations 
Draft  Not for Implementation 
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 
use; non-human research, 
or research in humans 
under an IND   
3PL   Provides or coordinates   Returns   Brokers, solution   Accepts or transfers   Has a valid 
warehousing, or other  processors or  providers, common  direct possession of a  license under 
logistics services of a  reverse logistics  carriers, logistics or  product from or to a  State law or 
product in interstate  providers  administrative services  manufacturer,  section 584(a)(1) 
commerce on behalf of a  conducting  contractors, entities that  repackager,  of the FD&C Act, 
manufacturer, wholesale  activities for  only return nonsaleable  wholesale  in accordance 
distributor, or dispenser  saleable returns  product to the  distributor, or  with 582(a)(7) of 
of a product, but does  that put the  manufacturer for credit or  dispenser  the FD&C Act; in 
not take ownership of the  product back into  disposition the product for  compliance with 
product, nor have  the  destruction  licensure 
responsibility to direct  pharmaceutical  reporting 
the sale or disposition of  supply chain by  requirements 
the product  way of sale or  under section 
transfer to a  584(b) of the 
trading partner  FD&C Act 
Dispenser   Retail pharmacy,     Person who only   Accepts or transfers   Has a valid 
hospital pharmacy, or  dispenses products to be  direct ownership of a  license under 
group of chain  used in animals in  product from or to a  State law 
pharmacies under  accordance with section  manufacturer, 
common ownership and  512(a)(5) of the FD&C  repackager, 
control that do not act as  Act  wholesale 
a wholesale distributor  distributor, or 
dispenser  
continued 
 
  3  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
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 
Dispenser   Person authorized by law     Person who only   Accepts or transfers   Has a valid 
to dispense or administer  dispenses products to be  direct ownership of  license under 
prescription drugs  used in animals in  a product from or to  State law 
 Affiliated warehouses  accordance with section  a manufacturer, 
or distribution centers  512(a)(5) of the FD&C  repackager, 
of a dispenser under  Act  wholesale 
common ownership and  distributor, or 
control that do not act  dispenser 
as a wholesale 
distributor 
714  *  
715   
  4