Definitions of Suspect Product 
and Illegitimate Product for 
Verification Obligations Under 
the Drug Supply Chain Security 
Act 
 
 
Guidance for Industry 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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)  
 
March 2023 
Procedural 
 
   
Definitions of Suspect Product 
and Illegitimate Product for 
Verification Obligations 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/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)  
 
 
March 2023 
Procedural 
 
  Contains Nonbinding Recommendations 
 
TABLE OF CONTENTS  
 
I.   INTRODUCTION............................................................................................................. 1  
II.   BACKGROUND ............................................................................................................... 2  
A.   Definitions of Suspect Product and Illegitimate Product ............................................................. 2  
B.   Scope of This Guidance ................................................................................................................. 2  
III.   INTERPRETATION OF TERMS  .................................................................................. 3  
A.   Counterfeit...................................................................................................................................... 4  
B.   Diverted........................................................................................................................................... 4  
C.   Stolen............................................................................................................................................... 5  
D.   Fraudulent Transaction................................................................................................................. 6  
E.   Unfit for Distribution..................................................................................................................... 6  
 
 
 
  Contains Nonbinding Recommendations 
 
Definitions of Suspect Product and Illegitimate Product for 
1 
Verification Obligations Under the Drug Supply Chain Security Act  
2 
Guidance for Industry1  
3 
4   
5   
6   
7  This guidance represents the current thinking of the Food and Drug Administration (FDA or 
8  Agency) on this topic. It does not establish any rights for any person and is not binding on FDA 
9  or the public. You can use an alternative approach if it satisfies the requirements of the 
10  applicable statutes and regulations. To discuss an alternative approach, contact the FDA office 
11  responsible for this guidance as listed on the title page. 
12   
13   
14   
15   
16  I.  INTRODUCTION  
17   
18  FDA is issuing this guidance to interpret the terms used in the definition of  suspect product set 
19  forth in section 581(21) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 
20  360eee(21), and the definition of  illegitimate product set forth in section 581(8) of the FD&C 
21  Act, to assist trading partners in meeting verification obligations (including notification) under 
22  section 582(b)(4), (c)(4), (d)(4), and (e)(4) (21 U.S.C. 360eee-1(b)(4), (c)(4), (d)(4), and (e)(4))), 
23  respectively.  
24   
25  The Drug Supply Chain Security Act (DSCSA) (Title II of Public Law 113-54) amended the 
26  FD&C Act to establish requirements for product tracing, verification, and identification for 
27  certain drug products that are distributed in the United States. Many of the terms used in these 
28  requirements are defined in section 581 of the FD&C Act. 
29   
30  In general, FDAs guidance documents do not establish legally enforceable responsibilities. 
31  Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
32  as recommendations, unless specific regulatory or statutory requirements are cited. The use of 
33  the word should in Agency guidances means that something is suggested or recommended, but 
34  not required. 
35     
 
1 This  guidance has been  prepared by the Center for Drug Evaluation and Research in cooperation with the Center 
for Biologics Evaluation and Research and the Office of Regulatory Affairs at the FDA. 
1 
  Contains Nonbinding Recommendations 
 
36  II.  BACKGROUND 
37   
38  A.   Definitions of Suspect Product and Illegitimate Product   
39   
40  On November 27, 2013, the DSCSA was signed into law. Section 202 of the DSCSA, which 
41  added section 581 to the FD&C Act, sets forth the definitions of suspect product and 
42  illegitimate product, among other terms. Suspect product is defined in section 581(21) of the 
43  FD&C Act, and illegitimate product is defined in section 581(8) of the FD&C Act:  
44   
45  SUSPECT PRODUCTThe term suspect product means a product for which 
46  there is reason to believe that such product: 
47  (A)   is potentially counterfeit, diverted, or stolen; 
48  (B)   is potentially intentionally adulterated such that the product would result 
49  in serious adverse health consequences or death to humans; 
50  (C)   is potentially the subject of a fraudulent transaction; or 
51  (D)   appears otherwise unfit for distribution such that the product would result 
52  in serious adverse health consequences or death to humans.  
53   
54  ILLEGITIMATE PRODUCTThe term illegitimate product means a product 
55  for which credible evidence shows that the product: 
56  (A)   is counterfeit, diverted, or stolen; 
57  (B)   is intentionally adulterated such that the product would result in serious 
58  adverse health consequences or death to humans; 
59  (C)   is the subject of a fraudulent transaction; or 
60  (D)   appears otherwise unfit for distribution such that the product would be 
61  reasonably likely to result in serious adverse health consequences or death 
62  to humans. 
63   
64  B.   Scope of This Guidance 
65   
66  This guidance applies to the definitions of suspect product and illegitimate product as described 
67  in section 581(21) and (8) of the FD&C Act, specifically as those terms are used to describe 
68  trading partners verification obligations (including notification) under section 582(b)(4), (c)(4), 
69  (d)(4), and (e)(4), respectively. Section 582 includes requirements that trading partners have 
70  systems in place to identify and handle suspect and illegitimate products.  
71   
72  This guidance is intended to help industry identify suspect and illegitimate product in the U.S. 
73  pharmaceutical distribution supply chain by interpreting certain terms used in the definitions of 
2 
  Contains Nonbinding Recommendations 
 
74  suspect product and illegitimate product.2  Trading partners are required to take specific actions if 
75  they identify such products.3    
76   
77  The Agency issued a revised draft guidance for industry in March 2022: Verification Systems 
78  Under the Drug Supply Chain Security Act for Certain Prescription Drugs.4  The 2022 draft 
79  guidance addresses other aspects of the verification requirements in section 582 of the FD&C 
80  Act. In addition, the Agency previously issued, under section 582(h)(2)(A)(iii) of the FD&C Act, 
81  the guidance for industry Drug Supply Chain Security Act Implementation: Identification of 
82  Suspect Product and Notification (June 2021) that describes the processes for notifying FDA and 
83  trading partners of illegitimate product, as well as terminating those notifications.   
84   
85   
86  III.   INTERPRETATION OF TERMS   
87   
88  To comply with the verification provisions (including notification) of section 582 of the FD&C 
89  Act, trading partners5 (manufacturers, repackagers, wholesale distributors, and dispensers) must 
90  be able to identify a suspect product and make a determination about whether that product is an 
91  illegitimate product. 
92   
93  To help satisfy these obligations, trading partners should focus on the potential supply chain 
94  security threats listed in the suspect product and illegitimate product definitions. These threats 
95  include drugs that are, or may be, counterfeit, diverted, stolen, intentionally adulterated, unfit for 
96  distribution, or the subject of a fraudulent transaction.   
97   
98  FDA is clarifying its interpretation of the terms counterfeit, diverted, stolen,  fraudulent 
99  transaction, and unfit for distribution to aid trading partners in determining whether a product is 
100  suspect and/or illegitimate.   
101   
102  Although this guidance does not create an exhaustive list of the circumstances that may result in 
103  a counterfeit drug, a diverted drug, a stolen drug, a fraudulent transaction, or a drug that is unfit 
104  for distribution, it describes the most common scenarios that FDA believes trading partners will 
105  encounter. 
 
2 FDAs interpretations  of terms in this guidance document are limited to identifying suspect and illegitimate 
product as described in section 581(21) and (8) of the FD&C Act,  because those terms are used to  describe trading 
partners verification obligations  (including notification) under section 582(b)(4), (c)(4), (d)(4), and (e)(4).  
Furthermore, these interpretations apply only to drugs that  meet the definition of product in section 581(13). The 
interpretations  of the terms in  this guidance do  not apply to  other parts of the FD&C Act or affect FDAs 
enforcement authority under other provisions of the FD&C Act.  
3 See section 582(b)(4), (c)(4), (d)(4), and (e)(4) of the FD&C Act.  
4 When the 2022  draft guidance is finalized, it will represent FDAs current thinking  on this topic.  We update 
guidances  periodically.  For the most recent  version of a guidance, check the FDA guidance web page at  
https://www.fda.gov/RegulatoryInformation/Guidances/default.htm. 
5  Trading partner is defined in section 581(23)(A) of the FD&C  Act.  Although third-party logistics providers are  
also considered trading  partners  under section 581(23)(B), the requirements of section 582(a) through (e) are not 
applicable to them.  
3 
  Contains Nonbinding Recommendations 
 
106  A.   Counterfeit 
107   
108  FDA interprets the term counterfeit drug as used in section 581(8) and (21) of the FD&C Act, 
109  and the verification provisions (including notification) in section 582(b)(4), (c)(4), (d)(4), and 
110  (e)(4) to mean: 
111   
112  [A] drug which, or the container or labeling of which,  without authorization, bears the 
113  trademark, trade name, or other identifying mark, imprint, or device, or any likeness 
114  thereof, of a drug manufacturer, processor, packer, or distributor other than the person or 
115  persons who in fact manufactured, processed, packed, or distributed such drug and which 
116  thereby falsely purports or is represented to be the product of, or to have been packed or 
117  distributed by, such other drug manufacturer, processor, packer, or distributor.  
118   
119  See section 201(g)(2) of the FD&C Act (21 U.S.C. 321(g)(2)).  
120   
121  B.   Diverted  
122   
123  For purposes of section 581(8) and (21) of the FD&C Act, and the verification obligations 
124  (including notification) in section 582(b)(4), (c)(4), (d)(4), and (e)(4), FDA interprets the term 
125  diverted to refer to a: 
126   
127     Product that left the U.S. pharmaceutical distribution supply chain and is reintroduced 
128  in the United States in a transaction with a trading partner. For example, this scenario  
129  would include when a trading partner reintroduces into the U.S. pharmaceutical 
130  distribution supply chain product after it was dispensed to a patient or otherwise 
131  removed from the U.S. pharmaceutical distribution supply chain; or 
132   
133     Product that is labeled for sale in a non-U.S. market and that is introduced into the 
134  U.S. pharmaceutical distribution supply chain through a transaction with a trading 
135  partner. 
136   
137  A product would not be considered diverted as described above and, therefore, would generally 
138  not be considered a suspect or illegitimate product solely if a trading partner obtains that drug 
139  product: 
140   
141     Through surveillance activities, including: 
142  (1)  The product was obtained by the trading partner from outside the U.S. 
143  pharmaceutical distribution supply chain, or 
144  (2)  The product was obtained by the trading partner from a consumer who obtained 
145  the product from outside the U.S. pharmaceutical distribution supply chain; or 
146   
147     As a result of FDAs regulatory action to address a drug shortage; or 
148   
149     When FDA has issued an Emergency Use Authorization for the product under section 
150  564 of the FD&C Act (21 U.S.C. 360bbb-3). 
4 
  Contains Nonbinding Recommendations 
 
151  C.   Stolen  
152   
153  For purposes of section 581(8) and (21) of the FD&C Act, and the verification obligations 
154  (including notification) in section 582(b)(4), (c)(4), (d)(4), and (e)(4), FDA interprets the term 
155  stolen as it applies to a package of product to refer to: 
156   
157     Any product in its entirety (i.e., the prescription drug and its packaging6) that has 
158  been taken or removed without permission of the owner of the product (e.g., a bottle 
159  and all of its content of drug are taken or removed from the trading partner, or 
160  product taken as a result of cargo theft, warehouse theft, or courier theft7); 
161   
162     Any packaging of a product that has been taken or removed without the permission of 
163  the owner (e.g., only the empty bottle or outer carton is taken or removed from the 
164  trading partner); 
165   
166     Any prescription drug that has been taken or removed without permission of the 
167  owner of the product (e.g., all or some of the tablets are removed from a bottle and 
168  then taken or removed from the trading partner); or 
169   
170     Any prescription drug and/or its packaging, in physical custody of a trading partner, 
171  that is missing all or any portion of the drug as a result of the drug being taken or 
172  removed without permission of the owner (e.g., half of the tablets are removed from a 
173  bottle and the bottle with the remaining tablets is left with the trading partner subject 
174  to the theft, or all the tablets are removed from the bottle and the bottle is left with the 
175  trading partner subject to the theft). 
176   
177  FDA recognizes that product may be unaccounted for that does not meet this definition of stolen. 
178  For example, a trading partner may encounter a situation involving lost or missing product. 
179  Trading partners who identify unaccounted-for product should use current company policies and 
180  procedures to look into the circumstances surrounding the lost or missing product to determine 
181  whether it has been stolen or is otherwise suspect or illegitimate product. Consult the guidance 
182  for industry Drug Supply Chain Security Act Implementation: Identification of Suspect Product 
183  and Notification where FDA describes how to help identify suspect and illegitimate product, and 
184  the 2021 draft guidance for industry Enhanced Drug Distribution Security at the Package Level 
185  Under the Drug Supply Chain Security Act8 where FDA discusses aggregation errors and other 
186  discrepancies. 
187   
 
6  Packaging  here refers to  package as defined  in section 581(11) of the FD&C Act: the smallest individual saleable  
unit of product for distribution  by a manufacturer or repackager that is intended  by the manufacturer for ultimate 
sale to the dispenser of such  product. 
7  Stakeholders are also encouraged to report suspected criminal activity to FDAs Office of Criminal Investigations  
(OCI) at https://www.accessdata.fda.gov/scripts/email/oc/oci/contact.cfm.  
8 When final, this guidance will represent FDAs current thinking on this topic. 
5 
  Contains Nonbinding Recommendations 
 
188  D.   Fraudulent Transaction 
189   
190  For purposes of section 581(8) and (21) of the FD&C Act, and the verification provisions 
191  (including notification) in section 582(b)(4), (c)(4), (d)(4), and (e)(4), FDA interprets the term 
192  fraudulent transaction as referring to a transaction in which the transaction information,  
193  transaction history, or transaction statement contains information knowingly falsified by a 
194  trading partner who has provided or received the information.   
195   
196  It may not be immediately evident whether product tracing information is knowingly falsified. 
197  There may be situations where there is a clerical error or discrepancy in the product tracing 
198  information that may not be indicative of a suspect product. In such circumstances, FDA 
199  recommends that a trading partner take steps to determine whether the error can be resolved and 
200  whether the product is suspect or illegitimate.9 If the error cannot be resolved and the product is 
201  determined to be suspect or illegitimate, the trading partner must refrain from further distributing 
202  or dispensing the product and follow the verification steps as appropriate under section 582 of 
203  the FD&C Act. 
204   
205  E.   Unfit for Distribution 
206   
207  For the purpose of determining whether a product is suspect or illegitimate as those terms are 
208  defined in section 581(8) and (21) of the FD&C Act, and for purposes of the verification 
209  provisions (including notification) in section 582(b)(4), (c)(4), (d)(4), and (e)(4), FDA interprets 
210  the term unfit for distribution as referring to a prescription drug that is nonsaleable because its 
211  sale would violate the FD&C Act and there is a reason to believe or credible evidence which 
212  shows that the product would be reasonably likely to result in serious adverse health 
213  consequences or death to humans. 
214   
215  Product that is unfit for distribution may include adulterated products (see section 501 of the 
216  FD&C Act) (21 U.S.C. 351)), including drugs rendered nonsaleable because conditions (such as 
217  return, recall, damage, including temperature excursion, or expiry) cast doubt on the drugs 
218  safety, identity, strength, quality, or purity (see section 501(a)(2)(B) of the FD&C Act) to the 
219  point where there is a reason to believe or credible evidence which shows that such product 
220  would be reasonably likely to result in serious adverse health consequences or death to humans.  
221   
222  In addition, product that is unfit for distribution may include misbranded products (see section 
223  502 of the FD&C Act (21 U.S.C. 352)) where there is a reason to believe or credible evidence 
224  which shows that such product would be reasonably likely to result in serious adverse health 
225  consequences or death to humans. FDA recognizes that nonsaleable products (e.g., expired) are 
226  frequently removed from the supply chain without triggering a suspect product investigation. 
227  Although FDA recognizes that not all nonsaleable drug products will be determined to be suspect 
228  product, trading partners should use current company policy and procedure to look into the 
 
9 See the draft guidance for industry  Enhanced Drug Distribution Security at the Package Level Under the Drug 
Supply Chain Security Act . When  final, this guidance will represent FDAs current thinking on this topic. 
6 
  Contains Nonbinding Recommendations 
 
229  circumstances to determine whether the nonsaleable product rises to the level of suspect 
230  product.10   
231   
232  This definition of unfit for distribution, used to determine whether a product could be considered 
233  suspect or illegitimate, does not include product that is awaiting reverse distribution and 
234  processing and will not be distributed to patients. These products awaiting reverse distribution 
235  are not considered unfit for distribution within the context of initiating an investigation of 
236  suspect product. Similarly, product granted a waiver, exception, or exemption under section 
237  582(a)(3) of the FD&C Act and product grandfathered under section 582(a)(5) would not be 
238  considered unfit for distribution. Although such product is not considered unfit for distribution 
239  solely because it fits in one of these categories, such product could be unfit for distribution 
240  because it otherwise falls under the definition laid out in this section.  
 
10 See the guidance for industry Drug  Supply Chain  Security Act Implementation: Identification of Suspect Product 
and Notification. 
7