Standardization of Data and 
Documentation Practices for 
Product Tracing 
Guidance for Industry 
 
 
 
 
DRAFT GUIDANCE 
 
  This guidance document is being distributed for comment purposes only. 
 
Comments and suggestions regarding this draft document should be submitted within 60 days of 
publication in the Federal Register of the notice announcing the availability of the draft 
guidance.  Submit electronic comments to https://www.regulations.gov.  Submit written 
comments to the 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 at 301-796-
3130 or drugtrackandtrace@fda.hhs.gov; 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) 
Office of Regulatory Affairs (ORA) 
 
March 2018 
Procedural 
   
Standardization of Data and 
Documentation Practices for 
Product Tracing 
Guidance for Industry 
 
 
 
 
Additional copies are available from: 
 
Office of Communications, Division of Drug Information  
Center for Drug Evaluation and Research 
Food and Drug Administration 
10001 New Hampshire Ave., Hillandale Bldg., 4th Floor  
Silver Spring, MD 20993-0002  
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353 
Email: druginfo@fda.hhs.gov  
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm 
 
and/or 
 
Office of Communication, Outreach and Development  
Center for Biologics Evaluation and Research 
 Food and Drug Administration 
10903 New Hampshire Ave., Bldg. 71, Room 3128 
Silver Spring, MD 20993-0002 
Phone: 800-835-4709 or 240-402-8010 
Email: ocod@fda.hhs.gov 
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm   
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research  
Center for Biologics Evaluation and Research 
Office of Regulatory Affairs 
 
March 2018 
Procedural 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
TABLE OF CONTENTS 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 2 
III.  SCOPE OF THIS GUIDANCE ....................................................................................... 3 
IV.  TRADING PARTNER DEFINITIONS AND RECOMMENDATIONS RELATING 
TO CERTAIN SPECIFIC SITUATIONS ...................................................................... 3 
A.  Manufacturer ................................................................................................................................. 4 
B.  Dispenser ......................................................................................................................................... 4 
1. Dispenser to Dispenser Sales to Fulfill a Specific Patient Need ..................................................... 4 
2. Exception for Licensed Health Care Practitioners .......................................................................... 5 
3. Third-Party Agreements................................................................................................................... 5 
V.  STANDARDIZATION OF DATA .................................................................................. 6 
A.  Standardizing the Transaction Information ................................................................................ 6 
1. Proprietary or Established Name of the Product ............................................................................ 6 
2. Strength and Dosage Form of the Product ...................................................................................... 7 
3. National Drug Code Number of the Product ................................................................................... 8 
4. Container Size .................................................................................................................................. 8 
5. Number of Containers ...................................................................................................................... 8 
6. Lot Number of the Product .............................................................................................................. 9 
7. Date of the Transaction ................................................................................................................... 9 
8. Date of the Shipment, If More Than 24 Hours After the Date of the Transaction ........................... 9 
9. Business Name and Address of the Person From Whom Ownership Is Being Transferred ............ 9 
10.  Business Name and Address of the Person to Whom Ownership Is Being Transferred .............. 9 
B.  Standardizing the Transaction History...................................................................................... 11 
C.  Standardizing the Transaction Statement ................................................................................. 12 
1. Transaction Statement ................................................................................................................... 12 
2. Direct Purchase Statement ............................................................................................................ 12 
D.  Clerical Errors and Other Discrepancies .................................................................................. 14 
VI.  DOCUMENTATION PRACTICES.............................................................................. 14 
A.  Product Tracing Information That a Manufacturer Must Provide to a Subsequent 
Purchaser ...................................................................................................................................... 15 
B.  Product Tracing Information That a Repackager Must Provide to a Subsequent Purchaser
  15 
C.  Transactions Involving a Direct Purchase by Wholesale Distributors ................................... 16 
1. What Product Tracing Information Must a Wholesale Distributor or an Exclusive Distributor 
Provide to a Subsequent Purchaser for Product That Was Purchased Directly From the 
Manufacturer? ............................................................................................................................... 16 
2. What Product Tracing Information Must a Wholesale Distributor Provide to a Subsequent 
Purchaser for Product That Was Purchased Directly From the Manufacturers Exclusive 
Distributor or From a Repackager That Purchased Directly From the Manufacturer? ............... 16 
i 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
D.  Subsequent Transactions of Product After a Direct Purchase ................................................ 17 
E.  Drop Shipments to Dispensers .................................................................................................... 18 
F.  Transactions Involving Grandfathered Products Under Section 582(a)(5)(B) ...................... 18 
1. Transaction Information ................................................................................................................ 19 
2. Transaction History Omitting Certain Elements ........................................................................... 19 
3. Transaction Statement ................................................................................................................... 19 
ii 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
Standardization of Data and Documentation Practices  
1 
for Product Tracing  
2 
1
Guidance for Industry  
3 
4   
5   
6  This draft guidance, when finalized, will represent the current thinking of the Food and Drug 
7  Administration (FDA or Agency) on this topic.  It does not establish any rights for any person 
8  and is not binding on FDA or the public.  You can use an alternative approach if it satisfies the 
9  requirements of the applicable statutes and regulations.  To discuss an alternative approach, 
10  contact the FDA staff responsible for this guidance as listed on the title page.  
11   
12   
13   
14  I.  INTRODUCTION 
15   
16  This guidance elaborates on the standards for the interoperable exchange of transaction 
17  information, transaction history, and transaction statements required by section 582 of the 
18  Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-1).  Section 582 was 
19  added by the Drug Supply Chain Security Act (DSCSA) (Title II of Public Law 113-54) and 
20  facilitates the tracing of products2 through the pharmaceutical distribution supply chain by 
21  requiring trading partners3 (manufacturers, repackagers, wholesale distributors, and dispensers) 
22  to exchange transaction information, transaction history, and transaction statements (referred to 
23  collectively in this guidance as product tracing information) when engaging in transactions4 
24  involving certain prescription drugs.  This requirement took effect on January 1, 2015, for 
25  manufacturers, repackagers, and wholesale distributors, and on July 1, 2015, for dispensers.5  
                                                           
1 This guidance has been prepared by the Office of Compliance in the Center for Drug Evaluation and Research 
(CDER) in cooperation with the Center for Biologics Evaluation and Research (CBER) and the Office of Regulatory 
Affairs (ORA) at the Food and Drug Administration. 
2 Product is defined in section 581(13) of the FD&C Act as a prescription drug in finished dosage form for 
administration to a patient without substantial further manufacturing (such as capsules, tablets, and lyophilized 
products before reconstitution), but for the purposes of section 582, does not include blood or blood components 
intended for transfusion, radioactive drugs or radioactive biological products (as defined in section 600.3(ee) of title 
21, Code of Federal Regulations) that are regulated by the Nuclear Regulatory Commission or by a State pursuant to 
an agreement with such Commission under section 274 of the Atomic Energy Act of 1954 (42 U.S.C. 2021), 
imaging drugs, an intravenous product described in section 581(24)(B)(xiv), (xv), or (xvi) of the FD&C Act, any 
medical gas (as defined in section 575), homeopathic drugs marketed in accordance with applicable guidance under 
the FD&C Act, or a drug compounded in compliance with sections 503A and 503B of the FD&C Act (21 U.S.C. 
353a and 353b). 
3 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) of the FD&C Act, the requirements of section 582(a)-(e) 
are not applicable to them. 
4 Transaction is defined in section 581(24) of the FD&C Act.  Generally, a transaction involves a transfer of product 
between persons in which a change of ownership occurs.  There are several exemptions from this definition listed in 
section 581(24)(B) of the FD&C Act. 
5 Under section 582(d)(5) of the FD&C Act, licensed health care practitioners authorized to prescribe or administer 
medication under State law and other licensed individuals under the supervision or direction of such practitioners 
 
  1  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
26  This guidance also addresses how the product tracing requirements6 of section 582 apply to 
27  certain prescription drugs that entered the pharmaceutical distribution supply chain before 
28  January 1, 2015. 
29   
30  This guidance is intended to assist trading partners in standardizing the data contained in the 
31  product tracing information that trading partners must provide, capture, and maintain under 
32  section 582.  This guidance is also intended to help trading partners understand the data elements 
33  that should be included in the product tracing information, particularly in situations where 
34  trading partners are permitted by law to provide other trading partners with product tracing 
35  information that omits certain elements that would otherwise be required.  In addition, this 
36  guidance recommends documentation practices that trading partners can use to satisfy the 
37  product tracing requirements of section 582.  This guidance does not address all provisions of the 
38  DSCSA.  As FDA works to implement other provisions of the DSCSA, the Agency expects to 
39  issue additional guidance and/or regulations and conduct public meetings to further delineate the 
40  requirements of the DSCSA. 
41   
42  In general, FDAs guidance documents do not establish legally enforceable responsibilities.  
43  Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
44  as recommendations, unless specific regulatory or statutory requirements are cited.  The use of 
45  the word should in Agency guidances means that something is suggested or recommended, but 
46  not required. 
47   
48   
49  II.  BACKGROUND 
50   
51  On November 27, 2013, the DSCSA was signed into law.  Section 202 of the DSCSA, which 
52  added new sections 581 and 582 to the FD&C Act, set forth new definitions and requirements 
53  related to product tracing.  Under section 582(b)(1), (c)(1), (d)(1), and (e)(1) of the FD&C Act, 
54  trading partners are required to provide the subsequent purchaser7 with product tracing 
55  information for certain prescription drugs.  Trading partners are required to capture and maintain 
56  the applicable product tracing information for not less than 6 years after the date of the 
57  transaction.8  Trading partners are also required to provide applicable product tracing 
58  information in response to a request from FDA or other appropriate Federal or State official in 
59  the event of a recall or for the purpose of investigating a suspect or illegitimate product.9 
                                                                                                                                                                                           
who dispense or administer product in the usual course of professional practice are exempt from the dispenser 
requirements to exchange product tracing information in section 582(d)(1). 
6 For purposes of this guidance, the term product tracing requirements means the requirements in section 582(b)(1), 
(c)(1), (d)(1), and (e)(1) of the FD&C Act relating to exchange of transaction information, transaction history, and 
transaction statements amongst trading partners, and the requirements to provide this information to FDA or other 
appropriate Federal or State officials in certain circumstances upon request.  For this purpose, exchanging 
transaction information, transaction history, and transaction statements involves providing, capturing, and 
maintaining such information in accordance with section 582(b)(1), (c)(1), (d)(1), and (e)(1) of the FD&C Act. 
7 The terms subsequent purchaser and subsequent owner are both used in section 582 of the FD&C Act.  For this 
guidance, we use the term subsequent purchaser to refer to both.  
8 Sections 582(b)(1)(A)(ii), (c)(1)(A)(v), (d)(1)(A)(iii), and (e)(1)(A)(iii) of the FD&C Act. 
9 See sections 582(b)(1)(B), (c)(1)(C), (d)(1)(D), and (e)(1)(C) of the FD&C Act. 
  2  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
60   
61  Pursuant to section 582(a)(2)(A) of the FD&C Act, FDA issued a draft guidance that established 
62  initial standards for the interoperable exchange of product tracing information, in paper or 
63  electronic format, for compliance with sections 582(a), (b), (c), (d), and (e) of the FD&C 
64  Act.10,11  In establishing such standards, FDA considered the feasibility of establishing 
65  standardized documentation to be used by members of the pharmaceutical distribution supply 
66  chain to convey the product tracing information to the subsequent purchaser of a product and to 
67  facilitate the exchange of lot-level data.  In addition, FDA considered the standards established 
68  under section 505D of the FD&C Act and developed standards that comply with a form and 
69  format developed by a widely recognized international standards development organization. 
70   
71   
72  III.  SCOPE OF THIS GUIDANCE 
73   
74  This guidance is intended to assist trading partners in standardizing the product tracing 
75  information that is captured, maintained, and provided to the subsequent purchaser, FDA, or 
76  other appropriate State or Federal officials pursuant to the requirements under section 582 of the 
77  FD&C Act.  This guidance is also intended to help trading partners understand the data elements 
78  that should be included in the product tracing information, particularly in situations where 
79  trading partners are permitted by law to provide other trading partners with product tracing 
80  information that omits certain elements that would otherwise be required.  In addition, this 
81  guidance recommends documentation practices that trading partners can use to satisfy the 
82  product tracing requirements of section 582.  Use of these recommendations will facilitate the 
83  interoperable exchange of transaction information, transaction history, and transaction statements 
84  between trading partners for each transaction involving a product pursuant to section 582(b)(1), 
85  (c)(1), (d)(1), and (e)(1) of the FD&C Act. 
86   
87   
88  IV.  TRADING PARTNER DEFINITIONS AND RECOMMENDATIONS RELATING 
89  TO CERTAIN SPECIFIC SITUATIONS 
90   
91  As noted above, section 582 of the FD&C Act generally requires trading partners to exchange 
92  product tracing information in connection with transactions involving products.  The 
93  requirements apply to an entity that meets the definition of a manufacturer, wholesale distributor, 
94  dispenser, or repackager.  The statutory definitions of these terms are set forth in section 581 of 
95  the FD&C Act.  To assist industry and State and local governments in understanding how to 
96  categorize the entities in the drug supply chain in accordance with the DSCSA, FDA issued a 
97  draft guidance entitled Identifying Trading Partners Under the Drug Supply Chain Security Act, 
                                                           
10 Draft guidance for industry, DSCSA Standards for the Interoperable Exchange of Information for Tracing of 
Certain Human, Finished, Prescription Drugs:  How to Exchange Product Tracing Information (November 2014).  
That guidance, when finalized, will represent FDAs current thinking on that topic.  To make sure you have the most 
recent version of a guidance, always consult the FDA Drugs guidance web page at 
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.  
11 Under section 582(b)(1)(C), manufacturers are required to provide product tracing information in electronic 
format for certain transactions, beginning on November 27, 2017. 
  3  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
98  Guidance for Industry.12  That draft guidance, when finalized, will explain FDAs current 
99  thinking on how certain requirements apply to entities that may be considered trading partners in 
100  the pharmaceutical distribution supply chain.  Understanding which definition(s) apply to an 
101  entity will help determine its product tracing responsibilities.  It is important to note that an 
102  entity may meet the definition of more than one type of trading partner, depending on the 
103  activities in which it engages.13  An entity that meets more than one definition must comply with 
104  all applicable requirements under section 582 of the FD&C Act, but it is not required to duplicate 
105  requirements.14  In addition, for each trading partner definition an entity meets, to be considered 
106  an authorized trading partner, the entity must have the applicable registration(s) and/or license(s) 
107  for that type of trading partner.15  This section clarifies trading partner product tracing 
108  responsibilities for certain situations. 
109   
110  A.  Manufacturer 
111   
112  FDA recognizes that there are business relationships that involve multiple entities that may meet 
113  the definition of a manufacturer under the DSCSA (e.g., a person that holds an application 
114  approved under section 505 of the FD&C Act, a co-licensed partner of such a person, or its 
115  affiliates16).  When these situations exist, such entities should determine and specify in a written 
116  agreement which of them will be carrying out the activities required under section 582(b) of the 
117  FD&C Act.  
118   
119  B.  Dispenser 
120   
121  The following section provides recommendations for dispensers.  
122   
123  1.  Dispenser to Dispenser Sales to Fulfill a Specific Patient Need 
124   
125  Section 582(d)(1)(A)(ii) requires a dispenser, in each transaction in which the dispenser transfers 
126  ownership of a product (but not including dispensing to a patient or returns),  to provide the 
127  subsequent purchaser with product tracing information.17  However, dispensers are not required 
128  to provide the product tracing information in the case of a sale by the dispenser to another 
129  dispenser to fulfill a specific patient need.18  A sale to fulfill a specific patient need occurs 
130  when ownership of a product is transferred from one pharmacy to another pharmacy to fill a 
131  prescription for an identified patient.19  Such sales of prescription drug products to fulfill a 
                                                           
12 Draft guidance for industry, Identifying Trading Partners Under the Drug Supply Chain Security Act (August 
2017). That guidance, when finalized, will represent FDAs current thinking on that topic.  To make sure you have 
the most recent version of a guidance, always consult the FDA Drugs guidance web page at 
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. 
13 See section 582(a)(1) of the FD&C Act. 
14 Id. 
15 Authorized is defined under section 581(2) of the FD&C Act. 
16 See section 581(10) of the FD&C Act. 
17 See section 582(d)(1)(A) of the FD&C Act. 
18 See section 582(d)(1)(A)(ii) of the FD&C Act. 
19 See section 581(19) of the FD&C Act. The term specific patient need does not include the transfer of a product 
from one pharmacy to another for the purpose of increasing or replenishing stock in anticipation of a potential need. 
Id. 
  4  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
132  specific patient need should be documented by each pharmacy in a manner that would facilitate 
133  appropriate actions by the pharmacy in the event of an investigation of suspect or illegitimate 
134  product, recall, or notification of illegitimate product.  
135   
136  2.  Exception for Licensed Health Care Practitioners 
137   
138  Licensed health care practitioners authorized to prescribe or administer medication under State 
139  law, or other licensed individuals under the supervision or direction of such practitioners who 
140  dispense or administer product in the usual course of their professional practice, are excepted 
141  from the product tracing requirements that apply to dispensers under section 582(d)(1) and 
142  (d)(5).20  The trading partners of dispensers (including licensed health care practitioners that are 
143  dispensers), however, must be authorized trading partners.21 
144   
145  3.  Third-Party Agreements 
146   
147  Dispensers are required to maintain the product tracing information for a transaction for not less 
148  than 6 years after the transaction.22  Section 582(d)(1)(B) of the FD&C Act allows a dispenser to 
149  enter into a written agreement with a third party, including an authorized wholesale distributor, 
150  under which the third party confidentially maintains the product tracing information on the 
151  dispensers behalf.  FDA considers authorized trading partners and entities that are not 
152  authorized trading partners to be acceptable third parties for this purpose.  When such an 
153  arrangement exists, the dispenser must maintain a copy of the written agreement.23   
154    
155  FDA recognizes that a dispenser that has entered into this type of agreement may request that the 
156  trading partner that sells product to the dispenser provide the product tracing information directly 
157  to the third-party.  Pursuant to such request from the dispenser, the trading partner that is 
158  transferring ownership to the dispenser has met its obligation to provide product tracing 
159  information, and the dispenser has met its obligation to capture and maintain product tracing 
160  information for the transaction by providing this information directly to the third-party.  Absent a 
161  request by a dispenser to provide product tracing information directly to a third party, a trading 
162  partner should not assume that providing product tracing information to a party other than the 
163  dispenser satisfies its statutory obligation to provide such information to the dispenser. 
164   
165  Dispensers using third-party agreements for the maintenance of product tracing information 
166  should be aware that such agreements do not relieve them of their other statutory obligations 
167  under section 582 of the FD&C Act. 
168     
                                                           
20 See section 582(d)(5) of the FD&C Act.  In addition, licensed health care practitioners are also exempted from 
verification requirements described in section 582(d)(4) of the FD&C Act. 
21 See section 582(d)(3) of the FD&C Act.  
22 See section 582(d)(1)(A)(iii) of the FD&C Act. 
23 See section 582(d)(1)(B) of the FD&C Act. 
  5  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
169  V.  STANDARDIZATION OF DATA  
170   
171  Wholesale distributors, dispensers, and repackagers generally must not accept ownership of a 
172  product unless the previous owner provides the transaction information, transaction history, and 
173  a transaction statement prior to, or at the time of, the transaction.24  As required by section 
174  582(a)(2)(A), FDA issued a draft guidance that established initial standards related to the 
175  methods for the interoperable exchange of product tracing information.25  In this guidance, we 
176  provide recommendations for standardizing the product tracing information that trading partners 
177  are required to exchange.  Certain transactions that may involve the exchange of product tracing 
178  information that is different from what is described in the statutory definitions of transaction 
179  information, transaction history, or transaction statements are also addressed in this guidance. 
180   
181  A.  Standardizing the Transaction Information 
182   
183  The transaction information that trading partners are required to exchange generally consists of 
184  10 distinct elements of information, which are set forth in section 581(26) of the FD&C Act.  To 
185  help ensure that this information is provided in a consistent manner, trading partners should 
186  follow the recommendations set forth below when exchanging the transaction information.  
187  Examples of situations in which a trading partner may receive transaction information that omits 
188  certain elements that are otherwise required for a product are described in section VI.C. and F. of 
189  this guidance.  For these situations, a trading partner should use the product information on the 
190  product label, as necessary, to complete the transaction information that it provides to a 
191  subsequent purchaser.  
192   
193  1.  Proprietary or Established Name of the Product 
194   
195  A manufacturer or repackager that is creating the first transaction information for the product it 
196  is introducing into commerce should use either the proprietary name26 or established name27, as 
197  written on the product label, in the transaction information that it provides to subsequent 
198  purchasers.28 Any subsequent trading partner should use the name that was provided in the 
199  transaction information it received from the products previous owner. 
200   
201  Trading partners should not truncate the proprietary or established name of a product in the 
202  transaction information unless the system that is being used to provide transaction information 
                                                           
24 See section 582(c)(1)(A)(i), (d)(1)(A)(i), and (e)(1)(A)(i) of the FD&C Act. 
25 Draft guidance for industry, DSCSA Standards for the Interoperable Exchange of Information for Tracing of 
Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information (November 2014). 
That guidance, when finalized, will represent FDAs current thinking on that topic.  
26 The proprietary name is the exclusive name of a drug product owned by a company under trademark law 
regardless of registration status with the U.S. Patent and Trademark Office.  See the draft guidance for industry Best 
Practices in Developing Proprietary Names for Drugs (May 2014). That guidance, when finalized, will represent 
FDAs current thinking on that topic.  To make sure you have the most recent version of a guidance, always consult 
the FDA Drugs guidance web page at 
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. 
27 See Section 502(e)(3) of the FD&C Act. 
28 The proper name should be used for biological products.  See 21 CFR 600.3(k). 
  6  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
203  has character or space limitations that make truncation necessary.  If truncation cannot be 
204  avoided, a trading partner should truncate the name in such a way that makes it possible to 
205  identify the product, including, for an established name that includes multiple active 
206  pharmaceutical ingredients (APIs), each of the APIs, from the truncated name.  When truncation 
207  cannot be avoided, FDA recommends truncating the product name in this manner to minimize 
208  the chance that the name will be misinterpreted by other trading partners or entities.  Trading 
209  partners should avoid using abbreviations of drug names, symbols, and or dose designations that 
210  the Institute for Safe Medications Practices (ISMP) has identified as being frequently 
211  misinterpreted or involved in harmful medication errors.29 
212   
213  2.  Strength and Dosage Form of the Product 
214   
215  Manufacturers and repackagers that are creating the first transaction information for the product 
216  they are introducing into commerce should use the strength and dosage form of the product as it 
217  is written on the product label in the transaction information that they provide to subsequent 
218  purchasers.  Subsequent trading partners should use the strength and dosage form that is on the 
219  transaction information they received from the products previous owner.  The strength and 
220  dosage form of the product should remain consistent in the documents for each transaction. 
221   
222  a.  Strength 
223   
224  The strength of the product that is provided in the transaction information should include the 
225  amount of each API and the corresponding unit of measure (e.g., 500 mg).  Units of measure 
226  may be abbreviated (e.g., mg for milligram, mL for milliliter).  For some products, the strength 
227  may be expressed in the form of a concentration (e.g., 100 mg/mL), which is composed of the 
228  amount of an API and its corresponding unit of measurement per unit of volume.  Appendix C of 
229  FDAs Approved Drug Products With Therapeutic Equivalence Evaluations (commonly known 
230  as the Orange Book) shows abbreviations used for strength at 
231  https://www.fda.gov/downloads/drugs/developmentapprovalprocess/ucm071122.pdf.  
232   
233  b.  Dosage form 
234   
235  The dosage form identifies the product in its physical form (e.g., tablet, capsule, solution, or 
236  powder).  If abbreviations are used, they should consist of at least three letters.  CDERs Dosage 
237  Form data standard shows abbreviations used for dosage forms at http://wayback.archive-
238  it.org/7993/20171115111312/https://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsS
239  ubmissionRequirements/ElectronicSubmissions/DataStandardsManualmonographs/ucm071666.h
240  tm.  
241   
242   
243     
                                                           
29 A list of abbreviations, symbols, and dose designations to avoid is available on ISMPs website.  See 
http://www.ismp.org/tools/errorproneabbreviations.pdf.  
  7  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
244   
245  3.  National Drug Code Number of the Product 
246   
247  The National Drug Code (NDC) is a three-segment number comprised of the labeler code, 
248  product code, and package code.  FDA publishes the listed NDC numbers for finished drugs that 
249  are submitted as part of the listing information30 in the NDC Directory, which is updated daily.  
250   
251  Some prescription drugs licensed under section 351 of the Public Health Service Act (42 U.S.C. 
252  262), such as certain minimally manipulated human cells, tissues, and cellular and tissue-based 
253  products (HCT/Ps), may use an alternatively formatted NDC that is approved for use by the 
254  appropriate Center Director of FDA.31     
255   
256  Manufacturers and repackagers that are creating the first transaction information for the product 
257  they are introducing into commerce should use their respective NDC number.  Subsequent 
258  trading partners should use the same NDC number and the same configuration that is on the 
259  transaction information they received from the products previous owner.  Repackagers, 
260  however, should provide the NDC number that they have assigned to the repackaged product. 
261   
262  4.  Container Size 
263   
264  The container size should reflect the packaging configuration of the individual saleable unit,32 
265  not larger shipping units of product such as a box, case, or tote.  The container size is the number 
266  of  dosage forms per container.  For example, for solid oral dosage forms, the container size for a 
267  100-count bottle of tablets should be expressed as 100 tablets, and for products that are 
268  measured by volume, the container size for a 120 mL bottle of a topical solution should be 
269  expressed as 120 mL. 
270   
271  5.  Number of Containers 
272   
273  The number of containers is the quantity of individual saleable units of a product of the same lot 
274  number included in a transaction.  If more than one lot number is associated with the products 
275  received in a transaction, the products should be grouped by lot number, and the number of 
276  containers for each group of lot numbers should be reflected on the transaction information 
277  provided to the subsequent purchaser. 
278     
                                                           
30 See 21 CFR part 207: Registration of producers of drugs and listing of drugs in commercial distribution. 
 
31 See 21 CFR 207.33(b)(4). 
32 Individual saleable unit is defined in section 581(11)(B) of the FD&C Act. 
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279   
280  6.  Lot Number of the Product 
281   
282  For the purposes of this guidance, a lot number is a set of alphanumeric characters that is 
283  assigned by the manufacturer or repackager to identify a batch, or a specific identified portion of 
284  a batch, that has uniform character and quality within specified limits.  A manufacturer should 
285  use the lot number it has assigned to the product in the transaction information that the 
286  manufacturer provides to subsequent purchasers.  If a repackager assigns a new lot number to the 
287  product, the repackager should use the new lot number in the transaction information that it 
288  provides to subsequent purchasers.  In all other situations, a trading partner should use the lot 
289  number that was on the transaction information it received from the products previous owner in 
290  the transaction information that the trading partner provides to subsequent purchasers.  If more 
291  than one lot number is associated with the products received in a transaction, each lot number 
292  should be reflected on the transaction information provided to the subsequent purchaser.  
293  Alternatively, each lot number can be represented in separate transaction information provided to 
294  the subsequent purchaser. 
295   
296  7.  Date of the Transaction 
297   
298  For the purposes of this guidance, the date of the transaction is the date on which ownership of 
299  the product involved in the transaction is transferred between trading partners.  If that date is 
300  specified in a contract between the trading partners, FDA recommends using the contractually 
301  specified date as the date of the transaction.  Otherwise, FDA recommends that trading partners 
302  use the products shipment date as the date of the transaction. 
303   
304  8.  Date of the Shipment, If More Than 24 Hours After the Date of the 
305  Transaction 
306   
307  The shipment date should reflect the date that the product is shipped to the trading partner that is 
308  to receive the product. 
309   
310  9.  Business Name and Address of the Person From Whom Ownership Is 
311  Being Transferred 
312   
313  FDA understands that a trading partner transferring ownership of a product may have multiple 
314  options regarding which address to provide in the transaction information (e.g., headquarters or 
315  corporate address, billing address, shipping address).  FDA views this as business decision 
316  between trading partners, however, FDA recommends using the address of the facility from 
317  which the product is being shipped as the business address of the trading partner that is 
318  transferring ownership of the product.  However, if the product is shipped from a third-party 
319  logistics providers facility, the business address of the trading partner that is transferring 
320  ownership of the product should be used, and not the address of the third-party logistics provider. 
321   
322  10.  Business Name and Address of the Person to Whom Ownership Is Being 
323  Transferred 
324   
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325  FDA understands that a trading partner to whom ownership is being transferred may have 
326  multiple options regarding which address to provide in the transaction information (e.g., 
327  headquarters or corporate address, billing address, shipping address).  FDA views this as a 
328  business decision between trading partners.  However, FDA recommends using the address of 
329  the facility to which the product is being shipped as the business address of the trading partner 
330  that is receiving ownership of the product.  However, if the product is shipped to a third-party 
331  logistics providers facility, the business address of the trading partner that is receiving 
332  ownership of the product should be used, and not the address of the third-party logistics provider. 
333     
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334   
335  B.  Standardizing the Transaction History 
336   
337  For each transaction, the transaction information should remain separate from the transaction 
338  history.  The transaction history is defined in section 581(25) of the FD&C Act as a statement in 
339  paper or electronic form, including the transaction information for each prior transaction going 
340  back to the manufacturer of the product.  In general, the transaction history for a product should 
341  be a compilation of the transaction information for each prior transaction involving that product.  
342  The recommendations in this section do not preclude a trading partner from providing more 
343  information than is described. 
344   
345  A trading partner should provide the transaction history for a product in one of the following two 
346  ways: 
347   
348  1.  The trading partner can compile the transaction information documents that it received 
349  from the products previous owner for each prior transaction involving the product.  
350  The transaction information documents should be arranged in reverse chronological 
351  order by transaction date. 
352   
353  For certain transactions involving wholesale distributors, the lot number and transaction 
354  and shipment dates from the manufacturer are not required to be included in the 
355  transaction information (see section VI of this guidance).  Consequently, some of the 
356  transaction information documents that make up the transaction history for a product 
357  might not contain this information.  In these situations, the trading partner should not 
358  add the information that is omitted from the transaction information documents for 
359  prior transactions.  The trading partner should instead compile the transaction 
360  information documents that it received from the products previous owner(s) and 
361  provide this information to the subsequent purchaser as the transaction history. 
362   
363  2.  The trading partner may create a new single document for the transaction history based 
364  on the documentation it has received from the products previous owner.  The product 
365  information for the current transaction (i.e., the proprietary or established name, 
366  strength, dosage form, NDC number, container size, lot number of the product) should 
367  be provided at the top of the document.  If this information does not change from 
368  transaction to transaction, it can be stated once in the transaction history.  Below the 
369  product information, the trading partner should provide the following information for 
370  each prior transaction:  the number of containers, the business name and address of the 
371  person that transferred ownership, the business name and address of the person that 
372  accepted ownership and the date of the transaction, and date of the shipment (if more 
373  than 24 hours after the date of the transaction).  This information should be provided in 
374  reverse chronological order by transaction date.  
375   
376  The trading partner that chooses to create this new single document should ensure that 
377  the information from documentation received from the products previous owner(s) is 
378  accurately transcribed. 
379   
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380  C.  Standardizing the Transaction Statement  
381   
382  Pursuant to sections 582(b)(1), (c)(1), (d)(1), and (e)(1) of the FD&C Act, a trading partner must 
383  provide the subsequent purchaser of a product with a transaction statement prior to, or at the time 
384  of, the transaction.  Trading partners should follow the recommendations set forth below when 
385  exchanging this transaction statement. 
386   
387  1.  Transaction Statement 
388   
389  Transaction statement is defined in section 581(27) of the FD&C Act as: 
390   
391  a statement, in paper or electronic form, that the entity transferring ownership in a 
392  transaction: 
393  (A)  is authorized as required under the Drug Supply Chain Security Act; 
394  (B)  received the product from a person that is authorized as required under the Drug Supply 
395  Chain Security Act; 
396  (C)  received transaction information and a transaction statement from the prior owner of the 
397  product, as required under section 582; 
398  (D)  did not knowingly ship a suspect or illegitimate product; 
399  (E)  had systems and processes in place to comply with verification requirements under 
400  section 582; 
401  (F)  did not knowingly provide false transaction information; and 
402  (G)  did not knowingly alter the transaction history.33 
403   
404  The transaction statement that a trading partner provides to a subsequent purchaser should 
405  identify the trading partner as the entity transferring ownership and indicate that the trading 
406  partner is in compliance with section 581(27)(A)-(G) of the FD&C Act.  A trading partner may 
407  indicate that it is in compliance by reproducing that section, word-for-word, in the transaction 
408  statements that it provides to subsequent purchasers.  Alternatively, a trading partner may 
409  indicate that it is in compliance with section 581(27)(A)-(G) by including the following sentence 
410  as the transaction statement that it provides to subsequent purchasers:  For this transaction, 
411  [Insert name of trading partner transferring ownership] is in compliance with section 
412  581(27)(A)-(G) of the Federal Food, Drug, and Cosmetic Act. 
413   
414  Trading partners should be aware that, for certain transactions, they may receive transaction 
415  information that does not contain certain elements listed in section 581(26) of the FD&C Act, or 
416  no transaction information, and a transaction statement that differs from section 581(27) of the 
417  FD&C Act (see section VI of this guidance).    
418   
419  2.  Direct Purchase Statement 
420   
421  Section 582(c)(1)(A) of the FD&C Act requires wholesale distributors that purchased a product 
422  directly from the manufacturer, the exclusive distributor of the manufacturer, or a repackager 
                                                           
33 For additional information on trading partner requirements related to transaction statements, please refer to section 
582(b), (c), (d), (e), and (f) of the FD&C Act. 
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423  that purchased directly from the manufacturer, to provide a statement relating to the direct 
424  purchase (referred to in this guidance as a direct purchase statement) with the transaction 
425  statement34 provided to a subsequent purchaser.  For purposes of this guidance, a wholesale 
426  distributor conducts a direct purchase if it purchases product directly from the manufacturer, the 
427  exclusive distributor of the manufacturer, or a repackager that purchased directly from the 
428  manufacturer. 
429   
430  The direct purchase statement must state, as required by section 582(c)(1)(A)(ii)(I)(aa)(AA), that 
431  the wholesale distributor, or a member of the affiliate of such wholesale distributor, purchased 
432  the product directly from the manufacturer, the exclusive distributor of the manufacturer, or a 
433  repackager that purchased directly from the manufacturer.  For this purpose, FDA recommends 
434  that wholesale distributors that conduct a direct purchase use the following language in the direct 
435  purchase statement that they provide to subsequent purchasers: [insert name of wholesale 
436  distributor that made a direct purchase] purchased this product directly from the manufacturer, 
437  exclusive distributor of the manufacturer, or a repackager that purchased directly from the 
438  manufacturer.  A direct purchase statement will help purchasing trading partners understand 
439  why the transaction history they received may not include transaction information that goes back 
440  to the manufacturer.   
441   
442  If a wholesale distributor purchases a product from another wholesale distributor that made a 
443  direct purchase of the product as described above, it must inform subsequent purchasers of the 
444  product that it received a direct purchase statement from the wholesale distributor that made the 
445  direct purchase.35  In these situations where a wholesale distributor is transferring ownership of a 
446  product it purchased from another wholesale distributor that made a direct purchase of the 
447  product, FDA recommends that the wholesale distributor inform subsequent purchasers that it 
448  received a direct purchase statement from the previous wholesale distributor by including the 
449  following language in the transaction statement: [insert name of wholesale distributor that 
450  received a direct purchase statement] received a direct purchase statement from the previous 
451  wholesale distributor. 
452     
                                                           
34  Apart from the addition of the direct purchase statement, the transaction statement should adhere to the content 
and format recommendations described in this guidance. 
35 See FD&C Act  582(c)(1)(A)(iv). 
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453   
454  D.  Clerical Errors and Other Discrepancies 
455   
456  FDA recognizes that clerical errors and other discrepancies in product tracing information may 
457  occur.  If a wholesale distributor, dispenser, or repackager purchases product and identifies a 
458  potential clerical error or other discrepancy in the product tracing information it has received, 
459  that trading partner should resolve the error or discrepancy as quickly as possible.  This may 
460  include immediately contacting the trading partner that provided the product tracing information 
461  to resolve the issue.  If the error or discrepancy cannot be resolved and the product is determined 
462  to be a suspect or illegitimate product, trading partners must follow steps for verification of 
463  product, including, if applicable, quarantine and investigation.36  
464   
465   
466  VI.  DOCUMENTATION PRACTICES 
467   
468  This section focuses on documentation practices and provides recommendations for how trading 
469  partners can meet their relevant product tracing obligations under section 582 of the FD&C Act.  
470  This section clarifies the product tracing information that should be provided to subsequent 
471  purchasers in situations where a trading partner is permitted by law to provide product tracing 
472  information that omits certain elements that are set forth in section 581(26), (25), and (27) of the 
473  FD&C Act for transaction information, transaction history, or transaction statements, 
474  respectively.  These situations involve:  
475   
476    Direct purchases by a wholesale distributor, in addition to transactions by a trading 
477  partner that further sells product that was purchased from a wholesale distributor that 
478  conducted a direct purchase.  
479   
480    Drop shipments to a dispenser. 
481   
482    Transactions involving grandfathered products under section 582(a)(5)(B) of the 
483  FD&C Act. 
484   
485  The descriptions below of transaction information, transaction history, and transaction statement 
486  that omit certain elements that would otherwise be required do not apply to transactions by 
487  dispensers or repackagers that purchase product directly from a manufacturer or from a 
488  repackager who purchased directly from the manufacturer.  For example, if you are a repackager 
489  that purchased product directly from the manufacturer, you must provide all of the elements for 
490  the product tracing information as required by section 582(e)(1)(A)(ii).  In addition, the 
491  recommendations in this section do not preclude a trading partner from providing additional 
492  information in the transaction information, transaction history, or transaction statement beyond 
493  what is required by law. 
494   
                                                           
36 See section 582(b)(4), (c)(4), (d)(4), and (e)(4) of the FD&C Act. 
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495  A.  Product Tracing Information That a Manufacturer Must Provide to a 
496  Subsequent Purchaser 
497   
498  The manufacturer must provide the following:37 
499   
500    The transaction information, which must include all of the information specified in 
501  section 581(26) of the FD&C Act, including the lot number of the product, 
502  transaction date, and shipment date, if more than 24 hours after the date of the 
503  transaction. 
504   
505    The transaction history, which must include all of the information specified in section 
506  581(25) of the FD&C Act for each prior transaction going back to the manufacturer, 
507  including the lot number of the product, transaction date, and shipment date. 
508   
509    The transaction statement, as defined in section 581(27)(A)-(G) of the FD&C Act 
510  (see section V.C). 
511   
512  B.  Product Tracing Information That a Repackager Must Provide to a 
513  Subsequent Purchaser 
514   
515  The repackager must provide the following:38 
516   
517    The transaction information, which must include all of the information specified in 
518  section 581(26) of the FD&C Act, including the lot number of the product, 
519  transaction date, and shipment date, if more than 24 hours after the date of the 
520  transaction. 
521   
522    The transaction history, which must include all of the information specified in section 
523  581(25) of the FD&C Act for each prior transaction going back to the manufacturer, 
524  including the lot number of the product, transaction date, and shipment date. 
525   
526    The transaction statement, as defined in section 581(27)(A)-(G) of the FD&C Act 
527  (see section V.C). 
528     
                                                           
37 See section 582(b)(1)(A)(i) of the FD&C Act. 
38 See section 582(e)(1)(A)(ii) of the FD&C Act. 
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529   
530  C.  Transactions Involving a Direct Purchase by Wholesale Distributors 
531   
532  As noted above, for purposes of this guidance, a wholesale distributor conducts a direct purchase 
533  if it purchases product directly from the manufacturer, the manufacturers exclusive distributor, 
534  or a repackager that purchased directly from the manufacturer.  Wholesale distributors are 
535  subject to the product tracing requirements set forth in section 582(c) of the FD&C Act.39  
536  1.  What Product Tracing Information Must a Wholesale Distributor or an 
537  Exclusive Distributor Provide to a Subsequent Purchaser for Product That 
538  Was Purchased Directly From the Manufacturer? 
539   
540  The wholesale distributor or exclusive distributor must provide the following:40 
541   
542    The transaction information, which must include all of the information specified in 
543  section 581(26) of the FD&C Act except the lot number of the product and the initial 
544  transaction and shipment dates from the manufacturer.41 
545   
546    The transaction history, which must include all of the information specified in section 
547  581(25) of the FD&C Act for each prior transaction going back to the manufacturer 
548  except the lot number of the product and the initial transaction and shipment dates 
549  from the manufacturer. 
550   
551    The transaction statement, as defined in section 581(27)(A)-(G) and which must also 
552  include a direct purchase statement (see section V.C). 
553   
554  2.  What Product Tracing Information Must a Wholesale Distributor Provide 
555  to a Subsequent Purchaser for Product That Was Purchased Directly 
556  From the Manufacturers Exclusive Distributor or From a Repackager 
557  That Purchased Directly From the Manufacturer? 
558   
559  The wholesale distributor must provide the following:42 
560   
561    The transaction information, which must include all of the information specified in 
562  section 581(26) of the FD&C Act except the lot number of the product.    
563   
564    The transaction history, which must include all of the information specified in section 
565  581(25) of the FD&C Act for each prior transaction going back to the manufacturer 
566  except the lot number of the product and the initial transaction and shipment dates 
                                                           
39 See section 582(c)(1)(A) of the FD&C Act. 
40 See section 582(c)(1)(A)(ii) of the FD&C Act.  
41 For the purposes of this guidance, FDA has interpreted the initial transaction date in section 582(c)(1)(A)(ii)(II) 
of the FD&C Act as the transaction date from the manufacturer. 
42 See section 582(c)(1)(A)(ii) of the FD&C Act.  
 
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567  from the manufacturer.  The transaction history should include the transaction date, 
568  shipment date, and the business name and address of the trading partner from whom 
569  the wholesale distributor received ownership (either the manufacturers exclusive 
570  distributor or the repackager who purchased directly from the manufacturer). 
571   
572    The transaction statement, as defined in section 581(27)(A)-(G) and which must also 
573  include a direct purchase statement (see section V.C). 
574   
575  D.  Subsequent Transactions of Product After a Direct Purchase  
576   
577  This section describes the product tracing information that a wholesale distributor must provide 
578  to the subsequent purchaser of a product, when that wholesale distributor obtained the product 
579  from a wholesale distributor that conducted a direct purchase.  Although this transaction is not 
580  considered a direct purchase, the product that is being transferred to the subsequent purchaser 
581  was obtained from a wholesale distributor that conducted a direct purchase (initial wholesale 
582  distributor).  For these transactions, the wholesale distributor that is transferring ownership of the 
583  product must provide the following to the subsequent purchaser:43 
584   
585    The transaction information, which must include all of the information specified in 
586  section 581(26) of the FD&C Act, including the lot number of the product, 
587  transaction date, and shipment date, if more than 24 hours after the date of the 
588  transaction . 
589   
590    The transaction history, which must include all of the information specified in section 
591  581(25) of the FD&C Act for each prior transaction going back to the initial 
592  wholesale distributor that conducted the direct purchase. 
593   
594    The transaction statement, as defined in section 581(27)(A)-(G), and which must also 
595  include a statement informing the subsequent purchaser that the wholesale distributor 
596  received a direct purchase statement from the initial wholesale distributor that 
597  conducted the direct purchase (section V.C). 
598     
                                                           
43 See section 582(c)(1)(A)(iii) and (iv) of the FD&C Act. 
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599   
600  E.  Drop Shipments to Dispensers 
601   
602  For the purposes of this guidance, a drop shipment means distribution of product to the dispenser 
603  by a wholesale distributor that does not physically handle or store the product, but arranges for a 
604  manufacturer, a repackager, or another wholesale distributor to directly ship the product to a 
605  dispenser on its behalf.  In drop shipment situations, section 582(f) of the FD&C Act allows  
606  wholesale distributors that do not physically handle or store product to be exempt from certain 
607  provisions of section 582 of the FD&C Act, provided that the manufacturer, repackager, or other 
608  wholesale distributor that distributes the product provides the contact information of the 
609  wholesale distributor on whose behalf the product was distributed.44  In these situations, he 
610  contact information of the wholesale distributor on whose behalf the product was distributed 
611  must be included on the transaction information and transaction history provided to the 
612  dispenser,45 and should consist of the wholesale distributors business name, address, and email 
613  address and/or phone number.  
614   
615  If a wholesale distributor and the trading partner that conducts the drop shipment directly to the 
616  dispenser do not exercise the exemption under 582(f), the wholesale distributor should provide 
617  the product tracing information to the dispenser as required under section 582(c). 
618   
619   
620  F.  Transactions Involving Grandfathered Products Under Section 582(a)(5)(B)  
621   
622  Section 582(a)(5)(B) of the FD&C Act addresses the tracing requirements for products that 
623  entered the pharmaceutical distribution supply chain before January 1, 2015 (pre-2015 products).   
624  The section exempts authorized trading partners from the requirement to provide transaction 
625  information for pre-2015 products under sections 582(b)(1)(A)(i), (c)(1)(A)(ii), (d)(1)(A)(ii), and 
626  (e)(1)(A)(ii) of the FD&C Act.46  It also requires that the transaction history for a pre-2015 
627  product begin with the products owner on January 1, 2015 (initial owner).47  In addition, section 
628  582(a)(5)(B)(iii) exempts the initial owner of pre-2015 product from asserting in a transaction 
629  statement that it received transaction information and a transaction statement from the prior 
630  owner of the product.48  FDA recommends that trading partners follow the practices set forth 
631  below when providing product tracing information for pre-2015 products. 
632   
                                                           
44For additional information on drop shipments, please refer to section 582(f) of the FD&C Act. 
45 See section 582(f)(1) of the FD&C Act. 
46 See section 582(a)(5)(B)(i) of the FD&C Act. 
47 See section 582(a)(5)(B)(ii) of the FD&C Act. 
48  As noted above, section 582(a)(5)(B)(i) exempts authorized trading partners from the requirement to provide 
transaction information for pre-2015 products under section 502(c)(1)(A)(ii) (addressing requirements applicable to 
a wholesale distributor that made a direct purchase).  In addition, FDA does not intend to take action against an 
authorized trading partner based on a failure to provide transaction information for pre-2015 products as described 
in section 582(c)(1)(A)(iii) (addressing requirements applicable to a wholesale distributor that did not make a direct 
purchase), or based on a failure by such authorized trading partner to assert receipt of transaction information and a 
transaction statement from the prior owner with respect to such products. 
 
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633  1.  Transaction Information 
634   
635  A trading partner should inform subsequent purchasers that the transaction involves pre-2015 
636  product and that the trading partner is exempt from providing transaction information for such 
637  product pursuant to section 582(a)(5)(B)(i) of the FD&C Act.  FDA recognizes that some trading 
638  partners will provide transaction information to subsequent purchasers of pre-2015 product even 
639  though they are exempt from doing so under section 582(a)(5)(B)(i), in the interest of supply 
640  chain security.  In these situations, FDA recommends that the trading partner inform subsequent 
641  purchasers that the transaction information is for a pre-2015 product.  
642   
643  2.  Transaction History Omitting Certain Elements 
644   
645  Pursuant to section 582(a)(5)(B)(ii), the transaction history that an initial owner provides to a 
646  subsequent purchaser of pre-2015 product (second owner) starts with the initial owner.  For all 
647  transactions after the initial owner-second owner transaction, the transaction history that is 
648  provided to a subsequent purchaser of pre-2015 product should go back to the products initial 
649  owner. 
650   
651  3.  Transaction Statement 
652   
653  An initial owner is required to provide a transaction statement to a subsequent purchaser but, 
654  pursuant to section 582(a)(5)(B)(iii) of the FD&C Act, is not required to assert in that transaction 
655  statement that the initial owner received transaction information and a transaction statement 
656  from the prior owner of the product, as required under section 582.  Although this statement 
657  described in section 581(27)(C) of the FD&C Act may, as a result, be absent from a transaction 
658  statement received from the initial owner, the absence of this statement will not prevent a trading 
659  partner that purchases pre-2015 product from the initial owner from having received the 
660  transaction information and transaction statement that is required under section 582.  When this 
661  trading partner transfers ownership of the product to a subsequent purchaser, it must provide a 
662  transaction statement that includes the statement set forth in section 581(27)(C).49   
                                                           
49 See section 582(b)(1)(A)(i), (c)(1)(A)(ii) and (iii), (d)(1)(A)(ii), and (e)(1)(A)(ii) of the FD&C Act related to 
transaction statements. 
  19