Grandfathering Policy for 
Packages and Homogenous 
Cases of Product Without a 
Product Identifier 
 
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) 
Office of Regulatory Affairs (ORA) 
 
September 2018 
Procedural 
 
  Grandfathering Policy for 
Packages and Homogenous 
Cases of Product Without a 
Product Identifier 
 
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 
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Silver Spring, MD 20993-0002 
Phone: 800-835-4709 or 240-402-8010 
Email: ocod@fda.hhs.gov 
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm    
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
Center for Biologics Evaluation and Research (CBER) 
Office of Regulatory Affairs (ORA) 
 
 
 
September 2018 
Procedural 
  Contains Nonbinding Recommendations 
TABLE OF CONTENTS 
 
I.  INTRODUCTION ...................................................................................................... 1 
II.  BACKGROUND ........................................................................................................ 2 
A.  Drug Supply Chain Security Act .................................................................................... 2 
B.  Scope of This Guidance ................................................................................................. 3 
III.  INTERPRETATION OF SECTION 582(a)(5)(A) OF THE DSCSA ......................... 4 
IV.  GRANDFATHERING POLICY ................................................................................ 4 
A.  Grandfathering Exemption from Certain Transaction-Related Requirements of  
Section 582........................................................................................................................... 5 
1. Scope of Grandfathering Exemption .................................................................................. 5 
2. Trading Partner Requirements under the Grandfathering Exemption...................................... 5 
B.  Saleable Returned Packages and Sealed Homogenous Cases of Product ............................ 9 
 
  Contains Nonbinding Recommendations 
 
Grandfathering  Policy for Packages and Homogenous  Cases of 
1 
Product Without a Product Identifier 
2 
Guidance for Industry1 
3 
4   
5   
6  This guidance represents the current thinking  of the Food and Drug Administration  (FDA or 
7  Agency) on this topic.  It does not establish any rights for any person and is not binding  on FDA 
8  or the public.2  You can use an alternative approach if it satisfies the requirements of the 
9  applicable statutes and regulations.  To discuss an alternative approach, contact the FDA office 
10  responsible for this guidance as listed on the title page. 
11   
12   
13   
14   
15  I.  INTRODUCTION 
16   
17  This guidance addresses product distribution  security provisions  in section 582 of the Federal 
18  Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-1).  Section 582 was added by 
19  the Drug Supply Chain Security Act (DSCSA) (Title II of Public Law 113-54) and facilitates the 
20  tracing of products through the pharmaceutical distribution  supply chain by requiring trading 
21  partners3 (manufacturers, repackagers, wholesale distributors,  and dispensers) to exchange 
22  transaction information,  transaction history,  and a transaction statement (product tracing 
23  information)  when engaging in transactions involving  certain prescription  drug products.  In 
24  addition,  section 582 requires manufacturers and repackagers to start affixing or imprinting  a 
25  product identifier to each package4 and homogenous  case5 of product no later than November 27, 
26  2017 (for manufacturers) and November 27, 2018 (for repackagers).6 
                                              
1 This guidance has been prepared by 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 This sentence does not apply to the discussion regarding the circumstances under which packages and homogenous 
cases of product that are not labeled with a product identifier and that are in the pharmaceutical distribution supply 
chain at the time of the effective date of the requirements of section 582 of the FD&C Act shall be exempted from 
the requirements of section 582. 
3 For this guidance, trading partner is defined as described in section 581(23)(A) of the FD&C Act (21 U.S.C. 
360eee(23)(A)).  Although third-party logistics providers are also considered trading partners under section 
581(23)(B) (21 U.S.C. 360eee(23)(B)) of the FD&C Act, they are not subject to the same product tracing 
requirements of section 582. 
4 Package is defined in section 581(11) of the FD&C Act. 
5 Homogeneous case is defined in section 581(7) of the FD&C Act.  The terms homogeneous and homogenous 
are used interchangeably throughout the DSCSA.  FDA has chosen to use only the term homogenous throughout 
this guidance. 
6 See section 582(b)(2)(A) and 582(e)(2)(A)(i) of the FD&C Act.  See also FDAs guidance for industry Product 
Identifier Requirements Under the Drug Supply Chain Security Act  Compliance Policy (explaining that FDA does 
not intend to act against manufacturers who do not affix or imprint a product identifier to each package and 
homogenous case of products intended to be introduced in a transaction into commerce before November 27, 2018).  
We update guidances periodically. To make sure you have the most recent version of a guidance, check the FDA 
 
  1  Contains Nonbinding Recommendations 
 
27   
28  We are issuing this guidance to help trading partners understand their compliance obligations 
29  under section 582 for packages and homogenous cases of product that are not labeled with a 
30  product identifier and that are in the pharmaceutical distribution  supply chain at the time of the 
31  effective date of the requirements of section 582.  This guidance, which is required by section 
32  582(a)(5)(A) of the FD&C Act, specifies whether and under what circumstances such packages 
33  and homogenous  cases of product shall be subject to the grandfathering exemption from certain 
34  requirements of section 582 (grandfathered).7   
35   
36  In general, FDAs guidance documents do not establish legally  enforceable responsibilities.   
37  Instead, guidances describe the Agencys current thinking  on a topic and should be viewed only 
38  as recommendations,  unless specific regulatory or statutory requirements are cited.  The use of 
39  the word should in Agency guidances means that something  is suggested or recommended, but 
40  not required. 
41   
42  An exception to that framework derives from section 582(a)(5)(A) of the FD&C Act, wherein 
43  Congress directed FDA to issue guidance specifying 
44   
45   . . . whether and under what circumstances product that is not labeled with a product 
46  identifier and that is in the pharmaceutical distribution supply chain at the time of the 
47  effective date of the requirements of section 582 shall be exempted from the requirements 
48  of [section 582]. 
49   
50  Accordingly,  insofar as this guidance specifies such circumstances, this document is not subject 
51  to the usual restriction in FDAs good guidance practice regulations  that guidances not establish 
52  legally  enforceable responsibilities.8   Therefore, the portion of this guidance that specifies the 
53  circumstances under which packages and homogenous  cases of product that are not labeled with 
54  a product identifier  and that are in the pharmaceutical distribution  supply chain at the time of the 
55  effective date of the requirements of section 582 shall be exempted from the requirements of 
56  section 582 has binding  effect, as indicated by the use of the words must, shall, or required. 
57   
58   
59  II.  BACKGROUND 
60   
61  A.  Drug Supply Chain Security Act 
62   
63  The DSCSA (Title II of Public Law 113-54) was signed into law on November 27, 2013.  
64  Section 202 of the DSCSA added section 582 to the FD&C Act, which established product 
65  tracing requirements for manufacturers, repackagers, wholesale distributors,  and dispensers of 
                                              
Drugs or Biologics guidance web pages at 
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. 
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. 
7 As used in this guidance, the terms grandfathering exemption and grandfathered refer to an exemption from the 
requirements of section 582 that is established by this guidance under the authority of section 582(a)(5)(A) of the 
FD&C Act. 
8 See 21 CFR 10.115(d). 
 
  2  Contains Nonbinding Recommendations 
 
66  most prescription drugs in a finished dosage form for administration  to a patient without 
67  substantial further manufacturing  (products).9  The DSCSA phases in its new requirements over 
68  a period of 10 years. 
69   
70  A critical component of the product tracing scheme outlined  in the DSCSA is the product 
71  identifier.10  Section 582 requires that each package and homogenous case of product in the 
72  pharmaceutical distribution  supply chain bear a product identifier  that is encoded with the 
73  products standardized numerical identifier,  lot number, and expiration  date by specific dates.  
74  Under the statute, manufacturers are required to begin affixing or imprinting  (adding) a product 
75  identifier  to each package and homogenous case of a product intended to be introduced into 
76  commerce no later than November 27, 2017.11  Repackagers are required to do the same no later 
77  than November 27, 2018.12 
78   
79  Sections 582(c)(2), (d)(2), and (e)(2)(A)(iii) of the DSCSA restrict trading partners ability  to 
80  engage in transactions involving  packages and homogenous  cases of product that are not labeled 
81  with a product identifier  after specific dates.  Beginning  November 27, 2018, repackagers may 
82  not receive or transfer ownership of a package or homogenous case of a product that is not 
83  encoded with a product identifier.13   Similar  restrictions go into effect for wholesale distributors 
84  and dispensers on November 27, 2019, and November 27, 2020, respectively.14 
85   
86  Section 582(a)(5)(A) directed FDA to: 
87   
88   . . . finalize guidance specifying whether and under what circumstances product that is 
89  not labeled with a product identifier and that is in the pharmaceutical supply chain at the 
90  time at the time of the effective date of the requirements of [section 582] shall be exempt 
91  from the [product tracing requirements] of [section 582]. 
92   
93  Only packages and homogenous cases of product that are in the pharmaceutical distribution 
94  supply chain at the time of the effective date of the requirements of [section 582] are eligible  for 
95  grandfathering under section 582(a)(5)(A). 
96   
97  B.  Scope of This Guidance 
98   
99  This guidance specifies the circumstances under which packages and homogenous cases of 
100  product that are not labeled with a product identifier  and that are in the pharmaceutical 
101  distribution  supply chain at the time of the effective date of the requirements of section 582, 
102  including  saleable returned packages and sealed homogenous cases of product, shall be 
                                              
9 Certain prescription drugs are excluded from the product tracing requirements of section 582.  See section 581(13) 
of the FD&C Act for the definition of the term product. 
10 Product identifier is defined in section 581(14) of the FD&C Act. 
11 For this requirement, see section 582(b)(2)(A) of the FD&C Act.  See also FDAs guidance Product Identifier 
Requirements Under the Drug Supply Chain Security Act  Compliance Policy, which describes a 1-year delay in 
enforcement of the product identifier requirement in section 582(b)(2)(A) of the FD&C Act. 
12 See section 582(e)(2)(A)(i) of the FD&C Act. 
13 See section 582(e)(2)(A)(iii) of the FD&C Act. 
14 See sections 582(c)(2), (d)(2) of the FD&C Act. 
 
  3  Contains Nonbinding Recommendations 
 
103  grandfathered from certain requirements of section 582.  This guidance does not address 
104  products or transactions for which a waiver, exception, or exemption  has been granted under 
105  section 582(a)(3) of the DSCSA from the requirement to bear a product identifier  on packages 
106  and homogenous  cases.  FDA addresses waivers, exceptions, and exemptions under section 
107  582(a)(3) in a separate guidance.15 
108   
109   
110  III.  INTERPRETATION OF SECTION 582(a)(5)(A) OF THE DSCSA 
111   
112  Under section 582(a)(5)(A), packages and homogenous cases of product that are not labeled with 
113  a product identifier  are eligible  to be exempted from the requirements of section 582 if they are 
114  in the pharmaceutical distribution  supply chain at the time of the effective date of the 
115  requirements of this section [(i.e., section 582)].  For the purposes of this guidance, a package 
116  or homogenous  case of product is in the pharmaceutical distribution  supply chain if it was 
117  packaged by the products manufacturer or repackaged by a repackager before November 27, 
118  2018.  We interpret the effective date of the requirements of this section as referring to the date 
119  set forth in section 582(e)(2)(A)(i) of the DSCSA regarding when repackagers must begin adding 
120  product identifiers to packages and homogenous cases of product (i.e., no later than November 
121  27, 2018). 
122   
123  Consequently,  a package or homogenous case of product that is not labeled with a product 
124  identifier  is eligible  for an exemption under section 582(a)(5)(A) as described in this guidance 
125  only if the products manufacturer packaged the product before November 27, 2018, or a 
126  repackager repackaged the product before November 27, 2018. 
127   
128   
129  IV.  GRANDFATHERING POLICY16 
130   
131  FDA has determined that there are circumstances under which it would be appropriate to exempt 
132  as grandfathered packages and homogenous  cases of product meeting the conditions  of section 
133  582(a)(5)(A) of the FD&C Act (i.e., the packages and homogenous cases of product that are not 
134  labeled with a product identifier  and are in the pharmaceutical distribution  supply chain at the 
135  time of the effective date of the requirements of section 582) from certain requirements of 
136  section 582.  Those circumstances, and the statutory requirements from which packages and 
137  homogenous cases of product without a product identifier  shall be grandfathered,17 are set forth 
                                              
15 See FDAs guidance for industry Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of 
the Federal Food, Drug, and Cosmetic Act.  This draft guidance, when finalized, will represent FDAs current 
thinking on this topic.  We update guidances periodically.  To make sure you have the most recent version of a 
guidance, check the FDA Drugs or Biologics guidance web pages at 
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. 
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. 
16 Insofar as section IV of this guidance specifies the circumstances under which packages and homogenous cases of 
product that are not labeled with a product identifier and that are in the pharmaceutical distribution supply chain at 
the time of the effective date of the requirements of section 582 of the FD&C Act shall be exempted from the 
requirements of section 582, it has binding effect. 
17 Grandfathered packages and homogenous cases of product are not considered misbranded under section 502(cc) 
of the FD&C Act, despite their failure to bear a product identifier. 
  4  Contains Nonbinding Recommendations 
 
138  below.  Our policy for saleable returned packages and sealed homogenous cases of product that 
139  are grandfathered as meeting the conditions  of section 582(a)(5)(A) is also described below.  
140   
141  A.  Grandfathering Exemption from Certain Transaction-Related Requirements 
142  of Section 582  
143   
144  1.  Scope of Grandfathering Exemption 
145   
146  A package or homogenous case of product that is not labeled with a product identifier  shall be 
147  grandfathered where there is documentation  that it was packaged by a manufacturer or 
148  repackaged by a repackager before November 27, 2018.  For example, if a package or 
149  homogenous case of product not labeled with a product identifier  is accompanied by transaction 
150  information  or a transaction history that includes a sale before November 27, 2018, that trading 
151  partner can reasonably conclude the product was packaged by a manufacturer or repackaged by a 
152  repackager before that date. 
153    
154  If the transaction information  or transaction history does not include a sale before November 27, 
155  2018, and absent other indicia that a product may be suspect or illegitimate,  the transaction 
156  statement is one indication  that the product was in the pharmaceutical distribution  supply chain 
157  before that date.18  Furthermore, since manufacturers and repackagers retain packaging date 
158  information  in the ordinary course of business,19 they should provide the packaging date to any 
159  trading partner who owns the product if they request it.  
160   
161  2.  Trading Partner Requirements under the Grandfathering Exemption 
162   
163  The specific requirements of section 582 from which a grandfathered product is exempted are set 
164  forth below.  To help trading partners understand the circumstances under which the 
165  grandfathering exemption applies to their activities,  the requirements for trading partners are 
166  addressed separately below.   
167   
168    Manufacturer Requirements 
169   
170  Manufacturers are exempted from two requirements of section 582 in circumstances 
171  where there is documentation  that the product involved  in the transaction was in the 
172  pharmaceutical distribution  supply chain before November 27, 2018. 
173   
174    First, for this grandfathered product, manufacturers are exempted from that 
175  part of section 582(b)(4)(A)(i)(II) which requires that they verify product at 
176  the package level using the product identifier beginning  November 27, 2017.  
177  However, a manufacturer must still validate any applicable  transaction history 
178  and transaction information  in its possession and otherwise investigate the 
                                              
18 Per section 581(27)(d) of the FD&C Act, the transaction statement indicates that an owner did not knowingly ship 
a suspect or illegitimate product. 
19 For example, batch production and control records are required under regulations for current good manufacturing 
practices for finished pharmaceuticals (21 CFR 211.188(b)(1)). 
  5  Contains Nonbinding Recommendations 
 
179  product to determine if it is illegitimate  in accordance with section 
180  582(b)(4)(A)(i)(II); the exemption  does not extend to these requirements.   
181   
182    Second, for this grandfathered product, manufacturers are exempted from that 
183  part of section 582(b)(4)(C) which, beginning  November 27, 2017, requires 
184  that, upon request from an authorized trading partner in possession or control 
185  of a product that it believes is from the manufacturer, such manufacturer 
186  verifies20 a product at the package level using the product identifier.   
187  However, a manufacturer must still follow all other steps as described in 
188  section 582(b)(4)(C). 
189   
190  Manufacturers must comply with all other applicable requirements of section 582 
191  when engaging in transactions involving  grandfathered product pursuant to this 
192  exemption. 
193   
194    Wholesale Distributor  Requirements 
195   
196  Wholesale distributors  are exempted from two requirements of section 582 in 
197  circumstances where there is documentation that the product involved  in the 
198  transaction was in the pharmaceutical distribution  supply chain before November 27, 
199  2018. 
200   
201    First, for this grandfathered product, wholesale distributors  are exempted from 
202  section 582(c)(2), which requires that they engage in transactions involving 
203  only product encoded with a product identifier  beginning  November 27, 2019.   
204   
205    Second, for this grandfathered product, wholesale distributors  are exempted 
206  from that part of section 582(c)(4)(A)(i)(II) which requires that they undertake 
207  certain activities to determine whether a product is illegitimate.   Specifically, 
208  wholesale distributors  shall not be required to verify the product at the 
209  package level using the product identifier beginning  November 27, 2019.  
210  However, wholesale distributors  must still validate any applicable transaction 
211  history and transaction information  in their possession and otherwise 
212  investigate the suspect product to determine if it is illegitimate.   The 
213  exemption does not extend to these requirements of section 
214  582(c)(4)(A)(i)(II).   
215   
216  Wholesale distributors  must comply with all other applicable requirements of section 
217  582 when engaging in transactions involving  grandfathered product pursuant to this 
218  exemption. 
219   
220    Dispenser Requirements 
221   
                                              
20 Verify is defined in section 581(28) of the FD&C Act. 
  6  Contains Nonbinding Recommendations 
 
222  Dispensers are exempted from two requirements of section 582 in circumstances 
223  where there is documentation  that the product involved  in the transaction was in the 
224  pharmaceutical distribution  supply chain before November 27, 2018.   
225   
226    First, for this grandfathered product, dispensers are exempted from section 
227  582(d)(2), which requires that they engage in transactions involving  only 
228  product encoded with a product identifier beginning  November 27, 2020.   
229   
230    Second, for this grandfathered product, dispensers are exempted from section 
231  582(d)(4)(A)(ii)(II),  which requires that they verify the product identifier of a 
232  portion of packages beginning  November 27, 2020, as part of an investigation 
233  conducted to determine whether a product is illegitimate.   However, 
234  dispensers must still verify the lot number of a suspect product as described in 
235  section 582(d)(4)(A)(ii)(I),  validate any applicable transaction history and 
236  transaction information  in their possession as described in section 
237  582(d)(4)(A)(ii)(III),  and otherwise investigate the product to determine if it is 
238  illegitimate  as required by section 582(d)(4)(A)(ii)(IV).   The exemption does 
239  not extend to these requirements of section 582(d)(4)(A)(ii).    
240   
241  Dispensers must comply with all other applicable requirements of section 582 when 
242  engaging in transactions involving  grandfathered product pursuant to this exemption. 
243   
244    Repackager Requirements 
245   
246  FDA has also determined that the grandfathering exemption applies to certain 
247  repackager activities in circumstances where there is documentation  that the product 
248  involved  in the transaction was in the pharmaceutical distribution  supply chain before 
249  November 27, 2018.   
250   
251    First, for this grandfathered product, repackagers are exempted from the 
252  requirement of section 582(e)(2)(A)(iii)  to only engage in transactions of 
253  product encoded with a product identifier beginning  November 27, 2018.  
254  Specifically,  repackagers may accept ownership of products without a product 
255  identifier  from a manufacturer or other repackager on and after November 27, 
256  2018, if such products are grandfathered.  Repackagers may also transfer 
257  ownership of product without a product identifier to another trading partner on 
258  and after November 27, 2018, if the product was repackaged by the 
259  repackager before November 27, 2018.  However, if a repackager accepts 
260  ownership of grandfathered product without a product identifier from a 
261  manufacturer or other repackager and repackages such product on or after 
262  November 27, 2018, the product must be encoded with a product identifier 
263  before the repackager transfers ownership. 
264   
265    Second, for this grandfathered product, repackagers investigating  suspect 
266  product without a product identifier  to determine whether that product is 
267  illegitimate  are also exempted from that part of section 582(e)(4)(A)(i)(II) 
  7  Contains Nonbinding Recommendations 
 
268  which requires that they verify product at the package level using the product 
269  identifier  beginning  November 27, 2018.  Specifically,  repackagers shall not 
270  be required to verify the product at the package level using the product 
271  identifier.  However, a repackager must still validate any applicable 
272  transaction history and transaction information  in its possession and otherwise 
273  investigate the product to determine if it is illegitimate  in accordance with 
274  section 582(e)(4)(A)(i)(II); the exemption does not extend to these 
275  requirements.   
276   
277    Third, if a repackager initially  repackaged product without a product identifier 
278  before November 27, 2018, it is exempted from that part of section 
279  582(e)(4)(C) which requires that, beginning  November 27, 2018, the 
280  repackager verify the product using the product identifier in response to a 
281  request from an authorized trading partner that is in possession or control of a 
282  product it believes is from such repackager.  However, a repackager must still 
283  follow all other steps as described in section 582(e)(4)(C). 
284   
285  Repackagers must comply with all other applicable requirements of section 582 when 
286  engaging in transactions involving  grandfathered product pursuant to this exemption. 
287   
288  Trading partners may engage in transactions involving  grandfathered product per the conditions 
289  of the grandfathering policy  until product expiry, regardless of when the transaction occurs.  
290  Although there is no sunset date for grandfathered products, FDA expects there to be relatively 
291  few of these packages and homogenous  cases of product without a product identifier  in the 
292  pharmaceutical distribution  supply chain by November 27, 2023.21   
293   
294  The FDA guidance Drug Supply Chain Security Act Implementation: Identification of Suspect 
295  Product and Notification notes that a package missing product tracing information  is a scenario 
296  that could significantly  increase the risk of a suspect product entering the drug supply chain.22  
297  As product identifier  requirements are implemented  over time, trading partners should be 
298  diligent  when engaging in a transaction of a package or homogenous case of product without a 
299  product identifier to ensure it is subject to the grandfathering policy,  other type of exemption, or 
300  a compliance policy. 
301   
302  FDA emphasizes that trading partners must comply with all other applicable requirements of 
303  section 582 when engaging in transactions covered by the exemption established by this 
304  guidance.  For example, a wholesale distributor  that transfers ownership of a package or 
305  homogenous case of product without a product identifier  after November 27, 2019, that is subject 
306  to the grandfathering  exemption must provide the subsequent owner with the products 
307  transaction information,  transaction history,  and transaction statement prior to, or at the time of, 
308  the transaction. 
309   
                                              
21 We note that the enhanced drug distribution security provisions of section 582(g) go into effect on November 27, 
2023. 
22 See FDAs guidance for industry at 
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.. 
  8  Contains Nonbinding Recommendations 
 
310  B.  Saleable Returned Packages and Sealed Homogenous Cases of Product 
311   
312  Section 582 addresses trading partners ability  to accept and redistribute  product that is returned 
313  to them in saleable condition.   Manufacturers, wholesale distributors,  and repackagers are 
314  required under sections 582(b)(4)(E), (c)(4)(D), and (e)(4)(E), respectively, to verify the product 
315  identifier  of a saleable returned package or sealed homogenous case of product that is intended 
316  for further distribution.   This requirement goes into effect on November 27, 2017 (per the 
317  statute) for manufacturers, November 27, 2018, for repackagers, and November 27, 2019, for 
318  wholesale distributors.  
319   
320  For returns23 of saleable packages and sealed homogeneous cases of product without product 
321  identifiers  that were in the pharmaceutical distribution  supply chain before November 27, 2018, 
322  manufacturers, wholesale distributors,  and repackagers are exempted from the requirements of 
323  sections 582(b)(4)(E), (c)(4)(D), and (e)(4)(E), respectively, to verify the product identifiers  of 
324  saleable returned packages or sealed homogenous cases of product that are intended for further 
325  distribution.   Manufacturers are exempted from the requirements of section 582(b)(2)(A) to add 
326  product identifiers before redistributing  such product if the product remains in the original 
327  package or sealed homogenous  case.  Repackagers are exempted from the requirements of 
328  sections 582(e)(2)(A)(i) and (e)(2)(A)(iii) to add product identifiers  before redistributing  such 
329  product if the product remains in the original  repackaged package or sealed homogenous case.  
330  Trading partners must comply with all other applicable requirements of section 582 when 
331  engaging in returns.  For example, wholesale distributors  must still meet the requirements of 
332  section 582(c)(1)(B)(i)(II) and only accept returned product from a dispenser or repackager 
333  beginning  November 27, 2019, if they can associate the returned product with the transaction 
334  information  and transaction statement for that product. 
                                              
23 Return is defined in section 581(17) of the FD&C Act. 
  9