Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier

Administrative guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.

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
10903 New Hampshire Ave., Bldg. 71, Room 3128
Silver Spring, MD 20993-0002
Phone: 800-835-4709 or 240-402-8010
Email: ocod@fda.hhs.gov
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
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
1
Grandfathering Policy for Packages and Homogenous Cases of	1
Product Without a Product Identifier	2
Guidance for Industry1
3
4
5
This guidance represents the current thinking of the Food and Drug Administration (FDA or	6
Agency) on this topic. It does not establish any rights for any person and is not binding on FDA	7
or the public.2 You can use an alternative approach if it satisfies the requirements of the	8
applicable statutes and regulations. To discuss an alternative approach, contact the FDA office	9
responsible for this guidance as listed on the title page.	10
11
12
13
14
I. INTRODUCTION	15
16
This guidance addresses product distribution security provisions in section 582 of the Federal	17
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-1). Section 582 was added by	18
the Drug Supply Chain Security Act (DSCSA) (Title II of Public Law 113-54) and facilitates the	19
tracing of products through the pharmaceutical distribution supply chain by requiring trading	20
partners3 (manufacturers, repackagers, wholesale distributors, and dispensers) to exchange	21
transaction information, transaction history, and a transaction statement (product tracing	22
information) when engaging in transactions involving certain prescription drug products. In	23
addition, section 582 requires manufacturers and repackagers to start affixing or imprinting a	24
product identifier to each package4 and homogenous case5 of product no later than November 27,	25
2017 (for manufacturers) and November 27, 2018 (for repackagers).6	26
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 FDA’s 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

Contains Nonbinding Recommendations
2
27
We are issuing this guidance to help trading partners understand their compliance obligations	28
under section 582 for packages and homogenous cases of product that are not labeled with a	29
product identifier and that are in the pharmaceutical distribution supply chain at the time of the	30
effective date of the requirements of section 582. This guidance, which is required by section	31
582(a)(5)(A) of the FD&C Act, specifies whether and under what circumstances such packages	32
and homogenous cases of product shall be subject to the grandfathering exemption from certain	33
requirements of section 582 (grandfathered).7	34
35
In general, FDA’s guidance documents do not establish legally enforceable responsibilities.	36
Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only	37
as recommendations, unless specific regulatory or statutory requirements are cited. The use of	38
the word should in Agency guidances means that something is suggested or recommended, but	39
not required.	40
41
An exception to that framework derives from section 582(a)(5)(A) of the FD&C Act, wherein	42
Congress directed FDA to issue guidance specifying	43
44
. . . whether and under what circumstances product that is not labeled with a product	45
identifier and that is in the pharmaceutical distribution supply chain at the time of the	46
effective date of the requirements of section 582 shall be exempted from the requirements	47
of [section 582].	48
49
Accordingly, insofar as this guidance specifies such circumstances, this document is not subject	50
to the usual restriction in FDA’s good guidance practice regulations that guidances not establish	51
legally enforceable responsibilities.8 Therefore, the portion of this guidance that specifies the	52
circumstances under which packages and homogenous cases of product that are not labeled with	53
a product identifier and that are in the pharmaceutical distribution supply chain at the time of the	54
effective date of the requirements of section 582 shall be exempted from the requirements of	55
section 582 has binding effect, as indicated by the use of the words must, shall, or required.	56
57
58
II. BACKGROUND	59
60
A. Drug Supply Chain Security Act	61
62
The DSCSA (Title II of Public Law 113-54) was signed into law on November 27, 2013.	63
Section 202 of the DSCSA added section 582 to the FD&C Act, which established product	64
tracing requirements for manufacturers, repackagers, wholesale distributors, and dispensers of	65
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).

Contains Nonbinding Recommendations
3
most prescription drugs in a finished dosage form for administration to a patient without	66
substantial further manufacturing (products).9 The DSCSA phases in its new requirements over	67
a period of 10 years.	68
69
A critical component of the product tracing scheme outlined in the DSCSA is the product	70
identifier.10 Section 582 requires that each package and homogenous case of product in the	71
pharmaceutical distribution supply chain bear a product identifier that is encoded with the	72
product’s standardized numerical identifier, lot number, and expiration date by specific dates.	73
Under the statute, manufacturers are required to begin affixing or imprinting (adding) a product	74
identifier to each package and homogenous case of a product intended to be introduced into	75
commerce no later than November 27, 2017.11 Repackagers are required to do the same no later	76
than November 27, 2018.12	77
78
Sections 582(c)(2), (d)(2), and (e)(2)(A)(iii) of the DSCSA restrict trading partners’ ability to	79
engage in transactions involving packages and homogenous cases of product that are not labeled	80
with a product identifier after specific dates. Beginning November 27, 2018, repackagers may	81
not receive or transfer ownership of a package or homogenous case of a product that is not	82
encoded with a product identifier.13 Similar restrictions go into effect for wholesale distributors	83
and dispensers on November 27, 2019, and November 27, 2020, respectively.14	84
85
Section 582(a)(5)(A) directed FDA to:	86
87
. . . finalize guidance specifying whether and under what circumstances product that is	88
not labeled with a product identifier and that is in the pharmaceutical supply chain at the	89
time at the time of the effective date of the requirements of [section 582] shall be exempt	90
from the [product tracing requirements] of [section 582].	91
92
Only packages and homogenous cases of product that are “in the pharmaceutical distribution	93
supply chain at the time of the effective date of the requirements of [section 582]” are eligible for	94
grandfathering under section 582(a)(5)(A).	95
96
B. Scope of This Guidance	97
98
This guidance specifies the circumstances under which packages and homogenous cases of	99
product that are not labeled with a product identifier and that are in the pharmaceutical	100
distribution supply chain at the time of the effective date of the requirements of section 582,	101
including saleable returned packages and sealed homogenous cases of product, shall be	102
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 FDA’s 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.

Contains Nonbinding Recommendations
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grandfathered from certain requirements of section 582. This guidance does not address	103
products or transactions for which a waiver, exception, or exemption has been granted under	104
section 582(a)(3) of the DSCSA from the requirement to bear a product identifier on packages	105
and homogenous cases. FDA addresses waivers, exceptions, and exemptions under section	106
582(a)(3) in a separate guidance.15	107
108
109
III. INTERPRETATION OF SECTION 582(a)(5)(A) OF THE DSCSA	110
111
Under section 582(a)(5)(A), packages and homogenous cases of product that are not labeled with	112
a product identifier are eligible to be exempted from the requirements of section 582 if they are	113
“in the pharmaceutical distribution supply chain at the time of the effective date of the	114
requirements of this section [(i.e., section 582)].” For the purposes of this guidance, a package	115
or homogenous case of product is “in the pharmaceutical distribution supply chain” if it was	116
packaged by the product’s manufacturer or repackaged by a repackager before November 27,	117
2018. We interpret “the effective date of the requirements of this section” as referring to the date	118
set forth in section 582(e)(2)(A)(i) of the DSCSA regarding when repackagers must begin adding	119
product identifiers to packages and homogenous cases of product (i.e., no later than November	120
27, 2018).	121
122
Consequently, a package or homogenous case of product that is not labeled with a product	123
identifier is eligible for an exemption under section 582(a)(5)(A) as described in this guidance	124
only if the product’s manufacturer packaged the product before November 27, 2018, or a	125
repackager repackaged the product before November 27, 2018.	126
127
128
IV. GRANDFATHERING POLICY16	129
130
FDA has determined that there are circumstances under which it would be appropriate to exempt	131
as grandfathered packages and homogenous cases of product meeting the conditions of section	132
582(a)(5)(A) of the FD&C Act (i.e., the packages and homogenous cases of product that are not	133
labeled with a product identifier and are in the pharmaceutical distribution supply chain at the	134
time of the effective date of the requirements of section 582) from certain requirements of	135
section 582. Those circumstances, and the statutory requirements from which packages and	136
homogenous cases of product without a product identifier shall be grandfathered,17 are set forth	137
15 See FDA’s 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 FDA’s 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.

Contains Nonbinding Recommendations
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below. Our policy for saleable returned packages and sealed homogenous cases of product that	138
are grandfathered as meeting the conditions of section 582(a)(5)(A) is also described below.	139
140
A. Grandfathering Exemption from Certain Transaction-Related Requirements	141
of Section 582	142
143
1. Scope of Grandfathering Exemption	144
145
A package or homogenous case of product that is not labeled with a product identifier shall be	146
grandfathered where there is documentation that it was packaged by a manufacturer or	147
repackaged by a repackager before November 27, 2018. For example, if a package or	148
homogenous case of product not labeled with a product identifier is accompanied by transaction	149
information or a transaction history that includes a sale before November 27, 2018, that trading	150
partner can reasonably conclude the product was packaged by a manufacturer or repackaged by a	151
repackager before that date.	152
153
If the transaction information or transaction history does not include a sale before November 27,	154
2018, and absent other indicia that a product may be suspect or illegitimate, the transaction	155
statement is one indication that the product was in the pharmaceutical distribution supply chain	156
before that date.18 Furthermore, since manufacturers and repackagers retain packaging date	157
information in the ordinary course of business,19 they should provide the packaging date to any	158
trading partner who owns the product if they request it.	159
160
2. Trading Partner Requirements under the Grandfathering Exemption	161
162
The specific requirements of section 582 from which a grandfathered product is exempted are set	163
forth below. To help trading partners understand the circumstances under which the	164
grandfathering exemption applies to their activities, the requirements for trading partners are	165
addressed separately below.	166
167
• Manufacturer Requirements	168
169
Manufacturers are exempted from two requirements of section 582 in circumstances	170
where there is documentation that the product involved in the transaction was in the	171
pharmaceutical distribution supply chain before November 27, 2018.	172
173
➢ First, for this grandfathered product, manufacturers are exempted from that	174
part of section 582(b)(4)(A)(i)(II) which requires that they verify product at	175
the package level using the product identifier beginning November 27, 2017.	176
However, a manufacturer must still validate any applicable transaction history	177
and transaction information in its possession and otherwise investigate the	178
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)).

Contains Nonbinding Recommendations
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product to determine if it is illegitimate in accordance with section	179
582(b)(4)(A)(i)(II); the exemption does not extend to these requirements.	180
181
➢ Second, for this grandfathered product, manufacturers are exempted from that	182
part of section 582(b)(4)(C) which, beginning November 27, 2017, requires	183
that, upon request from an authorized trading partner in possession or control	184
of a product that it believes is from the manufacturer, such manufacturer	185
verifies20 a product at the package level using the product identifier.	186
However, a manufacturer must still follow all other steps as described in	187
section 582(b)(4)(C).	188
189
Manufacturers must comply with all other applicable requirements of section 582	190
when engaging in transactions involving grandfathered product pursuant to this	191
exemption.	192
193
• Wholesale Distributor Requirements	194
195
Wholesale distributors are exempted from two requirements of section 582 in	196
circumstances where there is documentation that the product involved in the	197
transaction was in the pharmaceutical distribution supply chain before November 27,	198
2018.	199
200
➢ First, for this grandfathered product, wholesale distributors are exempted from	201
section 582(c)(2), which requires that they engage in transactions involving	202
only product encoded with a product identifier beginning November 27, 2019.	203
204
➢ Second, for this grandfathered product, wholesale distributors are exempted	205
from that part of section 582(c)(4)(A)(i)(II) which requires that they undertake	206
certain activities to determine whether a product is illegitimate. Specifically,	207
wholesale distributors shall not be required to verify the product at the	208
package level using the product identifier beginning November 27, 2019.	209
However, wholesale distributors must still validate any applicable transaction	210
history and transaction information in their possession and otherwise	211
investigate the suspect product to determine if it is illegitimate. The	212
exemption does not extend to these requirements of section	213
582(c)(4)(A)(i)(II).	214
215
Wholesale distributors must comply with all other applicable requirements of section	216
582 when engaging in transactions involving grandfathered product pursuant to this	217
exemption.	218
219
• Dispenser Requirements	220
221
20 Verify is defined in section 581(28) of the FD&C Act.

Contains Nonbinding Recommendations
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Dispensers are exempted from two requirements of section 582 in circumstances	222
where there is documentation that the product involved in the transaction was in the	223
pharmaceutical distribution supply chain before November 27, 2018.	224
225
➢ First, for this grandfathered product, dispensers are exempted from section	226
582(d)(2), which requires that they engage in transactions involving only	227
product encoded with a product identifier beginning November 27, 2020.	228
229
➢ Second, for this grandfathered product, dispensers are exempted from section	230
582(d)(4)(A)(ii)(II), which requires that they verify the product identifier of a	231
portion of packages beginning November 27, 2020, as part of an investigation	232
conducted to determine whether a product is illegitimate. However,	233
dispensers must still verify the lot number of a suspect product as described in	234
section 582(d)(4)(A)(ii)(I), validate any applicable transaction history and	235
transaction information in their possession as described in section	236
582(d)(4)(A)(ii)(III), and otherwise investigate the product to determine if it is	237
illegitimate as required by section 582(d)(4)(A)(ii)(IV). The exemption does	238
not extend to these requirements of section 582(d)(4)(A)(ii).	239
240
Dispensers must comply with all other applicable requirements of section 582 when	241
engaging in transactions involving grandfathered product pursuant to this exemption.	242
243
• Repackager Requirements	244
245
FDA has also determined that the grandfathering exemption applies to certain	246
repackager activities in circumstances where there is documentation that the product	247
involved in the transaction was in the pharmaceutical distribution supply chain before	248
November 27, 2018.	249
250
➢ First, for this grandfathered product, repackagers are exempted from the	251
requirement of section 582(e)(2)(A)(iii) to only engage in transactions of	252
product encoded with a product identifier beginning November 27, 2018.	253
Specifically, repackagers may accept ownership of products without a product	254
identifier from a manufacturer or other repackager on and after November 27,	255
2018, if such products are grandfathered. Repackagers may also transfer	256
ownership of product without a product identifier to another trading partner on	257
and after November 27, 2018, if the product was repackaged by the	258
repackager before November 27, 2018. However, if a repackager accepts	259
ownership of grandfathered product without a product identifier from a	260
manufacturer or other repackager and repackages such product on or after	261
November 27, 2018, the product must be encoded with a product identifier	262
before the repackager transfers ownership.	263
264
➢ Second, for this grandfathered product, repackagers investigating suspect	265
product without a product identifier to determine whether that product is	266
illegitimate are also exempted from that part of section 582(e)(4)(A)(i)(II)	267

Contains Nonbinding Recommendations
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which requires that they verify product at the package level using the product	268
identifier beginning November 27, 2018. Specifically, repackagers shall not	269
be required to verify the product at the package level using the product	270
identifier. However, a repackager must still validate any applicable	271
transaction history and transaction information in its possession and otherwise	272
investigate the product to determine if it is illegitimate in accordance with	273
section 582(e)(4)(A)(i)(II); the exemption does not extend to these	274
requirements.	275
276
➢ Third, if a repackager initially repackaged product without a product identifier	277
before November 27, 2018, it is exempted from that part of section	278
582(e)(4)(C) which requires that, beginning November 27, 2018, the	279
repackager verify the product using the product identifier in response to a	280
request from an authorized trading partner that is in possession or control of a	281
product it believes is from such repackager. However, a repackager must still	282
follow all other steps as described in section 582(e)(4)(C).	283
284
Repackagers must comply with all other applicable requirements of section 582 when	285
engaging in transactions involving grandfathered product pursuant to this exemption.	286
287
Trading partners may engage in transactions involving grandfathered product per the conditions	288
of the grandfathering policy until product expiry, regardless of when the transaction occurs.	289
Although there is no sunset date for grandfathered products, FDA expects there to be relatively	290
few of these packages and homogenous cases of product without a product identifier in the	291
pharmaceutical distribution supply chain by November 27, 2023.21	292
293
The FDA guidance Drug Supply Chain Security Act Implementation: Identification of Suspect	294
Product and Notification notes that a package missing product tracing information is a scenario	295
that could significantly increase the risk of a suspect product entering the drug supply chain.22	296
As product identifier requirements are implemented over time, trading partners should be	297
diligent when engaging in a transaction of a package or homogenous case of product without a	298
product identifier to ensure it is subject to the grandfathering policy, other type of exemption, or	299
a compliance policy.	300
301
FDA emphasizes that trading partners must comply with all other applicable requirements of	302
section 582 when engaging in transactions covered by the exemption established by this	303
guidance. For example, a wholesale distributor that transfers ownership of a package or	304
homogenous case of product without a product identifier after November 27, 2019, that is subject	305
to the grandfathering exemption must provide the subsequent owner with the product’s	306
transaction information, transaction history, and transaction statement prior to, or at the time of,	307
the transaction.	308
309
21 We note that the enhanced drug distribution security provisions of section 582(g) go into effect on November 27,
2023.
22 See FDA’s guidance for industry at
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm..

Contains Nonbinding Recommendations
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B. Saleable Returned Packages and Sealed Homogenous Cases of Product	310
311
Section 582 addresses trading partners’ ability to accept and redistribute product that is returned	312
to them in saleable condition. Manufacturers, wholesale distributors, and repackagers are	313
required under sections 582(b)(4)(E), (c)(4)(D), and (e)(4)(E), respectively, to verify the product	314
identifier of a saleable returned package or sealed homogenous case of product that is intended	315
for further distribution. This requirement goes into effect on November 27, 2017 (per the	316
statute) for manufacturers, November 27, 2018, for repackagers, and November 27, 2019, for	317
wholesale distributors.	318
319
For returns23 of saleable packages and sealed homogeneous cases of product without product	320
identifiers that were in the pharmaceutical distribution supply chain before November 27, 2018,	321
manufacturers, wholesale distributors, and repackagers are exempted from the requirements of	322
sections 582(b)(4)(E), (c)(4)(D), and (e)(4)(E), respectively, to verify the product identifiers of	323
saleable returned packages or sealed homogenous cases of product that are intended for further	324
distribution. Manufacturers are exempted from the requirements of section 582(b)(2)(A) to add	325
product identifiers before redistributing such product if the product remains in the original	326
package or sealed homogenous case. Repackagers are exempted from the requirements of	327
sections 582(e)(2)(A)(i) and (e)(2)(A)(iii) to add product identifiers before redistributing such	328
product if the product remains in the original repackaged package or sealed homogenous case.	329
Trading partners must comply with all other applicable requirements of section 582 when	330
engaging in returns. For example, wholesale distributors must still meet the requirements of	331
section 582(c)(1)(B)(i)(II) and only accept returned product from a dispenser or repackager	332
beginning November 27, 2019, if they can associate the returned product with the transaction	333
information and transaction statement for that product.	334
23 Return is defined in section 581(17) of the FD&C Act.