[Federal Register Volume 88, Number 169 (Friday, September 1, 2023)]
[Rules and Regulations]
[Pages 60333-60336]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-18899]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Chapter I

[Docket No. FDA-2019-D-4212]


Wholesale Distributor Verification Requirement for Saleable 
Returned Drug Product and Dispenser Verification Requirements When 
Investigating a Suspect or Illegitimate Product--Compliance Policies, 
Revision 1; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, Department of Health and Human 
Services (HHS).

ACTION: Notification of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a guidance for industry entitled ``Wholesale 
Distributor Verification Requirement for Saleable Returned Drug Product 
and Dispenser Verification Requirements When Investigating a Suspect or 
Illegitimate Product--Compliance Policies, Revision 1.'' This revised 
guidance explains that FDA intends to extend for an additional year 
(from November 27, 2023, to November 27, 2024), the enforcement 
policies

[[Page 60334]]

described in the guidance entitled ``Wholesale Distributor Verification 
Requirement for Saleable Returned Drug Product and Dispenser 
Verification Requirements When Investigating a Suspect or Illegitimate 
Product--Compliance Policies,'' published in the Federal Register on 
October 23, 2020 (the 2020 Compliance Policies). The 2020 Compliance 
Policies relate to provisions in the Federal Food, Drug, and Cosmetic 
Act (FD&C Act), as added by the Drug Supply Chain Security Act (DSCSA), 
requiring wholesale distributors to verify the product identifier prior 
to further distributing saleable returned product and requiring 
dispensers to verify the product identifier for suspect or illegitimate 
product in the dispenser's possession or control.

DATES: The announcement of the guidance is published in the Federal 
Register on September 1, 2023.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
    <bullet> If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
    <bullet> Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    <bullet> For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2019-D-4212 for ``Wholesale Distributor Verification Requirement 
for Saleable Returned Drug Product and Dispenser Verification 
Requirements When Investigating a Suspect or Illegitimate Product--
Compliance Policies.'' Received comments will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
    <bullet> Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the 
Division of Drug Information, Center for Drug Evaluation and Research, 
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale 
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Sarah Venti, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3130, 
<a href="/cdn-cgi/l/email-protection#f3978186948781929098929d978781929096b3959792dd9b9b80dd949c85"><span class="__cf_email__" data-cfemail="2145535446555340424a404f455553404244614745400f4949520f464e57">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background

    On October 23, 2020, FDA published the 2020 Compliance Policies. 
FDA is announcing the availability of a guidance for industry entitled 
``Wholesale Distributor Verification Requirement for Saleable Returned 
Drug Product and Dispenser Verification Requirements When Investigating 
a Suspect or Illegitimate Product--Compliance Policies, Revision 1'', 
which extends the enforcement policies described in the 2020 Compliance 
Policies for an additional year, from November 27, 2023, until November 
27, 2024. As described in this revised guidance, FDA does not intend to 
take enforcement action, prior to November 27, 2024, against wholesale 
distributors who do not verify the product identifier prior to further 
distributing saleable returned product, or against dispensers who do 
not verify the product identifier of the statutorily designated 
proportion of suspect or illegitimate product in the dispenser's 
possession or control, as required under section 582 of the FD&C Act 
(21 U.S.C. 360eee-1), as added by the DSCSA (Title II of Pub. L. 113-
54).
    This revised guidance is being issued consistent with FDA's good 
guidance practices regulations (21 CFR 10.115). FDA is implementing 
this guidance without prior public comment because the Agency has 
determined that prior public participation is not feasible or 
appropriate (21 CFR 10.115(g)(2)). FDA made this determination because 
this guidance document provides information pertaining to statutory 
requirements that FDA had planned to begin enforcing as of November 27,

[[Page 60335]]

2023, for wholesale distributors to verify the product identifier prior 
to further distributing saleable returned product under section 
582(c)(4)(D) of the FD&C Act and for dispensers to verify the product 
identifier, including the standardized numerical identifier, for 
suspect or illegitimate product in the dispenser's possession or 
control under section 582(d)(4)(A)(ii)(II) and (d)(4)(B)(iii) of the 
FD&C Act. It is important that FDA provide this information before that 
date. Although this guidance document is being implemented immediately, 
it remains subject to comment in accordance with the Agency's good 
guidance practices (21 CFR 10.115(g)(3)).
    Beginning November 27, 2019, wholesale distributors were required, 
under section 582(c)(4)(D) of the FD&C Act, to verify the product 
identifier, including the standardized numerical identifier, on each 
sealed homogeneous case of saleable returned product, or, if such 
product is not in a sealed homogeneous case, on each package of 
saleable returned product, prior to further distributing such returned 
product. In the Federal Register published September 24, 2019 (84 FR 
50044), FDA issued a notice announcing the availability of the 
Wholesale Distributor Verification Requirement for Saleable Returned 
Drug Product--Compliance Policy guidance (2019 Compliance Policy), 
which described a 1-year enforcement policy with respect to this 
wholesale distributor requirement, until November 27, 2020. The Agency 
subsequently published the 2020 Compliance Policies, which extended the 
enforcement policy in the 2019 Compliance Policy with respect to this 
wholesale distributor requirement for 3 years, until November 27, 2023, 
and also included an enforcement policy until that same date with 
respect to the requirement for dispensers to verify the product 
identifier, including the standardized numerical identifier, for 
suspect or illegitimate product in the dispenser's possession or 
control.
    Since the announcement of the 2020 Compliance Policies, FDA has 
received additional comments and feedback from wholesale distributors, 
as well as other trading partners and stakeholders, expressing concern 
with industry-wide readiness for implementation of the verification of 
saleable returned product requirement for wholesale distributors and 
the challenges stakeholders face with developing interoperable, 
electronic systems to enable such verification and achieve 
interoperability between networks. Specifically, comments received 
point out continuing challenges posed by the large volume of saleable 
returned product, explaining that wholesale distributors still need 
more time to test verification systems using real-time volumes of 
saleable returned product with all trading partners involved, as 
opposed to using small-scale pilot test projects. Given all these 
concerns, FDA recognizes that some wholesale distributors may need 
additional time, beyond November 27, 2023, before they can begin 
verifying returned products prior to resale or other further 
distribution as required by section 582(c)(4)(D) of the FD&C Act in an 
efficient, secure, and timely manner. Additionally, section 582 of the 
FD&C Act requires certain trading partners (manufacturers, repackagers, 
wholesale distributors, and dispensers) to exchange transaction 
information, transaction history, and a transaction statement when 
engaging in transactions involving certain prescription drugs. Section 
581(27)(E) of the FD&C Act (21 U.S.C. 360eee(27)(E)) requires that the 
transaction statement include a statement that the entity transferring 
ownership in a transaction had systems and processes in place to comply 
with verification requirements under section 582 of the FD&C Act. This 
revised guidance also explains that, prior to November 27, 2024, FDA 
does not intend to take action against a wholesale distributor for 
providing a transaction statement to a subsequent purchaser of product 
on the basis that such wholesale distributor does not yet have systems 
and processes in place to comply with the saleable return verification 
requirements under section 582(c)(4)(D) of the FD&C Act. The guidance 
explains the scope of the compliance policy in further detail.
    In addition to helping minimize possible disruptions in the 
distribution of certain prescription drugs in the United States, FDA 
believes that by extending the enforcement approach described in the 
2020 Compliance Policies until November 27, 2024, wholesale 
distributors will be able to focus resources and efforts on the 
requirements for enhanced drug distribution security under section 
582(g) of the FD&C Act (as described below). Thus, instead of 
developing separate processes or infrastructures solely for the 
saleable return verification requirement, wholesale distributors can 
incorporate the saleable return verification requirements into the 
enhanced verification required under section 582(g) of the FD&C Act.
    Further, section 582 of the FD&C Act, as added by the DSCSA, also 
established the requirements that specify how dispensers must 
investigate suspect and illegitimate product. As part of the 
investigation, section 582(d)(4)(A)(ii)(II) of the FD&C Act requires 
dispensers to verify the product identifier, including the standardized 
numerical identifier, of at least three packages or 10 percent of such 
suspect product, whichever is greater, or all packages, if there are 
fewer than three, corresponds with the product identifier for such 
product in the dispenser's possession or control. Section 
582(d)(4)(B)(iii) of the FD&C Act requires dispensers to verify product 
as described in section 582(d)(4)(A)(ii), which includes the section 
582(d)(4)(A)(ii)(II) requirement, in response to a notification from 
FDA or a trading partner that the product is an illegitimate product.
    In response to comments received from stakeholders regarding 
dispenser readiness to meet these requirements, and to minimize 
possible disruptions in the distribution of affected prescription drugs 
in the United States, this guidance also announces that FDA does not 
intend to take action before November 27, 2024, against dispensers who 
do not verify the product identifier of the statutorily designated 
proportion of suspect product as required by section 
582(d)(4)(A)(ii)(II) of the FD&C Act, and that part of section 
582(d)(4)(B)(iii) of the FD&C Act that requires dispensers to perform 
the same verification activities of section 582(d)(4)(A)(ii)(II) when 
responding to a notification of illegitimate product from FDA or 
another trading partner. FDA believes that the 1-year extension under 
this guidance of the applicable 2020 Compliance Policies will 
facilitate the ability of dispensers to ensure the systems and 
processes that are put into place to meet the enhanced drug 
distribution security requirements, which FDA will generally not 
enforce before November 27, 2024, will also fulfill the dispenser 
verification requirements under section 582(d)(4) of the FD&C Act.
    In the ``Enhanced Drug Distribution Security Requirements Under 
Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act--
Compliance Policies'' (Enhanced Drug Distribution Security Compliance 
Policies) (88 FR 58498), FDA announced a 1-year enforcement policy with 
respect to the enhanced drug distribution security requirements set to 
take effect on November 27, 2023. FDA chose to adopt this enforcement 
policy until November 27, 2024, because FDA was aware that some 
stakeholders were facing challenges with implementing the section 
582(g) requirements and needed additional time to comply with these 
requirements.
    While FDA generally expects trading partners to have the systems 
and

[[Page 60336]]

processes in place to meet the requirements of section 582(g) of the 
FD&C Act, FDA recognizes that some technical and operational issues may 
not be fully resolved by November 27, 2023. The Agency believes the 
Enhanced Drug Distribution Security Compliance Policies can help 
trading partners address such issues by accommodating the additional 
time that may be needed to implement, troubleshoot, and mature their 
systems and processes. For additional information about enhanced drug 
distribution security please see the June 2021 draft guidance for 
industry entitled ``Enhanced Drug Distribution Security at the Package 
Level Under the Drug Supply Chain Security Act'' (available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enhanced-drug-distribution-security-package-level-under-drug-supply-chain-security-act).
    This guidance represents the current thinking of FDA on ``Wholesale 
Distributor Verification Requirement for Saleable Returned Drug Product 
and Dispenser Verification Requirements When Investigating a Suspect or 
Illegitimate Product--Compliance Policies.'' It does not establish any 
rights for any person and is not binding on FDA or the public. You can 
use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.\1\
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    \1\ The Office of the Federal Register has published this 
document under the category ``Rules and Regulations'' pursuant to 
its interpretation of 1 CFR 5.9(b). We note that the categorization 
as such for purposes of publication in the Federal Register does not 
affect the content or intent of the document. See 1 CFR 5.1(c).
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II. Paperwork Reduction Act of 1995

    FDA concludes that this guidance contains no collection of 
information. Therefore, clearance by the Office of Management and 
Budget under the Paperwork Reduction Act of 1995 is not required.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: August 28, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-18899 Filed 8-31-23; 8:45 am]
BILLING CODE 4164-01-P


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