[Federal Register Volume 85, Number 206 (Friday, October 23, 2020)]
[Notices]
[Pages 67550-67552]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-23524]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[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; 
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final 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.'' This guidance explains 
that FDA intends to extend the delay in enforcement described in the 
guidance entitled ``Wholesale Distributor Verification Requirement for 
Saleable Returned Drug Product--Compliance Policy,'' published in the 
Federal Register on September 24, 2019 (the 2019 Compliance Policy), 
which relates to Drug Supply Chain Security Act (DSCSA) provisions 
requiring wholesale distributors to verify the product identifier prior 
to further distributing returned product beginning on November 27, 
2019. In addition, this guidance announces FDA's intended enforcement 
policy with respect to DSCSA provisions requiring dispensers to verify 
the product identifier for suspect or illegitimate product in the 
dispenser's possession or control beginning on November 27, 2020.

DATES: The announcement of the guidance is published in the Federal 
Register on October 23, 2020.

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:
     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.
     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:
     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.
     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.
     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

[[Page 67551]]

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, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    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.'' 
FDA does not intend to take action against wholesale distributors who 
do not, prior to November 27, 2023, verify the product identifier prior 
to further distributing returned product as required under the DSCSA 
(Title II of Pub. L. 113-54). This represents an additional 3-year 
delay from the delay set forth in the 2019 Compliance Policy in 
enforcement of the requirement for wholesale distributors to verify the 
product identifier prior to further distributing that returned product. 
In addition, FDA does not intend to take action against dispensers who 
do not verify the statutorily-designated portion of product identifiers 
of suspect or illegitimate product before November 27, 2023. This 
policy represents a 3-year delay in enforcement of the requirements for 
dispensers to verify the product identifier when investigating suspect 
or illegitimate product.
    This 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 
take effect November 27, 2020, for dispensers to verify the product 
identifier, including the standardized numerical identifier, for 
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 (21 U.S.C. 
360eee-1(d)(4)(A)(ii)(II) and (d)(4)(B)(iii)). It is important that FDA 
provide this information before that date. Although this guidance 
document is immediately in effect, 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) (21 U.S.C. 360eee-1(c)(4)(D)) of the Federal 
Food, Drug, and Cosmetic Act (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 2019 
Compliance Policy. The 2019 Compliance Policy indicated the Agency's 
intent to take no enforcement action against wholesale distributors who 
are not in compliance with this requirement under section 582(c)(4)(D) 
of the FD&C Act before November 27, 2020.
    Since the announcement of the 2019 Compliance Policy, 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. Additionally, 
wholesale distributors point to significant delays in testing these 
verification systems due to the competing priority of responding to the 
Coronavirus Disease 2019 (COVID-19) pandemic, namely the reassignment 
of logistics and supply chain experts from DSCSA matters to COVID-19 
pandemic response. Given all these concerns, FDA recognizes that some 
wholesale distributors may need additional time beyond November 27, 
2020, 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.
    To minimize possible disruptions in the distribution of certain 
prescription drugs in the United States, FDA has adopted the compliance 
policy described in this guidance. Under this compliance policy, FDA 
does not intend to take action before November 27, 2023, against 
wholesale distributors who do not verify a product identifier prior to 
further distribution of a package or sealed homogenous case of product 
as required by section 582(c)(4)(D) of the FD&C Act.
    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 guidance also

[[Page 67552]]

explains that, prior to November 27, 2023, 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.
    By extending the delay in enforcement initially provided in the 
2019 Compliance Policy until November 27, 2023, FDA believes that 
wholesale distributors will be able to focus resources and efforts on 
the requirements for the enhanced drug distribution security system, 
provided for in section 582(g) of the FD&C Act and required by November 
27, 2023. Instead of developing separate processes or infrastructures 
solely for the saleable return verification requirement, wholesale 
distributors can incorporate the saleable return verification 
requirements into enhanced verification required by 2023. Given this 
consideration, FDA has not adopted the approach suggested by some 
comments suggesting that the Agency revise the 2019 Compliance Policy 
to provide for a phased implementation of the saleable return 
verification requirements.
    FDA also received comments requesting that we extend the scope of 
the 2019 Compliance Policy beyond wholesale distributors to also cover 
manufacturers and repackagers, asking FDA to not take enforcement 
action where manufacturers and repackagers are not in compliance with 
their verification of saleable returned product obligations under 
section 582(b)(4)(C) and (e)(4)(C) of the FD&C Act. At this time, we do 
not intend to broaden the scope of the 2019 Compliance Policy in this 
way because we believe the policies outlined in this guidance will 
provide appropriate flexibility. As all trading partners work towards 
enhanced system requirements that go into effect in 2023, wholesale 
distributors can continue to work with manufacturers and repackagers 
for enhanced verification requirements, including those for saleable 
returned product. FDA intends to issue additional guidance about the 
enhanced system for drug distribution security at a later date.
    Finally, section 582 of the FD&C Act, as amended 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 3 packages or 10 percent of such 
suspect product, whichever is greater, or all packages, if there are 
fewer than 3, corresponds with the product identifier for such product 
in the dispenser's possession or control, beginning November 27, 2020. 
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 
of illegitimate product from FDA or a trading partner.
    In response to comments received from stakeholders, this guidance 
also announces that FDA does not intend to take action before November 
27, 2023, against dispensers who do not verify the statutorily-
designated portion of product identifiers 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 
dispensers can use the 3-year period to ensure the systems and 
processes that are put into place to meet the enhanced system 
requirements by November 27, 2023, will also fulfill all dispenser 
verification requirements under section 582(d)(4) of the FD&C 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.

II. Paperwork Reduction Act of 1995

    FDA tentatively 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 or https://www.regulations.gov.

    Dated: October 19, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-23524 Filed 10-22-20; 8:45 am]
BILLING CODE 4164-01-P