[Federal Register Volume 84, Number 185 (Tuesday, September 24, 2019)]
[Notices]
[Pages 50044-50045]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20651]


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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--Compliance Policy; Guidance for Industry; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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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--Compliance Policy.'' This guidance describes FDA's intention 
regarding enforcement of the Drug Supply Chain Security Act (DSCSA) 
provision requiring wholesale distributors to verify a product 
identifier prior to further distributing returned product beginning on 
November 27, 2019. Given concerns expressed by stakeholders and to 
minimize possible disruptions in the pharmaceutical distribution supply 
chain, FDA does not intend to take action against wholesale 
distributors who do not, prior to November 27, 2020, verify a product 
identifier prior to further distributing returned product as required 
under the DSCSA. This represents a 1-year delay in enforcement of this 
DSCSA requirement.

DATES: The announcement of the guidance is published in the Federal 
Register on September 24, 2019.

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--Compliance Policy.'' 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.
     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.gpo.gov/fdsys/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.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).

[[Page 50045]]

    Submit written requests for single copies of this 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, or to the Office of 
Communication, Outreach and Development, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, 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, 
drugtrackandtrace@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Wholesale Distributor Verification Requirement for Saleable 
Returned Drug Product--Compliance Policy.'' FDA is issuing this 
guidance consistent with the good guidance practices regulation (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 the statutory requirement that takes effect November 27, 
2019, for wholesale distributors to verify saleable returned drug 
products prior to redistribution under section 582(c)(4)(D) of the 
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-
1(c)(4)(D)). 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)).
    The DSCSA (Title II of Pub. L. 113-54) was signed into law on 
November 27, 2013. Section 202 of the DSCSA added section 582 to the 
FD&C Act. This section established product tracing, product identifier, 
authorized trading partner, and verification requirements for 
manufacturers, wholesale distributors, repackagers, and dispensers to 
facilitate the tracing of a product through the pharmaceutical 
distribution supply chain. Failure to comply with the requirements of 
section 582 is prohibited under section 301(t) of the FD&C Act (21 
U.S.C. 331(t)) and subject to enforcement action under the FD&C Act.
    Beginning November 27, 2019, wholesale distributors are 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.
    As described in the guidance, FDA has received 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. Given the 
concerns expressed, FDA recognizes that some wholesale distributors may 
need additional time beyond November 27, 2019, before they can begin 
verifying the product identifier on returned products prior to further 
distribution in an efficient, secure, and timely manner.
    To minimize possible disruptions in the distribution of 
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, 2020, 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. This guidance also explains that, prior to November 
27, 2020, 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). The 
guidance document explains the scope of the compliance policy in 
further detail.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). This guidance represents the 
current thinking of FDA on ``Wholesale Distributor Verification 
Requirement for Saleable Returned Drug Product--Compliance Policy.'' 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. This guidance 
is not subject to Executive Order 12866.

II. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics, or https://www.regulations.gov.

    Dated: September 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-20651 Filed 9-23-19; 8:45 am]
BILLING CODE 4164-01-P


