Document ID: FDA-2018-D-0338-0010
Agency: fda
Document Type: Notice
Title: Definitions of Suspect Product and 
Illegitimate Product for Verification 
Obligations Under the Drug Supply 
Chain Security Act; Draft Guidance for 
Industry; Availability
Posted Date: 2021-06-04T04:00Z

[Federal Register Volume 86, Number 106 (Friday, June 4, 2021)]
[Notices]
[Pages 30056-30058]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-11735]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-0338]

Definitions of Suspect Product and Illegitimate Product for 
Verification Obligations Under the Drug Supply Chain Security Act; 
Draft Guidance for Industry; Availability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the availability of a revised draft guidance for industry entitled 
``Definitions of Suspect Product and Illegitimate Product for 
Verification Obligations Under the Drug Supply Chain Security Act.'' 
The draft guidance is intended to help industry better understand the 
definitions of ``suspect'' and ``illegitimate'' product as defined in 
the Drug Supply Chain Security Act (DSCSA). The draft guidance lays out 
FDA's current understanding of the following key terms used to define 
``suspect'' and ``illegitimate'' product: ``Counterfeit,'' 
``diverted,'' ``stolen,'' ``fraudulent transaction,'' and ``unfit for 
distribution.'' This revised draft guidance clarifies certain points of 
the draft guidance for industry ``Definitions of Suspect Product and 
Illegitimate Product for Verification Obligations Under the Drug Supply 
Chain Security Act'' issued in March 2018 (March 2018

[[Page 30057]]

draft guidance), including FDA's current understanding of the term 
``stolen.''

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by August 3, 2021.

ADDRESSES: You may submit comments on any guidance 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-2018-D-0338 for ``Definitions of Suspect Product and Illegitimate 
Product for Verification Obligations Under the Drug Supply Chain 
Security Act; Draft Guidance for Industry; Availability.'' 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 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 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. 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, Office of Compliance, 
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 revised draft guidance for 
industry entitled ``Definitions of Suspect Product and Illegitimate 
Product for Verification Obligations Under the Drug Supply Chain 
Security Act.'' This guidance interprets the terms used in the 
definition of ``suspect product'' set forth in section 581(21) of 
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee(21)), 
and the definition of ``illegitimate product'' set forth in section 
581(8) of the FD&C Act to assist trading partners in meeting 
verification obligations (including notification) under section 
582(b)(4), (c)(4), (d)(4), and (e)(4) (21 U.S.C. 360eee-1 (b)(4), 
(c)(4), (d)(4), and (e)(4)), respectively.
    This draft guidance is intended to help industry better understand 
the definitions of ``suspect'' and ``illegitimate'' product as defined 
in section 581 of the FD&C Act. The draft guidance lays out FDA's 
current understanding of the following key terms used to define 
``suspect'' and ``illegitimate'' product in section 581 of FD&C Act: 
``Counterfeit,'' ``diverted,'' ``stolen,'' ``fraudulent transaction,'' 
and ``unfit for distribution.'' In response to comments received from 
stakeholders, this draft guidance revises the March 2018 draft 
guidance. Most significantly, this revised draft guidance: (1) Provides 
for FDA's current understanding of the term ``stolen''; (2) identifies 
certain scenarios that are unlikely to result in diverted product; (3) 
revises the definition of ``unfit for distribution'' by tying it more 
closely to the language in the DSCSA and referencing ``serious adverse 
health consequences or death to humans''; and (4) revises the 
definition of ``fraudulent transaction'' to apply to situations where 
information has been ``knowingly'' falsified.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on ``Definitions 
of Suspect Product and Illegitimate Product for Verification 
Obligations Under the Drug Supply Chain Security Act.'' It does not 
establish any rights for any person and is not binding on FDA or the 
public.

[[Page 30058]]

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 draft 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 
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or 
https://www.regulations.gov.

    Dated: May 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-11735 Filed 6-3-21; 8:45 am]
BILLING CODE 4164-01-P