[Federal Register Volume 86, Number 106 (Friday, June 4, 2021)]
[Notices]
[Pages 30054-30056]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-11732]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0609]


Drug Supply Chain Security Act Implementation: Identification of 
Suspect Product and Notification; 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 ``Drug 
Supply Chain Security Act Implementation: Identification of Suspect 
Product and Notification.'' The guidance addresses provisions in the 
Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Drug 
Supply Chain Security Act (DSCSA). The guidance is intended to aid 
certain trading partners (manufacturers, repackagers, wholesale 
distributors, and dispensers) in identifying a suspect product and 
specific scenarios that could significantly increase the risk of a 
suspect product entering the pharmaceutical distribution supply chain. 
The guidance also describes how trading partners should notify FDA of 
illegitimate product and sets forth a process for terminating 
notifications of illegitimate product in consultation with FDA. In 
addition, this guidance describes when manufacturers should notify FDA 
of a high risk that a product is illegitimate. This guidance responds 
to comments from stakeholders in order to clarify certain points and 
finalizes the remaining draft portion of the final guidance for 
industry entitled ``Drug Supply Chain Security Act Implementation: 
Identification of Suspect Product and Notification,'' issued in 
December 2016.

DATES: The announcement of the guidance is published in the Federal 
Register on June 4, 2021.

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

[[Page 30055]]

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-2014-D-0609 for ``Drug Supply Chain Security Act Implementation: 
Identification of Suspect Product and Notification; 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 guidance for industry 
entitled ``Drug Supply Chain Security Act Implementation: 
Identification of Suspect Product and Notification.'' The guidance 
addresses provisions in the FD&C Act, as amended by the DSCSA (Pub. L. 
113-54). Section 202 of the DSCSA adds section 582(h)(2) to the FD&C 
Act (21 U.S.C. 360eee-1(h)(2)), which requires FDA to issue guidance to 
aid certain trading partners (manufacturers, repackagers, wholesale 
distributors, and dispensers) in identifying a suspect product and 
terminating notifications. The guidance identifies specific scenarios 
that could significantly increase the risk of a suspect product 
entering the pharmaceutical distribution supply chain and provides 
recommendations on how trading partners can identify such product and 
determine whether the product is a suspect product as soon as 
practicable.
    Beginning January 1, 2015, section 582 of the FD&C Act required 
trading partners, upon determining that a product in their possession 
or control is illegitimate, to notify: (1) FDA and (2) all immediate 
trading partners that they have reason to believe may have received the 
illegitimate product, not later than 24 hours after making the 
determination. Manufacturers are additionally required under section 
582(b)(4)(B)(ii)(II) of the FD&C Act to notify FDA and any immediate 
trading partners that the manufacturer has reason to believe may 
possess a product manufactured by (or purported to be manufactured by) 
the manufacturer, not later than 24 hours after the manufacturer 
determines or is notified by FDA or a trading partner that there is a 
high risk that a product is illegitimate. The guidance also addresses 
how trading partners should notify FDA using Form FDA 3911. In 
addition, in accordance with section 582(h)(2) of the FD&C Act, the 
guidance sets forth the process by which trading partners must 
terminate the notifications using Form FDA 3911, in consultation with 
FDA, regarding illegitimate product and, for a manufacturer, a product 
with a high risk of illegitimacy, under section 582(b)(4)(B), 
(c)(4)(B), (d)(4)(B), and (e)(4)(B) of the FD&C Act.
    This guidance finalizes the remaining draft portion of the guidance 
for industry entitled ``Drug Supply Chain Security Act Implementation: 
Identification of Suspect Product and Notification,'' issued in 
December 2016. In particular, this guidance finalizes section III.C, 
which was issued for comment purposes in the December 2016 guidance. 
This guidance will now be final in its entirety and replaces the 
December 2016 guidance.
    In Federal Register of June 11, 2014 (79 FR 33564), FDA announced 
the availability of a draft guidance entitled ``Drug Supply Chain 
Security Act Implementation: Identification of Suspect Product and 
Notification.'' In response to comments received on that guidance, in 
the Federal Register of December 9, 2016 (81 FR 89112) FDA announced 
the availability of a guidance

[[Page 30056]]

of the same title. This guidance was published as a final guidance for 
industry with the exception of Section C entitled ``For Manufacturers: 
High Risk of Illegitimacy Notifications''. This new section was 
published as a draft guidance for industry and was added in response to 
comments and questions received about the 2014 guidance. In addition, 
based on comments on the 2014 guidance, Form FDA 3911, and the 
instructions for completing the form, were slightly revised.
    FDA received comments on the 2016 guidance from various 
stakeholders (e.g., pharmacy groups, wholesale distributor trade 
groups). In response to these comments, FDA has made some changes for 
clarity to the December 2016 version of the guidance. The changes 
include: Clarifying what FDA believes an ``immediate trading partner'' 
to be; replacing ``suspicious'' with ``questionable'' throughout the 
document; deleting the reference to ``pedigree'' in section III.A.1; 
clarifying that trading partners should consider whether product has 
been subject to a public alert or announcement of drug quality when 
considering scenarios that could increase the chances that a suspect 
product could enter the supply chain; in section III.B, clarifying that 
FDA's recommendations apply only ``as applicable'' to the individual 
trading partners; clarifying that trading partners only work with 
authorized trading partners in section III.B; and stating that trading 
partners should consult with manufacturers when conducting an 
investigation of suspect product.
    In response to stakeholder comments, FDA has also made some changes 
to the newly final section, III.C. These include: Clarifying that while 
manufacturers need not notify FDA of suspect product, they must do so 
if the circumstances surrounding the suspect product include at least 
one of three types of high risk factors; clarifying that manufacturers 
can learn of product with a high risk of illegitimacy either through 
their own investigation of suspect product, or through information they 
receive from a variety of other sources, including from within their 
own company, from their trading partners, from the FDA, or from other 
domestic and/or foreign regulatory authorities; clarifying that a 
manufacturer must make a notification to FDA where it is investigating 
the validity of the claim that a product has been stolen or diverted, 
and the manufacturer has reason to believe that an immediate trading 
partner has the potentially stolen or diverted product in its 
possession; and clarifying that while not a requirement, FDA does 
suggest that manufacturers inform trading partners of ``specific high 
risk[s]''.
    Finally, while FDA received a few comments on section IV of this 
guidance, which addresses notifications for illegitimate products and 
products with a high risk of illegitimacy, along with termination of 
those notifications, FDA did not incorporate the feedback from comments 
on response times because we feel that a 10-day response time is a 
reasonable amount of time for the Agency to review and evaluate such 
requests for the termination of notification of illegitimate product. 
Similarly, FDA did not add language on disclosure because the 
information submitted to FDA using Form FDA 3911 is treated like all 
other records obtained by FDA in regard to disclosure. FDA did make 
some revisions for clarity however, which include adding a brief 
discussion and footnote to FDA's guidance document Definitions of 
Suspect Product and Illegitimate Product for Verification Obligations 
Under the Drug Supply Chain Security Act. In addition, editorial 
changes were made throughout the entire guidance for clarity and 
references to section III.C being published for comment purposes only 
were removed.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Drug Supply Chain Security Act 
Implementation: Identification of Suspect Product and Notification.'' 
It does not establish any rights for any person and, with the exception 
of section IV.B, 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.
    As noted, section IV.B of this guidance, which sets forth the 
process by which trading partners must terminate notifications of 
illegitimate product and products with a high risk of illegitimacy in 
consultation with FDA, has binding effect, where indicated by the use 
of the words must, shall, or required. Such binding effect is 
authorized by section 582(h)(2)(A) of the FD&C Act, wherein Congress 
granted authorization to FDA to implement the process for terminating 
notifications of illegitimate product in consultation with FDA through 
guidance.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collection 
of information in this guidance has been approved under OMB control 
number 0910-0806.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or 
https://www.regulations.gov.

    Dated: May 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-11732 Filed 6-3-21; 8:45 am]
BILLING CODE 4164-01-P


