Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act; Draft Guidance for Industry; Availability, 30056-30058 [2021-11735]
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30056
Federal Register / Vol. 86, No. 106 / Friday, June 4, 2021 / Notices
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new section was published as a draft
guidance for industry and was added in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
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Jkt 253001
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
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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/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/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
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.
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
SUMMARY:
E:\FR\FM\04JNN1.SGM
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Federal Register / Vol. 86, No. 106 / Friday, June 4, 2021 / Notices
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
VerDate Sep<11>2014
17:08 Jun 03, 2021
Jkt 253001
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-201509-18/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.
PO 00000
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30057
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.
E:\FR\FM\04JNN1.SGM
04JNN1
30058
Federal Register / Vol. 86, No. 106 / Friday, June 4, 2021 / Notices
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/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–3175]
Product Identifiers Under the Drug
Supply Chain Security Act: Questions
and Answers; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance entitled ‘‘Product Identifiers
Under the Drug Supply Chain Security
Act: Questions and Answers.’’ The
guidance is intended to address
questions regarding product identifiers
that, under the Federal Food, Drug, and
Cosmetic Act (FD&C Act) as amended
by the Drug Supply Chain Security Act
(DSCSA), are required to be affixed to,
or imprinted on, packages and
homogenous cases of certain drug
products intended to be introduced in a
transaction into commerce. This
guidance is intended to clarify FDA’s
interpretation of these requirements,
including as they relate to the linear
barcode requirements under the Code of
Federal Regulations. This guidance
finalizes the draft guidance issued on
September 20, 2018.
SUMMARY:
VerDate Sep<11>2014
17:08 Jun 03, 2021
Jkt 253001
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:
DATES:
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–3175 for ‘‘Product Identifiers
Under the Drug Supply Chain Security
Act: Questions and Answers.’’ 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
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
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-201509-18/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 the office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Tia
Harper-Velazquez, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 4262,
Silver Spring, MD 20993–0002, 301–
796–3130.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\04JNN1.SGM
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]]>Agencies
[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,
[email protected].
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
