Drug Product Tracing: The Effect of Section 585 of the Federal Food, Drug, and Cosmetic Act-Questions and Answers; Guidance for Industry; Availability, 6572-6574 [2022-01926]
Download as PDF
lotter on DSK11XQN23PROD with NOTICES1
6572
Federal Register / Vol. 87, No. 24 / Friday, February 4, 2022 / Notices
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 71, Silver Spring, MD
20993–0002, 240–506–4946,
CBERVRBPAC@fda.hhs.gov; or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
FDA’s website at https://www.fda.gov/
AdvisoryCommittees/default.htm and
scroll down to the appropriate advisory
committee meeting link, or call the
advisory committee information line to
learn about possible modifications
before coming to the meeting.
SUPPLEMENTARY INFORMATION: Consistent
with FDA’s regulations, this notice is
being published with less than 15 days
prior to the date of the meeting based on
a determination that convening a
meeting of the Vaccines and Related
Biological Products Advisory
Committee as soon as possible is
warranted. This Federal Register notice
could not be published 15 days prior to
the date of the meeting due to a recent
request to amend the Emergency Use
Authorization (EUA) of the PfizerBioNTech COVID–19 mRNA vaccine for
administration to children 6 months
through 4 years of age, and the need for
prompt discussion of this request given
the COVID–19 pandemic.
Agenda: The meeting presentations
will be heard, viewed, captioned, and
recorded through an online
teleconferencing platform. On February
15, 2022, the committee will meet in
open session to discuss a request to
amend the Emergency Use
Authorization (EUA) of the PfizerBioNTech COVID–19 mRNA vaccine for
administration to children 6 months
through 4 years of age.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its website prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s website after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link. The meeting will include slide
presentations with audio components to
allow the presentation of materials in a
VerDate Sep<11>2014
18:50 Feb 03, 2022
Jkt 256001
manner that most closely resembles an
in-person advisory committee meeting.
Procedure: On February 15, 2022,
from 8:30 a.m. to 5 p.m. Eastern Time
the meeting is open to the public.
Interested persons may present data,
information, or views, orally or in
writing, on issues pending before the
committee. All electronic and written
submissions submitted to the Docket
(see ADDRESSES) on or before February
10, 2022, will be provided to the
committee. Comments received after
February 10, 2022, and by February 14,
2022, will be taken into consideration
by FDA. Oral presentations from the
public will be scheduled between
approximately 1 p.m. and 2 p.m. Eastern
Time. Those individuals interested in
making formal oral presentations should
notify the contact person and submit a
brief statement of the general nature of
the evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before February 8, 2022. Time
allotted for each presentation may be
limited. If the number of registrants
requesting to speak is greater than can
be reasonably accommodated during the
scheduled open public hearing session,
FDA may conduct a lottery to determine
the speakers for the scheduled open
public hearing session. The contact
person will notify interested persons
regarding their request to speak by
February 9, 2022.
For press inquiries, please contact the
Office of Media Affairs at fdaoma@
fda.hhs.gov or 301–796–4540.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact Prabhakara
Atreya or Christina Vert (see FOR
FURTHER INFORMATION CONTACT) at least 7
days in advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our website at
https://www.fda.gov/
AdvisoryCommittees/AboutAdvisory
Committees/ucm111462.htm for
procedures on public conduct during
advisory committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: February 1, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–02390 Filed 2–3–22; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
Frm 00090
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–1411]
Drug Product Tracing: The Effect of
Section 585 of the Federal Food, Drug,
and Cosmetic Act—Questions and
Answers; Guidance for Industry;
Availability
Food and Drug Administration,
Department of Health and Human
Services (HHS).
ACTION: Notice of availability.
AGENCY:
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry entitled ‘‘Drug
Product Tracing: The Effect of Section
585 of the FD&C Act—Questions and
Answers.’’ FDA is issuing this guidance
to assist industry and State and local
governments in understanding the
effects of the uniform national policy set
forth in the Federal Food, Drug, and
Cosmetic Act (FD&C Act) that was
added by the Drug Supply Chain
Security Act, which was enacted on
November 27, 2013. This guidance is
intended to help industry and States
understand the law as it is currently in
effect and clarify its effect on State
product tracing. This guidance finalizes
the draft guidance entitled ‘‘The Effect
of Uniform National Policy on Drug
Product Tracing and Wholesale Drug
Distributor and Third-Party Logistics
Provider Standards: Questions and
Answers’’ issued on October 8, 2014.
DATES: The announcement of the
guidance is published in the Federal
Register on February 4, 2022.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
SUMMARY:
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
E:\FR\FM\04FEN1.SGM
04FEN1
Federal Register / Vol. 87, No. 24 / Friday, February 4, 2022 / Notices
lotter on DSK11XQN23PROD with NOTICES1
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–1411 for ‘‘Drug Product
Tracing: The Effect of Section 585 of the
FD&C 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
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
VerDate Sep<11>2014
18:50 Feb 03, 2022
Jkt 256001
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; or 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:
Aaron Weisbuch, 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; or Stephen Ripley, Center
for Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71,
Rm.7301, Silver Spring, MD 20993–
0002, 240–402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a final guidance for industry entitled
‘‘Drug Product Tracing: The Effect of
585 of the FD&C Act—Questions and
Answers.’’ Title II of the Drug Quality
and Security Act (Pub. L. 113–54),
which is also referred to as the Drug
Supply Chain Security Act (DSCSA),
enacted on November 27, 2013,
established a Federal system for tracing
prescription drug products through the
pharmaceutical distribution supply
PO 00000
Frm 00091
Fmt 4703
Sfmt 4703
6573
chain and requires trading partners to
provide, receive, and maintain certain
product and distribution information.
The DSCSA also requires FDA to
establish Federal standards for licensing
of wholesale drug distributors and thirdparty logistics providers (3PLs); the
Agency is publishing a proposed rule
with respect to those standards
concurrently with this final guidance.
Section 585 of the FD&C Act (21 U.S.C.
360eee–4) sets forth a uniform national
policy preempting States from
establishing or continuing in effect
certain standards and requirements. The
guidance is intended to (1) help
industry and States understand the law
as it is currently in effect and (2) clarify
the effect of section 585(a) on State
product tracing.
This guidance finalizes the draft
guidance entitled ‘‘The Effect of
Uniform National Policy on Drug
Product Tracing and Wholesale Drug
Distributor and Third-Party Logistics
Provider Standards: Questions and
Answers’’ issued on October 8, 2014 (79
FR 60853). The draft guidance covered
section 585(a) and (b) of the FD&C Act.
This guidance does not cover the effect
of section 585(b) of the FD&C Act, given
that section 585(b) is addressed in the
preamble to the proposed rule with
respect to the standards for licensing
wholesale distributors and 3PLs,
published elsewhere in this issue of the
Federal Register. FDA considered
comments received on the draft
guidance as the guidance was finalized.
Changes from the draft to the final
guidance include the removal of the
discussion of the effect of 585(b) of the
FD&C Act. The title of the guidance has
been updated to reflect this change in
content. In addition, editorial changes
were made to improve clarity
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 Product
Tracing: The Effect of 585 of the FD&C
Act—Questions and Answers.’’ 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
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 https://
E:\FR\FM\04FEN1.SGM
04FEN1
6574
Federal Register / Vol. 87, No. 24 / Friday, February 4, 2022 / Notices
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents, or
https://www.regulations.gov.
Dated: January 25, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–01926 Filed 2–3–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–D–1041]
Immunogenicity Information in Human
Prescription Therapeutic Protein and
Select Drug Product Labeling—
Content and Format; Draft Guidance
for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or the Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Immunogenicity Information in
Human Prescription Therapeutic
Protein and Select Drug Product
Labeling—Content and Format.’’ This
draft guidance provides
recommendations for incorporating
clinically relevant immunogenicity
information into the labeling of
products having immunogenicity
assessments. Appropriate inclusion and
consistent placement of
immunogenicity information in the
Prescribing Information helps to make
clinically relevant information
accessible to the health care practitioner
and promotes the safe and effective use
of prescription drug and biological
products. When finalized, the
recommendations in this guidance will
supersede the immunogenicity labelingspecific recommendations in the
guidances for industry entitled
‘‘Labeling for Biosimilar Products’’ and
‘‘Clinical Pharmacology Section of
Labeling for Human Prescription Drug
and Biological Products—Content and
Format.’’
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
Submit either electronic or
written comments on the draft guidance
by April 5, 2022 to ensure that the
Agency considers your comment on this
DATES:
VerDate Sep<11>2014
18:50 Feb 03, 2022
Jkt 256001
draft guidance before it begins work on
the final version of the guidance.
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–
2021–D–1041 for ‘‘Immunogenicity
Information in Human Prescription
Therapeutic Protein and Select Drug
Product Labeling—Content and
Format.’’ 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
PO 00000
Frm 00092
Fmt 4703
Sfmt 4703
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 draft 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 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 draft guidance document.
FOR FURTHER INFORMATION CONTACT: Eric
Brodsky, Center for Drug Evaluation and
Research, Food and Drug
E:\FR\FM\04FEN1.SGM
04FEN1
Agencies
[Federal Register Volume 87, Number 24 (Friday, February 4, 2022)]
[Notices]
[Pages 6572-6574]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01926]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-1411]
Drug Product Tracing: The Effect of Section 585 of the Federal
Food, Drug, and Cosmetic Act--Questions and Answers; Guidance for
Industry; Availability
AGENCY: Food and Drug Administration, Department of Health and Human
Services (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
Product Tracing: The Effect of Section 585 of the FD&C Act--Questions
and Answers.'' FDA is issuing this guidance to assist industry and
State and local governments in understanding the effects of the uniform
national policy set forth in the Federal Food, Drug, and Cosmetic Act
(FD&C Act) that was added by the Drug Supply Chain Security Act, which
was enacted on November 27, 2013. This guidance is intended to help
industry and States understand the law as it is currently in effect and
clarify its effect on State product tracing. This guidance finalizes
the draft guidance entitled ``The Effect of Uniform National Policy on
Drug Product Tracing and Wholesale Drug Distributor and Third-Party
Logistics Provider Standards: Questions and Answers'' issued on October
8, 2014.
DATES: The announcement of the guidance is published in the Federal
Register on February 4, 2022.
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
[[Page 6573]]
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-1411 for ``Drug Product Tracing: The Effect of Section 585
of the FD&C 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 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; or 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: Aaron Weisbuch, 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]; or Stephen Ripley, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm.7301, Silver Spring, MD 20993-0002, 240-
402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a final guidance for industry
entitled ``Drug Product Tracing: The Effect of 585 of the FD&C Act--
Questions and Answers.'' Title II of the Drug Quality and Security Act
(Pub. L. 113-54), which is also referred to as the Drug Supply Chain
Security Act (DSCSA), enacted on November 27, 2013, established a
Federal system for tracing prescription drug products through the
pharmaceutical distribution supply chain and requires trading partners
to provide, receive, and maintain certain product and distribution
information. The DSCSA also requires FDA to establish Federal standards
for licensing of wholesale drug distributors and third-party logistics
providers (3PLs); the Agency is publishing a proposed rule with respect
to those standards concurrently with this final guidance. Section 585
of the FD&C Act (21 U.S.C. 360eee-4) sets forth a uniform national
policy preempting States from establishing or continuing in effect
certain standards and requirements. The guidance is intended to (1)
help industry and States understand the law as it is currently in
effect and (2) clarify the effect of section 585(a) on State product
tracing.
This guidance finalizes the draft guidance entitled ``The Effect of
Uniform National Policy on Drug Product Tracing and Wholesale Drug
Distributor and Third-Party Logistics Provider Standards: Questions and
Answers'' issued on October 8, 2014 (79 FR 60853). The draft guidance
covered section 585(a) and (b) of the FD&C Act. This guidance does not
cover the effect of section 585(b) of the FD&C Act, given that section
585(b) is addressed in the preamble to the proposed rule with respect
to the standards for licensing wholesale distributors and 3PLs,
published elsewhere in this issue of the Federal Register. FDA
considered comments received on the draft guidance as the guidance was
finalized. Changes from the draft to the final guidance include the
removal of the discussion of the effect of 585(b) of the FD&C Act. The
title of the guidance has been updated to reflect this change in
content. In addition, editorial changes were made to improve clarity
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 Product Tracing: The Effect of 585 of
the FD&C Act--Questions and Answers.'' 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
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
https://
[[Page 6574]]
www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-
drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances,
https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.
Dated: January 25, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-01926 Filed 2-3-22; 8:45 am]
BILLING CODE 4164-01-P