Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act

Administrative guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.

Waivers, Exceptions, and
Exemptions From the
Requirements of Section
582 of the Federal Food,
Drug, and Cosmetic Act
Guidance for Industry
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
August 2023
Administrative/Procedural

Waivers, Exceptions, and
Exemptions From the
Requirements of Section
582 of the Federal Food,
Drug, and Cosmetic Act
Guidance for Industry
Additional copies are available from:
Office of Communications, Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration
10001 New Hampshire Ave., Hillandale Bldg., 4 th Floor
Silver Spring, MD 20993-0002
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353
Email: druginfo@fda.hhs.gov
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs
and/or
Office of Communication, Outreach and Development
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave., Bldg. 71, Room 3128
Silver Spring, MD 20993-0002
Phone: 800-835-4709 or 240-402-8010
Email: ocod@fda.hhs.gov
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
August 2023
Administrative/Procedural

Contains Nonbinding Recommendations
TABLE OF CONTENTS
I. 	INTRODUCTION............................................................................................................. 1
II. 	BACKGROUND ............................................................................................................... 2
III. 	PROCESS FOR SUBMITTING WAIVER, EXCEPTION, OR EXEMPTION
REQUESTS TO FDA ....................................................................................................... 3
A. 	Entities that May Submit a Request ............................................................................................. 3
B. 	Information to Include in a Request............................................................................................. 3
1. Request-specific Information ........................................................................................................... 3
2. Attestation ........................................................................................................................................ 4
C. 	How to Submit a Request .............................................................................................................. 4
1. Submissions to FDA for CBER-regulated Products ........................................................................ 4
2. Submissions to FDA for CDER-regulated Products ........................................................................ 5
D. 	Notifying FDA of Material Changes ............................................................................................. 5
IV. 	PROCESS FOR REVIEWING AND DETERMINING WAIVER, EXCEPTION,
OR EXEMPTION REQUESTS ....................................................................................... 6
A. 	Review of Requests......................................................................................................................... 6
B. 	Determining Requests and Notifying Affected Entities .............................................................. 6
C. 	Reconsideration of a Granted Waiver, Exception, or Exemption ............................................. 7
D. 	Reconsideration of a Denied Request ........................................................................................... 7
V. 	PROCESS FOR FDA-INITIATED EXCEPTIONS AND EXEMPTIONS ................ 8
VI. 	REVIEW AND RENEWAL OF WAIVER, EXCEPTION, AND EXEMPTION
REQUESTS ....................................................................................................................... 9
A. 	Biennial FDA Review and Renewal of Waivers, Exceptions, and Exemptions ........................ 9
B. 	Authorized Trading Partner Renewal Requests of Expiring Waivers, Exceptions, and
Exemptions ..................................................................................................................................... 9
C. 	Terminating Previously Granted Requests and Notifying Affected Entities ............................ 9
APPENDIX .................................................................................................................................. 11

Contains Nonbinding Recommendations
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Waivers, Exceptions, and Exemptions From the Requirements of
Section 582 of the Federal Food, Drug, and Cosmetic Act
Guidance for Industry1
This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on
this topic. 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.
To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the
title page.
I. 	INTRODUCTION
This guidance describes the process an authorized2 trading partner3 or other stakeholder should
use to request a waiver, exception, or exemption from the requirements of section 582 of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-1), as amended by the
Drug Supply Chain Security Act (DSCSA) (Title II of Public Law 113-54). This guidance also
describes the factors the Food and Drug Administration (FDA) intends to consider when
evaluating such requests from an authorized trading partner or other stakeholder, and when
determining FDA-initiated exceptions and exemptions. Additionally, this guidance describes the
process the FDA intends to follow once every two years to review and make determinations on
the appropriateness of renewing a previously approved waiver, exception, or exemption, where
applicable. This guidance finalizes the draft guidance for industry Waivers, Exceptions, and
Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act,
issued in May 2018 as required by section 582(a)(3) of the FD&C Act. The revisions described in
this document update the policy articulated in the May 2018 draft guidance.
In general, FDA’s guidance documents do not establish legally enforceable responsibilities.
Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only
as recommendations, unless specific regulatory or statutory requirements are cited. The use of
the word should in Agency guidances means that something is suggested or recommended, but
not required.
1 This guidance has been prepared by the Office of Compliance in the Center for Drug Evaluation and Research
(CDER) in cooperation with the Center for Biologics Evaluation and Research (CBER) at the Food and Drug
Administration.
2 Authorized is defined in section 581(2) of the FD&C Act.
3 Trading partner is defined in section 581(23) of the FD&C Act. Although third-party logistics providers are also
considered trading partners under section 581(23)(B) of the FD&C Act, the provisions of sections 582(b)-(e) of the
FD&C Act do not impose requirements on those entities.

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II. 	BACKGROUND
The DSCSA outlines critical steps to enhance drug distribution security. These steps will
ultimately allow tracing of certain human finished prescription drugs in an electronic,
interoperable manner as they are distributed within the United States (U.S.). Section 582 of the
FD&C Act, as amended by the DSCSA, applies to manufacturers, repackagers, wholesale
distributors and dispensers (collectively referred to as “trading partners”) who engage in
transactions of product,4 and outlines requirements related to product tracing, verification,
product identification, and authorized trading partners.
Section 582(a)(3)(A) of the FD&C Act requires the FDA to issue a guidance that:
(i) establish[es] a process by which an authorized manufacturer, repackager,
wholesale distributor, or dispenser may request a waiver from any of the
requirements set forth in [section 582 of the FD&C Act], which the Secretary may
grant if the Secretary determines that such requirements would result in an undue
economic hardship or for emergency medical reasons, including a public health
emergency declaration pursuant to section 319 of the Public Health Service Act; 5
(ii) establish[es] a process by which the Secretary determines exceptions, and a
process through which a manufacturer or repackager may request such an
exception, to the requirements relating to product identifiers if a product is
packaged in a container too small or otherwise unable to accommodate a label
with sufficient space to bear the information required for compliance with [section
582 of the FD&C Act]; and
(iii) establish[es] a process by which the Secretary may determine other products
or transactions that shall be exempt from the requirements of [section 582 of the
FD&C Act].
Additionally, section 582(a)(3)(B) of the FD&C Act requires the FDA to issue guidance that
includes a process on how the FDA intends to review and renew granted waivers, exceptions, and
exemptions.
4 Product is defined in section 581(13) of the FD&C Act.
5 The emergency medical reason waiver described in section 582(a)(3)(A)(i) of the FD&C Act is distinct from the
emergency medical reason statutory exemption in section 581(24)(B)(iii) of the FD&C Act and exclusion in section
503(e)(4)(C) of the FD&C Act. Specifically, the emergency medical reason waiver in section 582(a)(3)(i) of the FD&C
Act can extend to section 582 requirements that are not within the purview of the statutory exemption described in
section 581(24)(B)(iii) of the FD&C Act and exclusion in section 503(e)(4)(C) of the FD&C Act for the definitions of
transaction and wholesale distribution, respectively. For purposes of the statutory exemption in section
581(24)(B)(iii) of the FD&C Act and exclusion in section 503(e)(4)(C) of the FD&C Act, a public health emergency
declared under section 319 of the Public Health Service Act is automatically considered an “emergency medical
reason” under the DSCSA. Upon declaration of a public health emergency, product distribution for such emergency
medical reasons is exempted from the definition of a transaction and excluded from the definition of wholesale
distribution” under the DSCSA. As a result, the DSCSA requirements related to product tracing and product
identification triggered by a “transaction” and the DSCSA requirements related to wholesale distribution do not apply
to trading partner activities that address the public health emergency declaration for the duration of the public health
emergency. All other DSCSA requirements apply.

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III. 	PROCESS FOR SUBMITTING WAIVER, EXCEPTION, OR EXEMPTION
REQUESTS TO FDA
This section provides essential information that describes the process to submit a waiver,
exception, or exemption request to the Center for Biologics Evaluation and Research (CBER) or
to the Center for Drug Evaluation and Research (CDER). FDA recommends that all
correspondence between FDA and a trading partner or other stakeholder, including submission of
an initial request and subsequent communication associated with an initial or granted request, be
exchanged electronically in a manner that is consistent with the procedures articulated in section
III.C. of this document.
A. 	Entities that May Submit a Request
Only an authorized manufacturer, repackager, wholesale distributor, or dispenser6 may request a
waiver under section 582(a)(3)(A)(i) of the FD&C Act, and only a manufacturer or repackager
may request an exception under section 582(a)(3)(A)(ii) of the FD&C Act.7 Any interested
stakeholder may request an exemption under section 582(a)(3)(A)(iii) of the FD&C Act.
B. 	Information to Include in a Request
1. 	Request-specific Information
Each request should include the following information:
• 	Name, telephone number, and email address of an individual who FDA can contact
about matters relating to the proposed waiver, exception, or exemption8
• 	Name and address of the trading partner(s) that the proposed waiver, exception, or
exemption would cover
• 	Description of the activities and/or products (including the product name and National
Drug Code number) for which the proposed waiver, exception, or exemption is being
sought
• 	Identification of the specific statutory provision(s) of section 582 of the FD&C
Act to which the proposed waiver, exception, or exemption would apply
• 	Description of the measures or controls that will be implemented to ensure the
6 Manufacturer, wholesale distributor, dispenser, and repackager are defined in sections 581(10), (29), (3), and (16)
of the FD&C Act, respectively.
7 An authorized representative of a trading partner, such as legal counsel and consultants, may submit a waiver or
exception request on behalf of the trading partner.
8 It is the responsibility of the requesting trading partner or other stakeholder to inform FDA of changes in contact
information.

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safety and security of the drug supply chain while operating under a waiver,
exception, or exemption
• 	Requested effective period (e.g., start and end date) of the proposed waiver, exception, or
exemption
• 	Unique or special circumstances of a product and/or transaction
• 	Detailed statement describing the reason(s) justifying the proposed waiver, exception, or
exemption request as well as pertinent supporting documentation, as applicable, to support
the request
2. 	Attestation
In addition, please affirm the following statement in your request:
I affirm that the information in this statement is correct, and I understand that under 18
U.S.C. 1001 it is illegal to make a materially false, fictitious, or fraudulent statement or
representation in this matter within FDA’s jurisdiction.
C. 	How to Submit a Request
FDA recommends that an authorized trading partner or other stakeholder seeking a waiver,
exception, or exemption from requirements of section 582 of the FD&C Act submit an electronic
request to FDA. FDA strongly encourages electronic submission to facilitate efficiency and
timeliness of submission and review. A table is provided in the Appendix to summarize where
requests and subsequent communication associated with an initial or granted request should be
submitted. Following the submission of a request, FDA intends to provide the trading partner or
other stakeholder an acknowledgement confirming receipt of the request.
1. 	Submissions to FDA for CBER-regulated Products
A request for a waiver, exception, or exemption for products that CBER reviews should be
submitted as product correspondence to the biologics license application (BLA), new drug
application (NDA), or abbreviated new drug application (ANDA) in the electronic common
technical document (eCTD) format.9
For submissions related exclusively to CBER-regulated products but not associated with a
specific application(s), a request should be sent to DSCSA-CBER-WEER@fda.hhs.gov.
9 See the guidance for industry Providing Regulatory Submissions in Electronic Format — Certain Human
Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (February 2020). We
update guidances periodically. To make sure you have the most recent version of a guidance, check the FDA
guidance web page at https://www.fda.gov/regulatory-information/search-fda-guidance-documents.

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2. 	Submissions to FDA for CDER-regulated Products
A request for a waiver, exception, or exemption for products that CDER reviews should be
submitted through FDA’s CDER NextGen Portal. All new users to the CDER NextGen Portal
who intend to submit a request should register for an account prior to creating and submitting a
request for a waiver, exception, or exemption to FDA. In addition, subsequent communications
made between CDER and a trading partner or stakeholder associated with an initial or granted
request for a waiver, exception, or exemption, should be made utilizing FDA’s CDER NextGen
Portal.
Access to the CDER NextGen Portal as well as information and tutorials on how to access the
application are located on FDA’s CDER NextGen Portal web page, which can be found at
https://edm.fda.gov.10
D. 	Notifying FDA of Material Changes
The recipient(s) of a waiver, exception, or exemption should notify the FDA Center that
originally issued the waiver, exception, or exemption whenever there is a material change in the
circumstances that formed the basis for granting the initial request for regulatory relief.
Furthermore, recipient(s) should notify FDA as soon as possible and FDA recommends no later
than 12 business days following the change, regardless of the duration of the waiver, exception,
or exemption.
The following example is for illustrative purposes and should not be construed as exhaustive of
all circumstances for when a material change occurs. The example is intended to help trading
partners and stakeholders understand when they should notify FDA of a material change.
A manufacturer receives an exception from FDA for a product packaged in a container that is
too small to accommodate a label with space to bear a product identifier. The exception has
an effective period of three years. One year after receiving the exception, the manufacturer
begins packaging the product in a larger container that can accommodate a label with a
product identifier. In this scenario, the manufacturer should notify FDA of this material
change when it begins production of product utilizing the larger container as opposed to
waiting until FDA’s biennial review of the valid exception.
If the recipient of a waiver, exception, or exemption is unsure about whether a material change
has occurred, the recipient should contact FDA as soon as possible using the applicable steps in
section III.C. of this guidance.
10 Waiver, exception, and exemption requests that are not related to specific products or where the lead center is
uncertain or unknown should be submitted through FDA’s CDER NextGen Portal, which can be found at
https://edm.fda.gov.

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IV. 	PROCESS FOR REVIEWING AND DETERMINING WAIVER, EXCEPTION,
OR EXEMPTION REQUESTS
A. 	Review of Requests
FDA intends to evaluate each request on a case-by-case basis to ensure that it contains sufficient
information to permit a substantive review. FDA may also use its discretion to contact a
requesting trading partner or other stakeholder to clarify an aspect of the request (e.g., the
products or transactions that the request covers) or to request additional information related to the
subject of the request. If FDA determines that a request lacks sufficient information to permit a
substantive review or a requesting trading partner or other stakeholder fails to provide requested
clarifying information, the Agency may deny the request.
During the review, FDA may consult with relevant subject matter experts within the Agency as
appropriate and assess, as applicable, whether:
• 	A waiver of the FD&C Act section 582 requirement(s) identified in the request is (1)
warranted because complying with the requirement(s) would result in undue economic
hardship or (2) appropriate for emergency medical reasons;
• 	An exception to the FD&C Act section 582 requirements relating to product identifiers is
warranted because the product identified in the request is packaged in a container that is
too small or otherwise unable to accommodate a label with sufficient space to bear the
information required for compliance with these requirements; or
• 	Exempting the product(s) and/or transaction(s) identified in the request from the FD&C
Act section 582 requirement(s) identified in the request is appropriate to maintain public
health or is otherwise appropriate.
FDA intends to also consider the potential risks that a proposed waiver, exception, or exemption
may pose to the security of the drug supply chain. Additionally, if the submission seeks a waiver,
exception, or exemption that could affect a broad segment(s) of industry and/or multiple trading
partners, FDA may deny or defer the request if it determines that an FDA-initiated exception,
exemption, or other regulatory action would be more appropriate.
B. 	Determining Requests and Notifying Affected Entities
Once FDA has received and reviewed all relevant information and documentation to support a
waiver, exception, or exemption request, FDA intends to notify the requesting trading partner or
other stakeholder of the Agency’s determination to grant, deny, or take other appropriate action
on the original request. The Agency intends to assess requests received in a timely manner;
however, the timeframe to complete a review and notify the requesting trading partner or other
stakeholder of its determination may vary depending on the nature of the request or the volume of
requests under assessment by the Agency at that time. In its notification, FDA intends to include
an explanation of the basis for the determination and, if granted, the effective and termination
date of the waiver, exception, or exemption. To minimize the potential risks to the drug supply

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chain that a waiver, exception, or exemption may incur, FDA may limit the duration of a waiver,
exception, or exemption based upon the nature of the circumstances surrounding a request.
However, FDA may grant a request for an undetermined period to address situations that involve
extraordinary circumstances.
Additionally, to help ensure that trading partners in the supply chain are aware of a granted
waiver, exception, or exemption, the recipient should notify its trading partners of such a waiver,
exception, or exemption.11 The Agency may, in its discretion, post information regarding a
determination to its website if it concludes that doing so is in the best interest of, or is necessary
to protect, public health. Such information would be posted in a manner that is consistent with the
laws and regulations governing the disclosure of confidential commercial information.
FDA recognizes that a granted waiver, exception, or exemption may affect DSCSA requirements
of downstream trading partners transacting product with the recipient of a waiver, exception, or
exemption. In FDA’s response to the recipient of a waiver, exception, or exemption, FDA intends
to provide corresponding relief for DSCSA requirements of downstream trading partners.
Additionally, FDA anticipates that product for which a waiver, exception, or exemption has been
granted may continue to be the subject of transactions beyond the granted effective period. For
product that may remain in the supply chain beyond the effective period of a granted waiver,
exception, or exemption, the Agency intends to also address those unique scenarios in its
response to the recipient.
C. 	Reconsideration of a Granted Waiver, Exception, or Exemption
If the recipient wants FDA to reconsider the scope of a waiver, exception, or exemption that has
been granted, the recipient may submit a request for reconsideration and should include
information adequate to explain the nature of the issue when submitting the request.
Additionally, new information should be provided to FDA to justify a change in FDA’s prior
conclusions concerning the scope of the waiver, exception, or exemption using the applicable
steps in section III.C. of this guidance. Following the submission of a request to reconsider the
scope of a waiver, exception, or exemption that has been granted, FDA intends to issue an
acknowledgement to the trading partner or other stakeholder confirming receipt of the request.
After FDA reviews the information submitted, the Agency intends to issue a response to the
requesting trading partner or other stakeholder, setting forth the basis of its decision.
D. 	Reconsideration of a Denied Request
If the recipient wants FDA to reconsider a denied request for a waiver, exception, or exemption,
a recipient may submit a request for the Agency to reconsider and re-evaluate the denied request.
In the request, the recipient should provide additional information, such as updated
11 In addition to notifying its trading partners of a granted waiver, exception, or exemption, FDA recommends that
the recipient maintain readily accessible resources for its trading partners that provide: (1) notification to trading
partner(s) about the FD&C Act section 582 requirement(s) that is waived, excepted, or exempted; and (2) a phone
number and/or email address of the recipient that trading partner(s) may contact to obtain timely confirmation of the
product(s) or transaction(s) subject to the waiver, exception, or exemption. The resource should be maintained until
the latest date of expiry of products covered under the waiver, exception, or exemption.

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documentation or analysis not previously provided to support the waiver, exemption, or
exemption, using the applicable steps in section III.C. of this guidance. FDA recommends this
information to be provided as soon as possible and preferably no later than 12 business days after
the date of the denial. Depending on the scope of information received in the request for
reconsideration, and when the request is received, FDA may consider such requests in the
context of a new waiver, exception, or exemption request. In this case, FDA intends to inform
the requestor, and the trading partner or stakeholder should submit a new request with supporting
information, as needed, using the steps applicable in section III.C. of this guidance.
Following the submission of a request to reconsider and re-evaluate a denied request, FDA
intends to issue an acknowledgement to the trading partner or other stakeholder confirming
receipt of the request. After FDA reviews the information submitted, the Agency intends to issue
a response to the requesting trading partner or other stakeholder, setting forth the basis of its
decision to affirm the denial decision or grant the requested waiver, exception, or exemption.
V. 	PROCESS FOR FDA-INITIATED EXCEPTIONS AND EXEMPTIONS
Under sections 582(a)(3)(A)(ii) and (iii) of the FD&C Act, FDA can establish exceptions or
exemptions from the requirements of section 582 of the FD&C Act on its own initiative.12 FDA
intends to use this authority when necessary to address an issue that affects a broad segment(s) of
industry and/or multiple trading partners, impacts many drug distribution activities, or involves
numerous products.
Consistent with the approach described in section IV. of this guidance, FDA intends to only
establish exceptions under section 582(a)(3)(A)(ii) of the FD&C Act on its own initiative when
the Agency determines that the excepted product(s) is packaged in a container that is too small or
otherwise unable to accommodate a label with sufficient space to bear the information required
for compliance with the section 582 requirements relating to product identifiers. Similarly, FDA
intends to only establish exemptions under section 582(a)(3)(A)(iii) of the FD&C Act on its own
initiative when the Agency determines that the exemption is appropriate to maintain public health
or is otherwise appropriate. As with exceptions and exemptions that are granted pursuant to a
request from an authorized trading partner or other stakeholder, FDA intends to consider how an
exception or exemption may affect the security of the drug supply chain prior to establishing the
exception or exemption on its own initiative.
If FDA establishes an exception or exemption to address a particular issue, the Agency intends to
communicate the information in writing using a method that is appropriate for the circumstances
(e.g., issuing a letter to the affected trading partners or posting on the Agency’s website if an
exception or exemption applies to a broad segment of industry). An exception or exemption that
FDA establishes may be limited in duration or valid until further notice from the Agency.
12 See sections 582(a)(3)(A)(ii) and (iii) of the FD&C Act.

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VI. 	REVIEW AND RENEWAL OF WAIVER, EXCEPTION, AND EXEMPTION
REQUESTS
A. 	Biennial FDA Review and Renewal of Waivers, Exceptions, and Exemptions
The FDA has discretion regarding whether to approve a waiver, exception, or exemption for the
duration specified in the request or for an alternative duration. For those requests that are
approved, once every two years, FDA intends to review waivers, exceptions, and exemptions
with an expiration date of an indeterminate period or longer than two years after the effective
date, and renew such waivers, exceptions, and exemptions, as applicable. During this review, the
Agency intends to assess, among other things, whether a material change in circumstances has
occurred, thereby making the waiver, exception, or exemption unwarranted. To assess whether a
material change in circumstances has occurred, the Agency may request supporting
documentation from the recipient of an approved waiver, exception, or exemption to substantiate
the continued need for such a request. For example, an authorized trading partner that received an
“undue economic hardship” waiver may be asked to submit updated financial information
demonstrating that the circumstances supporting the original waiver decision still exist.
B. 	Authorized Trading Partner Renewal Requests of Expiring Waivers,
Exceptions, and Exemptions
An authorized trading partner or other stakeholder may submit a renewal request for any waiver,
exception, or exemption it received that is of limited duration. A renewal request should be
submitted to the FDA Center that originally issued the waiver, exception, or exemption as soon
as the authorized trading partner or other stakeholder determines that a renewal is necessary. The
request should include a detailed statement justifying the continuance of the waiver, exception, or
exemption, and the desired length of the extension. In addition, the request should contain the
affirmation set forth in section III.B. of this guidance.
FDA intends to review and respond to renewal requests in the same manner that it reviews and
responds to initial requests for waivers, exceptions, and exemptions.13 FDA does not intend to
accept renewal requests for an FDA-initiated exception or exemption. If an authorized trading
partner or other stakeholder believes that renewing an expiring FDA-initiated exception or
exemption after the expiration date is necessary, that trading partner or other stakeholder should
submit a request for an exception or exemption.
C. 	Terminating Previously Granted Requests and Notifying Affected Entities
In the event FDA determines that a granted waiver, exception, or exemption is no longer
appropriate following a biennial review, FDA intends to terminate the waiver, exception, or
exemption prior to the expiration date. Similarly, if FDA learns – outside of the biennial review
process – of circumstances that render a previously granted waiver, exception, or exemption no
longer appropriate, FDA may terminate the waiver, exception, or exemption prior to the
expiration date. The Agency intends to notify the requesting trading partner or other stakeholder
of a previously granted waiver, exception, or exemption of its determination to terminate the
13 See sections IV.A. and IV.B. of this guidance.

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waiver, exception, or exemption. Additionally, FDA recommends that the recipient of a waiver,
exception, or exemption notify its trading partners if a previously granted waiver, exception, or
exemption has been terminated.
For FDA-initiated exceptions and exemptions, the Agency intends to announce the termination
using a written method appropriate for the circumstances, including posting information
regarding a termination to its website if it concludes that doing so is in the best interest of or is
necessary to protect public health. Such information would be posted in a manner that is
consistent with the laws and regulations governing the disclosure of confidential commercial
information.
The Agency intends to issue these written termination notices and announcements within a
reasonable amount of time before the stated termination date.

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APPENDIX
Where to Submit Waiver, Exception, and Exemption Requests and Subsequent
Communications
Requests related exclusively to CBER-
regulated products that are associated with
a BLA, NDA, or ANDA
Send in eCTD format through FDA’s
Electronic Submissions Gateway as product
correspondence to the application
Requests related exclusively to CBER-
regulated products that are not associated
with a specific application(s)
Send email to:
DSCSA-CBER-WEER@fda.hhs.gov
All other requests, including those for
CDER-regulated products, those that are
not related to specific products, or when
the lead center is uncertain or unknown
Submit through FDA’s CDER NextGen Portal
web page at:
https://edm.fda.gov
As explained above, FDA strongly encourages electronic submissions to facilitate efficiency and
timeliness of submission and review. However, paper submissions may be submitted to the
addresses below if needed:
Submissions to FDA for CBER-regulated products:
Food and Drug Administration
Center for Biologics Evaluation and Research
Document Control Center
10903 New Hampshire Ave.
Bldg. 71, Rm. G112
Silver Spring, MD 20993-0002
Submissions to FDA for CDER-regulated products, those that are not related to specific products,
or when the lead center is uncertain or unknown:
Office of Drug Security, Integrity, and Response
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave.
Bldg. 51, Rm. 4203
Silver Spring, MD 20993-0002
Attn: DSCSA WEER Team