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., 4th 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 
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, FDAs guidance documents do not establish legally enforceable responsibilities. 
Instead, guidances describe the Agencys 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. 
  1  Contains Nonbinding Recommendations 
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.  
  2  Contains Nonbinding Recommendations 
 
 
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. 
  3  Contains Nonbinding Recommendations 
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 FDAs 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.  
  4  Contains Nonbinding Recommendations 
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 FDAs 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 FDAs CDER NextGen 
Portal.  
 
Access to the CDER NextGen Portal as well as information and tutorials on how to access the 
application are located on FDAs 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 FDAs 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 FDAs CDER NextGen Portal, which can be found at 
https://edm.fda.gov.  
  5  Contains Nonbinding Recommendations 
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 Agencys 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 
  6  Contains Nonbinding Recommendations 
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 FDAs 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 FDAs 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. 
  7  Contains Nonbinding Recommendations 
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 Agencys 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. 
  8  Contains Nonbinding Recommendations 
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. 
  9  Contains Nonbinding Recommendations 
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. 
 
  10  Contains Nonbinding Recommendations 
APPENDIX 
 
Where to Submit Waiver, Exception, and Exemption Requests and Subsequent 
Communications  
 
Requests related exclusively to CBER- Send in eCTD format through FDAs 
regulated products that are associated with  Electronic Submissions Gateway as product 
a BLA, NDA, or ANDA  correspondence to the application 
Requests related exclusively to CBER- Send email to: 
regulated products that are not associated 
DSCSA-CBER-WEER@fda.hhs.gov  
with a specific application(s) 
All other requests, including those for  Submit through FDAs CDER NextGen Portal 
CDER-regulated products, those that are  web page at: 
not related to specific products, or when 
https://edm.fda.gov  
the lead center is uncertain or unknown 
 
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 
  11