Pre-Launch Activities 
Importation Requests 
(PLAIR) 
Guidance for Industry  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
Office of Regulatory Affairs (ORA) 
 
March 2022 
Procedural 
 
 
 
  OMB Control No. 0910-0046  
  Current expiration date available at https://www.reginfo.gov  
(Search ICR and enter OMB control number)   
See additional PRA statement in Section IV of this guidance 
 
   
Pre-Launch Activities 
Importation Requests 
(PLAIR) 
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 
 
 
 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
Office of Regulatory Affairs (ORA) 
 
March 2022 
Procedural 
 
  Contains Nonbinding Recommendations 
 
 
TABLE OF CONTENTS 
 
 
I.  INTRODUCTION ...................................................................................................... 1 
II.  BACKGROUND ........................................................................................................ 1 
III.  DISCUSSION ............................................................................................................. 2 
A.  Submitting a PLAIR ..................................................................................................... 3 
B.  Importation Procedures Under a PLAIR ........................................................................ 6 
C.  Post-NDA, ANDA, or CDER-Regulated BLA Approval ................................................... 6 
IV.  PAPERWORK REDUCTION ACT OF 1995 ............................................................ 7 
V.  CONTACTS ............................................................................................................... 8 
  Contains Nonbinding Recommendations 
 
Pre-Launch Activities Importation Requests (PLAIR) 
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 staff responsible for this guidance as listed on the 
title page.  
 
 
 
 
I.  INTRODUCTION 
 
This guidance finalizes the July 2013 draft guidance Pre-Launch Activities Importation Requests 
(PLAIR), which describes the FDAs policy regarding requests for the importation of unapproved 
finished dosage form drug products by an applicant preparing the product for U.S. market launch 
based on anticipated approval of a pending new drug application (NDA) or abbreviated new drug 
application (ANDA).2  This guidance also applies to unapproved biologics licensing applications 
(BLAs) regulated by the Center for Drug Evaluation and Research (CDER), and unapproved 
combination products assigned to CDER (21 CFR part 3) for which NDA, ANDA, or BLA 
approval is anticipated.  Moreover, this guidance describes the procedures for making requests 
for importation of unapproved finished dosage form drug products before final approval of the 
application and the factors that FDA will consider in granting such requests. 
 
The contents of this document do not have the force and effect of law and are not meant to bind 
the public in any way, unless specifically incorporated into a contract.  This document is 
intended only to provide clarity to the public regarding existing requirements under the law.  
FDA guidance documents, including this guidance, should be viewed only as recommendations, 
unless specific regulatory or statutory requirements are cited.  The use of the word should in 
Agency guidance means that something is suggested or recommended, but not required. 
 
 
II.  BACKGROUND 
 
Historically, when applicants sought to import unapproved finished dosage form drug products 
in preparation for market launch, FDA considered such requests, referred to as Pre-Launch 
Activities Importation Requests (PLAIRs), on a case-by-case basis.  In July 2013, FDA issued a 
draft guidance announcing the Agencys approach for overseeing the import of some unapproved 
 
1 This guidance has been prepared by the Office of Compliance, Center for Drug Evaluation and Research (CDER), 
in cooperation with the Office of Enforcement and Import Operations in the Office of Regulatory Affairs (ORA) at 
the Food and Drug Administration.  
2 We update guidances periodically.  For the most recent version of a guidance, check the FDA guidance web page 
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs. 
  Contains Nonbinding Recommendations 
 
finished dosage form drug products regulated by CDER prior to their approval to facilitate the 
availability of those products to patients upon approval.  This guidance adopts most elements of 
the PLAIR program announced in the July 2013 draft guidance, updates the information that 
should be submitted to FDA in a PLAIR, describes when and how a PLAIR can be submitted, 
and explains the circumstances under which the Agency intends to grant a PLAIR. 
 
 
III.  DISCUSSION 
 
Section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(a)) 
prohibits the introduction or delivery for introduction into interstate commerce of a new drug 
unless an approval of an application filed pursuant to subsection (b) or (j) is effective with 
respect to such drug.  Section 801(a)(3) of the FD&C Act (21 U.S.C. 381(a)(3)) states that a 
drug being imported or offered for import is subject to refusal of admission into the United States 
if, among other things, it appears that it violates section 505 of the FD&C Act.  If a drug is 
subject to refusal of admission under section 801(a)(3) because it appears to violate section 505 
of the FD&C Act, FDA issues a notice of the detention and the opportunity to introduce 
testimony to the owner or consignee of the shipment.  The owner or consignee may request an 
informal hearing to introduce testimony that the drug can be imported.  Under section 801(b) of 
the FD&C Act, if a drug is detained under 801(a)(3), the owner or consignee may also request 
permission to recondition the drug to bring it into compliance.  FDA has issued regulations on 
reconditioning found at 21 CFR 1.95-1.99. 
 
An applicant3 who has a pending NDA, ANDA, or CDER-regulated BLA nearing an FDA 
application decision (timeframes discussed below) can submit a PLAIR to FDA seeking 
permission to import an unapproved finished dosage form drug product for reconditioning in the 
form of approval.  As a benefit of PLAIR, FDA reviews the reconditioning request prior to the 
drugs arrival at the port of entry.  As a result, applicants whose PLAIR requests have been 
granted need not complete a Form FDA 766 requesting reconditioning, which is the process 
described in the Regulatory Procedures Manual, Chapter 9: Imports Operations and Actions4 for 
requesting reconditioning.  
 
The PLAIR submission should include a statement that the owner or consignee has requested to 
recondition the drug by obtaining FDA approval of the pending application.  Once the drug 
arrives at the port of entry, FDA will issue a Notice of FDA Action-Detained for any product 
associated with a granted PLAIR.  We intend to detain the product for up to 6 months pending a 
decision on the underlying application.  If FDA approves the underlying NDA, ANDA, or BLA, 
the Agency intends to issue a Release after Detention.  If FDA refuses to approve the 
application or 6 months otherwise elapse without FDA approval, FDA may determine that the 
product is subject to refusal and may issue a Notice of FDA Action-Refusal of Admission.5  
 
3 For purposes of this guidance, an applicant is any person who submits an NDA, ANDA, or a CDER-regulated 
BLA to request FDA approval of a new drug or biological product. 
4 See https://www.fda.gov/media/71776/download. 
5 We believe that 6 months is generally a reasonable limit for detentions under PLAIR because after 6 months, the 
Agencys goal date for most reviews of applications will have elapsed.  If applicants believe that FDA should extend 
the detention for more than 6 months, they may contact FDA. 
  2  Contains Nonbinding Recommendations 
 
 
Applicants are not required to submit a PLAIR.  FDAs granting of a PLAIR does not represent 
an implicit or explicit statement of the approvability of the NDA, ANDA, or CDER-regulated 
BLA.  Rather, PLAIR facilitates the process for importing unapproved finished dosage form 
products to prepare for market launch based on anticipated approval of the pending application.  
This guidance describes all the information FDA needs to evaluate PLAIR requests. 
 
A.  Submitting a PLAIR 
 
1.  Which Drug Products Does the PLAIR Program Cover? 
 
The PLAIR program covers finished dosage form drug products that are the subject of a pending 
NDA, ANDA, or CDER-regulated BLA.6  The unapproved finished dosage form drug products 
should either: 
 
  Call for minimal further processing, such as final packaging and/or labeling; or 
 
  Be in final packaged form. 
 
2.  What Should Be Included in a PLAIR? 
a.  The drug product name and how supplied (from product labeling per 21 
CFR 201.56 and 201.80). 
 
b.  The name of the CDER Office of New Drugs or Office of Generic Drugs 
regulatory project manager assigned to the pending application. 
 
c.  The National Drug Code (NDC) number, if assigned. 
 
d.  The name, address, registration number,7 and telephone number of the 
foreign manufacturer of the finished dosage form drug product. 
 
e.  The name, address, registration number, and telephone number of the U.S. 
consignee. 
 
f.  The application number for the finished dosage form drug product pending 
FDA approval. 
 
 
6 Consistent with our resources, FDA does not intend to consider PLAIR requests for drug products that are the 
subject of a supplement or other change to an approved application.  However, sponsors of such products may 
choose to offer those products for import.  Since they are unapproved drug products, the products are subject to 
detention.  FDA will review such entries and make admissibility determinations in accordance with FDA-
administered statutes and regulations.  
7 Note that FDA will assess whether foreign drug establishments are in compliance with applicable registration 
requirements in section 510(i) of the FD&C Act (21 U.S.C. 360(i)) and 21 CFR part 207.   
  3  Contains Nonbinding Recommendations 
 
g.  A letter from FDA officially documenting the user fee goal date.8  
 
h.  The precise quantities to be imported. 
 
i.  The name, address, facility identification number (such as a Data Universal 
Number or DUNS9), and telephone number of any facility where the 
finished dosage form drug product in final packaged form will be stored 
pending approval.10 
 
j.  When the finished dosage form drug product is imported for minimal further 
processing, information regarding the facility where minimal further 
processing activities will occur, including (1) the name, address, and 
registration number of the facility; and (2) a description of the further 
processing activities. This facility should be identified in the pending 
application.  
k.  A letter signed by an authorized representative of the applicant stating the 
following: 
 
i.  The applicants acknowledgment that the product is an unapproved 
new drug; 
 
ii.  That the PLAIR represents the applicants request to recondition the 
product, under section 801(b) of the FD&C Act and 21 CFR 1.95, by 
obtaining product approval within 6 months;  
 
iii.  For an unapproved finished dosage form drug product that calls for 
minimal further processing, that the unapproved finished dosage form 
drug product will be delivered to a facility identified in the finished 
dosage form drug products pending application to permit further 
processing.  Following completion of those activities, the product will 
remain subject to the terms and conditions of the U.S. Customs and 
Border Protection (CBP) entry bond that covers the specific shipment.  
 
For an unapproved finished dosage form drug product in final 
packaged form that does not call for further processing, that the drug 
product should be delivered to a single facility used for warehousing.  
The product will remain subject to the terms and conditions of the 
CBP entry bond that covers the specific shipment; 
 
8 As part of the reauthorization of the Prescription Drug User Fee Act and the Generic Drug User Fee Amendments, 
FDA commits to certain performance goals (see FDAs User Fee Programs web page, available at 
https://www.fda.gov/industry/fda-user-fee-programs).   
9 Dun & Bradstreet D-U-N-S Number is a unique nine-digit number used around the world to identify and access 
information on businesses (see https://www.dnb.com/duns-number.html).  
10 For entities that conduct activities of a third-party logistics provider, as defined in section 581(22) of the FD&C 
Act, please see the requirements of reporting and licensure requirements under section 584 of the FD&C Act (21 
U.S.C. 360eee-3). 
  4  Contains Nonbinding Recommendations 
 
 
iv.  That the facility used for warehousing complies with any applicable 
current good manufacturing practices (CGMP) or if applicable, other 
federal or state requirements.11  
 
v.  That the applicant understands that the unapproved finished dosage 
form drug product must be exported or destroyed within 90 days of the 
date of any notice of refusal, if refused admission. 
 
3.  When Should a PLAIR Be Submitted? 
 
The PLAIR should be submitted at least 30 days prior to the proposed entry date of the shipment 
to allow time to process the submission.  In addition, we provide the following timeframes: 
 
  For PLAIR-eligible ANDAs, NDAs, and CDER-regulated BLAs subject to standard 
review: The PLAIR should be submitted no more than 60 days before the user fee goal 
date.  
 
  For PLAIR-eligible NDAs and CDER-regulated BLAs subject to 6-month (priority) 
review,12 the PLAIR should be submitted up to 120 days before the user fee goal date.  
 
  For PLAIR-eligible ANDAs subject to priority review,13 the PLAIR should be submitted 
up to 80 days before the user fee goal date.  
 
These recommended timeframes will help ensure that PLAIR requests are processed in time for 
FDA to review the underlying application. 
 
4.   How Should a PLAIR Be Submitted? 
 
The PLAIR submission should be on the applicants letterhead and submitted by email to CDER-
OC-PLAIR@fda.hhs.gov14 in a file compatible with Portable Document Format (PDF).  The 
subject line of the submission should include the application number, drug product name and 
strength(s).  Consistent with our resources, FDA intends to accept one PLAIR submission per 
NDA, ANDA, or BLA.  
 
11 If third-party logistics providers are used, they shall have a valid license under state law or section 584(a)(1) of the 
FD&C Act in accordance with sections 582(a)(7).  They should also comply with the licensure reporting 
requirements under section 584(b) of the FD&C Act to be considered as authorized.   
12 FDA assigns priority review designation to applications for new drugs or biological products that are to treat 
serious conditions and, if approved, would provide significant improvements in the safety or effectiveness of the 
treatment, diagnosis, or prevention of serious conditions.  See FDAs guidance for industry Expedited Programs for 
Serious ConditionsDrugs and Biologics (May 2014).  In addition, the FD&C Act provides for other expedited 
programs for certain types of applications.  See 21 U.S.C. 356 and FDAs guidance for industry Expedited Programs 
for Serious ConditionsDrugs and Biologics (May 2014).   
13 Information on ANDAs eligible for priority or expedited review is provided in CDERs Manual of Policy and 
Procedures (MAPP) 5240.3 Prioritization of the Review of Original ANDAs, Amendments and Supplements.  See 
https://www.fda.gov/industry/generic-drug-user-fee-amendments/gdufa-guidances-and-mapps.  
14 If, and when, an electronic submissions portal becomes available, FDA will post instructions for use on our 
website.  
  5  Contains Nonbinding Recommendations 
 
 
5.   What Action Will FDA Take on a PLAIR? 
 
Once a complete PLAIR is submitted to FDA, the CDER Office of Drug Security, Integrity and 
Response (ODSIR), Division of Global Drug Distribution and Policy (DGDDP), will confirm 
receipt of the submission.  CDER will review the submission and assess, among other things, the 
foreign facilitys inspection history and conformity with applicable CGMP (e.g., 21 CFR parts 
210 and 211).  Following this review, DGDDP will notify the applicant whether the PLAIR has 
been granted or denied.  
 
If any changes to the PLAIR are proposed after FDA has granted the original PLAIR submission, 
an amended PLAIR should be submitted to FDA.  The firm may make the changes on the initial 
PLAIR.  However, the firm should explain all changes made and identify the document as an 
amendment to differentiate it from the initial PLAIR request.  After review, DGDDP will 
notify the applicant whether it has granted the amendment.  
 
B.  Importation Procedures Under a PLAIR 
 
Upon receiving a granted PLAIR, the importer may provide a copy of the granted PLAIR to the 
Office of Regulatory Affairs (ORA) Import Division where the product is imported.  The 
importer should provide an affirmation of compliance indicating the product is covered under a 
granted PLAIR as well as the associated drug application number in the Automated Commercial 
Environment (ACE).15  FDA will consider this action to mean that the owner or consignee is 
requesting to recondition the drug under section 801(b) of the FD&C Act and 21 CFR 1.95.  We 
also consider that the owner or consignee has opted not to request a hearing on refusal of 
admission under section 801(a) of the FD&C Act and 21 CFR 1.94.  For PLAIRs that FDA 
grants, FDA intends to detain the product as an unapproved new drug and to authorize the drugs 
reconditioning in the manner and under the conditions set forth in the granted PLAIR.  If FDA 
approves the products in the application (NDA, ANDA, or CDER-regulated BLA) within 6 
months of the date of entry of the shipment made under the PLAIR, then the Agency intends to 
issue a  Release after Detention for the drug product.  
 
If FDA refuses to approve the application or 6 months otherwise elapse without FDA approval, 
FDA may determine that the product is subject to refusal.  If FDA refuses admission into the 
United States under section 801(a)(3) of the FD&C Act, the finished dosage form drug product 
must be exported or destroyed within 90 days of the refusal. 
 
C.  Post-NDA, ANDA, or CDER-Regulated BLA Approval 
 
Upon receiving notice from FDA that a drug product application is approved, the applicant 
should immediately send a copy of the approval letter to the ORA Import Division where the 
product was detained and CDER-OC-PLAIR@fda.hhs.gov.  The applicant should notify FDA of 
 
15 For general information about importation and ACE, see FDAs web pages https://www.fda.gov/industry/import-
systems/automated-commercial-environmentinternational-trade-data-system-aceitds and 
https://www.fda.gov/industry/entry-process/entry-submission-process.  
  6  Contains Nonbinding Recommendations 
 
any deviation of the drug product detained under a PLAIR from the provisions in the approved 
drug application.  
 
In the past, the Agency has encountered instances in which drug products that had been 
warehoused subject to a pending drug approval did not conform with late changes made to the 
approved drug product labeling or instances in which the application did not receive FDA 
approval.  Under these circumstances, such products may be misbranded under section 502 of the 
FD&C Act (21 U.S.C. 352) and/or constitute unapproved new drugs under section 505 of the 
FD&C Act, because it may differ from the approval of the NDA, ANDA, or BLA.  Introduction 
or delivery for introduction into interstate commerce of any misbranded drug or any article in 
violation of section 505 of the FD&C Act is prohibited, and such products are subject to refusal 
of admission. 
 
Applicants must list their drug product(s) in accordance with section 510(j) of the FD&C Act. 
 
 
IV.  PAPERWORK REDUCTION ACT OF 1995  
 
This guidance contains information collection provisions that are subject to review by the Office 
of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501-3521).   
 
The collections of information pertaining to FDAs Pre-Launch Activities Importation Requests 
have been approved under OMB control number 0910-0046.   
 
The time required to complete this information collection is estimated to average 16 hours for the 
first submission, including the time to review instructions, search existing data sources, gather 
the data needed, and complete and review the information collection.  We expect the subsequent 
submissions to take less than 16 hours.  
 
Send comments regarding this burden estimate or suggestions for reducing this burden to the 
Office of Regulatory Policy, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6282, Silver Spring, MD 20993-
0002, and include Docket No. FDA-2013-D-0836 (see the announcement of the guidance 
published in the Federal Register on March 2, 2022). 
 
The guidance also refers to previously approved collections of information.  The collections of 
information in 21 CFR part 314 relating to new drug applications and abbreviated new drug 
applications have been approved under OMB control number 0910-0001; the collections of 
information in part 601 relating to biologics license applications have been approved under OMB 
control number 0910-0338; the collections of information in 21 CFR part 207 relating to 
domestic and foreign facility registration, including assignment of a national drug code, have 
been approved under OMB control number 0910-0045; and the collections of information in 
parts 210 and 211 pertaining to current good manufacturing practice requirements have been 
approved under OMB control number 0910-0139. 
 
  7  Contains Nonbinding Recommendations 
 
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of 
information unless it displays a currently valid OMB control number.  The OMB control number 
for this information collection is 0910-0046.  The current expiration date is available at 
https://www.reginfo.gov (search ICR and enter OMB control number). 
 
 
V.  CONTACTS 
 
For questions regarding this guidance or a PLAIR please contact: 
 
CDER Office of Compliance: 
Office of Drug Security, Integrity and Response  
Division of Global Drug Distribution and Policy 
Center for Drug Evaluation and Research 
Food and Drug Administration  
10903 New Hampshire Ave. 
Silver Spring, MD  20993-0002 
Main number:  301-796-3130 
Fax:  301-847-8747 
Email:  CDER-OC-PLAIR@fda.hhs.gov 
 
 
  8