Importation of 
Prescription Drugs 
Final Rule 
Questions and Answers 
Guidance for Industry 
 
 
(Small Entity Compliance Guide)
 
 
 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
Office of Regulatory Affairs (ORA) 
 
May 2022 
Import 
    
Importation of 
Prescription Drugs 
Final Rule 
Questions and Answers 
Guidance for Industry 
 
 
(Small Entity Compliance Guide)
 
 
 
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) 
 
May 2022 
Import 
  Contains Nonbinding Recommendations 
 
TABLE OF CONTENTS 
 
 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  DISCUSSION .................................................................................................................... 2 
  Contains Nonbinding Recommendations 
 
Importation of Prescription Drugs Final Rule 
Questions and Answers 
Guidance for Industry1 
(Small Entity Compliance Guide) 
 
 
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 is intended to help small entities better understand the final rule, Importation of 
Prescription Drugs, published October 1, 2020 (85 FR 62094).  The Secretary of Health and 
Human Services issued the final rule to implement section 804(b) through (h) of the Federal 
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 384(b) through (h)) to allow importation 
of certain prescription drugs from Canada.2  The purpose of the final rule is to achieve a 
significant reduction in the cost of covered products to the American consumer while posing no 
additional risk to the publics health and safety. 
 
The final rule became effective November 30, 2020.  FDA has prepared this guidance in 
accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public 
Law 104-121, as amended by Public Law 110-28).  This guidance document restates in plain 
language the legal requirements set forth in the final rule and is intended to assist small entities 
in complying with the final rule.3 
 
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 guidances means that something is suggested or recommended, but not required.  
 
 
 
1 This guidance has been prepared by the Center for Drug Evaluation and Research and the Office of Regulatory 
Affairs at the Food and Drug Administration with assistance from the Office of Combination Products.  
2 In addition to drugs, drug-device combination products (see 21 CFR 3.2(e)) may be eligible for importation under 
the rule.  The answers provided in this guidance are also applicable to those combination products. 
3 See 21 CFR part 251. 
  1  Contains Nonbinding Recommendations 
 
II.  DISCUSSION 
 
Q1.  Who may submit an importation program proposal?  Who may import 
eligible prescription drugs? 
 
Under the final rule, section 804 of the FD&C Act will be implemented through time-limited 
Section 804 Importation Programs (SIPs), which will be reviewed and authorized by FDA and 
managed by States or Indian Tribes, or in certain future circumstances by pharmacists or 
wholesale distributors (SIP Sponsors).  A SIP may be co-sponsored by a State, Indian Tribe, 
pharmacist, or wholesale distributor.  The personal importation provisions in section 804(j) of 
the FD&C Act will not be implemented through the final rule. 
 
In an authorized SIP, an Importer, which may be a pharmacist or a wholesaler, will import 
eligible prescription drugs.  An Importer must be a licensed pharmacist or wholesale distributor 
and the Importer must be the U.S. owner of an eligible prescription drug at the time of entry into 
the United States.  The Importers pharmacist license or wholesale distributor license (if issued 
by a State and not FDA) must be issued by a State that is a SIP Sponsor or SIP Co-Sponsor.  An 
Importers pharmacist or wholesale distributor license must be in effect or active (that is, not 
expired) and the Importers license must be in good standing with the licensor. 
 
Q2.  What prescription drugs are eligible for importation under the final rule? 
 
The final rule requires that a SIP Sponsor specify the eligible prescription drugs that will be 
included in the SIP.  To be eligible under the final rule, a drug must be approved by the Health 
Canadas Health Products and Food Branch (HPFB) and it must have HPFB-approved labeling 
when marketed in Canada.  Except for not having the required U.S. labeling when marketed in 
Canada, an eligible prescription drug must otherwise meet the conditions in an FDA-approved 
new drug application or abbreviated new drug application.  Essentially, eligible prescription 
drugs are those that could be sold legally on either the Canadian market or the American market 
with appropriate labeling. 
 
The final rule excludes certain types of drug products from eligibility: controlled substances, 
biological products, infused drugs (including peritoneal dialysis solutions), drugs that are inhaled 
during surgery, drugs that are injected intravenously (into a vein), intrathecally (into the spinal 
fluid), or intraocularly (into the eye), drugs that are subject to a risk evaluation and mitigation 
strategy (REMS), and drugs that are not subject to certain provisions of the Drug Supply Chain 
Security Act.  For a drug product not excluded by the final rule, FDA will determine whether the 
product can be imported safely in the context of a specific SIP Proposal on a product-by-product 
basis.  A SIP Sponsor would need to explain in its SIP Proposal how it will address any concerns 
arising from the manufacture, storage, and transport of each eligible prescription drug, including 
concerns related to controlling contamination, preserving sterility, and ensuring stability. 
 
  2  Contains Nonbinding Recommendations 
 
Q3.  Does the final rule provide for importation of drugs from countries other 
than Canada? 
 
The final rule only relates to importation from Canada because it will implement the statutory 
authority under section 804(b) of the FD&C Act, and section 804(b) is limited to importation of 
prescription drugs from Canada. 
 
Q4.  How can SIPs obtain eligible prescription drugs? 
 
In an authorized SIP, a Foreign Seller in Canada will purchase an eligible prescription drug 
directly from the drugs manufacturer and the Importer in the United States will buy the drug 
directly from the Foreign Seller.  Each drugs supply chain under a SIP must be limited to three 
entities, i.e., one manufacturer, one Foreign Seller, and one Importer. 
 
The final rule requires that the Foreign Seller be licensed to wholesale drugs by Health Canada 
and registered with FDA as a Foreign Seller.  The Foreign Seller cannot have an international 
pharmacy license that allows it to distribute drugs that are approved by countries other than 
Canada and that are not HPFB-approved for distribution in Canada.  
 
The final rule also includes a number of supply chain requirements for Foreign Sellers.  FDA 
retains the authority not to authorize a SIP or to discontinue a SIP, if a Foreign Seller does not 
meet all the relevant requirements. 
 
Q5.  Can a SIP Proposal be submitted without identification of a Foreign Seller?   
 
Yes, FDA may use a phased review process to review a SIP Proposal that does not identify a 
Foreign Seller in an initial submission but the SIP cannot be authorized by FDA without an 
identified Foreign Seller.  Under section 251.4 of the final rule, there is the possibility that a SIP 
Proposal would not be authorized if a Foreign Seller is not identified within 6 months of the 
initial submission date of the SIP Proposal. 
 
Q6.  What are the importation requirements under the final rule? 
 
After FDA has authorized a SIP Proposal, the Importer must submit a Pre-Import Request to 
FDA at least 30 calendar days before the scheduled date of arrival or entry for consumption of a 
shipment containing an eligible prescription drug covered by the SIP, whichever is earlier.  
Importation of drugs under this program cannot occur until the Importer receives formal 
notification from FDA that its Pre-Import Request has been granted.  Entry and arrival of a 
shipment containing an eligible prescription drug is limited under the final rule to the U.S. 
Customs and Border Protection (CBP) port of entry authorized by FDA.  The Importer or its 
authorized customs broker is required to electronically file an entry for consumption in the 
Automated Commercial Environment or other electronic data interchange system authorized by 
CBP for each eligible prescription drug imported or offered for import into the United States.  
These entries must be filed as formal entries.  If a drug that is imported or offered for import 
does not comply with the final rule, the drug may be subject to refusal under the FD&C Act. 
 
  3  Contains Nonbinding Recommendations 
 
Q7.  How are eligible prescription drugs tested? 
 
Section 804 of the FD&C Act and the final rule contain a number of provisions that work 
together to help ensure the quality of products imported under this rule.  Among other things, in 
accordance with section 804 of the FD&C Act, the final rule requires the manufacturer or the 
Importer to conduct testing of eligible prescription drugs for authenticity, for degradation, and to 
ensure that the eligible prescription drugs are in compliance with established specifications and 
standards (Statutory Testing).  The final rule provides that unless the manufacturer conducts the 
required testing, the Importer must submit a Statutory Testing plan that includes a description of 
how samples will be selected, the name and location of the qualifying laboratory in the United 
States that will conduct the Statutory Testing, and a description of the testing method or methods 
that will be used to conduct the Statutory Testing.  The final rule requires that the manufacturer 
provide the Importer with, among other things, protocols to support the required testing, 
including a validated stability-indicating assay so the drug can be tested for degradation.  The 
results of this testing will be subject to review and acceptance by FDA. 
 
Q8.  What are the labeling requirements for eligible prescription drugs? 
 
Eligible prescription drugs must be relabeled with the required U.S. labeling, including patient 
labeling such as Medication Guides, Instruction for Use documents, and patient package inserts.  
However, as described in the final rule, the Importers National Drug Code (NDC) for the 
eligible prescription drug must replace any other NDC otherwise appearing on the label of the 
FDA-approved drug and the labeling must include, among other things, the lot number assigned 
by the manufacturer, the name and place of business of the Importer, and the statement: [This 
drug was/These drugs were] imported from Canada without the authorization of [Name of 
Applicant] under the [Name of SIP Sponsor] Section 804 Importation Program.   
 
Q9.  What needs to be done after importation of eligible prescription drugs? 
 
Consistent with the FD&C Act, the final rule includes post-importation requirements.  Each SIP 
Sponsor is required to provide FDA with data and information about its SIP, including the SIPs 
cost savings to the American consumer.  An Importer is required to submit adverse event, field 
alert, and other reports to a drugs manufacturer and to FDA.  If FDA or any participant in a SIP 
determines that a recall is warranted, the SIP Sponsor is responsible for effectuating the recall.  
The final rule requires that each SIP proposal contain a written recall plan that describes the 
procedures to perform a recall of the product and specifies who will be responsible for 
performing those procedures.  SIP Sponsors and other SIP participants must also agree to submit 
to audits of their books and records and inspections of their facilities as a condition of 
participation in a SIP. 
 
Q10.  Can eligible prescription drugs imported under a SIP be returned? 
 
Yes, however, the SIP Sponsor must ensure that a product that is returned after distribution in the 
United States is properly dispositioned in the United States in accordance with SIPs return plan 
as required in the final rule, if it is a non-saleable return, in order to protect patients from expired 
or unsafe drugs.  The SIP Sponsor must prevent returned eligible prescription drugs from being 
  4  Contains Nonbinding Recommendations 
 
exported from the United States.  In certain circumstances, a saleable, returned eligible 
prescription drug may be re-distributed in the United States in accordance with the requirements 
in the final rule. 
 
Q11.  For how long are SIPs authorized?  Can a SIPs authorization be extended? 
 
A SIP may be authorized for up to 2 years from the date of importation of its first shipment.  
FDA may extend the authorization period for up to 2 years at a time. 
 
Q12.  Can a Sponsor make changes to its SIP? 
 
Yes, a SIP Sponsor may propose to modify an authorized SIP.  In reviewing a proposal to 
modify a SIP, among other things, FDA may take into account information learned subsequent to 
authorization of the SIP.  A Sponsor must not make or permit any changes to a SIP without 
FDAs authorization. 
  5