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        Guidance, Compliance, & Regulatory Information

Human Drug Imports Home
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          Guidance, Compliance, & Regulatory Information
          Human Drug ImportsGuidance, Compliance, & Regulatory Information Human Drug Imports
  	
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    PrintFDA protects public health by promoting supply chain integrity and working to ensure medicines imported to the U.S. comply with applicable legal and regulatory requirements. Imported drugs must meet FDA’s standards for quality, safety and effectiveness. For example, medicines from outside the legitimate U.S. drug supply chain do not have the same assurance of safety, effectiveness and quality as drugs subject to FDA oversight.
FDA reviews shipments of imported drugs to determine whether they are admissible into the U.S. An imported drug may be refused entry if, for example, it appears to be:

**Adulterated** – Federal law requires manufacturers to comply with quality requirements. A drug may be adulterated if, for example, it was not manufactured in compliance with these quality requirements.
	**Misbranded** – Appropriate label information is an important aspect of marketing a drug because it gives patients the information they need to take medications correctly. A drug label must comply with FDA regulations. A drug may be misbranded if, for example, its label is false or misleading, lacks FDA-required information, or otherwise does not follow FDA’s label rules. A drug may also be misbranded if a manufacturer has not complied with FDA requirements to register and list their drugs with the FDA. A drug may also be misbranded if it is a prescription drug offered for sale without a prescription.
	**Unapproved** – With certain exceptions, drugs must be proven to be safe and effective for use before companies can sell them in the U.S. A drug that lacks FDA-approval is considered to be unapproved.FDA examines and analyzes samples of imported drugs to ensure they comply with applicable standards and/or label requirements. See the human drug imports flyer for more information.

Import Information

Regulatory Procedures Manual Chapter 9: Import Operations and Actions
	Investigations Operations Manual Chapter 6: Imports
	Predictive risk-based evaluation for dynamic import compliance targeting (PREDICT)
	Automated commercial environment/international trade data system (ACE/ITDS)
	Import Basics
	Human Drugs
	FD&C Act chapter VIII: Imports and ExportsImportation of Drugs Originally Intended for Foreign Markets

FDA and the Department of Health and Human Services have provided two pathways to allow importation of certain prescription drugs that were originally intended for foreign markets.

One pathway is a final guidance for industry that describes procedures drug manufacturers can follow to facilitate importation of prescription drugs, including biological products, that are FDA-approved, manufactured abroad, authorized for sale in any foreign country, and originally intended for sale in that foreign country. For further information, please see the guidance: Importation of Certain FDA- Approved Human Prescription Drugs, Including Biological Products, and Combination Products under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The other pathway is known as the Section 804 Importation Program (SIP), which includes a final rule to implement section 804 of the FD&C Act.

Consistent with the Executive Order on Promoting Competition in the American Economy, FDA will work with states and tribes that propose to develop importation programs in accordance with section 804 of the FD&C Act and the FDA’s implementing regulation to reduce the cost of covered products to the American consumer without imposing additional risk to public health and safety.

States and tribes interested in working with the agency on a Section 804 Importation Program (SIP) proposal can contact FDA’s Intergovernmental Affairs Staff at IGA@fda.hhs.gov to begin the conversation.

States and tribes may submit a SIP proposal for agency review or ask questions about an existing proposal by email to SIPDrugImportsandRFP@fda.hhs.gov.

Pre-launch Activities Importation Requests (PLAIR)

FDA grants pre-launch activities importation requests (PLAIR) in certain circumstances to allow product sponsors anticipating approval of a drug application to import unapproved finished drug products in preparation for market launch.

FDA published a final guidance, *Pre-Launch Activities Importation Requests (PLAIR)*, which describes FDA’s 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 drug application. The guidance describes FDA’s process for detaining PLAIR shipments to ensure control and tracking of unapproved drugs awaiting an anticipated FDA approval consistent with the FD&C Act. The guidance allows PLAIR submissions earlier than 60 days before the user-fee goal date for applications with a priority review designation. FDA expects the policies in the PLAIR guidance to ensure timely access to safe and effective drugs.

To expedite this process, FDA has made the CDER NexGen Portal available to applicants. The portal lets applicants or their authorized U.S. agent submit a PLAIR request to FDA online. This process ensures real-time communication with receipt confirmation, two-way communication, and a communication history in a centralized location. The portal also uses multi-factor authentication to ensure data security.

Information on importing other specific FDA-regulated products

Heparin importation
	Importing animal-derived insulinPersonal importation policy (PIP)

In most circumstances, it is illegal for individuals to import drugs into the U.S. for personal use because such drugs often have not been approved by FDA . FDA’s personal importation policy provides guidance regarding situations where FDA does not intend to prevent the importation of an unapproved drug for personal use. Please note that FDA’s personal importation policy is not part of the pathways described above for importation of drugs originally intended for foreign markets.

Contact

Email CDERImports@fda.hhs.gov with questions about human drug importation.

                                                                                  Content current as of:
      09/21/2023
                  
                   
Regulated Product(s)
		 DrugsTopic(s)
			  ComplianceHuman Drug Imports
 
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