21 CFR 312.110 -- Import and export requirements.

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(1) An IND is in effect for the drug under § 312.40, the drug complies with the laws of the country to which it is being exported, and each person who receives the drug is an investigator in a study submitted to and allowed to proceed under the IND; or

(2) The drug has valid marketing authorization in Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa, or in any country in the European Union or the European Economic Area, and complies with the laws of the country to which it is being exported, section 802(b)(1)(A), (f), and (g) of the act, and § 1.101 of this chapter; or

(3) The drug is being exported to Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa, or to any country in the European Union or the European Economic Area, and complies with the laws of the country to which it is being exported, the applicable provisions of section 802(c), (f), and (g) of the act, and § 1.101 of this chapter. Drugs exported under this paragraph that are not the subject of an IND are exempt from the label requirement in § 312.6(a); or

(4) Except as provided in paragraph (b)(5) of this section, the person exporting the drug sends an certification to the Office of Global Policy and Strategy at , or a written certification to the Office of Global Policy and Strategy (HFG-1), Food and Drug Administration, New Hampshire Ave., Bldg. 31, Rm. , Silver Spring, MD , at the time the drug is first exported and maintains records documenting compliance with this paragraph (b)(4). The certification shall describe the drug that is to be exported (i.e., trade name (if any), generic name, and dosage form), identify the country or countries to which the drug is to be exported, and affirm that:

(i) The drug is intended for export;

(ii) The drug is intended for investigational use in a foreign country;

(iii) The drug meets the foreign purchaser's or consignee's specifications;

(iv) The drug is not in conflict with the importing country's laws;

(v) The outer shipping package is labeled to show that the package is intended for export from the United States;

(vi) The drug is not sold or offered for sale in the United States;

(vii) The clinical investigation will be conducted in accordance with § 312.120;

(viii) The drug is manufactured, processed, packaged, and held in substantial conformity with current good manufacturing practices;

(ix) The drug is not adulterated within the meaning of section 501(a)(1), (a)(2)(A), (a)(3), (c), or (d) of the act;

(x) The drug does not present an imminent hazard to public health, either in the United States, if the drug were to be reimported, or in the foreign country; and

(xi) The drug is labeled in accordance with the foreign country's laws.

(5) In the event of a national emergency in a foreign country, where the national emergency necessitates exportation of an investigational new drug, the requirements in paragraph (b)(4) of this section apply as follows:

(i) Situations where the investigational new drug is to be stockpiled in anticipation of a national emergency. There may be instances where exportation of an investigational new drug is needed so that the drug may be stockpiled and made available for use by the importing country if and when a national emergency arises. In such cases:

(A) A person may export an investigational new drug under paragraph (b)(4) of this section without making an affirmation with respect to any one or more of paragraphs (b)(4)(i), (b)(4)(iv), (b)(4)(vi), (b)(4)(vii), (b)(4)(viii), and/or (b)(4)(ix) of this section, provided that he or she:

(1) Provides a written statement explaining why compliance with each such paragraph is not feasible or is contrary to the best interests of the individuals who may receive the investigational new drug;

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(2) Provides a written statement from an authorized official of the importing country's government. The statement must attest that the official agrees with the exporter's statement made under paragraph (b)(5)(i)(A)(1) of this section; explain that the drug is to be stockpiled solely for use of the importing country in a national emergency; and describe the potential national emergency that warrants exportation of the investigational new drug under this provision; and

(3) Provides a written statement showing that the Secretary of Health and Human Services (the Secretary), or his or her designee, agrees with the findings of the authorized official of the importing country's government. Persons who wish to obtain a written statement from the Secretary should direct their requests to Secretary's Operations Center, Office of Emergency Operations and Security Programs, Office of Public Health Emergency Preparedness, Office of the Secretary, Department of Health and Human Services, 200 Independence Ave. SW., Washington, DC . Requests may be also be sent by FAX: 202-619- or by : .

(B) Exportation may not proceed until FDA has authorized exportation of the investigational new drug. FDA may deny authorization if the statements provided under paragraphs (b)(5)(i)(A)(1) or (b)(5)(i)(A)(2) of this section are inadequate or if exportation is contrary to public health.

(ii) Situations where the investigational new drug is to be used for a sudden and immediate national emergency. There may be instances where exportation of an investigational new drug is needed so that the drug may be used in a sudden and immediate national emergency that has developed or is developing. In such cases:

(A) A person may export an investigational new drug under paragraph (b)(4) of this section without making an affirmation with respect to any one or more of paragraphs (b)(4)(i), (b)(4)(iv), (b)(4)(v), (b)(4)(vi), (b)(4)(vii), (b)(4)(viii), (b)(4)(ix), and/or (b)(4)(xi), provided that he or she:

(1) Provides a written statement explaining why compliance with each such paragraph is not feasible or is contrary to the best interests of the individuals who are expected to receive the investigational new drug and

(2) Provides sufficient information from an authorized official of the importing country's government to enable the Secretary, or his or her designee, to decide whether a national emergency has developed or is developing in the importing country, whether the investigational new drug will be used solely for that national emergency, and whether prompt exportation of the investigational new drug is necessary. Persons who wish to obtain a determination from the Secretary should direct their requests to Secretary's Operations Center, Office of Emergency Operations and Security Programs, Office of Public Health Emergency Preparedness, Office of the Secretary, Department of Health and Human Services, 200 Independence Ave. SW., Washington, DC . Requests may be also be sent by FAX: 202-619- or by : .

(B) Exportation may proceed without prior FDA authorization.

FDA 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 Exports

Importation 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 to begin the conversation.

States and tribes may submit a SIP proposal for agency review or ask questions about an existing proposal by to .

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 insulin

Personal 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

  with questions about human drug importation.

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