On April 4, 2016, the Food and Drug Administration (FDA) implemented its administrative destruction authority aimed at certain imported drugs valued at $2,500 or less (or such higher amount as the Secretary of the Treasure may set by regulation) that have been refused admission into the United States.
In 2012, Congress amended section 801(a) of the Federal Food Drug & Cosmetic Act (FD&C Act; 21 U.S.C. 381(a)) to provide the FDA with the authority to destroy a refused drug valued at $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation) without providing the owner or consignee with the opportunity to export the drug. Congress directed the FDA to issue regulations that provide the drug’s owner or consignee with notice and an opportunity to present testimony to the Agency prior to the drug’s destruction (section 708 of the Food and Drug Administration Safety and Innovation Act (FDASIA).
Most drug products subject to the FDA’s administrative destruction authority come into the United States through the international mail. These mail parcels may include drugs that are adulterated, misbranded, or unapproved, and may also contain counterfeit drugs and tainted drug products that purport to be dietary supplements. All of these violative drugs can pose a serious public health threat to consumers in the United States.
The authority granted by FDASIA Section 708 is intended to protect the integrity of the United States drug supply chain and the public by preventing distribution or use of drugs that are believed to be adulterated, misbranded or unapproved, and therefore, pose a threat to consumer’s health.
Administrative destruction authority has been implemented at all nine international mail facilities (IMFs) located in Florida, Hawaii, Illinois, New Jersey, New York, Puerto Rico, U.S. Virgin Islands and two in California.
FDA has created a list of frequently asked questions related to administrative destruction that you may find useful.
- What products will administrative destruction apply to?
- Will this authority impact the availability of FDA-approved drugs?
- How does the FDA determine if my drug product is in violation of the FDA's laws and regulations?
- How will I be notified if my drug product violates the FDA's laws and regulations and is subject to administrative destruction?
- How should I respond to a Notice of FDA Action?
- What happens after I respond to the initial Notice of FDA Action?
- Will I be charged for storage and destruction costs if my imported drugs are detained and destroyed?
- What is the Personal Importation Policy? Can you explain what this means in light of administrative destruction?
- What is an International Mail Facility?
Administrative destruction applies to imported drugs valued at $2500 or less (or such higher amount as the Secretary of the Treasure may set by regulation) which are refused admission into the United States.
This authority will not impact the availability of FDA-approved drugs or drug products legally marketed in the United States.
The FDA uses a number of ways to determine if a drug violates the law and is subject to refusal and destruction. For example, if a drug’s labeling is not in English, this may indicate that the drug has not been approved by the FDA for use in this country. The lack of an English language label may also indicate that the drug is misbranded. The FDA's import personnel may also collect samples of products for laboratory analysis. If a product were to test positive for an active pharmaceutical ingredient (API) that should not be in the product, it would be considered adulterated. The FDA also is able to test drugs that are suspected of being counterfeit.
How will I be notified if my drug product violates the FDA's laws and regulations and is subject to administrative destruction?
If the FDA determines that your drug is subject to this rule and it violates the law, the FDA will provide you with a Notice of FDA Action (also known as a notice of detention) explaining (1) the reason(s) why the agency has determined that the drug is subject to refusal, (2) if refused admission, the fact that the product would be subject to destruction, and (3) your opportunity to appear and introduce testimony to the agency prior to refusal or destruction. You will be provided a contact name and means of making a response.
You may provide testimony to the agency stating why the product should not be refused or destroyed. Responses to Notices of FDA Actions can vary and include telephone conversations or more formal communications, during which you may introduce testimony for consideration by the agency. The FDA will consider the testimony you present and make a final decision on the admissibility.
Testimony is any information you wish to submit to overcome the appearance of the violation, or to otherwise support the release of your product. Testimony should be provided to the contact that is listed on the Notice of FDA Action, usually a compliance officer. Testimony can be provided in different ways, including email, telephone, fax, hard copy, etc.
After your imported drugs have been detained by the FDA at an international mail facility and you have been given the opportunity to respond and present evidence, the FDA will issue another Notice of FDA Action.
If after reviewing all of the evidence, the FDA determines that your products are in violation of the FDA's laws and regulations, they will be refused admission. The FDA will issue a Notice of FDA Action indicating the products have been refused (known as a notice of refusal). The notice of refusal will indicate to you in writing the reason(s) why your drug has been refused and is subject to administrative destruction. The notice of refusal will also indicate whether the drug will be destroyed or returned to sender. At this point, no further action will be required on your part.
If after reviewing all of the evidence, the FDA determines that your products are not in violation of the FDA's laws and regulations, they will be forwarded to you. The FDA will issue a Notice of FDA Action indicating the products have been released.
Will I be charged for storage and destruction costs if my imported drugs are detained and destroyed?
FDASIA section 708 provides that the owner or consignee is responsible for the costs of storage and disposal of the drug. At this time, the FDA generally does not intend to pursue recovery of storage and destruction costs against individual consumers who seek to import a drug for their own personal use that is then refused and destroyed.
Drugs with a value greater than $2500 are generally not to be processed through an international mail facility because they are considered by U.S. Customs and Border Protection (CBP) to be formal entries and are subject to different entry procedures, which include payment of a bond.
What is the Personal Importation Policy? Can you explain what this means in light of administrative destruction?
The FDA’s mission is to ensure that drugs are safe and effective. In carrying out this responsibility, the FDA also works to make drugs accessible and help doctors and patients use them as effectively as possible. The agency works to do this by approving safe, effective, and high-quality prescription and generic drugs. Any version of a drug that has not been approved by the FDA is considered an “unapproved drug,” and it is illegal for consumers to import unapproved drugs into the U.S. Drugs from foreign sources that are not FDA-approved do not have the same assurance of safety, effectiveness, and quality as drugs subject to FDA oversight. In many cases, such drugs have been found to be contaminated, counterfeit, contain varying amounts of active ingredients or none at all, or contain different ingredients altogether.
However, the FDA does have a policy regarding an individual’s importation of an unapproved drug for personal use, also known as the Personal Importation Policy (PIP). Under PIP, a patient interested in importing an unapproved drug for personal use must satisfy the following elements:
- The drug is for use for a serious condition for which effective treatment is not available in the U.S.;
- There is no commercialization or promotion of the drug to U.S. residents;
- The drug is considered not to represent an unreasonable risk;
- The individual importing the drug verifies in writing that it is for his or her own use, and provides contact information for the doctor providing treatment or shows the product is for the continuation of treatment begun in a foreign country; and
- Generally, not more than a three-month supply of the drug is imported.
The FDA’s administrative destruction authority does not change the FDA’s current policy with respect to personal importation of drugs.
To learn more about personal importation, please visit the following pages:
- Personal Importation
- FDA’s Regulatory Procedures Manual, Chapter 9-2, Coverage of Personal Importations
Mail entering the United States from abroad first arrives at a U.S. Postal Service sorting facility. The Postal Service then sends packages to U.S. Customs and Border Protection (CBP) for examination. CBP will refer FDA-regulated products for review.
Additional Information regarding the FDA’s administrative destruction authority can be found at:
- The Final Rule for FDASIA Section 708, Administrative Destruction of Certain Drugs Refused Admission to the United States