U.S. Customs and Border Protection enforces federal laws regarding the importation of prescription medicines and other medical goods. Below are answers to frequently asked questions about enforcement of these laws.
Q: Why has Customs and Border Protection (CBP) interdicted the drugs I purchased?
A: The Federal Food, Drug, and Cosmetic Act (FFDCA) prohibits persons from importing into the United States any prescription drug that has not been approved for sale by the United States Food and Drug Administration (FDA), or which is adulterated or misbranded. Moreover, in those instances where a United States manufacturer makes an FDA-approved prescription drug and sends it abroad, the FFDCA also prohibits any person other than the original manufacturer from importing the drug back into the United States. Thus, in virtually all instances, individual citizens are prohibited from importing prescription drugs into the United States.
Q: What can I do to get my medication back?
A: If the drugs that CBP interdicted are controlled substances, the Election of Proceedings document you received by mail can be completed requesting formal seizure.
If the drugs are non-controlled prescription drugs, such as Generic Viagra, Penicillin, Prozac, Lipitor, CBP will inform consignees who are in violation of this law. Consignees will receive a letter that they have 30 days to either abandon the shipment or request an admissibility review by the FDA. Their options are to: 1) abandon the shipment to CBP and CBP will destroy the package at the government’s expense, 2) the consignee can elect to have CBP send the package to FDA to determine the admissibility of the drug, or 3) if the consignee does not respond to the letter at all in 30 days, CBP will destroy the package. The FDA will make all final decisions on admissibility.
Q: I purchase my drugs from Canadian pharmacies. What evidence does CBP have that these drugs are not safe?
A: During a recent FDA ( FDA News ) enforcement effort, 85 percent of the medications purchased from Canadian pharmacies were actually shipped from countries other than Canada. Similarly, CBP has interdicted significant quantities of prescription drugs, which are exported from countries other than Canada. For more information visit FDA website. ( FDA Public Health Advisory )
Of particular concern, CBP, in cooperation with FDA, recently intercepted products at the border that purported to be “generic” Tamiflu but which, in fact, contained Vitamin C and other ineffective substances. Although the drugs were similar in appearance to genuine Tamiflu, they offer no therapeutic benefit.
The FDA has warned that medicines purchased outside the United States may be unsafe or ineffective for the following reasons:
* Medicines that have not been approved for sale in the United States may not have been manufactured under quality assurance procedures designed to produce a safe and effective product.
* Some imported medicines, even those that bear the name of a U.S.- approved product, may be counterfeit versions that are unsafe or even completely ineffective.
* Some imported medicines and their ingredients, although legal in foreign countries, may not have been evaluated for safety and effectiveness in the United States. These products may be addictive or contain other dangerous substances.
* There are risks of unsupervised use. Some medicines, whether imported or not, are unsafe when taken without adequate medical supervision.
* The medicine’s label, including instructions for use and possible side effects, may be in a language you do not understand and may make medical claims or suggest specific uses that have not been adequately evaluated for safety and effectiveness.
* An imported medicine may lack information that would permit you to be promptly and correctly treated for a dangerous side effect caused by the medicine.
Q: I thought that I could import a three-month supply of drugs. Is this not correct?
A: The FDA ( FDA ) has developed guidance allowing FDA Inspectors to exercise enforcement discretion. In deciding whether to exercise discretion to allow personal shipments of drugs or devices, FDA personnel may consider a more permissive policy in the following situations:
* When the intended use is appropriately identified, such use is not for treatment of a serious condition, and the product is not known to represent significant health risk; or
* When
1. the intended use is unapproved and for a serious condition for which effective treatment may not be available domestically either through commercial or clinical means;
2. there is no known commercialization or promotion to persons residing in the U.S. by those involved in the distribution of the product at issue;
3. the product is considered not to represent an unreasonable risk; and
4. the individual seeking to import the product affirms in writing that it is for the patient’s own use (generally not more than 3 month supply) and provides the name and address of the doctor licensed in the U.S. responsible for his or her treatment with the product, or provides evidence that the product is for the continuation of a treatment begun in a foreign country.
Q: I cannot afford to purchase medication from U.S. pharmacies. What should I do?
A: FDA ( FDA ) advises consumers that they must use great care when purchasing prescription drugs online. Evidence indicates that although a Web site may appear to be hosted by a reputable source and may look similar to other retail pharmacy Web sites, many of these sites in fact operate from outside the United States and are providing unapproved drugs from unreliable sources. The National Association of Boards of Pharmacy (NABP) has established a program called VIPPS designed to certify Web sites that meet industry standards. For more on this program and a list of pharmacies that display the Verified Internet Pharmacy:
U.S. Pharmacy
U.S. Online Pharmacy
USA Online Pharmacy
Consumers should also talk to their doctors about their concerns, ask their pharmacist for generic medication, and shop among different pharmacies for the best buy. For information about Medicare Part D visit the Centers for Medicare and Medicaid Services website. ( Centers for Medicare and Medicaid Services )
