Text Of FDA Import Bulletin

U.S. Food & Drug Administration Bulletin For Guidance In Handling Personal Importation Of Personal (90 day supply) Of Drugs [Pertinent portions only, emphasis supplied]

Imported Drugs

Persons wishing to ship a drug to the United States, and persons in the United States wishing to import the same must bear in mind that the article may be detained and refused admission if it does not comply with the applicable drug provisions of the Federal Food, Drug, and Cosmetic Act. A drug which has been used outside the United States, and which may be regarded as safe and effective by experts in other countries, but which has not been marketed in this country, is likely to be regarded as a new drug under the Federal Food, Drug, and Cosmetic Act. A new drug will be admitted only if the Food and Drug Administration has approved a New Drug Application for it. However, exceptions to this rule include drug importation for personal use only if specific conditions are met.

Coverage Of Personal Importations

GENERAL GUIDANCE

The statements in this chapter are intended only to provide operating guidance for FDA personnel and are not intended to create or confer any rights, privileges, or benefits on or for any private person.

FDA personnel may use their discretion to allow entry of shipments of violative FDA regulated products when the quantity and purpose are clearly for personal use, and the product does not present an unreasonable risk to the user. Even though all products that appear to be in violation of statutes administered by FDA are subject to refusal, FDA personnel may use their discretion to examine the background, risk, and purpose of the product before making a final decision. Although FDA may use discretion to allow admission of certain violative items, this should not be interpreted as a license to individuals to bring in such shipments.

PURPOSE

To provide guidance for the coverage of personal-use quantities of FDA-regulated imported products in baggage and mail and to gain the greatest degree of public protection with allocated resources.

BACKGROUND

Because the amount of merchandise imported into the United States in personal shipments is normally small, both in size and value comprehensive coverage of these imports is normally not justified. This guidance clarifies how FDA may best protect consumers with a reasonable expenditure of resources.

Commercial or Promotional Shipments

Commercial and promotional shipments are not subject to this guidance. Whether or not a shipment is commercial or promotional may be determined by a number of factors including, for example, the type of product, accompanying literature, size, value, and/or destination of the shipment. FDA personnel may also consider whether an importation of drugs or medical devices is a commercial shipment by evaluating whether the article appears to have been purchased for personal use or whether the quantity suggests commercial distribution (i.e., the supply exceeds what one person might take in approximately three months). Commercial shipments generally include shipments other than those products that are personally carried, shipped by a personal non-commercial representative of a consignee, or shipped from a foreign medical facility where a person has undergone treatment.

Drugs, Biologics, and Devices

When personal shipments of drugs and devices that appear violative are brought to FDA's attention by Customs, FDA personnel will use their discretion to decide on a case by case basis whether to detain, refuse, or allow entry of the product. Generally, drugs and devices subject to Import Alerts are not amenable to this guidance. Devices to be used by practitioners for treating patients should not be viewed as personal importations subject to this chapter. Drugs subject to Drug Enforcement Agency (DEA) jurisdiction should be returned to Customs for handling. 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 a significant health risk; or,
• when
  

  a) 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;

  b) 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;

  c) the product is considered not to represent an unreasonable risk; and

  d) 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.