Important note: Information in this article was accurate in 1992. The state of the art may have changed since the publication date.
Food and Drug Administration, U.S. Department of Health and Human Services - January 30, 1992
Brad Stone -- (301)443-3285
Many of these drugs are illegally advertised in periodicals and through direct mail, as foreign versions of approved prescription drugs. The promotion and distribution of unapproved drug products within the United States is illegal.
"In some cases, the drugs are counterfeit -- lacking any real similarity to the approved drug. The uncertain character and quality of these drugs constitute an unreasonable risk to the public health," FDA Commissioner David A. Kessler, M.D., said.
The import alert instructs FDA field offices to automatically detain all imported unapproved prescription products manufactured by six overseas companies which have promoted their products in this country. The companies cited are Interpharm, Inc., of Nassau, Bahamas; Northam Medication Service International Pharmacy of Nassau, Bahamas; Inhome Services of Delemont, Switzerland; International Products of Hannover, Germany; Azteca Trio Internacional, S.A. de C.V., of Zona Rio Tijuana, Mexico; and Interlab of London, England.
These companies have been promoting a wide variety of products purported to treat various conditions, including depression, high blood pressure, fungal infections, fatigue, chronic bronchitis and hair loss.
Many of the ads for these unapproved drugs claim that people can save money on the costs of prescription drugs, but in reality the drugs may pose a risk to the patient's health. Dr. Kessler said so-called "foreign versions" of prescription drugs are often of unknown quality with inadequate directions for use.
For many years FDA has permitted -- and will continue to permit -- its field offices to exercise discretion regarding the release for entry into the United States of small "personal-use" quantities of drugs sold abroad but not approved in the United States -- provided that the drugs do not pose unreasonable safety risks, that their use is not promoted in the United States and that they are for a serious condition for which there is no satisfactory treatment available in this country. The policy was designed to give FDA field offices discretion to release small quantities of medicines with which individuals returning to the United States may have been treated while traveling abroad and to allow individuals with serious conditions the ability to import, under certain limited conditions, personal-use quantities of unapproved drugs that they believe might be helpful in treating their conditions.
Personal-use quantities are generally considered to be amounts for a patient's treatment for three months or less. Imports involving larger quantities are not permitted as they lend themselves to commercialization.
FDA approves drugs on the basis of scientific data proving them to be safe and effective. FDA-approved labeling provides information on how and when the drugs can be used to maximize their effectiveness and minimize their harmful side effects. The manufacturing facilities and procedures for approved products are also carefully regulated by FDA to ensure product integrity.
The unapproved drugs promoted by these overseas operations lack these safeguards and quality assurance standards.
Consumers should also be aware that the acquisition and use of prescription drugs without the valid prescription of a physician or other licensed health professional may violate state or local laws. FDA warns that severe adverse reactions, including death, can result from the improper use of prescription drugs.
Persons with questions about importation of drugs for personal use should consult with their local FDA district office or the FDA Imports Operations Branch in Rockville, Md., at (301) 443-6553.
The Food and Drug Administration is one of the eight Public Health Service agencies within HHS.
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SOURCE: Food and Drug Administration (FDA).
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