CSMS Message: 97-000088

THIS IS TO PROVIDE NOTICE THAT, EFFECTIVE 2/1/97, THE FOOD AND DRUG
ADMINISTRATION (FDA) WILL BEGIN DETAINING SHIPMENTS OF UNAPPROVED
FOREIGN MANUFACTURED VERSIONS OF FERTILITY DRUGS.

FDA IS RESPONSIBLE FOR ASSURING THAT DRUGS, BIOLOGICAL PRODUCTS,
DRUGS AND MEDICAL DEVICES ARE SAFE AND EFFECTIVE, AND LABELED IN AN
ACCURATE AND TRUTHFUL MANNER. THE FEDERAL FOOD, DRUG, AND COSMETIC
ACT, WHICH FDA ADMINISTERS, PROHIBITS THE IMPORTATION AND INTERSTATE
SHIPMENT OF DRUGS AND MEDICAL DEVICES THAT HAVE NOT BEEN APPROVED
BY FDA.

SINCE FEBRUARY 1995, FDA HAS EXERCISED ITS ENFORCEMENT DISCRETION TO
ALLOW THE RELEASE OF UNAPPROVED FOREIGN VERSIONS OF FERTILITY DRUGS.
THE AGENCY TOOK THIS ACTION TO ALLEVIATE ASHORTAGE IN THE U.S. OF
TWO APPROVED FERTILITY DRUGS, PERGONAL AND METRODIN.

RECENTLY, THE U.S. SHORTAGE OF FERTILITY DRUGS HAS BEEN RESOLVED
THROUGH ADEQUATE SUPPLIES OF APPROVED PERGONAL AND METRODIN AND THE
AVAILABILITY OF MORE RECENTLY APPROVED FERTILITY DRUGS, HUMEGON AND
FERTINEX. FOR THIS REASON, FDA DISTRICT OFFICES WILL BEGIN TO DETAIN
SHIPMENTS OF UNAPPROVED FOREIGN VERSIONS OF FERTILITY DRUGS.

IF YOU HAVE ANY FURTHER QUESTIONS, PLEASE FEEL FREE TO CONTACT YOUR
FDA OFFICE OR THIS OFFICE.

THOMAS D. GARDINE
DIRECTOR
DIVISION OF IMPORT OPERATIONS AND POLICY
FOOD AND DRUG ADMINISTRATION
(301) 443-6553