Obtaining drugs from foreign markets

Guidelines are presented for pharmacist coordination of the importation for use by institutionalized patients of drugs not currently approved by the FDA. A prerequisite for importation of foreign drugs is that traditional therapies have failed or are not an option. Steps that are required for drug i...

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Bibliographic Details
Published inAmerican journal of hospital pharmacy Vol. 49; no. 11; p. 2731
Main Authors Shirk, M B, Hale, K N
Format Journal Article
LanguageEnglish
Published United States 01.11.1992
Subjects
Documentation
Drug Approval - legislation & jurisprudence
Drug Industry
Drugs, Investigational
Forms and Records Control
Humans
International Cooperation
Pharmacists
Physicians
Transportation
United States
United States Food and Drug Administration
United States
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Summary:Guidelines are presented for pharmacist coordination of the importation for use by institutionalized patients of drugs not currently approved by the FDA. A prerequisite for importation of foreign drugs is that traditional therapies have failed or are not an option. Steps that are required for drug importation and administration include completing an investigational new-drug application, obtaining institutional review board approval, obtaining informed consent, contacting a customs broker or the local FDA district import program manager, arranging for drug shipment, and documenting receipt and administration of the drug. Conditions are described under which portions of this process may be waived. By helping to ensure compliance with FDA requirements, pharmacists can expedite drug importation for institutionalized patients.
ISSN:0002-9289
DOI:10.1093/ajhp/49.11.2731