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 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.
Shirk
M B
MB
Department of Pharmacy, Ohio State University Hospitals, Columbus 43210.
Hale
K N
KN
D004282:Documentation; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004345:Drug Industry; D015507:Drugs, Investigational; D005568:Forms and Records Control; D006801:Humans; D007391:International Cooperation; D010595:Pharmacists; D010820:Physicians; D014186:Transportation; D014481:United States; D014486:United States Food and Drug Administration
D015507:Drugs, Investigational