MAIL-ORDER PHARMACY GMP REGULATION BY FDA

Executive Summary

MAIL-ORDER PHARMACY GMP REGULATION BY FDA was urged by Ferdic Inc. in an Oct. 21 citizen petition. Agency field investigators should inspect for compliance with Good Manufacturing Practices "all corporate facilities that dispense, package, and introduce into interstate commerce finished prescription drug products in the form of mail-order prescriptions for individual use pursuant to a" prescription, the company said. Ferdic is a news organization specializing in pharmacy and FDA topics. It's publications include "Dickinson's Pharmacy" and "Dickinson's FDA." The Ferdic petition contends that state pharmacy boards and local authorities, the traditional regulators of mail order pharmacies, "lack adequate financial resources and effective jurisdictional reach to police this interstate business." Furthermore, Ferdic argued, "unless FDA voluntarily and preemptively asserts its statutory federal jurisdiction over the industry, many more deaths from drug mix-ups will occur, some of these deaths will be publicly associated with the drugs involved, and the ensuing controversy may hurt the public esteem and trust that FDA has long enjoyed." Because there are fewer than "20 mail-order pharmacies large enough to warrant routine FDA inspection," the company continued, "the added burden of biennial inspections on agency field resources would be slight."