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MAIL ORDER PHARMACY REGULATION UNDER FDA GMP RULES

Executive Summary

MAIL ORDER PHARMACY REGULATION UNDER FDA GMP RULES is inappropriate, the American Managed Care Pharmacy Association asserted in July 24 comments to the agency. Production control requirements and ingredient quality specifications in the good manufacturing practices (GMP) regs "are largely or completely irrelevant" to pharmacies, the association stated. Formerly the National Association of Mail-Service Pharmacies, AMCPA argued that pharmacy practice is properly regulated by state pharmacy boards, not the federal agency. The association was responding to a citizen petition that was submitted by Washington newsletter publisher Ferdic Inc. that asked FDA to regulate mail order pharmacies under its GMP regs ("The Pink Sheet" Nov. 14, T&G-8). The petition contends that state pharmacy boards cannot adequately regulate mail service facilities because they engage in interstate commerce. AMCPA also maintained that "there are no health, safety, or other demonstrated grounds that would justify FDA applying GMP regulations to retail pharmacies generally or to retail pharmacies dispensing prescription drugs by mail in particular." Without evidence of dispensing hazards, "it will be difficult for the FDA to demonstrate significant benefits from" the regulatory action proposed by the petition, the association said. On the contrary, "imposition of GMP regulations on retail pharmacies would result in substantial and easily quantifiable burdens on the agency and on . . . mail service pharmacies." The American Association of Retired Persons seconded AMCPA's arguments in Aug. 1 comments to FDA. AARP provides mail order pharmacy service to members through its Retired Persons Services subsidiary. AARP noted that all its mail order facilities also "offer walk-in, community pharmacy service" and that an additional two of its pharmacies provide walk-in but not mail order service. AARP helped found the National Association of Mail-Service Pharmacies; however, it no longer is a member of the AMCPA, whose members market their services not directly to individuals but to managed care and insurance plans providing prescription drug benefits.
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