 | The 131st Annual Meeting (November 15-19, 2003) of APHA |
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| The 131st Annual Meeting (November 15-19, 2003) of APHA |
Sarah Sellers, PharmD, Department of Health Policy and Management, Bloomberg School of Public Health, 121 Rose Terrace, Barrington, IL 60010, 847-526-2248, ssellers@jhsph.edu
The Food Drug and Cosmetic Act sets forth strict regulations to ensure the safety and efficacy of US pharmaceuticals. Currently, pharmacists can by-pass the drug approval process and ignore manufacturing regulations for dosage forms made by scratch from raw chemical ingredients. This growing practice niche, referred to as pharmacy compounding, has resulted in an emerging substandard drug industry with important public health implications. Exposure to substandard drugs is responsible for significant morbidity and mortality worldwide. In the US, tip of the iceberg cases of injury associated with compounded drugs have included cases of meningitis, toxicity from overdoses and deaths from life-threatening infections. Laws that would provide deterrence to the substandard drug trade in the US have not been implemented. The Prescription Drug Marketing Act’s pedigree requirements would ensure a chain of custody for bulk chemicals used in pharmacy compounding, but to date these regulations have not been implemented. Federal regulations for compounding have been severed from the FDA Modernization Act as a result of a recent Supreme Court ruling, leaving primary enforcement discretion with states. Finally, the Bioterrorism Preparedness Act provides resources for ensuring food safety but eliminated important drug security measures that were contained in early drafts of the bill. The climate for substandard drug manufacturing is expected to persist and grow. Clear legal mandates, effective sanctions, inter-agency and industry cooperation are essential components for combating pharmacy compounding abuses and the associated threats to public health.
Learning Objectives:
Keywords: Drug Safety, Public Health Policy
Presenting author's disclosure statement:
I do not have any significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.