NCPA - National Center for Policy Analysis

Custom Potions No Panacea

March 10, 2004

"Pharmacy compounding," or the practice of mixing drugs to make customized prescription medications from scratch, poses enormous health risks to consumers, say experts.

Some pharmacists are purchasing bulk chemicals overseas and using them to make prescription medications in their drugstore laboratories.

However, some don't follow proper sterilization techniques and/or use impure compounds to mix their medicines. Indeed, they operate in something of a regulatory vacuum:

  • In 2002, the Supreme Court wiped out nearly all federal law directly addressing the practice of compounding.
  • Today, the Food and Drug Administration (FDA) says "virtually all" compounded products are technically illegal; however, the agency is selective in its enforcement.
  • The FDA generally targets only large-scale compounders who are acting more like manufacturers than corner pharmacies.

Experts estimate that compounders fill at least 30 million prescriptions a year or one percent of the three-billion-plus prescriptions dispensed in the United States annually.

States from Arkansas to Wyoming are moving to tighten their rules, and federal regulators are considering new action; California now requires compounding pharmacies to go through an accreditation process or get a special license in order to mix certain complex drugs.

The industry is hoping to stave off a regulatory crackdown by encouraging self-regulation. Industry leaders are assembling an accreditation program for compounders who currently must have only a standard pharmacy degree.

Source: Jane Spencer and Anna Wilde Mathews, "As Druggists Mix Customized Brews, FDA Raises Alarm," Wall Street Journal, February 27, 2004.


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