NCPA - National Center for Policy Analysis


March 28, 2005

To meet the needs of patients who can't get what they need from brand-name or generic drug companies, some pharmacies mix together drugs from bulk-purchased ingredients. But the lack of quality and safety rules of such pharmacies can result in potential dangers to patients, says USA Today.

"Compounding" pharmacies range from small, independently-owned drugstores to pharmacies owned by large, home-care companies. They provide products such as flavored syrups for patients who can't take pills or dye-free products for patients allergic to food coloring.

However, they also pose risks to patients, says USA Today:

  • In Kansas City, Mo., a pharmacy notified 19,000 patients nationwide of a recall of its respiratory drugs, which were found by state regulators to be contaminated with bacteria.
  • Drugmaker AstraZeneca analyzed pharmacy-produced copies of a respiratory drug sold by the company, and found that four out of five samples produced in compounding pharmacies failed potency tests.
  • In a Puerto Rican pharmacy, the Food and Drug Administration (FDA) found that the amounts in vials of respiratory drugs didn't match the label descriptions.
  • The FDA reports that since 1990, about 200 adverse events, including three deaths, have resulted from compounded drugs.

Unlike FDA-regulated drug companies, compounding pharmacies are state-regulated and are not held to the same standards. Furthermore, claims USA Today, many of them mass-produce products that are contaminated, too strong, or ineffective. Compounding pharmacies argue that they are not doing anything wrong as long as they have legitimate prescriptions from doctors, regardless of how many doses they produce of a certain drug.

However, several states are tightening controls over compounding pharmacies, but some patient advocates are pushing for FDA oversight.

Source: Julie Appleby, "Safety Concerns Grow Over Pharmacy-mixed Drugs," USA Today, March 24, 2005.

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