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10/16/2002

Compounding Problems Uncovered by FDA

Kate Traynor

The Food and Drug Administration (FDA) recently published on its Web site details of a study suggesting that many preparations compounded at specialty pharmacies contain less of the active ingredient than is required of similar products manufactured by pharmaceutical companies.

According to the online report, nine of the 29 formulations tested by FDA personnel had less of the active drug than is specified by United States Pharmacopoeia (USP) standards. Five of the compounded materials had 70 percent or less of the required ingredient.

One injectable preparation, alprostadil, had the correct amount of the drug but an unacceptably high level of endotoxins.

Drugs examined during the study were obtained from 12 pharmacies that were chosen because they accepted orders through the Internet. The research team selected for analysis 13 injectable formulations, nine ophthalmic preparations, four oral formulations, and one inhaled drug, tobramycin.

Injectable preparations of four drugs—betamethasone, hyaluronidase, papavarine, and progesterone—were of less-than-acceptable strength. Also failing to meet minimum concentration requirements were ophthalmic preparations of ciprofloxacin, dexamethasone, and timolol maleate; an oral formulation of progesterone; and the inhalational tobramaycin preparation.

The report noted that the so-called failure rate for the compounded preparations examined during the study exceeded the 1–2 percent failure rate associated with manufactured drug products. According to the report, pharmacies fill more than 13 million prescriptions for compounded preparations each year.