TABLE 4.

Controversies in compounding

Using drug moieties that were never approved or that have been recalled from market In some cases, compounding pharmacies are used to prepare drugs that were taken off the market or denied market clearance, which could present safety issues to the patients who use them.

Compounding for economic reasons Sometimes a compounding pharmacy will prepare a drug formulation that is identical to a commercially available drug because the compounded formulation is less expensive. This is not considered an acceptable reason, according to FDA compounding regulations, to compound a drug formulation.

Using a compounded formulation when a commercial drug would do The FDA does not allow for the compounding of a drug when the patient can be adequately and appropriately treated by an existing commercial product.12 This does not mean that the exact compounded drug must exist as a commercial product but that a commercial product would reasonably meet the patient’s needs.