PHARMACISTS CRITICIZE DRAFT COMPOUNDING BILL

Organizations representing more than 60,000 pharmacists sent a letter to three senators discouraging them from introducing a bill that would strengthen federal regulations on compounded drugs.

The "Safe Drug Compounding Act of 2007," which has not yet been introduced, would prevent patients from receiving necessary compounded prescription medications and add burdensome new requirements for prescribers and pharmacists, the letter said.

Millions of patients rely on compounded medications as their best and only treatment option, according to the letter sent to Sens. Edward Kennedy (D-Mass.), Richard Burr (R-N.C.) and Pat Roberts (R-Kan.). If passed, the bill would make it much more difficult for patients to fill needed prescriptions, the letter added.

Compounding is a practice where pharmacists manufacture prescription drugs from bulk ingredients and is traditionally done for medical reasons, such as when a patient is allergic to an inactive ingredient in the commercially manufactured drug. State boards of pharmacy regulate compounded pharmaceuticals.

The bill would give the FDA the authority to determine when compounded medications are necessary, taking power away from the states, the letter said. The FDA has a poor record on compounded medications and has failed to revise compliance policy guides despite requests from more than 100 members of Congress to do so, the letter added.