COMPOUNDING BILL WOULD PREVENT ILLEGAL MASS MANUFACTURING, CONSUMER GROUP SAYS

The draft "Safe Drug Compounding Act of 2007" would stop illegal mass manufacturing of drugs while allowing patients access to legally compounded medications, the Consumer Health Alliance for Safe Medications (CHASM) said.

In a letter to the bill's authors, Sens. Edward Kennedy (D-Mass.), Richard Burr (R-N.C.) and Pat Roberts (R-Kan.), CHASM noted an increase in the mass manufacturing of inhalation medications over the past decade. These products put patients at risk because companies do not disclose safety and efficacy information, CHASM said.

The bill would require all pharmacies to reveal facts about their compounded medications to help patients and healthcare professionals make informed decisions, the group said. CHASM is a group of patients and healthcare professionals convened by the Allergy & Asthma Network Mothers of Asthmatics.

Compounding allows pharmacists to manufacture prescription drugs from bulk ingredients when a patient cannot take an FDA-approved medication for medical reasons, such as an allergy to an inactive ingredient in the commercially manufactured drug. Currently, the law does not distinguish between mass manufacturing and legitimate compounding, CHASM said.

Critics of the bill say it would make it more difficult for patients to receive necessary compounded prescription medications by adding new requirements for prescribers and pharmacists. Organizations representing more than 60,000 pharmacists recently sent their own letter to the bill's authors, discouraging them from introducing it.

( http://www.fdanews.com/did/6_56/ )