Pharmacy Compounding Addressed in New Article

October 15, 2007

A recent article on drugtopics.com sheds additional light on an issue of long-standing concern among respiratory therapists: the pharmacy compounding of drugs already available in Food and Drug Administration (FDA)-approved products.

Quoting FDA official Steven Silverman, the author notes the agency is not against the compounding of drugs per se, but believes it is “manifestly inappropriate and a disservice to the pharmacy profession . . . to engage in drug manufacturing and call it compounding.”

Silverman further explained that problems arise when pharmacies compound drugs that are either an exact copy of an FDA-approved drug that is readily available, or when the pharmacy product is a “very close copy” of such a drug and the differences aren’t related to specific patient needs.

The article goes on to note that the FDA hopes to issue the long-awaited revision of its Compliance Policy Guide on compounding soon.

As a member of the Consumer Health Alliance for Safe Medication (CHASM), a coalition of patient and health professional organizations, the AARC supported a Citizen’s Petition circulated in the Spring of 2005 to stop the pharmacy compounding of FDA-approved respiratory medications.

These efforts were rewarded in the Summer of 2006, when the FDA issued warning letters to three national pharmacies asking them to cease the practice, and we learned Medicare would begin using special payment codes for pharmacy compounded respiratory medications that would significantly lower reimbursement for these medications when compared to FDA-approved versions.