Tuesday, September 5, 2006
Well, it’s about time the FDA took a hard look at the compounding of drugs at some pharmacies. Until now, the FDA sort of looked the other way at pharmacists who custom-blended drugs from bulk ingredients. Particularly popular have been custom hormone replacement therapies or drugs that remove an ingredient that may be an allergen.
Wyeth has been wanting the FDA to step up to the plate with tighter regulations. Of course, Wyeth has a drug that competes with some of these special blends of hormones. On the other side, pharmacists in Texas have argued that the FDA shouldn’t treat custom blends as unapproved new drugs, even if the pharmacists have been touting their blends as safer than the approved drugs.
If they want to make those kinds of claims about the safety of the drugs they are blending, then they better think about conducting some expensive clinical trials to prove it.