FDA guidelines unsettle compounding pharmacies

A new set of proposed compounding pharmacy guidelines issued by FDA last week has set off a round of concern among compounders.

A new set of proposed compounding pharmacy guidelines issued by FDA last week has set off a round of concern among compounders. FDA maintains the guidelines are "critical to protecting public health," but Scott Karolchyk of QmedRx, a compounder based in Maitland, FL, argues warns "if these [guidelines] go into effect, a lot of pharmacies face onerous restrictions. And limiting good compounding pharmacies only hurts patients and their access to medications." One stipulation affects only traditional compounding pharmacies that cater to individual patients and comprise the majority of compounders. The cap could actually be a more restrictive 5% if a state fails to sign an agreement with FDA. Traditional compounders believe that even a 30% cap is too restrictive and that some patients may not be able to obtain medicines as easily because not every compounder makes the same medications. The other stipulation that alarms some compounders concerns expiration dates for repackaging biologics. The guideline would require a biologic that is mixed or diluted by a traditional compounder to be administered to a patient within 4 hours unless microbial testing is done. In that case, there would be a 24-hour time limit.