Although lawmakers are working to increase oversight of some compounding pharmacies, they agree that the practice of traditional compounding serves an important purpose and should be protected.
Traditional compounding harks back to pharmacists’ mortar-and-pestle days. Then, as now, pharmacists would make a custom version of a drug for an individual patient with a specific need.
For example, a patient could have an allergy to a dye or other ingredient used in a medication and thus require a different formulation of the drug. Pediatricians also can request a medication be flavored or turned into liquid form so a child can take it more easily.
Because these drugs are manufactured for one specific patient with a prescription, they are not held to the same safety and efficacy standards as other new drugs. That is why compounding pharmacies are traditionally overseen by state boards of pharmacy, not the Food and Drug Administration.
Compounding pharmacies can also help produce more drugs in the event of a drug shortage. The National Community Pharmacists Association has asked the FDA to preserve compounders’ ability to make drugs in those situations.
The problem, the FDA says, is when pharmacies begin to operate more like drug manufacturers, producing drugs on a large scale for interstate sale and veering from typical compounding pharmacy practices. FDA officials have asked lawmakers to clarify the differences between those activities, so a pharmacy cannot slip into the wrong category.
The NCPA has advocated that state boards of pharmacy continue to regulate pharmacy compounding, while the FDA would oversee drug manufacturing.
The International Academy of Compounding Pharmacists estimates that 7,500 pharmacies in the country specialize in more complicated, advanced compounding, and of those, 3,000 perform sterile compounding. An estimated 1 percent to 3 percent of all prescriptions dispensed in the country are prescriptions for compounded drugs for an individual patient, the academy says.