FDA Commissioner Calls for New Regulations on Compounding Safety

January 11, 2013

Dr. Margaret Hamburg, Food and Drug Administration Commissioner, has urged officials from all 50 states to close regulatory loopholes involving the safety of compounding drugs and to issue new regulations to head off future public health disasters. FDA held discussions mid-December about the regulatory landscape of compounding drugs with more than 50 groups, including pharmacies, consumers, hospitals, clinics and medical professionals.

FDA has crafted a plan that would leave states responsible for overseeing traditional compounding pharmacies but allow the Agency to impose new federal standards for large-scale compounders; those standards would then be enforced by the Agency alone or in partnership with states. Critics of FDA’s plan warn that states are faced with tight budgets and do not have adequate funding to accomplish comprehensive oversight. In addition, some critics claim FDA’s plan would actually jeopardize drug safety by allowing large-scale compounders to operate under less strict safeguards than those now applied to drug manufacturing.

The opportunity for legislation is closing, but some experts are still holding out hope for the prospect of action in 2013.