House holds hearing on drug compounding law

The House Energy and Commerce Health Subcommittee today held a hearing on implementation of the Compounding Quality Act, which updated federal requirements for drug compounding facilities after a 2012 fungal meningitis outbreak that was associated with a contaminated compounded steroid medication distributed to patients and providers in 23 states. Witnesses at the hearing included Food and Drug Administration Commissioner Scott Gottlieb, M.D.; officials from two companies that manufacture compounded sterile drugs; a patient; and representatives from the American Academy of Dermatology, International Academy of Compounding Pharmacists, The Pew Charitable Trusts, National Community Pharmacists Association, and American Academy of Ophthalmology. As FDA continues to implement the law, Gottlieb said the agency “plans to take steps that preserve lawful pharmacy practices and expand the opportunities for pharmacies that want to engage in larger-scale compounding to efficiently become 503B facilities.”