S. 959, the "Pharmaceutical Quality, Security, and Accountability Act’’

On July 16, 2013, the Committee on Energy and Commerce held a legislative hearing to discuss three legislative proposals released in the aftermath of the September 2012 outbreak of fungal meningitis associated with injections of preservative-free methylprednisolone acetate (MPA) produced by the New England Compounding Center. 

S. 959, the Pharmaceutical Compounding Quality and Accountability Act, attempts to clarify oversight of pharmaceutical compounding, leaving traditional pharmacies under the supervision of states, while enabling the U.S. Food and Drug Administration to regulate companies that make compounded sterile drugs without prescriptions and  ship across state lines.  S. 959 allows traditional compounders to compound limited quantities of a drug based on history and the relationship between the pharmacy and patient/prescriber.  The bill also treats hospitals and health systems as traditional compounders so long as the compounded drug is dispensed within the hospital or health system.