Proposed legislation (S. 959) that would give the U.S. Food and Drug Administration (FDA) the authority to oversee compounding pharmacies that ship products across state lines has generated comment from a broad array of stakeholders. Additional details about the legislation, which was approved unanimously in late May 2013 and reported in the nature of a substitute by the Health, Education, Labor and Pension Committee, appear in Issue 56 of this Bulletin.
On behalf of the American Society of Health-System Pharmacists and American Hospital Trusts, the Pew Charitable Trusts submitted comments supporting the increase in oversight but calling for changes that would strengthen the bill. Among other matters, these groups call for expanding the bill’s application to “large-scale, intrastate sterile compounding and large-scale non-sterile compounding,” warning that by “reducing FDA’s authority over certain stateregulated pharmacies, the law may encourage the growth of these types of compounding.”
Meanwhile, compounding pharmacies have launched a campaign to stop the bill, claiming that it will “threaten the health and safety of men, women, children and pets.” They claim that the proposed legislation would give FDA unprecedented authority over their operations and seek to distance themselves from operations such as the New England Compounding Center, purportedly linked to a Hepatitis A outbreak, which “was in reality distributing many of its medications without the pharmacist-prescriber relationship, and therefore was acting as a manufacturer/ wholesaler.” See MyMedsMatter.com, June 12, 2013.