The Drug Quality and Security Act of 2013, enacted in response to the 2012 New England Compounding Center meningitis outbreak that killed 76 people. The DQSA established the modern regulatory framework for pharmaceutical compounding in the United States by creating two distinct categories of compounding facilities.

Section 503A governs traditional compounding pharmacies that prepare medications for individual patient prescriptions. Section 503B created a new category—outsourcing facilities—that can compound in larger quantities under FDA oversight and CGMP requirements. The DQSA is directly relevant to peptide access because it defines which pharmacies can legally compound copies of FDA-approved peptide drugs (like semaglutide and tirzepatide) and under what conditions—questions at the center of ongoing regulatory and legal disputes.