DQSA Compounding Pharmacy Requirements

The Drug Quality and Security Act (DQSA), signed into law on November 27, 2013, is the most significant piece of federal legislation affecting compounding pharmacies in the past two decades. Understanding its requirements is essential for providers who work with compounding pharmacy partners.

Why the DQSA Was Passed

The DQSA was a direct response to the 2012 New England Compounding Center (NECC) meningitis outbreak. Contaminated methylprednisolone acetate injections from NECC caused 753 infections and 64 deaths across 20 states. The tragedy exposed regulatory gaps between state and federal oversight of compounding facilities.

Title I: The Compounding Quality Act

The most relevant section for providers is Title I — the Compounding Quality Act, which amended the Federal Food, Drug, and Cosmetic Act to create the modern 503A/503B framework:

503A Requirements (Traditional Compounding Pharmacies)

• Must compound based on valid, patient-specific prescriptions
• Licensed under state pharmacy law
• Cannot compound drugs that are "essentially copies" of commercially available products
• Limited advertising restrictions for specific compounds
• Must use pharmaceutical-grade ingredients from FDA-registered suppliers

503B Requirements (Outsourcing Facilities)

• Must voluntarily register with the FDA
• Subject to FDA inspection on the same basis as drug manufacturers
• Must follow current Good Manufacturing Practice (cGMP) standards
• Must report adverse events to the FDA
• Can compound without individual patient prescriptions (office stock)
• Can distribute interstate
• Must list all compounds on the FDA registration

Title II: Drug Supply Chain Security Act

Title II addresses pharmaceutical supply chain integrity — track-and-trace requirements for drug distribution. While this primarily affects manufacturers and wholesalers, providers should understand that their compounding pharmacy partners are subject to these supply chain requirements for certain products.

Impact on Providers

The DQSA directly affects providers in several ways:

• Office stock rules: Only 503B facilities can legally supply office-stock compounds without prescriptions
• Quality assurance: The framework creates clear quality expectations you can verify
• Interstate shipping: Understanding which type of pharmacy can legally ship to your state
• Liability considerations: Working with DQSA-compliant pharmacies reduces malpractice risk

Learn more: 503A vs 503B Compounding Pharmacy Guide