National Pharmacy Health & Leadership Alliance Verify a MemberMember Login
NPHLANational Pharmacy Health & Leadership Alliance
Apply for Membership

02RegulatoryNPHLA Explains

What the Drug Supply Chain Security Act requires of pharmacies

The DSCSA builds an electronic, interoperable system to trace prescription drugs at the package level. For pharmacies — “dispensers” in the law — it sets rules on trading partners, tracing documentation, suspect and illegitimate products, and records.

By NPHLA IntelligencePublished AI-assisted · Editor reviewed

The signal

The DSCSA, enacted in 2013 as Title II of the Drug Quality and Security Act, aims to identify and trace certain prescription drugs at the package level as they move through the U.S. supply chain — and pharmacies are part of that chain.

Why this matters

Pharmacies may trade only with authorized trading partners, must keep tracing documentation for the products they receive and must act quickly on suspect and illegitimate products. The package-level electronic requirements also change pharmacy systems and vendor relationships.

NPHLA takeaway

For most pharmacies the practical work is in systems and contracts: confirm that trading partners are authorized, that tracing data arrives and can be retrieved for six years, and that there is a written process for suspect and illegitimate products. General information — confirm your obligations with counsel and your state board.

Source file

  1. [1]
    Drug Supply Chain Security Act (DSCSA)

    Primary sourceU.S. Food and Drug Administration

  2. [2]
  3. [3]
    Notify FDA of Illegitimate Products

    Primary sourceU.S. Food and Drug Administration

  4. [4]
  5. [5]
  6. [6]

Drafted with AI assistance from the sources listed in the Source File, then reviewed and approved by an NPHLA editor before publication. NPHLA links to sources and does not republish their text. Professional information only — not medical, legal or regulatory advice for any individual situation. Our standards.