DSCSA: Safeguarding the Drug Supply Chain

By: Karen Spano RPh, HDDP, ACHCU Pharmacy Educator 

Pharmacy accreditation expert Karen Spano is passionate about helping organizations succeed. She has over 30 years of experience with specialty and infusion pharmacies, from start-ups to large organizations. 

Posted: January 2, 2026

The Drug Supply Chain Security Act (DSCSA) was enacted by Congress in 2013 as Title II of the Drug Quality and Security Act. It was established to enhance the traceability, security, and integrity of the pharmaceutical supply chain; readily identify compromised pharmaceuticals, such as counterfeit, stolen, contaminated, dangerous, or otherwise harmful drugs; and remove compromised products from the pharmaceutical supply chain before they reach patients. In addition, DSCSA requires wholesale distributors and third-party logistics providers to obtain national licensure.

As of November 24, 2024, DSCSA requires compliance with the mandate for real-time, fully electronic interoperability track-and-trace systems to the package level across the supply chain, from manufacturers to dispensers.

ACHC currently does not have a standard specific to DSCSA for PCAB and Pharmacy Accreditation programs. A DSCSA standard will be included when the next PCAB and Pharmacy Standards are released. However, federal oversight of pharmacies does mandate compliance with DSCSA, and ACHC is committed to educating and supporting pharmacies in meeting the requirements.

Definitions drive compliance

The FDA defines a dispenser as a retail pharmacy, hospital pharmacy, group of pharmacies under common ownership and control, or any person authorized to dispense or administer prescription drugs to patients. DSCSA granted large dispensers a compliance grace period to work through electronic operability issues until November 27, 2025. The FDA considers a large dispenser to be any pharmacy or group of pharmacies under common ownership that employs 26 or more full-time, licensed pharmacists or personnel who function as pharmacy technicians. For small dispensers—pharmacies that employ 25 or fewer full-time, licensed pharmacists or personnel who function as pharmacy technicians as of November 27, 2024—an exemption until November 27, 2026, is available through application.

Section 582 of the Food, Drug, and Cosmetic Act defines a pharmaceutical product as a prescription drug in finished dosage form for administration to a patient without substantial further manufacturing (e.g., capsules, tablets, and lyophilized products before reconstitution). DSCSA requirements do not apply to:

  • Intracompany transfers between different facilities of the same company.
  • Veterinary drugs.
  • Blood or blood components intended for transfusion.
  • Certain IV products (e.g., large volume infusion solutions).
  • Lawfully compounded drugs.
  • Radiopharmaceuticals and imaging drugs.
  • Medical gases.
  • Homeopathic and OTC medications.

Fully electronic real-time interoperability requires the exchange of transaction information (TI) and transaction statements (TS) in a secure, interoperable manner, using Electronic Product Code Information Services (EPCIS), a GS1 international standard for data sharing and product verification at the package level. A non-exhaustive list of these platforms includes:

  • McKesson Connect.
  • Pulse by NABP.
  • TrackTraceRx®.
  • TraceLink.

Penalties for noncompliance

Noncompliance with DSCSA has serious consequences. These include:

  • Civil fines up to $500,000 per violation, and intentional violations can lead to criminal charges, including imprisonment.
  • Revocation of manufacturer, wholesaler, and dispenser licenses.
  • Illegitimate or non-traceable products may be confiscated or subject to recall, causing financial and reputational damage.
  • Increased FDA scrutiny and audits.
  • Risk of losing partnerships with authorized trading partners.

Tips to ensure compliance

1. Implement a process to verify the licensure of all authorized trading partners before purchasing any pharmaceuticals from them and at least annually, thereafter.

2. Develop solid policies and procedures that clearly address:

  • A process for handling serialized data.
  • A process for accepting TI and TS information and storing the information for six years.
  • A process for responding promptly with TI and TS upon request from regulatory agencies.
  • A process for product verification at the package level.
  • A process for real-time secure data exchange.
  • A process for saleable returns.

3. Educate and train staff on DSCSA requirements. Include:

  • Steps for detection of counterfeit, illegitimate, suspected products.
  • Appropriate actions to be taken (e.g., quarantining the shipment).
  • Investigation procedures.
  • How to notify the trading partner and FDA.
  • Documentation requirements.

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