Drug Supply Chain Security Act (DSCSA)

Trading partners must be licensed or registered, exchange transaction information electronically, verify product identifiers on serialized packages, quarantine and investigate suspect products, and respond to FDA requests. Enhanced requirements took effect on 27 November 2023, with a stabilization period that ended in November 2024. FDA exemptions for larger trading partners ended in 2025, and small dispensers with 25 or fewer pharmacists and technicians are exempt from certain enhanced requirements until 27 November 2027. Third-party logistics providers must be licensed and report annually to FDA.

DSCSA makes pharmaceutical fulfillment a specialized, licensed activity with serial-number data at its core. A 3PL handling prescription drugs needs state or federal 3PL licensing, annual FDA reporting and systems that preserve serialized data through receiving, storage and shipping. For example, a 3PL running returns processing for a drug manufacturer must verify each returned package's product identifier before it can be resold, and quarantine suspect units, which requires scanners and software that read the 2D serialized barcode.

• SerializationA unique serial number on every unit
• Lot TrackingRecording batch numbers so units can be traced
• Third-Party Logistics3PLAn outside warehouse that ships your orders

• EU Falsified Medicines Directive2011, safety features from 2019 · EU anti-counterfeit rules for prescription medicines
• Federal Food, Drug, and Cosmetic Act (FD&C Act)1938 · Core US law on food, drugs, devices and cosmetics

1. FDA: Drug Supply Chain Security Act (DSCSA) fda.gov
2. FDA: Exemptions under the Drug Supply Chain Security Act fda.gov