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DSCSA Resources for Dispensers

DSCSA Resources for Dispensers

In collaboration with:

 American Pharmacists Association American Society of Health System Pharmacists   National Association of Boards of Pharmacy
NCPA   Partnership for DSCSA Governance PDSA

HDA has developed this webpage in collaboration with supply chain partners to house information dispensers need to meet the 2023 milestone.

What is DSCSA?

The Drug Supply Chain Security Act (DSCSA), enacted in 2013, preempts a 50-state patchwork of pedigree requirements to create one federal traceability solution for prescription medicines. The DSCSA sets out a 10-year timeline to build an electronic, interoperable system for the exchange of transaction documentation [transaction information (TI), transaction history (TH) and transaction statements (TS)] to enable the tracing of prescription medicines throughout the pharmaceutical supply chain, with the final milestone quickly approaching.

DSCSA defines a dispenser as:

  • A retail pharmacy;
  • A hospital pharmacy;
  • A group of chain pharmacies under common ownership and control that do not act as a wholesale distributor; or
  • Any other person authorized by law to dispense or administer prescription drugs and the affiliated warehouses or distribution centers of such entities under common ownership and control that do not act as a wholesale distributor

Overview of DSCSA Milestones

2015

Lot-level traceability 
Manufacturers and wholesale distributors must provide lot TI, TH and TS. 
2017
Product identifiers by manufacturers 
Manufacturers must affix product identifiers to each package and homogenous case.
2018

Product identifiers by repackagers
Repackagers must affix product identifiers to each package and homogenous case.
2019
Verification by distributors
Wholesale distributors must only accept serialized product. They must also verify product identifiers with the manufacturer before redistributing returns. The FDA has announced it will not enforce the saleable returns verification requirement until November 27, 2023. The compliance policy described is limited to the requirements that wholesale distributors verify saleable returned products prior to further distribution and have verification systems in place to comply with the requirements of section 582(c)(4)(D) of the FD&C Act; it does not extend to the other requirements in section 582 of the FD&C Act.
2020*
Verification by dispensers
Dispensers must only accept products with product identifiers and also have verification requirements for suspect products. The FDA has announced it will not enforce the verification requirement for suspect products until November 27, 2023. This compliance policy does not address any of the other verification requirements set forth in section 582(d)(4) of the FD&C Act.
 2023
Unit-level traceability
Manufacturers, distributors and dispensers must provide and receive TI (including product identifier) and TS in a secure, electronic and interoperable manner.


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Resources for Dispensers

Checklists

Continuing Education Courses

FAQs

Podcasts

Presentations

Publications

Webinars


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