Drug Store Supply Chain Security Act Readiness
DSCSA is bringing secure, interoperable, electronic data exchange to the pharmaceutical supply chain. Are you ready?
Mitigate risk and maintain compliance under DSCSA.
DSCSA has been ten years in the making, starting with the Drug Quality and Security Act (DQSA). This act came into existence on November 27, 2013, for drug product tracing. Within DQSA, Title II, which is also referred to as the Drug Supply Chain Security Act (DSCSA), establishes a federal system for tracing prescription drug products through the pharmaceutical distribution supply chain. It requires trading partners to pass, receive, and maintain certain product and distribution information.
DSCSA went into effect in November 2019 for distributors and the enhanced drug distribution security requirements will come full circle on November 27, 2023.
A Brief DSCSA TimelineNoted here is a brief timeline of some key points throughout the DSCSA path.
- 2015: DSCSA goes into effect to start FDA’s 10-year plan to achieve an electronic, interoperable system for tracking and tracing prescription drugs.
- 2014-2015: Third-party logistics and wholesale distributors reporting to FDA.
- 2015: Product tracing and verification and authorized trading partners.
- 2017-2018: Product identification (serialization) required
- 2019+: Product verification (down to the package level)
- 2023: Electronic interoperable system for product tracing down to the package level.
- 2014-2023+: Licensure standards for 3PLs and wholesale distributors.
The five main goals of DSCSA per the Food and Drug Administration (FDA) are:
Product tracing
Product verification
Security
Licensure check
Patient safety
At a Glance: DSCSA Guidance
Now in 2023 and beyond, the DSCSA focus has been recalibrated for implementing interoperable, electronic tracing of pharmaceutical drugs down to the package level, while establishing national standards for Authorized Trading Partners (ATPs), state licensure verification for wholesale distributors, and third-party logistics (3PLs), and dispensers.
Maintaining integrity from the manufacturer to the end user – the patient – is mission critical and quality, trusted data is needed to validate and answer:- Who touches the product?
- Where are vulnerabilities?
- What are the threats?
In general, unless a drug is specifically noted as excluded, the DSCSA requirements will most likely apply. DSCSA does not apply to:
- Non-prescription or over-the-counter (OTC) drugs
- Animal drugs
- Blood or blood components intended for transfusion
- Radioactive drugs or biologic products
- Imaging drugs
- Certain IV products
- Medical gases
- Certain homeopathic drugs
- Lawfully compounded drugs
Source: FDA
What are Authorized Trading Partners? In the pharmaceutical supply chain, all trading partners are licensed either by the FDA or a State Board of Pharmacy. This includes manufacturers, re-packagers, wholesale distributors, dispensers, and third-party logistics. Members of the supply chain can buy or sell products only to those parties with active licenses. This effectively means that each partner in the supply chain is regularly evaluating the licenses of its customers and suppliers.
You need quality, up-to-date data you can trust to meet these compliance regulations and ensure all touchpoints throughout the drug supply chain are authorized parties and be prepared to meet audit requirements.
Here's the Reality of the New DSCSA Standard
The impact of DSCSA will reach far and wide. Here’s a snapshot of the impact and what your organization should consider when preparing your strategy and finding a solution. - Billions of transactions annually will need to have compliance checks electronically
- Need a method for ensuring accuracy and deduplication of supply chain entity data
- Ensure there is NO disruption to the supply chain distribution
- Compliance will be in jeopardy without proper wholesaler and third-party logistics (3PL) reporting
- License challenge with multiple shipments going across multi-states with different state-to-state
- Paper-based methods will need to be eliminated and have a digital “paper” trail
Are You Ready to Meet DSCSA Requirements?
LexisNexis® Risk Solutions helps supply chain participants validate trading partners' licensure to help operate more efficiently, meet pending compliance deadlines, and enable necessary reporting and confirmation of DSCSA compliance to the FDA. LexisNexis® MasterFile™ supplies nationwide state board licensure and supply chain organization key data assets.
- Leveraging vast state licensure data to meet FDA criteria for licensing 3PLs and wholesale drug distributors (WDD)
- Using API services to expedite validation of ATPs, wholesale drug distributors, third-party logistics, and pharmacies
- Obtaining needed data to support DSCSA reporting requirement
“Our business model requires near real-time results and data delivery to serve our customers accurately and efficiently. We utilize LexisNexis Risk Solutions as a data provider to fulfill these requirements to help ensure products are safely handled in the supply chain. The quality of data and reliability of their API are two of the reasons we selected them.”
William Wells, Vice President of IT, Infrastructure & Operations, R&S Solutions
