RXTRansparent presentation presented to the US Food and Drug Administration FDA during the November 5, 2018 Public Hearing

1. Future Format of the NDC
FDA Public Hearing November 5, 2018
The views, thoughts, and opinions expressed in this document
belong solely to the author, and not necessarily the author’s
employer, organization, partners, or customers.
Dwight de Vera
RXTransparent
Founder and CEO

2. Integrated US Drug Supply
Chain Enabled By NDC
NDC - Common identifier
Enabling drug supply
chain interoperability
Supply Chain
Dose Dispense
Data
Mfg.
Creation of Digital Identity
for Physical Asset :
SN Commissioning &
Fingerprint
Capture
Order Processing
Aggregation To
Shipper and Pallet
Drop Ship /
Direct Ship
Wholesale
Distribution
Hospital/
Pharmacy
Dispense
Patient
Authentication
Wholesale Distribution
Goods Receiving/
Custody transfer
Shipping/
Goods transfer
Goods
Receiving
Inspector Authority
Interoperable Blockchain
SN & secure
fingerprint
recorded on the
blockchain.
Goods transfer(s)
recorded on the
blockchain.
Goods receipt(s) / custody
transfer recorded on the
blockchain.
Fraud Prevention
Insight Analytics
Data Insight & BI
rxtransparent.com/ndcsurvey FDA Public Hearing Future Format of NDC

3. Interoperable Progress
NDC – 50242-044-13
Proprietary Name - Activase
Non Proprietary Name -Alteplase
Labeler Name - Genentech, Inc.
Product Type -HUMAN PRESCRIPTION DRUG
Package
1 KIT in 1 CARTON (50242-044-13) * 50 mL in 1
VIAL, SINGLE-USE * 50 mL in 1 VIAL, SINGLE-USE
Industry Collaboration Enables
• A safer, nimbler, transparent drug
supply chain
• Packaging inference
• Agreement on standards in the US
and internationally
• Fewer drug expirations
• Previously unavailable insight
• Future value beyond compliance
rxtransparent.com/ndcsurvey FDA Public Hearing Future Format of NDC

4. NDC Impact and Scope
Active US Pharma
Labelers
< 1,000
Active US Pharma
Wholesalers
< 2,000
Active US Points
of Dispense
> 300,000
rxtransparent.com/ndcsurvey FDA Public Hearing Future Format of NDC

5. Current Practices
Complete Drug Catalog
Therapeutic Equivalents
Therapeutic Classifications
Biosimilars
Patents and filings
CorPharma
DispensingAlgorithm
CorPharma
• Internally developed
• Continuously updated
• Cross references of all
US pharmaceutical
products
• Algorithm accounts for
all NDC permutations
rxtransparent.com/ndcsurvey FDA Public Hearing Future Format of NDC

6. NDC Evolution Options
No Changes
Option A Option B
6 Digit labeler
Future Date
Option C
11 Digit
Zero padding
Option D
Harmonized
12 Digit
Definitive
cutover
Greater
interoperability
Quicker
interoperability
Overview
Pro
Con
HIPAA confusion
Most
disruptive
Least
disruptive
Five formats Middle ground
Considerations and Value Beyond NDC
• Retire labeler designations of NDCs no longer in use
• Enhance the NDC to incorporate controlled substance designation
• Enhance the NDC to identify hazardous material status
• Enhance the NDC to accommodate current and future unit dosing practices
rxtransparent.com/ndcsurvey FDA Public Hearing Future Format of NDC

7. Q & A
Conclusions
The national drug code (NDC) while not perfect, is the
best compact identifier and final check on proper
identification and administration of drug product prior
to patient dosing. Any changes to the NDC format will
result in additional technical complexity and costs
within and through all facets of healthcare in the
United States, but in collaboration with stakeholders
throughout the industry we can all benefit from
greater interoperability, consistency in care and
greater long-term value within healthcare delivery
www.rxtransparent.com/ndcsurvey
FDA Public Hearing Future Format of NDC