1. SUMMER 2015
Get the Facts: DSCSA Pocket Guide
As a valued member of the Virginia
Pharmacists Association (VPhA) you’re
eligible to receive a complimentary copy of
the latest pocket guide, courtesy of the SME
Strategy Group. Available in electronic or
print format, get the facts on the Drug Supply
Chain Security Act (DSCSA) and information
about your new benefit, InfiniTrak. The
implementation of DSCSA will be spread out
over a 5 year period, and it’s important that
you’re equipped to handle the changes. This
valuable resource is the first step in
understanding the new FDA regulations and
enabling your organization to be compliant.
We hope you find the pocket guide serves
you well and that you take full advantage of
InfiniTrak today!
Request your guide with valid registration
by email at info@infinitrak.us
With the new U.S. Drug Supply Chain Security Act (DSCSA), it’s
important that your business is picking the right provider to assist in
compliance with FDA regulations. After thorough research, VPhA is
partnering with SME Strategy Group to give you licensing access to
their latest product launch, InfiniTrak. InfiniTrak is a breakthrough
Track and Trace product that allows independent pharmacies to take
control of their business, through easy automation, compliance and
connection to consumers. With a partnership between VPhA and
InfiniTrak rest assured that your team has support from two
organizations with a track record of success, and the product to
prove it. InfiniTrak offers the solution you’ve been looking for in
easing the transition into becoming compliant with DSCSA. The
Virginia Pharmacists Association is excited to bring you a product that
offers a comprehensive solution to the challenges your business
faces, allowing you to spend less time on administrative tasks and
more time on patient centered care.
Register at vpha.infinitrak.us today!
VPhA Endorses InfiniTrak:
Be Prepared
Early Adapters at this pilot
stage with be ready to
secure their supply chain
with the right technology to
ensure customer’s safety,
improve response rate to
calls and limit the product
pulled from their inventory.
InfiniTrak is a subsidiary of SME Strategy Group LLC,
headquartered in the Washington D.C Metro area.
Latest Compliance News

2. Copyright © 2015 InfiniTrak LLC, All rights reserved.
To summarize, the announcement
states as follows:
 Until November 1, 2015, dispensers
may continue to accept ownership of
products even if the product
transaction data (transaction
information, transaction history and
transaction statement) is not included.
 Until November 1, 2015, dispensers
will not be cited by FDA for failure to
capture and maintain product
transaction data.
Latest FDA News!
FDA Delays Product Tracing
Data Enforcement for
Pharmacies and Hospitals
The FDA recently issued guidance
announcing a 4 month enforcement delay
until November 1, 2015 for certain
product tracing requirements. This delay
applies to pharmaceutical supply chain
dispensers, such as pharmacies and
hospitals. The delay by the FDA was in
response to a request made last week by
industry stakeholders seeking more time
to work with trading partners in
developing and testing electronic
databases to exchange and store such
data. In addition, FDA has posted a
webinar for small business owners to
explain the essential components of
DSCSA. Visit collaboration.fda.gov for
more information.
Notwithstanding this latest
reprieve, be mindful that the FDA
or state regulators can enforce
the following dispenser
requirements at any time:
 Dispensers must have in place a
system to verify that all trading
partners are properly licensed and
authorized under federal or state
licensing laws;
 Dispensers must have a system is in
respond to requests and to
quarantine and perform
investigations to rule out suspect or
potentially illegitimate products.
Dispensers must be ready respond
to FDA or state recall requests
within 2 days.
 Dispensers who sell/transfer
ownership to another dispenser
(except for specific patient need or
other exceptions) will be required to
transfer transaction data along with
the product.
Interested in more information and guidance on DSCSA compliance?
Contact us to get the advice you need at: info@infinitrak.us