Frequently Asked Questions
What is DSCSA?
The Drug Supply Chain Security Act (DSCSA) is an ambitious overhaul of federal drug safety regulations that will eventually move the pharmaceutical industry toward unit level serialization of drugs. DSCSA was created in response to growing vulnerability in the pharmaceutical supply chain, and also addresses threats to public health, such as inefficient means to respond to a drug recall. The FDA began officially enforcing these requirements on March 1, 2016.
Who needs to comply with DSCSA?
Any company involved in the sale or purchase of prescription drugs. Commonly known as Trading Partners, these include manufacturers, repackagers, dispensers, wholesale distributors, and third-party logistic providers.
Why do I need InfiniTrak?
Simply put – because you need to be compliant. InfiniTrak is a cost effective and complete solution to all your DSCSA compliance requirements, centralizing and automating all the business requirements and processes required by the law. In addition, as DSCSA requirements change over the next 10 years and as the industry moves toward product level serialization, the cost effective solutions and best practices will be built into InfiniTrak.
Aren’t my wholesalers already doing this for me?
While wholesalers may store your data, if you have more than one, your information isn’t centrally located. The wholesalers also won’t be providing a compliance solution for the other parts of the law, such as verification of trading partners, and suspect product verification and quarantine requirements. Also, if you want to change wholesalers, you may have difficulty getting the data transferred to you in a form you can use.
Which distributors are you already exchanging info with?
We are working with a broad range of wholesalers, including Amerisource Bergen, Anda, Cardinal, McKesson, Parmed, TopRx, and Harvard. We are bringing on new wholesalers every day, and working closely with subscribers to make sure their wholesalers are connected quickly and efficiently. When you ask your distributor to share information with us, we arrange the electronic connection at no cost to them. In addition, you can upload paper documents or manually enter information for those distributors who may not be set up for electronic exchange.
What’s your average time to onboard my trading partners?
With wholesalers who are already in our system, it should be 3-5 business days. We have developed a streamlined process for bringing new wholesalers onboard and have a dedicated customer care professional to shepherd this process. At some level connectivity is dependent on the responsiveness of your trading partner, however we do everything we can to facilitate this process in 7-10 business days. And, as a courtesy, we don’t charge your account until at least one of your wholesalers is transmitting info.
What’s the cost?
The cost depends on how you buy the product. If you are a member of a state association that has an agreement with InfiniTrak, you are eligible for a 25% discount off the price of InfiniTrak. We also have agreements with several PSAO’s to provide a deep discount to their members. Check with your PSAO if appropriate. If you are not a member of an affiliated organization, you can purchase InfiniTrak for the very competitive price of $199 per month, with a 10% discount for an annual agreement.
How do I sign up?
If you are a member of a State Association or Buying Group that has an agreement with InfiniTrak, talk to them to receive your unique affiliation code for a special group rate. Not a part of an Endorsing State Association or Buying Group? We offer an affordable individual subscription plan that is right for you. Click HERE to get started.
Can I get a demo – try before purchasing?
Yes. Send an email to us at firstname.lastname@example.org and we will provide a demo and answer any questions.