Nearly a month after the FDA announced a one-year stabilization period for the final provisions of the Drug Supply Chain Security Act, we're hearing questions from many pharmacies about what they need to be doing now -- ahead of November 27, 2023 – and how to regard the following year.
Our recent webinar "The DSCSA Deadline: What it means and how to prepare" cleared up many of those questions; as our panelists all agreed, the chief concern is continuing toward full implementation.
The new requirements for enhanced drug distribution security say that trading partners must:
FDA has said that it “does not intend to take action to enforce” 582(g)(1) until November 27, 2024 -- with the caveat that it expects all trading partners, including pharmacies, to continue making progress toward full implementation, and that those who slow or stop their progress will be at risk of regulatory consequences.
Tish Pahl, Principal at Olsson Frank Weeda Terman Matz PC, said FDA representatives were "appalled" to learn that some trading partners "were trying to cancel their contracts, take their foot off the gas until August or September 2024," noting, "They were appalled since that is not the message that should be taken away from their stabilization policy ... They were interested in learning who those people were. They were very curious. If you are one of those people – FDA refers to them as 'recalcitrant' – then tell them the FDA is looking for them."
Jay Gilbreath of Cardinal Health/IDS encouraged viewers to get a solution in place to automatically and easily manage ATPs. "You have to do your due diligence. There are tools out there that can help you – LSPedia’s tools can help you. If your partners are not authorized to do business in your state, it will come out, and it’s not a minor issue. Those are the things that will cause blockages or stalls because companies are not used to verifying data, or not taking a strict approach to their trading partners." (Learn more about OneScan Pharmacy Pro here.)
Pharmacies must only conduct business with authorized trading partners, such as properly licensed and registered wholesalers permitted to ship in your state. So, lacking this status can directly keep a pharma business from operating. It's important to maintain the federal and state licenses of suppliers and customers, and also to keep trading partners updated on your own licenses.
As ATPs, wholesale distributors must accept or transfer direct ownership of a product from or to a manufacturer, repackager, a dispenser, or another wholesale distributor. They should also have a valid license under Sections 582 and 583 of the Food, Drug, and Cosmetic Act, comply with reporting requirements under Section 503(e), and follow any state licensing laws.
Manufacturers must either manufacture a product, be the approved application holder, or a co-licensed partner or affiliate, obtaining the product directly. A manufacturer must have valid registration in accordance with section 510 of the Food, Drug, and Cosmetic Act, and comply with all applicable obligations of the Act. Manufacturers who distribute their own products don't need to meet licensure requirements for wholesale distributors.
Pharmacies need to be able to receive, store, and share product tracing information at the lot level, and can only accept prescription drugs that are sent with correct T3 data (Transaction Information, Transaction History, and Transaction Statement).
The previously accepted standard for electronic product tracing was EDI 856 Advanced Shipping Notice (ASN); the industry is now increasingly adopting GS1’s Electronic Product Code Information Services (EPCIS), which provides a complete product event history, from manufacture to final sale. Trading partners must return shipments that arrive without an electronic product tracing document.
Pharmacies must establish procedures to investigate and properly handle suspect or illegitimate drugs, toward keeping dangerous products from reaching patients or entering the supply chain, and helping identify any situations where the public may be in danger.
Their responsibilities include:
This serves one of the core functions of DSCSA: safeguarding the public. Developing strong procedures for product investigations is both an immediate need and a way to protect your business from time-consuming, confusing, and even antagonistic situations.
Regulatory scrutiny. Pahl emphasized that the above measures will be enforced by FDA and state regulators, with violations incurring seizure, injunction, criminal fines and penalties, and other repercussions. She also noted that trading partners can (and many are already) setting other incentives for compliance, including contractual obligations and supply agreements; violations can incur product liability or class action challenges, and can seriously hurt the reputation of the company responsible. As examples, Pahl referenced the FDA warning letter to Safe Chain Solutions (detailed in our July 5 post) and the indictment of Steven Diamantstein (detailed in our June 30 post).
Partners who are slow to comply. Rose Campasano, LSPedia's VP of Services, told attendees, "You have to decide quickly what to do when your partners, the companies you’re buying from, say 'I’m not ready to be compliant yet.' That is a problem for you. If you don’t get the appropriate data, guess what? You can’t sell the product. [...] You can’t risk your business because the partners you buy from are slow to comply or won’t comply at all." This point was echoed by Jay Gilbreath of Cardinal Health/IDS, who added, "You have to make the decision to say no, you’re not going to use a trading partner because they are not in compliance. I know that’s a rough situation, but it is required. You have to say, 'I’m sorry, but I just cannot use you,' even from the dispenser side."
Staff who aren't trained. "Make sure your employees know what’s required of them," said Gilbreath, who commented that organizations must ensure employees maintain a knowledge base and document their training, with regular checks to ensure they're up to date on compliance even through "timeframes when you don’t see or practice certain issues."
Medication shortages. As Clayton Dickson, VP at Morris & Dickson, warned, the issue of noncompliance can create shortages if trading partners "don’t keep pushing" on DSCSA. "Especially for the patients, this creates a lot of risk. We could be delaying treatment for patients due to a data issue, when the product is in quarantine. It really emphasizes the need to keep pushing."
LSPedia's OneScan Pharmacy Pro is the leading DSCSA compliance solution for pharmacies, giving them the power to easily track and update Authorized Trading Partners, receive lot-level ASN and EPCIS files, coordinate product investigations with trading partners, and more.
Business of any size, from local independent pharmacies to chains, can easily implement DSCSA without replacing any systems. OneScan Pharmacy Pro’s elegant cloud design lets it work seamlessly with any dispensing or pharmacy management software; integrations are fast and effective, and teams can get started rapidly via an intuitive, easy-to-use interface.
The solution also goes beyond compliance, optimizing supply chain operations to bring down costs — so that, beyond avoiding expensive pitfalls, OneScan Pharmacy Pro makes DSCSA a chance for dispensers to boost efficiency and save money.
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