Josh Bolin, associate executive director of government affairs and innovation at the National Association of Boards of Pharmacy (NABP), spoke to Pharmacy Times® about the impending end of the of the 1-year stabilization allowed by the FDA to ensure compliance for the Drug Supply Chain Security Act's (DSCSA) small dispenser exemption. Bolin detailed steps that pharmacies and small dispensers should take, with assistance from NABP and their state boards of pharmacy, to ensure compliance by November 27, 2024.
Pharmacy Times: Can you explain the Drug Supply Chain Security Act (DSCSA) enhanced distribution security requirements due to be completed by November 27, 2024? What led to these new requirements being announced?
Josh Bolin, Associate Executive Director of Government Affairs & Innovation, NABP: The DSCSA was part of a comprehensive piece of legislation passed by Congress in 2013, and the portion of that that's relevant to the prescription drug supply chain focuses on how technology can be used and information sharing can be used to help keep counterfeit or otherwise unsafe medications out of the legitimate prescription drug supply chain. So, [it] started with a congressional act in 2013 and then there's been this phased implementation over the course of the past 10-plus years. And so, a good way to think about the DSCSA, there are many things that it does in terms of what it requires, but at its core, it requires that prescription drug products are serialized down to the saleable unit level. So, down to that package that's dispensed to the patient or the bottle that medications are taken out of and then put into an amber vial. So they have unique serial numbers associated with it. There's a 2-dimensional (2D) barcode that's affixed to the product package. And what that serialization and barcode enables is for trading partners––so pharmacies, wholesale distributors or manufacturers as well as regulators––to be able to ask questions about a specific serialized product. So, what that means is that a pharmacy could scan the 2D barcode of a product and inquire with the manufacturer if those product identifiers are legitimate. They can also scan the 2D barcode of the product and trace the ownership of the product. So effectively asking the manufacturer who they sold the product to asking the pharmacy who they purchased the product from. Both trading partners, so those folks in the supply chain, as well as state and federal regulators, can utilize those DSCSA tools to help detect counterfeit and otherwise unsafe medications.
Key Takeaways
- The DSCSA requires prescription drug products to be serialized down to the saleable unit level, enabling trading partners and regulators to trace and detect counterfeit medications.
- Small dispensers have a 2-year exemption from certain DSCSA requirements, but they must still comply with other aspects like only doing business with authorized trading partners and having systems to quarantine suspect products.
- NABP's Pulse platform helps trading partners ensure they are only doing business with authorized partners and facilitates uniform responses to regulator requests, making them an important resource for DSCSA compliance.
Pharmacy Times: How does this tie in with the FDA’s June announcement providing exemptions to some dispensers from certain requirements of the Food, Drug and Cosmetics Act?
Bolin: So, there are certain aspects of the DSCSA that small dispensers have received a 2-year exemption from. That doesn't mean, however, that they're exempt from complying with the law at all. There are parts of the law that dispensers have had to come into compliance with over the course of the past 10 years. So, for example, small dispensers still have to make sure that they're only doing business with trading partners that are authorized. Their suppliers and medications have to be appropriately licensed and have many other requirements in order for them to do business with those upstream trading partners or suppliers. Pharmacies still also have to know where the transaction information for their products is being stored. So, do they have a system or a database or a repository that does that for them? Are they relying on their wholesale distributor to store that transaction information for them? So, you need to know where to go find the information, especially in the event that a state or federal regulator requests that information as part of an investigation.
And then the final thing that pharmacists still should be doing is they need to make sure that if they find something that is suspect or illegitimate, if they have a product that they think could be harmful to a patient if they dispense it, or if there's something that looks different about the packaging or the medication itself, they have to have systems and processes in place to be able to quarantine that product and investigate that product to determine whether it is an illegitimate product or not. So those are all things that pharmacy should be doing anyway; the exemptions really play into them receiving that information in an electronic and interoperable manner, and using certain technological tools in order to in order to achieve compliance with those areas. The exemption is really on the use of certain technologies, not from the law overall. And I think that's, unfortunately, a common misconception, that they're just exempt from everything for 2 years, because that's not the case.
Pharmacy Times: What impact should pharmacists expect based on these announcements and deadlines?
Bolin: So if pharmacies have already been engaging with their upstream trading partners in terms of the information that they've been receiving, that transaction information, [in] a lot of cases, may already be flowing. For many of them, as long as they've accounted for those 3 primary areas that I mentioned previously, and then they have good policies and procedures to document how they will carry out those processes to keep track of their transaction information, knowing what to do if they identify a suspect or illegitimate product, and ensuring that they're only doing business with authorized trading partners. As long as they have policies and procedures around those they really shouldn't notice a significant shift or change at least in at least in this interim period. And that's irrespective of whether they're a small dispenser or a larger dispenser.
Pharmacy Times: Are there considerations you recommend for key stakeholders to stay DSCSA compliant?
Bolin: So really, kind of going back to those, the sort of 3 major tenents that I mentioned previously, if pharmacies are putting systems and processes in place to do those things, and they have policies and procedures to document, that really gets them well on their way toward being compliant, irrespective of their size. And NABP has a dispenser education guide that we're actually releasing next week that provides some more detail and good information for pharmacies to think about as they're building out their policies and procedures. And I'll be happy to share a link to that with you.
Pharmacy Times: How does NABP assist trading partners with adhering these new requirements? Why is NABP so important in that regard?
Bolin: So, there are a couple of things that NABP has been working on. As we've worked to build out our Pulse platform, which is really a directory for all the trading partners in the supply chain, as well as a directory for the products that move through the supply chain, what we've been able to do is unlock some additional communications tools that help not only the state regulatory community, but also dispensers, to be able to, one, ensure that they're only doing business with authorized trading partners, but two, in the event that they do need to investigate a product and contact their upstream trading partners of the manufacturer, we give them the tools to be able to do that. The other thing that becomes important with the platform is there is this obligation to respond to regulators if they request information as part of an investigation. And so by opting in and sort of coming in and claiming their Pulse profile, it enables them to actually deal with 50 states in a uniform way, as opposed to having disparate requests coming in 50 different flavors, if you will.
Pharmacy Times: Is there anything else that you would like to add?
Bolin: So, I think, from my perspective, I think it's one important that pharmacies, if they believe they do qualify for the small dispenser exemption, that they actually document that and document why it is that they believe they qualify. For pharmacies that may fall outside of that small dispensary exemption, if there is any question about whether they are going to be ready or going to be compliant in November of this year, we're also recommending that they file as part of the FDA waiver exemption and request process that is laid out in the statute, and information is also available on FDA’s website. Because at the end of the day, just having systems and processes in place to be able to receive transaction information doesn't mean that they're going to be compliant. They also have to have the data in order to be compliant. And so. if for some reason, they're not receiving complete transaction data from their upstream trading partners yet, that means that they will not be compliant. And so it's really important that they make that, if they're not getting enough data from their upstream trading partners, that they make that exemption request with the FDA, and again, importantly, document that they've made that request and be prepared to provide proof that you've made the request if you're inspected by a state board of pharmacy, because the boards can and will ask.
And then one more final point, as you're going through, from a pharmacy perspective, it's highly unlikely that the FDA is going to be the entity that is out inspecting for DSCSA compliance; that's going to fall to the state boards of pharmacy. And so again, being prepared to answer those 3 questions about doing business with authorized trading partners, knowing where to find your transaction information, knowing what to do if you find a suspect or illegitimate product, and having policies and procedures around that—being prepared to answer those questions at the time of at the time of inspection. And then finally, for those that are interested in taking advantage of Pulse and what we're what we're offering there, they can visit our website at www.pulse.pharmacy.
