With the Nov. 27, 2024, deadline for the Drug Supply Chain Security Act (DSCSA) less than three months away, many pharmacies and the organizations that represent them are sounding the alarm about lack of readiness from upstream trading partners, particularly at the manufacturer level.
“Most of our members have … been working with solution providers handling DSCSA compliance, but we are hearing from many of them that the manufacturers are only [providing] 20% to 30% of the data they need to actually track things through the system,” said Jillanne Schulte Wall, ASHP’s senior director of health and regulatory policy. She cited “cascading enforcement discretion periods” and the lack of “an absolute compliance push” as potential culprits.
These concerns have been reflected in surveys conducted by the FDA and the Partnership for DSCSA Governance, an independent, sector-neutral body. Nearly one-third of pharmacies recently surveyed reported that they are routinely receiving serialized data, such as transaction information, from 20% or less of their suppliers.
“Ask 10 dispensers what verification means, and you will get 10 different answers. There are so many new applications that are unfolding,” said Neal Long, chief executive officer for DSCSA compliance solution vendor ConsortiEx. “It’s more than just EPCIS [Electronic Product Code Information Services] files. It’s tracking, tracing, sellable returns, decommissioning and new ways of verification. There are just so many new elements that November 27 will come and go and there will still be a lot of work to be done to protect patients and the supply chain.”
In June, the FDA announced that it would grant small dispensers a two-year extension for complying with DSCSA’s enhanced tracking requirements, but that only applies to those with fewer than 25 employees. The agency also said it would consider requests for waiver, exceptions and exemption (WEE) from other trading partners that are not fully ready for implementation by this November.
“If you don’t think you will be ready or don’t think you will have complete data from your trading partners upstream, we advise that you consider going through the process of filing for a WEE,” said Josh Bolin, the associate executive director for government affairs and innovation for the National Association of Boards of Pharmacy (NABP). “And if you are doing that, it is very important to document specifically why you are seeking the WEE and why it is important for public health to get that request granted.”
Although the FDA announcement recommended that such requests were to be submitted by Aug. 1, Mr. Bolin noted that this is not a statutory date. “Trading partners can still submit a request, and they should keep records of what they submitted and when.”
Distributors Also Concerned
At the distributor level, the picture is much the same, said Elizabeth Gallenagh, a general counsel and senior vice president of supply chain integrity at the Healthcare Distribution Alliance. “Most of our members are connected, but they are not receiving fully serialized data from all of the manufacturers. This could get very complicated for the dispensers at the end of the chain as they try to keep up with all of this variability.”
What to Expect From Inspections
At the pharmacy level, DSCSA inspection will be rolled into existing state boards of pharmacy inspections, according to Mr. Bolin. “I’m not aware of any state that is establishing a separate process for DSCSA compliance,” he said.
For hospital pharmacies that receive a product for which they don’t have data from an upstream partner, but they have a patient that needs that medication, “we are advising a risk-based approach,” Mr. Bolin said. “If this is a product that you’ve purchased from the same wholesaler for years and you have an established relationship, you can say you are doing what is in the best interests of the patient and still dispense the product.”
Conversely, if you have a product that is in short supply “and you have purchased it from somebody that you don’t normally purchase from, that requires a much different level of due diligence on your side, and you need establish processes for that type of situation,” Mr. Bolin said.
More on the Web
For additional DSCSA preparedness tips, including how to assign responsibility for DCSCA compliance, see expanded version on PharmacyPracticeNews.com.NABP will release its Dispenser Guide to Achieving DSCSA Compliance in September that addresses these and other compliance questions. Pharmacies interested in obtaining the Guide should sign up for the NABP mailing list at www.pulse.pharmacy.
“Remember, DSCSA is not being done for paperwork reasons,” Mr. Long said. “It is to protect against that one moment where adulterated, recalled, expired or counterfeit drugs enter your supply chain.”
HDA Reaches out to the FDA
On Aug. 19, HDA sent a letter (bit.ly/3XdISuH) to the FDA calling for a phased, stepwise approach to implementing the enhanced drug distribution security (EDDS) requirements of DSCSA. In the letter, HDA encouraged the agency to:
- Establish narrow guardrails to allow more time for the supply chain to stabilize data exchange between trading partners.
- Swiftly approve WEEs requested by trading partners to mitigate supply chain disruption.
- Initiate weekly “rapid response” calls with industry stakeholders leading up to, and in the immediate aftermath of, the implementation of EDDS requirements on Nov. 27, 2024.
The sources reported no relevant financial disclosures beyond their stated employment.
This article is from the September 2024 print issue.