Take heed of the underscore! … or why the DSCSA Stabilization Period is not for fun
Those with a finger on the pulse of the US Drug Supply Chain Security Act (DSCSA) will have heard from all rooftops by now that FDA has granted all pharmaceutical Trading Partners a 12-month Stabilization Period. If you’re one such Trading Partner don’t lean back to relax just yet! There’s a lot that needs sorted out before November 2024.
What’s changed?
FDA does not intend to take action to enforce certain DSCSA requirements until November 27, 2024. Thus, FDA gives Trading Partners one more year to get properly set up for full compliance. Since this is a lengthy process, starting sooner rather than later or continuing existing efforts at pace would be very wise.
In FDA’s own words:
This guidance is not intended to provide, and should not be viewed as providing, a justification for delaying efforts by trading partners to implement the […] requirements […]. FDA strongly urges trading partners to continue their efforts to implement necessary measures to satisfy these […] requirements.
FDA, Aug 2023. Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act — Compliance Policies – Guidance for Industry.
As pointed out by Tish Pahl at the recent HDA Traceability Seminar, this bit above is underscored in the original FDA guidance. That’s no creative expression. FDA doesn’t seem to be into artistic text styling that much. They did this for real emphasis. Along the lines of, “We’re giving you some breathing space. Don’t mess about! We’ll be keeping a close eye on you.”
Overall, this seems in line with the original 10-year implementation roadmap starting back in 2013. The intent from the get-go of this law has been to give Trading Partners the opportunity to achieve compliance over time instead of a single point in time. FDA repeated this spirit in its recent guidance.
FDA believes the compliance policies provided in this guidance will help supply chain stakeholders, particularly trading partners, by accommodating the additional time that may be needed to continue to develop and refine appropriate systems and processes […] to achieve robust supply chain security under the DSCSA while helping ensure continued patient access to prescription drugs.
FDA, Aug 2023. Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act — Compliance Policies – Guidance for Industry.
Where’s the catch?
The key words to look out for above are “certain” and “FDA“.
Only certain requirements
The delay in enforcement action is not a carte blanche that puts all of DSCSA on hold. There are plenty requirements in force now with which Trading Partners should already comply and some are still due in November this year. As it stands, the Stabilization Period encompasses two August 2023 guidances with the following catchy titles:
- Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act — Compliance Policies – Guidance for Industry
- Let’s just call this EDDS Guidance.
- Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance Policies – Guidance for Industry
- Let’s just call this Product Verification Guidance.
These refer to the following sections of the the Federal Food, Drug, and Cosmetic (FD&C) Act (of which DSCSA is a part):
EDDS Guidance
- 582(g)(1) – requirements for manufacturers, wholesale distributors, dispensers, and repackagers for enhanced drug distribution security (interoperable, electronic, package-level product tracing, including systems and processes)
Product Verification Guidance
- 582(c)(4)(D) – wholesaler requirement to verify the product identifier prior to further distributing saleable returned product
- 582(d)(4)(A)(ii)(II) – dispenser requirement to verify the product identifiers of suspect product
- 582(d)(4)(B)(iii) – dispenser requirement to verify the product identifiers of illegitimate product that are the subject of a notification from FDA or a trading partner
The Product Verification Guidance is explicit about certain manufacturers’ and wholesalers’ obligations remaining unchanged:
This compliance policy does not relieve a manufacturer of its verification obligations pursuant to section 582(b)(4)(C) of the FD&C Act upon receiving a request for verification from an authorized wholesale distributor.
FDA, Aug 2023. Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance Policies – Guidance for Industry.
The respective draft guidance from March 2022 has more on this.
What else hasn’t changed? – Everything else!
In principle, the fundamental expectation hasn’t changed. The final DSCSA implementation deadline has not been delayed. All original requirements remain in effect. FDA may well address requirements outside of the above-mentioned guidances in inspections based on their respective due dates. November 2023 is still a serious and valid deadline. Anyone not seen to at least be working towards compliance by then will be in the bad books if caught. We’ve recently seen this demonstrated in the form of an FDA Warning Letter. This may not be the last one and we should not point at that one company as the source of all evil. DSCSA compliance is a large and complex piece of work. Inaction has consequences – whether this is being digitally tarred and feathered, fined or worse.
Only FDA
Even though FDA chooses to be selective in its enforcement actions, other inspectors or auditors may not follow this example, e.g. State boards, PBM, other Trading Partners.
Make no mistake, the Act itself will come fully into effect on Nov 27, 2023. This gives anyone, who can bring forth a reason to require your DSCSA compliance, the opportunity to use the Statute as leverage over you. You know your own supply chain partners best to gauge the risk resulting from non-compliance.
Further recent DSCSA opinion pieces
- What Does a DSCSA Stabilization Period Mean?
- Prioritizing DSCSA Adherence to Protect Patient Safety
- Are you concerned over DSCSA implementation and supply chain disruption?
- DSCSA deadline 2023… or 2024?
- Who Are You Sharing Information With? DSCSA Enhanced Drug Distribution Security System – A Point of View
- BREAKING NEWS FROM FDA: STAY THE COURSE ON DSCSA — DON’T GIVE REGULATORS AN EXCUSE TO AUDIT YOUR BUSINESS.
Disclaimer
I’m not qualified to provide legal advice. Nothing stated here should be taken as such.
Why am I writing about this? – Because FDA puts strong emphasis on digitalising the US pharma supply chain, especially through its EDDS Guidance. I am currently employed by a technology solution provider, called Spherity, that offers a tool to perform automated electronic ‘Authorized Trading Partner’ checks via Verification Router Services. So, the topic is not only close to my job but also super interesting to think about and watch unfold.