What Does the 2023 Drug Supply Chain Security Act (DSCSA) Implementation Mean for Pharmacy?

As we approach the 10 year anniversary of enactment of the DSCSA and move toward the final complex interoperable electronic tracking phase, every pharmacist needs to be aware of the effects this legislation has on the pharmaceutical supply chain.  The four main areas for change include verification, authorized trading partners, product tracing and serialization. While up until now, these have mostly affected non-pharmacy supply chain partners, by 2023 various DSCSA provisions will affect the pharmacy community.[1]

2023 Challenges

DSCSA has cast a wide net. Specifically, every transaction pharmacies enter into must be recorded on T3s (Transaction History, Transaction Information, Transaction Statement) and pharmacists must match up T3s with product.[2] If they are not doing so already, pharmacies will need to confirm the licenses of wholesalers. Pharmacies will need systems for storing these documents (for 6 years), generating them if they transfer product (e.g. to another pharmacy), and retrieving them quickly pursuant to regulatory requests.  FDA is more likely to conduct pharmacy inspections pursuant to suspect product and mandate products be quarantined.  DSCSA places a responsibility on pharmacists to monitor for suspect products and report product issues. Pharmacists can be fined under the DSCSA.

New Guidance

FDA issued two new draft guidance’s and finalized two others to assist trading partners in meeting the requirements of the DSCSA[3] to further enhance the security of prescription drugs in the U.S. Supply Chain (Table 1). One of the draft Guidance’s detailed below, “Enhanced Drug Distribution Security at the Package Level under DSCSA” has now resulted in requests from various pharmacy groups to FDA to withdraw it. Some of the key concerns for pharmacists include:

  • FDA has exceeded its legislative authority in that many of the Guidance’s recommendations are inconsistent with, and contrary to, the DSCSA (inter-operative tracing at the package level is specifically mentioned)
  • Requiring reconciliation for every shipment that comes through a pharmacy is beyond the scope of the DSCSA.
  • Additionally, pharmacies should not have to scan every product upon receipt. Not all pharmacy trading partners will have this capability.
  • The inter-operative system envisioned in the Guideline differs vastly from what industry has been working on for years, many of the functionalities do not exist and such a system cannot be built by 2023.
  • Many do not believe the system should be a single technology as DSCSA articulates “alternative methods for compliance”.
  • The 3 day period to correct clerical errors and/or discrepancies on T3 documents is too short.
  • The products cannot be dispensed until the discrepancy is resolved and must be quarantined while the pharmacy conducts an investigation.
  • There are no provisions for exceptions or flexibility. This lack of flexibility will delay patient access to medications and present inventory management issues for pharmacies (it has been estimated than over half of wholesaler deliveries to pharmacies are intended for immediate dispensing).
  • Pharmacy groups are requesting a longer time frame and the ability to dispense the product if the error is clerical in nature.
  • Clarification has been requested regarding whether pallets or homogenous cases with aggregated data with broken tape or wrap that was not unsealed by the purchasing trading partner renders product immediately suspect. Pharmacies frequently receive “mixed totes” and heterogeneous cases of products, rather than homogeneous cases or pallets.
  • FDA access and/or system-to-system connectivity envisioned in the Guidance poses a number of legal risks involving privacy of business information, security, confidentiality, and potentially even constitutional due process issues.
  • Several sections of the Guidance are unclear; stakeholders cannot reach consensus on what is required.
  • The 3911 Notification process should be reconciled, aligned with, and not replace existing recall processes to avoid confusion.

Table 1.

Summary of FDA June 3, 2021 Guidance Provisions Affecting Pharmacy

Product Identifiers Under the Drug Supply Chain Security Act- Questions and Answers

(Final Guidance)

·       Addresses  identifiers required on each package and homogenous case of product, in human- and machine-readable form (i.e. barcode)

Drug Supply Security Act Implementation: Identification of Suspect Product and Notification

(Final Guidance)

 

·       Aims to help dispensers identify suspect products

·       A process is identified to assist trading partners to notify FDA (Form 3911) and respond rapidly when such products are found

·       Pharmacies should consult with manufacturers when conducting an investigation of suspect product

Definitions of Suspect Product and Illegitimate Product for Verification Obligations under DSCSA

(Revised Draft Guidance)

 

·       Provides working definitions for what constitutes suspect, illegitimate, diverted or counterfeit products and includes a definition for stolen product

·       Specific scenarios are provided to aid pharmacists in identification as well as scenarios that may increase the risk of suspect product entering the supply chain

Enhanced Drug Distribution Security at the Package Level under DSCSA

(New Draft Guidance)

 

 

·       Discusses changes that go into effect on Nov. 27, 2023 regarding interoperable electronic tracing including necessary system attributes

·       Identifies requirements for selling and purchasing trading partners

·       T3 clerical errors (e.g. missing data, incorrect address, quantity error) should be resolved within 3 business days and the product may not be sold until the error or discrepancy is resolved

·       Pharmacies should be able to respond to FDA data requests within 1 day

The increased inquiries we have received from pharmacists regarding DSCSA compliance and how community pharmacies will connect with an interoperable system, portends the need for education and clarity for the pharmacy community with regard to the 2023 requirements. Pharmacies are struggling to identify which systems will meet DSCSA requirements and which vendors can supply those systems. Another concern is whether Boards of Pharmacy  will place additional requirements for DSCSA compliance for license renewals and inspections.

As systems and processes for compliance with the 2023 deadline continue to evolve over the next 27 months, an approach that does not detract from efficient and effective patient care is needed. There is no one-size-fits-all approach to meeting the 2023 compliance deadline and pharmacies will need to determine what works best for them.

How Frier Levitt Can Help  

Pharmacists should consider assessing current policies, procedures, systems and processes to analyze potential implications by these new, revised and finalized documents. Our FDA and Life Sciences Regulatory Practice has the necessary experience to navigate the evolving implementation of the DSCSA. Contact us today.

 

[1] NB: The term used throughout the Guidance’s and DSCSA is “dispensers”. This term is an obsolete misnomer. The term is replaced with “pharmacy community”.

[2] Since histories will be totally electronic by 2023, it was be a T2 document.

[3] P.L. 113-54.

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