Enacted in 2013, DSCSA is now taking 13 years to fully implement the federal regulations to the point of package-level (unit) traceability. We previously reported on FDA’s Guidance providing for a one year enforcement discretion period for the Drug Supply Chain Security Act (DSCSA)[1] requirement of electronic interoperability for tracking transactions to November 27, 2024. On June 12, 2024, FDA issued a two year exemption for implementation by pharmacies until November 27, 2026. The exemption only applies to small dispensers, which FDA defines as 25 or fewer full-time employees licensed as pharmacists or pharmacy technicians. FDA was made aware of the lack of readiness and the possibility of drug shortages and supply chain disruptions[2] that could occur if, on November 27, 2024, products not DSCSA compliant, i.e. products that do not have corresponding serialized electronic data records, suddenly could not be distributed or dispensed by pharmacies to patients.[3] FDA has now also re-opened the comment period which will end on September 12, 2024. Additionally, small dispensers and others who are unable to comply with the enhanced drug distribution security requests may request an exception/exemption by August 1, 2024.
Specifically, FDA reported that small dispensers have described challenges related to the time, costs, and resources needed to further develop the robust technologies and processes to enable data exchange, establish business relationships with their trading partners, and operationalize business practices. Many pharmacists continue to be unaware of the DSCSA requirements which are detailed in the FDA Guidance entitled “Implementing Interoperable Systems and Processes for Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug & Cosmetic Act” and the exemption FDA is granting is summarized in the Table below.
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· Requirement for all transaction data must be exchanged between trading partners using an interoperable electronic system. · Requirement for dispensers to verify the product identifier for incoming product, especially for serialization and respond to ‘verification’ requests from manufacturers and other trading partners (e.g. wholesalers) and requests from regulatory authorities (e.g. FDA and Boards of Pharmacy). · Requirement that the transaction information (TI) required to be exchanged include the product identifier at the package level for each package included in the transaction. · Requirement for systems and processes for verification of product be in accordance with standards established (see discussion below regarding Electronic Product Code Information Services (EPCIS) to verify the accuracy of prescription products ordered. Pharmacies need to have a Global Location Number (GLN) and Serialized GLN (SGLN)) · Requirement for systems and processes for gathering transaction information and responding to FDA, Board of Pharmacy, and other trading partner requests for transaction data. |
Especially problematic was the requirement for the receipt of Electronic Product Code Information Services (EPCIS) to verify the accuracy of prescription products ordered. Pharmacies need to have a Global Location Number (GLN) and Serialized GLN (SGLN), a type of pharmacy dispenser validation credential, for transmission of purchases moving through the supply chain. Most pharmacies have not even created their location number yet.
Pharmacies need to prepare for the DSCSA requirements with a November 27, 2026 FDA enforcement implementation to receive or exchange transaction information electronically and conduct package level verification. The implementation of systems to produce serialized transaction information in a readily retrievable manner and develop SOPs for regulatory or trading partner transaction data requests will take time, and pharmacies should start today, if they have not already, to ensure compliance with the new enforcement implementation date. That said, despite the DSCSCA granting an exemption for small dispensers until November 27, 2026, pharmacies should be aware of their obligations to make appropriate purchases and maintain inventory purchase information in accordance with their Pharmacy Benefit Manager (“PBM”) Provider Manuals and Agreements. PBMs continue to audit pharmacies to ensure their sourcing of inventory is valid and despite any exemption granted by the DSCSA, such audit measures are expected to continue.
How Can Frier Levitt Help
Our Life Science & Regulatory Practices guide our pharmacy clients regarding their DSCSA due diligence and risk management obligations and assist with GLNs, 3rd party service provider contracts, salable product returns, and preparation of SOPs. If you are looking to request an exemption/exception, Frier Levitt can assist with filing by the August 1st deadline or preparing comments for submission to FDA. Contact us to speak to a member of our team.
[1] P.L. 113-54.
[2] FDA Guidance. Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act- Compliance Policies. CDER, CBER, ORA. August 2023.
[3] Letter From T. Balderson and Ann Kuster, Members of Congress to FDA Commissioner, Robert M. Califf. August 1, 2023. https://balderson.house.gov/uploadedfiles/balderson_kuster_letter_to_fda_on_drug_supply_chain_shortage_act_dscsa.pdf.
