FDA Delays DSCSA Electronic Interoperability to November 27, 2024
On August 25, 2023, the FDA issued a 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. The delay was actively sought via letters by various pharmacy groups, wholesalers, as well as several members of Congress. The letters warned the FDA about potential drug shortages and supply chain disruptions[2]. Specifically, they highlighted concerns that if products not compliant with DSCSA — those without corresponding serialized electronic data records — were suddenly unable to be distributed or dispensed by pharmacies to patients after November 27, 2023, it could lead to significant issues[3].
Pharmacists need to take steps now to be in full compliance with key requirements of DSCSA, which will be enforced beginning November 27, 2024, including:
- All transaction data must be exchanged between trading partners using an interoperable electronic system. Pharmacists should reach out to their wholesalers to either use the wholesaler portal or use a 3rd party service provider. It is important to decide where transaction data from direct buying from manufacturers and purchases from small/secondary wholesalers will be maintained. There will need to be a written agreement with these entities.
- Develop processes to rapidly check 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).
- Pharmacy to pharmacy transfer of product not pursuant to a patient specific prescription or common ownership will be prohibited and pharmacy to prescriber transfer for office use (even if permitted under state law) will be limited. In every case, the pharmacy will need to generate transaction data.
- At a minimum, SOPs will be required for: 1) vetting/purchasing from authorized trading partners; 2) investigating suspect/illegitimate product; and 3) responding to FDA, Board of Pharmacy, and other trading partner requests for transaction data.
- Return of salable product will require that the pharmacy provide transaction data and will effectively prevent any return of product bought from one wholesaler to another.
How Can Frier Levitt Help
Pharmacies need to prepare for the November 27, 2023 DSCSA requirements with a November 27, 2024 FDA enforcement implementation to receive or exchange transaction information electronically and conduct package level verification. Systems to produce serialized transaction information in a readily retrievable manner for regulatory or trading partner transaction data requests should be implemented. 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. 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.
