With DSCSA Compliance Delay, Certain Requirements Still Require Action Now
Launching development of SOPs and communication with wholesalers is key.
The final phase for implementation of the 2013 Drug Supply Chain Security Act (DSCSA) was to have taken effect on November 27, 2023, with requirements for pharmacists to meet new compliance standards.1 The DSCSA, which helps achieve interoperable, electronic tracing of products at the package level for certain prescription drugs as they are distributed throughout the country, also helps to improve detection and removal of potentially dangerous drugs from the US drug supply chain.2 To accomplish this, the DSCSA creates a tighter, closed prescription drug distribution system that allows for easier detection of harmful drugs and enables a rapid response when such drugs are found.2,3
In 2023, various pharmacy organizations filed a joint letter seeking phased implementation and requesting a delay. A wholesaler trade association, the Healthcare Distribution Alliance, had estimated that only about 35% of manufacturers are sending serialization data to trading partners. On August 1, 2023, members of the US Congress warned the FDA of drug shortages and supply chain disruptions, explaining that if the DSCSA is upheld on November 27, 2023, products not compliant (ie, products that do not have corresponding serialized electronic data records) cannot be distributed or dispensed by pharmacies to patients.4 On August 9, 2023, the FDA announced its intention to contract with a consulting firm to perform a technology and software assessment of the ability of small dispensers (defined under the DSCSA as having 25 or fewer employees) to comply with the electronic operability tracing of products at the package level.5 All of this culminated on August 25, 2023, when the FDA issued guidance establishing the need for enforcement discretion regarding the electronic interoperability for tracking transactions until November 27, 2024.6
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Most pharmacists were aware of the approaching requirements that all transaction data needed to be exchanged between trading partners using an interoperable electronic system. However, many pharmacists were not aware of the DSCSA requirements for suspect or illegitimate product, standard operating procedures (SOPs), changes to transaction data, sales to other pharmacies and generating Electronic Product Code Information Services (EPCIS), and product returns. Considering these challenges, it is important for pharmacies to take steps now to develop SOPs and reach out to their wholesalers.
Suspect or Illegitimate Product
After November 27, 2024, all trading partners must work together when determining whether a product is illegitimate, including a duty to notify one another if FDA Form 3911 is submitted. Pharmacies may already do this, but after November 2024, it will be their duty to check incoming product (especially regarding serialization) and perform investigations. Pharmacies also will be required to retrieve transaction data quickly and respond to verification requests from manufacturers and other trading partners (eg, wholesalers) and requests from regulatory authorities (eg, FDA and boards of pharmacy).
Storage of Data
Currently, pharmacies store purchase data in their computer systems or in hard copy folders. With the electronic operability requirement for transaction data, pharmacies will have the option of using their wholesaler’s portal to store and retrieve transaction data. However, they will be required to have a written agreement in place with each wholesaler indicating that the wholesaler will be keeping its own data for the pharmacy. The alternative is for pharmacies to use a third-party service provider where all the transaction data from wholesalers and manufacturers (direct buying) will be pushed. The data (using EPCIS) can be stored in the pharmacy or the third-party location but must be readily retrievable and kept for 6 years. For the purposes of transaction data, pharmacies must obtain a Global Location Number (GLN), which is a unique identifier specific to a particular pharmacy location (notably, this must be changed if the pharmacy changes location). There is no exception for 340B contract pharmacies, and both the covered entity and the contract pharmacy will need a GLN. Additionally, only the covered entity can share transaction information with the contract pharmacy. Wholesalers will not be permitted to do so as the covered entity, as they are considered the purchaser.
Changes to Transaction Data
Serial numbers, lot numbers, and expiration dates are transaction requirements that after November 2024 must be provided electronically (paper or advance shipping notice files will no longer be acceptable). Much of this is already contained within 2D matrix barcodes. Further, transaction history (TH) will no longer be required as it will be electronic, turning the so-called T3 (TH, transaction information [TI], transaction statement [TS]) into a T2 (TI, TS) document.
Importantly, if a pharmacy sells product to another pharmacy, the 5% rule exemption is no longer applicable (DSCSA is a federal law that preempts any state 5% rule) and the pharmacy must register as a wholesaler. This effectively bars the pharmacy-to-pharmacy transfer of product unless under limited circumstances. The only exception is a sale to another pharmacy to fill a patient-specific prescription or limited distribution to practitioners for office use (if permitted under state law). In every case, the pharmacy must generate transaction data via EPCIS and send it electronically to the other pharmacy.
SOPs
After November 2024, pharmacies will be required to have systems and processes in place for enhanced drug distribution security. Because wholesalers will not be able to advise pharmacies on their SOPs or respond directly to regulatory or trading partner transaction data requests, pharmacies will need SOPs specific to their practice. At a minimum, SOPs will be required for: (1) vetting/purchasing from authorized trading partners (eg, state license and FDA listing verification), (2) investigating suspect/illegitimate product, and (3) responding to FDA, board of pharmacy, and other trading partner requests for transaction data. Pharmacies should prepare these SOPs now as the guidance delays FDA enforcement until 2024 but does not delay the November 2023 requirement itself.
Salable Product Returns
In its guidance, the FDA has also delayed enforcement of the requirement that wholesalers and reverse distributers look beyond the National Drug Code number when processing salable returns and match up product with the transaction data and the product identifier, including the Global Trade Item Number (GTIN), serial number, lot number, and expiration date on each package or each sealed homogenous case. Each person accepting a salable return must have systems and processes in place and may only accept salable returns if they can associate the salable return product with the transaction data for the product.7 The transparency of serialization will permit wholesalers to match up serial numbers with transaction data and will effectively prevent any return of product to a wholesaler if the pharmacy did not buy it. Wholesalers will only accept a product return into salable inventory if they sold that specific GTIN, serial number, lot, and expiration date to a pharmacy. Pharmacies will need to better manage their inventories because they will not be able to return product received from one wholesaler to another wholesaler. Pharmacies will also need to be mindful of different return goods policies.
Conclusion
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.
References
1. Drug Quality and Security Act, Pub L No. 113-54, 127 Stat 587 (2014). US Government Publishing Office. Accessed October 17, 2023. https://www.govinfo.gov/app/details/PLAW-113publ54/related
2. Drug Supply Chain Security Act (DSCSA). FDA. September 8, 2023. Accessed October 20, 2023. https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa
3. Pharmacists: Utilize DSCSA Requirements to Protect Your Patients. FDA. January 19, 2022. Accessed October 20, 2023. https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/pharmacists-utilize-dscsa-requirements-protect-your-patients
4. Balderson T, Kuster A,Miller-Meeks M, et al. Letter to FDA on Drug Supply Chain Security Act (DSCSA). Congressman Troy Balderson. August 1, 2023. Accessed October 17, 2023. https://balderson.house.gov/uploadedfiles/balderson_kuster_letter_to_fda_on_drug_supply_chain_shortage_act_dscsa.pdf
5. Drug Supply Chain Security Act (DSCSA) assessment of small dispensers. FDA. September 5, 2023. Accessed October 17, 2023. https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/drug-supply-chain-security-act-dscsa-assessment-small-dispensers
6. US Department of Health & Human Services; United States Food and Drug Administration; Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research; Office of Regulatory Affairs. Enhanced drug distribution security requirements under Section 582(g)(1) of the federal Food, Drug, and Cosmetic Act—compliance policies. August 2023. Accessed October 17, 2023. https://www.fda.gov/media/171592/download
7. Title II of the Drug Quality and Security Act. FDA. December 16, 2014. Accessed October 17, 2023. https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/title-ii-drug-quality-and-security-act
About the Authors
Martha M. Rumore, PharmD, MS, LLM, FAPhA, Esq, is a pharmacist-attorney in the Life Sciences Department at Frier Levitt.
Jesse C. Dresser, Esq, is a partner in Frier Levitt’s Life Sciences Department and heads the firm’s Pharmacy Practice Group.
