The Drug Supply Chain Security Act (DSCSA), signed in 2013 by President Obama, was set to take effect November 27, 2023. The main purposes of the Act are to give guidance on identifying illegitimate and suspicious products, make recalls more efficient, implement electronic track and trace systems, and define federal licensing standards. The DSCSA affects a variety of stakeholders, such as drug manufacturers, drug distributors, repackagers, and dispensers. The DSCSA only covers prescription drug products in their final dosage form, so items like compounded IV products are not included in its jurisdiction. The FDA issued a one-year delay until November 27, 2024, to ensure the supply chain continues to run smoothly as stakeholders adjust to the new standards.
The DSCSA puts some tracing requirements in place, such as tracking drug transaction history, mandating the storage of records for 6 years, and enhancing drug distribution security requirements, which will go into effect in November of 2024. It will soon be law to only accept ownership of products with compliant identifiers, including a 2D barcode, NDC, serial number, lot number, and expiration date on the label. It is mentioned that a QR code will no longer be acceptable on its own, so there is heavy emphasis on the 2D barcode. The Act also states that all parties involved must be licensed or registered, depending on the type of business. For example, pharmacies must be licensed, and manufacturers must be registered. PHSL has written about the specific requirements regarding the DSCSA since it was signed in 2013, with the most recent blog post from early 2023 available here.
A substantial change that will be implemented when the DSCSA debuts in November of 2024 is guidance on handling suspect and illegitimate products. Suspect products are those that the dispenser has a reasonable suspicion to believe are counterfeit or stolen, subject to fraud, or adulterated. On the other hand, illegitimate products show physical and credible evidence of the previously mentioned red flags. The protocol for each situation differs.
- For a suspect product, the product must be quarantined while the data is verified and the transaction history is confirmed. The report must be documented and maintained for 6 years. Pharmacies must verify the previously mentioned product identifier of at least 3 packages, or 10% of all products, or all packages if there are fewer than 3.
- For a confirmed illegitimate product, the Health and Human Services (HHS) secretary (via the FDA defined mechanisms) and the manufacturer must be notified within 24 hours of discovery. The product must be dispositioned (set aside from distribution) and samples must be retained upon the request of the HHS secretary or manufacturer. The product should still be quarantined with a report kept for 6 years just like with suspect products.
Another update is that transaction information must be electronically exchanged via a secure system. As of right now, it is acceptable for records to be kept on paper. In November of 2024, all records, new and old, must be transitioned to electronic format. The electronic requirement is a large part of the delay with the DSCSA going into effect, as it is difficult to get all stakeholders on the same page with the electronic transfer of information, most importantly in a secure system. In addition to this, independent pharmacies may not yet have in place or be able to afford such technology and will need to consult with third-party services. Transaction information must also include a product identifier on the physical packaging, as mentioned previously. Systems must be maintained to provide transaction information in the event of a recall or in situations with suspect and illegitimate products. All information must be tracked all the way back to the manufacturer.
There are a few reasons why the FDA delayed the DSCSA until November 27, 2024. First, the FDA stressed that the extension is not a justification to stop DSCSA implementation, but instead is a stabilization period to ensure the continued smooth running of the drug supply chain. The FDA approved the extension to give trading partners the time needed to finalize DSCSA processes and implement the required systems. These processes include implementation practices, troubleshooting problems, and preparing the systems for accurate and secure electronic data exchange. These systems will need to work between all sectors of the drug supply chain, including pharmaceutical manufacturers, wholesale distributors, and dispensers (pharmacies). Several advocates had a role in this extension, with perhaps the largest being the American Pharmacists Association (APhA). APhA strongly advocated to the FDA that readiness of all supply chain members was crucial to ensure that patients can get their needed medications accurately and safely on time, avoiding any unnecessary interruptions in the drug supply chain.
In addition to the initial delay, the FDA recently issued exemptions from specific requirements of Section 582 of the FD&C Act, pertaining particularly to small dispensers and applicable trade partners until November 27, 2026. This exemption gives small dispensers an additional opportunity to stabilize operations to fully implement the enhanced drug distribution security requirements part of the DSCSA. The FDA wants to allocate enough time for trading partners of small corporations to implement their systems to receive and exchange information electronically, conduct package level verification, and to develop standard operating procedures (SOPs) for regulatory or trading partner transaction data requests. This exemption period allows smaller dispensing pharmacies to reach full compliance with enhanced regulations of the DSCSA. Small dispensers deemed fit for this exemption, as of November 27, 2024, are companies that consist of 25 or fewer full-time employees that are licensed pharmacists or qualified pharmacy technicians.
With the one-year stabilization period coming to an end November 27, 2024 and no additional extensions anticipated, trading partners of the pharmaceutical supply chain that do not meet the requirements for the small dispenser exemption and are incapable of complying with the enhanced drug distribution security requirements of Section 582 of the FD&C Act by the end of this period may request a waiver or exemption from those requirements. These requests are expected to include a variety of information, including a statement describing a justifying reason for the request accompanied by applicable supporting documentation and any special circumstances of a product and/or transaction, as well as other pertinent information.
The FDA advises trading partners to submit a waiver/exemption request no later than August 1, 2024. The FDA evaluates each request on a case-by-case basis to confirm its necessity. FDA may also need to contact a requesting trade partner or other stakeholder to obtain additional information or clarification. The approval process requires extensive consideration, and it is not guaranteed that the waiver will be granted or denied by the November 27, 2024 cutoff. That being said, trading partners’ obligations to comply with enhanced security requirements will not be paused or extended upon request submission or even while the FDA reviews the case. The FDA firmly expects all to continue with their efforts to abide by the requirements until the request is approved or declined. For the small dispensers who fit the eligibility for the exemption, these pharmacies are still expected to make appropriate purchases and maintain inventory purchase information in accordance with their respective Pharmacy Benefit Manager (PBM). PBMs shall continue to audit pharmacies to confirm valid inventory sourcing despite any exemption granted by the DSCSA. If you are a trading partner still looking for a software provider to partner with and be DSCSA compliant, please reach out to PHSL for guidance.
References:
Waivers and Exemptions Beyond the Stabilization Period | FDA
Posted July 16, 2024