What Does The Drug Supply Chain Security Act Do?
Until the Drug Supply Chain Security Act (DSCSA), the pharmaceutical industry had asserted that these actions were the work of wrongdoers outside of their direct control. The FDA prides itself on ensuring the safety and security of the nation’s drug supply, and something needed to be done to prevent offenders from harming patients. Hence, the DSCSA came to reality.
With the DSCSA, no longer can a pharmaceutical company claim victimhood to criminal elements in the supply chain. Now, pharmaceutical companies are responsible for ensuring the integrity of pharmaceutical products from dock to receipt at the pharmacy. This article will help clarify the key points of the law from a 40+ page document, into a shorter executive summary.
What To Expect From The DSCSA
The endpoint of this law is to have every unit (i.e. bottle) of prescription pharmaceutical product individually identified, tracked, and traced in a large database (called an Interoperable System), so that any illegitimate product can be quickly identified, quarantined and removed.
At each point of ownership transfer in the supply chain, the seller needs to provide a manifest that tells the buyer the list of owners up until the unit was released from the pharmaceutical manufacturer. This information can then be authenticated by scanning a barcode on the unit (starting in 2017) and comparing that history to the information in the database.
Tracking will also be employed at the case level and the pallet level, to simplify the tracking requirements for homogenous cases and pallets (i.e. full pallets and cases containing all units from a single lot number of product).
No such enormous database for tracking currently exists, so the law will be implemented in milestones. As of the authoring of this summary, traceability should already be implemented at the lot level (as opposed to the individual container/unit level).
Pharmacies (known as Dispensers in the law) have a grace period for receiving this information by March 1, 2016, but all other supply chain entities are required to provide the manifest stating all previous ownership transactions at the point of sale.
Some smaller pharmacies have outdated computerized systems, which present a challenge to transferring this data. This grace period will provide time for pharmacies to either procure the correct systems or to outsource maintenance of this information with a contracted entity.
What Is The Purpose Of The DSCSA?
The law provides a means of reporting illegitimate products online. Illegitimate products are counterfeit, stolen, diverted, adulterated, fraudulent, or otherwise unfit for distribution. While it is the pharmaceutical manufacturer’s responsibility to ensure that only legitimate product reaches pharmacies for dispensing, everyone is responsible for reporting a suspicious product, performing an investigation, and collaborating with the FDA and the pharmaceutical manufacturer to determine whether a “potentially” illegitimate product is, in fact, illegitimate.
The distribution system ensures that all points of material transfer are monitored and that the FDA is alerted of suspicious activity. Pharmaceutical handlers must investigate anomalies within 24 hours, or not more than 48 hours for weekends and holidays.
The FDA outlines specific information that needs to be documented when investigating a potentially illegitimate product. Investigations include specific sampling requirements for product inspection/test, a review of transaction history, documentation requirements, and the need to have investigation data available for review for 6 years after conclusion of the investigation.
What Impact Will The Act Have On The Industry?
The investigation requirements will change the way that pharmacies and pharmaceutical logistics providers do business. Dispensers are regulated by state boards of pharmacy, and logistics providers/wholesalers are also regulated by the states. This law brings these businesses under Federal jurisdiction, with significantly different (if not more stringent) requirements.
According to Michelle Bonn, CEO of Compliance Team, here are the three most important impacts this will have on manufacturers.
Technology Investments
Significant upgrades to serialization systems and electronic data management are essential for compliance.
Supply Chain Coordination
Close collaboration with trading partners is necessary to ensure the entire chain is prepared for electronic product tracing and verification.
Enhanced Safety and Efficiency
While the compliance costs may be high, the long-term benefits include a more secure, transparent supply chain and improved patient safety.
What’s Changed Already?
For logistics providers and pharmacy wholesalers, documentation has already increased, in anticipation of future FDA licensing standards. For now, the FDA currently accepts state licensure to become “authorized” and expects an annual update of the licensing status, company name, address, and facility identifier, any disciplinary actions for the last few years.
This will make it easier for the FDA to identify the most effective standards for supply chain control. In the future, the state standards move to a single standard for FDA “authorization” for logistics providers and pharmacy wholesalers, much as is done for “registration” in the European Commission GDP Guideline.
The list of logistics providers and wholesalers is posted already online. Interested pharmaceutical companies can use this information for selecting dependable logistics services for their products.
How To Comply With The DSCSA
As the November 2024 deadline for the full implementation of the DSCSA approaches, pharmaceutical manufacturers, wholesalers, and dispensers must be ready to comply with the new, critical requirements. These changes will enhance the security and traceability of the entire U.S. pharmaceutical supply chain, from manufacturer to pharmacy.
According to Michelle Bonn, the pharma industry needs to comply to the following in order to to be fully enforced by the act.
Electronic, Interoperable Track-and-Trace System
All prescription drug packages must now be serialized with unique product identifiers and tracked electronically throughout the supply chain to ensure authenticity.
Enhanced Product Verification
Manufacturers and trading partners must verify product identifiers before accepting or reselling products to prevent counterfeit, diverted, or stolen medications from entering the market.
Complete Product Traceability
Every transaction along the supply chain, from manufacture to dispenser, will need to be electronically recorded, creating full visibility at the package level to ensure safe and efficient recalls if needed.
Handling Suspect and Illegitimate Products
Processes must be in place to identify, investigate, and remove any suspect or illegitimate products. Illegitimate drugs must be reported to the FDA within 24 hours, protecting patients from unsafe medications.
Wholesaler and Third Party Logistics (3PL) Licensing
Wholesalers and 3PL providers must meet federal licensure standards and report their information to the FDA to comply with distribution regulations.
Are You Ready For The DSCSA?
The deadline is fast approaching. If your company is part of the pharmaceutical supply chain, it’s time to ensure full compliance. Compliance Team is here to help! Get in touch with our leading team of experts.