DSCSA Preparation Readiness
It has been nearly 10 years since the Drug Supply Chain Security Act (DSCSA) was passed by congress to help ensure the integrity of medication distribution throughout the supply chain, while reducing/eliminating counterfeit medications.
The DSCSA has three main compliance components that need to be achieved:
- Lot-level tracking
- Product serialization
- Enhanced electronic tracing of products at the package level
Up until now, manufacturers and distributors have been working on-lot level tracking and product serialization. Now that the ability to track products has been completed, “dispensers” are now responsible for reporting their receipt of products. The deadline for complying with the final phase of the act is November 27, 2023. With the deadline quickly approaching, it is time to ensure all facilities are ready.
Where should I begin to comply with DSCSA?
- Know the law and the requirements for compliance
What is a GLN?
- A Global Location Number (GLN) is used by companies to identify their physical location
- GLNs enhance traceability throughout the supply chain
How do I obtain my facility’s GLN number?
- HealthTrust (HPG) is currently working to ensure all rostered accounts have a GLN
- Contact your CHC pharmacy account manager to obtain your facility’s GLN from HPG
What if we have a new facility that is not rostered; how do we obtain the GLN?
- Contact your CHC pharmacy account manager and they will connect you with the appropriate resource
- Non HealthTrust members or rostered members needing more than one GLN can go to GS1 to obtain a GLN
We have our GLN, now what?
- Ensure your GLN is shared with all trading partners involved in the supply chain process
What are examples of trading partners?
- Manufacturers and Repackagers
- Are required to affix product identifier information on each packages, which is then tracked by the dispenser receiving the product
- Examples of product identifiers are: (NDC, Serial number, LOT number, product expiration date)
- Dispensers (hospitals, clinics, physician offices)
- Must create a process to identify authorized trading partner (ATP) status of other entities in the supply chain
Are there any products that are exempt from DSCSA product identifier requirements?
- Blood or blood components intended for transfusion
- Certain radioactive drugs and biological products
- Certain intravenous products
- Any medical gas
- Homeopathic drugs marketed in accordance with applicable with FD&C Act
- Drugs compounded in compliance with 503A, 503B of the FD&C Act
Are there any other exemptions to be aware of?
- Yes, the following are exempt from barcode requirements
- Prescription drug samples
- Allergenic extracts
- Intrauterine contraceptive devices regulated as drugs
- Medical gases
- Low-density polyethylene form fill and seal containers that are not packaged with an overwrap
What are some operational things to consider when implementing the new DSCSA standard?
- Identify key stakeholders (buyers, providers, legal/regulatory, materials management)
- Determine SOPs and policies that need to be created
- Determine what education needs to take place and the targeted audience for this education
- Consider how to ensure tracking compliance with products that are received outside of the normal supply chain (drop-shipped items, direct orders, 340B products)
- Ensure to troubleshoot to ensure that any data errors in the DSCSA process do not disrupt patient medication access
- Consider using a third-party vendor to maintain compliance in case of an audit
- Compliance vendor on HPG contract (Inmar RX transparent)
What are the penalties for noncompliance with DSCSA by the deadline?
- Potential consequences include: fines, suspension or revocation of licenses, imprisonment, or civil penalties
For additional information please visit the HealthTrust Portal where DSCSA guidance documents are located.