Drug Supply Chain Security Act (DSCSA)
What is the Drug Supply Chain Security Act?
The FDA enacted the Drug Supply Chain Security Act, also known as DSCSA, in 2013 to provide safeguards for consumers. This act helps protect consumers from exposure to counterfeit, stolen, contaminated or otherwise harmful drugs. Ultimately, DSCSA prevents the release of potentially harmful drugs into the pharmaceutical supply chain.
Why is compliance with DSCSA important?
Failure to comply with DSCSA requirements is prohibited and may result in civil and criminal penalties, injunction of unlawful activity and seizure of goods. In addition, individual state penalties may apply.
What is the timeline for DSCSA implementation?
Due to the complexities and effort required to achieve the requirements of DSCSA, the FDA put the following key milestones into place.
Manufacturers serialize product
Manufacturers verify SNI
T3 transmitted electronically
Repackagers serialized product
Repackagers associate and verify SNI
Wholesalers receive and ship serialized product
Wholesalers verify SNI including returns
Dispensers* receive and ship serialized product
Dispensers verify SNI
Unit level traceability with aggregation and interference
Interoperable electronic system
How does DSCSA impact EMS?
The FDA has specific requirements for pharmaceutical manufacturers and distributors to be compliant with DSCSA. The federal DSCSA regulation now requires pharmaceutical manufacturers to serialize (apply a “product identifier”) on all prescription drug products.
This regulation went into effect on November 27, 2019 for pharmaceutical distributors. It prohibits all pharmaceutical distributors and wholesalers from selling pharmaceuticals below the lowest serialized unit of measure. It is up to the discretion of the pharmaceutical manufacturer to determine the lowest unit of measure quantity (i.e. each, box, case, etc.) they will serialize. As a result, a number of pharmaceuticals historically sold at the individual “each” quantity will not contain serialization required to permit future purchases at the smaller unit of measure.
The Drug Supply Chain Security Act and Bound Tree Medical
As your partner in EMS, Bound Tree takes compliance of healthcare regulations very seriously to ensure patient safety as well as our customers’ compliance to their local regulatory standards. Beginning in November 2019, Bound Tree will no longer sell low unit of measure quantities of prescription drugs unless they are serialized.
*Dispensers: Under DSCSA, dispensers include retail pharmacies and hospital pharmacies under common ownership and control. Any person authorized by law to dispense or administer prescription drug and affiliated warehouses distribution center of such entities under common ownership or control.