The Controlled Substances Act (CSA) requires manufacturers and distributors to have a system for detecting suspicious orders. To comply with this, DCS uses a Suspicious Order Monitoring System (SOMS) with an algorithm that flags orders with unusual size, pattern, or frequency for review, as outlined in 21 CFR 1301.74(b). Suspicious order monitoring is important because it helps prevent the misuse and diversion of controlled substances, such as opioids. By identifying unusual order patterns—like large quantities or frequent reorders—companies can detect potential red flags for illegal activity. This monitoring protects public health, supports compliance with federal regulations, and reduces the risk of fines, penalties, or license suspension for the business.You may be contacted to provide information about flagged orders. Our compliance staff will use this information to investigate and adjudicate these orders before shipping.
All customers receiving controlled substances from DCS must complete our KYC process. The goal is to verify and understand our customers. This includes filling out our KYC form and potentially participating in a KYC interview with our compliance staff. This process will be repeated at least every two years, or more frequently based on order volume and other factors.
Our SOMS process includes order monitoring algorithms and manual reviews to flag, investigate, and report suspicious or excessive order patterns in line with DEA expectations.
DSCSA, the Drug Supply Chain Security Act, is a U.S. federal law aimed at enhancing the security and traceability of prescription drugs throughout the supply chain. It establishes a national system for tracking and tracing pharmaceutical products to the packaging level, helping to prevent counterfeit, stolen, or contaminated drugs from reaching patients. Manufacturers, packagers, distributors, and dispensers are all subject to the requirements set forth by DSCSA.
Yes, as of November 2024, DCS is fully complaint with DSCSA.
GDP (Good Distribution Practices) is a subset of GMP (Good Manufaturing Practices) that specifically addresses the storage, transport, and distribution of pharmaceuticals. Adherence to GDP requirements ensures the quality, safety, and efficacy of pharmaceuticals is maintained throughout the supply chain. GDP prevents contamination, mixups, and product deterioration throughout distribution.
DCS has a dedicated Compliance team that monitors the licensing requirements of each state and US territory to ensure that DCS stays current on licensing requirements throughout the US.
External visibility into orders and inventory levels is provided through Power BI dashboards, which are refreshed every few hours to ensure up-to-date information. In addition, clients receive four automated daily email summaries detailing shipments, receipts, inventory levels, and open orders. Internally, DCS relies on our Warehouse Management System (D365), which offers real-time access to order and inventory data across all operational areas.
From an inventory standpoint, daily in-house audits are conducted to verify the accuracy of recorded inventory levels. This proactive approach ensures that the quantities listed in the system reflect what is physically available, allowing Operations to respond quickly and accurately to client requests as they come in.
Yes, DCS is registered with the FDA where applicable and complies with all required reporting and inspection readiness standards.
Controlled substances are managed under strict DEA guidelines, including physical security, inventory controls, SOMS monitoring, and required reporting.
We provide all required documentation, facility access, and personnel to support both internal and external audits or inspections related to licensing, DEA, or FDA.
Yes, our SOPs are reviewed on a scheduled basis and updated promptly in response to regulatory changes or process improvements.
In addition to routine monitoring of state and federal requirements, DCS is subscribed to third party organizations that monitor and provide updates from federal agencies.
Yes, DCS has two cold storage facilities. One unit that can accommodate up to 280 pallets, and a new, high security cooler that can accommodate up to 1800 pallets.