Invented by Mike Flanagan, Benny Delgado, Cheryl Wilson, Rohit Oberai, Preeti Singh, Richa Aggarwal, Amy Carney, Anilkumar Menon, Hammad Z. Muhammad, Satish B. Menon, United Parcel Service of America Inc

The market for systems and methods for supporting regulatory requirements for the distribution of controlled and non-controlled items is rapidly growing as businesses strive to comply with strict regulations and ensure the safe and legal distribution of their products. This article explores the importance of regulatory compliance, the challenges faced by businesses, and the emerging solutions in the market. Regulatory compliance is a critical aspect of any industry, particularly in sectors dealing with controlled items such as pharmaceuticals, chemicals, firearms, and alcohol. These industries are subject to stringent regulations imposed by government agencies to ensure public safety, prevent illegal activities, and protect consumers. Non-compliance can result in severe penalties, legal consequences, damage to reputation, and loss of business. The challenges faced by businesses in meeting regulatory requirements are numerous. Firstly, the complexity and ever-changing nature of regulations make it difficult for organizations to keep up with the latest requirements. Compliance involves understanding and adhering to a multitude of rules, including licensing, labeling, packaging, record-keeping, reporting, and security measures. Failure to comply with any of these can lead to serious consequences. Secondly, the distribution of controlled items often involves multiple stakeholders, including manufacturers, distributors, wholesalers, retailers, and end consumers. Coordinating and ensuring compliance across this supply chain is a complex task. Each stakeholder must have systems in place to track and verify the legality of the items being distributed, as well as the necessary documentation to prove compliance. To address these challenges, businesses are increasingly turning to systems and methods specifically designed to support regulatory requirements for the distribution of controlled and non-controlled items. These solutions leverage technology to streamline compliance processes, improve efficiency, and reduce the risk of non-compliance. One such solution is the implementation of robust tracking and traceability systems. These systems utilize unique identifiers, such as serial numbers or barcodes, to track the movement of items throughout the supply chain. By capturing and storing data at each stage, businesses can easily demonstrate compliance and quickly identify any potential issues or discrepancies. Another emerging solution is the use of automated compliance management software. These systems provide a centralized platform for businesses to manage and monitor their compliance activities. They can automate tasks such as license renewal reminders, regulatory reporting, and document management, reducing the administrative burden on businesses and minimizing the risk of human error. Furthermore, advancements in technology, such as blockchain and artificial intelligence, are being explored to enhance regulatory compliance in the distribution of controlled and non-controlled items. Blockchain, with its decentralized and immutable nature, can provide a secure and transparent record of transactions, ensuring the integrity of the supply chain. Artificial intelligence can analyze vast amounts of data to identify patterns, anomalies, and potential compliance risks, enabling proactive measures to be taken. In conclusion, the market for systems and methods supporting regulatory requirements for the distribution of controlled and non-controlled items is witnessing significant growth. Businesses are recognizing the importance of compliance and the need for efficient and effective solutions to navigate the complex regulatory landscape. By leveraging technology and innovative approaches, organizations can streamline their compliance processes, mitigate risks, and ensure the safe and legal distribution of their products.

The United Parcel Service of America Inc invention works as follows

The patent describes “Systems and Methods for Supporting Regulatory Requirements for the Distribution of Controlled and Non-Controlled Items such as, For example, Medical Devices, controlled Substances, and non-controlled Prescriptions (Rx) in Countries such as United States and Canada. The systems and method incorporate a module for license verification that performs license validation on a specific order for a controlled or non-controlled item. In some embodiments, the module compares data from an order to previously sorted data, and if there are any discrepancies, validation fails. The license verification module can also query a third-party database to obtain updated license information if validation fails. The systems and method also incorporate a suspicious orders monitoring module which is configured to perform multiple checks on an order in order to identify it as an “order of interest”. The systems and methods also incorporate a suspicious order monitoring module that is configured to perform a plurality of checks on the order in order to identify it as an?order of interest?

Background for Systems and Methods for Supporting Regulatory Requirements for the Distribution of Controlled and Non-Controlled Items

Field of Invention

The disclosed invention relates to various embodiments that support regulatory requirements in the distribution of controlled items and non-controlled products such as non-controlled prescriptions, medical devices and controlled substances, such as those found, for instance, in the United States, Canada and other countries.

Description of Related Art.

In the United States, distributors are required to register with the Drug Enforcement Administration. Controlled substances are drugs or chemicals whose use and possession is regulated by the Controlled Substances Act of the United States. Examples include prescription medications and narcotics. According to federal regulations, distributors registered with the government must verify licenses of customers and design and implement a system that identifies suspicious orders and reports them. Orders that are suspicious can include, but not be limited to, unusually large orders, orders that deviate substantially from the norm, unusually frequent orders, etc. If you fail to verify your licenses effectively and diligently reduce the number of suspicious orders, you may be fined or lose your privilege to ship these substances.

In the past, drug retailers have implemented a variety of stand-alone software applications to verify license information and/or identify suspect orders. In many cases, a threshold-based calculation will be used to determine suspicious orders. A customer might be assigned a threshold monthly for each controlled substance family. If the customer tries to place an online order above the threshold monthly, it is flagged suspicious. These approaches set a value for a number that is not automatically adjusted over time to reflect changes in customer behavior. These approaches also do not take into account other clients or customers of the same type that may place orders for controlled substances in the same family. These systems do not verify the license status when evaluating an order as suspicious. The license of a customer may not be valid or the predetermined threshold might not be accurate as seen across a larger sample of customers.

Therefore there is a need for an improved method and system for verifying license information and identifying suspicious order for a client in which the method and system automatically check license information and account for historic order data across a large sampling of clients and customers.

According to different embodiments of this invention, there is a system for identifying and verifying the customer license data that was received along with orders for controlled substances. The system includes one or multiple memory storage areas that store data related to parameters of a plurality customer regulatory licenses, and one or several computer processors. The one-or-more computer processors can be configured to perform the following tasks: “(A) receive an ordered for a regulated chemical from a client, where the order contains order data containing customer input data relating to one or several parameters associated with a plurality of regulatory licenses that are associated with the client; (B), retrieve at least a part of the data stored in the memory storage areas; [C] compare the customer input and the retrieved data to identify any discrepancies. (D)

According to different embodiments of the invention, a computer implemented method for license verification is provided in relation to orders of one of more regulated substances. The method can be embodied in various ways, including: (A), receiving and storing within one memory storage area, order data for an order placed by a client for a regulated chemical, where the order data comprises customer input data relating to the parameters of one of a plurality customer regulatory licenses. (B), retrieving at least a part of stored data from the memory storage areas.

According to different embodiments of the invention, an computer program product comprises at least one computer readable storage medium with computer readable program code portions embedded therein. The computer-readable code portions include a first executable part configured to receive data associated with the customer license that was received along with an order of regulated substances, a second executable part configured to compare the customer input data with at least a partial portion of the stored information in order identify one or multiple discrepancies, and a final executable section configured to generate one or several reports based on the comparison. The data that is associated with the license of a customer received by the first portion of the program code includes order data associated to an order placed by a client for a regulated chemical, where the order data comprises customer input data relating to the parameters of one of a plurality associated customer licenses; and stored information, which contains data pertaining to parameters of a plurality associated customer regulatory licenses. The third executable part is configured to: if no discrepancies are identified, generate a successful report of validation for the ordered, which approves further processing; if discrepancies are detected, generate an unsuccessful report of validation for the ordered, which prevents further processing.

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