in an industry where increasing regulatory scrutiny is the norm. Proactively identifying industry complexities helps manufacturers create a clear plan for handling pharmaceutical product recalls, retrievals, and returns. Establishing the most appropriate infrastructure is a crucial first step in successful planning and execution.
Stericycle Expert Solutions’ quality-driven processing infrastructure includes state-of-the-art security, segregated storage of recalled product, advanced product handling equipment, and the surge capacity to assist clients in all steps of the pharmaceutical product lifecycle.
Both over-the-counter drug manufacturers and retailers face the daunting task of notifying consumers during the recall process. The wide distribution and use of these products complicates the logistics of their removal. The Stericycle global field team can help remove affected products from shelves with the speed and accuracy required by regulatory agencies. To meet operational challenges, our trained recall consultants offer critical drug recall services including: on-site product effectiveness checks, notification services, product processing, secure storage facilities, and government-mandated preparedness planning.
Effective recall management requires immediate access to pharmaceutical distribution lists in order to reach vast networks of retailers, pharmacies, medical providers, and — most importantly — patients. Unfortunately, many manufacturers have gaps in their distribution networks, which can delay their recall response. An industry-leading planning and implementation process, combined with proven tools and expertise, help Stericycle enhance the speed and effectiveness of pharmaceutical recall notifications.
Despite rigorous clinical testing and a stringent new FDA drug approval process, prescription drug recalls continue to occur. When any single oversight could lead to class action litigation, unprecedented fines, or even imprisonment, pharmaceutical recalls have no margin for error. The right team of recall experts can handle a pharmaceutical recall or withdrawal of any size. From satisfying complex regulatory guidelines to coordinating seamless notification and response, product retrieval, storage, and ultimate product disposition, the Stericycle team is singularly qualified to navigate prescription drug recalls.
Our proprietary recall data management system enhances visibility, monitoring, and tracking during each step of the recall lifecycle. Additionally, utilizing a central data repository helps manufacturers ensure timely and accurate compliance reporting to regulatory agencies. From planning and initiation through execution, reporting, and termination, Stericycle has brought unparalleled experience while managing recalls of all sizes for 17 of the top 20 pharmaceutical companies.
To effectively manage product returns, pharmaceutical companies need streamlined processes and a proven infrastructure. Our fully automated, in-house tracking and monitoring services simplify the returns process to effectively handle expired and nonperforming inventory, reduce human error, and increase processing efficiencies. With fast returns processing and a focus on accurately applying each manufacturer’s specific return policy, the Stericycle system efficiently generates the data necessary for reimbursement.