U.S. supply chain network

Quality and regulatory guidance

Find support for the quality, regulatory, and operational processes that help products move safely, so you can focus on patient care instead of regulatory complexity.
Disponible pour
  • Pharmacie
  • Cabinet de médecin
  • Gouvernement
  • Système de santé
Disponible en
  • États-Unis
Fonctionnalités associées
  • Distribution en gros et spécialisée
  • Solutions pour les fournisseurs
  • Solutions pour les systèmes de santé et les hôpitaux
  • Solutions destinées aux pharmacies

Navigate evolving quality and regulatory complexity with confidence

Quality and regulatory requirements are not getting simpler, and Cencora’s role is to help reduce that complexity for customers and partners. We build product integrity, regulatory readiness, and secure operating processes into how the supply chain runs every day — from manufacturer partners to sites of care. Through defined controls, experienced teams, product visibility, and coordinated issue management, we help reduce friction for your team, support compliant product and data movement, and build confidence across the healthcare ecosystem.

Product integrity

Defined controls support appropriate receiving, storage, handling, fulfillment, and transportation—including requirements for temperature-sensitive, specialty and controlled products.

Regulatory readiness

Network-wide quality systems, licensing, documented procedures, and inspection-readiness practices support compliance with applicable federal, state, and local requirements.

Coordinated issue response

Established processes for deviations, temperature excursions, returns, recalls, and suspect products help teams investigate issues, document actions, and communicate next steps.

DSCSA requirements

The Drug Supply Chain Security Act establishes requirements for serialized product tracing, verification, and interoperable data exchange across the U.S. pharmaceutical supply chain. Cencora provides operational support, resources, and communications to help customers and partners understand DSCSA requirements, support ongoing compliance, and manage impacts on product data, ordering, verification and returns.

NDC12: what you need to know 

Learn what the FDA’s 12-digit National Drug Code final rule may mean for product identifiers, data exchange, systems, and supply chain readiness.

Quality is built into how the supply chain operates

Quality and regulatory controls are integrated across the product journey, supported by standardized processes and dedicated teams throughout Cencora’s U.S. distribution network.

Receive and verify

Confirm product identifiers, lot information, condition, and temperature requirements when applicable.

Store and control

Maintain appropriate storage environments, inventory controls, restricted access, and traceability.

Fulfill and document

Apply standardized picking, packing, shipping, and record-keeping processes designed to support accuracy and product integrity.

Respond and improve

Investigate deviations and excursions, coordinate corrective actions, manage exceptions, and maintain audit-ready documentation.

Regulatory resources that support your compliance

As regulatory and data standards evolve, Cencora continues to monitor developments that may affect product traceability, product identification, and customer operations.

Controlled Substance Ordering System (CSOS)

The DEA system for electronic ordering of controlled substances.

FDA CDER NextGen Portal

The FDA CDER portal for regulatory submissions and industry support.

FDA Supply Chain Guidance

FDA guidance on pharmaceutical supply chain security and integrity.

Dedicated teams supporting quality and compliance across the network

Behind the scenes, specialized teams apply consistent quality systems, regulatory processes, and documented controls across Cencora’s U.S. distribution network to support product integrity, regulatory readiness, and coordinated action when issues arise.

Product and compliance issue management

Defined processes help identify, escalate, investigate, and resolve product-quality and compliance-related issues.

Deviation and corrective-action oversight

Teams document and investigate deviations, determine appropriate follow-up, and coordinate corrective and preventive actions when needed.

Inspection and audit readiness

Standardized procedures, documentation, and ongoing assessments support readiness for regulatory inspections and customer audits.

Returns, recalls and exception management

Coordinated processes support product returns, recall notification and quarantine, suspect-product review, and other distribution exceptions.

Licensing and regulatory reporting

Teams manage applicable facility licenses, registrations, reporting obligations, and regulatory documentation across the distribution network.

Temperature integrity oversight

Monitoring, documented handling controls, and excursion-investigation processes help protect temperature-sensitive products during storage and distribution.

Coordinating quality across the healthcare ecosystem

Quality and regulatory responsibilities are shared across manufacturers, distributors, and sites of care. Cencora works with trading partners on product data, pharmaceutical track and trace, secure distribution, and issue resolution to support consistency from product receipt through delivery. This coordination helps each organization meet its responsibilities with better information and clearer processes.

Explore our U.S. supply chain network

Take a closer look at the reach, infrastructure, and operational capabilities behind our U.S. supply chain network to learn how our coordinated distribution model helps support reliable product access, strengthen continuity, and serve sites of care with greater consistency and confidence.

U.S. supply chain network

Our U.S. supply chain network helps healthcare providers access the products patients need, stay resilient when disruptions happen, and prepare for what comes next.

Distribution excellence

How our wholesale and specialty distribution networks deliver, including cold-chain capabilities.

Supply chain resiliency

How we plan for disruption, build contingencies, and help protect product access.

Ressources connexes

he Drug Supply Chain Security Act (DSCSA) requires traceability and verification of prescription drug products

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Connect with our supply chain team

Our team of supply chain experts is here to assist you. Whether you have questions or need more detailed information, don’t hesitate to get in touch. We’re dedicated to providing the support you need.

Or, if you need general support or additional contact information, visit our Contact us page.