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.
Cencora associate verifying pharmaceutical product data for regulatory compliance.
Available for
  • Pharmacies
  • Physician practices
  • Government
  • Health systems
Available in
  • U.S.
Related capabilities
  • Wholesale and specialty distribution
  • Practice and clinic solutions
  • Hospital and health system solutions
  • Pharmacy solutions

Navigate evolving quality and regulatory complexity with confidence

Quality and regulatory requirements aren't getting simpler, and our role is to help reduce complexity for our customers and partners. Through defined controls, experienced teams, and coordinated issue management, we help reduce friction, 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 processes, including 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 response

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

DSCSA requirements

Regulatory checks
The Drug Supply Chain Security Act (DSCSA) 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 requirements, support ongoing compliance, and manage impacts on product data, ordering, verification, and returns.
Regulatory checks
Logistics quality control at Cencora.

NDC12: what you need to know 

Logistics quality control at Cencora.
Learn what the FDA’s 12-digit National Drug Code (NDC12) final rule may mean for product identifiers, data exchange, systems, and supply chain readiness.
Logistics quality control at Cencora.

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. We build secure operating processes into the U.S. supply chain to protect product integrity and support regulatory readiness. 

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 our 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 or 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. This coordination helps each organization meet its responsibilities with better information and clearer processes.

Cencora associate performs quality controls.

Explore our U.S. supply chain network

Take a closer look at the infrastructure and operational capabilities behind our network. Our coordinated distribution model helps support reliable product access, strengthens continuity, and serves diverse sites of care with confidence.
Cencora’s US pharmaceutical distribution network.

U.S. supply chain network

We help healthcare providers access the products patients need, stay resilient, and prepare for what comes next.
Cencora associate fulfilling pharmaceutical orders in a US distribution center.

Distribution excellence

We deliver wholesale and specialty products safely with a focus on continuity, visibility, and agile solutions for providers and patients.
Cencora team monitoring the US pharmaceutical supply chain.

Supply chain resiliency

We keep critical medications moving across the U.S. When disruptions occur, we help protect patient access and product availability.

Related resources

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

Article

One nation under the Drug Supply Chain Security Act (DSCSA)

Article

Building a more resilient pharmaceutical distribution ecosystem

Article

Distribution excellence: How the U.S. network delivers every day
 

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.