Common Frequently Asked Questions

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Yes.

DSCSA does not regulate based on whether a practice operates a pharmacy or dispenses medications for take-home use. It regulates drug movement.

If your practice:

• Purchases Rx products
• Stores Rx products on-site
• Administers Rx products to patients
• Transfers product between locations

you are considered part of the regulated supply chain.

Reputation alone is no longer sufficient.

DSCSA requires practices to demonstrate:

• Authorized Trading Partner (ATP) sourcing
• Documentation tying purchased product to administered product
• Ability to reconcile inventory movement with patient use

Assumptions are no longer defensible without documentation.

 The most common risks are not intentional wrongdoing, 

but:

• Inability to prove sourcing
• Documentation gaps
• Vendor relationships assumed to be compliant but not verified
• Mismatches between purchased and administered product

Potential consequences include:

• FDA inspection findings (Form 483)
• Required corrective action plans
• Disruption to clinical operations
• Vendor or manufacturer scrutiny
• Reputational and financial risk

The cost is often not the fine itself, but the operational disruption and exposure once issues are discovered under scrutiny.

  Common risk amplifiers include:

• Injectable therapies
• Use of multiple distributors or secondary vendors
• Samples converting into billable use
• Expansion into other business models without operational redesign
• Product transfers between locations
• Authorized Trading Partner (ATP) sourcing
• Product identification and labeling
• Reconciliation between purchased product and patient      use
• Handling of suspect or illegitimate product
• Documentation that ties product to legitimate sources

Importantly, these evaluations are increasingly data-driven, not verbal or policy-based.

  A successful engagement delivers:

• Clear understanding of DSCSA exposure
• Verified vendor and sourcing posture
• Documented reconciliation between purchase and use
• Defined next steps prioritized by risk
• Confidence in responding to inspection or inquiry

The goal is clarity and defensibility, not perfection.

No.

No consultant, auditor, software provider, or advisor can guarantee that a practice will never receive a regulatory citation.

What this program does provide is a clear, evidence-based assessment of how your practice operates today, identification of where risk exists, and a defensible path to address it so the practice is not surprised or forced to react under pressure.

Regulatory outcomes depend on factors outside any advisor’s control, including:

• How recommendations are implemented
• Ongoing adherence to processes over time
• The scope and timing of an inspection
• Regulatory interpretation at the time of review

Practices are rarely cited for intent. Most citations result from documentation gaps, inability to demonstrate sourcing, or mismatches between purchased and administered product.

When all identified deficiencies are fully addressed, implemented, and documented, practices are in a strong position and historically have a very high likelihood of avoiding supply-chain-related findings.

This audit is designed to reduce risk by improving clarity, preparedness, and defensibility not by making guarantees.

What are the most common findings

• Authorized source verification

             Every Rx product traced to an authorized trading partner

• Purchase-to-administration reconciliation

             Every unit purchased matched to a documented patient administration

• Labeling and lot-level tracking

             Product identifiers cross-referenced to purchase records

• Suspect product procedures in writing

             A documented procedure communicated to all staff - Commonly called a Scope of    

             Work (SOW)