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Our Method and Approach

503A Regulations and Compliance
Risk Based Auditing for 503A Pharmacies
Collaborative Method of Accreditation
Experienced Compounding Pharmacy Auditors
Ongoing Compliance Support
2 Phase Accreditation Process

Preliminary Review of Documents

On-site Audit focused on observation, follow-up, interactions

Your Pharmacy is the Focus
Our Approach to Accreditation is Superior

Prepare clients for whomever might walk in the door:

  • USP

  • OBRA 90

  • GDP – Good Documentation Practices

  • HIPAA

  • DEA

  • FDA

  • State boards of pharmacy

  • Nonresident licensure inspections

Risk-Based Versus Checklist-Approach to Auditing

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How does CCE define “risk”?

  • Based on FDA’s ICH Q9(R1) definition:

  • Risk = Severity X Probability X Detectability

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​Scope of risk:

  • Patient harm

  • Worker harm

  • Financial harm

  • Litigation

  • Regulatory

  • Operational efficiency​​

  • Premium placed on providing suggestions and information, not just findings.

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  • Deficiency encountered? Auditor immediately clicks into “solution mode” with the client.

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  • Many pharmacies might be surprised at the number of initial “findings."​​​

​No other 503A accreditor invests the number of auditor hours that CCE does:

Auditor Hours Spent on 503A Accreditation

“Many pharmacies got serious about quality – about three months before they were due for their next survey.”

  - Rad Dillon, former PCAB surveyor

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  • CCE requires the submission of a small number of documents to maintain accreditation.

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  • If this is seen as onerous, the client has far bigger problems!

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  • Ongoing mini-self-audits.

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  • Ongoing presentations on key topics.

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  • While CCE refers clients desiring true consultative services to a small list of other entities, we’re always there to offer answers and advice.

A return to auditors with deep experience and expertise.

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A two-phase process:

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  • Preliminary office review of most documents

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  • On-site audit focused on observation, follow-up, interactions

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  • Multiple eyes on your processes and paperwork

Summary

  • Broad scope

  • Risk-based versus checklist-approach to auditing

  • Collaborative approach

  • Unprecedented auditor investment

  • On-going monitoring and support

  • Low overhead equals low cost

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