Question 1

What makes CCE different from its competitors?

Accepted Answer

• Our price. CCE avoids the overhead costs and outrageously high compensation paid to senior executives that our competitors often indulge in: CCE labor costs are only incurred on a client-by-client basis.

• Our auditors. All on-site auditors are pharmacists with deep experience in 503A pharmacy practice. They often either work for or actually own such pharmacies. They therefore approach the audit experience with the client in mind, determined to be courteous, respectful, and informative.

• Technicians sometimes conduct the preliminary evidence review process - but they are the very best and brightest paraprofessionals out there, typically with many years of experience performing compounding. They are carefully trained on the audit process, have excellent "people skills," and are under the supervision of a pharmacist.

• Our attitude. Auditors have "been there and done that" regarding compounding. We've all been subjected to ill-informed, arrogant, arbitrary inspectors: this is what motivated us to create CCE! While we must expect your compliance with applicable standards, we are doing you a favor by doing so. The instant that we announce a deficiency we click into "Solution Mode," suggesting ways that you can resolve the finding.

Question 2

We think we're doing things pretty well: why should we pay for a CCE audit?

Accepted Answer

503A pharmacies are staffed by committed pharmacists doing all sorts of innovative things. CCE auditors have all had the pleasure of visiting large numbers of such pharmacies. They enjoy nothing more than sharing their experiences - and those of their colleagues - with clients during the inspection process.

Even the most well-read 503A leader who attends many conferences and has a large network of colleagues that he/she communicates with is very unlikely to have visited as many other pharmacies as the typical CCE inspector, or match what the "CCE brain trust" can bring to each inspection.

Question 3

Why do you insist on preliminary evidence review, versus doing this on-site?

Accepted Answer

Compliance with rules and regulations impacting 503A pharmacies involves a lot of documentation. Every minute spent on-site reviewing such documentation is a minute the auditor is not able to interact with the client. This is often a challenging process due to distractions, limited workspace, and the inability of the client to provide documentation.

It is costly to send an auditor to a pharmacy! Minimizing this on-site time saves money, which is another reason why CCE pricing can be so reasonable.

Insisting on the preliminary review of documentation allows  auditors to carefully review it without distraction or time limitations.

Deficiencies that are detected are brought to the attention of the client, who can then correct them before the on-site inspection even happens. If clients do not have all requested documentation, they  may create and submit it in advance, or show it to the on-site auditor.

Question 4

How do you ensure that one auditor says the same thing as the next one?

Accepted Answer

CCE realizes how frustrating this is to pharmacies. We take these steps to minimize this problem:
 • All CCE audits involve two auditors who review each other's work. 
 • CCE audit criteria are written to be clear and concise. Auditors are expected to carefully follow these criteria.

Question 5

What if we disagree with a deficiency?

Accepted Answer

CCE finds it extraordinary that some entities inspecting 503A pharmacies have no appeal process! CCE clients may challenge any audit "finding" that they do not agree with.

Client appeals are directed to CCE's Advisory Council (not the individuals involved in the audit) and given a full review. Pharmacies are then notified of the results of this review.

Question 6

Who gets to see our audit report?

Accepted Answer

That is your decision. CCE provides you with a final, detailed report that not only includes any deficiencies, but a suggested plan of correction, and a written list of most of the information and best practice recommendations. CCE "works for you" in this regard and will not share your report with any other entity.

Question 7

Do you share confidential information about other pharmacies when talking with other clients?

Accepted Answer

Absolutely not! Auditors will simply state that they have seen something or learned something at another pharmacy without revealing its identity. This never involves trade secrets or other sensitive information.

Question 8

Are on-site audits unannounced, or can we specify a date?

Accepted Answer

On-site audits are announced, and occur on a date agreed upon with the client. Unannounced audits serve no function for a voluntary audit process. CCE wants clients to be ready on the day of the audit in terms of staff availability and the presence of per diem workers if needed so as to free up leadership's time to interact with the auditor.

Question 9

I need an audit ASAP! What is the normal turnaround time?

Accepted Answer

CCE prides itself on rapidly addressing client needs. Our large number of auditors means that it is likely that we can audit you rapidly, instead of putting you on a long wait list.

After the audit, you will receive your accreditation decision within five business days, and your full report one business day after payment of any remaining balance.