The origin of the audit

The choice of the audited pharmacy can be explained by:

• suspected regulatory violations(e.g., non-compliant website),
• thedesire to conduct targeted inspectionsat the regional or national level (e.g., alcohol sales),
• information provided by a colleagueregarding possible irregularities,
• areport from a customer.

Things you could get in trouble for

The irregularities identified by the inspector can be of two types:

• orders or directivesbased onnoncompliance with a law or regulation(e.g., dispensing veterinary drugs without a prescription, Art. L. 5143-5 of the Public Health Code),
• recommendations aimedatcorrecting operational failuresorhigh-risk violations that are not subject to enforceable legal provisions (e.g., failure to comply with cold chain management recommendations).

The pharmacy inspector also serves as a technical and legal advisor. Any professional issues can be brought to their attention.

In addition, if, during the inspection, you do not have or cannot locate a document requested by the inspector, inform them immediately that you will look for it and provide it as soon as possible.

Inspection in Practice

In practice, the inspection covers all regulations applicableto the practice of the profession:

• A pharmacist must be presentduring all business hours,
• Participation in on-call duty,
• Marketingfor the pharmacy (website, green cross, etc.),
• Reception facilities(private space, name badge, accessibility for people with disabilities, etc.),
• Product storage(temperature readings, etc.),
• Preparation and dispensingof medications (best practices, hygiene guidelines, prescription log, etc.),
• Narcotics Registry,
• Hygiene guidelines, 
• Viewing schedules.

What the inspector can do or ask

Tour the facilities(customer service area, preparation area, medical waste storage room, etc.)

Request the documentsnecessary for the audit andobtain copiesofthem (diploma, order book, access to software and data),

Collect samplesandquarantine the suspect productspending the results of the analysis.

The pharmacist mustprovide all documents requestedduring the inspection, or facepenalties.

If any discrepancies are found, the operator mustaddress each oneinwriting and maysubmit any missing documentson the day of the inspection as part of theirright to respond.

How can you best prepare for an inspection?

Be available and assist the inspector.

To seek assistance, after the inspection has been conducted, in responding to the report with the help of legal counsel, promptly providing all documents relevant to the defense of one’s interests to support one’s arguments.

Keep all supporting documents at the pharmacy to demonstrate compliance with applicable regulations to an inspector.

Take the initiative by contacting the regulatory agency to resolve a technical or regulatory issue and seek clarification on legal matters related to your personal situation.

Periodically verify the pharmacy’s compliance with pharmaceutical regulations, for example, using the practical guides in the “Summary of Regulations Applicable to Pharmacies ” (ARS Île-de-France) or the “Practical Guide to Pharmacy Operations” (Section A of the National Order of Pharmacists), particularly when developing new or mandatory activities.

If the inspection report includes provisional corrective measures to address the identified deficiencies, the pharmacist’s response must be concise, well-reasoned, and supported by documentation (photographs, contracts, etc.).