French Public Health Code
In forceAll entries and withdrawals of substances and medicinal products classified as narcotics are recorded by the persons mentioned in article R. 5132-76 in a register or recorded by a specific computer system meeting the following conditions:
a) It must not be possible to modify the data once it has been validated;
b) It must be possible to print out the information provided for in this article immediately at the request of any supervisory authority;
c) Each page published must include the name and address of the establishment.
The entry or recording of entries and withdrawals must be made for each operation, specifying the date on which it was made.
The entry or record of receipts includes the description and quantity of narcotics received and, in the case of pharmaceutical specialities, their description and the quantities received in dosage units.
The registration of withdrawals includes :
1° For magistral and officinal preparations, including those mentioned in article R. 5125-45, the designation and quantity of narcotics used;
2° For proprietary medicinal products, their description and the quantities dispensed in units of dosage.
A monthly balance of entries and withdrawals is entered in the register or printed out. These entries are made in ink, without blanks or overwriting.
Each year, an inventory of the stock is taken, by weighing and counting. Any discrepancies between the balance and the inventory are subject to control by the inspectors mentioned in article L. 5127-1 or, where applicable, by the official veterinarian, during the first visit following the establishment of the inventory. Any discrepancies noted are recorded on the inventory. This inventory is entered in the register in ink, without blank spaces or erasures or overwriting, or by electronic recording. It must not be possible to modify the data once it has been validated. The data must be recorded on a medium that guarantees its permanence and integrity. They must be duplicated on two separate media, the first used for normal consultation, the second kept in reserve. Archived data must be accessible, consultable and usable for as long as it is kept.
In the event of expiry, alteration or return, the pharmacist in charge of the pharmacy, or the veterinarian mentioned in article L. 5143-2, denature substances, preparations or medicinal products classified as narcotics in the presence of a colleague, appointed under conditions that exclude any reciprocity or conflict of interest by the president of the regional council of the pharmacists' association or, for pharmacists in overseas territories, the central council E, or, for veterinarians, the president of the regional council of the veterinarians' association. One month before the planned operation, it informs in writing the inspectors mentioned in article L. 5127-1, or, where applicable, the departmental director responsible for population protection, indicating the planned date, the names, quantities and all details of the forms and packaging of the products to be destroyed. Once the denatured products have been destroyed, it sends a copy of the document certifying this destruction to the inspectors mentioned in article L. 5127-1 or, where applicable, to the departmental director responsible for population protection. The procedures for destroying denatured products must comply with current waste disposal regulations. A document attesting to the destruction is kept by the holder at the disposal of the supervisory authorities. The model for the document certifying destruction is laid down by order of the ministers responsible for health and agriculture. These provisions also apply to residues resulting from the deconditioning of specialities.
The register, the computer records and the editions of these records per maximum period of one month as well as the documents attesting to the destruction are kept for ten years from the date of their last mention, to be presented at the request of the control authorities.
