Infectious feline peritonitis: prescription of dispensers' preparations

GS-441524, offered by some pharmacies, is a dispenser's preparation made on veterinary prescription, in accordance with Regulation 2019/6 as part of the therapeutic cascade. This solution is considered in the absence of a veterinary medicinal product authorised and appropriate for the pathology and species concerned. The production of these preparations must comply with the good extemporaneous preparation practices defined in the Order of 9 June 2004 and the good preparation practices (GPP) which are the enforceable standards for dispensing pharmacists to guarantee the quality of their pharmaceutical preparations by describing the requirements to be met including the use of quality raw materials.

As the dispensers' preparations are not subject to prior authorisation, no assessment of quality, safety or efficacy is carried out by the ANMV. The latter therefore does not carry out a specific assessment of the galenic form used. Dispensers' preparations are not evaluated by the ANMV because they are made to measure for a specific patient, unlike medicinal products with MAs that are subject to rigorous assessment for large-scale use.

It should be noted that advertising for dispensers' preparations is not allowed, as these preparations are designed to meet the specific needs of an animal, on the prescription of a veterinarian. They are performed individually and extemporaneously and are not mass-produced like medicinal products with a marketing authorisation (MA). Due to their special nature and the regulations in place, it is therefore not possible to promote them commercially.

These dispensers' preparations are included in the scope of pharmacovigilance and to date no side effects have been reported for these preparations. 

Veterinarians may use extemporaneous preparations in the absence of authorised medicinal products to provide appropriate treatment for animals. Currently, these preparations can be made by a dispensing pharmacy on prescription, either presented by the owner of the animal, or ordered by the veterinarian for professional use. Article L. 5143-9-1 of the Public Health Code provides for the possibility of subcontracting these preparations, but this requires the publication of a decree to be applicable. This decree is currently being drafted. In the meantime, veterinarians must comply with the current rules, which do not yet allow subcontracting for direct delivery to customers.