Re: Legal Requirements of Drug Labels

espicer.rvn — Thu, 29 Nov 2012 14:07:13 GMT

That's perfect, thank you!

Re: Legal Requirements of Drug Labels

Matthew Harrison — Wed, 28 Nov 2012 21:29:08 GMT

I've copied this from the Bsava guide to the use of veterinary medicines, hope it helps. Matt If a medicine is supplied in the container provided by the manufacturer, all information on the label/packaging must remain readable. Changes may only be made by a veterinary surgeon or by a pharmacist acting on instructions contained in a prescription written by a veterinary surgeon, and even then all of the original information must still be readable. If the medicine is intended for a condition and species listed on the datasheet there is no legal requirement for any additional label. However, it is the recommendation of the RCVS Professional Conduct Department that all supplied medicines should be labelled with the information listed below. If a VMP is supplied in a container other than that specified in the marketing authorization (details can be found in the datasheet), then the person supplying the VMP must ensure that there is sufficient information for the medicine to be used safely. Under the Veterinary Medicines Regulations (VMR) 2011, this legal requirement may be met by writing the information on a label or by providing a copy of the package insert. However, it is the recommendation of the RCVS Professional Conduct Department that all supplied medicines should be labelled with the information listed below. Only when using a medicine prescribed under the cascade is it legally necessary to attach a label, which must contain the following details: ■■ The name and address of the pharmacy, veterinary surgery or approved premises supplying the VMP ■■ The name of the veterinary surgeon who has prescribed the medicine ■■ The name and address of the animal’s owner ■■ The identification (including the species) of the animal or group of animals ■■ The date of supply ■■ The expiry date of the medicine (if applicable) ■■ The name or description of the medicine, which should include at least the name and quantity of the active ingredient(s) ■■ The dosage and administration instructions ■■ Any special storage precautions ■■ Any necessary warnings with reference to the user, target species, administration or disposal of the product ■■ The words ‘Keep out of reach of children’ and ‘For animal treatment only’. The words ‘For external use only’ for topical preparations.