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The Veterinary Medicines Regulations 2006 / Clarification: products containing citronella oil or eucalyptus oil

The Veterinary Medicines Regulations 2006, which came into force on 1 October 2006, revoke and replace The Veterinary Medicines Regulations 2005. The Veterinary Regulations 2006 were introduced by Statutory Instrument 2006/2407

The following changes from the Veterinary Regulations 2005 are relevant to pharmacists involved in the receipt and supply of veterinary medicinal products (VMPs).

A pharmacist may only supply a VMP classified as a POM-V, POM-VPS or NFA-VPS from registered pharmacy premises.

Written prescriptions Pharmacists supplying a VMP against a written prescription may only supply the product specified on that prescription. They must take all reasonable steps to satisfy themselves that the prescription has been written and signed by a person entitled to prescribe the product and must also ensure that it is supplied to the person named on the prescription.

A written prescription for a POM-V or POM-VPS must now include the telephone number of the person prescribing the product in addition to their name and address.

Where that prescription is for a Controlled Drug, it is now valid for 28 days (this has increased from three weeks) in accordance with the Misuse of Drugs Regulations 2001, as amended.

Supplies made under the cascade Pharmacists must not supply a medicinal product authorised for human use for administration to an animal, other than in accordance with a prescription from a veterinary surgeon that specifically states that the medicinal product is for administration under the cascade, either by that veterinary surgeon or under his direction and responsibility.

Pharmacists supplying a VMP for use under the cascade must ensure that the VMP is labelled in accordance with the Regulations. This includes the name and address of the pharmacy or veterinary surgery supplying the VMP. Previously there was a requirement to include the date of dispensing on the label. There is now a requirement for the VMP to be labelled with the date of supply.

Supplies of products for incorporation into feedingstuffs A pharmacist may only supply a VMP which is intended to be incorporated into a premixture or feedingstuff to an approved premixture manufacturer or an approved feedingstuffs manufacturer.

Records of the receipt or supply of prescription products When any person permitted under the Regulations to supply a VMP classified as POM-V or POM-VPS, receives or supplies any such VMP they must keep all documents relating to the transaction, which must now also include a record of the batch number.

However, where the VMP is for a non-food-producing animal, the batch number need only be recorded either on the date he receives the batch or the date he starts to use it.

The labelling of a VMP at the time of retail supply Pharmacists must not supply a VMP which is in the container specified in its marketing authorisation (MA) if any information on the outer packaging (or, if there is no outer packaging, the immediate packaging) is not clearly visible at the time of supply or has been changed in any way. This does not apply where a pharmacist amends the label in accordance with a prescription from a veterinary surgeon, provided that the unamended information remains clearly visible.

A pharmacist who supplies a VMP in a container other than that specified in the MA must supply sufficient written information (which may include a copy of the summary of product characteristics or the package leaflet) to enable the product to be used safely.

Guidance on the sale and supply of veterinary medicines is currently being updated, but will be on the Society’s website (www.rpsgb.org) in due course.

Clarification: products containing citronella oil or eucalyptus oil

Further to the recent Law and Ethics Bulletin regarding products containing citronella oil or eucalyptus oil (PJ, 7 October, p430), pharmacists should note that the information does not apply to medicinal products. As was clearly stated in the text, it is only biocidal products containing these oils that were required to be removed from the market by 1 September 2006. Pharmacists are advised to check stocks of biocidal products such as insect killers/ repellants and cat and dog flea preparations.

Citation: The Pharmaceutical Journal URI: 10007132

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