Distribution categories | BSAVA Library

Distribution categories

Authorized small animal medicines within Great Britain now fall within the first four categories below and all packaging supplied by  drug manufacturers and distributors was changed in 2008. Medical products not authorized for veterinary use retain their former  classification (e.g. GSL, P, POM). Other laws apply in other jurisdictions. Some nutritional supplements (nutraceuticals) are not  considered medicinal products and therefore are not classified. Where a product does not have a marketing authorization it is designated ‘general sale’.

Authorized veterinary medicine – general sales list. This may be sold by anyone. 

Non-food animal medicine – veterinarian, pharmacist, Suitably Qualified Person (SQP). These medicines for companion animals must be supplied by a veterinary surgeon, pharmacist or SQP. An SQP must be registered with the Animal Medicines Training Regulatory Authority (AMTRA). Veterinary nurses can become SQPs, but it is not automatic.

Prescription-only medicine – veterinarian, pharmacist, SQP (formerly PML livestock products, MFSX products and a few P products). These medicines for food-producing animals (including horses) can only be supplied on an oral or written veterinary prescription from a veterinary surgeon, pharmacist or SQP and can only be supplied by one of those groups of people in accordance with the prescription.

Prescription-only medicine – veterinarian. These medicines can only be supplied against a veterinary prescription that has been prepared (either orally or in writing) by a veterinary surgeon to animals under their care following a clinical assessment and can only be supplied by a veterinary surgeon or pharmacist in accordance with the prescription.

These products, formerly known as Small Animal Exemption Scheme (SAES) products, are veterinary medicinal products (VMPs) that can be administered to minor species of small animals kept as pets (e.g. caged birds, fish, companion rabbits and small rodents), the active ingredient of which has been declared by the Secretary of State as not requiring veterinary control. They do not have a marketing authorization and are therefore not required to prove safety, quality or efficacy. They may be sold retail by anyone but must be manufactured to the same standards as authorized medicines and are subject to pharmacovigilance reporting. A wholesale dealer’s authorization (WDA) is required to sell these products wholesale.

Controlled Drug. A substance controlled by the Misuse of Drugs Act 1971 and Regulations. The CD is followed by (Schedule 1), (Schedule 2), (Schedule 3), (Schedule 4) or (Schedule 5) depending on the Schedule to The Misuse of Drugs Regulations 2001 (as amended) in which the preparation is included. You could be prosecuted for failure to comply with this act. Prescribers are reminded that there are additional requirements relating to the prescribing of Controlled Drugs. For more information see the BSAVA Guide to the Use of Veterinary Medicines.

Includes LSD, cannabis, lysergide and other drugs that are not used medicinally. Possession and supply are prohibited except in accordance with Home Office Authority. 

Includes etorphine, fentanyl, ketamine, morphine, methadone, papaveretum, pethidine, secobarbital (quinalbarbitone), diamorphine (heroin), cocaine and amphetamine. Record all purchases and each individual supply (within 24 hours). Registers must be kept for 2 calendar years after the last entry. Drugs must be kept under safe custody (locked secure cabinet), except secobarbital. There are specific requirements regarding the destruction of Schedule 2 Controlled Drugs, which may require an independent veterinary surgeon or person authorized by the Secretary of State to witness.

Includes buprenorphine, pentazocine, the barbiturates (e.g. pentobarbital and phenobarbital but not secobarbital – which is Schedule 2), midazolam, tramadol, gabapentin and others. Buprenorphine, with some others (e.g. diethylpropion and temazepam), must be kept under safe custody (locked secure cabinet); it is advisable that all Schedule 3 drugs are locked away. Tramadol, gabapentin and pregabalin are exempt from safe custody requirements but must follow CD prescription writing requirements. Retention of invoices for 2 years is necessary.

Includes most of the benzodiazepines except midazolam and temazepam (which are now Schedule 3), and androgenic and anabolic steroids (e.g. clenbuterol, nandralone). Exempted from control when used in normal veterinary practice.

Includes preparations (such as several codeine products) which, because of their strength, are exempt from virtually all Controlled Drug requirements other than the retention of invoices for 2 years. 

Extemporaneous preparations (also known as ‘veterinary specials’ and denoted as in the Formulations section of the monographs) are products that do not hold a marketing authorization. These products have not been assessed against the same standards of quality, safety (for the target animal, user, consumer and environment) and efficacy as authorized veterinary medicines. They can legally be prescribed, supplied and used under the last step of the cascade (see below). Extemporaneous preparations carry a higher risk than authorized medicines and this should be taken into consideration when prescribed. Manufacturers of extemporaneous products must be authorized (i.e. hold a ManSA) and comply with the general principles of Good Manufacturing Practice (GMP). Their facilities, equipment and procedures are regularly inspected to ensure they manufacture extemporaneous products to a set quality standard (Appendix of Useful Websites).

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