Chiropodists: Prescribing

Medicines which may be sold, supplied or administered by means of a specific exemption may be purchased wholesale.

MHRA advice on the use of chemicals by chiropodists and podiatrists 
We have been asked by the Society of Chiropodists and Podiatrists to clarify the position around the long established use of chemicals in podiatric practice.

We understand that chiropodists and podiatrists use several chemicals in practice - specifically liquid phenol, pyrogallol, monochloroacetic acid and salicylic acid. The first three have a corrosive action. Salicylic acid is primarily a keratolytic although it also has some analgesic properties.

Historically, these substances were considered to be medicinal products where medical claims were being made. However, the change to the definition of a medicinal product means that the mode of action is important in determining the regulations that apply to it. This is because where a substance does not have a primary mode of action which is pharmacological, metabolic or immunicological it falls outside the definition of a medicinal product.

The acids mentioned in the paragraph above are primarily chemical in action and therefore fall outside the definition of a medicinal product. This means they are not covered by medicines legislation. However, if they are placed on the market with medical claims, they will come within the remit of the medical device regulations and should therefore be CE marked as medical devices. At the moment, we are only aware of one phenol product on the market that falls into this category.

There is no bar to a chiropodist/podiatrist purchasing a chemical that makes no medicinal or medical claims for use in his practice. The Agency would expect that such use is accepted professional practice. The Agency also acknowledge that professional regulation of practice means that a chiropodist/podiatrist using these chemical products should be competent to do so and would abide by other relevant legislation related to the use of harmful substances, for example: Control of substances hazardous to health (COSHH).

Nevertheless, we understand that manufacturers of these chemical products may not be subject to approved quality assurance systems or any other safety requirements. As they are administered to patients, we would therefore recommend that the Society raises this issue directly with their suppliers to encourage them to manufacture their products as medical devices, complying with the requirements of the Medical Devices Directive 93/42/EEC and CE marking them accordingly.