Commercial Compounders

Commercial Compounders

Commercial Compounders manufacture unlicensed, aseptically prepared intravenous (IV) solutions which are used to treat and/or manage a range of diseases, disorders and medical conditions.

The IV solutions that the Commercial Compounders produce include chemotherapy, parenteral nutrition, antibiotics and Central Intravenous Additive Service (CIVAS).

What is aseptic preparation?

Aseptic preparation is the manipulation of sterile starting materials and components in such a way that they remain sterile and uncontaminated whilst being prepared for presentation in a form suitable for administration to patients. Aseptic techniques aim to prevent pathogenic organisms from being introduced to susceptible sites by the user, environment or equipment. IV solutions are prepared using carefully defined aseptic techniques and processes to avoid contamination. These include use of clean production facilities, clean clothing, non-touch techniques and environmental air filtration. Further methods include automated compounding devices, vacuum fill chambers or by the traditional method of gravity fill in appropriate sterile cabinets or isolators. Further specifics can be found here.

Commercial Compounders produce four main types of IV solutions :

  1. Chemotherapy: Chemotherapy is the use of cytotoxic (anti-cancer) drugs.
  2. Parenteral Nutrition (PN): PN is the provision of nutrition to patients intravenously via the veins in the form of a liquid infusion. The liquid infusion typically contains a nutritionally balanced combination of protein, carbohydrate, fat, minerals, electrolytes and vitamins. For more information visit the BSNA Parenteral Nutrition page.
  3. IV Antibiotics: IV antibiotics are antibiotics that are administered directly into the bloodstream.
  4. Central Intravenous Additive Service (CIVAS): CIVAS can include any preparation of a drug, which needs to be manipulated aseptically (e.g. reconstituted diluted or added to an infusion) to create a ready-to-use injectable drug.

Regulation

Aseptically compounded medicines are governed under the Human Medicines Regulations 2012, which sets out processes for the authorisation, manufacture, importation, distribution, sale, supply, labelling and marketing of medicines for human use. The Medicines and Healthcare Products Regulatory Agency (MHRA) is the government agency responsible for enforcing compliance to relevant legislation. As a result, aseptic compounding is highly regulated and must conform to rigorous standards set by the MHRA.

Unlicensed specials

A special unlicensed medicine is one that is manufactured without a Marketing Authorisation (MA) from the MHRA. Manufacturers of aseptically prepared compounded products hold a Manufacturing Specials (MS) license issued by the MHRA and are subject to regular audits to maintain high quality standards and retain their license.