Pharmacopoeial services, or ‘drug making’ services, are not a new concept. The practice has been followed for centuries, and the idea of documenting services in pharmacopoeial volumes was common until relatively recently. As technology has advanced, however, printed volumes have fallen out of favor.
Today, new drugs are developed on a regular basis and it is hard for pharmacopoeial volumes to stay up to date. For this reason, there are now far more databases and records of drugs that are kept online.
With the passing of the Adulteration of Food and Drugs Act, which covers the use of pharmacopeial, and sets it as a standard for preparations and drugs, there have been some complications. Pharmacopoeia is really intended to be a standard for the composition of and the nature of, substances used in medicine. It is not, and was never intended to be a comprehensive database of everything and everyone in medicine. It is a purely pharmaceutical reference, and it should be treated as that. There are many things that are listed in the Pharmacopoeia that are not purely used in medicine – they also have other uses. Ingredients such as oil of turpentine, gum arabic, linseed oil, beeswax and others are used in numerous different applications from food to cosmetics, as well as in medicine. It is important for regulators, and for the markets, to understand that the regulations in the pharmacopoeial standards are for medical use and that commercial standards of purity will likely be different. Medicines are required to be pure, and to be held to incredibly high standards. There is less of a need for such exacting purity for something that is not being used in a niche where doses and contents are so strictly required to be regulated.
Tepnel Pharma Services suggest that some trade synonyms used in the pharmacopeial, and these offer a partial solution to the question of understanding what a pure substance is. For example, saltpeter is a purified form of potassium nitrate, and precipitated sulfur is sometimes called milk of sulfur. This is not necessarily a good solution, however, because it can create situations where a chemist may be prosecuted if they sell commercial grade goods for trade purposes, rather than the purified preparation. The British Pharmaceutical Code offers some solutions to this and is a step in the right direction when it comes to the challenge of regulating medicine in the United Kingdom.