Marini-Bettolo G B
Ann Ist Super Sanita. 1975;11(3-4):254-68.
In every country drug control depends on the existence of technical norms which are generally represented by the Pharmacopoeia. In effects, since the beginning of XIII century, when the profession of pharmacist was for the first time established by law, pharmacopoeias have had not only the purpose of supplying the composition and the preparation of drugs, but also to establish and enforce the quality of the drugs. In the present times the pharmacopoeias adopted throughout the world by the different countries are intended mainly as a codex of specifications for the control of drug quality. These pharmacopoeias are national, regional and international. Nevertheless several difficulties can be found in the use of the pharmacopoeias for control of drugs, owing to the fact that not all the drugs, allowed and in therapeutical use are included in pharmacopoeias, and also because, in some cases, the final control is not sufficient to establish drug quality especially in the case of biological preparations. The existence of a Formulary or "Codex", beyond pharmacopoeia, may be of help for the control authorities but generally is not sufficient. Some suggestions are made in order to envisage a modern pharmacopoeia, considered as a dynamic collection of specifications of drug quality, always up to date, and thus in condition to fulfil its task for the need of the drug control by the health authorities in the aim of a better protection of public health.
在每个国家，药品管制都依赖于技术规范的存在，这些规范通常由药典来体现。事实上，自13世纪初首次依法设立药剂师职业以来，药典不仅旨在提供药品的成分和制剂方法，还旨在确立并执行药品质量标准。在当今时代，世界各国采用的药典主要用作控制药品质量的规范法典。这些药典包括国家药典、区域药典和国际药典。然而，在使用药典进行药品管制时会发现一些困难，这是因为并非所有获准使用且用于治疗的药品都包含在药典中，而且在某些情况下，最终检验不足以确定药品质量，尤其是生物制剂的情况。除了药典之外，存在一本处方集或“法典”可能对管制当局有所帮助，但通常并不充分。为设想一部现代药典提出了一些建议，这部药典被视为药品质量规范的动态集合，始终与时俱进，从而能够满足卫生当局为更好地保护公众健康而进行药品管制的需求，完成其任务。
