Legislation pharmacy preparation

The allowance of preparation of medicines in the pharmacy is not self-evident. The main aim of EU legislation is to ensure that medicinal products have a license. This requirement results in a comprehensive external control of the efficacy, effectiveness and safety of the pharmaceutical quality. Medicines prepared in the pharmacy don t have a license and but pharmacy preparation is an allowed exception to this rule. The reason for this exception is the need for some medicines which are not available with a license. The exception is only applicable to the patients of the pharmacist, which should have a prescription from the treating physician. The essence of the exception is limiting the patient s risk of getting an ineffective, inefficient and unsafe medicine by ... 

The Netherlands have not had their own national Pharmacopoeia, since 1993. Various other countries in Europe have retained their own national Pharmacopoeia. Examples are the British Pharmacopoeia (BP) [2] and the Deutsches Arzneibuch (DAB) [5, 6]. In these countries the national Pharmacopoeia is part of the legislative framework of pharmacy preparations. However, throughout Europe, the Ph. Eur. is the accepted standard and legally enforced. 

Section 35.5 is about Legislation and Quality Standards, for pharmacy preparation and for manufacturing. These give the quality objectives as well as some guidance how to create a PQS. 

In Volume 1, EU pharmaceutical legislation for medicinal products for human use, the main directive is Directive 2001/83/EC on the Community Code relating to medicinal products for human use. It is directed at licensed medicines. Pharmacy preparations are however mentioned in Article 40 ... 

Usually the date the medicine is dispensed will appear on the label. It is important to notice that this date may be different from the date it is actually delivered to the patient The date can be used as an instrument for tracing a dispensed medicine, but in most of the national legislation a batch number is required for pharmacy preparations... 

Most information in the book is universally applicable in the field of preparation and manufacturing of medicines. Eocus on specific items has been guided by European legislation and guidelines, and by country-specific examples put forward by the authors and an editorial advisory group. Most Countries in Europe have produced Guidelines, Publications and Textbooks to cover aspects of pharmacy that is of particular interest to their unique practice. The emphasis in each Country differs, usually as a result of some historic incident, which focused efforts in a particular direction. This... 

Pharmacy legislation defines the framework in which pharmacists can prepare medicines, however there are other legislative and quality frameworks that they must be aware of if other categories of products are requested, such as biocides, medical devices, or placebo s, or agents used for euthanasia Veterinary and homeopathic medicines are also dealt with, as are raw materials, especially hazardous materials and precursors. 

From those medicines prepared in one of a selection of European hospital pharmacies, half to three-quarters are available in the market in another EU country, North America or Australia [80]. Although the European legislation has been aimed at decreasing trade barriers since 2001, the purchase of medicines from other countries is an5 thing but simple. A patient is allowed to travel abroad and buy an authorised medicine for personal use and import it into Europe, however, a pharmacist can only import a medicinal product if he has a wholesale import authorisation. The complicated rules for reimbursement (in some Countries) and the amount of time the whole process takes, renders import a laborious way to make medicines available for the patient. 

Legislation for extemporaneous preparation of radiopharmaceuticals is in principle not different from extemporaneous preparation in general (Sect. 35.5). There is a great variation in interpretation and approach in Europe [14]. In some countries radiopharmaceuticals are prepared based on the pharmacy status of the radiopharmacy unit. In other countries radiopharmaceuticals are prepared in laboratories, in university institutions or research laboratories without pharmacy status, with authorisation based on radiation protection legislation only. 

In the context of this textbook legislation is discussed that affects preparation in pharmacies, mainly concerning exposure to chemical substances. Legislation provides the logic for determination of safe levels , for which risk acceptance by Society takes part. 

The quality characteristics of medicinal products and quaUty objectives of a preparing pharmacy or manufacturer are generally and sometimes in detail covered by European and national legislation and guidelines. A quality system for medicinal products will therefore have to connect with the appropriate legislation and professional guidelines that are meant to support their quality. 

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