Regulatory Requirements for Small-Scale Preparation of Radiopharmaceuticals

INTRODUCTION . The concept of pharmacy preparation of radiopharmaceuticals (RPs) was first introduced in Russia with the entry into force of the Federal Law No. 61-FZ “On Circulation of Medicines” of 12 April 2010. Recently, significant legislative changes have been gained regarding RP production and preparation. Today it has become possible to make unregistered RPs at a medical organisation covering the in-house needs, which will allow to promptly advance new methods and means to treat malignant neoplasms as well as some other diseases. AIM . This study aimed to analyse main growth vectors for Russian organisations planning to preparing RPs. DISCUSSION . The term “nuclear pharmacy” is applied to a special unit of a medical organisation where RFLP synthesis and quality control is carried out. The practice of foreign hospital nuclear pharmacies has proven their advantages in terms of ensuring the shortest route of vital drugs to patients. The article analyses the main requirements of Russian regulatory documents and recommendations on the functioning of a nuclear pharmacy, as well as the experience of the first nuclear pharmacy based on A.F. Tsyb Medical Radiological Research Center — Branch of the National Medical Research Center of Radiology of the Ministry of Health of the Russian Federation. Regular work of the radiopharmacy allows to treat up to several hundred patients with vital but not yet registered drugs. However, nuclear pharmacies are far from being a routine practice for Russia, and a number of issues has to be addressed to allow for a proper function of these pharmacies: creating a training system for radiopharmacists; defining the scope of preliminary studies of RPs extemporaneously produced at a pharmacy; updating radiation safety documents regulating process launch for new radionuclides at a pharmacy, and so on. CONCLUSIONS . The world practice of hospital radiopharmacies has proven this system effective for RP commerce. Globally, approaches to RP preparation may be defined at the national or regional level. Pharmacies authorised to prepare RPs is a new type of pharmacy not previously known in the EAEU Member states. The creation of a regulatory framework for RP preparation should accommodate world practices with proven efficiency. The high-priority tasks to be addressed are training specialised personnel; revising a variety of documents on radiation safety; creating an expert panel assisting numerous issues associated with developing radiopharmacies; and obtaining funding sources for RP treatment.