## 3 Results
### Compliance of Latvian Laws with the Requirements of the Resolution
344 provides that only those active substances can be used in the compounding of extemporaneous preparations, which were purchased from manufacturers and distributors registered with SAM. Active substances should be produced in accordance with principles of good manufacturing practice and guidelines [21]. CM Regulations No. 288 provide that it is the duty of the head of a pharmacy to draft instructions for compounding and control of extemporaneus preparations, while the pharmacist's task is to compound extemporaneous preparations in accordance with the instructions approved by the head [15]. Having carried out quality control of the compounded medicinal product, a pharmacist issuing the medicinal product shall check compliance of packaging of the medicinal product with physical and chemical properties of the components included in the medicinal product [16]. Latvian regulatory enactments do not provide for reconstitution of medicinal products in health care establishments in accordance with Paragraph 9 of the resolution. The Latvian regulations meet the requirements of Paragraph 10 \"Authorisation for pharmacies or licences for companies making preparations for pharmacies\" of the resolution. In accordance with CM Reg. No. 800 a licence should be received to open a community pharmacy. A licence for opening (operation) of a pharmacy is issued by SAM, and it is entitled to suspend and renew the licence [24]. In Latvia preparation of extemporaneous medicinal products is within the competence of pharmacies only. The Pharmaceutical Law defines preparation of medicinal products as a component of pharmaceutical care [19]. In order to compound extemporaneous preparations, a pharmacy should receive permission from SAM, which specifies the special operation condition \"preparation of medicinal products in the pharmacy\" in the annex to the licence [24]. Community pharmacies may prepare medicinal products for an individual patient based on individual prescriptions or upon a written request of a medical institution [19]. Since the compounding of extemporaneous preparations is an additional service of a pharmacy and not all Latvian pharmacies offer this service, the Latvian laws support the pharmacies preparing medicinal products. To protect these pharmacies, CM Regulations No. 610 provide that when a pharmacy is moved, it cannot be located within a 500-metre radius of other community pharmacy, which prepares medicinal products [25]. This restriction for movement of pharmacies was first set in 2002 [26]. Since then the number of pharmacies having a special operation condition \"preparation of medicinal products in the pharmacy\" in the annex to their licence has increased more than three times--120 pharmacies in 2003, 422 pharmacies in 2019 [27; 28]. The pharmacies, which do not compound extemporaneous preparations, should conclude an agreement on the compounding of the medicinal product with a pharmacy, which has this special operation condition in the annex to its licence [15]. Paragraph 11 of the resolution is devoted to \"Transparency and safety\". As it was mentioned before, in accordance with CM Reg. No. 304, the process of preparation and analysis of medicinal products shall be documented by pharmacies. The Health Inspectorate shall inspect the pharmacies preparing medicinal products at least once a year [16]. SAM has information about all the pharmacies preparing medicinal products, lists of these pharmacies are published on a regular basis [28]. At present, SAM does not have accurate data about the full composition of the available pharmacy preparations and preparing pharmacies' portfolio of different preparations. However, the State Agency of Medicines has taken measures to obtain this information asking pharmacies to send compositions of prescriptions, which are compounded most often. Compositions of medicinal products prescribed by physicians and compounded by pharmacies are not subject to clinical expertise.