Article 56. Compounding and Dispensation of Medicinal Products

1. Compounding of medicinal products by pharmacy institutions, veterinary pharmacy institutions, individual entrepreneurs licensed to carry out pharmaceutical activity shall be performed based on the medicinal products prescriptions, requirements of medical organizations and veterinary institutions according to the rules for compounding and dispensation of medicinal products, as approved by the authorized federal executive body.

2. When they compound medicinal products, pharmacy institutions, veterinary pharmacy institutions, individual entrepreneurs licensed to carry out pharmaceutical activity shall use the pharmaceutical substances included into the state register of medicines for and the state register of medicines for veterinary use respectively in the appropriate way. The pharmacy institutions, veterinary pharmacy institutions, individual entrepreneurs with a pharmaceutical license are not allowed to compound the medicinal products registered in the Russian Federation.

3. Marking and labeling of medicinal products compounded by a pharmacy institution, a veterinary pharmacy institution and an individual entrepreneur with a pharmaceutical license shall be consistent with the rules specified in Clause 1 of this Article.

4. A pharmacy institution, a veterinary pharmacy institution and an individual entrepreneur with a pharmaceutical license shall bear responsibility for failure to comply with the rules for compounding and dispensation of medicinal products in accordance with the legislation of the Russian Federation.