Roszdravnadzor calls on medical and pharmacy organizations to observe the necessary temperature conditions during storage and transportation of medicines
Federal Service for Supervision of Health Care in order to implement paragraph 188.8.131.52. Decree of the Government of the Russian Federation of June 30, 2004 No. 323 “On approval of the Regulation on the Federal Service for Supervision of Health Care” and due to the fact that at present the situation is unfavorable due to abnormally hot weather, as well as high humidity in certain regions Russia, pays particular attention to the need for medical and pharmacy organizations to comply with applicable laws and regulations regarding compliance with the temperature regime in the premises of hospitals, clinics, pharmacies ice-obstetric points, trading floors of pharmacies, as well as compliance with the rules for storage of drugs, especially heat-sensitive drugs and drugs that require storage in a “dry place”.
Roszdravnadzor recalls that, in accordance with Decree of the Government of the Russian Federation dated December 22, 2011 No. 1081 “On Licensing of Pharmaceutical Activities”, non-compliance with storage conditions for medicines, including those requiring special storage conditions, is a flagrant violation of licensing requirements. Violation of the rules for storage of drugs leads to a decrease in therapeutic properties and can pose a threat to life or harm the health of citizens.
Given the above, Roszdravnadzor recommends that the heads of pharmacy and medical organizations strengthen internal control over compliance with the temperature regime in the premises of organizations, ensure air conditioning, comply with the rules for storage and transportation of drugs, including thermolabile drugs.
When conducting scheduled inspections, the territorial bodies of Roszdravnadzor for the constituent entities of the Russian Federation will pay special attention to the storage and transportation of drugs. With respect to medical and pharmaceutical organizations that violate the conditions of storage and transportation of drugs, supervisory response measures will be taken in accordance with the Code of Administrative Offenses of the Russian Federation.