The Ministry of Health of the Russian Federation has drafted a regulation titled "Rules for Dispensing Medicinal Products for Medical Use" (Project ID 01/02/04-21/00114788) (hereinafter, the "Rules").

According to the explanatory note accompanying the draft, the regulatory body developed these Rules to replace those approved by Order of the Ministry of Health of the Russian Federation No. 403n dated July 11, 2017 "On Approval of the Rules for Dispensing Medicinal Products for Medical Use, Including Immunobiological Medicinal Products, by Pharmacy Organizations and Sole Proprietors Licensed for Pharmaceutical Activities"; Order of the Ministry of Health and Social Development of the Russian Federation No. 562n dated May 17, 2012 "On Approval of the Procedure for Dispensing Medicinal Products for Medical Use to Individuals, Containing Other Pharmacologically Active Substances in Addition to Small Amounts of Narcotic Drugs, Psychotropic Substances, and Their Precursors"; and Order of the Ministry of Health and Social Development of the Russian Federation No. 735n dated August 26, 2010 "On Approval of the Rules for Dispensing Medicinal Products for Medical Use by Medical Organizations Licensed for Pharmaceutical Activities and Their Isolated Subdivisions (Outpatient Clinics, Feldsher and Feldsher-Obstetric Stations, Centers (Departments) of General Medical (Family) Practice) Located in Rural Settlements Lacking Pharmacy Organizations."

The new Rules outline the specific categories of medicinal products dispensed under currently approved prescription forms. Specifically, the regulation details a corresponding list of medicinal products subject to dispensing for each prescription form type.

The draft Rules establish procedures for scenarios where a retail pharmacy lacks the specific medication specified in a prescription. In such instances, the pharmacy must fulfill the prescription within the following timeframes:

• Prescriptions marked "statim" (immediate) must be fulfilled within 1 business day from the date of presentation;
• Urgent prescriptions marked "cito" require fulfillment within 2 business days from presentation;
• Orders for medicinal products included in the mandatory minimum assortment necessary for providing medical care must be processed within 5 business days from presentation;
• Medication dispensed free of charge or at a discount that falls outside the minimum assortment requires fulfillment within 10 business days from presentation;
• Prescriptions issued pursuant to a medical commission decision must be fulfilled within 15 business days from the date the individual submits the prescription to the retail entity.

Furthermore, the Rules clarify the specific circumstances under which pharmacies may dispense medications with compromised primary or secondary packaging. Specifically, a pharmacy organization licensed for pharmaceutical activities with compounding privileges may alter the primary packaging of a medicinal product when dispensing it at the request of a medical organization. When dispensing medications to individuals, retail pharmacies may alter the secondary (consumer) packaging if the quantity specified in the prescription is less than the quantity contained within the original secondary packaging.

Pursuant to the directive set forth in Subparagraph 7 of Paragraph 2 of Section I of the Minutes of the Meeting of the Government Council of the Russian Federation on Guardianship in the Social Sphere, chaired by T.A. Golikova, Deputy Prime Minister of the Russian Federation, dated July 28, 2020, No. 5, the draft order includes provisions allowing the dispensing of medicinal products to individuals caring for terminally ill patients. Specifically, if terminally ill patients at the end-of-life stage cannot execute a power of attorney granting the right to obtain the narcotic and psychotropic medicinal products specified in the first paragraph of this section, pharmacies may dispense these medications to other caregivers. To receive these products, the caregiver must present, concurrently with the prescription, a personal identification document and a document confirming the patient's terminal condition. This terminal status document must contain details of the individual receiving the prescription drugs (full name, type, series, and/or number of the identification document) and must be certified by the signature and seal of a healthcare professional, which will remain on file with the pharmacy organization.

The draft establishes that to dispense medicinal products via electronic prescriptions, pharmacy organizations must connect to the state health information system of the respective constituent entity of the Russian Federation.

In practice, these Rules consolidate and streamline all currently effective regulations governing the dispensing of medicinal products into a single comprehensive framework.