T/CAPC 011-2024 The retail pharmacy shall operate the self-adjacent T cell (CAR-T) treatment drug service in accordance with the specifications

Scope

Scope: Applicable to retail pharmacies that operate autologous chimeric antigen receptor T-cell therapy drugs, providing a series of professional pharmaceutical management services such as supply chain management, business operations, and pharmaceutical services; Main technical content: 1. Retail pharmacies (hereinafter referred to as pharmacies) that operate autologous chimeric antigen receptor T-cell therapy drugs (hereinafter referred to as cell therapy drugs) shall strictly comply with the relevant provisions of laws and regulations such as the Drug Administration Law, the Drug Circulation Quality Management Regulations, and the Prescription Management Measures, and meet the customized and specialized service needs of cell therapy drugs in the supply chain, business operations, and pharmaceutical services in accordance with the requirements of these regulations. 2. This document aims to standardize the pharmaceutical management services such as supply chain assurance and pharmaceutical services provided by retail pharmacies in the operation of cell therapy drugs, so that patients receiving cell therapy and their families (hereinafter referred to as patients) can obtain quality-assured drugs as needed while receiving standardized and consistent pharmaceutical services, thereby fully leveraging the role of retail pharmacies in meeting the accessibility and safety needs of patients for special treatment products.

Development Information

Related Standards