美国FDA 指导原则 利用外包设施进行放射性药物的合成和再包装工业指南 英文原版.pdf

Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities Guidance for Industry U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) September 2018 Compounding and Related Documents Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities Guidance for Industry Additional copies are available from: Office of Communications, Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10001 New Hampshire Ave., Hillandale Bldg., 4th Floor Silver Spring, MD 20993-0002 Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353 Email: druginfo@ /Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) September 2018 Compounding and Related Documents Contains Nonbinding Recommendations TABLE OF CONTENTS I. INTRODUCTION AND SCOPE 1 II. BACKGROUND 2 A. Radiopharmaceuticals, Generally 2 B. Compounding, Generally 3 III. POLICY 5 A. Compounding 5 B. Repackaging of Radiopharmaceuticals 7 C. Establishment Registration and Drug Listing 10 Contains No