Compounding and Repackaging of Radiopharmaceuticals By Outsourcing Facilities Guidance for Industry
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
September 26, 2018
May 7, 2020
4a6e41fb-5d18-47fc-98b0-1dbe619a89b6
Related Documents
Insanitary Conditions at Compounding Facilities Guidance for Industry
Guidance DocumentNovember 6, 2020Center for Drug Evaluation and Research
Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities Guidance for Industry
Guidance DocumentSeptember 26, 2018Center for Drug Evaluation and Research
Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act
Guidance DocumentMay 10, 2018Center for Drug Evaluation and Research
Quick Actions
Transform Regulatory Data into Actionable Intelligence
Join leading pharmaceutical and medical device companies who trust KeyPedia for their regulatory compliance needs.