Regulatory Roundup: FDA Issues Final Guidance Regarding cGMPs for PET Drugs

FDA issued a final guidance in early August regarding cGMPs for positron emission tomography (PET) drugs. The document covers resources, procedures, and documentation for PET drug-production facilities. The 1997 Food and Drug Administration Modernization Act called for these cGMPs to be established, and they are now part of 21 CFR Part 212. This guidance complements those requirements by providing information for small entities working on these drugs, such as academic and nonprofit facilities. Most PET drugs are administered on site because of their short half-life, says the guidance, but more and more facilities are independent and PET drugs are being distributed further away from their manufacturing site. According to the guidance, "Production and cGMP differences among PET drug producers are primarily a function of the size, scope, and complexity of their production operations. We have also found that implementing certain production standards and controls can ensure the production of quality PET drugs, regardless of differences among the various PET drug production facilities." The guidance covers cGMP requirements including USP requirements, production and process controls, labeling and packaging, personnel and pharmacy issues, and more.

USP is inviting stakeholders, especially heparin API manufacturers, to participate in a study evaluating and setting acceptance criteria for newly developed protein impurities and nucleotidic impurities procedures in the USP Heparin Sodium monograph. The study is meant to help disseminate new procedures to users, to solicit batch data using these procedures, and to gain feedback from industry. USP plans to use the information gained to set meaningful acceptance criteria.