Human Drug Compounding: FDA Issues Four Guidance Documents

FDA had a busy holiday season, issuing two final guidance documents and two draft guidance documents for industry related to human drug compounding right before the start of the new year. These guidance documents cover prescription requirements under Section 503A of the Federal Food, Drug, and Cosmetic Act (FFDCA); compounding and repackaging of radiopharmaceuticals; and electronic drug product reporting by Outsourcing Facilities under the FFDCA. Read more >>