The US Food and Drug Administration (FDA) has released draft guidance for pharmaceutical manufacturers wishing to replace a color in a drug product. These changes are now viewed as a moderate change and necessitate the filing of a changes being effected in 30 days supplement (CBE-30).
The new guidance, when finalized, will supersede questions 1 and 2 in the component and composition changes of an earlier guidance issued in February 1997 titled “SUPAC-IR Questions and Answers about SUPAC-IR Guidance.” SUPAC stands for Scale-Up and Post-Approval Changes. In the earlier guidance, changing colors was considered a major change that required the submission of a prior approval supplement (PAS).
The guidance applies to drug products marketed under a new drug application (NDA) or an abbreviated new drug application (ANDA), contract manufacturers, non-prescription drugs that are subject to a monograph, and compounded drug products under section 503B of the Federal Food, Drug, and Cosmetic Act…
