FDA published a guidance document aimed at sponsors that are developing drug products with the potential for abuse that may need to be scheduled by the Drug Enforcement Agency (DEA) under the Controlled Substances Act. Within the draft guidance document, FDA addresses both the definition of abuse potential and information on submitting an adequate abuse potential assessment and scheduling request – covering such topics as study design and administrative recommendations. Comments should be submitted by March 29, 2010 to be considered when the FDA drafts its final guidance.