The regulations for the content and format of labeling for human prescription drug and biological products (found in 21 CFR 201.57(c)(10)) provide for a special section to convey information on a drug’s potential for abuse, misuse, addiction, physical dependence, and tolerance to health care providers. This section is known as the Drug Abuse and Dependence section, and CDER/CBER have just issued a draft guidance on the content and format for this section. The guidance covers drugs and biologics that are on the Controlled Substance Schedule (either active or pending) and those not on the Schedule but have properties that should be conveyed in the subsections for Abuse or Dependence. Of particular note in the guidance are those new entities that lack abuse or dependence potential, particularly in therapeutic categories where most other products are controlled substances.  As for all draft guidance, comments are welcomed, and readers interested in submitting comments may find the link to the Federal Register notice and the docket for comments submission on the guidance web page.

Text Copyright © 2019 Katrina Rogers