FDA Issues Two Draft Guidances on Compounding

The FDA has issued two draft guidances describing how the FDA would implement provisions of federal law that restrict compounding human drug products that are essentially copies of commercially available or approved drug products:

• Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act
• Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act

The public comment period on these draft guidance documents closes in 90 days.

The agency also posted a statement related to these two guidances:

• FDA issues proposals to implement statutory restrictions on compounding drugs that are essentially copies of commercially available or approved drugs

For more information on pharmacy compounding go to FDA's Information on Compounding.