Outsourcing Facilities Get FDA Policy on Compounding Bulk Drugs

The FDA finalized Monday an interim regulatory policy for outsourcing facilities that compound drugs using bulk drug substances while the agency develops a list of medicines that have a clinical need.

The Food and Drug Administration’s final guidance describes the conditions under which the agency doesn’t intend to take action against an outsourcing facility for compounding a drug using certain bulk drug substances that are not eligible for use in compounding under section 503B of the Federal Food, Drug, and Cosmetic Act.

Compounders produce drugs using bulk drug substances, also known as active pharmaceutical ingredients.

Outsourcing facilities compound under section ...