Pew Comments on FDA Draft Guidance for Compounded Drug Ingredients

Pew Comments on FDA Draft Guidance for Compounded Drug Ingredients

The Pew Charitable Trusts offered comments on a draft guidance document issued by the Food and Drug Administration in March 2018 regarding which active drug ingredients—known as bulk drug substances—can be used by outsourcing facilities (businesses that compound stock supplies of drugs).

The policies would promote public health by balancing the needs of individuals for whom an approved or commercially available medication is not available with the safety risks that compounded drugs can pose.