Pew Comments on FDA Draft Guidance for Compounded Drug Ingredients

Pew Comments on FDA Draft Guidance for Compounded Drug Ingredients
Pew Comments on FDA Draft Guidance for Compounded Drug Ingredients

The Pew Charitable Trusts offered comments on a draft guidance document issued by the Food and Drug Administration in March 2018 regarding which active drug ingredients—known as bulk drug substances—can be used by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.

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Fact Sheet

What Ingredients Can Be Used in Compounded Drugs

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Fact Sheet

What Ingredients Can Be Used in Compounded Drugs

When patients have medical needs that cannot be met by commercially available medicines that have been approved by the Food and Drug Administration, they can instead take compounded drugs, medications made by physicians or pharmacists. Neither FDA nor state authorities evaluate these drugs for safety or efficacy before they are administered to patients, but compounders cannot use just any chemicals to create a drug. Rather, there are criteria under federal law for determining which active drug ingredients—known as bulk drug substances— can be used to compound drugs.