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BIO Comments on FDA Draft Guidance on Evaluation of Bulk Drug Substances Nominated for Use in Compounding

May 25, 2018

BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act.

Compounded drugs can serve an important role for patients who have clinical needs that cannot be met by an FDA-approved product. Access to medically necessary compounded medicines is important – but access cannot and should not come at the expense of product quality and patient safety.

BIO strongly encourages and supports the FDA’s allocation of resources to enable the safety of compounded drugs. BIO agrees these drugs should only be used by patients whose medical needs cannot be met by an FDA-approved drug. In addition, BIO is pleased to see the FDA discuss the importance of the drug approval process and the need to ensure compounded drugs do not weaken incentives for companies to conduct clinical testing and bring new drugs to market.

In the comments, BIO also discusses issues including the process for nomination and review of the 503B list for bulk compounding, clarification of what constitutes “clinical need,” and non-biologic complex drugs and narrow therapeutic index drugs.

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2018-05-25 BIO Comments On Bulk Drug Substances FINAL
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