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Pharmaceutical Industry › Food and Drug Administration (FDA) › Section 503

Quarles & Brady LLP

FDA Releases Draft Interim Guidance on Bulk Drug Substances in Compounding Under Sections 503A and 503B of FDCA

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The Food and Drug Administration (“FDA”) has released draft interim guidance documents that impact the use of bulk drug substances in compounding under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act...more

Alston & Bird

Alston & Bird Healthcare Week in Review

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Alston & Bird’s Week in Review provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and Congressional committee action; reports, studies, and analyses; and other health...more

Robinson+Cole Health Law Diagnosis

FDA’s New Draft Guidance on Bulk Drug Substances in Compounding

Robinson+Cole Health Law Diagnosis on

This week, the U.S. Food & Drug Administration (FDA) published draft guidance, describing FDA’s policy and process for evaluating bulk drug substances used in compounding by outsourcing facilities that are registered under...more

Polsinelli

Key Takeaways from FDA's New Guidance for Prescription Drug Compounders

Polsinelli on

On April 15, 2016, the Food and Drug Administration (FDA) released draft guidance that describes the FDA's interpretation of drug compounding standards under Sections 503A and 503B of the Food Drug & Cosmetic Act (FD&C Act)....more

BakerHostetler

FDA Establishes Docket for Public Comments on Drug Compounding

BakerHostetler on

The Food and Drug Administration (FDA) recently announced a new docket for public comments on the compounding of human drug products under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FFDCA). The FDA...more

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