FDA

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Client Alert – Members of Congress Call for Review of FDA Guidance on Compounding under Section 503A

June 27, 2017 - Earlier this year, we focused one of our client alerts on a new Guidance issued by the Food and Drug Administration (FDA) concerning certain prescription requirements for compounding human drug products under section 503A of the Federal Food, Drug, and Cosmetic Act. See "FDA Issues Guidance on Prescription Requirement for Compounded [...]

Client Alert: FDA Issues Guidance on Prescription Requirement for Compounded Drugs

January 20, 2017 — The Food and Drug Administration (FDA) recently issued a Guidance concerning certain prescription requirements for compounding human drug products under section 503A of the Federal Food, Drug, and Cosmetic Act (the “Act”).  The Guidance does not set forth any legal responsibilities.  Rather, the FDA describes how the agency plans to implement and [...]