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UCM496288.pdf
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🔗 Source: fda.gov
📊 Size: 86 KB
👤 Author: FDA/CDER/"Purdie, Florine P"
⬇️ Downloads: 117

Summary

The FDA provides guidance on the definition of a facility under Section 503B of the Federal Food, Drug, and Cosmetic Act, which defines an outsourcing facility as a facility at one geographic location or address that is engaged in the compounding of sterile drugs, has elected to register as an outsourcing facility, and complies with all requirements of this section. The guidance aims to clarify the meaning of this term, including whether multiple suites at a single street address constitute one or multiple facilities, and how to ensure that compounding occurs only in accordance with Section 503B.

Description

The FDA provides guidance on the definition of a facility under Section 503B of the Federal Food, Drug, and Cosmetic Act, which defines an outsourcing facility...

Technical Information

  • File Format: PDF
  • File Size: 86 KB
  • Pages: 11
  • Language: EN
  • Author: FDA/CDER/"Purdie, Florine P"
  • Total Downloads: 117
  • Last Updated: 2 months ago

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