FDA COMPLIANCE POLICY GUIDE Sec. 448.100 Reconditioning of New Drugs Which Do Not Have Approved NDAs/ANDAs (CPG 7132c.03)

Title:
FDA COMPLIANCE POLICY GUIDE Sec. 448.100 Reconditioning of New Drugs Which Do Not Have Approved NDAs/ANDAs (CPG 7132c.03)

https://www.gmp-compliance.org/files/guidemgr/CPG Reconditioning of New Drugs Which Do Not Have Approved NDAs-ANDAs.pdf

Origin/Publisher:

Office of Regulatory Affairs, FDA

Document Type:
Compliance Policy Guide
Content:
Compliance Policy Guides explain the FDA policy on regulatory issues related to FDA laws and regulations. They also advise the field inspection staff about the FDA-standards to be applied when determining industry compliance.

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