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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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CPG Sec. 430.300 Labeling Shipping Containers of Drugs

 

BACKGROUND:
 

Because of the pilferage problem, some firms prefer not to name the drugs on shipping containers, so that *their contents are not easily determined*. Questions have been raised as to whether or not the FDC Act requires mandatory label information on such shipping containers.
 

POLICY:
 

If the outer carton is used only to protect the goods during shipment and is stripped away by the consignee, then the FDC Act does not require any information to be stated on such shipping carton.
 

*Material between asterisks is new or revised*

Issued:7/12/76 as 7132b.12
Revised: 10/1/80, 5/22/87