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GUIDANCE DOCUMENT

CPG Sec. 430.300 Labeling Shipping Containers of Drugs May 1987

Final

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


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.