Description
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.
Scope & Applicability
Product Classes
1Drugs
Clinical investigations of drugs, including human drugs and biological products
Stakeholders
1Consignee
The party receiving the imported goods, responsible for submitting evidence.
Identified Hazards
Hazards
1Pilferage
Theft risk associated with naming drugs on shipping containers
Related CFR Sections (1)
- 21CFR10.115§ 10.115 Good guidance practices.
(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →
See Also (8)
- Draft Guidance for Industry: New Dietary Ingredient Notification Master Files for Dietary Supplements (Status: Draft)
- Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry : Draft Guidance for Industry (Status: Draft)
- CPG Sec. 460.300 Return of Unused Prescription Drugs to Pharmacy Stock (Status: Final)
- CPG Sec. 444.100 Recovery of Investigational New Drugs from Clinical Investigators (Status: Final)
- CPG Sec. 400.900 Class I Recalls of Prescription Drugs (Status: Final)
- CPG Sec. 454.100 OTC Ear Drop Preparations (Status: Final)
- CPG Sec. 455.100 Inert Glandular Preparations *(OTC)*, Inadequate Full Disclosure and Claims (Status: Final)
- CVM GFI #55 Supportive Data for Cat Food Labels Bearing "Reduces Urinary pH Claims: Protocol Development (Status: Final)