CPG Sec. 400.500 Identical or Similar Product Names

Description

*Periodically different drugs, or drugs and other products, are marketed under identical brand names similar enough to cause confusion. It is apparent that a serious danger to health could exist if a relatively mild drug or other product was dispensed in the place of a vitally needed antibiotic or vice versa. Other situations, equally serious could also be imagined. We investigated a complaint where a prescription drug was dispensed in the place of the prescribed vitamin with a similar name.

Scope & Applicability

Regulatory Context

• 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 →

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• CPG Sec. 446.100 Regulatory Action Regarding Approved New Drugs and Antibiotic Drug Products Subjected to Additional Processing or other Manipulations (Status: Final)
• CPG Sec. 450.300 OTC Drugs - General Provisions and Administrative Procedures for Marketing Combination Products (Status: Final)
• Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances (Status: Final)