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COMPLIANCE POLICY GUIDE (CPG)

CPG Sec. 400.500 Identical or Similar Product Names March 1995

Final
Docket Number:
None found
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

BACKGROUND:

*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.

POLICY:

All instances of drugs of different composition including different dosage strengths being marketed under identical or similar brand names are regarded as serious violations of the Act due to the inherent potential health hazards. Regulatory action will normally be authorized*

REGULATORY ACTION GUIDANCE:

The following represents criteria for recommending legal action to the *Division of Drug Labeling Compliance, HFD-310*.

  1. Identical Brand Names for Drugs of Different Composition. Section 502(i)(3) of the Act specifies that a drug shall be deemed to be misbranded if it is offered for sale under the name of another drug. This charge is to be used when regulatory action is recommended in this situation.
  2. Similar Brand Names for Drugs of Different Composition. Section 502(a) of the Act specifies that a drug shall be deemed to be misbranded if its labeling is false or misleading in any particular. This charge is to be used when regulatory action is recommended in this situation.

The initial action of choice where no direct health hazard is involved is a *warning* letter. Recall is the initial action of choice in situations involving a hazard to health.

*Material between asterisks is new or revised*

Issued: 10/1/80
Revised: 5/22/87, 3/95

 

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