Manual of Standard Operating Procedures and Policies

General Information - Review

Review of CBER Regulated Product Proprietary Names

SOPP 8801.4

Version #1

Date: August 15, 2002

Appendix 2: Criteria for review of Biological Product Proprietary Names

Reference texts

The APLB relies on the following reference texts in the evaluation process of the acceptability of proprietary names:

  • The American Drug Index,
  • The Physicians Desk Reference,
  • The Red Book,
  • The Blue Book
  • Drug Facts and Comparisons,
  • Martindale Extra Pharmacopoeia,
  • Merck Index,
  • Code of Federal Regulations
  • Food Drug and Cosmetic Act
  • Other resources, references or data as necessary.

Regulations

The Food Drug and Cosmetic Act (Act) - section 502(a) states that a drug is misbranded "If its labeling is false or misleading in any particular." The implementing regulations for this section of the Act, reference 21 CFR 201.10(c)(1) through (5), lists five factors that among others could make the labeling for a drug misleading. They are:

  1. The order in which the names of the ingredients present in the drug appear in the labeling, or the relative prominence otherwise given such names.
  2. Failure to reveal the proportion of, or other fact with respect to, an ingredient present in such drug, when such proportion of other fact is material in the light of the representation that such ingredient is present in such drug.
  3. The employment of a fanciful proprietary name for a drug or ingredient in such a manner as to imply that the drug or ingredient has some unique effectiveness or composition when, in fact, the drug or ingredient is a common substance, the limitations of which are readily recognized when the drug or ingredient is listed by its established name.
  4. The featuring in the labeling of inert or inactive ingredients in a manner that creates an impression of value greater than their true functional role in the formulation.
  5. Designation of a drug or ingredient by a proprietary name that, because of similarity in spelling or pronunciation, may be confused with the proprietary name or the established name of a different drug or ingredient.

Evaluation Criteria

It is based on factors three and five as cited in the regulations and listed above, that the following criteria were formed for use in determining the acceptability of a proposed name:

  • Sound-alike and Look-alike names - Names that when printed, written or verbally ordered may be difficult to differentiate from one another. Potential sound-alike names may be more difficult to detect due to the wide variation in pronunciation and accents found in verbal orders.

    • In determining whether the degree of similarity in spelling or sound of names may be problematic, the following several factors are taken into consideration:

    • The dosage forms or routes of administration
    • The marketing status (Rx or OTC)
    • The indication(s) and directions for use
    • The storage configuration
    • The clinical setting for dispensing or use (inpatient or outpatient hospital or clinic vs. retail pharmacy for use at home)
    • The packaging and labeling
    • The strength

Generally, if one or more of these factors are different to a point where the potential for confusion can be minimized e.g., an Rx vs. an OTC drug then there may be less concern for the chance of a medication error.

  • Inclusion or reference to dosing regimens or intervals in a name that may be misleading - An example of this would be using the syllable "bid" or "tid," (bid = twice daily; tid = three times daily) when the product is administered once a day (qd).
  • The use of prefixes or suffixes that may be common medical abbreviations or may be confused with common abbreviations. Common prefixes or suffixes such as those below should be used only if appropriate.

    • For example:

    • the suffix "HS," could be used to signify half-strength, or interpreted to mean the common medical abbreviation HS or hs for "At bedtime."
    • the suffix "XL" could be mistaken as a sound-alike for "S / L" (sublingual)
    • "HCT" could be interpreted as hematocrit or both hydorchlorothiazide and hydrocortisone
    • the use of common pharmaceutical abbreviations such as "H-BIG" or "AHF-M" as a proprietary name for "Hepatitis B Immune Globulin (HBIG)" or "Anti-Hemophilic Factor (AHF)"
  • Use of prefixes or suffixes that suggest a dosage form. e.g., use of the suffixes "tab" or "tabs" designating "tablets" and "cap" or "caps" for capsules when the dosage form is a liquid, powder, or an injectable, etc. Since different dosage forms may later be approved. The use of dosage form descriptors may be used with a proprietary name e.g., Product Injection
  • The inappropriate use of Roman and Arabic numbers.
  • Names that suggest or imply that the drug product may be used to treat conditions not supported by substantial evidence or contained in the approved labeling.
  • Names that suggest or imply that the product is safer or more effective than what is described in the supporting data or approved labeling.
  • Proprietary names containing too much of the USAN name or USAN stems in the stem position when the product does not have the therapeutic, or pharmaceutical parameters associated with the USAN stem. e.g., the use of the suffix "-kine" when the product is not a cytokine However, the use of a USAN stem when it is not in the stem position, may be useful if it accurately represents the product's characteristics and assists in differentiating one product from another.
  • Same proprietary name for different products - CBER will not approve the use of the same or similar proprietary name for products that do not contain the same active substance(s) as the original product(s). The use of the same or similar proprietary name for products with different active substances has a high potential for confusion.
  • Different proprietary names for the essentially the same product but for a different indication. The existing proprietary name may be modified accordingly to clearly differentiate the dose, dosage form, or intended use.
 
Updated: August 21, 2002