Description
Under section 502(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) a drug is misbranded if its labeling (including labels) is false or misleading in any particular. A drug product’s labeling can be misleading because of the representations it makes, or because it omits material facts about possible consequences of using of the drug as intended.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
5The category of products covered by this guidance.
Proprietary names should not use the proprietary name of a discontinued product
used to manufacture medicated feed; A concentrated form of a drug used to manufacture medicated feed.; Concentrated drug form used to manufacture medicated feed; single ingredient component for medicated feed; Medicated feed mill license is required to manufacture a Type B or Type C medicated feed from a Category II, Type A medicated article.; Concentrated drug form for manufacturing medicated feed; Concentrated form of animal drug used to manufacture medicated feed; Type A medicated articles fo
intermediate medicated feed; A medicated feed intended for further manufacture of another medicated feed.; Intermediate medicated feed; Intermediate medicated feed product; medicated feed intended for further mixing; Intermediate medicated feed used to manufacture Type C feed
Final medicated feed intended for consumption; Medicated feed intended for consumption as a complete feed; medicated feed intended for direct consumption by animals; Medicated feed intended for direct consumption by animals
Stakeholders
4Entity responsible for submitting applications under section 524B
creates the stem list used to screen proposed proprietary names
patient, caregiver, physician, nurse, pharmacist involved in medication use
Entity responsible for submitting NDINs
Regulatory Context
Regulatory Activities
6Premarket notification submission type
The submission should be identified as Request for Pre-dissemination Review
PMA application for high-risk devices
New animal drug applications; New Animal Drug Application
Abbreviated new animal drug applications
Investigational New Animal Drug file
Document Types
5Cybersecurity information should be included in device labeling
APPENDIX Screening Checklist for Proposed Proprietary Name
accompanied by a complete set of the distributor labeling
applicants should submit a special drug experience report (DER)
performing label review for each new batch
Attributes
4standardized syllables within established names indicating pharmacological traits
Proprietary names should not be similar in spelling or pronunciation to established names
Commercial name granted by an authority for marketing
incorporating dosing intervals like QD or BID in proprietary names
Technical Details
Substances
3Medicinal product names or active ingredient names should be provided.; If MPID/PhPID unavailable, each active ingredient should be specified individually
Ingredients in the TDS that may affect adhesion properties.
safety evaluation in labeled population
Processes
1product-specific attributes like lyophilization
Identified Hazards
Hazards
3Example of a special safety situation.
potential concern for milk-based products; Chemical hazards in milk, honey, and game meat; Potential hazard identified for dairy and egg products.; Potential chemical hazard in game meat
Risk of inappropriate administration of extra doses
Standards & References
External Standards
3Is there a United States Adopted Name (USAN) stem in the proprietary name?
Official compendium for device recognition
Official compendium for homeopathic drugs
Related CFR Sections (4)
- 21CFR201.6§ 201.6 Drugs; misleading statements.
(a) Among representations in the labeling of a drug which render such drug misbranded is a false or misleading representation with respect to another drug or a device or a food or cosmetic.Read full regulation →
- 21CFR201.10§ 201.10 Drugs; statement of ingredients.
(a) The ingredient information required by section 502(e) of the Federal Food, Drug, and Cosmetic Act shall appear together, without any intervening written, printed, or graphic matter, except the proprietary names of ingredients, which may be included with the listing of established names, and suchRead full regulation →
- 21CFR514.80§ 514.80 Records and reports concerning experience with approved new animal drugs.
The following table outlines the purpose for each paragraph of this section:Read full regulation →
- 21CFR558.3§ 558.3 Definitions and general considerations applicable to this part.
(a) Regulations in this part provide for approved uses of drugs and combinations of drugs in animal feeds. Approved combinations of such drugs are specifically identified or incorporated by cross-reference. Unless specifically provided for by the regulations, a combination of two or more drugs is noRead full regulation →
Related MFDS Guidelines
Korean regulatory guidelines covering similar topics
See Also (8)
- Guidance for Industry for the Evaluation of Combination Vaccines for Preventable Diseases: Production, Testing and Clinical Studies: Guidance for Industry (Status: Final)
- PDUFA Pilot Project: Proprietary Name Review - Concept Paper (Status: Final)
- Contents of a Complete Submission for the Evaluation of Proprietary Names (Status: Final)
- Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products; Draft Guidance for Industry: Draft Guidance for Industry (Status: Draft)
- Best Practices in Developing Proprietary Names for Human Prescription Drug Products; Guidance for Industry: Guidance for Industry (Status: Final)
- CVM GFI #231 Distributor Labeling for New Animal Drugs (Status: Final)
- CVM GFI #57 Preparation and Submission of Veterinary Master Files (Status: Final)
- CVM GFI #83 Chemistry, Manufacturing and Controls Changes to Approved NADA/ANADA (Status: Final)