Description
FDA is issuing this guidance to help sponsors of human prescription drug products develop proprietary names for those products. This guidance describes best practices to help minimize proprietary name-related medication errors and otherwise avoid adoption of proprietary names that contribute to violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations. It also describes the framework FDA uses in evaluating proposed proprietary names that is also available to sponsors to use before submitting names for FDA review if they wish. This guidance does not address the designation of established names or proper names.
Scope & Applicability
Product Classes
8Scope of the guidance document; Scope of the proprietary name guidance
When evaluating proprietary names for specialty drugs
Commonly understood meaning for modifiers XR and ER
Products combining drug, device, or biological constituents; Generally recommended for Enhanced Documentation; Requires 14971-based framework incorporating ICH Q9; A drug-device combination where the device constituent part detects ingestion.
development program for drug and biological products
products subject to DSCSA tracing requirements
Example of a class with specific naming conventions; Use of modifiers Lo and Tri in naming
Marketed versions of discontinued brand drugs
Stakeholders
7Entity responsible for submitting applications under section 524B
MAHs are expected to follow-up all pregnancy reports from consumers
Individual who administers compounded drugs in a health care setting
patient, caregiver, physician, nurse, pharmacist involved in medication use
End users who use proprietary names for prescribing and dispensing; actively practicing health care professionals, such as prescribers, medical transcribers, pharmacists, pharmacy technicians, or nurses
Target audience for recommendations on assessment of overall survival
creates the stem list used to screen proposed proprietary names
Regulatory Context
Attributes
10Visual similarity between names that may cause errors
combined score is ≤54%
present the proprietary name with the corresponding product characteristics
evaluating pubertal development for evaluation of safety
Outcome measure for participant response to drug names
Indicated by the modifier Lo
Meaning of the modifier LA
Meaning of the modifier DS
portion of the proprietary name such as a letter, number, or word
Product characteristic evaluated alongside name similarity.
Identified Hazards
Hazards
2Risk of inappropriate administration of extra doses
Risks resulting from misinterpreted abbreviations, poor legibility, or look-alike packaging.
Related CFR Sections (8)
- 21CFR314.80§ 314.80 Postmarketing reporting of adverse drug experiences.
(a) Definitions. The following definitions of terms apply to this section:Read full regulation →
- 21CFR600.3§ 600.3 Definitions.
As used in this subchapter:Read full regulation →
- 21CFR201.57§ 201.57 Specific requirements on content and format of labeling for human prescription drug and biological products described in § 201.56(b)(1) .
The requirements in this section apply only to prescription drug products described in § 201.56(b)(1) and must be implemented according to the schedule specified in § 201.56(c) , except for the requirement in paragraph (c)(18) of this section to reprint any FDA-approved patient labeling at the end oRead full regulation →
- 21CFR314.3§ 314.3 Definitions.
(a) The definitions and interpretations contained in section 201 of the Federal Food, Drug, and Cosmetic Act apply to those terms when used in this part and part 320 of this chapter .Read full regulation →
- 21CFR312.32§ 312.32 IND safety reporting.
(a) Definitions. The following definitions of terms apply to this section:Read full regulation →
- 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 →
- 21CFR210.3§ 210.3 Definitions.
(a) The definitions and interpretations contained in section 201 of the act shall be applicable to such terms when used in this part and in parts 211 , 225 , and 226 of this chapter .Read full regulation →
See Also (8)
- Accelerated Approval – Expedited Program for Serious Conditions (Status: Draft)
- CPG Sec 120.500 Health Fraud - Factors in Considering Regulatory Action (Status: Final)
- Review of FDA's Implementation of the Drug Export Amendments of 1986 (Status: Final)
- E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (Status: Final)
- Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report (Status: Final)
- Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines: Draft Guidance for Industry (Status: Draft)
- Guidance for Hospitals, Nursing Homes, and Other Health Care Facilities - FDA Public Health Advisory: Guidance for Hospitals, Nursing Homes, and Other Health Care Facilities (Status: Final)
- E2BM Data Elements for Transmission Of Individual Case Safety Reports (Status: Final)