Description
Human User Safety (HUS) is an integral component of the overall safety evaluation of proposed new animal drugs. The FD&C Act does not provide specific guidance on data requirements or assessment methods to identify the risks or the risk mitigation measures for human users of new animal drugs. This guidance clarifies the current approaches and recommendations for HUS assessment and submission of HUS information to support the overall safety of proposed new animal drugs prior to approval.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
10ACTP products mentioned in abbreviations.
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
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
IGA products mentioned in abbreviations.
Specific category requiring HUS considerations.
Specific category requiring HUS considerations.
The category of products covered by this guidance.
typically do not present novel HUS considerations
Human User Safety in New and Abbreviated New Animal Drug Applications
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
Stakeholders
4Entity responsible for submitting applications under section 524B
Intended audience for understanding HUS principles.
any person who may come into contact with the new animal drug
entity responsible for evaluating HUS throughout the drug lifecycle
Regulatory Context
Regulatory Activities
4New animal drug applications; New Animal Drug Application
Abbreviated new animal drug applications
Investigational New Animal Drug file
Generic Investigational New Animal Drug file
Document Types
8SDS used as a source of safety information.
Safety Data Sheet for the product
Freedom of Information summary for approved drugs
User Safety Warnings section of the package insert
Representative labeling for Type B and Type C medicated feeds
Specific labeling element used as a mitigation strategy.
SDS may provide information on the physical properties of chemical components.
Cybersecurity information should be included in device labeling
Attributes
6toxicology endpoint for starting dose
Personal Protective Equipment recommended for use
Time the animal should be secluded without human contact to mitigate exposure.
Chronic exposures are generally considered to be those where there are multiple exposures events over 91 days
Acute exposures are generally considered to be single exposures
factor influencing HUS assessment
Technical Details
Substances
3examples of such components include but are not limited to the active moiety (API)
If the animal drug protein is highly homologous to a human protein, it may cross-react.
active substances regulated by the DEA
Testing Methods
6exposure studies conducted with the drug product, such as dislodgeable residue studies
Conducted with representative users to assess the adequacy of the product-user interface design.
Type of post-administration study recommended for topical products.
Studies conducted in the target animal species to demonstrate effectiveness and safety.
Studies conducted in the target animal species to provide information on the safety of an investigational product.
Studies conducted in vivo or in vitro to assess hazards associated with exposure to an animal drug.
Processes
2estimating the risk to the human user using hazard and exposure
products necessitating special disposal procedures
Clinical Concepts
2Examples of adverse immune system responses subsequent to accidental exposure.
reporting suspected adverse events
Identified Hazards
Hazards
3exposure outside the scope of labeled instructions like spills or self-injection
substances that may contribute to antimicrobial resistance
Potential risk associated with viral vectors
Standards & References
Specifications
2The highest dose that did not elicit an adverse effect in a toxicological study
calculation of the margin of exposure (MOE)
Related CFR Sections (3)
- 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 →
- 21CFR514.1§ 514.1 Applications.
(a) Applications to be filed under section 512(b) of the act shall be submitted in the form and contain the information described in paragraph (b) of this section, as appropriate to support the particular submission. If any part of the application is in a foreign language, an accurate and complete ERead 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)
- Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products — Content and Format (Status: Final)
- Updating ANDA Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn Guidance for Industry (Status: Draft)
- Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry (Status: Draft)
- Pediatric Information Incorporated Into Human Prescription Drug and Biological Products Labeling Good Review Practice (Status: Final)
- QTc Information in Human Prescription Drug and Biological Product Labeling: Draft Guidance for Industry (Status: Draft)
- Drug Interaction Information in Human Prescription Drug and Biological Product Labeling (Status: Draft)
- CVM GFI #169 Drug Substance Chemistry, Manufacturing, and Controls Information (Status: Final)
- CVM GFI #255 Elemental Impurities in Animal Drug Products Questions and Answers (Status: Final)