Description
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled “Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products--Content and Format.” This guidance is intended to assist applicants in developing the DOSAGE AND ADMINISTRATION section of labeling. The purpose of this guidance is to assist applicants in ensuring that the DOSAGE AND ADMINISTRATION section contains the dosage- and administration-related information needed for safe and effective use of a drug and that the information is clear, concise, and presented in a manner that is pertinent and understandable to health care practitioners. We are withdrawing the guidance for industry entitled “Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products--Content and Format” issued on March 29, 2010, and issuing this draft guidance.
Scope & Applicability
Product Classes
10guidance applies to drugs regulated under section 505
Handling and dosimetry requirements
Guidance for labeling of interchangeable biosimilar products
Products requiring visual inspection for particulate matter
Two or more separate drugs in a single package intended to be used together
Two or more active ingredients combined at a fixed dosage
Substitution recommendations
Guidance does not specifically provide recommendations addressing dosage optimization for radiopharmaceuticals
Requires analytical comparability per ICH Q5E
recommended dosage section
Stakeholders
6Entity submitting development data and knowledge; Entity performing the work process for change
Dosage recommendations for patients 65 years of age and older
Dosage recommendations for pediatric subpopulations
User reviewing data via web-applications
target audience for prescribing information
Persons submitting drug applications using designated AMTs
Regulatory Context
Attributes
10fundamental dosage-related information; Upper limit for safety and effectiveness
FDA recommends avoiding this system to prevent medication errors
FDA recommends using the metric system for dosage instead of the British Imperial System
Requirement for devices provided sterile or non-sterile
A functional role of sodium in food
Instructions for drug discontinuation to avoid withdrawal
Required information for intravenous administration
Genetic characteristic requiring dosage modification
required information in dosage section
limit beyond which safety/effectiveness not established
Identified Hazards
Hazards
4Visual inspection requirement for parenteral products
Drugs requiring special handling per OSHA
Hazardous and unnecessary exposure from electronic products
Information required if drug is mixed in vitro with other diluents
Related CFR Sections (4)
- 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 →
- 21CFR201.100§ 201.100 Prescription drugs for human use.
A drug subject to the requirements of section 503(b)(1) of the act shall be exempt from section 502(f)(1) if all the following conditions are met:Read full regulation →
- 21CFR600.3§ 600.3 Definitions.
As used in this subchapter:Read full regulation →
- 21CFR201.56§ 201.56 Requirements on content and format of labeling for human prescription drug and biological products.
(a) General requirements. Prescription drug labeling described in § 201.100(d) must meet the following general requirements:Read full regulation →
See Also (8)
- Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry (Status: Draft)
- Drug Interaction Information in Human Prescription Drug and Biological Product Labeling (Status: Draft)
- Clinical Drug Interaction Studies With Combined Oral Contraceptives Guidance for Industry: Guidance for Industry (Status: Final)
- QTc Information in Human Prescription Drug and Biological Product Labeling: Draft Guidance for Industry (Status: Draft)
- Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products — Content and Format (Status: Final)
- Labeling for Biosimilar Products Guidance for Industry (Status: Final)
- Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway (Status: Final)
- Labeling for Biosimilar and Interchangeable Biosimilar Products (Status: Draft)