Description
This guidance is intended to assist applicants in writing the DRUG ABUSE AND DEPENDENCE section of labeling, as described in the regulations for the content and format of labeling for human prescription drug and biological products (21 CFR 201.57(c)(10)). , This guidance applies to:• Prescription drugs controlled under the Controlled Substances Act (CSA)• Prescription drugs not controlled under the CSA for which there is important information to convey to health care providers related to abuse and dependence
Scope & Applicability
Product Classes
6guidance applies to drugs regulated under section 505
Requires analytical comparability per ICH Q5E
labeling for opioid products typically includes information on abuse
labeling for Schedule II controlled substances typically includes a BOXED WARNING
Products with abuse-deterrent properties discussed in labeling
Excluded from eligibility for importation
Stakeholders
4Entities submitting supplements to BLAs
Prescribers who may require particular training or certification; health care providers' attitudes about the risk and safe-use interventions
The entity responsible for responding to SLC notifications and orders.; Entity responsible for submitting labeling supplements or rebuttals; Entity responsible for submitting labeling supplements and appeals
Prescribing professional who does not need to intervene for interchangeable substitution
Regulatory Context
Attributes
2Characteristics of a product intended to reduce abuse.; Characteristics of a drug product intended to reduce abuse
critical information on the PDP
Identified Hazards
Hazards
1Abuse of DRUG-X poses a risk of overdosage, which may lead to death
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 →
- 21CFR201.56§ 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 →
- 21CFR314.70§ 314.70 Supplements and other changes to an approved NDA.
(a) Changes to an approved NDA.Read full regulation →
- 21CFR601.12§ 601.12 Changes to an approved application.
(a) General.Read full regulation →
See Also (8)
- Assessment of Abuse Potential of Drugs (Status: Final)
- Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry: Guidance for Industry (Status: Final)
- Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products — Content and Format (Status: Final)
- Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products — Content and Format: Guidance for Industry (Status: Final)
- Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry (Small Entity Compliance Guide) (Status: Final)
- Updating ANDA Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn Guidance for Industry (Status: Draft)
- Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products — Content and Format (Status: Final)
- Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway (Status: Final)