Description
This guidance is intended to assist sponsors of investigational new drugs and applicants for approval of a new drug in evaluating whether their new drug product has abuse potential. This guidance also provides recommendations to applicants who intend to submit new drug applications (NDAs) for prescription drug products that may have abuse potential.
Scope & Applicability
Product Classes
5Scope of drugs addressed in the guidance
drugs controlled under the CSA used as positive controls
Products with approved NDAs or ANDAs subject to SLC provisions.
Drugs that require abuse potential assessment
New Molecular Entities requiring assessment
Stakeholders
6Entity responsible for submitting applications under section 524B
Final decision maker for HHS/OHRP referrals
HAP studies should be conducted in experienced recreational drug users who have a recent history of using drugs in the same general pharmacological class.
Assist sponsors in the nonclinical evaluation
Entity submitting development data and knowledge; Entity performing the work process for change
CSS performs the scientific evaluation of the abuse potential
Regulatory Context
Attributes
7The likelihood of a drug being used in a non-medical way
Post-marketing abuse data should be presented within the context of prescription volume
Maximum induction effect
VAS subjective measure used in HAP studies.
VAS subjective measure used in HAP studies.
time to reach peak exposure
Cmax may be more informative for safety
Identified Hazards
Hazards
1aversive effects following drug discontinuation
Related CFR Sections (6)
- 21CFR312.64§ 312.64 Investigator reports.
(a) Progress reports. The investigator shall furnish all reports to the sponsor of the drug who is responsible for collecting and evaluating the results obtained. The sponsor is required under § 312.33 to submit annual reports to FDA on the progress of the clinical investigations.Read full regulation →
- 21CFR312.60§ 312.60 General responsibilities of investigators.
An investigator is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the control of drugs Read full regulation →
- 21CFR312.62§ 312.62 Investigator recordkeeping and record retention.
(a) Disposition of drug. An investigator is required to maintain adequate records of the disposition of the drug, including dates, quantity, and use by subjects. If the investigation is terminated, suspended, discontinued, or completed, the investigator shall return the unused supplies of the drug tRead full regulation →
- 21CFR314.50§ 314.50 Content and format of an NDA.
NDAs and supplements to approved NDAs are required to be submitted in the form and contain the information, as appropriate for the particular submission, required under this section. Three copies of the NDA are required: An archival copy, a review copy, and a field copy. An NDA for a new chemical enRead 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 →
- 21CFR314.70§ 314.70 Supplements and other changes to an approved NDA.
(a) Changes to an approved NDA.Read full regulation →
Related Warning Letters (10)
- 2025-09-23
Clinical Investigator/Sponsor
Ralph A. DeFronzo, M.D.
- 2025-09-09
Clinical Investigator
Shirish M. Gadgeel, M.D.
- 2025-08-26
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
CCIC Huatongwei International Inspection Co., Ltd.
- 2025-08-26
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
Jiangsu Kerbio Medical Technology Group Co.
- 2025-07-15
Clinical Investigator
Mark J. Savant, M.D
- 2025-07-01
Clinical Investigator
Peter Michael, M.D.
- 2025-06-03
Bioresearch Monitoring Program
Amy Lightner, MD
- 2025-05-06
Clinical Investigator
Nana Barseghian, M.D.
- 2025-03-18
Clinical Investigator
Mehran Michael Bahrami, M.D.
- 2024-12-03
Clinical Investigator
Han C. Phan, M.D.
See Also (8)
- Safety Reporting Requirements for INDs and BA/BE Studies: Guidance for Industry and Investigators (Status: Final)
- Safety Reporting Requirements for INDs (Investigational New Drug Applications) and BA/BE (Bioavailability/Bioequivalence) Studies: Guidance for Industry and Investigators (Status: Final)
- Long Term Follow-up After Administration of Human Gene Therapy Products: Guidance for Industry (Status: Final)
- Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment: Draft Guidance for Industry (Status: Draft)
- COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention: Guidance for Industry (Status: Final)
- Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies: Draft Guidance for Industry (Status: Draft)
- Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices: Draft Guidance for Industry (Status: Draft)
- Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment: Guidance for Industry; Availability (Status: Final)