Assessment of Abuse Potential of Drugs

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Contains Nonbinding Recommendations. Draft – Not for Implementation

1 Guidance for Industry1
2 Assessment of Abuse Potential of Drugs
6 This draft guidance, when finalized, will represent the Food and Drug Administration’s (FDA’s) current
7 thinking on this topic. It does not create or confer any rights for or on any person and does not operate to
8 bind the FDA or the public. You can use an alternative approach if the approach satisfies the
9 requirements of the applicable statutes and regulations. If you want to discuss an alternative approach,
10 contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate
11 FDA staff, call the appropriate number listed on the title page of this guidance.

15 I. INTRODUCTION

17 This guidance is intended to assist sponsors who are developing drug products with the potential
18 for abuse that may need to be scheduled under the Controlled Substances Act (21 U.S.C. 811(b),
19 811(c)). Examples of products that are addressed in this guidance include new molecular entities
20 and new dosage forms of drug substances already controlled under the Controlled Substances
21 Act (21 U.S.C. 812(c)). Drugs with abuse potential generally include drugs that affect the
22 central nervous system, drugs that are chemically or pharmacologically similar to other drugs
23 with known abuse potential, and drugs that produce psychoactive effects such as sedation,
24 euphoria, or mood change.2
26 Specifically, the guidance discusses the following:
28 • The definition of abuse potential
29 • Information on submitting an abuse potential assessment, including a proposal for
30 scheduling
31 • A description of what constitutes an adequate abuse potential assessment
32 • Information for sponsors performing an assessment, including (1) the design and conduct
33 of appropriate studies and investigations and (2) general administrative recommendations
34 for submitting a proposal for scheduling
36 FDA’s guidance documents, including this guidance, do not establish legally enforceable
37 responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should
38 be viewed only as recommendations, unless specific regulatory or statutory requirements are
39 cited. The use of the word should in Agency guidances means that something is suggested or
40 recommended, but not required.

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