Guidance For Industry - Assessment Of Abuse Potential Of Drugs - U.s. Department Of Health And Human Services - 2017 Page 13
ADVERTISEMENT
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37Contains Nonbinding Recommendations
E. The Drug Scheduling Process
Following review of abuse-related data in the NDA submission, FDA makes a determination
regarding its recommendation for the appropriate scheduling of the drug under the CSA and
makes findings as described in 21 U.S.C. 812(b). If the NDA is approved, scheduling in one of
four schedules is based on the drug’s relative potential for abuse, accepted medical use in
treatment in the United States, and relative potential for psychological or physiological drug
dependency.
Drug scheduling is a multi-step process that involves several federal agencies. Under the CSA, a
medical and scientific analysis of the abuse potential of the drug is conducted by the Department
of Health and Human Services (HHS) (see 21 U.S.C. 811(b)). At the conclusion of this analysis,
the Secretary of HHS will make a recommendation for scheduling to the Drug Enforcement
11
Administration (DEA),
as described in 21 U.S.C. 811 and 812. The role of the Secretary is
typically delegated to the Office of the Assistant Secretary for Health (ASH) within HHS. The
final decision on whether to control a substance in one of the schedules of the CSA is made by
the DEA on behalf of the Attorney General.
HHS designates the role of conducting the medical and scientific analysis to the FDA. The FDA
provides the National Institute on Drug Abuse (NIDA) with an opportunity to present its views
12
on drug scheduling during this process.
Within the FDA, this medical and scientific analysis is
conducted by CSS, and occurs in parallel with the NDA review process.
Under 21 U.S.C. 811(b) of the CSA, the medical and scientific analysis considers the following
eight factors determinative of control of the drug under the CSA (21 U.S.C. 811(c)):
1. Its actual or relative potential for abuse.
2. Scientific evidence of its pharmacological effect, if known.
3. The state of current scientific knowledge regarding the drug or other substance.
4. Its history and current pattern of abuse.
5. The scope, duration, and significance of abuse.
6. What, if any, risk there is to the public health.
11
The Administrator of the DEA receives the scheduling recommendations and acts on behalf of the Attorney
General of the Department of Justice with regard to these scheduling actions.
12
Memorandum of Understanding with the National Institute on Drug Abuse (Notice; 50 FR 9518-20; March 8,
1985).
10
ADVERTISEMENT
0 votes
Related Articles
Related forms
Guidance For Industry And Food And Drug Administration Staff - U.s. Department Of Health And Human Services - 2012
Legal
Department Of Health And Human Services Family Medical Leave/family Illness Leave Request Form
Business
Form Nih 2762-3 - Undergraduate Scholarship Program (ugsp) - Academic Enrollment Certification And Service Obligation Deferment Request - U.s. Department Of Health And Human Services
Legal
Form Acf-196t - Administration For Children And Families - U. S. Department Of Health And Human Services
Legal
Related Categories
Parent category: Legal