CDER DATA STANDARDS MANUAL


FDA Data Element Number. Pending.

CDER Data Element Number. C-DRG-0933

Data Element Name. SPL DEA SCHEDULE

Data Element OID: n/a

Data Element NCI ConceptID: C48670

Version Number: 001

Description. The abuse potential category to which an active ingredient, or combination of active ingredients, is assigned, as regulated by both the United States Drug Enforcement Administration (DEA) and the United States Food and Drug Administration.

Source. 21 USC Sec. 812 (see http://www.usdoj.gov/dea/pubs/csa/812.htm); 21CFR1302.03; 21CFR1308

Relationship. None.

FDA Specifications.

CDER Specifications. No further specifications.

FDA Approved Date. 14-SEP-2005

CDER Approved Date. 14-SEP-2005

FDA Revised Date.

CDER Revised Date.

Data Values.

Term Definition Code
CI Schedule I C48672
CII Schedule II C48675
CIII Schedule III C48676
CIV Schedule IV C48677
CV Schedule V C48679

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