Controlled Substances Act
Federal statute (21 USC 801 et seq.) regulating the manufacture, distribution, and dispensing of controlled substances.
1 min read · Last reviewed May 23, 2026
At a glance
- Category
- Compliance Program
- Primary sources
- 1
- Workspace handoff
- compliance binder →
Where this comes up
Compliance committees and practice managers operate at this level — written policy, workforce training, sanction policy, monitoring and auditing cadence, response and corrective action. The seven elements of an effective compliance program (OIG) are the scaffolding; this term lives somewhere on that scaffold.
Full definition
What it is in practice
DEA implementing regulations at 21 CFR cover schedules, prescription requirements, recordkeeping, security, and registration. Prescribers register through DEA Form 224.
How it shows up in your practice
Maintain DEA registration, complete biennial inventory, secure prescription pads, and follow EPCS rules. State prescription drug monitoring program (PDMP) checks are increasingly required.
Sources
- DEA — Controlled Substances Acthttps://www.deadiversion.usdoj.gov/21cfr/cfr/
Track DEA compliance in the Compliance Binder
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D3rx is a healthcare-billing and compliance research aid maintained by D3rx Inc. Articles are drafted by an LLM (Anthropic Claude) against primary HHS, OCR, CMS, eCFR, NIST, and state-regulator publications, and reviewed for restraint and source fidelity by the D3rx team.
Reviewer status: a named credentialed reviewer (CHC, CHPC, or healthcare attorney) is being engaged. Until that engagement is finalized, this page does not claim credentialed review.
Related across the archive
- GlossaryE-Prescribing of Controlled Substances (EPCS)DEA-regulated electronic prescribing of Schedule II-V controlled substances.
- GlossaryPrescription Drug Monitoring Program (PDMP)State-administered electronic database tracking controlled substance prescriptions.
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- ComplianceBehavioral Health Compliance: 42 CFR Part 2 + HIPAA TogetherHow SAMHSA's 42 CFR Part 2 framework for substance use disorder records overlays HIPAA after the 2024 final rule alignment, and what behavioral health practices must document.
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This glossary entry is a research aid for billing and compliance staff. It does not provide legal, medical, or financial advice and does not replace counsel. References cited link to primary sources at HHS, OCR, CMS, eCFR, NIST, and the relevant payer or industry body.