DEA Investigations
DEA inspections, controlled substance compliance, and Drug Supply Chain Security Act enforcement.
Memoranda of Agreement With DEA
What a DEA Memorandum of Agreement resolves, the terms it commonly imposes, and what a breach of those terms means for the registr…
The 5 Percent Distribution Rule for Pharmacies
How the 5 percent rule at 21 CFR 1307.11 lets pharmacies transfer controlled substances without a distributor registration, and wh…
The Five Public Interest Factors in DEA Cases
DEA weighs five statutory factors in registration cases, but final orders turn on one threshold: an unequivocal acceptance of resp…
Telemedicine Controlled Substance Prescribing Rules
The Ryan Haight in-person exam rule, the DEA's fourth extension through 2026, and what pharmacists must verify before dispensing.
Suspicious Order Reporting: Beyond Monitoring
What 21 CFR 1301.74(b) requires beyond a monitoring system, the current DEA reporting channel, and how to document due diligence o…
State Controlled Substance Registration Running Parallel to DEA
Most states require their own controlled substance registration alongside the federal DEA number, creating dual jeopardy exposure…
Separate Registration for Each Location
DEA registration attaches to the address, not the owner. What the separate-registration rule requires when a pharmacy moves or exp…
Practitioner DEA Registration Denials and Appeals
A DEA registration denial reaches every corner of a practice. What the public interest factors require, the hearing right, and how…
Preparing for a DEA Inspection Before It Happens
A self-audit of controlled substance records, staff preparation, and corrected deficiencies shape how a DEA inspection goes before…