DEA Keeps Electronic Controlled Substance Prescription Records Going
Published Date: 1/30/2025
Notice
Summary
The Drug Enforcement Administration (DEA) is keeping its rules for how doctors and pharmacies must keep electronic records of prescriptions for controlled substances. They’re asking for public feedback by March 3, 2025, but no changes are planned—just an extension of the current system. This affects healthcare providers who handle these prescriptions and helps keep things safe and organized without adding extra costs or paperwork.
Analyzed Economic Effects
5 provisions identified: 1 benefits, 4 costs, 0 mixed.
Recordkeeping Rules Continue; Mandatory Burden
DEA is keeping the current mandatory recordkeeping rules for electronic prescriptions for controlled substances. The collection covers 158,884 respondents, requires about 1.043 hours per respondent once per year, and the total estimated annual time burden is 107,733 hours.
Credentialing and Identity Proofing Requirement
Each registered practitioner must apply to an approved credential service provider for identity proofing and a credential, though hospitals and institutional practitioners may perform identity proofing in-house and hospitals/clinics must check government-issued photographic ID for affiliated practitioners.
Two-Person Logical Access Controls Required
For individual practitioners two people must enter logical access control data to grant permissions for signing controlled-substance electronic prescriptions; for institutional practitioners two people from an entity separate from identity-proofing must enter logical access control data; pharmacies must also set logical access controls so only authorized employees may alter prescription records.
Incident Report Review Duty
If the electronic prescription or pharmacy application generates an incident report, practitioners, hospitals/clinics, and pharmacies must review it to decide whether it represents a security incident.
No Estimated Monetary Costs Listed
The DEA estimates total annual other (monetary) costs of $0 for this information collection, and the obligation to respond is mandatory.
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