21 CFR §1306 Every subsection, on every file — verified, not assumed

The most rigorous DEA special-registration readiness file a telehealth platform can have.

TeleRxGuard assembles a documentation-complete, per-prescriber compliance file — every statutory element, every required PDMP check, identity verification, EPCS audit trail, and the DEA reporting package — checked against the letter of the proposed Special Registration rule and current temporary flexibilities before a credentialed healthcare compliance reviewer releases it.

Every subsection of 21 CFR §1306 & proposed ruleMulti-jurisdiction PDMP checks, gate-checkedGovernment-ID identity verification evidenceMandatory EPCS compliance audit trailCredentialed reviewer release on every file
Why files fail

A single missing element can trigger a DOJ investigation.

A telehealth platform's controlled-substance prescribing is only as strong as the compliance file behind it. Miss a multi-jurisdiction PDMP check, skip government-ID verification, fail to log EPCS controls, or mis-time the DEA reporting window — and the platform can face enforcement action, license revocation, or criminal referral.

Most platforms run this by hand, from memory, across dozens of prescribers and states. The proposed rule has not been read end-to-end since it was frozen. That is exactly where compliance gaps hide.

TeleRxGuard exists to close that gap with a single, exhaustive standard applied identically to every prescriber.

$3.6M+
DOJ settlement over unauthorized controlled-substance distribution practices
The benchmark

Measured against the letter of the statute and proposed rule — subsection by subsection.

We do not summarize the law and hope. Every file is scored against a versioned rule pack tied to the exact text of 21 CFR §1306, the DEA Special Registration proposed rule (January 2025), and current temporary flexibilities. These are the provisions each file is held to.

21 CFR §1306.04

Legitimate medical purpose

Each prescription is verified to have been issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice, with supporting encounter documentation.

Proposed Rule §1306.25(a)

Multi-jurisdiction PDMP checks

For each prescriber and patient, PDMP queries are confirmed in every jurisdiction where the patient resides or the prescription is dispensed, logged with timestamps and results.

Proposed Rule §1306.25(b)

Government-ID identity verification

Patient identity is verified via government-issued ID at each initial encounter, with a copy or record retained in the compliance file.

21 CFR Part 1311

Mandatory EPCS compliance

All controlled-substance prescriptions are electronically prescribed (EPCS) with two-factor authentication, audit logs, and DEA-compliant software certification.

Proposed Rule §1306.25(c)

Annual DEA reporting

An annual report of telemedicine controlled-substance prescribing activity is prepared and ready for submission, including prescriber identifiers, patient counts, and drug schedules.

21 CFR §1306.05

Prescriber licensure verification

Each prescriber's DEA registration and state medical licenses are verified as active and unrestricted in every state where patients are treated.

How a file is built

Intake to credentialed reviewer release, with deterministic gates the AI cannot overrule.

AI extracts and drafts. Deterministic rules — running as code, outside the model — decide what is complete. A credentialed healthcare compliance reviewer signs every release. That order is never reversed.

01

Compliance Gap Scan

Upload prescriber roster, encounter records, PDMP logs, and EPCS configuration. We return a free completeness read: which statutory elements and searches you already have, and which are missing.

02

Evidence & license verification

As your authorized clerical agent, we verify DEA registrations, state licenses, and order PDMP checks across all required jurisdictions, building the prescriber-patient matrix.

03

Grounded drafting

The compliance file is drafted from your validated data and the rule pack into field-locked templates — no legal opinions, no invented facts.

04

Deterministic completeness gates

PDMP checks reconcile to every encounter; identity verification evidence is present; EPCS audit logs are complete; licensure is verified. Any failure blocks release.

05

Credentialed reviewer release

A healthcare compliance reviewer (not a physician re-litigating clinical decisions) reviews the exception queue and signs the release. High-risk patterns route to outside regulatory counsel.

06

Delivery

You receive the per-prescriber compliance file: evidence log, PDMP matrix, identity verification records, EPCS audit trail, DEA reporting package, and a continuous monitoring dashboard — ready for audit or special-registration application.

The bar we hold

Rigor you can measure.

100%
Credentialed-reviewer-released
No file ships without a human signature.
5 days
Standard SLA per prescriber
From complete intake to released file.
<1%
Critical-defect target
Tracked against a gold-standard file library.
4+
Compliance-check sources
DEA · state boards · PDMP · EPCS logs, every applicable file.
Why TeleRxGuard

Built to be the most thorough option a telehealth platform has.

Documentation-complete, by design

The deliverable is completeness itself — every statutory element and check accounted for or explicitly exception-coded. Nothing is left implicit.

Deterministic, not vibes

The gates that decide completeness are code, not a model's opinion. A drafting error cannot slip past a regulatory requirement.

In its lane, on purpose

We prepare documentation and run checks as your clerical agent. We never provide legal advice, contact patients, or make clinical decisions.

Engagement

Flat fee, per prescriber onboarded and per month monitored. No hourly billing, ever.

Simple, predictable, and aligned with a compliance standard — not an open-ended consulting retainer.

  • A free Compliance Gap Scan before you commit — see exactly what is missing.
  • One flat fee per prescriber onboarded; one flat monthly monitoring fee per active prescriber.
  • Disclosed pass-through costs for PDMP checks and license verifications.
  • Optional fixed-fee outside regulatory counsel escalation for high-risk patterns.
FAQ

Questions, answered precisely.

Is TeleRxGuard a law firm?
No. TeleRxGuard, a service of Your Deputy, Obuke LLC, provides documentation-completeness services. It is not a law firm, does not provide legal advice, and does not represent you in any legal matter. Outside regulatory counsel review is available and recommended for high-risk compliance patterns.
Do you contact patients or prescribe medications?
Never. TeleRxGuard is not a healthcare provider and does not contact patients, prescribe medications, or make clinical decisions. The telehealth platform remains the prescribing entity and the party responsible for all patient care.
What makes a file 'complete'?
Completeness is defined by the statute and proposed rule: legitimate medical purpose documentation, multi-jurisdiction PDMP checks, government-ID identity verification, EPCS compliance, annual DEA reporting, and prescriber licensure verification. Deterministic gates enforce each one before release.
How fast is it?
The standard SLA is five business days per prescriber from complete intake to a credentialed-reviewer-released file. The free Gap Scan is returned much sooner and tells you exactly what is still needed.
How are you priced?
A flat fee per prescriber onboarded and a flat monthly monitoring fee per active prescriber. No hourly billing, no contingency, and no percentage of any revenue.

See what's missing before it costs you a license.

Start with a free Compliance Gap Scan. Send your prescriber roster, encounter records, PDMP logs, and EPCS configuration and we'll return a completeness read against every subsection of the DEA Special Registration proposed rule and current flexibilities.

Documentation-completeness service · not legal advice · the telehealth platform remains the prescribing entity.