For nearly six years, telehealth companies have prescribed controlled substances without an in-person visit under a series of temporary DEA “flexibilities” that began during the COVID-19 public health emergency. That arrangement has an end date: December 31, 2026. And this time, the permanent replacement is finally moving.

On August 25, 2026, DEA's final rule, Special Registrations for Telemedicine and Limited State Telemedicine Registrations (RIN 1117-AB40), was received by the White House Office of Information and Regulatory Affairs for review. That is the last stop before publication in the Federal Register. The text of the final rule is not yet public, but the proposed rule DEA published in January 2025 tells us what the framework is likely to look like, and it is considerably more demanding than the status quo.

If your business prescribes testosterone, phentermine, ketamine, stimulants, benzodiazepines, or any other controlled substance through a telehealth model, you have roughly three months to get ready for one of two outcomes: a new registration regime, or a fifth temporary extension. Planning for the first is the only safe approach.

Where things stand

The Ryan Haight Act generally requires at least one in-person medical evaluation before a practitioner may prescribe a controlled substance to a patient via the internet. The Act contemplated a “special registration” for telemedicine that would allow prescribing without that visit, but DEA never issued the regulations to create it. The pandemic-era flexibilities papered over that gap, and DEA and HHS have now extended them four times. The fourth extension, published December 31, 2025, runs through December 31, 2026, with the stated purpose of preventing a “telemedicine cliff” while DEA finishes the permanent rule.

That permanent rule is what arrived at OIRA in August. Publication is projected for late 2026. Whether it takes effect before the flexibilities lapse, and whether DEA pairs it with a transition period, are the two open questions every telehealth operator should be watching.

What the proposed rule would require

Under the January 2025 proposal, a practitioner who wants to prescribe controlled substances via telemedicine without an in-person evaluation would need one of three new DEA registrations, plus a separate State Telemedicine Registration in every state where patients are located.

Telemedicine Prescribing Registration. Available to physicians and mid-level practitioners who can show a legitimate need to treat patients for whom in-person evaluation would be burdensome. Covers Schedule III–V only. For most weight-management, men's health, and sleep-medicine platforms, this is the relevant tier, and it would cover testosterone (Schedule III) but not stimulants or most opioids.

Advanced Telemedicine Prescribing Registration. Available to a narrower set of board-certified specialists (psychiatrists, hospice and palliative care physicians, neurologists, pediatricians, and practitioners treating long-term care patients) and covers Schedule II–V. This is the tier ADHD-focused and psychiatric telehealth companies would need.

Telemedicine Platform Registration. A registration for the online platform itself, available to platforms that can demonstrate they oversee their clinicians' prescribing practices and maintain patient-safety safeguards. This is the first time DEA has proposed registering the platform as an entity distinct from its prescribers, and it would bring the platform's policies, oversight structure, and records directly within DEA's inspection authority.

Layered on top of the registrations, the proposal included several operational requirements that are worth planning around now:

•             Schedule II limits. Practitioners with an advanced registration would have to keep telemedicine Schedule II prescriptions below 50 percent of their total Schedule II prescribing, and would have to be physically located in the same state as the patient when issuing a Schedule II prescription.

•             PDMP checks. A check of the prescription drug monitoring programs in the patient's state, the practitioner's state, and any reciprocal jurisdictions before every controlled-substance prescription, expanding to a nationwide check within three years.

•             Identity verification, recordkeeping, and reporting. Photo identification of the patient, telemedicine-specific prescription notations, and annual reporting to DEA.

•             Fees. A proposed $50 fee per State Telemedicine Registration for clinician practitioners and $888 for platform practitioners, on top of the underlying DEA registration.

The final rule may relax or tighten any of these. DEA received thousands of comments, many of them objecting to the Schedule II ratio and the nationwide PDMP requirement. But the three-tier structure and the state-by-state registration concept were the core of the proposal, and a final rule that abandons them entirely would be unusual.

What this means for California telehealth operators

Testosterone and men's health platforms are the most exposed group in our client base. Testosterone is Schedule III, which places it within the base Telemedicine Prescribing Registration, but every prescribing clinician would need both the DEA special registration and a State Telemedicine Registration for California and every other state where patients are located. Platforms that rely on contracted physicians across many states should inventory those prescribers now and determine who is willing and eligible to register.

Weight-management platforms prescribing phentermine (Schedule IV) alongside compounded GLP-1s face the same registration requirement for the phentermine side of the business. Some platforms will conclude that the compliance overhead is not worth it and drop controlled substances from their formulary; that decision is easier to make in October than in late December.

Ketamine and psychiatric telehealth companies would need the advanced registration tier, which is limited by specialty. A platform whose prescribers are not board-certified in a qualifying specialty may not be able to continue Schedule II or ketamine (Schedule III) prescribing at all without an in-person visit.

Platform-level registration deserves particular attention in California, where the corporate practice of medicine doctrine already constrains how a management company may interact with clinical decision-making. A DEA platform registration that requires the platform to “oversee the clinician practitioner's prescribing practices” sits in tension with a California MSO structure that must not control clinical judgment. Companies will need to draft platform policies that satisfy DEA's oversight expectations without crossing the line the Medical Board and the Attorney General police.

What to do before December 31

1.          Inventory your controlled-substance prescribing. Which drugs, which schedules, which states, which prescribers, and what volume. This is the input for every decision that follows.

2.          Map prescribers to registration tiers. Identify which clinicians could qualify for the base registration, which (if any) could qualify for the advanced tier, and where you have gaps.

3.          Decide whether to keep controlled substances on the formulary. For some businesses the honest answer is that a Schedule IV appetite suppressant is not worth a DEA platform registration.

4.          Build the in-person pathway. If the rule slips or a prescriber cannot register, an in-person evaluation, or a qualifying referral from a DEA-registered practitioner who has examined the patient, restores prescribing authority under the Ryan Haight Act's existing exceptions. Partnerships with brick-and-mortar clinics are the fallback.

5.          Get your PDMP and identity-verification workflows ready. Even if the final rule softens the nationwide PDMP requirement, multi-state PDMP checks and patient photo ID are almost certainly in the final version. Build them into the platform now.

6.          Review your MSO and platform agreements. Confirm that the oversight language you would need for a platform registration is consistent with California's corporate practice rules.

7.          Watch for the Federal Register notice. Once the final rule publishes, the effective date and any transition period will drive the rest of the calendar. We will publish an update the week it appears.

The bottom line

DEA has extended the flexibilities four times, and it may do so a fifth. But the final rule is now at the last stage of review, and the agency's own timeline points to publication before the end of the year. A business that plans for a fifth extension and gets a final rule instead will be scrambling in December. A business that plans for the rule and gets an extension will have lost nothing but a few weeks of preparation.

Balogh Law advises telehealth platforms, compounding pharmacies, and wellness clinics on DEA registration, Ryan Haight compliance, and California corporate practice structuring. If you would like help mapping your prescribing model to the proposed framework, contact us.

This post is for general informational purposes and is not legal advice. Reading it does not create an attorney-client relationship.