Month: December 2025

Credit to Caitlin A. Koppenhaver, Esq.

Sources: Federal Register :: Fourth Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications; Telehealth policy updates | Telehealth.HHS.gov

On December 31, 2025, the Drug Enforcement Administration (DEA), jointly with the U.S. Department of Health and Human Services (HHS), published a temporary rule that extends the COVID-era “telemedicine flexibilities” for prescribing Schedule II–V controlled substances through December 31, 2026 (the fourth temporary extension). The rule is effective January 1, 2026 through December 31, 2026, and is intended to avoid a sudden return to pre-pandemic restrictions, which would otherwise potentially and abruptly limit patients’ access to care while DEA and HHS work toward final, long-term regulations.

What the December 31, 2025 “Fourth Temporary Rule” Means

This rule does not create a new telemedicine prescribing regime; rather, it extends the existing COVID-era flexibility window. These telemedicine flexibilities have been in place since March 2020 for prescribing controlled substances via telemedicine. Under the rule, during the period May 12, 2023 through December 31, 2026, a DEA-registered practitioner may prescribe Schedule II–V controlled substances via telemedicine to a patient without an in-person medical evaluation if specified conditions are met.

A practitioner is only authorized to issue prescriptions for controlled substances if all of the following conditions are met:

1. The prescription is issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice (i.e., consistent with an appropriate practitioner–patient relationship and documentation supporting medical necessity);

2. The prescription is issued pursuant to a communication between a practitioner and a patient using an interactive telecommunications system referred to in 42 CFR 410.78(a)(3) (i.e., real-time, two-way audio-video telehealth);

3. The practitioner is authorized under their registration under 21 CFR 1301.13(e)(1)(iv) to prescribe the basic class of controlled substance specified on the prescription (i.e., the practitioner’s DEA registration covers that schedule/class); or exempt from obtaining a registration to dispense controlled substances under 21 U.S.C. 822(d); and

4. The prescription is consistent with all other requirements of 21 CFR part 1306 (i.e., it must comply with DEA’s prescribing rules, including form/content and related requirements).

These conditions are federal baseline requirements for the telemedicine pathway and do not eliminate any separate obligations under applicable state law, professional practice standards, or other DEA compliance requirements.

Why DEA/HHS say they are doing this: avoiding the “telemedicine cliff”

DEA and HHS explain that the extension is intended to prevent a “telemedicine cliff,” meaning an abrupt end to the ability to prescribe controlled substances via telemedicine (in certain circumstances) before a permanent framework is finalized and implemented. DEA and HHS cite concerns that expiration could disrupt access to care and create significant operational backlogs if large numbers of patients were required to obtain in-person evaluations on a compressed timeline. They also state that the extension provides additional time to finalize and implement regulations that balance access to care with safeguards against diversion, while allowing stakeholders time to prepare for future implementation.

How this interacts with other DEA telemedicine rules

DEA and HHS also clarify that this temporary extension is a separate legal pathway from the other DEA telemedicine rules published in January 2025 with delayed effective dates and a path to go into effect at the end of 2025 (the one addressing buprenorphine treatment via telemedicine, and another addressing continuity of care for Veterans Affairs patients). They clarify that practitioners may rely on the temporary rule during 2026 if its conditions are met, even if the prescription could also fit within one of those other rules.

For telehealth/virtual care providers

The rule preserves the ability to initiate (and continue) controlled-substance prescribing for certain patients via telemedicine without forcing an immediate in-person visit solely to satisfy Ryan Haight’s baseline requirement, through December 31, 2026. Operationally, the explicit tie-back to 21 CFR Part 1306 keeps “classic” DEA expectations in play (legitimate medical purpose/usual course; compliant prescribing practices), even when the initial in-person evaluation has not occurred.

For pharmacies: Dispensing remains governed by the usual Controlled Substances Act/DEA rules; the prescription may originate from a qualifying telemedicine encounter under the temporary flexibility. 

For patients: The extension is primarily aimed at avoiding disruption for patients who rely on telemedicine access, particularly where in-person access is difficult or delayed, while DEA works toward a permanent framework

The December 31, 2025 temporary extension is best understood as a bridge: it buys time for DEA/HHS to finalize and operationalize permanent rules while preventing a hard snapback to pre-pandemic limitations.

Credit: Caitlin Koppenhaver

Florida is signaling an important message in the compounding and weight-loss ecosystem: the Florida Legislature is not waiting for federal enforcement to catch up. Florida Senate Bill 860 (2026), filed on December 10, expressly states that while the FDA sets internationally recognized standards and bears the “responsibility for enforcing federal laws to protect citizens from misbranded and adulterated pharmaceutical ingredients”, FDA enforcement has “proven insufficient” to stop “illicit, substandard, and potentially harmful active pharmaceutical ingredients that jeopardize patient health and safety”.

The Florida Legislature “therefore finds it necessary for the state to take action to protect its residents by ensuring that all active pharmaceutical ingredients used in compounding are sourced from reputable, registered, and inspected establishments, and that only pharmaceutical-grade, safe, and unadulterated ingredients are used in medications for weight loss”. This proposed section will not be in the Florida Pharmacy Practice Act (Chapter 465), but instead is introduced as a new section proposed in the Florida Drug and Cosmetic Act (Chapter 499), the part of Florida law that focuses on drug distribution, adulteration/misbranding concepts, and supply chain controls.

What would this mean if enacted?

Under this proposed section titled “Regulation of medications containing certain active pharmaceutical ingredients”, the term “compounded medication” would be defined as “a customized drug prepared by a licensed pharmacist or licensed physician by combining, mixing, or altering the ingredients of one or more drugs or products, which drug is commonly prescribed if a commercially available medication does not meet a patient’s specific health need.”

If this bill becomes law, it would prohibit a person or entity from engaging in the sale, transfer, or distribution of a compounded medication for weight loss unless the person or entity provides documentation to the Department of Business and Professional Regulation certifying all of the following:

1. FDA-approved drug “match” requirement: If the weight-loss compound is being compounded by a licensed pharmacist or licensed physician pursuant to the federal provision that allows compounding from bulk drug substances (Section 503A of the FD&C Act), the active pharmaceutical ingredient must be (i) identical to that used in the manufacture of an FDA-approved drug and (ii) manufactured according to the manufacturing process for that ingredient as specified on the label of an FDA-approved drug.

2. Pharmaceutical-grade requirement: The active pharmaceutical ingredient (API) must be a pharmaceutical-grade product.

3. Certificate of Analysis (COA) plus underlying data: The API must be accompanied by a valid COA that includes informational material as to the safety and effectiveness of the drugs compounded using the active pharmaceutical ingredient, including the identity and content of the active pharmaceutical ingredient and the identity of each impurity by chemical name and amount present. A certificate of analysis is not valid unless it is accompanied by testing data from the original manufacturing establishment demonstrating that the information on the certificate of analysis is accurate.

4. FDA registration and recent inspection requirement: The API must be manufactured in a facility that is FDA-registered pursuant to 21 U.S.C. s. 360 and has been inspected by FDA as a human drug establishment within the past two years. The inspection must have included monitoring for cGMP compliance for the relevant API and must have resulted in an FDA classification of either NAI (No Action Indicated) or VAI (Voluntary Action Indicated).

5. Incoming quality control testing requirement: Quality control testing of the API must be conducted before use in a compounded drug to confirm the API’s identity and content and to confirm (i) the identity and content of the active pharmaceutical ingredient and (ii) that any impurity present has been identified, characterized, quantified, and justified given the product or the product’s intended use.

Violations of this section would trigger a fine of $1,000 per dose of the “illegally compounded” drug sold, dispensed, transferred, or distributed and subject the person or entity to license or permit revocation by the Board of Pharmacy or the Department of Business and Professional Regulation, as applicable. DBPR may adopt implementing rules and conduct inspections as necessary, and the section would take effect upon becoming law.

Who would this apply to?

SB 860 would apply to any person or entity that sells, transfers, or distributes compounded weight-loss medications in Florida, which functionally includes compounding pharmacies and dispensing providers, as well as any distributor or permitted entity involved in delivering the product or its APIs through the supply chain.

Will this pass?

As of the last posted action, SB 860 has been filed and then referred to three Senate committees: Regulated Industries (RI), Appropriations Committee on Agriculture, Environment, and General Government (AEG), and Fiscal Policy (FP). The bill would then need to pass the full Senate and the House (with any differences reconciled into identical final text), and then be signed by the Governor (or enacted over a veto).

Practical Takeaways

In the meantime, this proposal is a useful compliance “direction-of-travel” signal even if it does not ultimately pass. Industry stakeholders can use it as a practical checklist now by identifying every compounded weight-loss product in scope, confirming the API’s source and inspection status, organizing COAs and underlying manufacturer test data, documenting incoming API testing before use, and tightening vendor qualification files and contracts so suppliers must provide these materials on demand. Even if SB 860 stalls, these steps reflect where Florida legislators appear to be headed on weight-loss compounding and supply-chain expectations.

Source: flsenate.gov/Session/Bill/2026/860/BillText/Filed/HTML