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News & Regulatory

Peptide & Telehealth News

Source-cited coverage of the FDA rulings, regulatory shifts and research that change what you can access online. Editorially independent, every claim referenced.

LegalOct 26, 2026·8 min read

Hims & Hers Asks a Federal Court to Dismiss the FTC's Privacy and Subscription Lawsuit

Hims & Hers asked a federal court on October 22, 2026 to dismiss all nine counts of the FTC-led privacy and subscription lawsuit, arguing its privacy policy disclosed advertiser data sharing and that its fixed-term plans are not illegal auto-renewals. The case (FTC, California, and Utah v. Hims & Hers Health, Case No. 3:26-cv-07871) is pending in the Northern District of California, with a hearing set for January 7, 2027.

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LegalOct 23, 2026·7 min read

Columbus Doctor and Clinic Manager Admit to a $1.6 Million Telehealth Medicaid Fraud

A Columbus physician, Dr. Patrick Muffley, and his clinic's office manager, Lisa Fillhart, pleaded guilty on October 19, 2026 to charges tied to a Medicaid telehealth billing scheme the Ohio Attorney General's office valued at $1,645,052. Prosecutors said the clinic billed more than 27,000 claims for telehealth visits that were never provided, many on dates the doctor never logged into the telehealth portal.

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RegulatoryOct 22, 2026·7 min read

Apothecary Pharma Recalls Compounded Tirzepatide Nationwide Over a Lack of Assurance of Sterility

Apothecary Pharma, LLC, a 503B outsourcing facility in Cary, North Carolina, is voluntarily recalling 22 vials of compounded tirzepatide injection, plus one vial of a compounded NAD+ injection, nationwide for a lack of assurance of sterility. The FDA classified the recall as Class II. The action follows a December 2025 FDA warning letter that cited sterility deficiencies at the facility.

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RegulatoryOct 21, 2026·7 min read

FDA Approves the First Generic of Climara Pro, a Once-Weekly Estrogen Plus Progestin Menopause Patch

The FDA announced on October 20, 2026 that it approved the first generic of Climara Pro, a once-weekly estradiol and levonorgestrel skin patch made by Zydus Pharmaceuticals. It is cleared for moderate to severe menopausal hot flashes and for preventing postmenopausal osteoporosis in women with a uterus, and it carries the same boxed warning as the brand. Here is what the approval covers and what it means for menopause care, including telehealth.

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RegulatoryOct 18, 2026·10 min read

FDA's Interim Peptide Compounding Policy: Where It Stands at the White House (Live Tracker)

As of October 23, 2026, the FDA's Interim Access Policy for Compounding Using Certain Peptides (RIN 0910-ZD94) is still pending review at the White House Office of Management and Budget, where it arrived on October 14. It has not been issued and its text is not public. The OMB public log shows six meetings with outside groups on the policy between October 21 and 28. This page is updated as the review moves.

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RegulatoryOct 16, 2026·8 min read

DEA Files a Notice of Intent to Temporarily Place 7-OH and Mitragynine Pseudoindoxyl in Schedule I Above a Concentration Threshold

On October 14, 2026, the DEA filed a notice of intent to temporarily schedule 7-hydroxymitragynine (7-OH) and mitragynine pseudoindoxyl in Schedule I above a set concentration threshold, following an October 8 HHS recommendation. It is a notice of intent, not a final order, and the controls it describes have not taken effect.

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LegalOct 16, 2026·6 min read

Massachusetts Doctor Sentenced to 36 Months in Two Telemedicine Fraud Schemes Tied to More Than $40 Million in False Claims

Le Thu, a Boston physician, took kickbacks to approve telemedicine prescriptions and signed thousands of false orders for genetic tests and equipment for Medicare patients she never treated. She was sentenced to 36 months in prison and more than $27 million in restitution, the U.S. Attorney's Office for the District of New Jersey said.

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LegalOct 15, 2026·7 min read

DEA Revokes an Indiana Nurse Practitioner's Controlled Substance Registration, Citing Opioids Prescribed by Telehealth Without an In-Person Exam

The DEA has revoked nurse practitioner Katherine Curtis's controlled substance registration after finding she prescribed opioids and other controlled drugs to six patients outside the usual course of practice, including opioids ordered by telehealth without the in-person exam Indiana law requires, and after her Indiana prescribing authority lapsed. The order takes effect November 13, 2026.

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RegulatoryOct 10, 2026·8 min read

FDA Tells Court It Expects Mifepristone Safety Study Results by December and a Final Report by March 2027, With Telehealth Prescribing Unchanged for Now

On October 7, 2026, the FDA told a federal court in the Louisiana mifepristone case that it expects to complete its safety study of the drug by mid-December 2026 and to issue a report on the findings no later than March 2027, after which it will decide whether to change how mifepristone is prescribed and distributed. The review includes reconsidering the 2023 decision that allowed telehealth prescribing and mail delivery. Access is unchanged for now under a Supreme Court order.

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LegalOct 9, 2026·7 min read

Louisiana, Alabama, and Arkansas File Two Lawsuits Targeting Telehealth Abortion Shield Laws and 30 Out-of-State Providers

On September 30, 2026, the attorneys general of Louisiana, Alabama, and Arkansas filed two lawsuits over telehealth abortion: a motion asking the U.S. Supreme Court to let them sue New York, California, and Massachusetts over their abortion shield laws, and a companion federal suit against 30 out-of-state providers. Both are early-stage allegations; no court has ruled.

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AccessOct 6, 2026·7 min read

CMS Awards South Dakota $7.2 Million to Expand Ambulance-Based Telemedicine and Modernize Rural EMS

On October 2, 2026, CMS announced $7.2 million in Rural Health Transformation Program funding for South Dakota to expand ambulance-based telemedicine, train EMS workers, and improve how crews share patient data with hospitals. The award covers 25 EMS projects and adds to the more than $189 million the state is set to receive over five years under the $50 billion federal program.

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LegalOct 5, 2026·7 min read

Federal Jury Convicts Michigan Doctor of Distributing More Than 2 Million Stimulant Pills Through Done's ADHD Telehealth Platform

A federal jury in the Western District of Michigan convicted Jonathan Decker, 46, on October 2, 2026 of conspiring to distribute and distributing controlled substances, finding he wrote prescriptions for more than 2 million stimulant pills through the Done ADHD telehealth platform. Prosecutors said he prescribed to patients he never examined, including people with substance use disorders and serious mental illness, and was paid more than $1 million. He is the 11th person convicted in the broader Done Global case.

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RegulatoryOct 2, 2026·7 min read

Texas Pharmacy Greenwich Rx Recalls 10 Lots of Compounded Glutathione Injection Nationwide Over Elevated Endotoxin

On October 1, 2026, Greenwich Rx, a 503A compounding pharmacy in Tomball, Texas, announced a voluntary nationwide recall of 10 lots of compounded Glutathione Injection (200 mg/mL) over potential elevated endotoxin levels. The vials, formulated for subcutaneous injection, were shipped directly to patients between June 26 and September 21, 2026. The recall adds to a run of 2026 Texas glutathione recalls now under a CDC and FDA investigation.

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AccessSep 26, 2026·7 min read

CMS Will Add Heart Failure, COPD, Substance Use and Tobacco Tracks to Its Technology-Enabled ACCESS Model in Spring 2027

CMS said on September 15, 2026 that its voluntary ACCESS Model will add Medicare tracks for heart failure, COPD, substance use disorders and tobacco cessation, plus extended bone, joint and mobility support, beginning in spring 2027. The model pays organizations for measurable health gains and lets them deliver care through virtual visits, remote monitoring and connected devices.

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AccessSep 25, 2026·6 min read

Senate Agrees by Unanimous Consent to a Resolution Designating September 20 to 26, 2026, as Telehealth Awareness Week

On September 24, 2026, the U.S. Senate agreed by unanimous consent to Senate Resolution 902, designating September 20 to 26, 2026, as Telehealth Awareness Week. The bipartisan measure recognizes telehealth's role in Medicare and rural care and urges steps to expand access. It is non-binding and changes no coverage; major Medicare telehealth flexibilities run separately through December 31, 2027.

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RegulatorySep 24, 2026·7 min read

CDC and FDA Investigate a Multistate Cluster of Illnesses Tied to Compounded Injectable Glutathione

The CDC, with the FDA and state health and pharmacy authorities, is investigating illnesses in people who received injectable glutathione compounded from dietary supplement grade ingredient. As of September 15, 2026, CDC reports more than 25 people ill across at least four states, with at least three hospitalized and no deaths. The FDA has tied adverse events in at least 30 patients to a common ingredient supplier, Medisca Inc.

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RegulatorySep 23, 2026·8 min read

FDA Warning Letter Alleges Empower Pharmacy's Compounded Semaglutide and Tirzepatide Are Illegal Copies of Approved GLP-1 Drugs

On September 18, 2026, the FDA issued a warning letter to Empower Pharmacy, one of the largest US compounders, alleging its compounded semaglutide and tirzepatide are essentially copies of the approved GLP-1 drugs and that added B vitamins are a pretext. The letter also cites insanitary conditions for products meant to be sterile. It is an enforcement notice of alleged violations, not a final finding.

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RegulatorySep 22, 2026·8 min read

FDA Sends Five Warning Letters to Online Peptide Sellers, Rejecting 'Research Use Only' Labels on Injectable Peptides

On August 24, 2026, the FDA's drug center sent warning letters to five online peptide sellers and posted them September 1, alleging they sold unapproved new drugs such as semaglutide and tirzepatide. The agency rejected 'research use only' disclaimers as a defense. Here is what the letters say and what they mean for the online peptide market.

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RegulatorySep 18, 2026·7 min read

FDA Issues a Temporary Compounding Policy to Head Off a Shortage of Starter IV Nutrition for Newborns as Two Outsourcing Facilities Close

On September 9, 2026, the FDA published temporary guidance easing federal compounding rules so hospital pharmacies and outsourcing facilities can keep making starter parenteral nutrition for neonates through March 8, 2027, after two outsourcing facilities that supply the standardized product said they are permanently closing. The policy is enforcement discretion, not a permanent change to the law.

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ResearchSep 17, 2026·6 min read

Use of BPC-157, the Unapproved 'Wolverine' Peptide, Is Climbing Fast in U.S. Medical Records

Documented use of BPC-157, an unapproved peptide sold as part of the 'Wolverine stack,' rose about 33-fold from 2020 to 2026, according to a preliminary analysis of more than 15 million U.S. medical records that the firm nference released ahead of peer review. It identified 1,039 patients, found users skewing younger and more male, and lands as the FDA logs a cluster of serious adverse-event reports.

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AccessSep 16, 2026·7 min read

Mississippi Awards More Than $104 Million in Rural Health Transformation Grants, Including 27 Telehealth Hub Awards

On September 14, 2026, Governor Tate Reeves announced 167 awards totaling $104,115,146 through the Mississippi Rural Health Transformation Program, including 27 grants under a dedicated Telehealth Hub Connectivity, Equipment, and Education program. The awards are the first round of Mississippi's roughly $205.9 million first year budget under the $50 billion federal Rural Health Transformation Program.

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RegulatorySep 15, 2026·7 min read

Houston Pharmacy Centric Compounding Recalls Glutathione, Myer's Cocktail and Tri-Immune Boost Nationwide Over Elevated Endotoxin

Centric Compounding LLC of Houston, Texas is voluntarily recalling six lots of injectable products (Glutathione 200 mg/mL, Myer's Cocktail and Tri-Immune Boost) to the consumer level after the products were compounded with a glutathione API containing elevated endotoxin levels. FDA posted the notice on September 13, 2026, and the pharmacy reports nine adverse-event reports.

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RegulatorySep 12, 2026·7 min read

FDA Blocks Imports and Prompts Recall of Sildenafil and Tadalafil Ingredients From an Indian Plant That Supplied U.S. Compounding Pharmacies

The FDA placed Shoolin Pharma Chem on import alert on August 11, 2026 and the firm recalled its U.S. drug ingredients after an April inspection found insanitary conditions at its Gujarat, India plant. The APIs include sildenafil and tadalafil used by compounding pharmacies, the same active ingredients behind many telehealth erectile dysfunction programs.

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LegalSep 5, 2026·8 min read

Fifth Circuit Sets September 9 Oral Argument in Louisiana's Challenge to Telehealth Prescribing of Mifepristone

The Fifth Circuit is scheduled to hear oral argument September 9, 2026, in State of Louisiana et al. v. FDA (No. 26-30203), a challenge to the FDA's 2023 decision to drop the in-person dispensing rule that had blocked telehealth prescribing and mail delivery of mifepristone. Access is unchanged for now under a Supreme Court stay while the appeal proceeds.

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RegulatorySep 4, 2026·8 min read

CMS Confirms Its Pandemic-Era Telehealth Enrollment Flexibility Is Now Permanent, Letting Home-Based Clinicians Enroll and Bill From a Physical Practice Location

CMS guidance current as of mid-2026, and highlighted in the agency's August 20, 2026 Medicare Learning Network newsletter, confirms that clinicians who furnish Medicare telehealth from home but keep a physical practice location no longer have to report their home address to enroll. The flexibility does not extend to teleradiology, and state licensure rules still apply.

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LegalSep 1, 2026·8 min read

Third Circuit Upholds New Jersey's Requirement That Out-of-State Doctors Hold a New Jersey License Before Treating Patients by Telemedicine

On August 31, 2026, the U.S. Court of Appeals for the Third Circuit affirmed the dismissal of a constitutional challenge to New Jersey's rule that any physician practicing telemedicine with a patient in the state must first hold a New Jersey medical license. The precedential decision held the requirement is a content-based speech regulation that survives because medical licensing fits a long tradition of such rules.

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RegulatoryAug 31, 2026·6 min read

FCC Publishes Rural Health Care Program Proposal in the Federal Register, Opening a Public Comment Period

The FCC's Third Further Notice of Proposed Rulemaking on the Rural Health Care Program (WC Docket No. 17-310, FCC 26-54), adopted August 6, 2026, was published in the Federal Register on August 31, 2026, opening a public comment period. Comments are due September 30, 2026 and reply comments October 30, 2026. It is a proposal seeking comment, not a final rule.

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LegalAug 30, 2026·9 min read

Fifth Circuit Affirms FDA's Decisions to End the GLP-1 Drug Shortages, Upholding Limits on Compounded Semaglutide and Tirzepatide

On August 27, 2026, the U.S. Court of Appeals for the Fifth Circuit affirmed two judgments for the FDA, upholding the agency's removal of Ozempic and Wegovy (semaglutide) and Mounjaro and Zepbound (tirzepatide) from its drug shortage list. Because federal law only relaxes the ban on compounding copies of an approved drug while it is in shortage, the rulings leave in place the legal limits on mass compounding of these GLP-1 medicines, which many patients obtain through telehealth. Here is what the decisions say and what they mean.

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RegulatoryAug 25, 2026·6 min read

Houston Pharmacy Recalls Compounded Glutathione Across 14 States, the Second Texas Endotoxin Recall in Two Weeks

Optimal Balance Pharmacy of Houston, Texas is voluntarily recalling one lot of Compounded Glutathione 200 mg/mL multi-dose vials to the patient level after its own testing found elevated bacterial endotoxin. The product reached patients in 14 states, and the pharmacy says it has received adverse-event reports. It is the second Texas compounding pharmacy in about two weeks to recall injectable glutathione for the same reason.

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AccessAug 22, 2026·7 min read

Dartmouth Health Plans to End Its Tele-ICU and Tele-ED Programs for 13 Rural Hospitals in New Hampshire and Vermont, Citing Unsustainable Costs

Dartmouth Health plans to end its Tele-ICU and Tele-ED programs, which remotely support the intensive care units and emergency departments of 13 rural hospitals in New Hampshire and Vermont, citing costs a spokesperson called unsustainable without external funding after a reported $63.5 million operating deficit. No firm end date is set, and the system says it will help affected hospitals line up alternatives first. Here is what is closing, who is affected, and what it signals for rural telehealth.

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LegalAug 18, 2026·9 min read

Bupe.me and Church Ekklasia Sozo: Inside the Telehealth Opioid Nonprofit at the Center of a Federal Buprenorphine Prescribing Case

Church Ekklasia Sozo, which operated online as Bupe.me, was a North Carolina nonprofit that prescribed the addiction medication buprenorphine to thousands of patients through telemedicine. Federal investigators say prescriptions were issued using clinicians' DEA registrations without the clinicians evaluating patients. Here is what is known about the company, its founder Doug Smith, the one conviction so far, and what remains under investigation.

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LegalAug 18, 2026·6 min read

North Carolina Physician Sentenced After a Telemedicine Company Used His DEA Registration for More Than 25,000 Buprenorphine Prescriptions

A federal court sentenced Waxhaw physician Dr. Henry Ronald Emery Jr. to six months in prison and one year of supervised release after prosecutors said he let a telemedicine opioid treatment company use his DEA registration to issue more than 25,000 buprenorphine prescriptions to patients he never interacted with. Here is what the case shows about controlled substance prescribing by telehealth, and how it differs from legitimate online treatment for opioid use disorder.

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LegalAug 15, 2026·8 min read

Ninth Circuit Revives a Justice Department Subpoena to Telehealth Provider QueerDoc and Sends the Overbreadth Question Back to the Trial Court

On August 14, 2026, a divided Ninth Circuit panel reversed a Seattle judge who had quashed a Justice Department administrative subpoena to QueerDoc, a telehealth clinic, and sent the case back to weigh whether the demand is overbroad. QueerDoc has not been charged with any violation and the investigation is pending. Here is what the ruling decided, the subpoena authority at issue, and what it signals for telehealth providers.

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RegulatoryAug 14, 2026·7 min read

Apollo Care Recalls More Than 162,000 Vials of Compounded Semaglutide Nationwide After Particulate Matter Found

Apollo Care, LLC, an FDA registered 503B outsourcing pharmacy in Columbia, Missouri, is voluntarily recalling more than 162,000 multi-dose vials of compounded semaglutide nationwide after particulate matter identified as nylon/polyamide and silk/proteinaceous material was found in the vials. The firm initiated the recall on July 29, 2026, and the FDA has classified it as a Class II recall.

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LegalAug 8, 2026·7 min read

Federal Court Dismisses Compounder's GLP-1 Antitrust Suit Against Eli Lilly and Novo Nordisk Over Telehealth Deals

A federal judge in Texas dismissed Strive Specialties' antitrust lawsuit against Eli Lilly and Novo Nordisk, which alleged the drugmakers used exclusive telehealth partnerships to lock compounded GLP-1 pharmacies out of the market. The court found compounded and branded GLP-1 drugs do not compete in the same market. Here is what the ruling says and what it means for telehealth GLP-1 access.

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RegulatoryAug 7, 2026·7 min read

CMS Proposes to Expand the Medicare Telehealth List and Add New Telehealth Modifiers in the CY2027 Fee Schedule

In the proposed CY2027 Medicare Physician Fee Schedule (CMS-1848-P, released July 14, 2026), CMS proposes adding five services to the Medicare Telehealth Services List, creating two informational telehealth modifiers (BB and BC) to flag third-party platform and incident-to arrangements, raising the originating site facility fee to $32.65, and implementing the Consolidated Appropriations Act, 2026 telehealth flexibilities through the end of 2027. Nothing is final. Public comments are due September 14, 2026.

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AccessAug 7, 2026·7 min read

New Jersey Revises the Rules for Prescribing Schedule II Controlled Substances by Telemedicine

A New Jersey law enacted in July 2026, P.L. 2026, c. 40, amends N.J.S.A. 45:1-62 and keeps an in-person examination as the default for prescribing a Schedule II controlled dangerous substance by telemedicine, both at the start of care and every three months, unless a statutory exception applies. The law adds a telehealth pathway for adult stimulant prescriptions and full exceptions for patients in cancer, hospice, palliative, or long-term care, patients under the Medical Aid in Dying Act, and medications used to treat a substance use disorder.

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AccessAug 4, 2026·6 min read

CMS Will Require Rural Health Clinics and FQHCs to Bill Individual Telehealth Codes Instead of G2025 Starting October 1, 2026

Starting October 1, 2026, Medicare will require rural health clinics (RHCs) and federally qualified health centers (FQHCs) to bill the individual CPT or HCPCS code for each distant site telehealth service instead of the bundled code G2025, and to add modifier 93 (audio only) or 95 (audio and video). CMS set the requirement in Change Request 14468 (Transmittal R13776OTN), effective October 1, 2026 with an implementation date of October 5, 2026. It is a coding and reporting change, not a change to coverage, and payment stays tied to national average Physician Fee Schedule telehealth rates.

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RegulatoryAug 3, 2026·6 min read

FCC Is Scheduled to Take Up a Rural Health Care Program Overhaul Aimed at Cutting Telehealth Red Tape

The FCC is scheduled to consider Promoting Telehealth in Rural America (WC Docket No. 17-310) at its August 6, 2026 open meeting, a Third Further Notice of Proposed Rulemaking and Order that would seek comment on cutting administrative burdens in the Rural Health Care Program and would let rural providers reuse previously approved rural rates for funding year 2027. It is a proposal that only seeks comment, not a final rule.

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LegalAug 2, 2026·8 min read

Three Sentenced in $2 Billion Telemedicine Fraud as Alleged Ringleader Remains at Large in Russia

In May 2026 a federal court in Brooklyn sentenced three members of an international criminal organization to lengthy prison terms for a roughly $2 billion telemedicine health care fraud that billed private insurers using sham online visits. The man prosecutors identify as the leader, Brian Sutton, has not been tried and is reported to be living freely in Russia. Here is what the Justice Department proved, what remains an allegation, and what the case shows about telehealth fraud.

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LegalJul 27, 2026·7 min read

Telehealth Company Drops Compounded Semaglutide Weight Loss Claims After Novo Nordisk Ad Challenge

On July 24, 2026, BBB National Programs' National Advertising Division said Willow Health Services, a telehealth company, permanently discontinued advertising claims for its compounded semaglutide products after a challenge by Novo Nordisk. Here is what the self-regulatory case decided, what claims were at issue, and what it signals for the compounded GLP-1 market.

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LegalJul 26, 2026·6 min read

Austin Men's Health Clinic Chain Agrees to Up to $600,000 in Controlled Substances Act Settlement

Total MD Physicians Group, doing business as Total Men's Primary Care, and Dr. Mason Jones agreed to a consent judgment of up to $600,000 to resolve alleged Controlled Substances Act violations, including recordkeeping failures and electronically signing Schedule II prescriptions without a doctor-patient relationship. The claims are allegations only, with no determination of liability.

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RegulatoryJul 25, 2026·8 min read

FDA Advisory Panel Recommends Six of Seven Peptides for Compounding, Overriding FDA Staff

On July 23-24, 2026, the FDA's Pharmacy Compounding Advisory Committee voted to recommend six of seven peptides, including BPC-157 and TB-500, for the 503A compounding list, going against FDA scientists who urged rejection. Only emideltide (DSIP) was turned down. The recommendation is advisory and would still require a formal FDA rulemaking. Here are the tallies, the conflict-of-interest concerns, and what happens next.

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