The Regulator

10,879 confirmed Ebola cases and 5,302 deaths: that is the Congo outbreak CDC cited as it extended, through December 10, its order barring entry of non-citizens who were recently in the Democratic Republic of the Congo, Uganda or South Sudan. The Centers for Disease Control and Prevention (CDC) signed the continuing order November 10 and published it in the Federal Register today, with the case count current as of November 6. The order keeps the suspension unchanged, covers people who were in those countries during the last 21 days, and no longer exempts lawful permanent residents (green card holders), per the notice’s own history of the policy. Who it hits: travelers, employers and universities sponsoring people from the three countries, and clinicians planning deployments or recruiting from the region. CDC cites no dollar figure; written comments are due November 30 under Docket CDC-2026-0892. Confidence: High on the order and dates, which are in the notice itself. Sources: CDC order, Federal Register.

UPDATE: DEA put Takeda’s new narcolepsy drug oveporexton (Orzeyful) in Schedule IV, effective immediately November 12. The Drug Enforcement Administration (DEA) issued an interim final rule, a rule that takes effect before public comment, under a law that lets DEA schedule newly approved drugs on HHS’s recommendation. The Food and Drug Administration (FDA) approved the drug August 5 for narcolepsy type 1 in adults, and DEA says its abuse potential is similar to other Schedule IV drugs, citing “euphoric mood” as the most common abuse-related adverse event in non-narcolepsy trial participants. Who it hits: prescribers, pharmacies and distributors, who now handle it under Schedule IV controls. The rule carries no price; comments and hearing requests are due December 14. Confidence: High. Sources: DEA interim final rule, Federal Register.

A New York doctor was indicted in Florida over $6.8 million in Medicare claims tied to the same telemedicine company whose owner just got 20 years. The Justice Department (DOJ) says a Southern District of Florida grand jury charged Dr. Edgard Salazar, 57, of Armonk, New York, with conspiracy and five counts of health care fraud, alleging he signed pre-filled orthotic brace prescriptions for Medicare patients he did not examine and billed consultations that never occurred. The company, TelevisitMD, was owned by Christopher Harwood, who pleaded guilty in March, agreed to $17.9 million in restitution and was sentenced last month to 20 years. Who it hits: telemedicine groups and the supplier networks that buy signed orders. Each count carries up to 10 years; an indictment is an allegation, not a finding. Confidence: High on the charges as described by DOJ. Sources: DOJ press release, HHS Office of Inspector General enforcement listing.

FDA confirmed the ban on Orange B dye in frankfurter and sausage casings took effect September 8. The Food and Drug Administration (FDA) said no one filed objections or hearing requests against its July 23 final order, so the repeal of the color additive listing at 21 CFR 74.250 stands. Who it hits: casing and sausage makers that used the dye on casings or surfaces. FDA gives no cost figure. Confidence: High. Sources: FDA confirmation notice, Federal Register.

FDA says Dibenzyline (phenoxybenzamine) 10 mg capsules were not pulled for safety or effectiveness, keeping the door open for generic approvals. The notice covers the brand capsule and other products FDA found are no longer marketed. The determination means FDA will not move to withdraw approvals of generics that reference them and can keep approving new generic applications that meet legal requirements. Who it hits: generic drugmakers weighing an application. No market figures are published. Confidence: High. Sources: FDA determination notice, Federal Register.

Quiet note: no same-day Centers for Medicare & Medicaid Services rule appeared in today’s Federal Register, only paperwork-collection notices, so today leans on CDC, DEA, FDA and DOJ items.