The biggest item this week: DEA revoked two Texas pharmacies for filling controlled substance prescriptions that looked the same from patient to patient. Texas rules list “substantially identical” prescriptions and cash payment as red flags a pharmacist must resolve before filling. If your hormone program writes the same order for every patient, read item 1 first.
Covers October 2 to 8, 2026. Every item links to the agency document it comes from.
1. DEA revokes two Texas pharmacies over pattern prescribing and unresolved red flags
On October 7, 2026, DEA published decisions revoking the registrations of Wellwise Pharmacy Inc. of Houston and Conroe, Texas (FR Doc. 2026-20552), and Arenbii Pharmacy LLC of Missouri City, Texas (FR Doc. 2026-20535). Both orders take effect November 6, 2026. Both pharmacies defaulted, so the allegations were deemed admitted.
DEA relied on 21 CFR 1306.04(a) and the Texas red flag list at 22 Tex. Admin. Code § 291.29(f). That list includes “a reasonably discernible pattern of substantially identical prescriptions” that indicates “a lack of individual drug therapy,” prescriptions at the highest strength or in large quantities, several people at one address with similar prescriptions, and patients who “consistently pay for controlled substance prescriptions with cash.” At Wellwise, three prescribers wrote 91 percent of the pharmacy’s oxycodone 30 mg prescriptions. At Arenbii, more than 90 percent of Schedule II opioid prescriptions came from a single prescriber.
These cases involve opioids. The red flag list applies to every controlled substance, and testosterone is Schedule III.
What to do: if your clinic prescribes testosterone or another controlled substance from a protocol, make sure each chart shows why that dose fits that patient. Expect the pharmacy to call when every order looks the same and the patient pays cash, and answer the call with the chart. Hormone therapy oversight.
Sources: Federal Register 2026-20552 and 2026-20535.
2. CMS proposes CLIA changes for remote review and lab personnel
On October 8, 2026, CMS and CDC published a proposed rule amending the CLIA regulations at 42 CFR part 493 (CMS-3478-P). It would define “virtual access,” letting qualified personnel review digital lab data, results and images from outside the lab under the primary lab’s CLIA certificate, with cytology excluded. CMS says virtual access would not apply to provider-performed microscopy (PPM) certificates. The laboratory director stays responsible for all testing under the certificate, including remote work. The rule also proposes changes to the personnel requirements that took effect December 28, 2024, including qualifications for Mohs dermatology laboratory directors. Comments close December 7, 2026.
What to do: if you run a lab or a dermatology practice with a Mohs lab, read the personnel section before the comment window closes. A clinic that only runs waived tests should keep its certificate current and watch for the final rule. CLIA waivers for in-house labs.
Source: Federal Register 2026-20613
3. A preworkout sold nationwide contained DMAA
On October 6, 2026, Leader Formulas, LLC recalled one lot (260327-4) of RAPTURE Preworkout, a dietary supplement powder, after FDA testing found 1,3-dimethylamylamine (DMAA). FDA posted the notice October 7. The product was sold nationwide through retail and the company’s website from January 29, 2025 to May 25, 2026. The notice warns that DMAA “can result in elevated blood pressure and could lead to cardiovascular problems, including heart attack,” along with “shortness of breath and tightening of the chest.” The company reports no adverse events.
What to do: if your gym sells supplements at the front desk, check the lot, and pull anything you cannot trace. If you run a weight-loss program in a gym, ask about preworkout products at intake and check blood pressure before you start. Gyms and fitness.
4. FDA opens a docket on ibogaine trial design and cites serious safety concerns
On October 5, 2026, FDA announced a request for information on how to design early-phase clinical trials of ibogaine drug products (Docket FDA-2026-N-10429; FR Doc. 2026-20427, published October 6). FDA says there are “serious safety concerns” with ibogaine and asks about dose selection, care setting, cardiac and neurologic safety monitoring, and oversight. FDA also says any proposed starting dose should be justified by data and “not exceeding 10 mg/kg.” The request applies to research under an investigational new drug application. Comments close November 20, 2026.
What to do: if a partner offers your wellness clinic an ibogaine program or retreat referral, read this as FDA’s view: ibogaine is a research drug with serious risks, studied under cardiac and neurologic monitoring. Keep it out of your menu and your marketing. IV and wellness clinics.
Source: FDA press announcement
What this means for you
This week’s lead is about how a chart reads to the pharmacist who fills it. A protocol makes your clinic consistent. It does not replace the patient-specific reason a pharmacist or an investigator will look for. Pull three controlled substance charts this week and check that each one explains its own dose. If they read like copies of each other, book a call and we will review your protocol with you.
This is general information, not legal advice. Rules vary by state and change. Confirm your own facts with counsel.