The quarter in one paragraph
As of September 24, 2026, three regulatory decisions have no public date and could each arrive on a Tuesday afternoon: FDA's final order removing semaglutide and tirzepatide from the 503B bulks list (proposed April 30, comments closed July 30), the DEA's special registration rule for telemedicine (sent to the White House review office on August 25), and FDA's decision on CagriSema (Novo Nordisk says fourth quarter). Around them sit the dated items: Hims & Hers reports third-quarter results in the first week of November, ACA open enrollment opens November 1, NovoCare's $199 introductory price on Wegovy and Ozempic pens ends December 31, and the DEA's telemedicine flexibilities expire the same day. Below is the calendar, then the build list.
This post replaces the H2 2026 metabolic calendar as the current version. We will refresh it monthly; the updated date in the header tells you when.
Dated, in order
| When | What | Status and source | Build before it |
|---|---|---|---|
| Any week | FDA final order excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list | Proposed April 30, 2026; comment period closed July 30; no committed date (FDA). Fifth Circuit affirmed FDA's shortage decisions on August 27 (Nos. 25-10600 and 25-10758) | The prewritten patient email, pricing-page swap and support macros in the 72-hour plan |
| Early October | Rock Health Q3 2026 funding report | H1 came in at $7.4B across 244 deals; Q3 typically publishes in the first days of October | Nothing to build; useful for investor and partner conversations |
| Early Q4 | CVS app shows Lilly cash prices for Zepbound and Foundayo with same-day pickup at about 9,000 stores | Announced August 5, 2026 (CVS Health); CVS also sells a $29 online visit | A price-and-value comparison on your own site before patients build one from retail pages |
| October (typical) | KFF 2026 Employer Health Benefits Survey | 2025 edition: 43% of firms with 5,000+ workers covered GLP-1s for weight loss; 2026 edition usually lands in October | Update the employer channel numbers in your pitch, see the employer and HSA channel |
| October to November | Employers communicate 2027 plan designs | Mercer (June 11, 2026): 6% of large employers dropped GLP-1 weight-loss coverage in 2026 and 5% more are weighing it for 2027 (Mercer); Business Group on Health: 10% of covering employers unlikely to continue | The coverage-loss funnel live before plan documents hit inboxes |
| November 1 to January 15 | ACA open enrollment | Standard federal window | The Q4 demand plan and HSA/FSA receipts |
| November 2 to 9 (projected) | Hims & Hers Q3 2026 earnings | Q2 (August 10): revenue $753M, gross margin 64%, 2.9M subscribers; Q3 date not yet confirmed | Run the earnings listening guide |
| November (expected) | DEA special registration final rule published | At OIRA since August 25, 2026; DOJ forecasts November (NASCSA) | The scenario tree in the DEA cliff plan; decide your in-person fallback by mid-November regardless |
| Q4 (per Novo) | FDA decision on CagriSema | NDA filed December 18, 2025; Novo guided to a Q4 2026 decision in its August 4 report | Formulary and intake logic that adds a molecule without a rebuild, see CagriSema readiness |
| December 31 | DEA telemedicine flexibilities expire | Fourth extension, published December 31, 2025 (Federal Register) | Patient communications for TRT and ADHD programs drafted by December 1 |
| December 31 | NovoCare and TrumpRx $199 first-two-fills pricing on Wegovy and Ozempic pens ends | Promo terms published by Novo; standard NovoCare price returns to $349 for pens; Wegovy pill stays at $149 for the starting dose | January pricing page and the cohort plan in the January surge build list |
| January 1, 2027 | New plan year | Coverage changes announced in October take effect | Intake branch that captures coverage status on day one |
| Q1 2027 | Lilly files retatrutide | Pushed from 2026 on July 23, 2026 | Nothing yet; read the trial data |
The three that can land any week
The 503B order. The legal fight is over. On August 27 the Fifth Circuit affirmed FDA in both shortage cases, tirzepatide and semaglutide, and the semaglutide opinion was revised on September 1 without changing the result. What remains is paperwork: the final order that removes the three molecules from the 503B bulks list. Nothing about the timing is public. The practical position, which the Alliance for Pharmacy Compounding has told its own members, is that no 503B facility has a current basis to compound semaglutide or tirzepatide anyway, so the order will mostly formalize what supply already looks like. The reason to prepare for it is the news cycle, not the supply: patients will read a headline and email you within the hour.
The DEA rule. The proposal from January 2025 created three registrations, one for Schedule III through V prescribing, an advanced one that reaches Schedule II, and a platform registration that would apply to telehealth companies themselves. What the final rule keeps is unknown until it publishes. If it publishes in November as forecast, there are roughly six weeks to comply before December 31, which is why the fallback decision cannot wait for the text. Testosterone is Schedule III; every TRT program is in scope.
CagriSema. Novo's guidance is a Q4 decision with no public PDUFA date. If it approves, the question for a program is whether adding a molecule means a formulary row and an intake branch or a replatform. We built Turbopills so it is the former, a configuration change to the product catalog, intake logic and pricing rather than an engineering project, and the readiness post above walks through the sequence; if your platform needs a sprint to add a SKU, that is worth knowing before the approval, not after.
The build list by month
October. Coverage-loss funnel live, HSA receipts working in the billing engine, price-comparison content answering the $29 retail visit on your own domain, employer pitch refreshed with KFF numbers. If you run controlled-substance programs, name the in-person partner clinics you would route to under a lapse scenario, even if you never call them.
November. DEA decision date on your own calendar (we suggest November 15: if the rule is not out, plan for the lapse scenario). Hims Q3 numbers into your benchmark sheet. January capacity model built: intake reviewers, support macros, pharmacy commitments, ad budget staging, using the surge post above. Open-enrollment acquisition campaigns running.
December. New pricing page staged for January 1 with the post-promo anchors ($349 pens, $149 pill, $299 to $449 Zepbound vials at LillyDirect). Patient letters for TRT and ADHD programs sent by December 1 if the rule lapses. Support staffed for the first two weeks of January, when intake volume in this category typically runs three to five times the November baseline.
What we are watching but not planning around
Retatrutide is a 2027 filing now, so a 2028 launch at the earliest. The HIPAA Security Rule update moved to a July 2027 target on the regulatory agenda. The FTC's click-to-cancel rule is back at the pre-rule stage after the Eighth Circuit vacated it in 2025, while the FTC keeps bringing subscription cases under existing law, including its July 29 complaint against Hims & Hers. Medicaid coverage of GLP-1s for obesity, down to 13 states in January, could lose more in state budget cycles. None of these has a Q4 date, and none should change what you build this quarter, which is the point of writing the calendar down: it separates the things with deadlines from the things with headlines.
FAQ
When do the DEA telehealth flexibilities expire? December 31, 2026, under the fourth temporary extension published December 31, 2025. The special registration final rule that would replace them has been at OIRA since August 25, 2026, with publication expected around November.
Has the FDA finalized the order removing semaglutide from the 503B list? Not as of September 24, 2026. The proposal was published April 30, the comment period closed July 30, and the Fifth Circuit affirmed FDA's underlying shortage decisions on August 27. The final order has no announced date.
When will the FDA decide on CagriSema? Novo Nordisk guided to a decision in the fourth quarter of 2026 in its August 4 half-year report. There is no public PDUFA date.
When does the $199 Wegovy promotion end? NovoCare's and TrumpRx's $199 first-two-fills pricing on Wegovy and Ozempic pens runs through December 31, 2026, after which the standard NovoCare pen price of $349 applies. The Wegovy pill starting dose stays at $149.
When does open enrollment start? The federal ACA window runs November 1, 2026 to January 15, 2027. Employer enrollment windows cluster in October and November, and plan-design changes take effect January 1.