Compounded Modafinil / Armodafinil for clinics: coming Q2 2027

ModafinilArmodafinil

Compounded modafinil / armodafinil is not orderable on AffinityRx yet: AffinityRx adds controlled-substance support (testosterone and other scheduled medications) in Q2 2027. When it launches, clinics will source it like every other SKU on AffinityRx, through a multi-pharmacy marketplace with prices side by side, one login and failover within 1 to 2 minutes. AffinityRx clinics can source GLP-1s, peptides and other non-controlled medications today.

Coming Q2 2027. Modafinil / Armodafinil is a DEA Schedule IV controlled substance. AffinityRx adds controlled-substance support (testosterone and other scheduled medications) in Q2 2027. It cannot be ordered through AffinityRx before then.

Q2 2027
Controlled-substance support
not orderable today
1
Modafinil SKUs listed
Coming Q2 2027
2
FDA-approved products
with this active ingredient
Oct 2026
Status checked
FDA and state sources

By Tim Yoon, CEO, AffinityRx · Last updated

AffinityRx Modafinil / Armodafinil lineup

AffinityRx's catalog lists 1 modafinil / armodafinil SKU, below. Concentration, fill and mixer come from the AffinityRx catalog.

SKUConcentrationFillMixer / additiveStatus
Armodafinil (Oral)200 mg30 tabs—Coming Q2 2027

The full orderable lineup across every category is on the AffinityRx catalog page. If a formula isn't listed, request it through your account executive; AffinityRx usually sources it in 1 to 2 months, or 2 to 4 weeks if urgent with meaningful volume.

Why clinics source Modafinil / Armodafinil through AffinityRx

AffinityRx is the multi-pharmacy marketplace clinics will use for compounded modafinil / armodafinil once controlled-substance support launches in Q2 2027: prices side by side across 15+ pharmacies, one login and one invoice, and automatic failover. AffinityRx clinics can source GLP-1s, peptides and other non-controlled medications today.

StatusComing Q2 2027. AffinityRx adds controlled-substance support (testosterone and other scheduled medications) in Q2 2027. Not orderable today.
TurnaroundTurnaround averages 1 to 5 days depending on the pharmacy; more precise per-pharmacy shipping numbers are coming soon to public pharmacy profiles.
Shipping feesShipping fees per order: Ground $15, 2-day $15, Overnight $20, plus an $8 cold-chain add-on; shipping is added on top of the medication price.
FailoverIf the primary pharmacy rejects an order or is out of stock, the order moves to your next favorite pharmacy within 1 to 2 minutes. Prescriber re-sign is the default; turning on auto re-sign removes that step.
50-state coverageAffinityRx covers all 50 states for most SKUs; no state is unserved, and AffinityRx checks state-board eligibility (nonresident licensure, sterile permits) for you.
Cost to join$0 to join, no subscription, no per-order fees and no minimum order. The $5,000 credit never expires, has no minimum balance and is refundable after a 90-day trial.
Office useNot available yet. Ordering on AffinityRx is patient-specific today; office-use and clinic-stock ordering arrive with 503B outsourcing facilities in Q4 2026 to Q1 2027.

Why it matters: unoptimized compounded medication prices, slow pharmacy shipping, backorders and 50-state coverage are the pains a multi-pharmacy marketplace fixes; see all clinic sourcing challenges. Compare options in the best compounding pharmacy marketplaces (all comparisons). Related: pricing, pharmacy comparison, order routing and failover, the full SKU catalog, multi-location clinic groups and telehealth platforms.

Forms, strengths and additives commonly compounded for Modafinil / Armodafinil

Compounded Modafinil / Armodafinil is commonly listed by pharmacies in the forms, strengths and additives below. Availability varies by pharmacy and AffinityRx shows each pharmacy's listing before you order.

Forms
  • oral tablet/capsule (limited; commercial generics dominate)
Strengths and fills
  • armodafinil 200 mg x 30 tabs (catalog-listed, coming soon)
  • modafinil 100 mg and 200 mg tablets/capsules (commercial strengths)
Additives
  • none typical

Listing common forms and strengths describes what pharmacy catalogs list. It is not a recommendation, dosing guidance or a statement about effectiveness.

Sourcing considerations for compounded Modafinil / Armodafinil

AffinityRx adds controlled-substance support (testosterone and other scheduled medications) in Q2 2027. The points below are regulatory context for planning your Q2 2027 workflow.

  • Controlled substance (Schedule IV): the filling pharmacy must hold DEA registration and valid state controlled-substance licensure; confirm both before first order.
  • Prescriber requirements: DEA registration in the patient's state, a valid prescription, and state PDMP/telehealth rules. DEA and HHS telemedicine flexibilities run through December 31, 2026; permanent rules were pending at the time of research.
  • Essentially-a-copy: generic modafinil and armodafinil are commercially available, so a compounded version requires documented patient-specific clinical differences; 503B/office-use supply is not supported by any FDA list.
  • Non-sterile compounding: oral preparations fall under USP <795>; ask for non-sterile licensure, API COA and potency testing.
  • State shipping rules: several states limit or prohibit mail-order dispensing of controlled substances; verify destination-state non-resident pharmacy licensure and controlled-substance rules.
  • Packaging and tracking: C-IV orders require record keeping and secure packaging; ask about signature-on-delivery and lot traceability.
  • Quantity limits: C-IV prescriptions are subject to refill and expiration limits (up to 5 refills within 6 months under federal rule); state limits may be tighter.

Modafinil / Armodafinil compounding regulatory status (2026)

Modafinil and armodafinil are active ingredients of FDA-approved Provigil and Nuvigil and both have USP-NF monographs, and neither is on FDA's 503A Category 2 list (May 14, 2026).

Both are Schedule IV controlled substances under the Controlled Substances Act, so a compounding pharmacy needs DEA registration and the prescriber must meet DEA and state rules; DEA and HHS extended the telemedicine prescribing flexibilities for controlled substances through December 31, 2026, and the permanent rules were still pending at the time of research. Because FDA-approved and generic tablets are widely available, a compounded version must not be essentially a copy of a commercially available product and needs a prescriber-documented clinically significant difference; no shortage-based pathway applies. Not a 503B bulks-list item.

FDA-approved products containing Modafinil / Armodafinil

ProductManufacturerApprovedApproved indication (per label)
Provigil (modafinil)Cephalon (Teva)1998Improve wakefulness in adults with excessive sleepiness associated with narcolepsy, obstructive sleep apnea or shift work disorder Source
Nuvigil (armodafinil)Cephalon (Teva)2007Improve wakefulness in adults with excessive sleepiness associated with narcolepsy, obstructive sleep apnea or shift work disorder Source

Listed for regulatory reference only. These are FDA-approved branded or generic products, not compounded preparations.

Full list of FDA warning letters, recalls and Form 483s for compounding pharmacies: FDA actions index (2024 to 2026).

Frequently asked questions about compounded Modafinil / Armodafinil

Can clinics order compounded modafinil / armodafinil through AffinityRx today?
Not yet. AffinityRx adds controlled-substance support (testosterone and other scheduled medications) in Q2 2027. Modafinil / Armodafinil SKUs are listed as Coming Q2 2027 and cannot be ordered before then. AffinityRx clinics can source GLP-1s, peptides and other non-controlled medications today.
Can compounding pharmacies make modafinil or armodafinil?
Yes, in principle: both are active ingredients of FDA-approved drugs with USP monographs, so 503A pharmacies with DEA registration can compound them on a valid patient-specific prescription. Because approved and generic tablets are commercially available, a compounded version must not be essentially a copy and needs a documented clinical difference. AffinityRx adds controlled-substance support in Q2 2027.
Is modafinil a controlled substance?
Yes. Modafinil and armodafinil are Schedule IV controlled substances, so pharmacies need DEA registration and prescribers must follow federal DEA rules and state law.
Can telehealth clinics prescribe modafinil in 2026?
Telehealth prescribing of Schedule IV drugs without a prior in-person exam is permitted under DEA and HHS flexibilities extended through December 31, 2026, subject to state law and the prescriber's DEA registration. Permanent rules were pending at the time of research, so clinics should check DEA's current status.
Is modafinil on FDA's 503A Category 2 list?
No. FDA's May 14, 2026 categories list does not include modafinil or armodafinil in Category 2; both qualify for 503A compounding as approved-drug components with USP monographs.
Can a 503B outsourcing facility supply modafinil to clinics?
Not on any FDA list or shortage basis as of AffinityRx's October 2026 review. Clinics should rely on patient-specific 503A orders and confirm the pharmacy's DEA registration.
What states restrict shipping controlled substances from compounding pharmacies?
State rules vary and change; many require non-resident pharmacy licensure and controlled-substance registration, and some restrict mail-order C-IV dispensing. Clinics should verify each destination state's board rules; AffinityRx's review did not compile a state-by-state list.
Does AffinityRx list modafinil or armodafinil?
Not yet. Modafinil and armodafinil are DEA Schedule IV controlled substances, and AffinityRx adds controlled-substance support (testosterone and other scheduled medications) in Q2 2027. The armodafinil SKU is listed as Coming Q2 2027 and cannot be ordered before then. AffinityRx is not a pharmacy and does not dispense.

Sources

Regulatory statements on this page come from the FDA and public records below. Verify current status on fda.gov before relying on it.

  1. https://www.fda.gov/media/94155/download
  2. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
  3. https://www.hhs.gov/press-room/dea-telemedicine-extension-2026.html

By Tim Yoon, CEO, AffinityRx · Last updated

Get ready for Modafinil / Armodafinil on AffinityRx in Q2 2027

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