The short answer. NAD+ is not an approved drug, but NAD sits in FDA’s 503A Category 1. As of September 25, 2026, a 503A pharmacy may compound it for a named patient under FDA’s interim policy, using ingredient suitable for sterile compounding. The outsourcing-facility position is unresolved.
| FDA approved | No approved NAD+ drug. |
|---|---|
| 503A pharmacy | NAD and NADH are in Category 1, no route restriction. A separate salt form (disodium salt trihydrate) is in Category 3. |
| 503B outsourcing facility | Unresolved. Beta-NAD is in 503B Category 1 on FDA’s 2025 list, but a January 2026 warning letter called NAD+ ineligible. |
| Latest FDA action | Warning letter to GenoGenix, a Florida outsourcing facility, Jan 20, 2026. |
| MDside position | Patient-specific from a 503A pharmacy, with documentation that the ingredient is suitable for sterile use. |
| Last verified | 2026-09-25 |
Category 1 is a policy, and it has conditions
Category 1 means FDA does not intend to act against a 503A pharmacy compounding from that substance while it evaluates it, provided the pharmacy meets the interim policy’s conditions. It is enforcement discretion. It does not approve NAD+ for any use, and it does not permit claims about what an infusion does.
The 503B side contradicts itself
FDA’s March 2025 503B categories list places beta-NAD in Category 1. FDA’s January 20, 2026 warning letter to GenoGenix, an outsourcing facility in Boca Raton, states that NAD+ is not eligible under 503B or its interim policy. The same letter reports an NAD+ lot with endotoxin at 3,360 EU/mL that sent three patients to the emergency room. As of September 25, 2026, no FDA document reconciles the two. Until one does, the 503A route is the one to rely on.
The ingredient grade is where NAD+ programs fail
In October 2024 FDA warned that compounders were making IV NAD+ from food-grade ingredient supplied by repackagers, and that patients reported severe chills, shaking and vomiting. Food-grade material is made for eating. It is not made to be injected into a vein.
NR is a different molecule
Nicotinamide riboside, sold as Niagen, is an oral supplement ingredient and a precursor of NAD+. Its FDA filings (a GRAS notice in 2016 and a new dietary ingredient notification in 2018) cover NR taken by mouth. They say nothing about NAD+, and nothing about anything given by IV.
What this means for you
Source IV NAD+ from a 503A pharmacy for named patients, and ask for the ingredient’s grade and certificate of analysis before the first order. If your supplier is an outsourcing facility, ask it how it squares the GenoGenix letter. Then read your marketing against what you can and cannot claim. Our IV therapy program is sourced this way.
Read next
Frequently asked questions
Is IV NAD+ legal?
Yes, through a 503A pharmacy for a named patient. NAD is in FDA’s 503A Category 1, so FDA does not intend to act while it evaluates the substance, if the pharmacy meets the interim policy’s conditions. As of September 25, 2026 NAD+ is not an approved drug, and its outsourcing-facility status is unresolved.
Can a 503B outsourcing facility make NAD+?
It is unresolved. FDA’s 2025 503B list places beta-NAD in Category 1, but a January 2026 FDA warning letter to a Florida outsourcing facility called NAD+ ineligible under 503B. Until FDA reconciles them, a 503A pharmacy is the safer route.
Is Niagen the same as NAD+?
No. Niagen is nicotinamide riboside, an oral supplement ingredient the body converts to NAD+. Its FDA filings cover oral use of NR. They do not cover NAD+ itself and do not cover intravenous use of anything. Vendor pages that cite Niagen to support IV NAD+ are mixing up two molecules.
Primary sources. Last verified September 25, 2026. Corrections are welcome: contact us.
- FDA, 503A bulk drug substance categories (updated May 14, 2026)
- FDA, 503B bulk drug substance categories (updated Mar 21, 2025)
- FDA, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A (Jan 2025)
- FDA warning letter, GenoGenix LLC (Jan 20, 2026)
- FDA, FDA reminds compounders to use ingredients suitable for sterile compounding (Oct 30, 2024)
- FDA, GRAS Notice GRN 000635, nicotinamide riboside chloride (Aug 3, 2016)
This is general information, not legal advice. Rules vary by state and change. Confirm your own facts with counsel.