Cellular Energy, NAD+ & IV
FDA Status for Licensed Clinics
Three substances that most suppliers quote the same way, and shouldn’t
NAD, cyanocobalamin and methylcobalamin sit in three different places in the FDA record. One has an approved drug product behind it. The other two sit in Category 1 of FDA’s nominations documents, where FDA has said it does not intend to act against a compounder provided the guidance conditions are met. That difference decides how each preparation has to be arranged, and it is the part a purchase order rarely captures. We work it out per substance, show you the document, and coordinate through licensed pharmacy partners.
Where each one stands, update August 2026
Cyanocobalamin: An FDA-approved drug product exists — Cyanocobalamin Injection, USP, ANDA 080737. In the ordinary case this is approved-product distribution, not a compounding question at all.
NAD+: Beta-NAD appears in Category 1 of both FDA nominations documents, 503A and 503B, each carrying its own statement that FDA does not intend to act where the guidance conditions are met. The disodium salt trihydrate form sits in 503B Category 3. Neither form is on either Bulks List.
Methylcobalamin: Category 1 on both documents, on the same terms.
Regulatory tracking only. Not medical or legal advice.
What this page is for. A clinic looking at this category is usually holding three quotes that all say the same thing. They should not. The route that applies to cyanocobalamin does not apply to NAD, the form of NAD named on a certificate of analysis changes its 503B category, and none of that is visible on an invoice. This page sets out what we found, when we found it, and what each finding permits — with the source linked so your counsel reads FDA rather than us.
Scope. This page addresses federal requirements under the Federal Food, Drug, and Cosmetic Act. State pharmacy law, medical practice acts, prescribing and dispensing rules and facility requirements apply on top, and for intravenous administration in an office setting they frequently do more work than the federal question. See how the compounding rules work for the framework this rests on.
PHOENIX MEDS REGULATORY SUPPORT MODEL
Built for a Category Where the Answer Splits
Most categories resolve one way for every substance in them. This one does not, and the work is shaped around that.
Approved Product or Compounded Preparation
The first question here is which of the two you are buying. Distributing an approved finished product and compounding from bulk are different regimes with different rules, and a supplier quoting one while shipping the other is the failure we look for first.
Category 1 Read Properly
Two substances here sit in Category 1. That is a real FDA position with real conditions attached, and explaining which conditions apply to your arrangement is part of what we do. It is not approval, and it is not the Bulks List.
The Copy Question
Where an approved commercial product exists, compounding the same active at a same or easily substitutable strength and route engages the essentially-a-copy restrictions. We raise that before an order rather than after an inspection.
Grade of the Starting Material
FDA has published a specific warning about food-grade material bought from repackagers being used to compound intravenous products in this category. That is a purchasing failure, not a clinical one, and it sits squarely in what a coordinator should be checking.
Matching the Route to the Facility
A 503A pharmacy filling patient-specific prescriptions and a 503B outsourcing facility supplying office stock are not interchangeable here, because FDA has taken different positions under each section. We match the arrangement to the finding.
Monitoring
We track both Bulks Lists, the nominations document, FDA’s safety-risks page, warning letters and Federal Register notices, and re-date this page when something moves.
SUBSTANCE BY SUBSTANCE
What the Record Actually Shows
Each checked independently August 2026 against 21 CFR 216.23, 21 CFR 216.24, FDA’s 503B Bulk Drug Substances List, FDA’s nominations document, FDA’s safety-risks page and FDA’s warning letter database. Nothing below is carried over from another substance on this page.
Cyanocobalamin
What it is: A synthetic form of vitamin B12, long established as an injectable pharmaceutical.
The short answer: an FDA-approved product exists, so in the ordinary case this is not a compounding question at all. Cyanocobalamin Injection, USP, 1,000 mcg/mL, is approved under ANDA 080737, sponsored by American Regent, for intramuscular or subcutaneous injection, with labeling revised January 2021. Its indications are vitamin B12 deficiency due to malabsorption: pernicious anemia, gastrointestinal pathology, dysfunction or surgery, fish tapeworm infestation, pancreatic or bowel malignancy, and folic acid deficiency. It is also labeled for use in the vitamin B12 absorption test.
A clinic obtaining that approved product through licensed distribution against a valid prescription is doing ordinary pharmaceutical purchasing. The 503A and 503B frameworks govern compounding from bulk drug substances; they do not reach the distribution of an approved finished product. We coordinate cyanocobalamin on that basis, and our cyanocobalamin coordination page sets out the detail.
Where it does become a compounding question. If a pharmacy compounds cyanocobalamin from bulk powder rather than supplying the approved product, the analysis changes and gets harder rather than easier. Cyanocobalamin is the active ingredient of an approved product, which satisfies one of the three conditions under section 503A on its face. But the existence of that approved product also engages the essentially-a-copy restrictions, and that question has to be answered for the specific formulation. We also checked 21 CFR 216.24 and found no cobalamin entry; its cobalt entry expressly excludes “cobalamin and its derivatives.” FDA’s 503B nominations document corroborates the approval finding from the other direction: cyanocobalamin appears there in Category 1 carrying the marker FDA defines as “Designates bulk drug substances that are components of FDA approved drugs.”
NAD (nicotinamide adenine dinucleotide)
What it is: A coenzyme present in all living cells, supplied for intravenous and injectable use in energy and longevity settings.
The short answer: no approved product exists, so this is a compounding question, and the answer differs by section.
Under section 503A, NAD appears in FDA’s nominations document, updated 14 May 2026, in Category 1 — Bulk Drug Substances Under Evaluation. FDA describes Category 1 substances as nominated with sufficient supporting information and potentially eligible for inclusion on the 503A Bulks List, and states: “FDA does not intend to take action against a compounder for compounding drugs using bulk drug substances listed in category 1, provided that the conditions described in the guidance document are met.” Those conditions come from FDA’s Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A, final guidance issued January 2025, and section 503A itself requires a prescription for an identified individual.
This is a real position and it is worth understanding precisely. It is not approval, it is not inclusion on the Bulks List, and it is not a statutory condition. It is a stated enforcement posture with conditions, and it can change. What it does mean is that a qualifying 503A pharmacy compounding NAD against a patient-specific prescription is operating in territory FDA has expressly addressed rather than in silence.
Under section 503B there is a parallel policy, and a form distinction that matters. FDA maintains a separate 503B nominations document, updated 21 March 2025, with its own categories and its own statement: “FDA does not intend to take action against an outsourcing facility for compounding drugs using bulk drug substances identified in category 1 provided that the conditions described in the guidance document are met.” Beta-Nicotinamide Adenine Dinucleotide appears in 503B Category 1. Beta-Nicotinamide Adenine Dinucleotide Disodium Salt, Trihydrate appears in 503B Category 3, which FDA titles “Bulk Drug Substances Nominated Without Adequate Support.” Same substance family, two forms, two different positions. The form named on the certificate of analysis decides which applies.
Three layers, and they are not the same thing. Statutory eligibility under 503B means the 503B Bulks List or the drug shortage list; NAD is on neither. The interim enforcement policy is separate, and beta-NAD sits in its Category 1 with conditions attached. FDA approval is a third thing again. In a warning letter dated 20 January 2026 to GenoGenix LLC, FDA wrote that the firm “compounded drug products using bulk drug substances that are not eligible for the use in compounding under section 503B, including 5-amino-1-methylquinolinium iodide (5-Amino-1MQ) and nicotinamide adenine dinucleotide (NAD+),” citing section 503B(a)(2)(A)(i). That is a finding about those products at that facility under the statute. It is not a statement that the interim policy does not exist, and we do not present it as one.
Two safety findings on the record. The same GenoGenix letter records that three people developed adverse symptoms during or shortly after administration of a compounded NAD+ product, and that a tested product contained bacterial endotoxins at 3,360 EU/mL. A second letter, to ProRx LLC on 7 April 2026, concerns a registered outsourcing facility and cites labeling failures on a Nicotinamide Adenine Dinucleotide Injection 1200 mg: a missing established name, a missing “Not for Resale” statement and a removed ingredient list. FDA cited section 503B(a)(10). We report both as they read; the first speaks to eligibility, the second to labeling, and we are not merging them.
How we coordinate it: through 503A pharmacy partners against patient-specific prescriptions, with the Category 1 conditions documented. See NAD 500 mg and NAD 1000 mg.
Methylcobalamin
What it is: A second form of vitamin B12, chemically distinct from cyanocobalamin and regulated differently.
The short answer: the same Category 1 position as NAD, and a different position from its own chemical cousin.
Methylcobalamin appears in Category 1 of both nominations documents — listed as “Methylcobalamin/Methyl B12” in the 503B document — on the same terms and with the same conditions in each. It appears on neither Bulks List, it is not on FDA’s safety-risks page, and we did not identify an approved US drug product containing it. Like cyanocobalamin, it is untouched by 21 CFR 216.24.
The GenoGenix letter of 20 January 2026 also records an “injectable methylcobalamin 5,000 mcg/mL, which was determined to have 65.3% the amount of methylcobalamin listed on the label,” cited under section 501(c). That is a potency failure at the compounder, and it is the reason certificates of analysis get checked rather than filed.
The contrast with cyanocobalamin is the point of this page. Both are vitamin B12. One has an approved product and a distribution route; the other has a Category 1 position and a compounding route with conditions. They are not interchangeable, and a supplier who moves between the two names in one conversation is either careless or hoping you are. See methylcobalamin coordination.
SIDE BY SIDE
The Three Compared
Updated August 2026. Every source below changes without notice; verify before relying on any row.
| Question | Cyanocobalamin | NAD | Methylcobalamin |
|---|---|---|---|
| FDA-approved US drug product | Yes — ANDA 080737 | None identified | None identified |
| Ordinary route to supply | Distribution of the approved product against a prescription | 503A compounding, patient-specific prescription | 503A compounding, patient-specific prescription |
| 503A Bulks List (21 CFR 216.23) | Not listed | Not listed | Not listed |
| 503B Bulks List (statutory) | Not identified on the current list | Not identified on the current list | Not identified on the current list |
| 503B nominations document (21 Mar 2025) | Category 1, marked as a component of an FDA-approved drug | Beta-NAD Category 1; disodium salt trihydrate Category 3 | Category 1 as “Methylcobalamin/Methyl B12” |
| 21 CFR 216.24 | Not listed; cobalamin expressly excluded from the cobalt entry | Not listed | Not listed; cobalamin expressly excluded |
| 503A nominations document (14 May 2026) | Does not appear | Category 1 | Category 1 |
| What that means under 503B | Approved product exists; compounding raises the copy question | Interim policy may apply to beta-NAD on its conditions; FDA found the products at one named facility ineligible under the statute in Jan 2026 | Interim policy may apply on its conditions |
| Recent FDA activity naming it | None identified in this review | GenoGenix 20 Jan 2026; ProRx 7 Apr 2026 | GenoGenix 20 Jan 2026 (potency) |
Why this table has two nomination rows. FDA publishes two separate nominations documents with two separate category schemes, one for section 503A and one for section 503B, each with its own enforcement statement. They do not contain the same entries. Reading one and assuming the other is a common error, and it produces the wrong answer in both directions. It is also why the exact chemical form matters: within the same table above, one form of NAD sits in 503B Category 1 and another in Category 3.
Where Clinics Get Caught
There are 2 Questions Specific to This Category
An approval can make compounding harder, not easier
The instinct is that an FDA-approved product settles the question in your favour. For distribution it does. For compounding it can do the opposite. Section 503A restricts compounding drugs that are essentially copies of commercially available drug products; section 503B restricts copies of approved drug products. The provisions are worded differently and apply to different compounders.
Under 503A a compounded product can fall within the restriction when it has the same active ingredient, a same, similar or easily substitutable strength, and the same route, subject to the statutory provision for a significant difference for an identified individual. So an approved cyanocobalamin injection does not clear the way for a compounded cyanocobalamin injection. It opens a question that has to be answered on the specific formulation, which is usually an argument for buying the approved product instead.
The grade of the starting material is a purchasing question
On 30 October 2024 FDA published a reminder to compounders about ingredient suitability, stating: “The agency is aware of compounders using food-grade nicotinamide adenine dinucleotide (NAD+) sold by repackagers to make intravenous products.” It continued: “Ingredients identified as food grade are not suitable for compounding sterile drugs without appropriate processing, due to the high risk of contamination with microbes and endotoxins, which can harm patients.”
FDA also recorded that it had “received adverse event reports following use of NAD+ injectable drugs, including severe chills, shaking, vomiting and fatigue with some requiring medical treatment,” and that “these reactions are consistent with excessive levels of endotoxins.”
This falls to whoever arranges supply rather than whoever administers the product. A certificate of analysis for food-grade material is a genuine document describing material unsuitable for the use in question, which is exactly why a certificate on its own settles nothing.
IV PREPARATIONS
A Combination Is Not a Shortcut
Combining several ingredients into one intravenous preparation does not create a position that none of the components had. FDA’s framework operates on bulk drug substances one at a time, and the requirements attach to the specific preparation: the position of each substance, the prescription, the copy restrictions, labeling, quality and the compounder’s own statutory standing.
Familiarity is not an argument either. Several ingredients used routinely in IV settings are familiar precisely because approved products exist, which raises the copy question rather than settling it. We do not treat a multi-ingredient bag as clear because each component is well known, and we do not treat it as closed because one component is unfamiliar. Each substance is checked on its own, then the combination is checked as a preparation. Our IV infusion kits and Lipovite pages carry the component detail for those specific preparations.
WHAT A PRACTICE GETS FROM THIS
Clinic Benefits
The work below is the same work whichever way a finding lands. Knowing a substance sits in Category 1 with conditions attached is as useful as knowing it has an approved product.
✓ The Split Answered
A clear statement of which substance in your protocol runs through distribution and which through compounding, with the application number or the category entry named.
✓ Conditons Spelled Out
Where Category 1 applies, what its conditions require of the pharmacy and the prescription, in writing, for your file.
✓ Section Matched To Facility
FDA’s position on NAD differs between 503A and 503B. We match your arrangement to the finding rather than assuming one covers both.
✓ Copy Analysis Raised Early
Where an approved product exists, the essentially-a-copy question surfaces before a purchase order rather than during an inspection.
✓ Ingredient Grade Checked
Confirmation of what the starting material actually is, against FDA’s published position on food-grade material in sterile compounding.
✓ Two B12 Kept Apart
Cyanocobalamin and methylcobalamin documented separately, so no supplier borrows one position for the other.
BEFORE YOUR ORDER
What to Ask, and What Should End the Conversation
Ask which specific product you are buying: an FDA-approved finished drug product, or a compounded preparation. Ask for the application number if the answer is the former. If it is the latter, ask which section the compounder is operating under, and whether the arrangement is patient-specific or office stock, because that changes the answer for NAD.
Ask what grade the starting material is and who supplied it. Ask whether the compounder is a state-licensed 503A pharmacy or a registered 503B outsourcing facility, then ask separately what makes the particular product eligible, because registration alone does not answer that. Our guides to choosing a supplier and choosing an NAD supplier go through the documentation in detail.
Answers that should stop the conversation: that Category 1 means FDA has approved it; that a 503B registration number settles product eligibility; that a certificate of analysis establishes a compounding position; that an approved cyanocobalamin product covers a methylcobalamin preparation; or that a research-use-only label removes the question. Under 21 CFR 201.128, intended use is established by the circumstances surrounding distribution, and labeling is one piece of evidence among several.
AVAILABILITY
How We Coordinate This Category
Our approach is narrower than what some suppliers in this category claim, and the narrowness is the point. We establish the current position of each substance separately, distinguish an approved finished product from a compounded preparation, match the section to the facility, raise the essentially-a-copy question where an approved product exists, check what the starting material actually is, and assemble the file that documents all of it. Where we can identify an applicable basis, we coordinate through licensed pharmacy partners in the ordinary way.
We maintain this page because clinics are being told otherwise. If a supplier has quoted you NAD for office stock without mentioning that FDA has addressed 503A and 503B differently, or offered methylcobalamin on the back of cyanocobalamin’s approved product, that is worth knowing before you order rather than after.
If FDA opens a rulemaking, amends either Bulks List, revises the interim policy, or alters the nominations document in a way that affects these substances, we update this page and re-date it. The full range we coordinate is listed on our product coordination index, and our supply chain overview explains how the arrangement works end to end.
Verify This Yourself
FDA — Bulk drug substances used in compounding under section 503A — FDA’s own description of Categories 1, 2 and 3 and the enforcement statement quoted on this page. Content current 14 May 2026 when checked.
FDA guidance — Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A — final guidance, January 2025. The conditions referred to in the Category 1 statement.
FDA — bulk drug substances nominated under section 503A — the 503A categories document, where NAD and methylcobalamin both appear in Category 1. Version reviewed was updated 14 May 2026.
FDA — bulk drug substances nominated under section 503B — the separate 503B categories document, updated 21 March 2025. Beta-NAD, methylcobalamin and cyanocobalamin all appear in 503B Category 1; the NAD disodium salt trihydrate form appears in Category 3.
FDA — bulk drug substances used in compounding under section 503B — FDA’s own description of the 503B categories and the enforcement statement quoted on this page. Content current 7 January 2025 when checked.
21 CFR 216.23 — the 503A Bulks List as codified, plus the paragraph naming substances that may not be used. None of the three appears in either.
21 CFR 216.24 — drug products withdrawn or removed for safety or effectiveness reasons. The cobalt entry expressly excludes cobalamin and its derivatives.
FDA — 503B Bulk Drug Substances List — the substances outsourcing facilities may use, plus the separate list of those FDA found no clinical need for. None of the three appears on either. Content current 16 May 2024 when checked.
FDA warning letter — GenoGenix LLC, 20 January 2026 — the 503B eligibility statement for NAD+, the endotoxin finding, and the methylcobalamin potency result.
FDA warning letter — ProRx LLC, 7 April 2026 — labeling citations on a compounded NAD injection at a registered outsourcing facility, under section 503B(a)(10).
FDA — ingredients suitable for sterile compounding, 30 October 2024 — the food-grade NAD+ warning and the adverse event reports quoted above.
FDA — bulk substances that may present significant safety risks — checked for all three; none appears. Content current 22 April 2026.
21 CFR 201.128 — how intended use is established from the circumstances surrounding distribution.
Related Clinic Resources
FDA Regulatory Status & Compounding Considerations
The statutory framework behind every page on this site, with 503A and 503B kept separate.
Cyanocobalamin Coordination
The substance on this page with an approved drug product behind it.
NAD Coordination
Arranged through 503A partners against patient-specific prescriptions, on the Category 1 footing.
Methylcobalamin Coordination
Category 1, and a different position from its chemical cousin.
IV Infusion Kits
Component detail for the multi-ingredient preparations we coordinate.
Immune Support & Healthy Aging
Thymosin Alpha-1 and Epitalon, and why foreign approval reaches neither.
Gut Health & Inflammation
BPC-157 and KPV, and what FDA was actually asked about each.
Skin, Hair & Aesthetic
GHK-Cu by route, and why a blend’s trade name carries no FDA determination.
Disclaimer & Legal Status:
This page is regulatory information for licensed clinics, compiled from publicly available FDA materials. It is not medical or legal advice, and it is not a determination that any product, formulation, pharmacy, outsourcing facility or protocol is lawful. Work with qualified counsel in your state.
This page addresses federal requirements under the Federal Food, Drug, and Cosmetic Act. State pharmacy, medical practice, prescribing, dispensing and facility requirements may impose additional restrictions.
Phoenix Meds Inc. is not a pharmacy, clinic, prescriber or medical provider, and we do not dispense medications. We coordinate sourcing between licensed clinics and licensed pharmacies in the United States. Any compounded preparation is prepared, dispensed and shipped by the pharmacy or outsourcing facility, subject to the requirements that apply to that facility and that product. Our pharmacy partners represent that they are state-licensed 503A pharmacies or FDA-registered 503B outsourcing facilities.
Whether a particular product may lawfully be compounded, prescribed, dispensed or administered depends on the substance, the formulation, the route, the prescription, and applicable federal and state law. That determination rests with the clinic, the pharmacy and their own counsel. Phoenix Meds does not make it.
Last reviewed: August 2026. Sources change without notice; verify current status directly.