Are compounded NAD+, sermorelin, glutathione and MIC + B12 FDA-approved?
No. Compounded NAD+, compounded sermorelin, compounded glutathione and compounded MIC + B12 are not FDA-approved. A compounding pharmacy prepares each one for an individual patient on a licensed provider’s prescription, and FDA does not review compounded drugs for safety, effectiveness or quality before they reach patients.
Each section below gives one medication’s FDA record, with the primary source and the date it was checked. Through Cora Health, VialsRx, a US-licensed 503A compounding pharmacy, prepares all four.
Facts and prices checked October 10, 2026.
FDA status at a glance
| Medication | FDA-approved? | Prepared through Cora Health by | FDA record |
|---|---|---|---|
| Compounded NAD+ | No | VialsRx | FDA proposed in 2019 not to add NAD to the 503A bulks list; the rule has not been finalized. |
| Compounded Sermorelin | No | VialsRx | No FDA-approved sermorelin product is marketed today. |
| Compounded Glutathione | No | VialsRx | Category 1 (under evaluation) on FDA’s May 14, 2026 list; FDA’s 2022 position was not to add it; no rule issued. |
| Compounded MIC + B12 | No | VialsRx | No FDA-approved product combines these ingredients. |
Is compounded NAD+ FDA-approved?
No. Compounded NAD+ is not FDA-approved. A search of FDA’s Drugs@FDA database on October 10, 2026 found no FDA-approved drug with nicotinamide adenine dinucleotide (NAD) as its active ingredient.
FDA's Pharmacy Compounding Advisory Committee voted in May 2017 not to add NAD (nicotinamide adenine dinucleotide, the ingredient in compounded NAD+) to FDA's list of bulk ingredients pharmacies can use in 503A compounding, and in a 2019 proposed rule FDA proposed not to add it. The committee's votes are advisory, and the rule has not been finalized.
In October 2024, FDA reminded compounders that food-grade NAD+ is not suitable for compounding sterile drugs without appropriate processing. FDA said it had received adverse event reports after NAD+ injectable drugs, including severe chills, shaking, vomiting and fatigue, with some patients requiring medical treatment.
FDA does not review compounded drugs for safety, effectiveness or quality before they reach patients.
Is compounded sermorelin FDA-approved?
No. Compounded sermorelin is not FDA-approved, and no FDA-approved sermorelin product is marketed today (FDA’s Drugs@FDA database, searched October 10, 2026).
FDA has not reviewed compounded sermorelin for safety, effectiveness or quality, and compounded sermorelin is not therapeutically equivalent to any FDA-approved product.
Is compounded glutathione FDA-approved?
No. Compounded glutathione is not FDA-approved. A search of FDA’s Drugs@FDA database on October 10, 2026 found no FDA-approved drug that uses glutathione as an injectable active ingredient.
Glutathione is in Category 1 of FDA's list of bulk drug substances nominated for 503A compounding, the substances FDA is still evaluating (list updated May 14, 2026). In June 2022, FDA's position before its Pharmacy Compounding Advisory Committee was that glutathione should not be added to FDA's list of bulk ingredients pharmacies can use in 503A compounding; the committee voted to recommend adding it. The committee's votes are advisory, and FDA has not issued a rule.
In August 2026, FDA reported adverse events in at least 30 patients after intravenous (IV) glutathione made with dietary-supplement-grade glutathione, and said dietary-supplement-grade glutathione is not an appropriate ingredient to make injectable drugs. FDA also said two Texas pharmacies had recalled glutathione injectable drugs because of elevated endotoxin levels.
FDA does not review compounded drugs for safety, effectiveness or quality before they reach patients.
Is compounded MIC + B12 FDA-approved?
No. MIC + B12 is a compounded combination, not an FDA-approved product. A search of FDA’s Drugs@FDA database on October 10, 2026 found no FDA-approved product that combines methionine, inositol and choline with vitamin B12.
FDA does not review compounded drugs for safety, effectiveness or quality before they reach patients.
What “not FDA-approved” means for a compounded medication
FDA says compounded drugs are not FDA-approved, which means FDA does not verify their safety, effectiveness or quality before they are marketed. A compounded drug is not a generic drug: a generic is FDA-approved and shown to be therapeutically equivalent to a brand-name drug, and a compounded drug is not.
According to FDA, state boards of pharmacy generally have primary responsibility for the day-to-day oversight of state-licensed pharmacies that are not registered with FDA as outsourcing facilities. FDA also notes that people who buy compounded drugs online may not know which compounder produced them.
Through Cora Health, a licensed provider decides whether to prescribe each medication after an online visit for it, and VialsRx, a US-licensed 503A compounding pharmacy, prepares it. Cora Health connects patients with licensed providers; Cora Health does not prescribe, compound or dispense medication.
Questions
Is compounded NAD+ FDA-approved?
No. Compounded NAD+ is not FDA-approved. A search of FDA’s Drugs@FDA database on October 10, 2026 found no FDA-approved drug with nicotinamide adenine dinucleotide (NAD) as its active ingredient. FDA's Pharmacy Compounding Advisory Committee voted in May 2017 not to add NAD (nicotinamide adenine dinucleotide, the ingredient in compounded NAD+) to FDA's list of bulk ingredients pharmacies can use in 503A compounding, and in a 2019 proposed rule FDA proposed not to add it. The committee's votes are advisory, and the rule has not been finalized. In October 2024, FDA reminded compounders that food-grade NAD+ is not suitable for compounding sterile drugs without appropriate processing. FDA said it had received adverse event reports after NAD+ injectable drugs, including severe chills, shaking, vomiting and fatigue, with some patients requiring medical treatment. FDA does not review compounded drugs for safety, effectiveness or quality before they reach patients.
Is compounded sermorelin FDA-approved?
No. Compounded sermorelin is not FDA-approved, and no FDA-approved sermorelin product is marketed today (FDA’s Drugs@FDA database, searched October 10, 2026). FDA has not reviewed compounded sermorelin for safety, effectiveness or quality, and compounded sermorelin is not therapeutically equivalent to any FDA-approved product.
Is compounded glutathione FDA-approved?
No. Compounded glutathione is not FDA-approved. A search of FDA’s Drugs@FDA database on October 10, 2026 found no FDA-approved drug that uses glutathione as an injectable active ingredient. Glutathione is in Category 1 of FDA's list of bulk drug substances nominated for 503A compounding, the substances FDA is still evaluating (list updated May 14, 2026). In June 2022, FDA's position before its Pharmacy Compounding Advisory Committee was that glutathione should not be added to FDA's list of bulk ingredients pharmacies can use in 503A compounding; the committee voted to recommend adding it. The committee's votes are advisory, and FDA has not issued a rule. In August 2026, FDA reported adverse events in at least 30 patients after intravenous (IV) glutathione made with dietary-supplement-grade glutathione, and said dietary-supplement-grade glutathione is not an appropriate ingredient to make injectable drugs. FDA also said two Texas pharmacies had recalled glutathione injectable drugs because of elevated endotoxin levels. FDA does not review compounded drugs for safety, effectiveness or quality before they reach patients.
Is compounded MIC + B12 FDA-approved?
No. MIC + B12 is a compounded combination, not an FDA-approved product. A search of FDA’s Drugs@FDA database on October 10, 2026 found no FDA-approved product that combines methionine, inositol and choline with vitamin B12. FDA does not review compounded drugs for safety, effectiveness or quality before they reach patients.
Who prepares compounded NAD+, sermorelin, glutathione and MIC + B12 through Cora Health?
VialsRx, a US-licensed 503A compounding pharmacy, prepares all four on a licensed provider’s prescription. Cora Health does not prescribe, compound or dispense medication. Compounded medications are not FDA-approved.
Sources
- FDA, Drugs@FDA database (openFDA drugsfda endpoint), searched October 10, 2026
- Federal Register, proposed rule on the 503A bulks list (84 FR 46688), September 5, 2019
- FDA, FDA reminds compounders to use ingredients suitable for sterile compounding, October 30, 2024
- FDA, 503A bulk drug substances categories, updated May 14, 2026
- FDA, Pharmacy Compounding Advisory Committee final summary minutes, June 8, 2022
- FDA, FDA reminds compounders not to use dietary supplement grade glutathione for injectables, August 27, 2026
- FDA, Compounding and the FDA: Questions and Answers
Related
Compounded medications are not FDA-approved. They are prepared by state-licensed pharmacies based on a valid prescription from a licensed provider. Through Cora Health, VialsRx, a US-licensed 503A compounding pharmacy, prepares compounded NAD+, sermorelin, glutathione and MIC + B12. Cora Health connects patients with licensed providers, who decide whether to prescribe; Cora Health does not prescribe, compound or dispense medication. This page is information, not medical advice.