If you are asking what is a USP monograph, it is the United States Pharmacopeia's published quality standard. Each monograph covers one named substance or preparation. It defines identity, strength, and purity, plus the lab tests and limits that check them.
Think of it as an official quality rulebook for one specific ingredient. Instead of trusting a seller's claim, a lab tests the powder against that checklist. The standard states what is checked, how it is tested, and what score passes.
In prescription compounding, that checklist carries legal weight. Federal law uses USP monographs as the first check for active ingredients in compounded medications. Still, meeting a monograph is an ingredient standard rather than FDA approval, as compounded drugs are not FDA-approved.
What Is a USP Monograph in the Official Rules?
These standards sit in the USP–NF, which combines the United States Pharmacopeia and the National Formulary. "USP–NF provides quality standards for drug substances, excipients, and finished preparations," states the 2022 USP–NF general chapter on product performance. Excipients are inactive ingredients that carry or stabilize a drug.
Each monograph includes a definition, specifications, and sometimes packaging or storage rules. A specification combines tests, analytical procedures, and acceptance limits. Routine checks cover "a series of universal tests (description, identification, impurities, and assay)," where assay means strength.
A listing in the USP–NF does not mean a powder has a drug monograph for injection. Public entries separate a 2024 oxytocin drug monograph, a 2022 glutathione dietary-supplement monograph, and a 2017 beta-NAD reagent entry. Reagent entries cover lab chemicals "with specifications appropriate to their intended uses," while supplement monographs do not prove injectable suitability.
USP Grade vs Food Grade and Supplement Ingredients
Comparing USP grade vs food grade or supplement grade comes down to intended use. Food-grade and supplement-grade powders are made for swallowing, not sterile injections. They can carry bacterial endotoxins (toxic bacterial fragments) that trigger severe reactions when injected.
"Ingredients identified as food grade are not suitable for compounding sterile drugs without appropriate processing," warned an October 30, 2024 FDA NAD+ notice. FDA also reported severe chills, shaking, vomiting, and fatigue after injectable NAD+, with some patients needing medical care. It described the reactions as consistent with excessive endotoxins.
After a February 1, 2019 warning, a June 7, 2019 FDA glutathione alert described seven patients harmed by injectable dietary-ingredient glutathione. One of those seven patients had low blood pressure and difficulty breathing and was transferred to a hospital. A separately reported patient was hospitalized for possible bloodstream infection.
FDA's powder tests found endotoxin levels as high as five times the appropriate limit. As of October 17, 2026, the day this article was written, an August 27, 2026 FDA alert reported "at least 30 patients" harmed. Those cases followed IV glutathione made with supplement-grade powder.
Reported symptoms included "fever, chills, pain, dizziness, signs of shock and sepsis-like symptoms," with some hospitalizations. The FDA advised patients to "discontinue use of the IV glutathione product" from that supply.
An October 1, 2026 FDA-hosted recall separately cited "potential elevated endotoxin levels" in subcutaneous glutathione lots. It noted "two reports involving patients who received emergency department care" after IV use of those lots.
NAD+ prescribed through Promise is dispensed by a licensed U.S. compounding pharmacy, and the compounded formulation offered here is not FDA-approved. An accountable prescribed route identifies the reviewing provider and dispensing pharmacy. That gives a patient a contact for ingredient-source questions, batch checks, suspected reactions, or recall concerns.
A prescription alone does not establish sterility. Reduced glutathione is coming soon to Promise, and the compounded formulation Promise will offer will not be FDA-approved.
How a Monograph Checks Identity, Purity, and Strength
A single purity percentage on a sales sheet does not establish a peptide's identity or strength. A 2023 study in Pharmaceutical Research by Diane McCarthy and colleagues explains "USP Peptide Quality Attributes and Analytical Methodology" in practice. "Strength is referred to as Assay in USP monographs and general chapters," the authors note.
Identity tests check amino-acid sequence and structure. Purity tests check related peptide fragments, solvents, and counterions (bound charged molecules). Labs calibrate tests with a physical reference standard, a measured sample supporting the written monograph.
A 2015 study in the Journal of Pharmaceutical and Biomedical Analysis by Mindy Johnson and colleagues tested a cyclic lab peptide, p-Cl-Phe-DPDPE. Chromatography found "a high degree of purity, 99.5 ± 0.1%, n=3," while nitrogen analysis found "a peptide content of 80.3 ± 0.1%, n=2" by weight.
Water and trifluoroacetic-acid counterions accounted for part of the remaining mass. The paper's measurements totaled 96%, with possible impurities and method error contributing to the balance.
How the 503A Monograph Pathway Works
Under Section 353a(b)(1)(A)(i) of Title 21 in the 2023 U.S. Code, a bulk drug substance follows three conditional routes in strict order. The FDA's May 14, 2026 Section 503A bulk substances page summarizes the same rules.
First, if an applicable monograph exists, the bulk ingredient must meet the USP compounding chapter. It must also "comply with the standards of an applicable United States Pharmacopoeia or National Formulary monograph" on file.
Second, "if such a monograph does not exist," the substance must be a component of an approved drug. Third, if neither condition applies, it must appear on the 503A bulks list established by regulation.
| Condition | Statutory Rule | Example |
|---|---|---|
| Applicable USP or NF monograph exists | Meet the monograph and USP compounding chapter | Oxytocin has a 2024 USP drug monograph. |
| No applicable monograph exists | Be a component of an approved drug | Semaglutide requires the exact active ingredient, not a salt. |
| Neither condition applies | Appear on the 503A bulks list | FDA's May 11, 2026 BPC-157 evaluation addressed possible listing; staff review does not establish final inclusion. |
The Pharmacy Compounding Advisory Committee reviews candidates for that third route, alongside advising on withdrawn drugs and compounding difficulties. A May 11, 2026 FDA evaluation memo for the July 2026 meeting explained why BPC-157 fell under that route.
The memo found no "applicable United States Pharmacopeia (USP) or National Formulary (NF) drug substance monograph" for BPC-157 free base or acetate. Both forms are also not components of an FDA-approved drug. BPC-157 is not FDA-approved, and BPC-157 prescribed through Promise is dispensed by a licensed U.S. compounding pharmacy.
Common Mistakes When Reading Ingredient Claims
When evaluating a pharmaceutical grade ingredient, people often mistake USP compliance for product approval. "Compounded drugs are not FDA-approved," notes the FDA page on compounded drug risks. Thus, "the agency does not review their safety, effectiveness or quality before they are marketed" to patients.
The March 2026 Pitocin label lists "Pitocin (oxytocin injection, USP)" under "NDA018261," showing that an application and a monograph are separate. Oxytocin is coming soon to Promise as a compounded medication, which is different from an FDA-approved product: the formulation Promise will offer will not be FDA-approved.
Public USP–NF searches show no official drug monograph or proposal for NAD+ or semaglutide, though full checks require a subscription. Separately, the FDA's May 14, 2026 interim categories list places "Nicotinamide Adenine Dinucleotide (NAD)" and "Nicotinamide Adenine Dinucleotide Disodium Reduced (NADH)" in Category 1.
That list places "Beta-Nicotinamide Adenine Dinucleotide Disodium Salt Trihydrate" in Category 3. Category 1 is an interim policy "provided that the conditions described in the guidance document are met," rather than FDA approval.
Chemical form matters too, according to the FDA page on unapproved GLP-1 drugs. "These salt forms, including semaglutide sodium and semaglutide acetate, are different active ingredients than are used in the approved drugs," the agency states.
Semaglutide prescribed through Promise is dispensed by a licensed U.S. compounding pharmacy. It is dispensed by a licensed U.S. compounding pharmacy as a compounded medication, which is different from an FDA-approved product: the formulation offered here is not FDA-approved.
Related Terms and How Prescribing Works
Two other standards sit beside a monograph in compounding law. First, Section 503A requires bulk ingredients from a registered manufacturer to come "accompanied by valid certificates of analysis for each bulk drug substance" used. A certificate of analysis reports one batch's actual test results.
Second, an ingredient monograph differs from USP chapter <797>, as seen in the 2023 USP <797> introduction. That chapter sets "the minimum standards to be followed for the preparation of compounded sterile preparations (CSPs) for human and animal drugs" in pharmacies.
At Promise, a licensed provider reviews every request and not everyone qualifies. A compounded formulation is not FDA-approved, and a licensed provider may still prescribe — that decision is between you and your doctor. When a prescription is written, it is dispensed by a licensed U.S. compounding pharmacy.
