Last reviewed: June 8, 2026

Last updated: June 8, 2026

Written by: Jay Hastings, CEO of PlexusDx

Jay Hastings is the CEO of PlexusDx, a precision health company focused on genetic testing, blood biomarker insights, and personalized wellness recommendations. He has more than 20 years of experience across healthcare innovation, genomics, laboratory operations, healthcare investing, and strategic finance.

Medically reviewed by: Jayden Lee, PharmD, EMBA

Jayden Lee, PharmD, EMBA, is the PlexusDx Medical Science Liaison with a PharmD and MBA specializing in pharmacogenomics and clinical product development, with a proven ability to bridge the gap between genomic research and practical patient outcomes. Dr. Lee has more than 10 years of professional experience in clinical pharmacy, academia, and research.

Compounding pharmacies do not receive semaglutide from Novo Nordisk. They purchase semaglutide as a bulk drug substance — the active pharmaceutical ingredient — from ingredient manufacturers, and federal law sets specific conditions on that purchase. Under section 503A of the Federal Food, Drug, and Cosmetic Act, a bulk drug substance used in compounding must comply with an applicable United States Pharmacopeia or National Formulary monograph if one exists, must be manufactured by an establishment registered with the FDA, and must be accompanied by a valid certificate of analysis. Those three conditions are the entire sourcing framework.

What the Statute Actually Requires

Section 503A sets out the conditions under which a licensed pharmacist in a state-licensed pharmacy may compound a drug product. On ingredients, it requires bulk drug substances that either comply with the standards of an applicable USP or NF monograph and the USP chapter on pharmacy compounding, or — where no monograph exists — are components of drugs approved by the Secretary, or appear on a list developed by the Secretary through regulation.

It further requires that those substances be manufactured by an establishment registered under section 510 of the Act, including foreign establishments registered under section 510(i), and that they be accompanied by valid certificates of analysis for each bulk drug substance.

The same section prohibits compounding drug products that appear on the FDA list of products withdrawn or removed from the market for safety or effectiveness reasons, and prohibits compounding regularly or in inordinate amounts any drug product that is essentially a copy of a commercially available drug product.

Registered Establishments and the Border

A large share of pharmaceutical active ingredients used in the United States is manufactured abroad, and registration under section 510(i) is what brings foreign establishments inside the framework. Registration is not the same as approval, and it is not the same as inspection having occurred recently.

The FDA has acted specifically on this supply chain. The agency has established a green list import alert (66-80) intended to stop GLP-1 active pharmaceutical ingredients with potential quality concerns from entering the United States supply chain. The alert does not apply to API from manufacturers that, based on FDA inspection or other evaluation, appear to comply with manufacturing practice standards, and it does not create new limits on the legal compounding of GLP-1 drugs.

The agency framed the purpose plainly: protecting consumers from receiving poor-quality compounded drugs containing foreign-made APIs manufactured without appropriate controls to assure quality.

The Salt Form Problem

This is the sourcing issue that most directly affects what ends up in a vial. The FDA has stated that some semaglutide products sold by compounders may be salt forms, including semaglutide sodium and semaglutide acetate, and that these salt forms are different active ingredients than those used in the approved drugs.

The agency has also said it does not have information on whether these salts share the chemical and pharmacologic properties of the active ingredient in the approved drug. That is not a technicality about nomenclature; it goes to what molecule is present.

It is a reasonable and specific question to ask any pharmacy: what form of the active ingredient is used, and is a certificate of analysis available for the lot dispensed.

Certificates of Analysis and What They Do Not Prove

A certificate of analysis documents testing performed on a specific lot of ingredient — identity, assay, impurities, and related measurements. Section 503A requires one for each bulk drug substance, which makes it a legal condition rather than a courtesy.

What a certificate does not do is verify the finished compounded preparation. The FDA is explicit that compounded drugs are not FDA-approved, meaning the agency does not verify the safety, effectiveness or quality of compounded drugs before they are marketed. Ingredient documentation and finished-product approval are different things.

Who Inspects Whom

Oversight is layered and it is worth knowing which body does what. The FDA states that state boards of pharmacy generally have primary responsibility for day-to-day oversight of state-licensed pharmacies that are not registered as outsourcing facilities, while the FDA conducts surveillance and for-cause inspections of those pharmacies.

Quality standards also differ by setting. Drugs compounded in outsourcing facilities are subject to current good manufacturing practice requirements; drugs compounded by a licensed pharmacist in a state-licensed pharmacy in accordance with section 503A are not. Federal provisions on insanitary conditions apply regardless of setting.

What This Means for Someone Filling a Prescription

The sourcing chain is only as good as its weakest documented link, and most of it is invisible from the patient side. What is visible: whether the pharmacy is state-licensed, whether a licensed prescriber wrote an individual prescription, and whether the pharmacy will answer direct questions about ingredient form and lot documentation.

The FDA also warns about fraudulent compounded GLP-1 products carrying false label information — in some cases naming pharmacies that do not exist, in others naming licensed pharmacies that did not compound the product. Verifying the dispensing pharmacy independently is a reasonable step, not a paranoid one.

How Your Genetics Relate to GLP-1 Pathways

Not everyone responds to GLP-1 medications the same way. Genetic variants — including GIPR rs1800437, FTO rs9939609, and MC4R rs17782313 — relate to the biological pathways these medications act on. These are pathway-level associations only and do not predict how much weight you will lose or how you will respond to any specific medication. PlexusDx maps 14 pathways, 49 peptides, and 150+ genetic insights so you and your provider can see how your genes relate to these pathways. It does not recommend, prescribe, or determine which medication, dose, or peptide is right for you. The PlexusDx Precision Peptide Genetic Test ($298) gives you and your provider pathway-level genetic context to support a more personalized conversation. Genetics is a guide, not a guarantee.

Access Personalized GLP-1 Care Through PlexusDx

PlexusDx offers seven prescription GLP-1 protocols to all 50 states — no membership, no insurance required, async intake or live consult. The Semaglutide Injection is $189/mo month-to-month, or from $149/mo on the 6-month plan. Medications are dispensed from licensed 503A compounding pharmacies following strict quality and safety standards. Add a Precision Peptide Genetic Test for $298 to personalize your protocol from day one.

Frequently Asked Questions

Do compounding pharmacies buy semaglutide from Novo Nordisk?

No. They purchase semaglutide as a bulk drug substance from active pharmaceutical ingredient manufacturers. Section 503A of the Federal Food, Drug, and Cosmetic Act requires that such substances comply with an applicable USP or National Formulary monograph where one exists, be manufactured by an establishment registered with the FDA, and be accompanied by valid certificates of analysis for each substance.

Is the active ingredient the same as what is in Ozempic or Wegovy?

Not necessarily. The FDA has stated that some semaglutide products sold by compounders may be salt forms including semaglutide sodium and semaglutide acetate, that these are different active ingredients than those used in the approved drugs, and that the agency lacks information on whether they share the same chemical and pharmacologic properties. Ask the pharmacy which form it uses.

What is a certificate of analysis and why does it matter?

It is lot-specific documentation of testing performed on an ingredient, covering identity, assay and impurities among other measures. Federal law requires one for each bulk drug substance used in compounding under section 503A. It documents the ingredient, not the finished preparation, and it is not a substitute for FDA review, which compounded drugs do not undergo.

Does the FDA inspect compounding pharmacies?

The FDA states that state boards of pharmacy generally hold primary responsibility for day-to-day oversight of state-licensed pharmacies that are not registered as outsourcing facilities, and that the FDA conducts surveillance and for-cause inspections of those pharmacies. Outsourcing facilities are separately inspected by the FDA on a risk-based schedule and are subject to current good manufacturing practice requirements.

What is the GLP-1 import alert?

The FDA has established a green list import alert, numbered 66-80, to help stop GLP-1 active pharmaceutical ingredients with potential quality concerns from entering the United States supply chain. It does not apply to ingredient manufacturers that appear compliant based on FDA inspection or evaluation, and the agency states it creates no new limits on the legal compounding of GLP-1 drugs.

Medical and Editorial Standards

Medical review process: This article was reviewed for medical accuracy, scientific clarity, evidence alignment, and appropriate discussion of genetics, medications, supplements, biomarkers, and health-related claims.

Sources and evidence: PlexusDx educational content is developed using peer-reviewed research, clinical literature, reputable medical references, and, where applicable, public health or regulatory guidance.

Commercial transparency: PlexusDx offers genetic testing, blood biomarker testing, personalized supplement recommendations, and related precision wellness services. Product mentions are intended to help readers understand available options and should not be interpreted as medical advice.

Important disclaimer: PlexusDx educational content is for informational purposes only and should not be used as a substitute for professional medical advice, diagnosis, or treatment. Always consult a qualified healthcare provider before making decisions about medications, supplements, genetic testing, lab testing, or health-related care.

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