Compounded Semaglutide: What Providers Need to Know (Safety, Regulation, Best Practice)

November 27, 2025
Blog
Journal

Authors

Reviewed by Dr. Rasoul Montazeri

Triple Board Certified Physician and The Founder

Niayesh Najafi

Medical student and researcher in Health Sciences

Table of contents

Why Compounded Semaglutide Exists
FDA Guidance on Compounded Semaglutide
Inside 503A Compounding Pharmacy Standards
How to Verify Quality & Safety
Novanex Standards & Pharmacy Oversight
Best Practices for Clinicians Prescribing Compounded GLP-1s
Frequently Asked Questions

Key takeaways

Regulatory Framework: Compounded semaglutide is legal during shortages with a patient-specific prescription under Section 503A.
Branded vs. Compounded: Branded semaglutide is FDA-approved; compounded is not and may vary in quality.
Patient Safety: Verify licensed 503A pharmacies, use approved semaglutide base, and request a Certificate of Analysis (COA).
FDA Guidance: Follow FDA warnings, and always document safety checks (e.g., COA) in patient records.

Close-up of semaglutide injection pen used for diabetes and weight management representing GLP-1 medication compounding context

As a healthcare provider, you’re likely encountering heightened patient demand for semaglutide and similar GLP-1 medications. During periods of national shortages, compounded versions can become a necessary alternative to maintain continuity of care. Having a clear grasp of the regulatory boundaries and safety standards governing these products is essential for protecting patients and ensuring compliant prescribing.

This guide equips prescribers with the critical information needed to authorize compounded semaglutide safely and legally. It focuses on the FDA’s framework for compounding, standards for pharmacy oversight, and evidence-based clinical practices that support safe use.

The surge in GLP-1 utilization for both diabetes and weight management has led to unprecedented strain on the supply chain. As a result, compounded semaglutide may be used when FDA-approved products are unavailable. However, prescribing compounded medications requires a firm understanding of the legal and regulatory requirements that shape their use.

This article provides an evidence-based roadmap for clinicians. We explain the federal standards governing drug compounding, including key provisions of the Drug Quality and Security Act, and outline how to evaluate pharmacy compliance. You’ll learn what to verify before issuing a prescription, including sterility, ingredient sourcing, and documentation practices that ensure patient safety.

Under specific conditions in the FDA’s 503A framework, traditional compounding pharmacies are legally permitted to prepare semaglutide for individual patients with a valid prescription, particularly when brand-name products appear on the official drug shortage list. Recognizing these parameters helps ensure that prescribers remain aligned with federal expectations while supporting patient access to treatment.

Why Compounded Semaglutide Exists

Glass vials in HPLC laboratory system representing pharmaceutical quality testing and purity verification for compounded semaglutide formulations

The availability of compounded semaglutide is a direct response to a significant gap in the pharmaceutical supply chain. Persistent drug shortages of branded GLP-1 medications have left many patients without access to their prescribed treatments. This has created an urgent need for alternatives that can meet their medical needs.

Human drug compounding is permitted in these circumstances to fill the void. This guide will explain the background of this situation, the legal framework that allows for compounding, and the critical differences between compounded and branded drugs.

Background On GLP-1 Medication Demand And Supply Shortages

The demand for GLP-1 medications has skyrocketed, driven by their effectiveness in managing type 2 diabetes and promoting weight loss. This surge has overwhelmed the supply chain, leading to widespread and persistent drug shortages of popular brands like Ozempic and Wegovy. As a result, countless patients have faced challenges in obtaining their necessary treatments.

These supply issues disrupt patient care and create a significant challenge for healthcare providers. When commercially available drugs are not accessible, you are often left searching for viable alternatives to prevent treatment lapses for your patients. This is where compounding pharmacies play a vital role.

While 503A compounding pharmacies are primarily regulated by state boards of pharmacy, they must also comply with federal regulations outlined in the Federal Food, Drug, and Cosmetic Act. The FDA retains oversight authority, especially concerning the ingredients used and the conditions under which compounding is permitted.

When Compounding Becomes Legally Permissible Under FDA Policy

Compounding a drug is not a free-for-all. It becomes a legal option under specific circumstances defined by federal law. The primary justification is the presence of a drug on the FDA’s official drug shortage list. When a manufactured drug is not commercially available, compounding pharmacies can prepare a similar version to meet patient needs.

This practice is governed by Section 503A of the Federal Food, Drug, and Cosmetic Act. This law sets the regulatory standards for traditional compounding pharmacies, requiring that they compound drugs based on a valid, patient-specific prescription. The FDA guidance clarifies that this exemption exists to ensure patients don't go without necessary medication during a supply disruption.

503A pharmacies must follow these key guidelines: the drug must be compounded for an identified individual patient based on a prescription, and it must comply with United States Pharmacopeia (USP) chapters on quality and sterility, such as USP <797> for sterile preparations. They are prohibited from compounding large batches for office use or creating copies of commercially available drugs unless there's a shortage.

Key Differences Between Compounded Semaglutide And Branded Drugs (Ozempic, Wegovy)

Gaining clarity on the key differences between a compounded drug and its branded counterpart is essential for managing patient expectations and ensuring safety. Branded drugs like Ozempic and Wegovy undergo rigorous, multi-phase clinical trials and a thorough FDA approval process to verify their safety, efficacy, and quality. A compounded drug does not.

Compounded medications are created in a pharmacy to meet a specific patient's needs and are not FDA-approved. This means their stability, purity, and potency have not been federally verified. While both types of drugs aim to deliver a therapeutic benefit, their regulatory pathways and manufacturing scales are fundamentally different. A 503A pharmacy compounds for individual patients, whereas a 503B outsourcing facility can produce large batches for healthcare facilities and must follow stricter Current Good Manufacturing Practices (cGMPs).

Feature	Branded Drugs (Ozempic, Wegovy)	Compounded Semaglutide (from a 503A Pharmacy)
FDA Approval	Yes, FDA-approved for safety and efficacy.	No, not FDA-approved. Made to fill a patient-specific prescription.
Manufacturing	Mass-produced in industrial facilities under cGMPs.	Prepared for an individual patient in a state-licensed pharmacy.
Regulation	Heavily regulated by the FDA.	Primarily regulated by state boards of pharmacy, with adherence to USP standards.
Prescription	Standard prescription required.	Patient-specific prescription is mandatory.

Why Patient Access And Safety Hinge On Proper Pharmacy Sourcing

Where you source a compounded medication from is arguably the most critical factor in ensuring patient safety. Not all compounding pharmacies operate with the same level of integrity or adherence to standards. Partnering with a vetted, compliant pharmacy is the only way to minimize risks and ensure your patients receive a quality product.

The risks of improper pharmacy sourcing are significant. They include receiving a product with the wrong potency, contamination, or one made from unapproved ingredients. These issues can lead to adverse events or a complete lack of therapeutic effect. Proper sourcing ensures patient access to necessary medications without compromising their well-being.

Both you and your patients can take steps to verify a pharmacy’s legitimacy. Patients should always confirm that the pharmacy is licensed by their state board of pharmacy, which can often be checked online. Other verification steps include:

Ensuring the pharmacy requires a patient-specific prescription.
Checking if the pharmacy has a physical address and phone number in the United States.
Asking the provider if they have vetted the pharmacy's quality and compliance standards.

FDA Guidance on Compounded Semaglutide

The FDA has been actively monitoring the rise of compounded semaglutide and has issued specific guidance to protect public health. While federal law allows for compounding during shortages, the agency has expressed clear concerns about the quality and safety of some compounded products on the market.

Appreciating the FDA's position goes beyond regulatory requirements and directly supports high-quality patient care. The agency's warnings about unapproved ingredients and quality control failures underscore the need for vigilance from prescribers. Let's explore the specifics of this FDA guidance.

The FDA’s Position During And After The National Semaglutide Shortage

During the national drug shortages of GLP-1 medications, the FDA has permitted licensed pharmacies to compound semaglutide to meet patient needs, provided they follow the rules outlined in the Federal Food, Drug, and Cosmetic Act. This policy is designed as a temporary measure to ensure continuity of care when FDA-approved drugs are not commercially available.

However, the agency has also issued several FDA guidance documents and public warnings about the risks associated with these compounded products. The FDA has voiced concerns about pharmacies using unapproved ingredients, improper labeling, and a lack of quality control. The agency is actively working with state regulatory partners to take enforcement action against entities that violate the law.

Current FDA guidelines state that compounding should only occur when the branded drug is on the shortage list, and it must be done using an approved bulk drug substance. The agency has specifically warned against using salt forms of semaglutide. If the shortage ends, the legal basis for compounding these drugs will likely cease.

Clarifying FDA Concerns Around Salt Forms (Semaglutide Sodium And Acetate)

A major point of concern for the FDA involves the active pharmaceutical ingredients (APIs) used by some compounders. The agency has explicitly warned against the use of semaglutide salt forms, such as semaglutide sodium and semaglutide acetate. These are different chemical structures from the base semaglutide used in the FDA-approved drugs.

Because these salt forms are not the same active ingredient as the one that has undergone rigorous testing for FDA approval, their safety and effectiveness are unknown. The FDA has stated it is not aware of any lawful basis for using these salt drug substances in compounding. Prescribing a product with these unverified ingredients exposes patients to unknown risks.

Yes, there are significant safety concerns when prescribing compounded GLP-1s if not sourced correctly. The primary risks involve the quality of the drug substances used. If a pharmacy uses unapproved ingredients like salt forms, there is no data on how they will affect the body, their potency, or potential side effects. This is why verifying the API through a Certificate of Analysis is essential.

What Prescribers Should Verify Before Authorizing Compounded Semaglutide

Before you write a prescription for compounded semaglutide, due diligence is non-negotiable. As prescribers, you have a responsibility to ensure the product you are authorizing meets essential quality standards. This verification process is your first line of defense in protecting your patients from potentially harmful products.

Start by confirming you are working with a licensed 503A pharmacy that requires a patient-specific prescription. 503A pharmacies help meet individual patient needs by creating customized medications that are not commercially available, such as when a patient has an allergy to an ingredient in a mass-produced drug or when that drug is in shortage. Their focus is on the individual, not on mass production.

To ensure safety and compliance in drug compounding, you should:

Confirm the pharmacy only uses semaglutide base API, not salt forms.
Request and review the Certificate of Analysis (COA) for the specific batch of API being used to ensure its identity, purity, and potency.

When Compounded Products May No Longer Meet FDA Shortage Exemptions

The legal allowance for compounding semaglutide is directly tied to the FDA's official drug shortage list. If the branded versions of semaglutide become fully available and are removed from this list, the exemption that permits compounding will end. At that point, continuing to compound the drug would be a violation of federal law.

Clinicians and pharmacies must stay informed about the supply status of these medications. Once a drug is no longer in shortage, the expectation is that patients will be prescribed the FDA-approved product. Pharmacies that continue to compound the drug could face regulatory action. It's also important to remember the role of adverse event reporting; any issues with compounded drugs should be reported to the FDA's MedWatch program.

Safety concerns with compounded drugs from 503A pharmacies often stem from a lack of adherence to pharmacy standards rather than the practice itself. A compliant 503A pharmacy that follows USP guidelines and sources high-quality APIs can produce a safe medication. However, risks arise when pharmacies cut corners, use unverified ingredients, or lack proper sterility testing, leading to potential contamination or incorrect dosing.

Inside 503A Compounding Pharmacy Standards

Illustration explaining quality assurance and best practices for ensuring safety and purity in compounded semaglutide preparations

To confidently prescribe compounded semaglutide, you must understand the environment where it's made. Traditional compounding pharmacies, known as 503A pharmacies, operate under a specific set of rules designed to ensure patient-specific care and safety. These facilities are the backbone of customized medication.

Governed primarily by state boards of pharmacy, these pharmacies must also follow federal guidelines. We will now look at what defines a 503A pharmacy, why patient-specific prescriptions are mandatory, and the quality controls they must have in place.

What Defines A 503A Pharmacy And How It Differs From 503B Outsourcing Facilities

There are two main types of pharmacies permitted to compound drugs: 503A and 503B facilities. A 503A pharmacy is a traditional pharmacy that compounds medications pursuant to a prescription for an identified individual patient. These pharmacies are regulated primarily by state boards of pharmacy and must comply with United States Pharmacopeia (USP) standards.

In contrast, a 503B facility, or "outsourcing facility," can produce large batches of compounded drugs with or without prescriptions to be sold to healthcare facilities. Because they operate more like manufacturers, 503B facilities must register with the FDA and follow stringent Current Good Manufacturing Practices (cGMP) requirements, which are the same standards drug manufacturers must meet.

Here are the key distinctions:

Prescriptions: 503A pharmacies require a patient-specific prescription; 503B facilities do not.
Scale: 503A pharmacies compound on a small scale for patient-specific prescriptions, while 503B facilities produce large batches for “office use” or distribution to health systems.
Oversight: 503A pharmacies are primarily state-regulated; 503B facilities are FDA-regulated and must adhere to cGMPs.
Distribution: 503A products go directly to the patient; 503B products are sold to healthcare facilities.

Why Patient-Specific Prescriptions Are Mandatory Under 503A Law

The requirement for a patient-specific prescription is a foundational principle of 503A compounding law. This legal mandate ensures that compounding is reserved for situations where an identified individual patient has a unique medical need that cannot be met by a commercially available, FDA-approved drug. It prevents pharmacies from mass-producing unapproved drugs under the guise of compounding.

This provision directly supports the role of the healthcare provider in determining a specific course of treatment. The medication must be prepared by or under the supervision of a licensed pharmacist, based on a valid order from a prescribing practitioner. This creates a clear chain of accountability, linking the drug directly to the patient and the prescriber.

By focusing on an individual, 503A pharmacies help meet patient needs in a tailored way. For example, if a patient is allergic to a dye in a commercial tablet, a 503A pharmacy can compound that medication without the allergen. During a shortage, they can prepare a version of a needed drug, ensuring a patient’s treatment is not interrupted.

Required Quality Controls, Sterility Testing, And Documentation

To ensure drug quality and patient safety, 503A pharmacies must implement robust quality controls. These are not optional suggestions but are requirements outlined in USP standards, particularly USP Chapter <797> for sterile preparations like injectable semaglutide. Adherence to these standards is critical for preventing contamination and ensuring the final product is safe.

Key among these controls is sterility testing. Since injectable drugs bypass the body’s natural defenses, any microbial contamination can lead to serious infections. Pharmacies must perform tests to confirm that their compounded sterile products are free from bacteria and other contaminants. Thorough documentation of every step of the compounding process is also mandatory.

Oversight for 503A pharmacies is managed by state boards of pharmacy through routine inspections and audits. Compliance actions can include fines, license suspension, or revocation. Key quality control requirements include:

Following detailed procedures for sterile compounding in a controlled environment.
Conducting batch testing for sterility and potency.
Maintaining meticulous records of all ingredients, processes, and test results.
Ensuring proper staff training and validation.

How Pharmacists Ensure Compliance Through Certificates Of Analysis (COAs)

A Certificate of Analysis (COA) is a critical document that a pharmacist uses to verify the quality of the active ingredient they purchase from a supplier. This document provides detailed information about a specific batch of a chemical, confirming its identity, purity, and potency. For compounded semaglutide, the COA is proof that the pharmacy is starting with a high-quality, legitimate semaglutide base.

A diligent pharmacist will not compound a medication without first reviewing the COA for the active pharmaceutical ingredient (API). This step ensures they are not using substandard, contaminated, or incorrect substances, such as the unapproved salt forms of semaglutide. It is a fundamental part of upholding quality standards within a 503A pharmacy.

As a provider, you can verify a pharmacy’s compliance by asking for a copy of the COA for the semaglutide API they use. A transparent and compliant pharmacy will readily provide this documentation. Reviewing the COA yourself, or confirming the pharmacy has a strict protocol for doing so, is a powerful way to ensure you are partnering with a responsible compounding pharmacy.

How to Verify Quality & Safety

Young woman reviewing prescription label in pharmacy representing patient education and safe sourcing of compounded semaglutide

Merely finding a compounding pharmacy is not enough; you must actively verify its commitment to quality standards and safety. This proactive approach protects your patients, your license, and the integrity of your practice. It involves looking beyond a pharmacy's claims and examining tangible evidence of compliance.

This verification process does not have to be complicated. By knowing what to look for and what questions to ask, you can quickly assess a pharmacy's legitimacy. We’ll discuss how to review key documents, what to ask your compounding partners, and how to spot the signs of an unsafe product.

Reviewing COAs For Active Ingredient Identity And Potency

The Certificate of Analysis (COA) is your most important tool for verifying the quality of a compounded medication. When you review a COA for semaglutide, you are looking for specific information that confirms the active ingredient is legitimate and meets quality benchmarks. Don't be intimidated by the technical nature of the document; a few key sections will tell you what you need to know.

First, confirm the identity of the substance. The COA should explicitly state that the active ingredient is "Semaglutide," not "Semaglutide Sodium" or "Semaglutide Acetate." Next, check the potency or assay result. This value, typically expressed as a percentage, should be close to 100% (e.g., 98-102%) to ensure the dose will be accurate.

Providers can verify a pharmacy's compliance by taking these steps:

Request the COA for the exact lot of API used for your patients' prescriptions.
Confirm the testing lab that issued the COA is reputable.
Check that the potency and purity results fall within acceptable pharmaceutical ranges.

What To Ask Compounding Partners About Sourcing And Batch Testing

Your relationship with compounding pharmacies should be a partnership built on transparency. To establish this, you need to ask direct questions about their processes, particularly concerning the sourcing of drug substances and their testing protocols. A trustworthy pharmacy will welcome these questions and provide clear answers.

Start by asking about their suppliers. Where do they get their active pharmaceutical ingredients? Are their suppliers FDA-registered? This helps ensure they are not using materials from questionable sources. Then, inquire about their batch testing procedures. Do they test every batch of compounded medication for sterility and potency before dispensing it? This is a critical safety step that goes beyond just testing the raw ingredient.

Patients can also take an active role. They can verify if their semaglutide pharmacy meets standards by:

Asking their doctor if they have vetted the pharmacy.
Calling the pharmacy to ask if they test every batch for sterility.
Confirming the pharmacy is licensed with their state board of pharmacy.
Making sure the pharmacy requires a valid prescription from their doctor.

How Prescribers Can Document Safety Verification In The Patient Record

Thorough documentation is a foundational element of medical and legal best practices. When prescribing a compounded medication, documenting your safety verification steps in the patient record is essential. This creates a clear and defensible record of your due diligence, protecting both you and your patient.

Your note in the patient record should be concise but thorough. It should state the clinical justification for using a compounded drug, such as the unavailability of the FDA-approved product due to a shortage. It should also name the compounding pharmacy you have chosen to work with.

Most importantly, document that you have verified the pharmacy's compliance and the drug's quality. For example, you might write, "Verified pharmacy's 503A state licensure. Reviewed Certificate of Analysis for semaglutide base API, lot #[number], confirming identity and potency. Counseling patients on use and potential side effects." Creating a simple documentation checklist can help ensure consistency.

Signs Of Unverified Or Unsafe Compounded Semaglutide

Not all compounded semaglutide is created equal, and unfortunately, unsafe products exist. Knowing the red flags associated with unverified or counterfeit drugs can help you and your patients avoid significant public health risks. These unapproved drugs often cut corners on quality standards, putting patients in danger.

One of the biggest warning signs is a pharmacy that does not require a patient-specific prescription. This is a direct violation of 503A compounding laws. Another red flag is unusually low pricing, which may indicate the use of cheap, substandard, or even fake ingredients. The FDA has also warned about fraudulent products with spelling errors or incorrect pharmacy information on the labels.

No, not all compounded semaglutide formulations are safe. Safety depends entirely on the pharmacy's adherence to quality standards. Signs of a potentially unsafe product include:

Being sold online without a prescription.
Labeled as "for research use only" or "not for human consumption."
Claims that it is an "FDA-approved" compounded drug (which is false).
The pharmacy cannot or will not provide a Certificate of Analysis.

Novanex Standards & Pharmacy Oversight

At Novanex, we recognize that patient safety is paramount. That's why we have built a rigorous system of pharmacy oversight and quality assurance that aligns with the highest industry standards. Our approach is designed to give you confidence when prescribing compounded medications for your patients.

Our platform was developed to solve the challenges of inconsistent quality in the compounding space. By implementing strict verification protocols in line with the Drug Administration Modernization Act, we ensure every medication dispensed through our network meets stringent criteria for safety, potency, and purity.

How Novanex Partners Only With 503A-Verified Compounding Pharmacies

Our commitment to safety begins with our partnership selection process. Novanex exclusively partners with 503A compounding pharmacies that have been thoroughly vetted for compliance and quality. We don't just take their word for it; we conduct our own verification to ensure they meet and exceed state and federal pharmacy standards.

This meticulous vetting process means you can be confident that any medication sourced through Novanex is prepared in a licensed, compliant 503A pharmacy. These pharmacies operate legally under federal law, which permits them to compound semaglutide for a specific patient with a valid prescription, especially during a recognized drug shortage.

Our partnership criteria ensure every pharmacy in our network:

Holds a valid 503A license in good standing with its state board of pharmacy.
Adheres strictly to the patient-specific prescription requirement.
Has a proven track record of upholding USP <797> sterile compounding standards.

Pharmacist-Led Review And COA Confirmation For Each Batch

Novanex adds an extra layer of security through our internal, pharmacist-led quality control process. Before any batch of compounded medication is approved for dispensing through our platform, our own licensed pharmacists conduct a thorough review of all relevant documentation, starting with the Certificate of Analysis (COA).

Our pharmacists scrutinize the COA for the active pharmaceutical ingredient to confirm its identity as semaglutide base, not a salt form. They verify its purity and potency to ensure it meets pharmaceutical quality standards. This hands-on confirmation provides an essential double-check that goes beyond relying solely on the pharmacy's internal processes.

Through this upfront verification process, we ensure that every prescription facilitated through our platform is tied to a verified, high-quality batch of API. This gives you peace of mind that you are prescribing a product that has passed multiple checkpoints.

Quality Assurance Systems Aligned With FDA And USP <797> Standards

Novanex has engineered its quality assurance systems to mirror the main laws and guidelines that govern safe drug compounding. Our protocols are directly aligned with FDA guidance and the standards set by the United States Pharmacopeia (USP), particularly USP <797> for sterile compounding, which is essential for injectables like semaglutide.

Our platform ensures that our pharmacy partners follow these critical rules. This includes confirming that their facilities are designed for sterile preparations, that their staff is properly trained, and that they perform necessary testing on their compounded products. We believe that technology can and should be used to enforce compliance and elevate safety across the board.

Our quality assurance system mandates that our partners adhere to:

USP <797>: Strict standards for sterile compounding environments and procedures.
FDA Guidelines: Using only approved bulk drug substances and avoiding salt forms.
Patient-Specific Prescriptions: Following the core tenet of 503A law.
Third-Party Testing: Performing batch testing for sterility and potency.

How Novanex Ensures Traceability And Patient Safety Through Documentation

Complete traceability is fundamental to patient safety. The Novanex platform is built to provide end-to-end documentation, creating a clear and unbroken chain of information from the API supplier to the patients. This ensures accountability at every step of the compounding and dispensing process.

For every prescription, our system logs which 503A pharmacy compounded the medication, the specific batch of API used, and the results of quality tests for that batch. This meticulous documentation means that in the unlikely event of an issue, we can quickly trace the product back to its source and take immediate action. This level of traceability is a powerful tool for risk management.

By managing this complex documentation, Novanex enhances the ability of 503A pharmacies to focus on what they do best: meeting individual patient needs. Our platform handles the administrative and quality oversight, allowing pharmacists to concentrate on safely preparing customized medications, thereby ensuring continuity of care without compromising on safety.

Best Practices for Clinicians Prescribing Compounded GLP-1s

Doctor consulting patient about compounded semaglutide prescription, safety verification, and appropriate clinical use

As a healthcare provider in a busy practice or physician office, incorporating compounded GLP-1s requires a clear, systematic approach. While these drugs have not undergone large-scale clinical trials like their branded counterparts, you can still prescribe them responsibly by adhering to established best practices for safety and compliance.

Following a defined protocol not only protects your patients but also provides you with clinical and legal safeguards. This final section will outline a practical checklist for verifying compliance, counseling patients, identifying red flags, and building a robust documentation strategy.

Steps For Verifying Compounding Compliance Before Prescribing

Before you send any prescription to a compounding pharmacy, a quick but thorough compliance check is essential. This step can be standardized across your practice using a simple clinical checklist to ensure nothing is overlooked. This is one of the most effective best practices for improving safety.

Your verification process should confirm both the legitimacy of the pharmacy and the quality of the product. Start by ensuring the pharmacy is a licensed 503A facility and that they will be compounding the medication for a specific patient. Then, shift your focus to the drug itself, making sure the pharmacy uses the correct active ingredient.

To ensure compliance before prescribing, follow this checklist:

Confirm the pharmacy’s 503A license with the state board of pharmacy.
Verify the pharmacy requires a patient-specific prescription.
Request and review the Certificate of Analysis (COA) to confirm the use of semaglutide base API.
Ask if the pharmacy conducts third-party sterility and potency testing on finished batches.

How To Counsel Patients On Safety, Storage, And Expectations

Patient counseling is a critical component of prescribing any medication, especially a compounded one. Your patients need to understand that their medication is not the same as a mass-produced, FDA-approved drug. Set clear expectations about what a compounded drug is and why you are prescribing it.

Discuss the potential side effects, which are often similar to those of the branded drug, and instruct patients on when to seek medical attention. Proper drug administration and storage are also vital topics. Since many compounded injectables require refrigeration, emphasize the importance of maintaining the cold chain to ensure the drug's quality and stability. This oversight helps prevent issues from improper handling.

When counseling patients, be sure to cover:

Safety: Explain that the drug is not FDA-approved but has been prepared to quality standards.
Storage: Provide clear instructions on refrigeration and handling.
Side Effects: Review common side effects and advise them to report any adverse events to your office.

Red Flags For Counterfeit Or Unregulated Online Products

The internet is filled with entities selling counterfeit and unapproved drugs, and semaglutide is a prime target. It is important to educate your patients on how to spot a fraudulent online pharmacy or product. The most significant red flag is any website that offers to sell semaglutide without requiring a prescription.

These illegal operations often use deceptive marketing, making bold claims about their product while selling something that could be useless or dangerous. Patients should be wary of prices that seem too good to be true, as this often indicates a counterfeit product made with cheap, unknown ingredients. Remind them that legitimate pharmacies always operate under the supervision of a licensed pharmacist.

Patients can verify a pharmacy's legitimacy and avoid dangerous products by looking out for these red flags:

The website does not require a doctor's prescription.
The online pharmacy is not licensed in the United States.
The product is labeled "for research only."
There is no physical address or U.S. phone number for the pharmacy.

Building A Documentation Checklist For Clinical And Legal Protection

One of the best practices for safety and legal protection is consistent, thorough documentation. Creating a standardized documentation checklist for your practice ensures that every provider follows the same protocol when prescribing a compounded medication. This creates a powerful record of due diligence.

This checklist should be integrated directly into the patient's electronic health record. It serves as a formal attestation that you have taken the necessary steps to ensure the safety and appropriateness of the compounded drug. It should include the clinical reason for prescribing the compounded version, such as a drug shortage.

Your documentation checklist for legal protection should include:

The name of the vetted 503A compounding pharmacy.
A note confirming review of the Certificate of Analysis (COA) for the semaglutide base API.
A statement that the patient was counseled on the nature of compounded drugs, storage, and potential side effects.
A plan for monitoring the patient and instructions for filing an adverse event report if needed.

Frequently Asked Questions

Can 503A Pharmacies Legally Compound Semaglutide For Weight Loss?

Yes, a 503A pharmacy can legally compound semaglutide for weight loss if it is prescribed by a licensed provider for an individual patient. This is permissible as long as the branded, FDA-approved drug is on the official FDA drug shortage list and the pharmacy adheres to all state and federal pharmacy standards.

How Can Patients Verify If Their Semaglutide Pharmacy Meets FDA And Safety Standards?

Patients can verify a pharmacy by checking its license with their state board of pharmacy, ensuring it requires a patient-specific prescription, and asking their provider if they have vetted the pharmacy’s safety and quality protocols. Compliant pharmacies follow FDA guidance and state-mandated pharmacy standards for drug compounding.

Are There Specific Safety Concerns When Prescribing Compounded GLP-1 Drugs From 503A Pharmacies?

Yes, the primary safety concerns involve the quality of the active ingredient and risk of contamination. If a pharmacy uses unapproved salt forms or fails to perform sterility testing, it can lead to an adverse event. Proper drug administration and sourcing from a verified 503A pharmacy are essential to minimizing risks.

What Are The Current FDA Guidelines On Compounded Semaglutide?

Current FDA guidelines permit the compounding of semaglutide only when the FDA-approved drug is on the national shortage list. The regulations also specify that compounders must use the base form of semaglutide, not salt forms, to ensure drug quality and stay within the bounds of federal law.

How Can Providers Verify A Pharmacy’s Compliance With 503A Standards?

Providers can verify compliance by checking the pharmacy’s license with the state board of pharmacy, confirming they require patient-specific prescriptions, and requesting to see the Certificate of Analysis (COA) for the active ingredient. This documentation is key to confirming drug quality and adherence to pharmacy standards.

Are All Compounded Semaglutide Formulations Safe For Patients?

No, not all compounded semaglutide formulations are safe. Safety is entirely dependent on the drug quality and the pharmacy's compliance with standards set by state boards of pharmacy. Products from unverified sources pose significant public health risks due to potential contamination, incorrect potency, or use of unapproved ingredients.

What Best Practices Improve Safety When Prescribing Compounded Semaglutide?

Best practices for safety include partnering only with vetted 503A pharmacies, verifying the active ingredient with a Certificate of Analysis, maintaining thorough documentation of your due diligence, and properly counseling patients on the nature of their compounded drug. These steps ensure compliance and protect patients.