Improving access to life-changing treatment
Currently, less than 40% of insurers cover GLP-1 medications for weight loss, leaving many individuals living with obesity without the financial support they need. Even for those with insurance coverage, more than half say their GLP-1 medication is still difficult to afford.*
The challenge doesn’t stop at cost—national shortages have made it difficult to find brand-name GLP-1 medications consistently.
For eligible patients, compounded semaglutide presents a more accessible option, improving both affordability and availability, and helping patients avoid interruptions in their treatment.
Not representative of actual medication prescribed, which will be dispensed by a licensed pharmacy.
How we chose a compounded GLP-1 pharmacy
WeightWatchers Clinic clinicians only prescribe compounded GLP-1s produced by a 503B outsourcing facility that’s registered with the FDA and is subject to FDA inspection and oversight. Whereas, many med-spas and telehealth providers obtain compounded GLP-1s from 503A pharmacies, which are not subject to the same safety requirements as 503B outsourcing facilities.
Alongside our internal clinical and legal experts, we engaged an outside team with experience in compounded drug manufacturing, microbiology, FDA law, and state pharmacy regulation to thoroughly vet potential 503B facilities to meet our high standards and commitment to safety and patient care.
Phase 01
Narrowing the field
First, our team evaluated numerous 503B outsourcing facilities. For each, they reviewed the following:
FDA & board of pharmacy inspection history
Looked at frequency and recency of inspections by the FDA and state boards of pharmacy and evaluated the inspection results and the facility’s response to these results
Quality program and team
Evaluated the level of quality oversight based on size of the quality team and the team’s experience with Current Good Manufacturing Practices (CGMP)
Product recall history
Prioritized 503Bs with no history of product recalls and no reported Adverse Drug Events (ADEs)
Production automation
Looked at use of automation to reduce risk of human error
Other operational risks
Evaluated other potential risks impacting product manufacturing, such as risk of natural disasters, which could cause production shutdowns
Phase 02
Site inspections
Our team of experts then visited the facility in person to see where and how the medication is produced. Inspections were conducted using the FDA’s six-system inspection model, which covers the following areas and helps assess compliance with Current Good Manufacturing Practices (CGMP):
Quality
Assesses the procedures, processes, and controls that address the identity, strength, quality, and purity of drug products. This system includes oversight of deviations, corrective and preventive actions, complaints, and internal audits.
Production
Governs the manufacturing and packaging processes, determining whether procedures are followed and proper documentation is maintained. Establishes whether finished products meet predetermined specifications.
Facilities and equipment
Focuses on the proper design, maintenance, and cleaning of buildings and equipment used in the manufacturing of drug products. Assesses whether equipment used is adequate and functioning correctly to maintain product quality.
Laboratory controls
Analyzes whether testing and validation methods are reliable and scientifically sound. This system oversees laboratory procedures for sample testing, data integrity, validation, and calibration of laboratory equipment.
Materials
Involves the control of materials (raw materials, in-process materials, and finished products) used throughout the production process. This system assesses proper handling, storage, testing, and release of materials to prevent contamination or mix-ups.
Packaging and labeling
Reviews whether drugs are correctly packaged and labeled to prevent contamination, mix-ups, and errors during distribution. It focuses on label accuracy, appropriate storage conditions, and the application of barcodes or tamper-evident seals.
Phase 03
Third-party testing
We also engaged an independent, third-party lab to test the facility’s semaglutide product. These tests help confirm that the medications are what they are held out to be – they contain semaglutide in the concentration specified, are free of harmful ingredients, and are produced consistently.
Potency
Checks the compounded semaglutide to ensure it has an appropriate therapeutic concentration of semaglutide
Sterility
Confirms that the medication is free from contaminants such as bacteria or toxins
Bacterial endotoxicity
Verifies the medication is free from harmful toxins
Particulate matter
Confirms that no foreign particles are present in the solution, which could be harmful if injected
pH
Confirms the medication has the optimal acid/base balance to reduce injection site irritation
Appearance
Visual inspection of the medication to check for changes in color, clarity, or consistency
Quality and Safety Testing
The compounding facility provides a Certificate of Analysis (COA) for each batch of compounded semaglutide that’s produced. The COA confirms the quality of each batch and shows it has passed testing for potency, sterility, bacterial endotoxicity, particulate matter, pH, and appearance. You can request a copy of the Certificate of Analysis for your batch of medication by messaging your Care Team.
Learn more about compounded semaglutide
What are compounded GLP-1s?
- Compounded GLP-1s are custom-made weight-loss medications sold through specialized pharmacies. These medications are “identical to or nearly identical to” FDA-approved GLP-1 medications. These medications may be compounded as long as the FDA-approved drug remains on the FDA drug shortages list.
- As a result of nationwide medication shortages, a number of compounding pharmacies and outsourcing facilities have begun producing compounded GLP-1s.
- For GLP-1 medications that are being compounded during a drug shortage, the compounded medications must be identical to or nearly identical to the brand-name medications they are based on. However, compounded medications do not go through their own clinical trials and are not separately tested for efficacy.
Why does WeightWatchers offer compounded semaglutide?
- Shortages of GLP-1s have plagued the market for years, and we’ve heard our members raise concerns of unattainably high drug costs and limited insurance coverage—which often means those who need weight-management medications the most can’t easily afford or access them.
- We believe eligible members deserve to receive treatment from a source they can trust. To provide accessible weight health care to our members and support health equity, we’ve decided to offer access to a compounded GLP-1 medication through our team of licensed and experienced clinicians. Using our WeightWatchers app, members will continue to receive the high-touch support that’s needed throughout their weight health journey, including nutritional support tailored for those on a GLP-1 journey, virtual Clinician and Registered Dietitian visits, side effect monitoring, Workshops, a digital community and relationship building through Connect, and more.
- Our ultimate goal is to provide more weight-health treatment options to meet our members where they are based on what they feel is right and works for them.
Are compounded GLP-1s FDA approved?
- Compounded GLP-1 medications are not approved by the FDA. This means that the FDA does not verify the safety, effectiveness, or quality of compounded GLP-1s before they hit the market. However, WeightWatchers Clinic prescribes compounded medications that are produced by a 503B outsourcing facility, which is a facility that’s registered with the FDA. By law, the facility is subject to FDA inspection, must follow Current Good Manufacturing Practice (CGMP) standards, and must report adverse events, just like manufacturers of FDA-approved drugs.
- WeightWatchers Clinic clinicians only prescribe compounded GLP-1s produced by a 503B outsourcing facility that is registered with the FDA and that WeightWatchers has vetted and inspected.
How do I get prescribed a compounded GLP-1?
- A WeightWatchers Clinic licensed clinician may prescribe a compounded GLP-1 medication after reviewing all treatment options, risks, and a member’s unique medical history and goals. Any patient who is prescribed compounded medication will receive detailed instructions on how to administer the medication.
- After watching an instructional video on how to administer the medication, patients must complete a quiz to validate understanding and provide further instruction on concepts where needed. All members also have the option to set up a video visit in order to receive live instruction from their Care Team on how to administer the medication.
- Currently, clinicians may prescribe GLP-1s to patients who live in all states except Alabama, California, Louisiana, and Mississippi.
Who makes compounded GLP-1s?
- FDA-approved drugs that are on the FDA drug shortage list, including GLP-1 medications, may be compounded by 503A licensed pharmacies, individual physicians, or 503B outsourcing facilities. Many med-spas and telehealth providers are obtaining compounded GLP-1s from 503A pharmacies, which are not subject to the same safety and manufacturing requirements as a 503B outsourcing facility. WeightWatchers Clinic clinicians, on the other hand, only prescribe compounded GLP-1s that are produced by a 503B outsourcing facility.
- By law, 503B facilities must meet certain standards:
- The ingredients are sourced through official facilities. The facility must obtain active pharmaceutical ingredients (APIs) from FDA-registered facilities that adhere to Current Good Manufacturing Practices (CGMP). These practices aim to ensure the quality of ingredients’ quality, potency, and purity, which are crucial for the safety and efficacy of compounded medications.
- The ingredients are combined following specific protocols. The facility must compound the medication, package it, and label the final product in accordance with United States Pharmacopeia (USP) compounding standards for identity, strength, quality, purity, packaging, and labeling.
- The facility meets the same manufacturing requirements as FDA-approved drug manufacturers. The facility must abide by the same CGMP manufacturing requirements imposed on manufacturers of FDA-approved drugs. This helps to ensure accurate strength, labeling, and sterility and takes into account control of raw materials, facility design and maintenance, production techniques and controls, personnel practices, and testing samples of the finished drug product for quality before batch release.
Does the outsourcing facility check the Certificate of Analysis for each batch?
- Yes. For each new batch of compounded semaglutide that’s produced, the outsourcing facility reviews the Certificate of Analysis (COA), which confirms the product’s consistency, quality, and potency. Your Care Team can provide the COA for your batch upon request.
Is compounded semaglutide just a fake or counterfeit?
- No, the compounded GLP-1s WeightWatchers Clinic clinicians prescribe are identical or nearly identical to FDA-approved medications, meaning they and the FDA-approved drug have the same active ingredient(s), route of administration, dosage form, dosage strength, and inactive ingredients. The FDA allows the compounding of GLP-1s while the brand-name medications are in shortage, and the compounded GLP-1s WeightWatchers Clinic clinicians prescribe are produced in an FDA-registered facility that we have vetted and inspected. WeightWatchers does not condone counterfeit or fake medications, and we encourage consumers to ensure their GLP-1 medications are prescribed by a licensed clinician and produced by a trusted source.
Doctor-led Care Team
A team of experts
Under the leadership of Dr. Jamil Alkhaddo, a seasoned endocrinologist with over 20 years of experience, our clinical team has developed evidence-based safety and treatment protocols. With a deep commitment to member well-being, our clinicians focus on ensuring everyone has access to the right medication for their unique needs.
“I am passionate about addressing the current gaps in our healthcare system, where despite having excellent doctors, technology, and medicine, outcomes often fall short.”
Dr. Jamil Alkhaddo, Medical Director
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