The Science
How compounded protocols work
Every Nuvari protocol is compounded by US pharmacies that are state-licensed, FDA-registered, and follow USP standards for compounding. Here's exactly how the process works.
What are compounded medications?
Compounded medications are prescription drugs that are custom-prepared for an individual patient by a licensed pharmacist. Unlike mass-produced medications that come in fixed doses and forms, compounded medications can be tailored to your specific needs — adjusting the dosage, delivery method, or combining multiple active ingredients into a single formulation.
This is not a new concept. Compounding is how all medications were made before mass manufacturing existed. Today, compounding pharmacies serve patients who need dosages or combinations that aren't commercially available, or who need medications at a fraction of brand-name pricing.
Key distinction: Compounded medications are not FDA-approved drugs and are not interchangeable with brand-name medications. They are prepared specifically for you, by a licensed pharmacist, based on a physician's prescription — which allows for personalized dosing or formulations not available off the shelf.
How the prescribing process works
At Nuvari, every protocol begins with a licensed physician. There are no shortcuts, no AI-only assessments, and no rubber stamps. Here's how your prescription is created:
Step 1
Health Assessment
You complete a detailed wellness questionnaire covering your health history, current medications, goals, and any contraindications. This takes about 5 minutes.
Step 2
Physician Review
A board-certified physician reviews your assessment in full. They evaluate your eligibility, select the right compound, and determine the appropriate dosage for your profile.
Step 3
Prescription Issued
If clinically appropriate, your physician writes a prescription and sends it directly to the compounding pharmacy. If you're not a candidate, you're informed immediately — no charge.
Step 4
Ongoing Oversight
Your provider monitors your progress through regular check-ins and adjusts your protocol as needed. You can message your provider anytime through your patient portal.
How 503A compounding pharmacies are regulated
Nuvari partners exclusively with 503A-licensed compounding pharmacies. These pharmacies operate under Section 503A of the Federal Food, Drug, and Cosmetic Act and are subject to multiple layers of oversight:
- State Board of Pharmacy licensing — Every pharmacy holds a current license from the state board of pharmacy in the states where it operates. State boards conduct routine inspections and enforce pharmacy practice standards.
- FDA registration and oversight — 503A pharmacies are registered with the FDA. Compounded medications themselves are not FDA-approved drugs, but the pharmacies are subject to FDA inspection and enforcement.
- Pharmacist oversight — All compounding is performed by or under the direct supervision of a licensed pharmacist.
- Valid prescription required — Every compounded medication requires an individualized prescription from a licensed physician for a specific patient. No bulk manufacturing.
- USP standards — Pharmacies follow United States Pharmacopeia (USP) chapters 795 (non-sterile) and 797 (sterile) standards for compounding procedures.
Why 503A matters: Unlike 503B outsourcing facilities that can produce medications in bulk without individual prescriptions, 503A pharmacies compound each medication for a specific patient based on a specific prescription. This means your medication is made for you.
Quality testing and verification
Quality isn't optional — it's built into every step of the compounding process. Our pharmacy partners maintain rigorous quality assurance programs:
- Raw ingredient testing — Active pharmaceutical ingredients are sourced from FDA-registered suppliers and tested for identity, purity, and potency before use.
- Certificate of Analysis (COA) — Each batch of raw material comes with a COA verifying its composition and purity levels.
- Beyond-use dating — Every compounded medication is assigned a beyond-use date (BUD) based on stability testing, ensuring potency through the labeled expiration.
- Sterility testing — For injectable compounds, sterility testing is performed on each batch to ensure the medication is free from microbial contamination.
- Potency verification — Finished products are tested to confirm that the active ingredient concentration matches the prescribed dosage within strict tolerance ranges.
- Environmental monitoring — Compounding areas are regularly tested for air quality, surface contamination, and personnel compliance with clean-room protocols.
How shipping and cold-chain works
Getting your medication from the pharmacy to your door safely is just as important as how it's made. Nuvari's pharmacy partners use specialized shipping protocols to maintain medication integrity:
- Temperature-controlled packaging — Medications that require refrigeration are shipped in insulated containers with cold packs to maintain proper temperature throughout transit.
- Expedited shipping — All orders ship via expedited carriers to minimize time in transit. Most orders arrive within 3-5 business days.
- Tamper-evident packaging — Every shipment uses tamper-evident seals so you can verify your package hasn't been opened.
- Discreet delivery — All packages are shipped in plain, unmarked boxes with no indication of the contents. Your privacy is protected.
- Free shipping — Nuvari covers shipping on every order. No hidden fees, no minimum spend.
Cold-chain integrity: For peptide and injectable protocols that require refrigeration, our pharmacy partners use validated cold-chain packaging tested to maintain 2-8 degrees C for up to 48 hours in transit — even in summer months.
Frequently asked questions
What is a compounded medication? ▾
A compounded medication is a prescription drug custom-prepared for an individual patient by a licensed pharmacist. Unlike mass-produced medications that come in fixed doses, compounded medications can be tailored to specific dosage needs. Compounded medications are not FDA-approved drugs and are not interchangeable with brand-name medications.
Are compounded GLP-1 medications FDA-approved? ▾
No. Compounded GLP-1 medications are not FDA-approved as finished products. However, they are legally prescribed and dispensed through 503A compounding pharmacies that are licensed by state boards of pharmacy and subject to FDA oversight. The active pharmaceutical ingredients are sourced from FDA-registered suppliers.
Is 503A or 503B better? ▾
They serve different purposes. 503A pharmacies compound medications for individual patients based on a specific prescription, which allows for personalized dosing. 503B facilities can produce larger batches without individual prescriptions. Nuvari partners with 503A pharmacies so each medication is compounded specifically for the patient.
How do I know the pharmacy is legitimate? ▾
Every pharmacy Nuvari works with holds an active license from the state board of pharmacy in the states where it operates, is registered with the FDA, and follows USP chapters 795 and 797 for non-sterile and sterile compounding. License information is verifiable through state pharmacy board websites.
What quality testing is done? ▾
Raw active pharmaceutical ingredients are tested for identity, purity, and potency and arrive with a Certificate of Analysis. Finished compounds undergo potency verification to confirm concentration matches the prescription. Injectable compounds are tested for sterility. Compounding environments are monitored for air quality and contamination.
Can I get a refund? ▾
If a physician determines a protocol is not medically appropriate for you during the review, you are not charged. Because compounded medications are prepared specifically for the individual patient once a prescription is issued, dispensed medication generally cannot be returned for a refund. Contact support for details on your specific situation.
