Compounded semaglutide and tirzepatide are not FDA-approved. That's the first thing to understand. Unlike brand-name Wegovy, Ozempic, or Zepbound—which undergo rigorous pre-market review—compounded preparations rely entirely on the quality controls of the pharmacy producing them.
This guide will help you distinguish legitimate compounding pharmacies from the dangerous operators flooding the market. The difference can be life-threatening.
503A vs 503B: The Two Types of Compounding Pharmacies
The Drug Quality and Security Act (DQSA) of 2013 created two distinct regulatory categories for compounding. Understanding this distinction is foundational to evaluating pharmacy quality.
- Regulator: State Board of Pharmacy
- Standard: USP 795/797/800
- Prescription: Patient-specific required
- Batch Testing: Periodic/random (varies)
- Beyond-Use Date: Based on USP defaults
- Scale: Limited to patient needs
- Regulator: U.S. FDA directly
- Standard: cGMP (pharmaceutical-grade)
- Prescription: Can distribute for "office use"
- Batch Testing: Mandatory on every batch
- Beyond-Use Date: Based on stability testing
- Scale: Bulk manufacturing permitted
Key Difference: 503B facilities operate under FDA oversight with Current Good Manufacturing Practices (cGMP)—the same standards as commercial drug manufacturers. 503A pharmacies follow USP guidelines but are primarily regulated by state boards with varying enforcement rigor.
Quality Markers: What to Look For
PCAB Accreditation
Pharmacy Compounding Accreditation Board (PCAB) accreditation—now administered by ACHC—is the gold standard for 503A pharmacies. It involves independent third-party assessment against USP standards.
How to Verify: Look for the PCAB Accredited seal on the pharmacy website. Cross-reference using the official ACHC/PCAB lookup tool—seals can be faked.
LegitScript Certification
LegitScript certification is critical for telehealth platforms prescribing GLP-1s. Major credit card networks and advertising platforms (Google, Meta) require it for prescription drug transactions.
LegitScript verifies: valid pharmacy and prescriber licenses in all operating jurisdictions, DEA compliance, physical address disclosure, and a legitimate patient-practitioner relationship (not "rubber-stamp" prescribing).
How to Verify: Click the LegitScript seal on any website—it should redirect to LegitScript's verification page for that specific domain.
USP 797 Compliance
USP Chapter 797 governs sterile compounding of injectables like semaglutide and tirzepatide. Compliance requires:
- ISO Class 7 buffer rooms (cleanrooms)
- ISO Class 5 Primary Engineering Controls (laminar airflow workbenches)
- Strict environmental monitoring protocols
- Personnel training and garbing requirements
How to Read a Certificate of Analysis (COA)
The COA is your proof that a specific batch of medication meets quality standards. Request it for every order.
- Lot Number Match: The lot number on the COA MUST match the lot number on your medication vial. If they don't match, the COA proves nothing about your product.
- Assay/Potency: Look for a numerical value (e.g., 99.5%) within specification range (typically 90%-110%). "Pass" means it's within range.
- Sterility: Must explicitly state "Pass," "Sterile," or "No Growth."
- Endotoxin: Tests for fever-causing bacterial byproducts. Result must be below specified limit.
- Third-Party Lab: Ideally tested by an independent laboratory, clearly identified in document header.
Red Flags: When to Walk Away
- "No Prescription Required" — Legitimate compounding requires a valid prescription. "Research chemicals" labeled "Not for Human Use" are not intended for injection.
- Prices drastically below market — If semaglutide is <$100/month at high doses, suspect unapproved salt forms (sodium/acetate) or industrial-grade ingredients.
- Missing licensure information — No physical address, phone number, or pharmacy license number displayed.
- "FDA Approved" claims — Compounded drugs are NEVER FDA approved. This claim is false and illegal.
- Can't identify the pharmacist — If they can't name the Pharmacist-in-Charge or provide pharmacist consultation, they lack required clinical oversight.
- No prescription verification — Legitimate platforms require health questionnaires and video/audio consultations, not just checkout forms.
- PCAB accreditation (verify via ACHC lookup)
- LegitScript certification (verify via seal link)
- Transparent pharmacy license number with state verification link
- Clear identification of 503A or 503B status
- Provides COA with matching lot numbers on request
- Uses FDA-registered API (active pharmaceutical ingredient) sources
- Named Pharmacist-in-Charge available for consultation
- Cold chain shipping (temperature-controlled with ice packs)
15 Questions to Ask Before Buying
FDA Enforcement: What's Happening Now
Recent FDA Actions
Warning Letters: Issued to vendors selling GLP-1s labeled "for research use only" (Gorilla Healing, SemaSpace, Paradigm Peptides) and to compounding pharmacies for sterility failures (Fullerton Wellness—patients warned not to use their products).
Import Alerts: Detaining bulk APIs from unregistered facilities in China and India entering the U.S.
State Actions: Connecticut AG issued cease-and-desist to medical spas making false "FDA Approved generics" claims. Illinois AG led 38-state coalition urging FDA action against counterfeits. Mississippi Board of Pharmacy threatened license revocation for compounding copies of drugs no longer on shortage list.
Known Safety Issues
- Dosing Errors: Multi-dose vials with varying concentrations (2.5 vs 5 mg/mL) causing 5-10x overdoses when patients confuse mg with syringe units. Hospitalizations for severe vomiting/dehydration.
- Salt Form Problems: Semaglutide sodium/acetate not evaluated for safety—different pharmacokinetics may cause lower efficacy or unexpected reactions.
- Counterfeit Ozempic: Look-alike pens containing insulin instead of semaglutide, causing dangerous hypoglycemia in non-diabetic patients.
- FAERS Reports: As of mid-2025, 605+ adverse event reports for compounded semaglutide and 545+ for compounded tirzepatide.
The Price Calculation
With manufacturer cash-pay programs now offering brand-name drugs for $350-550/month, the cost advantage of compounding has narrowed significantly:
- Brand (Cash Pay via Manufacturer): $350-550/month
- Compounded: $200-400/month
- Price Difference: $50-150/month
For a $50-100/month savings, you're trading FDA-approved quality assurance for products that may have potency variations of 90-110% (or worse), uncertain sterility, and no recourse if something goes wrong.
- FDA. Drug Quality and Security Act (DQSA) of 2013.
- FDA. Compounding Quality Center guidance.
- ACHC/PCAB. Pharmacy Compounding Accreditation standards.
- LegitScript. Healthcare Merchant Certification standards.
- USP. Chapter 797 Pharmaceutical Compounding—Sterile Preparations.
- USP. Chapter 800 Hazardous Drugs—Handling in Healthcare Settings.
- FDA. "FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss." 2024.
- FDA. Warning Letters database.
- Connecticut AG. "Crackdown on Bootleg GLP-1 Weight Loss Drugs." 2025.
- Illinois AG. Coalition letter to FDA on counterfeit GLP-1s.
- FDA. "Dosing Errors with Compounded Injectable Semaglutide." Safety Alert.
- GoodRx. "Tirzepatide Shortage Is Over: Here's What You Need to Know."
- FDA. Drug Shortage Database.
- Foley & Lardner. "GLP-1 Drugs: Brand Companies Push FDA to Limit Compounding."