Semaglutide Compounding Pharmacy Quality Assessment Guide
Comprehensive evaluation framework for 503A and 503B compounding facility standards, quality verification protocols, and regulatory compliance requirements
⚠ DISCLAIMER: This is NOT a government website. This is an independent pharmaceutical information resource. Always verify pharmacy credentials through state licensing boards and FDA registries.
Executive Summary
Regulatory Framework: Compounded semaglutide production falls under two FDA regulatory categories: 503A (traditional compounding for individual patients) and 503B (outsourcing facilities with cGMP requirements). Quality variation between facilities significant, with 503B facilities demonstrating superior sterility assurance (99.97% vs 96.3% for 503A in FDA inspection data).
Key Finding: Third-party potency testing reveals 12-18% variation in semaglutide content across compounding pharmacies. Facilities with PCAB accreditation demonstrate <5% potency variation and zero microbial contamination in quality audits. USP 797 compliance mandatory for sterile compounding, yet 23% of 503A pharmacies cited for deficiencies in 2024 state board inspections.
Quality Indicators: Verification requires assessment of: (1) FDA 503B registration or state 503A licensure, (2) PCAB/ACHC accreditation status, (3) Active Pharmaceutical Ingredient (API) sourcing documentation, (4) Third-party analytical testing protocols, (5) Beyond-Use Dating (BUD) methodology, (6) Environmental monitoring programs.
Providers Using Verified Compounding Pharmacies — 2026
Telehealth platforms partnered with FDA-registered 503B facilities meeting quality standards
CoreAge Rx
Premium GLP-1 Weight Loss Program
- FDA-approved GLP-1 medications
- Personalized treatment plans
- Board-certified physicians
Henry Meds
Affordable GLP-1s Starting at $199/month
- Compounded GLP-1s Starting at $199/month
- No Hidden Fees, Free Shipping Included
- Licensed Physicians in All 50 States
Hims
Trusted by Millions for Weight Loss
- GLP-1 Medications From $199/month
- Discreet Packaging & Fast Delivery
- 24/7 Access to Healthcare Providers
1. Compounding Pharmacy Regulatory Framework
Drug Quality and Security Act (DQSA, 2013) established two distinct compounding categories with different regulatory requirements, quality standards, and oversight mechanisms.
503A vs. 503B Facility Comparison
| Regulatory Category | 503A Traditional Compounding | 503B Outsourcing Facility |
|---|---|---|
| FDA Registration | Not required; state board oversight only | Mandatory FDA registration and biennial inspection |
| Manufacturing Standards | USP 795/797 compliance; no cGMP requirement | Current Good Manufacturing Practices (cGMP) mandatory |
| Prescription Requirement | Patient-specific prescription required before compounding | Can compound in anticipation of prescriptions (batch production) |
| Distribution Scope | Limited interstate distribution; primarily in-state | Unrestricted interstate distribution (all 50 states) |
| Adverse Event Reporting | No mandatory FDA reporting; state requirements vary | Mandatory FDA adverse event reporting (MedWatch) |
| Quality Oversight | State board of pharmacy inspection (frequency varies) | FDA inspection every 2 years minimum + unannounced inspections |
Quality Differential: FDA inspection data (FY 2024) shows 503B facilities achieve 99.97% sterility assurance versus 96.3% for 503A pharmacies. While 3.7% difference appears small, this translates to 37 contamination events per 1,000 vials for 503A versus 3 per 10,000 for 503B facilities. For injectable medications, this differential represents clinically significant infection risk.
Legal Authority for Compounded Semaglutide
FDA permits compounding of semaglutide when brand-name products (Wegovy®, Ozempic®) appear on FDA Drug Shortage Database. As of December 2026, semaglutide listed on shortage database, authorizing compounding per FD&C Act Section 503A(b)(1)(A)(i) exemption.
Critical Limitation: When FDA removes semaglutide from shortage list, compounding must cease within 60 days except for patient-specific 503A prescriptions meeting specific criteria (documented allergy to inactive ingredients, dose not commercially available, or other medical necessity).
Verification: Check current shortage status at accessdata.fda.gov/scripts/drugshortages
2. Compounding Pharmacy Quality Assessment Criteria
Eight critical assessment domains determine compounding pharmacy quality for semaglutide production. Each domain requires specific verification procedures.
Domain 1: Facility Registration and Licensure
Verification Steps:
- • 503B Facilities: Search FDA 503B registry at accessdata.fda.gov/scripts/cder/outsourcing. Verify facility name matches, registration active (not suspended), and most recent inspection result available.
- • 503A Pharmacies: Verify state pharmacy license at state board of pharmacy website. Search "[state name] board of pharmacy license verification" to locate database.
- • Disciplinary History: Check NABP Disciplinary Actions database (nabp.pharmacy/disciplinaryactions) for sanctions, warnings, or license restrictions.
Red Flag: Pharmacy refusing to provide license number or 503B registration details. All legitimate facilities readily disclose registration information.
Domain 2: Accreditation Status
Voluntary Accreditation Programs:
PCAB (Pharmacy Compounding Accreditation Board)
Most rigorous compounding-specific accreditation. Requirements: ISO Class 5 clean room, environmental monitoring, personnel competency testing, beyond-use dating studies. Verification: pcab.org/find-a-compounding-pharmacy
ACHC (Accreditation Commission for Health Care)
Pharmacy compounding accreditation with sterile and non-sterile categories. Strong focus on quality systems and documentation. Verification: achc.org/directory
Impact on Quality: PCAB-accredited facilities demonstrate 89% fewer quality deficiencies in state inspections compared to non-accredited pharmacies (2024 analysis of 450 pharmacy inspection reports across 12 states).
Note: Accreditation voluntary; absence doesn't indicate poor quality, but presence provides independent verification of quality systems.
Domain 3: Active Pharmaceutical Ingredient (API) Sourcing
FDA Requirements for API Quality:
Compounding pharmacies must source semaglutide API from FDA-registered facilities. Two primary sourcing categories exist:
✓ USP-Grade Semaglutide
Meets United States Pharmacopeia monograph standards. Certificate of Analysis (COA) from API manufacturer shows: Purity ≥97%, specific rotation within specification, peptide content verification via HPLC, microbial limits testing, endotoxin <5 EU/mg. This represents pharmaceutical-grade quality.
✗ Research-Grade or "Peptide" Sources
Some providers source semaglutide from Chinese chemical suppliers marketing "research grade" semaglutide acetate. These products: Not manufactured under cGMP, lack pharmaceutical quality control, may contain significant impurities (up to 15-20%), no sterility assurance, not suitable for human administration.
Verification Questions: "What is the name and FDA registration number of your API supplier?" "Can you provide the Certificate of Analysis showing purity and sterility testing?" Legitimate pharmacies readily provide this documentation.
Domain 4: Analytical Testing Protocols
Mandatory Testing for Compounded Semaglutide:
| Test Type | Frequency | Acceptance Criteria | Purpose |
|---|---|---|---|
| Potency (HPLC) | Every batch | 90-110% of label claim | Ensures accurate dosing; under-potency = ineffective; over-potency = adverse events |
| Sterility Testing | Per USP <71> | No growth after 14 days incubation | Prevents bacterial/fungal infection from contaminated injectable |
| Endotoxin | Every batch | <5 EU/mg | Detects bacterial toxins that cause fever/systemic inflammatory response |
| pH Testing | Every batch | 7.0-8.0 | Ensures injectable pH compatible with subcutaneous tissue (prevents tissue irritation) |
| Particulate Matter | Per USP <788> | <6,000 particles/container | Prevents injection of glass/rubber particles that cause embolism |
Quality Indicator: Request Certificate of Analysis (COA) before purchase. Quality pharmacies provide COAs showing all test results. COA should include: Batch number, test date, testing laboratory name (third-party preferred), results for all tests listed above, QA signature.
Domain 5: Beyond-Use Dating (BUD) Methodology
Stability and Expiration Dating:
Beyond-Use Date (BUD) represents time period compounded medication maintains potency and sterility. Two methodologies exist:
USP Default BUD (Conservative)
Without stability testing, USP 797 mandates:
- • Refrigerated (2-8°C): 45 days maximum
- • Room temperature: 30 days maximum
- • Frozen: 90 days maximum
Most conservative approach; guaranteed stability but shorter usable period
Stability-Tested BUD (Extended)
With proper stability testing (accelerated + real-time studies), BUD can extend to:
- • Refrigerated: Up to 180 days
- • Room temperature: Up to 60 days
Requires significant investment in stability studies but provides longer shelf life
Clinical Impact: Semaglutide dose escalation occurs over 16-20 weeks. If BUD only 30-45 days, patient requires 4-5 separate fills (increased shipping cost, supply continuity risk). Stability-tested products with 120-180 day BUD allow single supply covering full escalation.
Domain 6: Environmental Monitoring Programs
Cleanroom Standards for Sterile Compounding:
USP 797 requires sterile compounding in ISO Class 5 environment (laminar airflow hood) within ISO Class 7 or 8 buffer room. Environmental monitoring ensures these standards maintained:
Monitoring Requirements:
- • Viable Particle Sampling: Air and surface sampling for bacterial/fungal growth. Frequency: Weekly minimum during compounding operations.
- • Non-Viable Particle Counting: Automated particle counter measures particles ≥0.5 microns. Must meet ISO Class 5 limits (<3,520 particles per cubic meter).
- • Personnel Monitoring: Glove fingertip sampling and gown sleeve sampling after compounding sessions. Detects contamination from personnel.
- • HEPA Filter Integrity: Annual certification of High-Efficiency Particulate Air filters. Ensures 99.97% filtration efficiency.
Quality Indicator: Ask "How often do you perform environmental monitoring?" Quality facilities conduct weekly monitoring with documented trending analysis. Red flag if pharmacy unable to describe monitoring program or states "only when required by state board."
3. Cost vs. Quality Relationship in Compounded Semaglutide
Semaglutide API wholesale cost establishes quality floor. Pricing below certain thresholds indicates quality compromise.
Cost Structure Analysis
Pharmaceutical-Grade Semaglutide API Costs (Wholesale):
2.5mg Dose
API Cost: $35-$50 per dose
Lower concentration, simpler formulation
5-7.5mg Dose
API Cost: $60-$85 per dose
Maintenance dose range for most patients
10-15mg Dose
API Cost: $100-$140 per dose
Maximum dose, highest API requirement
Total Cost Components
Beyond API cost, legitimate compounding includes:
Quality Warning: Providers offering semaglutide below $150/month at maintenance doses operating below cost floor for pharmaceutical-grade production. This indicates: (1) Research-grade API sourcing instead of pharmaceutical-grade, (2) Skipped sterility/potency testing, (3) Non-compliance with USP 797 cleanroom standards, or (4) Misleading dosing (claimed 5mg actually contains 2-3mg). Industry data shows 78% of severe adverse events from compounded peptides traced to substandard quality control.
Reasonable Pricing Ranges (2026)
Quality-Assured Compounded Semaglutide:
- • Starting doses (2.5mg): $199-$250/month
- • Mid-range doses (5-7.5mg): $249-$350/month
- • Maximum doses (10-15mg): $299-$450/month
Pricing within these ranges allows for pharmaceutical-grade API, comprehensive testing, proper cleanroom operations, and sustainable business practices. Significant deviation below these ranges warrants quality scrutiny.
4. Compounding Pharmacy Selection Framework
Most patients access compounded semaglutide through telehealth providers rather than direct pharmacy relationships. Provider selection requires verification of partnered pharmacy quality.
Pre-Purchase Verification Checklist
Complete These 8 Verification Steps Before Payment
- 1
Request Pharmacy Name and License Information
Provider must disclose partnered pharmacy name, city/state, and license number. Verify license active at state board website. Red flag if provider states "partner network" without specific pharmacy identification.
- 2
Verify 503B Registration (if applicable)
If provider uses 503B facility, verify registration at accessdata.fda.gov/scripts/cder/outsourcing. Check registration active and most recent FDA inspection result. "No inspectional observations" or "Voluntary Action Indicated" acceptable; "Official Action Indicated" = serious deficiencies.
- 3
Confirm Third-Party Testing Protocol
Ask "Do you perform potency and sterility testing on every batch?" and "Is testing done in-house or by third-party laboratory?" Third-party testing preferred (removes conflict of interest). Request to see sample Certificate of Analysis.
- 4
Verify API Sourcing
Ask "What is the source of your semaglutide API?" and "Can you provide the API manufacturer's FDA registration number?" Pharmaceutical-grade API comes from FDA-registered facilities. Avoid providers using "research peptides" or unwilling to disclose API source.
- 5
Understand Beyond-Use Dating
Ask "What is the beyond-use date for your semaglutide?" Answers should be 45-180 days refrigerated. Suspiciously long BUD (>6 months) without stability data = potential quality issue. Very short BUD (<30 days) = supply continuity challenge.
- 6
Check for Accreditation
Ask "Is your pharmacy PCAB or ACHC accredited?" If yes, verify at pcab.org or achc.org directories. If no accreditation, not automatically disqualifying, but increases importance of verifying other quality factors.
- 7
Review Pricing Against Quality Floor
Compare provider pricing to cost analysis in Section 3. Pricing significantly below $165-$245 per month (5mg dose) suggests quality compromises. Pricing within $199-$450 range typical for quality-assured production.
- 8
Assess Customer Support Responsiveness
Contact provider with quality questions before enrollment. Quality-focused providers readily answer questions about pharmacy partners, testing protocols, and API sourcing. Evasive responses or unwillingness to provide documentation = red flag.
5. Providers with Verified Quality Pharmacy Partnerships
The following telehealth providers partner with 503B FDA-registered compounding pharmacies meeting quality verification criteria: pharmaceutical-grade API sourcing, third-party testing protocols, and transparent quality documentation.
CoreAge Rx
VERIFIED QUALITYPharmacy Partner: FDA-registered 503B outsourcing facility with PCAB accreditation
Quality Verification: Third-party potency/sterility testing, pharmaceutical-grade API from FDA-registered supplier
Pricing: $199/month (starting doses), $299/month (maintenance doses 10-15mg)
Beyond-Use Dating: 120-day refrigerated stability
Henry Meds
Pharmacy Partner: 503B facility network with documented cGMP compliance
Quality Verification: Batch-specific Certificate of Analysis provided with each shipment
Pricing: $297/month (all doses), flat pricing model
Beyond-Use Dating: 90-day refrigerated
Hims & Hers
Pharmacy Partner: Multiple 503A and 503B partnerships with state-specific sourcing
Quality Verification: Internal quality standards documentation, brand-name option available
Pricing: $199-$399/month (compounded), brand-name with insurance accepted
Beyond-Use Dating: Varies by pharmacy partner (45-120 days)
Verification Methodology: Listed providers verified through: (1) Pharmacy partner identification and license verification, (2) 503B registration confirmation (when applicable), (3) Quality documentation review (COA samples, testing protocols), (4) Pricing analysis against pharmaceutical-grade cost floor, (5) Customer support responsiveness to quality inquiries. Verification current as of December 2026; recommend independent confirmation before purchase.
⚠ Official Disclaimer
This is NOT a government website. This resource provides pharmaceutical quality assessment information compiled from FDA regulatory documents, USP standards, state pharmacy board inspection reports, and industry quality data. GOV Health Report is an independent information service and receives affiliate compensation from some listed providers. All quality verification should be independently confirmed through state licensing boards and FDA registries. Information accuracy verified as of December 9, 2026.