Sereno GPO · serenoGPO.com

FDA-compliant products.
Network pricing.
Zero compromise.

The only Group Purchasing Organization built exclusively for longevity medicine practices — giving physician clinics, med spas, and wellness centers direct access to USA-made, batch-tested 503B outsourcing facility products, 503A patient-specific compounds, and USP <797>-compliant sterile preparations at pricing no individual practice can negotiate alone.

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503B
Compliant sourcing only
100%
USA-manufactured
COA*
On every batch
OIG
Safe-harbor structure

FDA Enforcement Notice: Wholesale distribution of compounded drugs through brokers or middlemen violates FDCA §503B. Compliant sourcing means 503B outsourcing facilities, licensed 503A pharmacies, and USP <797>-compliant sterile compounders — direct to the practitioner. Sereno GPO connects you to all three.

What We Provide

Everything your practice needs
in one compliant platform.

Sereno GPO is not a vendor. It is a Group Purchasing Organization that aggregates buying power across a national network of practices — giving every member access to FDA-compliant products, legal structure, expert educators, and business support that would otherwise cost multiples more to assemble independently.

01
503B, 503A & USP <797> Sourcing
Direct access to the full compliant compounding landscape — FDA-registered 503B outsourcing facilities for office-use products, licensed 503A pharmacies for patient-specific prescriptions, and USP <797>-compliant sterile compounders for injectable preparations. Every product USA-manufactured, independently tested, Certificate of Analysis on every batch.
Core Service
02
Network Pricing Power
Your practice joins a collective that negotiates as one. Aggregated volume secures pricing no individual clinic, med spa, or physician practice can obtain directly — typically materially below retail 503B rates. Transparent pricing, no markups.
GPO Structure
03
Audit-Ready Compliance Documentation
Every membership includes the documentation package your medical director and attorney need: supplier registrations, DSCSA pedigree records, and a written compliance framework reviewed by our healthcare regulatory counsel.
Legal Infrastructure
04
Prior Authorization for GLP-1s
Dedicated prior authorization processing for GLP-1 medications. We manage the administrative burden of insurance approvals so your team focuses on patient care, not paperwork. Faster approvals, fewer denials, documented outcomes.
GLP-1 Program
05
MSO Business & Marketing Services
Through Sereno MSO, members access practice optimization, sales strategy development, marketing content creation, staff training, and program build-out support — the operational infrastructure that turns a compliant practice into a growing one.
MSO Services
The Compliance Landscape

Buying wholesale
is a federal violation.

FDCA §503B prohibits compounded drugs from moving through brokers or resellers. There are three compliant sourcing pathways — 503B, 503A, and USP <797> — and only a GPO gives you structured access to all three at network pricing.

Wholesale Brokers
Gray-market vendors
Federal violation.
Illegal distribution channel. No pedigree. No COA. Full liability transfers to your practice the moment you administer the product.
Direct 503A/B/797
Individual pharmacy
Compliant. Retail pricing.
503A patient-specific, 503B office-use, and USP <797> sterile preparations are all legally sound when purchased direct — but you pay retail with no volume leverage, no documentation infrastructure, and no supplier redundancy.
Sereno GPO
OIG safe-harbor structure
Compliant. Best pricing.
Aggregated network volume negotiates across 503B outsourcing facilities, licensed 503A pharmacies, and USP <797> sterile compounders. Every member receives pricing no individual practice can match — across all three compliant pathways, with full legal documentation.

Why this matters for med spas: Your business operates under a supervising physician whose license is on the line for what gets administered under their delegation. Medical directors are walking away from practices that cannot document their supply chain. A med spa without a medical director is a med spa that is closed.

Why this matters for physician clinics: A defensible state board audit response requires a documented FDA-registered supplier, current DSCSA pedigree, a valid compounding pathway, and a written compliance framework. Penalties reach license suspension and FDA civil penalties up to $597,317 per violation.

Formulary

USA-made. Tested.
Ready when you are.

The Sereno GPO formulary spans three compliant pathways: 503B outsourcing facilities for office-use bulk products, 503A licensed pharmacies for patient-specific prescriptions, and USP <797>-compliant sterile compounders for injectable preparations. Every product USA-manufactured, independently tested, Certificate of Analysis on every batch.

503B Outsourcing Facility
Office-use products manufactured at scale under FDA registration and cGMP standards. Ships directly to your practice without a patient-specific prescription. Highest compliance tier for high-volume clinic use.
503A Licensed Pharmacy
Patient-specific prescriptions compounded by a state-licensed pharmacy for individual patients. Required pathway for certain formulations not available through 503B. Sereno GPO connects you to vetted 503A partners at network pricing.
USP <797> Sterile Compounding
Injectable and sterile preparations produced under USP Chapter <797> standards — the highest sterility standard for compounded pharmaceuticals. Required for all injectable peptide and hormone preparations administered in-office.
BPC-157
Peptide · Tissue Repair
503B · USP <797>
Sermorelin
Peptide · GH Secretagogue
503B · USP <797>
Testosterone Cypionate
Hormone · TRT
503B · USP <797>
Testosterone Enanthate
Hormone · TRT
503B · USP <797>
Progesterone
Hormone · BHRT
503A · 503B
DHEA
Hormone · Adrenal Support
503A · 503B
PT-141
Peptide · Sexual Health
503A · USP <797>
Gonadorelin
Peptide · Testicular Function
503A · USP <797>
Thymosin Beta-4
Peptide · Recovery
503B · USP <797>
Semaglutide
GLP-1 · Weight Management
503B · Prior Auth
Tirzepatide
GLP-1 · Metabolic Health
503B · Prior Auth
Custom Formulations
503A · Patient-Specific
503A Rx Required
+ Expanding
Formulary updated quarterly
Compounding Pathways

503A, 503B, and USP <797>.
What they mean for your practice.

Most practices only know one pathway. Sereno GPO members access all three — matched to the right product, the right patient, and the right compliance framework every time.

503B Outsourcing Facility
The highest-volume, highest-compliance tier.
503B outsourcing facilities are FDA-registered manufacturers that produce compounded drugs at scale for office use — without requiring individual patient prescriptions. They operate under cGMP (current Good Manufacturing Practice) standards, the same quality framework applied to commercial pharmaceutical manufacturers.
No patient-specific prescription required for office stock
cGMP manufacturing — same standard as commercial pharma
Full DSCSA pedigree — traceable from facility to your shelf
Certificate of Analysis on every batch, independent third-party tested
Must ship direct facility → licensed practitioner — no brokers
Best for: High-volume clinic use of peptides, hormones, and injectables where office stock is preferable to individual prescription routing.
503A Licensed Pharmacy
Patient-specific. Prescription-required.
503A pharmacies are state-licensed compounding pharmacies that prepare medications for individual patients based on a valid prescription from a licensed practitioner. They are the traditional compounding model — capable of formulating products in dosages, strengths, and delivery forms not commercially available, tailored to a specific patient's clinical needs.
Individual patient prescription required for every order
Custom dosing, strength, and delivery form for each patient
Access to formulations not available through 503B pathways
Regulated by state pharmacy boards under USP standards
Sereno GPO connects you to vetted 503A partners at network pricing
Best for: BHRT, individualized hormone protocols, and formulations requiring patient-specific dosing that cannot be addressed by off-the-shelf 503B products.
USP <797> Sterile Compounding
The sterility standard for every injectable.
USP Chapter <797> is the United States Pharmacopeia's mandatory standard for sterile compounding — covering facilities, equipment, personnel training, environmental monitoring, and testing protocols required for any compounded preparation intended to be sterile. Every injectable peptide and hormone administered in-office must originate from a USP <797>-compliant facility.
Mandatory for all injectable compounded preparations
Covers ISO-classified cleanroom environments and airflow standards
Requires endotoxin testing, sterility testing, and beyond-use dating validation
All Sereno GPO 503B and 503A injectable suppliers are <797>-compliant
Non-797-compliant injectable products are a direct patient-safety liability
Best for: Any injectable preparation administered in-office — peptides, testosterone, hormones. If it goes in a needle, USP <797> compliance is not optional.
How Sereno GPO Selects the Right Pathway
When you submit your formulary request, our compliance team evaluates each product against current FDA regulatory status, your clinical use case, and your patient volume — then routes every SKU through the highest-compliance, lowest-cost pathway available. You don't manage the complexity. We do.
Clinical Education

Expert educators in
peptides & hormones.

Access to the right products means nothing without the clinical knowledge to deploy them effectively. Sereno GPO members receive direct access to our network of educators specializing in peptide therapy and hormone optimization — practitioners who translate complex science into safe, effective protocols for your team.

Member Benefit · Educator Access
The knowledge your team needs, on demand.
Our clinical educators work directly with your practice — from onboarding your medical director to training your injectors and front desk team on patient conversations.
Peptide therapy protocols — evidence-based dosing guidance, contraindication review, and patient selection criteria developed by practitioners, not vendors.
Hormone optimization training — comprehensive TRT, BHRT, and adrenal support education for your clinical team and supervising physicians.
Staff certification programs — structured education for injectors, medical assistants, and patient coordinators on compliance, consent, and clinical delivery.
Ongoing CME-aligned content — regular clinical updates as the FDA landscape and clinical evidence evolve, delivered directly to your practice.
Sereno MSO

Compliant practice.
Growing business.

Compliance is the foundation. Growth is the goal. Through Sereno MSO, GPO members access a full suite of practice management and marketing services designed specifically for longevity medicine practices.

Practice Optimization
Workflow analysis, service menu design, pricing strategy, and operational infrastructure review — turning a compliant practice into an efficient one.
Sales Strategy
Patient acquisition frameworks, consultation conversion training, membership program design, and upsell pathway development tailored to longevity medicine.
Marketing Content
Done-for-you educational content, social media strategy, email campaigns, and patient communication frameworks — built on compliant clinical messaging.
Staff Training
Comprehensive onboarding for new hires, clinical protocol training for injectors, and patient communication coaching for your front-desk and coordinators.
Program Launch Support
Full build-out support for new program launches — peptide programs, hormone optimization, and weight management — from protocol to patient collateral.
Compliance Infrastructure
Consent frameworks, patient intake templates, documentation standards, and audit preparation — so your practice is ready for any oversight event.
GLP-1 Program

Prior authorization,
handled.

GLP-1 medications represent one of the largest and fastest-growing categories in longevity medicine — and one of the most administratively complex. Sereno GPO manages the prior authorization process so your team doesn't have to.

01
Patient Eligibility Assessment
We review the patient's clinical profile against payer criteria to identify the strongest prior auth pathway before a single form is filed.
02
Documentation & Submission
Our team prepares and submits the prior authorization with complete clinical documentation, reducing denials from incomplete paperwork.
03
Appeals Management
If a prior auth is denied, we manage the appeal process — including peer-to-peer review coordination with your physician if required.
04
Approval & Fulfillment
Once approved, prescriptions route to compliant dispensing. We track every approval and flag renewals before they lapse.
GLP-1 at Sereno GPO
Prior Auth
End-to-end management — submission through approval
503B
Compliant compounded GLP-1 sourcing where legally available
Cash-Pay
Manufacturer enrollment programs for cash-pay patient access
Zero+
Administrative burden added to your clinical team
How to Join

Up and running
in four steps.

STEP 01
Request Access
Complete the practice intake form. Tell us what you currently buy, your approximate volumes, and what you're paying. No obligation, no patient data required.
STEP 02
Free Analysis
We benchmark your current sourcing and pricing against Sereno network rates and flag every compliance gap in your current vendor relationships. Report delivered within 2 business days.
STEP 03
Membership Agreement
Review our GPO membership structure — designed to OIG safe-harbor standards. Your attorney reviews. our counsel's published analysis is available for reference. You decide.
STEP 04
First Compliant Order
Place your first order at network pricing with full DSCSA documentation. Your educator introduction is scheduled. Your compliance package is delivered. Your practice is protected.
Get Started

Ready to join the network?
Complete the practice intake form.

Tell us about your practice, what you currently source, and what you're paying. Our team reviews every submission and follows up within 2 business days with your personalized pricing and compliance analysis. No obligation.

Begin Practice Intake

No patient data requested · Response within 2 business days · No commitment required