Trust Should Never Be Assumed.
Every pharmacy in our network is evaluated through a documented framework examining regulatory standing, sterile-compounding controls, ingredient traceability, quality testing, and operational reliability.
How a 503A Licenced Pharmacy Qualifies.
Every pharmacy is evaluated for compliance with applicable federal and state requirements, including Section 503A or 503B of the Federal Food, Drug, and Cosmetic Act. Our review examines licensing, regulatory and inspection history, sterile-compounding standards, ingredient sourcing, independent testing, prescription controls, and dispensing practices before a pharmacy can join and remain in our network.
Partner pharmacies must also maintain LegitScript certification or applicable NABP accreditation, providing an additional layer of independent compliance verification and ongoing monitoring.
01- Licensing & Regulatory Standing
We verify active state pharmacy licenses, dispensing authority, regulatory history, and any publicly available disciplinary actions, recalls, warning letters, or enforcement records.
What we examine
- Active state-board licensing
- Authority to dispense into applicable states
- FDA registration status, when relevant
- Inspection and disciplinary history
- Recalls, warning letters, and unresolved sanctions
02- Sterile Compounding Controls
For sterile preparations, baseline licensing is not enough. We assess the systems used to control the environment, personnel, processes, and contamination risk.
What we examine
- Alignment with USP <797>
- ISO-classified compounding environments
- Environmental and surface monitoring
- Personnel training and competency testing
- Sterility-assurance procedures
- Beyond-use-date documentation
03- Ingredient Sourcing & Traceability
Quality begins before compounding. Pharmacy partners must demonstrate documented sourcing and traceability for active pharmaceutical ingredients and excipients.
What we examine
- Qualified API and excipient suppliers
- Documented chain of custody
- Supplier qualification procedures
- Raw-material identity testing
- Lot-level traceability
- Storage and handling controls
04- Testing & Quality Verification
We examine how pharmacies verify the identity, strength, purity, sterility, and consistency of compounded preparations.
What we examine
- Potency testing
- Sterility testing
- Endotoxin testing, where applicable
- Particulate-matter testing
- Third-party laboratory verification
- Batch-specific documentation and COA availability
05- Clinical & Operational Reliability
A quality formulation still requires dependable prescribing support, fulfillment, packaging, and patient communication.
What we examine
- Patient-specific prescription processes
- Pharmacist accessibility
- Prescription and dosage verification
- Packaging and temperature-management procedures
- Fulfillment accuracy and turnaround time
- Adverse-event and complaint-handling processes
06- Continuous Oversight
Acceptance into our network is not permanent approval. Pharmacy partners remain subject to ongoing review as regulations, ownership, accreditation, performance, and quality records change.
What we monitor
- License and accreditation status
- Regulatory actions and recalls
- Material operational changes
- Practitioner and patient concerns
- Fulfillment and service performance
- Continued documentation compliance