Most 503A compounding pharmacies operate in good faith under real regulatory obligations. We still apply a consistent vetting framework before any pharmacy joins the Stack network, because "licensed" covers a wide range of operational quality and a license alone does not tell you whether a pharmacy can produce safe, consistent compounded product. The framework runs in two layers: baseline gates and core quality standards.
Layer 1: Baseline gates
These are binary checks. A pharmacy that fails any of them is not considered further.
Active licensure. The pharmacy must hold an active state pharmacy license in its operating state, plus nonresident licenses for every state it ships to. Earning that licensure requires passing a state board facility inspection, complying with the state's pharmacy practice act, and employing a licensed pharmacist-in-charge who holds an active individual license in that state. Licenses must be current and in good standing.
No open FDA warning letters. The FDA publishes a database of compounding inspections, recalls, and enforcement actions. An unresolved warning letter is a hard stop: it means the agency identified conditions serious enough to document and the pharmacy has not resolved them.
No active state board disciplinary actions. State boards publish license and disciplinary records. An active action means the pharmacy's home regulator has identified a problem. This check runs against the state board's public database.
DEA registration where required. Pharmacies that handle controlled substances must hold an active DEA registration. Certain peptide stacks include scheduled compounds, and a pharmacy without DEA registration cannot legally fill those prescriptions.
Layer 2: Core quality standards
USP compliance
USP <795> applies to non-sterile preparations: capsules, creams, gels. It sets formulation requirements, beyond-use dating, and documentation standards for compounds that are not injected.
USP <797> applies to sterile preparations, meaning injectables. It requires cleanroom infrastructure, HVAC controls, environmental monitoring programs, personnel competency testing, and beyond-use dating for sterile products. Roughly 87 percent of state boards require USP <797> or treat it as the minimum standard for sterile compounding. Any pharmacy filling injectable peptide prescriptions through Stack is asked to provide evidence of USP <797> compliance as part of onboarding.
USP <800> applies to hazardous drug handling, including certain hormones and some compounds adjacent to chemotherapy. If a prescription we are routing requires USP <800> compliance, the filling pharmacy must hold it. We do not route those prescriptions to pharmacies that do not.
What USP requires of a pharmacy is broader than what we verify ourselves. Under USP <795> and USP <797>, compliant operations include master formulation records, per-batch compounding records with lot traceability, standard operating procedures for technique and cleaning, environmental monitoring where sterile compounding occurs, and staff competency documentation. Those obligations sit with the pharmacy and its state board; we do not pull and review those files during onboarding.
For core quality, we ask each pharmacy to provide evidence of USP compliance appropriate to its scope (non-sterile, sterile injectable, and hazardous drug handling where applicable). That is typically documentation or attestation supplied by the pharmacy, not an independent audit by Stack.
API sourcing
Pharmacies must represent that active pharmaceutical ingredients are sourced from FDA-registered suppliers. We may request supporting documentation when the relationship warrants it. We do not run our own analytical lab program or review a certificate of analysis for every lot.
What these standards cover
The framework describes the minimum for joining the Stack network. It does not speak to the clinical evidence for any specific compound, which varies considerably across the peptide category. Sourcing and quality standards are a prerequisite for taking the evidence question seriously. They are not a substitute for it.
Related: Research Glossary, Screening Tool