In short
- Compounded prescriptions for Crimson Health members are prepared by state-licensed 503A compounding pharmacies.
- Pharmacy partners control, test, and document each step, from ingredient sourcing to delivery.
- Compounded medications are not FDA-approved. The FDA does not review them for safety, effectiveness or quality before they are dispensed.
Compounded prescriptions for Crimson Health members are prepared by state-licensed 503A compounding pharmacies that make patient-specific preparations under USP <795>, <797>, and <800>. Our pharmacy partners control, test, and document each step, from ingredient sourcing to delivery. This page summarizes those standards.
Important: Compounded medications are not FDA-approved. The FDA does not review them for safety, effectiveness or quality before they are dispensed. Compounded preparations are dispensed only for individual patients with a valid prescription from a licensed prescriber. This article is for informational purposes. It is not medical advice and makes no claims about the safety or effectiveness of any therapy.
Sterile compounding environment and controls
- ISO-classified cleanrooms. Sterile preparations are made in ISO-classified buffer and ante areas inside certified primary engineering controls, with strict cleaning, sanitation, and cross-contamination controls.
- Environmental monitoring. Our pharmacy partners routinely monitor viable air and surface contamination and nonviable particle counts, and investigate any excursion.
- Personnel qualification. Compounding staff must pass gloved fingertip testing and media-fill (aseptic process simulation) testing before they compound sterile preparations, and are requalified on a set schedule.
- Certification. Hoods and cleanrooms are certified by qualified certifiers at the intervals USP <797> requires.
Release testing and lot traceability
- Independent release testing. Independent analytical labs routinely test active ingredients and finished compounds for sterility, bacterial endotoxins, potency, and identity.
- Lot traceability. Each preparation can be traced from its ingredient lots and certificates of analysis (COAs), through its compounding and testing records, to dispensing.
Ingredient sourcing
- FDA-registered sources with COAs. Bulk ingredients come from FDA-registered establishments and arrive with valid COAs.
- Vetting beyond registration. Each supplier is qualified on its FDA inspection history, its cGMP compliance, and inspections by other health authorities. FDA registration alone is not treated as enough.
- Consistency. Our pharmacy partners use vetted suppliers, validate the product, and keep it consistent.
Standards our pharmacy partners follow
- USP <797>, <795>, <800>: sterile compounding, non-sterile compounding, and hazardous-drug handling.
- State licensure: licensed by the state boards of pharmacy where they operate and dispense.
- Section 503A of the FD&C Act: compounding for individual patients based on a valid prescription, using bulk drug substances that meet 503A requirements and come from FDA-registered establishments with valid COAs.
Quality management system
- SOPs, training, and competency. Written SOPs govern compounding, testing and dispensing. Staff receive continuous training and regular competency assessments in aseptic technique.
- Deviations and CAPA. Deviations are documented, investigated for root cause, and closed out with corrective and preventive actions (CAPA).
- Change control. Changes to formulations, suppliers, equipment, or procedures are assessed and approved before they are implemented.
- Complaints and recall readiness. Complaints are logged and investigated, and documented recall procedures are in place.
- Internal quality audits. An internal quality-assurance program regularly reviews procedures and records.
Stability studies
An initial potency test tells only part of the story, because a low-quality ingredient can pass at first and then degrade faster. Partner stability programs test how each formulation holds up over time:
- Stability-indicating methods. HPLC methods track potency and separate out degradation products and impurities.
- Multiple time points. Samples are stored under the labeled storage conditions and tested at several intervals through the proposed beyond-use date (BUD).
- Full quality profile. Each time point is tested for potency, purity and degradants, sterility, endotoxins, container-closure integrity, pH, appearance, and particulates.
- Data-driven BUDs. Extended BUDs are assigned only when study data support them, as USP <797> and <795> allow.
Shipping validation
Packaging and cold chain are qualified so that product arrives within its labeled storage conditions:
- Simulated real-world transit. Packaging is qualified against seasonal hot and cold temperature profiles and realistic transit times.
- Temperature data loggers. Loggers record what the product experiences during validation runs.
- Defined excursion limits. Each pack-out has acceptance criteria and a procedure for handling shipments that fall outside them.