USP 795 and USP 800 Explained: The Standards That Protect Compounding Patients

The short answer: USP <795> is the national standard governing how non-sterile compounds, creams, capsules, solutions, must be prepared, from ingredient sourcing to the beyond-use date on your label. USP <800> adds strict handling rules for hazardous drugs such as hormones. Together they are the quality floor every legitimate compounding pharmacy stands on, and California enforces them through Board of Pharmacy inspections.

KeyPoints

• USP 795 covers non-sterile compounding: ingredients, facilities, training, documentation, dating
• USP 800 covers hazardous drug safety: ventilation, protective equipment, dedicated areas
• Beyond-use dates (BUDs) are science-based limits on how long your compound stays reliable
• California incorporates these standards into enforceable pharmacy regulation
• Sterile injectables fall under a different, stricter chapter, USP 797

EndKeyPoints

What does USP 795 actually require?

• Ingredient integrity: USP/NF-grade ingredients from FDA-registered suppliers, each with a certificate of analysis verifying identity and purity.
• Designated compounding space: clean, organized, and separated from dispensing traffic, with calibrated equipment.
• Trained personnel: documented initial and ongoing competency for everyone who compounds.
• Master formulation and compounding records: every preparation traceable. What went in, who made it, when, and how.
• Beyond-use dating: conservative, evidence-based limits on shelf life by formulation type.

How do beyond-use dates work?

These defaults can extend only when stability studies support it. If a pharmacy hands you a water-based cream labeled good for a year with no stability data behind it, that's a standards problem. And a reason we label conservatively.

Why does USP 800 matter for hormone therapy?

Many commonly compounded drugs appear on the NIOSH hazardous drug list, among them estradiol, progesterone, testosterone and finasteride. That is not because they are dangerous to the patient using them as prescribed. It is because chronic occupational exposure poses risks to pharmacy staff, and incidental exposure poses risks to others. USP <800> mandates dedicated storage and compounding areas, engineering controls like ventilated enclosures, protective equipment, and decontamination routines. When your BHRT cream is made in a USP 800-compliant facility, cross-contamination into someone else's prescription isn't a possibility you have to think about.

What should you ask your pharmacy?

• "Do you compound under current USP 795 and 800?"
• "Where do your ingredients come from, and do you keep certificates of analysis?"
• "How do you determine the beyond-use date on my prescription?"
• "When was your last Board of Pharmacy inspection?"

Confident, specific answers are the mark of a pharmacy that treats standards as identity rather than obligation. Evasive ones tell you to keep looking.

The bottom line

Standards are invisible when they work. Your cream simply works, your capsules are simply consistent. Learn more about how compounding pharmacies work, browse our formulation catalog, or call 424-228-1049 to ask our pharmacists anything about how your medication is made.