USP REGULATION GUIDELINES

The United States Pharmacopeia (USP) is a scientific nonprofit organization that sets standards for strength, quality and purity of medicines. USP standards are recognized in various provisions of the federal Food, Drug and Cosmetic Act (FDCA) and in laws, regulations and policies recommended by states.

USP General Chapters

USP General Chapters are set in place to provide minimum practice guidelines and standards for healthcare facilities overseeing compounding activities. These guidelines are to be used by practitioners to help ensure the quality of compounded procedures and preparations. Contec Healthcare provides USP cleaning and disinfection best practices and requirements to help break down each regulation and how to use them in practice.

USP Guideline <797>
Pharmaceutical Compounding

The objective of the USP <797> Guidelines is to describe conditions and minimum cleaning requirements to prevent harm, including death, to patients as a result of contaminated or inadequately made compounded sterile preparations (CSPs). USP <797> provides minimum practice and quality criteria for CSPs of drugs and nutrients, based on current scientific information and best sterile compounding compliance practices.

USP Guideline <800>
Hazardous Drugs in Healthcare

The proposed chapter of USP provides pharmacy cleanroom requirements meant “to protect personnel and the environment when handling HDs. This includes but is not limited to receipt, storage, mixing, preparing, compounding, dispensing, administering, disposing, and otherwise altering, counting, crushing, or pouring HDs, and includes both sterile and nonsterile products and preparations.”

USP Guideline <825>
Radiopharmaceuticals

Radiopharmaceuticals are a subset of radioactive materials (RAMs) under the supervision of the U.S. Nuclear Regulatory Commission (NRC) or NRC-contracted agreement state agency.

USP Chapter <825> is meant to provide uniform minimum standards for the preparation, compounding, dispensing, and repackaging of sterile and non-sterile radiopharmaceuticals for humans and animals that are part of state-licensed activities (e.g., the practice of pharmacy and practice of medicine).

Chapter <825> pertains to all practice environments where radiopharmaceuticals are prepared, compounded, dispensed, or repackaged. Practice settings include state-licensed nuclear pharmacies, federal nuclear pharmacy facilities, and other healthcare facilities, including nuclear medicine departments in hospitals and clinics, nuclear cardiology clinics (fixed site or mobile), and other specialty clinics.