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28 Pharmaceutical Technology ® Quality and Regulatory Sourcebook March eBook 2023 PharmTech.com Manufacturing The US Pharmacopeia (USP) updated its chapters on drug compounding in November 2022. To gain some per- spective on these changes, Pharmaceutical Technology® spoke with Brian Serumaga, PhD, senior manager–person- alized medicine at USP to see how these changes impact drug compounders. PharmTech: How do standards for drug compounding differ from standards for traditional pharmaceuticals? Serumaga (USP): Under Section 503A of the Federal Food, Drug, and Cosmetic Act, many federal requirements otherwise applicable to medicines do not apply if a compounder making individualized preparations by prescription follows certain requirements. These requirements include compounding in compliance with the USP chapters on pharmacy compounding and using bulk drug substances and ingredients that comply with an applicable USP monograph (standard), if one exists. The compounding must be done by a licensed pharmacist in a state-licensed facility or by a licensed physician for an identified individual patient based on the unsolicited receipt of a valid prescription. Additionally, the facility cannot compound inordinate amounts or copies of commercially available drugs. Compounded drugs that do not meet the conditions of section 503A are subject to all the requirements of the Federal Food, Drug, and Cosmetic Act applicable to conventional drug manufacturers, such as drug approval and compliance with federal current good manufacturing practices. PharmTech: Are USP standards enforceable rules or guidelines to follow? Serumaga (USP): Standards in the United States Pharmacopeia and National Formulary (USP–NF ) for compounded preparations may be enforced by both the states (as pharmacy practice/compounding is traditionally regulated by state boards of pharmacy), and FDA (as compounded preparations remain subject to the adulteration and misbranding provisions of the Federal Food, Drug, and Cosmetic Act, which require conformance to certain USP–NF standards). USP has no role in enforcement of these or other provisions that recognize USP–NF standards. PharmTech: How many chapters does USP have that address drug compounding? Serumaga (USP): There are currently seven essential compounding General Chapters, which are contained in the USP-NF and published in the USP Compounding Compendium: • <795> Pharmaceutical Compounding–Nonsterile Preparation (revised version published Nov. 1, 2022) • <797> Pharmaceutical Compounding–Sterile Preparations (revised version published Nov. 1, 2022) • <800> Hazardous Drugs–Handling in Healthcare Settings • <825> Radiopharmaceuticals–Preparation, Compounding, Dispensing, and Repackaging • <1160> Pharmaceutical Calculations in Pharmacy Practice • <1163> Quality Assurance in Pharmaceutical Compounding • <1176> Prescription Balances and Volumetric Apparatus Used in Compounding. PharmTech: Which USP standards should drug compounders be aware of? Serumaga (USP): USP recently revised General Chapters <795> and <797>–quality standards related to compounding that help to advance the quality of compounded medicines and support patient safety and access. General Chapter <795> provides standards for compounding quality nonsterile medicines and describes requirements for processes, facilities, equipment, components, documentation, quality controls, and training. This chapter also provides general parameters for determining beyond-use dates for nonsterile preparations. General Chapter <797> provides standards for compounding quality sterile preparations and describes several requirements, including responsibilities of compounding personnel, training, facilities, environmental monitoring and control, and storing and testing of finished preparations. These standards help to prevent harm that could be caused by microbial contamination, excessive bac terial endotoxins, variability in the intended strength of correct ingredients, unintended chemical and physical contaminants, or ingredients of inappropriate quality. In addition to USP's standards, compounders should refer to their relevant regulator(s) and/or oversight organization (e.g., The Joint Commission) to determine their legal/regulatory responsibilities. PharmTech: What do USP standards address that regulator guidelines do not? Serumaga (USP): USP, state agencies (e.g., State Boards of Pharmacy), and regulators such as FDA all have unique roles related to compounded preparations. For pharmacies operating under section 503A of the Federal Food, Drug, and Cosmetic Act, FDA collaborates with state authorities to address pharmacy activities that may violate the Act, particularly on actions to address compounders whose products present an immediate public health threat. FDA also invites states to accompany the Agency on inspections of compounders, and the states often take action for violations of state law that they identify during those inspections. A majority of state boards of pharmacy adopt and require compliance with USP General Chapters <795> and <797> or incorporate the standards of the chapters into their statutes, regulations or policies. PharmTech: What standards are new or updated in the revised compounding USP chapters that were recently published? Serumaga (USP): Through a process of robust stakeholder input, USP has revised General Chapters <795> and <797> Contin. on page 29 USP Standards in Drug Compounding