On November 1, 2023, long-awaited revisions to the United States Pharmacopeia (USP) Chapters <795>: Pharmaceutical Compounding – Nonsterile Preparations and <797>: Pharmaceutical Compounding – Sterile Preparations became official. Chapters <795> and <797> present the standards for preparing compounded medications. The revisions to <795> and <797> reflect advancements in medical science that help ensure patients can access high-quality, safely prepared compounded medicines. Adhering to our mission to protect the public health, we have also adapted to these USP updates, including making necessary changes to our Compounding Pharmacy Accreditation standards.
Understanding the Updated USP Chapters
Every year, millions of medications are compounded in the US to treat patients with unique medical needs. Compounding is crucial for patients who cannot use commercially available drugs due to specific dosing requirements, allergies, or rare conditions. All compounded medications must adhere to strict safety standards to protect public health. USP <797> covers the preparation of sterile medications, which are given via injection or infusion, and USP <795> covers the preparations of nonsterile medicines, which are mostly taken orally or applied topically. The pharmacy (or physician) compounding these preparations needs to follow these updated standards, or compounded medications may be improperly prepared or contaminated, posing serious risks to patients, including adverse events or even death.
Implemented changes to USP Chapters will make a huge difference in protecting patient safety. For example, both USP Chapters <795> and <797> include requirements for training and personnel, garbing and hand hygiene, cleaning frequency, and storage. Key changes to Chapter <797> include facility and ventilation requirements, creation of a master formulation record, and quality control updates specific to injectable and IV compounded preparations. USP Chapter <800> went into effect in November 2023; it provides guidance on handling hazardous drugs and must also be referenced and followed for hazardous drug compounding.
How NABP Has Adapted
As USP has no role in enforcing these standards, it is the job of the state boards of pharmacy to regulate compounding pharmacies and ensure their practices are up to date. We have provided resources for the boards of pharmacy to implement the USP Chapter changes in their jurisdictions, and we will continue to adapt to make sure their needs are met.
We have reviewed our recent updates to the Model Pharmacy Act/Rules, which provides the boards of pharmacy with model language that may be used when developing state laws or board rules, reflecting the USP changes. We have also updated our inspection form in alignment with the standards of the updated USP Chapters. We also held a webinar to help pharmacists understand the revisions, which is now available as an on demand, home study CPE activity.
Compounding Pharmacy Accreditation
Along with our inspection programs, NABP’s Compounding Pharmacy Accreditation has changed to meet the requirements of the USP Chapter updates. Achieving Compounding Pharmacy Accreditation demonstrates your pharmacy’s alignment to current USP <795>, <797>, and <800> standards and compliance with Section 503A of the Federal Food, Drug, and Cosmetic Act. Becoming accredited signifies that your pharmacy maintains high-quality standards and dedication to overall patient safety.
To apply for our Compounding Pharmacy Accreditation, your pharmacy must meet and maintain all our eligibility requirements, including completing a prerequisite Verified Pharmacy Program (VPP) inspection within 6 months of your application date. The VPP inspection confirms several operational requirements are met, including compounding is compliant with current USP standards and Section 503A of the Federal Food, Drug, and Cosmetic Act.
Curious on how you can better position your business to serve patients and ensure you comply with all USP Chapter updates? Complete the contact form to learn more about the program and download the Compounding Accreditation standards overview to view all the program requirements.