Excellence exemplified
Compounding Pharmacy Accreditation
Confirming quality in nonsterile and sterile compounding.
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Welcome
PCAB Accreditation to the rescue
The United States Pharmacopeia (USP) sets standards to drive medication quality through consistent ingredients, manufacture, and labeling. In the U.S., pharmacies are regulated by the FDA at the federal level and by individual Boards of Pharmacy at the state level. This often results in a patchwork of expectations for requirements the timing of compliance.
PCAB Accreditation provides compounders with the resources to guide them through complex and sometimes competing regulations. Perhaps best of all, ACHC’s program staff shares deep expertise and experience with PCAB customers to solve practical implementation challenges.
In short, ACHC’s PCAB brand is the internationally-recognized benchmark for excellence in compounding practice.
Do you need a nonresident inspection?
If you are shipping compounded medications across state lines, the receiving state’s BOP may require a specific license that is dependent on a nonresident inspection. This is not the same as accreditation, but ACHC is approved in some states to perform this service. Learn more.
The ACHC approach: Surrounding you with education
ACHC surrounds you with accessible, responsive resources to fit your needs.
ACHC Clinical Staff provides resources for standards interpretation and problem solving.
Our Regulatory Team conducts research and shares knowledge about federal and state requirements.
PCAB Accreditation Services
Services
ACHC Standards—the requirements you must meet to achieve PCAB Accreditation—are designed to be relevant to your compounding focus. ACHC will work in partnership with you to build a customized accreditation solution based on your needs. View available services below.
Non-Sterile Pharmacy Compounding is a process by which ingredients are combined, mixed, or altered to create pharmaceutical preparations. These preparations are designed to be administered by a route that does not require sterility as result of a practitioner’s prescription. Compounding includes the preparation of drugs in anticipation of receiving prescriptions based on routine, regularly observed prescribing patterns. PCAB Non-Sterile Pharmacy Compounding Accreditation references USP <795> and measures a specific set of process standards that concentrate on the quality and consistency of compounded preparations.
Revised PCAB CFNS Standards that include USP updates to Chapter <795> took effect June 1, 2024. Organizations must now meet new USP requirements. Accreditation options offered before that date have ended.
Compounding pharmacies that handle hazardous drugs must add Hazardous Drug Handling PCAB (HDPCAB) Accreditation as a service. HDPCAB Accreditation Standards incorporate safety requirements of USP Chapter <800>. (Options offered before June 1, 2024, have ended.) The PCAB Distinction in Hazardous Drug Handling (HDH) has been retired and is no longer available.
Sterile Pharmacy Compounding is the practice of creating sterile preparations for patients through strict procedures to prevent contamination and maintain patient safety. PCAB Sterile Pharmacy Compounding Accreditation references USP <797> and measures a specific set of process standards that concentrate on the quality and consistency of medications that are produced.
Revised PCAB CFST Standards that include USP updates to Chapter <797> took effect June 1, 2024. Organizations must now meet new USP requirements. Accreditation options offered before that date have ended.
Compounding pharmacies that handle hazardous drugs must add Hazardous Drug Handling PCAB (HDPCAB) Accreditation as a service. HDPCAB Accreditation Standards incorporate safety requirements of USP Chapter <800>. (Options offered before June 1, 2024, have ended.) The PCAB Distinction in Hazardous Drug Handling (HDH) has been retired and is no longer available.
Hazardous Drug Handling PCAB (HDPCAB) standards incorporate patient, employee, and environmental protection requirements established by USP General Chapter <800>, which became enforceable November 1, 2023. It is not a stand-alone service and is available for compounding pharmacies seeking or renewing PCAB Accreditation for Non-Sterile (CFNS) Pharmacy Compounding or Sterile (CFST) Pharmacy Compounding.
ACHC Pharmacy Accreditation offers nine additional services and four specialty distinctions. Click here for more information.
Ready to get started?
As soon as USP updates are released, ACHC digs in, revising standards and resources to keep you ahead of the curve and simplify the work of maintaining compliance.
A brochure and a self-assessment tool are free resources available from ACHC’s educational division—ACHCU—to help compounders ensure readiness for PCAB surveys and visits from the State Board of Pharmacy.
Get more insight into ACHC standards and resources by subscribing to our Did You Know? newsletter.
Reach out to our team with questions any time, or visit our FAQs for more info.
Supporting Accreditation Success
ACHC surrounds you with essential resources to empower your team and advance improvements. Our popular Surveyor Quality Review delivers valuable insights on top deficiencies and must-have tips for compliance.
Sign up now to receive a FREE copy of the latest Surveyor Quality Review.
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Regulatory Updates
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It’s who you know
Associations that partner with ACHC and advocate for excellence in compounding practice
External Resources
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National Resources
Alliance for Pharmacy Compounding (APC)
American Association of Colleges of Pharmacy (AACP)