Demonstrate your pharmacy’s compliance to United States Pharmacopeia (USP) standards <795>, <797>, and <800> for complex, high-risk compounding with our Compounding Pharmacy Accreditation. NABP’s Compounding Pharmacy Accreditation is a three-year accreditation best suited for compounding pharmacies that provide an advanced level of patient care services and dedication to reducing the risks associated with compounding practices and medication safety.
Compounding Pharmacy Accreditation is ideal for any US licensed pharmacy that is actively compounding as part of the pharmacy’s business and:
- follows Federal Food, Drug, and Cosmetic Act (FD&C Act) section 503A requirements;
- follows USP requirements;
- compounds patient-specific preparations pursuant to prescriptions;
- is primarily for human patients; and
- has successfully completed our prerequisite Verified Pharmacy Program (VPP) inspection and been deemed eligible to apply for Compounding Pharmacy Accreditation.
Whether NABP accreditation is new for your business or you are already NABP accredited and are looking to expand your portfolio, our processes simplify your journey toward Compounding Pharmacy Accreditation.
Apply for Compounding Pharmacy Accreditation as a stand-alone program or maximize your investment by creating a comprehensive compliance package for one streamlined, cost-effective accreditation process.
How do I get started?
The first step is to apply for a VPP inspection and indicate your interest in Compounding Pharmacy Accreditation. Based on the VPP inspection report, we will notify you if you are eligible to apply for Compounding Pharmacy Accreditation.
After you respond to the eligibility letter and address any corrective actions, the first step in the process is to confirm that the program meets your pharmacy’s needs and that your pharmacy is able to demonstrate compliance with the eligibility requirements, standards, and on-site survey. Once you deem you are ready for accreditation, you will need to apply. Once your application, supplemental documentation, and specified fees have been received, we will:
Review your supporting documentation
Verify pharmacy & pharmacist licensure
Review the pharmacy’s remediation to any deficiencies from the on-site survey of your pharmacy
Looking for additional help to get started?
Consider preparing for the accreditation process by attending a complimentary training from NABP Solutions on pharmacy or drug supply chain compliance. NABP Solutions is a subsidiary company of NABP that was created to provide consulting services to pharmacies and the drug supply chain that focus on regulatory compliance.
Interested in learning more?
Practices that demonstrate compliance and high-quality patient care can earn this voluntary accreditation and better position their business to patients. Complete the accreditation form to request more information.
To apply for an NABP accreditation, businesses must meet basic eligibility requirements. To avoid unnecessary delays, review the Compounding Pharmacy Accreditation eligibility requirements below to determine if you are qualified to apply.
- Must be a licensed pharmacy operating in the United States, with current and active licenses in good standing, in all jurisdictions in which it is conducting business (unless licensure is not required by law) and serving predominately human patients
- Business location must not be a personal residence, and must be operational in all its activities for at least 30 days and compliance with all state regulations, laws, and rules applicable to the business
- Business must have a licensed pharmacist (ie, responsible person/pharmacist-in-charge) in full and actual charge of the pharmacy operations and personnel.
- Must be in compliance with all applicable USP sections and FDA 503A requirements and compound patient-specific preparations pursuant to a prescription
- Has successfully completed our prerequisite Verified Pharmacy Program® (VPP®) inspection
NABP advises applicants to not complete the application if their business location had an application cancelled by NABP in the past 180 days for non-compliance with Standards.
The Compounding Pharmacy Accreditation Standards Overview provides a brief introduction to the set of standards a pharmacy must meet to achieve accreditation. Download the Compounding Pharmacy Accreditation Standards Overview document.
Get started on your path to accreditation by following the steps below:
- Confirm your eligibility
- Review the Standards Summary to confirm that the program meets your business’s needs
- Create and complete a business e-Profile account:
- Gather appropriate supporting documents
- Submit the application for one or multiple accreditations
Interested in pricing?
Log in to your business e-Profile account and visit the FAQs and Resources section to access pricing. Don’t have an account? Create your free business e-Profile account today.
This accreditation program is part of the Compounding Pharmacy Information-Sharing Project developed in partnership with FDA, NABP, and the boards of pharmacy. Learn more.