Compounding Pharmacy
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 (defined as veterinary prescription volume less than 20%); 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.
You must complete a VPP Inspection before applying for Compounding Pharmacy Accreditation. Once the inspection is complete and you are deemed eligible for accreditation, you can complete your application in the Applications section of NABP e-Profile.
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 review the eligibility requirements for Compounding Pharmacy Accreditation. If you determine your business meets these requirements for accreditation, then apply for a Verified Pharmacy Program® (VPP®) inspection indicating your interest in Compounding Pharmacy Accreditation. Based on the VPP inspection report, we will confirm if you are eligible to apply for Compounding Pharmacy Accreditation.
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.
Eligibility
To apply for an NABP Compounding Pharmacy Accreditation, businesses must meet basic eligibility requirements. To avoid unnecessary delays, review the eligibility requirements listed below.
- 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 (defined as veterinary prescription volume less than 20%)
- Business location must not be a personal residence, not be licensed or registered as an outsourcing facility or nuclear pharmacy, and be in compliance with all federal and 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 chapters; Food, Drug, and Cosmetic Act Section 503A requirements; and compound patient-specific preparations pursuant to a prescription
- Must be compliant with program standards and requirements at time of application submission and through the application and accreditation period
- Must have completed our prerequisite VPP inspection within the past 6 months and received a Compounding Pharmacy Accreditation eligibility letter
- Complete and submit a Compounding Pharmacy Accreditation application, which includes an agreement to the accreditation terms and conditions and applicable payment
Accreditation 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.
Apply
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
- Log in to your business e-Profile account and apply for a VPP inspection
- Review the information needed when creating your business e-Profile
- Read the basic instructions on creating a new business e-Profile
- Use this guide to request access to additional Business e-Profile Accounts, after creating your initial e-Profile
- Complete the VPP inspection and receive an accreditation eligibility letter
- Gather appropriate supporting documents
- Log in to your business e-Profile account and apply for Compounding Pharmacy Accreditation
- Provide any requested documents to evidence compliance and/or remediation of inspection findings
For basic instructions on submitting your application, read the Application Basics document.
Interested in pricing?
Log in to your business e-Profile account and visit the Instructions and FAQs 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.