Compounding Pharmacy

Demonstrate your pharmacy’s alignment to United States Pharmacopeia (USP) standards <795>, <797>, and <800> for high-quality compounding with our Compounding Pharmacy Accreditation.

NABP’s Compounding Pharmacy Accreditation is a 3-year accreditation for compounding pharmacies that provide dedication to reducing the risks associated with compounding practices and medication safety.

Compounding Pharmacy Accreditation is available for any US licensed pharmacy that is actively compounding as part of the pharmacy’s business.

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.

On December 18, 2024, NABP is adjusting the pricing for certain accreditation and inspection programs. To apply under current pricing, your application and payment must be submitted on or before 6 PM CST on December 18, 2024. Log in to your business e-Profile account to access pricing.

NABP’s Compounding Pharmacy Accreditation demonstrates your alignment with applicable USP sections and FDA’s 503A requirements.

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A pharmacy performing nonsterile compounding must comply with the current USP <795> chapter.

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A pharmacy performing sterile compounding must comply with the current USP <797> chapter.

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A pharmacy performing hazardous drug compounding must comply with applicable sections of USP chapter <800>.

Compounding Pharmacy Eligibility

To apply for an NABP accreditation, businesses must meet and maintain basic eligibility requirements. Review the eligibility requirements listed below to determine if you are qualified to apply.

  • You are a licensed pharmacy operating in the United States, with current and active licenses in good standing, in all jurisdictions where you conduct business (unless licensure is not required by law).
  • You predominately serve human patients (defined as veterinary prescription volume less than 20%).
  • Your business location cannot not be a personal residence, cannot be licensed or registered as an outsourcing facility or a nuclear pharmacy.
  • You are in compliance with all federal and state regulations, laws, and rules applicable to the business.
  • You have a licensed pharmacist (ie, responsible person/pharmacist-in-charge) in full and actual charge of the pharmacy operations, personnel, and compliance with federal and state regulations, laws, and rules regarding the practice of pharmacy.
  • You are in compliance with all applicable USP chapters; Food, Drug, and Cosmetic Act Section 503A requirements; and compound patient-specific preparations pursuant to a prescription.
    • A pharmacy performing nonsterile compounding must comply with the current USP chapter 795.
    • A pharmacy performing sterile compounding must comply with the current USP chapter 797.
    • A pharmacy performing hazardous drug compounding must comply with applicable sections of USP chapter <800>.
  • You are compliant with program standards and requirements at time of application submission and through the application and accreditation period.
  • You have completed our prerequisite VPP inspection within the past 6 months.
  • If a new applicant not yet accredited, have received a Compounding Pharmacy Accreditation eligibility letter.

Accreditation Standards Overview

The Compounding Pharmacy Accreditation Standards Overview provides a brief introduction to the set of standards a pharmacy must meet to achieve accreditation.