Understanding the ‘Designated Person’ in USP Compliance

By Dustin Herring, PharmD, Pharmacy Surveyor 

Dustin Herring is an ACHC Pharmacy Surveyor with a strong professional focus on pharmaceutical compounding and sterile manufacturing. He has worked in both cGMP and 503B outsourcing facility environments and is well-versed in maintaining compliance with FDA and state board regulations in addition to ACHC and PCAB Accreditation Standards.

Posted: May 11, 2026

Failing to formally name a “designated person” (DP) is one of the most frequently cited deficiencies for compounding pharmacies. As of November 1, 2023, USP General Chapter <800> became enforceable, along with updated revisions to USP General Chapters <795> and <797>. A common theme among these three chapters is the requirement to designate a person or persons responsible for maintaining operational quality.

This requirement isn’t just for traditional compounding pharmacies. It applies to any facility engaged in sterile or non-sterile compounding, or in handling hazardous drugs.

What is a designated person?

A designated person is the individual formally assigned responsibility and accountability for the performance and operation of the facility and its personnel, as it relates to the preparation of compounded sterile products (CSPs), compounded non-sterile products (CNSPs), and/or hazardous drug handling.

Before the new requirement to name a designated person, most pharmacies had a “go-to person” that everyone relied on for answers about compounding, compliance, procedures, and standards. Now, USP requires that this role be clearly identified and documented.

This expectation is reinforced in ACHC Pharmacy Accreditation Standards DRX4-2M and DRX7-8Z.01 and corresponding PCAB (Compounding Pharmacy) Accreditation Standards TCRX1-D and TCRX7-A.

Who should be the designated person?

Although many facilities appoint a pharmacist as the DP, the role is not limited to a pharmacist.

The best candidate:

  • Is the most knowledgeable about USP requirements and compounding.
  • Understands the pharmacy’s workflows and compliance obligations.
  • Can provide strong leadership with clear expectations.
  • Knows and has experience in quality assurance and quality control programs and activities.
  • Exhibits strong oral and written communication skills.
  • Has computer skills that include proficiency in using databases to compile and analyze information to prepare reports.
  • Offers strong organizational skills for maintaining accurate records.
  • Knows all applicable state and federal pharmacy laws, rules, and regulations.

Can the DP delegate responsibilities?

Yes. Not only can the DP delegate responsibility, but it is preferred, given the large number of responsibilities that fall to the role.A great way to assign DP responsibilities is to create a checklist that clearly documents who is assigned to complete each task. Without a checklist, responsibilities will likely fall through the cracks and lead to deficiencies during your next accreditation survey or Board of Pharmacy inspection.

Why is a designated person required?

USP’s intent is clear: Compliance must have ownership.

The DP ensures:

  • Ongoing adherence to USP standards.
  • Proper training and competence of personnel.
  • Development and revision of Master Formulation Records.
  • Selection of an appropriate and reliable source for components, active ingredients (API), equipment, and supplies to be used in compounding.
  • Environmental monitoring and quality assurance oversight.
  • Implementation and review of policies and procedures.
  • Corrective actions when deficiencies are identified.

Without a clearly assigned DP, accountability becomes unclear — and that creates compliance risk.

What are the DP’s responsibilities?

There is no single consolidated list within the USP chapters. Instead, responsibilities are woven throughout USP <795>, <797>, and <800>, each with similar expectations and important nuances. ACHC and PCAB Standards provide essential details and are wonderful resources for understanding the responsibilities of the designated person.

Key considerations:

  • Responsibilities vary slightly by USP chapter for sterile, non-sterile, and hazardous drug preparations.
  • Even if a responsibility does not apply to your pharmacy, it is best practice to document that it was reviewed and determined to not be applicable.
  • Responsibilities should reflect not only chapter requirements but also the unique needs of your facility.

Bottom line

The designated person requirement formalizes what many pharmacies were already doing, but now that role must be documented, structured, and defensible.

This year, if your pharmacy compounds or handles hazardous drugs, ask yourself:

  • Is our designated person(s) formally named?
  • Are their responsibilities clearly outlined?
  • Is delegation documented?
  • Could we defend our structure during a survey or inspection today?

If you are unsure, it may be time to take a closer look.

Need help?

ACHCU, the education division of ACHC, offers training in 2026 for Hazardous Drug Designated Person (HDDP) Certification and other educational resources to help pharmacies understand and fulfill DP requirements.

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