The first wave of site visits done by the National Association of Boards of Pharmacy (NABP) after the group updated its Verified Pharmacy Program (VPP) inspection forms to better align with revised USP General Chapter <797> and <795> standards are in.
Betty Jones, RPh, the compliance senior manager of NABP’s accreditation and inspection programs, presented the aggregated findings at the NHIA 2025 Annual Meeting, in National Harbor, Maryland. Her message was both encouraging and cautionary.
“The numbers overall look pretty good,” Ms. Jones said. “But the details tell a different story, one that shows us where pharmacies need targeted education and process improvement.”
Designated Person Documentation
One of the simplest improvements is commonly overlooked: formally naming a designated person responsible for compounding compliance. According to NABP data, 89% of inspected pharmacies documented the presence of a designated person. This role is a newer requirement in the most recent revision of USP Chapter <797>, which may explain why more than 10% of surveyed facilities have been slow to incorporate it into their standard operating procedures (SOPs). “This is an easy one to fix. Make sure the role is explicitly designated and documented,” Ms. Jones said.
Patricia Kienle, RPh, the director of accreditation and medication safety at Cardinal Health, noted in a separate interview with Pharmacy Practice News that while most facilities have a designated person, they may not be documenting it in policy or retrievable records. “That’s not only an issue with NABP inspections,” she said. “It’s also coming up on accreditation surveys and state board inspections. Simply making sure it appears in policies, meeting minutes, or another accessible format can quickly close this gap.”
Facility design presented bigger challenges. Compliance across segregated compounding areas (SCAs) was just 75%. Cleanroom suites scored 78% overall, largely due to cracks, divots, or unsealed surfaces that made cleaning impossible. Even in higher-scoring areas, inspectors found troubling workarounds, such as a pharmacy that installed an HVAC unit directly inside an ISO 8 space to address airflow issues. In another example, Ms. Jones cited the aforementioned “train wreck” of a cleanroom compromised by multiple safety violations.
Certification reports for primary and secondary engineering controls were another weak spot, with only 77% at full compliance. The primary issue was not typically equipment failure but instead inconsistent reporting. Some certification vendors left out key elements such as dynamic conditions or personnel counts, leaving designated persons without enough information to confirm state of control. “If it isn’t documented, regulators will assume it wasn’t done,” Ms. Jones said.
Ms. Kienle added that pharmacies should be proactive about certification. “Too often, staff just let the certifiers walk in alone. The designated person should accompany them,” she said. “It’s an excellent opportunity to understand what’s being assessed, make sure the right elements are included in the report, and request corrections if information is missing.”
Record-keeping continues to trip up pharmacies. Master formulation records and compounding records scored 79% and 86% compliance, respectively. “These are the kinds of findings that will land you in trouble with state inspectors,” Ms. Jones warned. “If your records are incomplete or missing required elements, you can expect citations.”
For a more in-depth look at the NABP's first wave of inspections, see an expanded version of this article in the November print issue.
The sources reported no relevant financial disclosures.