A regulatory board complaint may be filed against a pharmacist by a patient, colleague, employer, prescriber, and/or a regulatory agency, such as the State Department of Health. Complaints are subsequently investigated by the State Board of Pharmacy (the Board) to ensure that licensed pharmacists are practicing safely, professionally, and ethically. Board of Pharmacy investigations may lead to outcomes ranging from no action against the pharmacist to revocation of the pharmacist’s license to practice.
This case study involves a licensed pharmacist who had been practicing for 10 years and worked as the pharmacist-in-charge (PIC) at a compounding pharmacy. At the time of the incident, she had been working in this capacity for six months.
Summary
The compounding pharmacy had been preparing injections of a natural product extract with antioxidant and anti-inflammatory effects for about one year. (There were no FDA-approved injection products marketed with the active ingredient.) One of the facilities receiving the compounded sterile emulsion was a naturopathic clinic. The clinic notified the pharmacy that a patient to whom the injection had been administered had experienced an anaphylactic reaction and passed away. Five days later, the insured PIC reported the incident to the State Board of Pharmacy, who initiated an investigation into the pharmacy. (The pharmacy’s policy was to report adverse effects associated with or potentially attributable to a sterile drug product to the Board within 12 hours of discovery, in compliance with state law.)
The PIC explained to the State Board investigators that she would compound the injection with polyethylene glycol castor oil (PEG). During their inspection, the investigators identified significant concerns regarding the PEG used in the preparation, including labeling indicating it was intended for manufacturing and laboratory use only, the presence of detectable diethylene glycol (DEG) contamination, and warnings regarding potential hypersensitivity reactions.
The investigators requested a list of all clinics, providers, and patients to whom the compounded injection had been dispensed. The PIC provided these records, but the investigators found that the patient records were incomplete. Although the compounded product should have been dosed based on patient weight, there was no record of the patients’ weight and no indication that weight had been considered before dispensing. The records also did not include information on patient allergies.
The investigators contacted the clinics receiving the compounded injections for further information. They learned that a patient of a second naturopathic clinic also had experienced an anaphylactic reaction and passed away after receiving the compounded injection. This incident had occurred about two months prior to the initial reported patient death. When questioned by the investigators about the second patient death, the PIC stated that she had not been notified of that incident.
The investigators retained bottles of the PEG and sent them for chemical analysis. The analysis found the PEG to contain approximately 0.2% DEG, and the Board subsequently issued a request to the pharmacy to recall all the injections compounded with the laboratory grade PEG. The PIC issued the recall accordingly.
Outcome
The Board found multiple causes for discipline against the pharmacy and PIC, including offering and compounding adulterated drug products, offering and compounding misbranded medications, dispensing prescriptions with significant errors, failure to complete non-sterile to sterile end product testing, failure to maintain sufficient records, and subverting a Board investigation by providing incomplete records. The PIC’s license was revoked, and the cost to defend the case was $25,000.
Risk Management Recommendations
Recommendations for Pharmacists and Pharmacists-in-Charge (PICs)
Strengthen patient assessment and clinical screening
- Obtain and document clinically relevant patient information before dispensing compounded sterile preparations, including allergy history, patient-specific dosing information, route of administration, and other factors necessary for safe use.
- Communicate with prescribers whenever patient-specific information is incomplete, inconsistent, or raises safety concerns.
- Consider whether the anticipated benefits of a compounded preparation are supported by available evidence, particularly for unusual routes of administration or non-traditional therapies.
Verify formulation appropriateness before dispensing
- Evaluate both the quality of ingredients and the scientific rationale supporting the compounded preparation itself.
- Confirm that all labeling, patient instructions, storage requirements, warnings, and directions for use are complete and clinically appropriate.
- Ensure that patients and prescribers receive relevant information regarding administration risks, monitoring requirements, and potential adverse effects.
Provide active PIC oversight of compliance and quality systems
- Regularly review supplier qualification activities, compounding records, environmental monitoring results, and quality assurance reports.
- Verify that personnel training, competency assessments, and corrective actions are completed and documented.
- Monitor compliance with applicable state regulations, USP standards, and federal compounding requirements.
- Foster a culture in which staff promptly report quality concerns, process deviations, and potential patient safety issues.
Respond decisively to patient safety signals
- Treat serious adverse events, unexpected reactions, and product quality concerns as potential indicators of a broader systems issue until proven otherwise.
- Participate in timely investigations, risk assessments, and corrective actions.
- When patient safety is uncertain, prioritize patient protection, product quarantine, and rapid communication rather than waiting for definitive proof of causation.
Recommendations for Pharmacy Owners
Establish a robust ingredient qualification and product review program
- Verify that all active and inactive ingredients are appropriate for the intended route of administration, particularly for sterile injectable products.
- Obtain ingredients from qualified suppliers and maintain appropriate documentation, including certificates of analysis and supplier qualification records.
- Confirm that ingredients meet applicable USP standards or other recognized quality specifications when available.
- Establish a clinical and regulatory review process for sterile injections and other high-risk formulations, such as specialty treatments and products lacking a well-established safety profile.
Maintain comprehensive sterile compounding quality systems
- Implement quality systems consistent with USP <797>, applicable state compounding regulations, and pharmacy-specific policies and procedures.
- Validate aseptic processes and maintain ongoing competency assessments for personnel involved in sterile compounding.
- Conduct environmental monitoring, equipment certification, cleaning verification, and other sterility assurance activities as required by applicable standards and regulations.
- Maintain complete compounding logs, batch records, quality review documentation, and traceability records for all compounded preparations.
Support beyond-use dates with objective scientific evidence
- Establish beyond-use dates based on stability data, sterility considerations, and applicable USP and state requirements.
- Ensure that assigned beyond-use dates are supported by appropriate studies, testing, or other scientifically defensible evidence.
- Periodically review compounded formulations and supporting data to verify continued appropriateness of assigned dating.
Implement a formal adverse event and recall management process
- Develop written procedures for adverse event investigations, product quarantines, recalls, and regulatory notifications.
- Establish clear escalation pathways for serious adverse events, product quality complaints, and potential patient safety concerns.
- Promptly assess whether production should be suspended and affected lots quarantined pending investigation.
- Maintain systems for timely reporting to state regulators and FDA MedWatch when required.
Key Takeaway
An important lesson from this matter is that patient harm often emerges not from a single error, but from multiple decisions and system weaknesses occurring simultaneously: questionable ingredient selection, inadequate clinical screening, insufficient quality controls, delayed response to safety signals, and ineffective oversight. A comprehensive risk management program addressing each of these areas provides the strongest protection for patients, pharmacists, and compounding pharmacies.
Resources
- Example state requirements for sterile compounding
- FDA Compounding and Reporting Resources.
- USP Chapters.
Disclaimer
The information, examples and suggestions presented in this material have been developed from sources believed to be reliable as of the date they are cited, but they should not be construed as legal or other professional advice. CNA, Aon, Affinity Insurance Services, Inc., NSO, or HPSO accepts no responsibility for the accuracy or completeness of this material and recommends the consultation with competent legal counsel and/or other professional advisors before applying this material in any particular factual situations. This material is for illustrative purposes and is not intended to constitute a contract. Please remember that only the relevant insurance policy can provide the actual terms, coverages, amounts, conditions and exclusions for an insured. All products and services may not be available in all states and may be subject to change without notice. Certain coverages may be provided by a surplus lines insurer. Surplus lines insurers do not generally participate in state guaranty funds, and insureds are therefore not protected by such funds. The claims examples are hypothetical situations based on actual matters. Settlement amounts are approximations. Certain facts and identifying characteristics were changed to protect confidentiality and privacy. Any references to non-CNA, non-Aon, AIS, NSO, and HPSO websites are provided solely for convenience, and CNA, Aon, AIS, NSO and HPSO disclaim any responsibility with respect to such websites. “CNA” is a registered trademark of CNA Financial Corporation. Certain CNA Financial Corporation subsidiaries use the “CNA” trademark in connection with insurance underwriting and claims activities. This material is not for further distribution without the express consent of CNA. Copyright © 2026 CNA. All rights reserved.
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