The goal of an inspection is to safeguard the health and safety of consumers. This is also an important educational opportunity for inspectors to provide guidance and answer your questions about pharmacy laws and regulations.
What You Can Expect
An inspector will:
- Identify himself/herself with a board-issued badge and provide a business card.
- Be professional and courteous.
- Provide a receipt for any records taken into possession.
- Review and leave a copy of the inspection report with the pharmacist on duty and/or pharmacist-in-charge.
- Provide information and answer questions about pharmacy laws and regulations.
What is Expected of You
Pharmacy staff will:
- Provide access to the inspector during regular business hours.
- Provide access to review all stocks of dangerous drugs or devices.
- Provide access to review all records of manufacture, sale, acquisition, receipt, shipment and disposition.
- Allow the inspector to secure samples or specimens.
Documents for Inspection
Pharmacies are required to have certain documents readily available for inspectors to review. Hard and electronic copies of records must be available during business hours.
Documents to have available include:
- Past inspection reports.
- Pharmacy self-assessments.
- Copies of staff licenses.
- Master list of pharmacist and technician initials.
- DEA 222 forms.
- Drug take-back records.
- Wholesaler invoices.
- Records of drug returns.
- Off-site records waiver.
- Pedigrees for drugs purchased.
- Controlled substances refill reports.
The inspector also will check:
- DEA registration.
- Drug expiration dates.
- Drug take-back receptacles.
- Confidential waste disposal.
- Patient consultation.
- Posted pharmacy license and renewal.
- Prescription labeling.
- Prescription records.
- Quarantine area for expired and recalled drugs.
- Security features.
- Transmission of CURES data.
After the Inspection
If the inspector orders a correction, you will be instructed on how to submit a plan or proof of correction to the board within a specified period. Keep all documentation related to completing the correction order with the inspection report.
If the inspector suspects a violation of pharmacy law has occurred, you may receive a written notice. Depending on the type of violation, the board may:
- Issue a letter of admonishment.
- Issue a citation (with or without a fine).
- Refer the case for disciplinary action against the pharmacy and/or individual licensee(s).
Letters of admonishment and citations are not considered to be discipline or disciplinary actions. You may contest a letter
of admonishment or citation by requesting an informal office conference. In the case of a citation, you also may request a formal hearing before an administrative law judge. You will receive a letter from the board about the administrative action process, and you must reply by the specified due date.
Information taken from CA State Board of Pharmacy. Refer to this brochure for more information.