State Board of Pharmacy Inspections: The Top 10 Violations That Get Pharmacists Fined, A Checklist to Ensure You’re Compliant

State board inspections can feel unpredictable, but they follow patterns. Inspectors look for risks to patients, sloppy records, and weak controls. Fines usually come from the same core problems. This guide covers the 10 violations that most often cost pharmacists money and time, and a practical checklist you can use to fix issues before an inspection.

How State Board Inspections Typically Work

Inspections are often unannounced. The scope ranges from a quick compliance review to a full operational audit. Inspectors focus on documentation and physical conditions that affect safety, diversion, and patient privacy. They will ask for specific records (inventories, logs, licenses) and then walk the pharmacy to verify reality matches paperwork. If you can’t produce a required document on the spot, it’s treated as missing. Knowing what they will ask for—and why—keeps you in control.

The Top 10 Violations That Get Pharmacists Fined

1. Expired, adulterated, or improperly stored drugs. Inspectors pull random bottles and check dates, seals, and storage conditions. Expired stock risks patient harm and shows poor quality control. Fix: Do weekly date-checks, quarantine anything within 90 days of expiry for fast turnover, and keep a clearly labeled “Quarantine/Do Not Dispense” bin. Record and destroy per policy.
2. Controlled substance record discrepancies. Missing, late, or inaccurate inventories; incomplete DEA 222/CSOS files; unlogged spills/thefts; or C-II counts that don’t match the safe. This signals diversion risk. Fix: Perform a blind C-II count each shift change (or per state rule) and reconcile daily. Keep biennial inventories, DEA 222s, and invoices filed and retrievable by schedule. Investigate any variance the same day and document resolution.
3. Temperature and storage logs missing or out of range. Medications must be stored within labeled ranges. Inspectors look for continuous or twice-daily logs for refrigerators and freezers, and room temperature monitoring. Fix: Use calibrated thermometers or data loggers. Typical targets: refrigerator 36–46°F (2–8°C), freezer -13–14°F (-25 to -10°C), controlled room temp 68–77°F (20–25°C) with permitted excursions. Document corrective actions for any excursion.
4. Incomplete prescription records and labeling. Missing prescriber info, directions, beyond-use dates, lot numbers for compounds, or patient counseling documentation. Poor records block traceability and patient understanding. Fix: Run weekly label audits. Ensure labels include required elements: patient name, drug name/strength, directions, quantity, prescriber, pharmacy name/address/phone, Rx number, date, pharmacist initials as required, and BUD/lot for compounds.
5. PDMP and corresponding responsibility gaps. No documented PDMP checks where required, filling outside prescriber scope, or ignoring red flags. Boards view this as failure to prevent abuse. Fix: Embed PDMP checks into workflow for opioids/benzodiazepines/stimulants per state rules. Document review, clinical notes, and prescriber clarifications.
6. Technician ratio/scope violations and lack of final check documentation. Too many technicians per pharmacist or techs performing prohibited tasks. Final verification must be by a pharmacist. Fix: Post ratio limits, maintain a duties matrix, and ensure system logs capture the pharmacist’s final check. Train float staff on your state’s tech rules.
7. Compounding noncompliance (USP <795>, <797>, <800>). Missing formulas, BUD logic, master records, cleaning logs, and certification for sterile hoods; no hazardous drug policies/PPE. Fix: Keep master formulation records and compounding logs with lot/expiry of ingredients, calculations, process, in-process checks, and BUD justification. Hood certification every 6 months for sterile compounding; surface and fingertip testing per schedule. Maintain a hazardous drug list, PPE, and spill kit.
8. Immunization and clinical service paperwork gaps. No standing orders, outdated protocols, missing vaccine temperature logs, or incomplete consent/VAERS/VIS documentation. Fix: File current protocols with medical director signatures, keep competency/CE on file, maintain vaccine inventory logs and cold chain documentation, and record manufacturer/lot/expiry, site, and VIS date for each dose.
9. Licensure lapses or untimely notifications. Expired pharmacy, pharmacist, tech, DEA, or wholesaler permits; failure to notify the board of PIC change, relocation, or hours changes on time. Fix: Use a license calendar with 90/60/30-day reminders. Keep current certificates displayed and copies in a compliance binder. Submit PIC change forms immediately upon change.
10. Security and HIPAA failures. Unsecured prescription bins, unlocked drug storage, weak alarm access controls, PHI in open trash, or screens visible to the public. Fix: Limit keys/alarm codes, auto-lock terminals, use privacy screens, shred PHI, and secure after-hours delivery areas. Document breaches and corrective actions.

Your Compliance Checklist (Use It Before Every Inspection)

• Licenses and postings
  • Current pharmacy, PIC, pharmacist, tech, and DEA registrations posted and unexpired.
  • State-required notices (counseling rights, price posting, hours) visible.
  • Timely board notifications for PIC change, address/hours changes.
• Controlled substances
  • Biennial inventory on hand and signed; separate records for C-II vs. C-III–V as required.
  • Perpetual C-II inventory maintained and reconciled at required intervals; investigate variances same day.
  • DEA 222/CSOS forms complete, matched to invoices, filed in order, and readily retrievable.
  • Reverse distributor records for destructions; theft/loss reported with documentation.
  • PDMP checks documented per state requirements; red flag notes retained.
• Prescription processing
  • Valid prescriptions include prescriber credentials, patient identifiers, drug, directions, and signatures (or valid e-signature).
  • Transfers documented with sending/receiving pharmacy info, pharmacist names, dates, and remaining refills.
  • Final verification logged by a pharmacist; DUR and counseling offered/documented.
  • Label meets state elements; auxiliary labels used when needed.
• Storage and environmental controls
  • Refrigerator/freezer/room temps logged per policy; calibrated devices used; corrective actions documented.
  • Expired/short-dated stock segregated and labeled “Do Not Dispense.”
  • Quarantine area for recalls/returns; recall notices acted on with documentation.
• Compounding
  • Master formulation records and individual compounding logs maintained, including lot numbers and BUD rationale.
  • USP <795> BUDs applied unless stability data support otherwise: nonaqueous up to 90 days; water-containing oral up to 14 days refrigerated; water-containing topical up to 30 days.
  • SOPs for cleaning, calibration, and quality checks; logs current.
  • Sterile: hood certification within 6 months, media-fill and fingertip testing current, pressure differentials logged.
  • USP <800> hazardous drug list, PPE, designated areas, spill kit, and waste procedures in place.
• Immunizations and clinical services
  • Standing orders/protocols current and signed; scope matches state law.
  • Consents, VIS provision, lot/expiry, site, and adverse event documentation completed.
  • Vaccine cold-chain logs continuous or twice daily with alarmed data logger preferred.
  • Immunizer training and CE certificates on file.
• Staff and training
  • Technician duties align with state scope; ratio compliance by shift.
  • PIC responsibilities documented: monthly audits, controlled substance reviews, policy updates.
  • Annual training: HIPAA, fraud/waste/abuse, opioid safety, hazardous drug handling if applicable.
• Privacy and security
  • Alarm monitoring active; access limited and documented.
  • PHI stored securely; shredding/bin procedures followed.
  • Computer screens shielded; auto-logoff enabled.
  • After-hours delivery protocol prevents unauthorized access.
• Record retention
  • Prescriptions and controlled substance records readily retrievable for the full state-required retention period.
  • Temperature, cleaning, and maintenance logs accessible for inspection.
  • Incident reports and corrective actions kept and reviewed by PIC.

What Inspectors Ask For First

• Licenses and DEA registration.
• Most recent controlled substance biennial inventory and current C-II counts.
• Temperature logs and calibration records.
• PIC policy manual and SOPs (compounding, immunizations, hazardous drugs).
• Random three to five prescriptions (new, transfer, controlled, and a compound) with complete documentation.

One-Week Tune-Up Before An Inspection

• Day 1–2: Full date-check of shelves and will-call. Pull anything expiring within 90 days. Verify refrigerator/freezer temps; replace batteries and recalibrate thermometers if due.
• Day 3: Controlled substance reconciliation. Blind count all C-IIs; match to perpetual and resolve discrepancies. File DEA 222s and invoices in order.
• Day 4: Label and record audit. Grab 10 recent prescriptions (including at least two controls and one compound). Check for all required elements and counseling notes.
• Day 5: Protocols and training. Confirm immunization standing orders, VIS library, and CE files are current. Review technician ratio and duties.
• Day 6: Facility walk-through. Test alarms, lock controls, privacy screens, and shred bins. Clean and organize quarantine/returns areas.
• Day 7: PIC review. Document findings, corrective actions, and any policy updates. Place everything in the compliance binder.

Common Gray Areas That Trigger Write-Ups

• Remote verification or telepharmacy: You need written policies and state authorization. Inspectors check how final verification and counseling are handled.
• Partial fills for C-IIs: Document quantities and deadlines. Incomplete or late completions look like diversion.
• Emergency kits and automated dispensing: Keep contents lists, seals, access logs, and restock documentation.
• Pseudoephedrine sales: Ensure log accuracy, ID checks, and daily/monthly limits enforced by the system, with overrides tightly controlled.

Retention Timeframes to Double-Check

States vary. Confirm your jurisdiction, but these are common expectations:

• Prescription records: 5 years or longer.
• Controlled substance records and inventories: at least 2 years federally; many states require longer.
• Temperature, cleaning, and maintenance logs: 2–3 years.
• Immunization records: often the same as prescriptions, sometimes longer for minors.
• Compounding records and equipment certifications: at least the BUD plus state minimums, commonly 2–3 years.

During the Inspection: How to Respond

• Designate one spokesperson (usually the PIC). Others keep workflow going.
• Answer questions directly and honestly. If you don’t know, say you will retrieve the document or policy.
• Fix easy issues on the spot (e.g., move expired item to quarantine) and note the corrective action.
• Request clarification if a citation is unclear and take notes for your response plan.

Bottom Line

Most fines come from predictable, preventable gaps: expired stock, weak controlled-substance controls, poor documentation, and missing logs. Treat the checklist above as a weekly habit, not a last-minute scramble. When your records match what’s on the shelf and your team can explain the “why” behind each step, inspections go faster and end better.

G S Sachin

I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.

Mail- Sachin@pharmacyfreak.com