Community & hospital pharmacy

Pharmacy SOPs: the procedures an inspector asks to see

A pharmacy SOP is a written procedure for one task that, done wrong, harms a patient or loses the licence: dispensing, handling controlled substances, keeping vaccines cold, pulling expired stock, compounding. A community pharmacy needs 30 to 50 of them; a hospital pharmacy several hundred. The five below are the ones a board inspector, a DEA auditor or a UK GPhC inspector will ask for by name.

Download the pharmacy SOP pack (Word)

Which SOPs a pharmacy operation needs

The full set, with when each one is used, what it leaves behind as a record, and the rule it answers to. The ones a pharmacy gets asked about first are written out in full below.

Procedure	When	Record	Basis
Dispensing and final check	Every prescription	Dispensing record; checker's initials	State board rules; GPhC standards (UK)
Controlled substances: receipt, storage, counts	Every receipt; perpetual count for Schedule II	CII perpetual inventory; biennial inventory	21 CFR 1304.11, 1301.75; Misuse of Drugs Regs 2001 (UK)
Cold-chain monitoring	Twice daily minimum	Temperature log; data logger	CDC Vaccine Storage and Handling Toolkit; manufacturer's SPC
Expiry date checks	Monthly, by section	Expiry check log	Board rules; USP <795>/<797> for compounded BUDs
Non-sterile compounding	Every compounded preparation	Compounding record; MFR	USP <795> (2023 revision)
Hazardous drug handling	Every hazardous drug	Training record; spill log	USP <800>; NIOSH list
Recalls and withdrawals	Every notice	Recall log	FDA; MHRA (UK)
Counselling and new-prescription DUR	Every new prescription	Pharmacist's note	OBRA '90; state rules
Returns and waste	Every return	Waste log; CS destruction record	DEA 21 CFR 1317; EPA; state rules
Dispensing errors and near misses	Every event	Error log; root cause	Board rules; PSO reporting

The procedures, written out

These are general procedures. Your equipment, your products, your site rules and your local law come first — change the names, the limits and the forms to match, then have the right person approve each one before it is used.

Dispensing and final check

Area

Dispensary

Done by

Technician fills; pharmacist checks and releases

Purpose. Hand the patient the drug the prescriber meant, at the dose and quantity ordered, with the right label and the right advice — checked by someone other than the person who filled it.

Scope. Every outpatient and community prescription, paper and electronic. Compounded preparations and controlled substances have additional steps in their SOPs.

Safety.

• A pharmacist checks every prescription before release. A technician never releases their own fill. If the pharmacist is away from the dispensary, the basket waits.

Step	Action	Key point / warning
1	Receive the prescription. Confirm the patient: full name, date of birth, and a second identifier (address or phone). Check it is a valid prescription: prescriber, date, signature or e-signature, no alteration.	Two patients with the same name are in every pharmacy's system. The date of birth is not optional.
2	Enter or verify the order in the system. Read the drug, strength, form, dose, directions, quantity and refills from the prescription, not from the previous fill.	"Same as last time" is how a dose change is missed.
3	Pharmacist: drug utilisation review. Check interactions, duplications, allergy flags, dose against age and renal function where known, and whether the directions make sense for the drug.	Resolve every hard-stop alert with a note. Clicking through alerts is a documented cause of fatal errors.
4	Technician: pull the stock bottle. Scan its barcode against the order. Count or measure. Compare the stock bottle NDC, strength and form to the label before you fill the vial.	Scan the bottle you are pouring from, not the one on the shelf next to it.
5	Label the vial. Attach the auxiliary labels the system prints. Put the stock bottle in the basket with the filled vial and the prescription.
6	Pharmacist final check: prescription against label against stock bottle against vial contents. Open the vial and look at the tablets. Initial the record.	Four things, in the hand, every time. The stock bottle in the basket is what makes the check possible; fill from a bottle and put it back and the checker is checking a label against a label.
7	At the counter: confirm the patient again by name and date of birth, and address. Offer counselling for every new prescription and any change; the pharmacist counsels, not the technician.	Pick-up by someone else: name and relationship recorded, and ID where the law requires it.
8	Record the dispensing: date, pharmacist, technician, lot and expiry where required.

Record. Dispensing record with the checking pharmacist's identifier; DUR override notes; counselling record or documented refusal.
Basis. State board of pharmacy rules; OBRA '90 counselling requirement; GPhC Standards for Registered Pharmacies (UK); ISMP guidance on independent double checks.

Controlled substances: receipt, storage and counts

Area

Dispensary; CS safe

Done by

Pharmacist in charge; designated staff for receipt

Purpose. Account for every dose of a controlled substance from the moment it arrives until it is dispensed or destroyed, so that a diversion is found in days, not at the biennial count.

Scope. All Schedule II–V drugs (US) and Schedule 2–3 controlled drugs (UK). Schedule II/CD2 have the stricter steps marked.

Safety.

• Controlled substances are never left on the bench. The safe is locked when not being accessed. Access is limited to named staff, and the list is reviewed when anyone leaves.

Step	Action	Key point / warning
1	Receipt: check the delivery against the invoice and, for Schedule II, against the DEA Form 222 or CSOS order. Count every container. Two people sign the receipt for Schedule II.	Discrepancy: do not accept and shelve. Record it and notify the supplier and the pharmacist in charge the same day.
2	Record the receipt in the controlled-substance register (perpetual inventory for Schedule II; UK CD register for all Schedule 2 drugs): date, supplier, drug, strength, quantity, running balance, initials.	Entries are in ink, in order, with no gaps, no erasures. A mistake is ruled through and initialled, not covered.
3	Store Schedule II in the locked safe or steel cabinet (21 CFR 1301.75). Schedule III–V may be dispersed among stock to deter theft, if the board allows.	UK: all Schedule 2 and some Schedule 3 drugs in the CD cabinet to the Misuse of Drugs (Safe Custody) Regulations.
4	Dispensing: record each Schedule II dispensing in the register with the prescription number and the new running balance. Count the remaining stock of that item and check it matches the balance.
5	Periodic count: count the full Schedule II stock at the interval set by the pharmacist in charge (many pharmacies: weekly; UK: at least monthly per RPS guidance, many weekly). Reconcile to the register. Investigate any difference the same day.	A count that is 'close' is a count that is wrong. Zero difference or an investigation.
6	Biennial inventory (US): a complete physical count of all controlled substances at least every two years, on the same day for all schedules, recorded and kept 2 years (21 CFR 1304.11). Many states require annual.
7	Loss or theft: report to the DEA on Form 106 (or to the police and NHS England/MHRA in the UK) as the regulation requires, and to the board. Record the investigation.

Record. CS register / perpetual inventory; receipt records with Form 222 copies kept 2 years; count records; biennial inventory; DEA 106 reports.
Basis. 21 CFR 1304.11 (inventory), 1301.75 (storage), 1305 (Form 222); DEA Pharmacist's Manual; UK Misuse of Drugs Regulations 2001 and RPS guidance on controlled drug registers.

Cold-chain monitoring and temperature excursions

Area

Vaccine and refrigerated-drug storage

Done by

Designated vaccine coordinator; all staff who open the fridge

Purpose. Keep refrigerated vaccines and medicines between 2°C and 8°C (36°F and 46°F) at all times, know when they were not, and never give a patient a dose that may have lost potency.

Scope. Every pharmacy refrigerator and freezer holding vaccines or temperature-sensitive medicines. Not domestic fridges, which should not be used for vaccines.

Safety.

• Never store food, drink or specimens in a vaccine fridge. Never store vaccines in the door or on the floor of the fridge.

Step	Action	Key point / warning
1	Use a digital data logger with a buffered probe (glycol vial) and an alarm, with a current certificate of calibration. The fridge's own dial is not the record.	CDC: temperature monitoring device accurate to ±0.5°C, calibration tested every 1 to 2 years.
2	Read and record the current, minimum and maximum temperature at the start and end of each day on the log. Reset the min/max after recording.	Min and max are the record. A current reading of 5°C says nothing about last night.
3	Keep the fridge between 2°C and 8°C (36°F to 46°F), aiming for 5°C (41°F). Keep water bottles in the door and the floor to buffer temperature swings. Do not overfill.
4	Any reading outside 2–8°C, or an alarm: label the stock "DO NOT USE — EXCURSION" and move it to a working fridge or a cooler with the logger. Do not discard it.	Discarded stock cannot be assessed. Quarantine it.
5	Record the excursion: date, time first noted, duration (from the logger download), min and max reached, which products, what was done. Call each manufacturer (or the state immunisation programme for public vaccines) with the data to decide whether each product is usable.	Some vaccines tolerate hours above 8°C; others are lost at the first freeze. Only the manufacturer can say which.
6	Usable stock goes back into service with a note on the lot. Non-usable stock is wasted and recorded. Find the cause: door, power, loading, failing compressor.
7	Download the logger weekly and file the trace. Review the log at the monthly check.

Record. Twice-daily temperature log with min/max; logger downloads kept 3 years (CDC); excursion reports with the manufacturer's decision; calibration certificates.
Basis. CDC Vaccine Storage and Handling Toolkit (2023); manufacturers' summaries of product characteristics; Public Health England/UKHSA Protocol for ordering, storing and handling vaccines (UK).

Expiry date checks

Area

All stock locations

Done by

Technician by section; pharmacist signs the monthly log

Purpose. Make sure nothing past its expiry date — or too close to it to complete a course — is on the shelf to be dispensed.

Scope. All stock: dispensary shelves, over-the-counter, fridge, controlled-substance safe, compounding chemicals, emergency and first-aid stock.

Safety.

• Expired controlled substances stay in the safe, segregated and marked, until destroyed by the approved method. They are not binned.

Step	Action	Key point / warning
1	Divide the pharmacy into sections and assign each section a week of the month. Every section is checked monthly.
2	Check every pack in the section. Pull anything that expires within the short-date window: 3 months is usual for dispensary stock, longer for slow movers, and at least the length of the course for items dispensed as whole packs.	"Expires end of this month" on the 28th is already expired for a 30-day supply.
3	Mark short-dated stock with a coloured sticker and move it to the front of the shelf. Add it to the short-date list for the pharmacist to decide: use first, return to wholesaler, or waste.
4	Expired stock: segregate in the returns bin at once, out of the dispensing area. Controlled substances to the CS returns section of the safe with a register entry.
5	Compounded preparations and opened multi-dose containers: check the beyond-use date written on the label, not the manufacturer's expiry.	An opened insulin vial, an eye drop, a reconstituted antibiotic each have a BUD that is shorter than the printed expiry.
6	Record the check on the expiry log: section, date, who, items pulled. Pharmacist reviews and signs monthly.

Record. Monthly expiry check log; returns and waste records; CS destruction records.
Basis. State board rules on expired stock; USP <795> and <797> for beyond-use dates; manufacturer labelling for in-use periods.

Non-sterile compounding

Area

Compounding area

Done by

Trained technician compounds; pharmacist verifies each step marked and the final preparation

Purpose. Make a non-sterile preparation that contains what the label says, at the strength it says, with a beyond-use date that is justified, and a record that would let someone make it again.

Scope. Simple and moderate non-sterile compounding under USP <795> (2023): oral liquids, creams, ointments, capsules, suppositories. Sterile preparations are under <797> and hazardous drugs add <800>.

Safety.

• Hazardous drugs (NIOSH list) are compounded only with the engineering controls and PPE in USP <800>. If the drug is on the list and the pharmacy has no containment hood, it does not compound it.
• Weigh powders in a powder-containment hood or with a dust mask at minimum. Clean the balance and the area before and after.

Step	Action	Key point / warning
1	Check there is a master formulation record (MFR) for the preparation: ingredients, quantities, equipment, method, BUD and its justification, quality checks. No MFR: the pharmacist writes and approves one first.
2	Start the compounding record: date, preparation, prescription, who compounded, who verified. Record each ingredient's source, lot and expiry as you use it.
3	Calculate the quantities. Pharmacist verifies the calculations and initials them before any ingredient is weighed.	Most compounding errors are calculation errors. The check happens before, not after.
4	Weigh and measure. Use a balance checked that day with the check weights, and glassware of the right size (fill to at least 20% of the capacity). Pharmacist verifies each weighing where the MFR requires it.
5	Compound by the MFR method, in the order written. Note any deviation on the record.
6	Assign the beyond-use date from the MFR within USP <795> limits: non-aqueous 90 days; aqueous with a preservative 35 days; aqueous without a preservative 14 days refrigerated; solid oral 180 days — unless stability data supports longer or a component's expiry is shorter.	The BUD is the shorter of the <795> limit and the earliest ingredient expiry.
7	Pharmacist final check: appearance, weight or volume against the expected yield, label against the MFR and the prescription, BUD, storage instructions. Sign the record.
8	Label: name, strength, quantity, BUD, storage, "compounded preparation", and the auxiliary labels. Dispense with counselling.

Record. Master formulation record per preparation; compounding record per batch kept 3 years (or as the board requires); balance check log; cleaning log; training and competency records.
Basis. USP General Chapter <795> Pharmaceutical Compounding — Nonsterile Preparations (2023); USP <800> for hazardous drugs; state board compounding rules.

Where pharmacy SOPs go wrong

The stock bottle goes back on the shelf before the check

The final check only works if the pharmacist can see the bottle that was poured from. A fill where the bottle is returned to the shelf makes the check a label-to-label comparison, which is exactly what the scan already did. Bottle in the basket, every time.

Alerts are clicked through

A pharmacist who sees 200 interaction alerts a day stops reading them. That is a system problem — tune the alert severity — and a procedure problem: the SOP should require a note for every hard stop, and the notes get reviewed. Both together bring the rate down.

The CII count is 'about right'

A count off by two tablets, written as reconciled, is a diversion investigation that was closed before it started. The register balance is the balance. Any difference is investigated today, recorded, and reported if it is not resolved.

The vaccine fridge has a thermometer and a tick

A current reading twice a day misses the overnight compressor failure every time. Min/max from a buffered logger, written down and reset, is the minimum; an alarm that calls someone is the standard. And a 'short' excursion with the stock thrown away cannot be assessed — quarantine it.

Beyond-use dates are copied from the ingredient expiry

A cream made today from a drug that expires in 2028 does not expire in 2028. The <795> default is 90 days for non-aqueous and 14 or 35 for aqueous, and shorter if any component is shorter. Put the rule in the MFR so it is not re-decided at the bench.

Getting the pharmacy team to follow them

Pharmacy procedures are long because they have to be. The version at the bench does not: the four-point final check on a card by the checking station, the 2–8°C rule and the excursion steps on the fridge door, the receipt steps inside the CS safe. Technicians rotate and locums arrive at 9 am on a Saturday; a two-minute video of the final check and the fridge procedure, in the languages your team speaks, is what gets them to the standard before the first prescription. The chemical labels talk covers the SDS and labelling rules for compounding chemicals.

Questions

Which pharmacy SOPs are legally required?

In the US, state boards require written procedures for controlled substances, compounding (USP <795>/<797>/<800> are enforceable in most states), and in many states for dispensing, error reporting and technician supervision. DEA regulations require the inventory and record-keeping procedures above. In the UK, the GPhC's Standards for Registered Pharmacies require SOPs for all pharmacy services, and the Responsible Pharmacist Regulations 2008 require them to be in place and reviewed.

How often should pharmacy SOPs be reviewed?

At least every two years, and whenever the law, the premises, the equipment or the service changes. Many pharmacies align the review to the responsible pharmacist's annual audit. Record who reviewed, when, and that staff were retrained on any change.

What temperature range is the cold chain?

2°C to 8°C (36°F to 46°F) for refrigerated vaccines and most refrigerated medicines, with 5°C as the target. Frozen vaccines have their own ranges (for example −50°C to −15°C for varicella-containing vaccines). Any time outside the range is an excursion to be assessed, not ignored because it was brief.

Can a technician do the final check?

In most US states, no — a pharmacist verifies each prescription before release, though some states allow technician product verification (tech-check-tech) in defined settings. In the UK an accuracy checking technician (ACT) can do the accuracy check, but the clinical check remains the pharmacist's. Write the SOP to your jurisdiction and name the roles.

Sources

• DEA Pharmacist's Manual
• CDC Vaccine Storage and Handling Toolkit
• USP General Chapter <795> (2023)
• GPhC Standards for Registered Pharmacies (UK)