Checklist template

Compounding area for pharmacies

A ready-to-use checklist with 120 items in 6 sections, covering Area and equipment, Ingredients, Procedures, Labelling, Cleaning, Records. Use it as-is in Bindy, or adapt it to your own standards in minutes.

  • 6 Sections
  • 120 Items
  • 102 Yes / No checks
  • 6 Scored ratings
  • 132 Points

Use this template How audits work

1. Area and equipment 20 items

  1. The compounding area is a designated space set apart from the dispensing counter and from customer traffic Yes / No 1 pt
  2. The compounding bench is cleared of prescriptions, stock bottles and paperwork unrelated to the preparation in progress Yes / No 1 pt
  3. The work surface is smooth and non-porous, with no cracks or chipped laminate Yes / No 1 pt
  4. Lighting over the bench allows the balance display and a label to be read without a task lamp Yes / No 1 pt
  5. A sink with hot and cold running water is in or next to the compounding area Yes / No 1 pt
  6. Purified or distilled water is on hand for compounding and for the final rinse of equipment Yes / No 1 pt
  7. The electronic balance sits on a level, vibration-free surface away from air vents and doors Yes / No 1 pt
  8. The balance carries a calibration sticker that is still in date Yes / No 1 pt
  9. Calibration weights are kept in their closed case, together with the forceps used to handle them Yes / No 1 pt
  10. The minimum quantity that can be weighed accurately is posted at the balance Yes / No 1 pt
  11. Balance reading for the reference test weight during the visit (g) Number
  12. Date of the last external calibration of the balance Date
  13. Graduated cylinders, mortars, pestles and spatulas are free of chips, cracks and dried residue Yes / No 1 pt
  14. Separate, labeled equipment is reserved for hazardous or sensitizing drugs such as hormones Yes / No 1 pt
  15. Powders are weighed inside a powder containment hood or ventilated enclosure where company policy requires one Yes / No 1 pt
  16. The filter of the powder hood was changed within the interval set by its manufacturer Yes / No 1 pt
  17. Each powered device on site (ointment mill, capsule machine, hot plate) switches on and runs when tested Yes / No 1 pt
  18. A thermometer in the compounding area is read and logged on each day of compounding Yes / No 1 pt
  19. Room temperature in the compounding area (°F or °C) Number
  20. Condition of the compounding area and equipment Rating
    • Dedicated, orderly and fully equipped 5 pts
    • Usable with minor gaps 3 pts
    • Cluttered, or equipment missing or damaged 1 pt

2. Ingredients 19 items

  1. Bulk chemicals are bought only from suppliers on the company's approved list Yes / No 1 pt
  2. A certificate of analysis is on file for each lot of bulk active ingredient on the shelf Yes / No 1 pt
  3. Each bulk container is marked with the date it was received Yes / No 1 pt
  4. Each opened bulk container is marked with the date it was first opened Yes / No 1 pt
  5. Every bulk container shows an expiry or retest date Yes / No 1 pt
  6. None of 10 ingredient containers sampled on the compounding shelves was past its date Yes / No 1 pt
  7. Out-of-date ingredient containers found during the visit Number
  8. Ingredients transferred out of their original container are labeled with name, lot number and expiry date Yes / No 1 pt
  9. Ingredients that need refrigeration are kept in the pharmacy refrigerator, on a shelf with no food or drink Yes / No 1 pt
  10. Light-sensitive ingredients are kept in amber or opaque containers Yes / No 1 pt
  11. Flammable ingredients such as alcohol are held in the quantity and the cabinet allowed by company policy Yes / No 1 pt
  12. Hazardous drug powders are stored apart from other ingredients in a marked location Yes / No 1 pt
  13. Safety data sheets for the bulk chemicals can be opened by compounding staff at the bench Yes / No 1 pt
  14. Commercial products used as ingredients (tablets, creams, bases) are within the manufacturer's expiry date Yes / No 1 pt
  15. Ingredient containers are closed tightly, with no powder on the outside Yes / No 1 pt
  16. The lot expiring first is placed at the front and used first Yes / No 1 pt
  17. The most recent supplier recall notice on file is initialed as checked against the ingredient shelf Yes / No 1 pt
  18. Ingredients that are out of date or of doubtful quality sit in a marked quarantine bin awaiting disposal Yes / No 1 pt
  19. Control of compounding ingredients Rating
    • All dated, in date and documented 5 pts
    • Minor labeling or dating gaps 3 pts
    • Out-of-date or undocumented ingredients in use 1 pt

3. Procedures 22 items

  1. A master formulation record exists for each of 5 preparations sampled from the last 30 days Yes / No 1 pt
  2. The master formula is at the bench while the preparation is made Yes / No 1 pt
  3. Calculations are checked by a second person before any ingredient is weighed Yes / No 1 pt
  4. The pharmacist verifies the identity, lot and weighed quantity of each ingredient before it is mixed Yes / No 1 pt
  5. Only one preparation is on the bench at a time Yes / No 1 pt
  6. Hands are washed at the compounding sink before gloves are put on Yes / No 1 pt
  7. Powder-free gloves are worn throughout compounding Yes / No 1 pt
  8. A clean lab coat or gown reserved for compounding is worn Yes / No 1 pt
  9. A hair cover is worn during compounding Yes / No 1 pt
  10. A mask is worn when powders are handled Yes / No 1 pt
  11. Staff asked confirm that anyone with an open lesion on the hands or a respiratory illness does not compound Yes / No 1 pt
  12. Weighing boats and weighing papers are used once and discarded Yes / No 1 pt
  13. Quantities below the balance's minimum are prepared by dilution of a larger weighed amount, not weighed directly Yes / No 1 pt
  14. The pharmacist checks the appearance, the final weight or volume and the label of the finished preparation before release Yes / No 1 pt
  15. The beyond-use date is taken from the master formula, not estimated at the bench Yes / No 1 pt
  16. A written reason is on file when a preparation duplicates a commercially available product Yes / No 1 pt
  17. A written risk assessment is on file for each hazardous preparation made at this pharmacy Yes / No 1 pt
  18. Each compounder has a competency assessment on file within the interval set by company policy Yes / No 1 pt
  19. Date of the most recent compounding competency assessment on file Date
  20. A hazardous drug spill kit is within reach of the compounding bench Yes / No 1 pt
  21. A compounder asked could describe the steps to take after a spill of hazardous powder Yes / No 1 pt
  22. Compounding technique observed or described during the visit Rating
    • Follows the master formula with independent checks 5 pts
    • Follows the formula but checks are sometimes skipped 3 pts
    • Works from memory or without checks 1 pt

4. Labelling 19 items

  1. The label of each finished preparation names every active ingredient with its strength or concentration Yes / No 1 pt
  2. The beyond-use date is printed on the label Yes / No 1 pt
  3. The label carries the prescription number or the internal batch number Yes / No 1 pt
  4. Storage instructions such as "Refrigerate" appear on the label when the master formula calls for them Yes / No 1 pt
  5. Suspensions carry a "Shake well" auxiliary label Yes / No 1 pt
  6. Topical preparations carry a "For external use only" auxiliary label Yes / No 1 pt
  7. The label states that the product was compounded by the pharmacy Yes / No 1 pt
  8. Preparations containing a hazardous drug carry a caution label Yes / No 1 pt
  9. Labels are printed rather than handwritten Yes / No 1 pt
  10. The label is fixed to the container itself, not only to the lid or the outer bag Yes / No 1 pt
  11. The container used (amber bottle, ointment jar, oral syringe) is the one named in the master formula Yes / No 1 pt
  12. A child-resistant closure is used unless the patient's request for an easy-open cap is on file Yes / No 1 pt
  13. Batches made in advance are labeled with name, strength, batch number, date made and beyond-use date Yes / No 1 pt
  14. Stock solutions and intermediate mixtures kept for later use are labeled with contents, concentration and date made Yes / No 1 pt
  15. No unlabeled beaker, jar or syringe containing product was on the bench during the visit Yes / No 1 pt
  16. Oral liquids are handed out with an oral syringe or dosing cup marked in the units of the dose Yes / No 1 pt
  17. Finished preparations awaiting pickup that were sampled Number
  18. Sampled preparations with a label error or a missing label element Number
  19. Labels on finished preparations sampled Rating
    • Complete and matching the compounding record 5 pts
    • Minor omissions 3 pts
    • Wrong or missing key information 1 pt

5. Cleaning 21 items

  1. The work surface is cleaned and sanitized before each compounding session Yes / No 1 pt
  2. The work surface is cleaned again between two different preparations Yes / No 1 pt
  3. Equipment is washed and then rinsed with purified water after each use Yes / No 1 pt
  4. Washed equipment is air-dried or dried with lint-free wipes Yes / No 1 pt
  5. Clean equipment is stored inverted or covered in a closed cabinet Yes / No 1 pt
  6. The cleaning agents in use are the ones listed in the company procedure Yes / No 1 pt
  7. The cleaning log has an entry for each day of compounding in the last 30 days Yes / No 1 pt
  8. Date of the last entry in the compounding cleaning log Date
  9. The floor of the compounding area is mopped on the schedule in the company procedure Yes / No 1 pt
  10. The cleaning log shows the ingredient shelves wiped down at least once in the last month Yes / No 1 pt
  11. The inside of the powder hood is wiped after each use Yes / No 1 pt
  12. The balance pan and the bench around it are free of powder residue Yes / No 1 pt
  13. The waste bin in the compounding area has a lid and is not filled above the rim Yes / No 1 pt
  14. Hazardous drug waste goes into a designated, labeled container Yes / No 1 pt
  15. No food, drink or personal belongings are in the compounding area Yes / No 1 pt
  16. No cardboard shipping cartons are stored in the compounding area Yes / No 1 pt
  17. The compounding sink has liquid soap in a dispenser Yes / No 1 pt
  18. Single-use towels are stocked at the compounding sink Yes / No 1 pt
  19. Wipes and cloths used in the compounding area are not shared with the front store Yes / No 1 pt
  20. No sign of insects or rodents is visible in the compounding area or the ingredient cabinet Yes / No 1 pt
  21. Cleanliness of the compounding area at the time of the visit Rating
    • Clean, with the log complete 5 pts
    • Clean but the log has gaps 3 pts
    • Visible residue or dirt 1 pt

6. Records 19 items

  1. A compounding record is completed for every preparation, including refills Yes / No 1 pt
  2. The record lists the lot number and expiry date of each ingredient used Yes / No 1 pt
  3. The record shows the quantity actually weighed or measured for each ingredient Yes / No 1 pt
  4. The compounder is identified on the record Yes / No 1 pt
  5. The pharmacist who performed the final check is identified on the record Yes / No 1 pt
  6. The record shows the date of preparation and the beyond-use date assigned Yes / No 1 pt
  7. The record can be traced to the prescription or batch number it belongs to Yes / No 1 pt
  8. A compounding record chosen at random was retrieved within 5 minutes Yes / No 1 pt
  9. Compounding records are kept for the period required by local regulation Yes / No 1 pt
  10. Each master formulation record is signed and dated by a pharmacist Yes / No 1 pt
  11. The daily balance check with a test weight is logged for each day of compounding in the last 30 days Yes / No 1 pt
  12. Complaints and adverse reactions involving compounded preparations are recorded with the follow-up taken Yes / No 1 pt
  13. Errors caught at the final check are recorded as near misses Yes / No 1 pt
  14. Supplier invoices for bulk chemicals are filed where the lot numbers can be traced Yes / No 1 pt
  15. Compounding records reviewed during the visit Number
  16. Reviewed compounding records with a missing entry Number
  17. Name of the pharmacist responsible for compounding Short text
  18. Overall standard of non-sterile compounding Rating
    • No gap found in any section 5 pts
    • Gaps limited to records, dating or the cleaning log 3 pts
    • Gaps in technique, ingredient control or cleanliness 1 pt
  19. Corrective actions and the person responsible for each Comments

About this template

This checklist is part of the Bindy template library. Yes / No checks score 1 point when met; ratings score the points shown for each option. The overall score is the percentage of points earned, with N/A answers excluded. In Bindy you can add photos, assign corrective actions, require sign-off and compare results across sites.

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