Pharmacy Compounding Compliance Survey

Title Page

Pharmacy Name
Conducted on
Prepared by
Location
Primary Contact

Regulatory Requirements

The organisation has the appropriate licenses/permits for all states that they service
Licenses/permits posted in public view
There are no restrictions on proprietors of the pharmacy which restrict compounding activities on the pharmacy.
Provide details of restrictions
Do compounding pharmacists have appropriate professional indemnity insurance in place?
All current state and Commonwealth legislation relating to pharmaceutical compounding are available to compounding staff and accessible from the compounding laboratory
Select current references, guidelines, standards and resources relevant to a pharmacy's area of pharmaceutical compounding which are available to compounding staff and accessible from the compounding laboratory
- Therapeutic Goods Act 1989 Cth
- Therapeutic Goods Regulation 1990
- Pharmacy Board of Australia Guidelines on compounding of medicines
- Australian Formulary & Handbook 25th Ed.
- The Standard for the Uniform Scheduling of Medicines and Poisons
- Relevant State Pharmacy Guidelines including those specific to compounding
- Pharmaceutical Society of Australia Professional Practice Standards
- United States Pharmacopeia General Chapter <795> Non-sterile compounding
- United States Pharmacopeia General Chapter <797> Sterile Compounding
- United States Pharmacopeia General Chapter <800> Hazardous Compounding
A register of safety data sheets (SDS) for hazardous materials are accessible in the area which they are being prepared.

Premises

All pharmaceutical compounding activities take place within a pharmacy premises which is suitably designed and equipped
All pharmaceutical compounding activities take place within a designated area within a pharmacy premise, away from routine dispensing activities and high traffic areas. Must be separated by walls and lockable door.
Non-sterile complex compounding activities take place in the pharmacy in a secure, sanitary and dedicated area (a compounding laboratory), separated from other parts of the pharmacy premises by floor to ceiling walls with at least one door to enable entry and exit. If located in the retail area (i.e. easily accessible by the public), doors are lockable to prevent unauthorised or public access.
Areas where pharmaceutical compounding activities take place are free from food or drinks at all times
The compounding laboratory
has an impervious floor e.g. continuous laminate (floor covering with covered edges continuing up the wall for at least 15 centimetres to minimise the harbouring of dirt etc. and permit effective cleaning),
Provide photo of non-compliance
is an area of at least 9 square metres to permit the orderly layout and segregation of materials and equipment as well as sufficient space to undertake compounding activities,
Provide photo of non-compliance
has clearly identifiable and labelled dedicated area(s) which can be used to isolate raw materials and compounded preparations not to be used or released (e.g. unchecked orders, product recalls, expired stock),
Provide photo of non-compliance
has easy to clean surfaces (walls, bench tops, shelves) made from an impervious material,
Provide photo of non-compliance
is adequately lit and ventilated,
Provide photo of non-compliance
has facilities to maintain and monitor an ambient temperature of 25 degrees Celsius or less,
Provide photo of non-compliance
has a dedicated stainless steel sink or similarly impervious sink positioned to avoid contamination and is supplied with hot and cold running water
Provide photo of non-compliance
has at least one bench (excluding the powder containment cabinet) of at least 2 metres in length and 90 centimetres in width to provide sufficient working space for the compounding activities.
Written policies are established and implemented for compounded non-sterile preparations that outline the use, maintenance and cleaning of compounding facilities that result in an environment that is appropriate to the scope of compounding performed by the pharmacy.
The compounding laboratory is cleaned and sanitized per the written policies and procedures
Cleaning and sanitization is documented per written policies and procedures
Attach a copy of most recent month cleaning log
The pharmacy maintains a pest control program as necessary

Equipment

All equipment is dedicated to pharmaceutical compounding activities, protected from contamination and potential damage during storage, and cleaned before and after use.
The pharmacy premises has equipment required under the Health Practitioner Regulation (New South Wales) Regulation 2016 relevant to pharmaceutical compounding including:
Dispensing balance
heavy duty scales, capable of weighing up to 1kg and a set of metric weights compatible for use with those scales - - or an electronic scale capable of weighing up to 1kg in increments of no more than 50mg
200mL dispensing measure
100mL dispensing measure
10mL dispensing measure
5mL dispensing measure
Funnel
2 mortar & pestles (atleast 1 of the mortars and pestles being made of glass)
stirring rod
2 spatulas
ointment slab
Equipment used in non-sterile complex compounding activities are in good working order and dedicated to pharmaceutical compounding. This equipment includes:
appropriate powder containment cabinet with high efficiency particulate air (HEPA) filtration and a continuous pressure monitoring device to be used to confine all activities likely to release powders (e.g. recirculating fume cabinet or double HEPA filter where appropriate).
Attach a copy of the most recent certificate of compliance
appropriate electronic balances that are externally validated and calibrated at intervals no greater than 12 months and that enable quantities to be accurately measured with a sensitivity of +/- 2%
Attach a copy of the most recent external validation/calibration record
Appropriate heating source
appropriate Fridge and freezer (where required) to store compounded preparations and raw materials in accordance with the manufacturer's recommended conditions
Can this be operated in the event of a power failure?
What do you do in the case of a power outage to maintain the integrity of temperature sensitive materials?
The pharmacy maintains temperature logs for fridges and freezers (where required)
Are there mechanisms to alert pharmacy staff in the case that temperatures are out of specification?
a safe and/or secure fridge (if required) to store drugs of addition (S8 raw materials or compounded preparations) in accordance with state poisons regulations.
Equipment and packaging appropriate to the dosage forms of preparations and quantities to be compounded (e.g. Electronic mortar and pestle, ointment mill, capsule machine, pH meter)
The pharmacy maintains a maintenance log relating to equipment (e.g. servicing of air-conditioning filters, powder containment cabinets, pest inspections)

Patient Communication & Complaints Handling

Patient Counselling

Written policies and procedures are established and implemented that address the counselling of patients and/or caregivers prior to deciding to compound. This includes but is not limited to collecting the patient's; • Age & sex • Medical history • Allergies • Current medications (prescription & non-prescription) • Other co-mordbidities or conditions (e.g. pregnant or breastfeeding)
A registered pharmacist reviews the patient medications and medical history as it pertains to the compounded medication and consults with other healthcare professionals (i.e. prescriber) as required.
Written policies & procedures are established and implemented that address the information which will be provided to patients and methods of delivery for counselling after the compounded medication is dispensed. This includes but is not limited to; • an explanation of why a compounded product is being supplied, and how this differs from a commercially available one which requires the manufacturer to meet the requirements of the TGA • instructions on the correct use of the product • the appropriate storage requirements and expiry date • side effect profile • contraindications • any other specific counselling points which would normally be obtained in a written CMI • how to report adverse events
Every patient or their agent is offered counselling and relevant written information by the pharmacist on each occasion a compounded preparation is supplied. Pharmacists address any queries or concerns raised about the patient’s compounded medicine

Complaints Handling

Policies and procedures address how client/patient grievances, complaints and concerns are investigated and resolved

Adverse events, incidents & non-conformances

Written policies and procedures describe the process for identifying, reporting, monitoring, investigating, and documenting all adverse events, incidents, accidents, variances, or unusual occurrences.
Policies & procedures include, but are not limited to:
Action to notify the supervisor
Time frame for verbal and written notification
Appropriate documentation and routing of information
Guidelines for notifying the prescriber, if applicable
Follow-up reporting to the administration/board/owner
Identification of the person responsible for collecting incident data and monitoring trends, investigating all incidents, taking necessary follow-up actions and completing appropriate documentation.
The pharmacy investigates all adverse events, incidents, accidents, variances, or unusual occurrences that involve patient services and develops a plan of correction to prevent the same or a similar event from occurring again. Events include, but are not limited to: • Unexpected death • A serious injury • Significant adverse drug reaction • Significant medication error • Other undesirable outcomes as defined by the pharmacy • Patient injury
The pharmacy documents all incidents, accidents, variances, and unusual occurrences as follows
There is a standardized form developed by the organization used to report incidents
The investigation is initiated within 24 hours after an organization becomes aware of an incident resulting in a patient's hospitalization or death
For other occurrences, the pharmacy investigates within 72 hours after being made aware of the incident, accident, variances or unusual occurrences

Advertising

Advertising of compounded preparations only occurs for compounded preparations containing unscheduled medicines, Schedule 2 medicines and Schedule 3 medicines included in Appendix H of the Poisons Standard, provided that: - evidence of efficacy is included in the advertisement - pre-approval from the Secretary of the Department of Health has been granted if advertisements are placed in certain types of media including (but not limited to) billboards, newspaper, magazines and television.
Pharmacy website, where applicable, does not advertise or list prescription only medicines with pricing.

Staff Training

Written policies and procedures define the minimum education and training, licensure, certification, experience, and the minimum competencies required for each service offered, as well as the method for documenting that personnel have received the required training (e.g., certificates and diplomas)
Personnel receive training & competency assessment intially, at time of hire and before performing compounding
Personnel receive training & competency assessment annually, to improve skills
Personnel receive training & competency assessment on an ongoing basis, for improvement of skills, when new processes or equipment are introduced
All pharmacy services are provided under the direction of a Registered Pharmacist with sufficient education and experience in the scope of services offered.
The pharmacy keeps a copy of each pharmacist's current AHPRA registration in personnel files.
Pharmacy maintains a staff training & competency register which is reviewed annually for currency
Pharmacy maintains a register of signatures of all compounding staff, their position title and job description (signed by staff member and manager)
Pharmacy conducts baseline and regular health monitoring (e.g. pathology tests where required) of compounding staff
Written policies and procedure are established and implemented in regard to personnel who work with hazardous drugs receiving training and demonstrating competency in their storage, handling and disposal.
Personnel receive training & competency assessment g in the identification, storage, handling, and disposal of these drugs
Personnel confirm in writing that they understand that they understand the risk of handling hazardous drugs

Risk Management

Risk Assessments

Risk assessments address decision to compound in accordance with guidelines
Risk assessments address patient related risks
Risk assessments address premises related risks
Risk assessments address product related risks
Risk assessments address personnel related risks
Risk assessment is completed and signed off by a competent compounding pharmacist

Workplace Risk Assessments

Pharmacy has completed a general workplace risk assessment to identify hazards within the compounding laboratory
Is there documented evidence of this?
Attach copy of hazard register
Is there a written hazard communication for the pharmacy?
Is there a hazardous drugs register?

Raw Materials

Procurement & suppliers

10.1 Raw materials are procured from acceptable manufacturers: - Australian manufacturers have an appropriate Therapeutic Goods Administration (TGA) licence to manufacture for the raw material that is being procured, - overseas manufacturers have certification relevant to the manufacturer of raw materials, (e.g. a certificate of Good Manufacturing Practice (GMP) compliance or equivalent accreditation from a regulatory or accrediting authority equivalent to the TGA). Independent inquiries are made when raw materials are procured via a supplier or third-party to determine whether the original manufacturer engaged by the supplier or third party is acceptable.
10.2 A genuine Certificate of Analysis is provided with raw materials
10.3 Independent testing of each batch of raw material is conducted to confirm identity, purity and conformity against pharmacopoeial standards (e.g. BP, USP or PhEur) if the quality of the raw material or the acceptability of the manufacturer is in doubt.

Quality of Raw materials

The pharmacy has established a criteria for the acceptable quality of raw materials.
All raw materials (ingredients) used are of the highest pharmaceutical grade and comply with the requirements of pharmacopoeial standards (e.g. British Pharmacopoeia (BP), European Pharmacopoeia (PhEur), United States Pharmacopeia and National Formulary (USP) or other relevant standards if applicable).
Evidence is obtained for ingredients not approved for human use to demonstrate compliance with the requirements of pharmacopoeial standards and show they are safe for human use before using it in a compounded product for human use.
Water used in non-sterile preparations is Purified Water BP that has been freshly boiled and cooled or Water for Irrigation BP

Storage of Raw materials

Raw materials (ingredients) are stored in accordance with the manufacturer’s recommended conditions or requirements specified in the relevant Safety Data Sheet, and labelled with an expiry date and batch number
Raw materials and compounded preparations are stored in accordance with the current Poisons Standard (Standard for the Uniform Scheduling of Medicines and Poisons) (Cth) and state poisons legislation including storage of Schedule 8 medicines.
Raw materials use in compounding activities are stored in the compounding laboratory.
Raw materials that are hazardous materials: • are labelled clearly with elements of the Globally Harmonised System of Classification and Labelling of chemicals (GHS) which includes hazard statement and pictograms, and • are stored in a separate dedicated area in the compounding laboratory, separate from other material and equipment to minimise risk of contamination and compounding staff exposure e.g. on a dedicated shelf in the compounding laboratory.
Temperature of storage areas, fridges and freezers are monitored & recorded
There is a clearly labelled and separated area for the quarantine of raw materials and compounded preparations which are not in use.

Shipping

The organization uses delivery containers that assure pharmaceuticals are maintained under appropriate conditions of sanitation, light and temperature in the course of deliveries
Shipping methods are tested periodically to ensure that containers stay within specified temperature requirements
How are shipping methods tested and at what frequency?

Documentation

Documentation per compounding instance

Documentation relating to each episode of compounding and/or compounding request is kept, including
Completed Risk Assessment in accordance with state requirements. Include notes on the frequency of written risk assessment
Completed Compounding Worksheet
Prescriptions and dispensing records
Reports of adverse reactions (if any)
Evidence to support suitability of formulations where non-pharmacopeial formulations are used or where there is no precedent for formulations from reputable references

Compounding Worksheet

The Compounding worksheet contains
Patient details
Prescriber details
Prescription details
the pharmacopeial name (if applicable)
the formula and it's source
expiry date
the manufacturer batch numbers and expiry dates of ingredients
notes about stability, methodology, calculations and references
records of names of any supervised staff
signature of the compounding pharmacist and date
duplicate dispensing label

Master Formulations

Where a non-pharmacopoeial formulation is used, evidence is obtained from reputable references (as defined in the Pharmacy Board of Australia’s Guidelines on compounding of medicines) or peer reviewed journals and not based on testimonials or impressions
For formulations without precedent in reputable references and/or inadequate published safety, efficacy, pharmacokinetic and clinical data on the intended formulation, additional data and/or evidence is obtained and documented to justify the decision to compound. This includes: - evidence of efficacy, pharmacokinetic and clinical data - the basis for the assigned expiry date - the process to maintain the safety of the pharmacy staff where compounding is taking place - any other steps in relation to ensuring that the dispensing and supply of the compounded medicine is consistent with the safety of the individual patient
Written policies and procedures are established and implemented in regard to assigning each non-sterile preparation a expiry date or beyond-use-date (BUD), to assure that the preparation retains its strength, purity and quality until the labelled expiry date.
Expiry dates for non-sterile compounded medicines are 28 days or less, dependent on circumstance. Assigning an expiry date longer than 28 days is based on reliable literature (e.g. the results of a reliable stability study that used the same formulation as the compounded product), and does not exceed six months

Labelling

Labels of compounded preparations meet requirements under Commonwealth and New South Wales legislation, and include: - the approved pharmacopoeial or APF name - the amount/concentration of all active ingredients - the name and amount/concentration of any added preservatives - expiry date - directions for use including frequency and dose - storage details - cautionary advisory labels (where necessary) - a statement indicating that the product has been compounded - the patient’s name or, in the case of an animal, the owner’s name and species of animal, - the date of dispensing or supply - the initials of the dispensing pharmacist (and if different, the initials of the pharmacist checking and issuing the medicine) - a unique identifying code for the dispensed medicine, - the name, address and telephone number of the pharmacy or pharmacy department at which the preparation was compounded, - the words ‘KEEP OUT OF REACH OF CHILDREN’ in red on white background, - if the substance is intended for external use only, the word ‘POISON’, or the words ‘FOR EXTERNAL USE ONLY’. In addition, compounded preparations for veterinary use specify ‘For veterinary use only’ and the species of animal being treated
Labels are firmly attached to the immediate packaging container or primary packaging in cases where a label would compromise the patient’s ability to use the medicine. Labels are durable and remain legible for the expected duration of use.
Labels are clearly and legibly printed in plain English. Other languages that are accurate translations of the English label may be included in addition to English.
19.4 If batch preparations are compounded, these are labelled in accordance with the requirements of the Therapeutic Goods Order No.69 General Requirements for Labels for Medicines.

Hazardous Compounding

7.1 Additional precautions are taken when compounding is undertaken with hazardous materials (e.g. hormones).
7.2 Activities involving hazardous materials are carried out in a way that minimises both  cross contamination of the preparation being compounded with other preparations, and  exposure to hazardous materials by pharmacy staff.
7.3 A risk assessment is conducted to identify key risks, their likelihood of occurrence and potential consequence. A risk management plan is in place and addresses how: - risks will be controlled, so far as reasonably practicable, to minimise risk to pharmacy staff, - records of these risks will be kept, and - risk controls in place will be regularly reviewed
7.4 Standard Operating Procedures for compounding involving hazardous materials are in place as part of the risk assessment process. These include: - use of Safety Data Sheets to identify appropriate use of PPE and handling of hazardous materials - cleaning protocols, - circumstances for exclusion (e.g. pregnancy, wounds), and - workflow processes to streamline hazardous materials handling.
7.5 To manage the additional risks associated with compounding involving hazardous materials: the pharmacy ensures no other compounding takes place in the compounding laboratory while compounding activities involving hazardous materials are being conducted and only compounds one preparation at a time OR the pharmacy has a separate and dedicated powder containment hood within the compounding laboratory OR the pharmacy has a separate and dedicated compounding laboratory (or room within the compounding laboratory)
Written policies and procedures are established and implemented in regard to hazardous non-sterile compounded preparations and components being manipulated and prepared in, at minimum, a Class I biological safety cabinet (BSC).

Compounding Practice

Performs critical processes appropriately, including but not limited to weighing, measuring, and mixing
Prepares each dosage form according to applicable USP standards, the art and science of pharmacy and applicable laws and regulations
Performs appropriate checks and rechecks for each procedure at each stage of the process
Uses the MFR, the Compounding Record, and associated written procedures to compound each preparation and documenting any deviation in procedures
Cleaning and sanitizing compounding areas and equipment prior to compounding
Segregating of compounding activities to prevent mix-ups among ingredients, containers, labels, in-process materials, and finished preparations
Performing compounding activities in a manner designed to prevent cross contamination
Thoroughly and promptly cleaning the compounding area and all equipment after use
Avoiding interruptions during the compounding process
Personnel wash hands, gown and glove appropriately to perform compounding

Packaging

18.1 Packaging containers maintain the quality and stability of the compounded preparations.
18.2 Containers and closure types used in the packaging of compounded preparations are appropriate. This depends on the physical and chemical characteristics of the compounded preparation (e.g. light sensitive) and its intended use
18.3 Packaging material containers are stored off the floor to prevent contamination
18.4 Child-resistant closures are used for required products. Refer to Therapeutic Goods Order No. 80 for further information

Recalls

Written policies and procedures are established and implemented for preparation and/or component recall.
Dispensing/compounding records are maintained to identify each patient who has received recalled preparations or components in a timely and effective manner.

Product Testing

Written policies and procedures are established and implemented regarding continuous quality control for finished preparations
The quality control program includes details on
When to test preparations
What test(s) should be performed
Appropriate methods and equipment to use
How to interpret the test
Limits of the test
Specific actions required when a preparation does not meet the test
How quality control information is used to improve the performance of personnel
How quality control information is incorporated into the pharmacy's PI program
Pharmacy sends compounded products out for external testing at least annually. Two APIs and two dose forms per staff member will be tested for accuracy.

Performance Improvement

The pharmacy develops, implements, and maintains an effective, ongoing, organization-wide Performance Improvement (PI) Program.
The pharmacy collects data for self-assessment including but not limited to;
Adverse events
Patient complaints
Patient records
At least one important aspect related to the service provided
Ongoing monitoring of processes that involve risks including infections and communicable diseases
The pharmacy ensures the implementation of an organizational-wide Performance Improvement (PI) Plan by the designation of a person responsible for coordinating PI activities.
Personnel receive training related to PI activities and their involvement
Each performance improvement (PI) activity or study contains the required items
a description of indicator(s) to be monitored/activities to be conducted
Frequency of activities
Designation of who is responsible for conducting activities
Methods of data collection
Acceptable limits for the findings (thresholds)
Who will receive the reports
Plans to re-evaluate if the findings fail to meet acceptable thresholds
Performance Improvement (PI) activities include an assessment of processes that involve risks, including infections and communicable diseases.
Performance Improvement (PI) activities include ongoing monitoring of at least one important aspect related to the non-sterile compounding process. Examples include; • Monitoring of the finished compounded preparation by testing that the potency is performed in accordance with the pharmacy's written policies and procedures • Tracking and classifying quality-related events to identify opportunities for improvement • Auditing of compounding and formulation records for accuracy and completeness • Auditing of personnel records to ensure that sterile compounding training and competency assessments are performed as required
Performance Improvement (PI) activities include ongoing monitoring of at least one important aspect related to the sterile compounding process.
Performance Improvement (PI) activities include ongoing monitoring of patient complaints
There is a written plan of correction developed in response to any Performance Improvement (PI) findings that do not meet acceptable thershold
There is a comprehensive, written annual report that describes the PI activities, findings and corrective actions that relate to the service provided. (In a large, multi-service organization, the report may be part of a larger document addressing all of the organization’s programs.)

Sterile Compounding

Written policies and procedures are established and implemented requiring all sterile compounding personnel to receive training and/or education and to competently perform the required client/patient service activities prior to being assigned to work independently
Do sterile compounding personnel receive didactic training?
Sterile compounding personnel complete media fill test prior to starting sterile compounding & annually thereafter (every 6 months for high-risk)
Gloved fingertip sampling consistent with risk level of compounding is performed
Written policies and procedures are established and implemented in regard to compounding sterile preparations in accordance with USP Chapter <797> standards, the art and science of pharmacy, applicable laws and regulations.
Non-hazardous sterile preparations are compounded in an environment that meets requirements for the appropriate risk level as defined by USP <797>, state board of pharmacy regulations, and standards of good practice
Written policies and procedures are established and implemented in regard to how hazardous sterile preparations are compounded in an environment that meets requirements for the appropriate risk level as defined by USP Chapter <797>, state board of pharmacy regulations, and standards of good practice.
Written policies and procedures are established and implemented for cleaning, disinfecting and monitoring the controlled air environment(s).
Written policies and procedures are established and implemented in regard to assigning each sterile preparation a Beyond-Use Date (BUD) to assure that the preparation retains its strength, purity and quality until the labelled BUD date
Written policies and procedures are established and implemented to assure preparations adhere to requirements for sterility and endotoxin limits. This standard only applies to Pharmacies that: Assign Beyond-Use Dates (BUDs) that exceed USP defaults for each risk level, and prepare high-risk compounded sterile products
What method of sterilization is used?
- Filtration
- Steam
- Dry Heat
- Depyrogenation
What testing does the pharmacy complete for sterile products?
- Sterility Testing
- Endotoxin Testing

Pharmacy Compounding Compliance Survey

Go digital today!

Convert your paper checklists into digital forms

Patient Counselling

Complaints Handling

Adverse events, incidents & non-conformances

Advertising

Risk Assessments

Workplace Risk Assessments

Procurement & suppliers

Quality of Raw materials

Storage of Raw materials

Documentation per compounding instance

Compounding Worksheet

Master Formulations

Labelling

Related checklists

Pharmacy Compounding Compliance Survey

Free Pharmacy Compounding Compliance Survey Checklist

Go digital today!

Convert your paper checklists into digital forms

Patient Counselling

Complaints Handling

Adverse events, incidents & non-conformances

Advertising

Risk Assessments

Workplace Risk Assessments

Procurement & suppliers

Quality of Raw materials

Storage of Raw materials

Documentation per compounding instance

Compounding Worksheet

Master Formulations

Labelling

Related checklists