The information herein is not a substitute for reading CSHP's Compounding: Guidelines for Pharmacies or the National Association of Pharmacy Regulatory Authority's model standards for pharmacy compounding. It is given without warranty of any kind, either expressed or implied. It remains the responsibility of the user to judge its suitability for his or her particular purpose within the context of his or her practice and the applicable legislative framework. In no event shall the CSHP or any persons involved in the development and review of this information be liable for damages arising from its use.
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What topics does CSHP's Compounding: Guidelines for Pharmacies cover?
This comprehensive set of guidelines draws on the experience of Canadians, information from standards, guidelines and other papers on the topic of compounding from around the world. One resource for all types of compounding by pharmacies.
The guidelines provide foundational information that is applicable to various types of compounding, providing information that is specific to aseptic compounding, non-aseptic compounding, and compounding which involves hazardous drugs - including radiopharmaceuticals.
There's information for architects, engineers, nurses, pharmacists, pharmacy technicians, planners, – and others who are involved in decisions or activities involved in compounding.
|Glossary||Personal Health and Hygiene||Sterility Tests|
|Decision to Compound||Personal Practices and Behaviours||Sterilization|
|Oversight of Compounding Practices||Clothing and other Garb||Preparation Validation|
|Quality Management Program||Equipment and Utensils||Process Validation|
|Capacity Planning||Cleaning, Disinfection, and Decontamination||Storage|
|Physical Environment||Environmental Monitoring||Distribution|
|Workflow||Anticipation of Compounding||Preparation Failure, Complaints, and Recalls|
|Planning and Designing the Environment||Process of Compounding||Documentation|
In general terms how do CSHP's guidelines compare and contrast to NAPRA's model standards?
CSHP's guidelines have one document to address the following forms of compounding: aseptic and nonaseptic (for both compounding with and without hazardous drugs, including radiopharmaceuticals). The National Association of Pharmacy Regulatory Authorities (NAPRA) has 2 sets of model standards (with a third yet to come):
- Model Standards for Pharmacy Compounding of Non-hazardous Sterile Preparations- Revised November 2016
- Model Standards for Pharmacy Compounding of Hazardous Sterile Preparations - Revised November 2016
Like many other guidelines or standards on compounding, CSHP's guidelines and NAPRA's model standards are similar in many ways.
NAPRA's model standards set the regulatory requirement in Canada (as decided by provincial pharmacy regulatory authorities) for compounding performed by pharmacies; CSHP's guidelines help pharmacies achieve that standard and go beyond.
Why does CSHP's guideline use terms that are different from what NAPRA used in is model standards for compounding?
It was a matter of timing: CSHP's guidelines were published before NAPRA published its model standards. Secondly, the writing team decided to take the opportunity and improve upon the terms used in other documents and create new terms which more accurately describe the function of the equipment or space.
People and Clothing
What is personal protective equipment?
Personal protective equipment (PPE) are clothing or equipment worn to reduce exposure to chemical hazards. Examples of PPE include N95 respirators, safety eye goggles, face shields, chemotherapy-approved gloves, and impermeable protective gown. PPE is not the same as the garb (e.g., gowns, shoe covers, head covers, and gloves) worn when working with nonhazardous drugs, whose main function is to contain particles shed by personnel and clothing.
May staff wear henna or other temporary tattoos in the cleanroom?
The NAPRA model standards specifically indicate henna tattoos are not permitted in the cleanroom. The application of temporary tattoos including henna tattoos increases the amount of particle shedding from skin surfaces making the wearing of henna or temporary tattoos not desired for cleanroom staff.
May an outer garment (e.g., gown) be re-worn during the same shift?
Yes, it may, but that permission is given with conditions. Persons who are not working in the primary clean air device may reuse the outer garment during the same work shift only provided it is not visibly soiled or contamination is not suspected. In these instances, while the outer garment is not worn during the shift, it shall be hung up on the on the clean side of the anteroom.
- Working with non-hazardous drugs: Gowns worn by persons working in the primary clean air device are not to be re-worn.
- Working with hazardous drugs: Reusing an outer garment used in the compounding of hazardous drugs is not recommended, however, the inner gown may be worn throughout the day provided it continues to meet specification.
May a person who wears a splint on a hand or arm be allowed to work in a controlled work area?
No. Splints and casts are not permitted in the controlled work area because they (including fasteners) cannot be properly cleaned.
What garb is required to disinfect supplies and drugs in the anteroom?
The garb should be suitable for the location in the anteroom (“clean side” versus “dirty side”) and the activities undertaken. For instance, a worker shall don personal protective equipment (PPE) if she is using a disinfectant that requires the wearing of PPE.
Cleaning and Disinfection
Why shouldn't spray bottles be used to clean or disinfect?
The use of spray bottles increases the risks of a) inhalation of the agent being sprayed and b) dispersion of contaminants from the outer package. Instead, a pour bottle of the cleaning or disinfecting agent should be used to saturate a stack of single-use, low-shedding towels which will be then be used to clean or disinfect by wiping the surface of the object.
Why should sterile 70% isopropyl alcohol be used, and not nonsterile 70% isopropyl alcohol?
Isopropyl alcohol supports the growth of fungal spores, causing it to be a vector for spores, leading to fungal contamination of the environment or product. A container of sterile isopropyl alcohol does not contain spores and therefore is a better choice. Preferably the bottles of sterile 70% isopropyl alcohol would be used in a short period because once the bottle is opened, the contents are no longer sterile. It should also be stressed that bottles of cleaning and disinfecting liquids should never be topped up.
When should terminal re-cleaning of the cleanroom occur (in relation to an HVAC or power failure?
A terminal or full clean should occur immediately after a shut down due to maintenance or repair of the HVAC. If electrical power to the room is lost and then likely production can continue. If you work in a space where the HVAC has shut down and you must continue preparing sterile compounds consideration to the BUD should occur. A compounding environment with a non-functioning HVAC is considered an uncontrolled space and therefore appropriate BUD would apply.