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With the release of the new NAPRA Model Standards for Pharmacy Compounding of Non-Sterile Preparations, many community pharmacies may be looking for information on best practices on how to implement these standards.
In 2014, CSHP published Compounding: Guidelines for Pharmacies, which includes a wealth of information on non-aseptic (non-sterile) compounding. This comprehensive set of guidelines covers the compounding in pharmacies whenever compounded preparations are intended for human use, regardless of the route of administration or whether the preparation is related to research purposes. These guidelines also apply to the preparation of radiopharmaceuticals and other hazardous pharmaceuticals.
Available in English & French.
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These guidelines are available for purchase from CSHP. Bulk discounts are available for orders over 100 copies.
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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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.
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):
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.
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.
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.
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.
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.
No. Splints and casts are not permitted in the controlled work area because they (including fasteners) cannot be properly cleaned.
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.
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.
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.
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.