Compounding: Guidelines for Pharmacies

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.

Compounding: Guidelines for Pharmacies (2014)(Electronic Copy) Price
CSHP member & supporter price $375.00
Full Price $750.00
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Compounding FAQs

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.

Suggestions on how to improve the information are welcome. Please use the Contact Us page to provide your suggestions.

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.

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.