FOR PHARMACY COMPOUNDING OF NON-STERILE …

1 GUIDANCE DOCUMENTFOR PHARMACY COMPOUNDING OF NON-STERILE PREPARATIONSCOMPANION TO THE MODEL STANDARDS FOR PHARMACY COMPOUNDING OFNON- sterile PREPARATIONS Guidance Document for PHARMACY COMPOUNDING of NON-STERILE Preparations Companion to the Model Standards for PHARMACY COMPOUNDING of NON-STERILE PreparationsApproved by the National Association of PHARMACY Regulatory Authorities (NAPRA) Board of Directors November 2017, published March 2018. Adapted with permission from Pr parations magistrales non st riles en pharmacie Norme , Ordre des pharmaciens du Qu bec, 2012 National Association of PHARMACY Regulatory Authorities, 2018.

2 All rights reserved. No part of this document may be reproduced in any form by any photographic, electronic, mechanical or other means, or used in any information storage and retrieval system, without the written permission of the National Association of PHARMACY Regulatory Authorities (NAPRA)130 Albert Street, Suite 1800, Ottawa, ON K1P 5G4 E-mail: | Telephone: 613-569-9658 | Fax: 613-569-9659 ACKNOWLEDGEMENTSThe National Association of PHARMACY Regulatory Authorities (NAPRA) would like to first thank one of its members, the Ordre des pharmaciens du Qu bec, for having made possible the adaptation of its document entitled Pr parations magistrales non st riles en pharmacie Norme to create this national document, Model Standards for PHARMACY COMPOUNDING of NON-STERILE Preparations, and the accompanying Guidance Document for PHARMACY COMPOUNDING of NON-STERILE Preparations.

3 In addition, NAPRA would like to thank the members of the National Advisory Committee on PHARMACY Practice for their continued diligence in the development of these Connolly, Chair - Nova Scotia college of pharmacists Anjli Acharya - Alberta college of PharmacistsGuylaine Bertrand/Annie Boulanger - Ordre des pharmaciens du Qu becHeather Christ - New Brunswick college of PharmacistsDale Cooney/Jennifer Mosher - Alberta college of PharmacistsJeanne Eriksen - Saskatchewan college of PHARMACY ProfessionalsMelanie Healey - Newfoundland and Labrador PHARMACY BoardSuzanne Solven/David Pavan - college of pharmacists of British ColumbiaAnne Resnick - ontario college of PharmacistsSue Sampson - Nova

4 Scotia college of PharmacistsMichelle Wyand - Prince Edward Island college of PharmacistsTodd Mereniuk/Jill Hardy - college of pharmacists of ManitobaNAPRA also acknowledges, with thanks, the support and technical contribution of Della Croteau (consultant) in the preparation of these DOCUMENT FOR PHARMACY COMPOUNDING OF NON-STERILE PREPARATIONSNATIONAL ASSOCIATION OF PHARMACY REGULATORY AUTHORITIES (NAPRA)1 CONTENTS1. INTRODUCTION 32. OBJECTIVES General guidance on whether to compound a preparation 43. REGULATORY FRAMEWORK General guideline on COMPOUNDING and manufacturing activities 54.

5 ASSESSING RISK FOR COMPOUNDING NON-STERILE PRODUCTS Some factors to consider in risk assessment Decision algorithm for risk assessment References for assessing risk 95. REQUIREMENTS FOR ALL LEVELS OF NON-STERILE COMPOUNDING ACTIVITIES COMPOUNDING personnel PHARMACY manager or PHARMACY department head NON-STERILE COMPOUNDING supervisor Regulated PHARMACY personnel Non-regulated PHARMACY personnel Training and skills assessment Training of COMPOUNDING personnel Knowledge required for cleaning personnel Policies and procedures Examples of policies and procedures Template for developing a procedure Facilities and equipment Facilities for NON-STERILE COMPOUNDING

6 Equipment for NON-STERILE COMPOUNDING 226. PRODUCT AND PREPARATION REQUIREMENTS Beyond-use date and dating methods General guidelines for assigning beyond-use dates Master Formulation Record Template for a Master Formulation Record Ingredients used for NON-STERILE COMPOUNDING quality and storage Selection of ingredients Sources of ingredients Quality of ingredients Safety data sheets Storage COMPOUNDING record Conduct of personnel in COMPOUNDING areas Verification of final compounded NON-STERILE preparations Labelling and

7 Packaging Labelling policy Label and supplementary label Packaging process and procedure Storage Temperatures for different types of storage Transport and delivery of compounded NON-STERILE preparations 33 GUIDANCE DOCUMENT FOR PHARMACY COMPOUNDING OF NON-STERILE PREPARATIONSNATIONAL ASSOCIATION OF PHARMACY REGULATORY AUTHORITIES (NAPRA) Product recalls Incident and accident management Example of a template for incident/accident reporting and follow-up form 347. QUALITY ASSURANCE Program content Quality assurance of equipment and COMPOUNDING areas Certification Temperature readings Quality assurance of personnel Quality assurance related to processes and procedures Documentation of quality control activities Example of components of a quality assurance program 378.

8 LEVELS OF REQUIREMENTS Level A Level B Level C Summary of requirements for compounded NON-STERILE preparations 439. REQUIREMENTS FOR HAZARDOUS PREPARATIONS Facilities for handling hazardous products (Level C requirements) COMPOUNDING rooms Heating, ventilation and air conditioning system for controlled rooms Windows and other openings Area for unpacking hazardous products Area for storing hazardous products Signage Equipment for handling hazardous products Containment primary engineering control Other instruments, devices and accessories related to the COMPOUNDING of hazardous NON-STERILE preparations Personal protective equipment Deactivating.

9 Decontaminating and cleaning in areas reserved for the COMPOUNDING of hazardous NON-STERILE preparations Garbing of cleaning personnel Surface deactivation, decontamination and cleaning Surface deactivation, decontamination and cleaning of the containment primary engineering control Incident and accident management Accidental exposure Spills Documentation for incidents and accidents Hazardous waste management (see standard for cross reference) Verification of controlled rooms and the containment primary engineering control Certification Certificate provided by manufacturer (in factory) Environmental verification Documentation 5510.

10 GLOSSARY OF TERMS (WITH ABBREVIATIONS) 5611. LIST OF DIAGRAMS, TABLES, CHECKLIST AND TEMPLATES 5812. BIBLIOGRAPHY 59 GUIDANCE DOCUMENT FOR PHARMACY COMPOUNDING OF NON-STERILE PREPARATIONSNATIONAL ASSOCIATION OF PHARMACY REGULATORY AUTHORITIES (NAPRA)31. INTRODUCTIONThe Guidelines to PHARMACY COMPOUNDING published by the National Association of PHARMACY Regulatory Authorities (NAPRA) in October 2006 have recently been reviewed, a process that has resulted in a new set of documents: the Model Standards for PHARMACY COMPOUNDING of Non-hazardous sterile Preparations1, the Model Standards for PHARMACY COMPOUNDING of Hazardous sterile Preparations2, and the Model Standards for PHARMACY COMPOUNDING of NON-STERILE Preparations with its accompanying document, the Guidance Document for PHARMACY COMPOUNDING of NON-STERILE Preparations (referred to hereafter as the Guidance Document).