Commonly asked questions regarding the implementation of the NAPRA Standards for Pharmacy Compounding of Non-Sterile Preparations. For more information, please visit the Non-Sterile Compounding Key Initiative.
Updated January 3, 2022
GENERAL
Refer to Sections 3 and 5 of the NAPRA Guidance Document for Pharmacy Compounding of Non-sterile Preparations.
Compounding is within the scope of practice and authorized acts for pharmacy professionals defined in the Pharmacy Act, and compounding non-sterile preparations according to recognized guidelines and standards is an entry-to-practice competency for both pharmacists and pharmacy technicians. Therefore, it is reasonable that the public and other health practitioners expect any pharmacy to provide some compounding services.
The requirements for “all levels of compounding” (Section 5), corresponding to Level A, should be attainable for all pharmacies already engaged in compounding. Moreover, the College ‘s Code of Ethics expects that “registrants make every reasonable effort to provide quality cost-effective pharmacy care and services to patients and society.”
As explained in Section 3 of NAPRA’s Guidance Document, “given that pharmacists and pharmacy technicians are expected to maintain competency in basic compounding skills, they are also expected to provide compounded preparations within their level of expertise and within the limitations of available and appropriate facilities and equipment.”
As for all prescriptions, it is expected that a pharmacist will assess the prescription for a non-sterile preparation to determine whether it is the most appropriate therapy for the particular patient or if there is a suitable, safer alternative. If a compounded preparation is the best option, the Designated Manager/department head must ensure that the pharmacy has the resources necessary to safely and accurately prepare a quality preparation. If not, they have an ethical obligation to “assume responsibility for making reasonable efforts to ensure continuity of patient care when they are unable to provide requested pharmacy services.”
Refer to Sections 1, 2 the NAPRA Guidance Document for Pharmacy Compounding of Non-sterile Preparations.
Standards outline the minimum mandatory expectations that must be met by the profession, using the language of “must.” Therefore, these Model Non-Sterile Compounding Standards represent the minimum requirements to be applied in compounding to ensure the overall quality and safety of non-sterile preparations.
Each standard has a corresponding section in the Guidance Document with details concerning how the standard can be achieved. The Guidance Document was developed by NAPRA as a supplemental resource and establishes professionally-accepted means by which pharmacies can achieve compliance with the standards.
Where the guidance uses the language of “should”, it may be acceptable to meet the required standard using other technologies, techniques, materials and procedures than those suggested, if they have been proven to be equivalent or superior to those described in the Guidance Document.
Refer to Section 5.4 and 5.4.1.1 of the NAPRA Guidance Document for Pharmacy Compounding of Non-sterile Preparations.
The NAPRA Non-Sterile Compounding Standards do not specify a minimum size or dimensions for Level A compounding. There must be a separate space designated for compounding with an area large enough for compounding personnel to work comfortably and safely, with room to store equipment and products in an orderly manner in clean and secure surroundings. Also, the area should be designed and arranged to prevent cross-contamination between products, and it should be located away from parts of the pharmacy where there is a considerable amount of traffic (e.g., aisles, entrance and exit).
Refer to Section 5.2, Table 1, Table 2, Checklist 1 and Table 8.4 of the NAPRA Guidance Document for Pharmacy Compounding of Non-sterile Preparations.
There is no requirement in the NAPRA Non-Sterile Compounding Standards for personnel to complete a formal, accredited or third-party training program. The pharmacy manager/department head (or designated non-sterile compounding supervisor) may choose to develop their own training tools and assessment program to suit their specific needs. The intended outcome is that the expertise of personnel responsible for compounding must be commensurate with their assigned duties.
The potential need for training and routine assessment is not limited to the compounding processes or technique; personnel must also be educated on policies and procedures, such as those related to attire, personal protective equipment, cleaning, and conduct.
Refer to Table 8.4 of the Guidance Document for an overview of training topics for each Level (A, B or C), as well as the specific sections relevant to the type of personnel or preparation.
For registrants interested in exploring external courses, OCP provides a listing of CE resources. Please note the listings are not exhaustive, and inclusion of a course is not to be construed as an endorsement.
Refer to Sections 5.4.1, 9.1.1 and 9.2.1 of the NAPRA Guidance Document for Pharmacy Compounding of Non-sterile Preparations.
It is a standard of accreditation for all pharmacies to have two sinks (or one double sink) in the dispensary. Accredited pharmacies engaged in non-sterile compounding must also meet the NAPRA Non-Sterile Compounding Standards to have a clean water supply, with hot and cold running water, available in or close to the compounding area.
Please refer to the table below which summarizes the accompanying Guidance to meet the Standards.
Compounding must take place within the accredited pharmacy area. Any material changes to the existing accredited area or layout require a Notice of Renovation to be submitted to the College, and an Operations Advisor will be assigned to review the proposed floor plan.
| LEVEL | Sink Location | GD Section | Comments |
|---|---|---|---|
| A |
|
5.4.1.4 |
|
| B |
|
5.4.1.4 |
|
| C |
|
5.4.1.4
9.11 |
|
| All levels |
|
5.4.1.4 |
|
Refer to Sections 9.1, 9.1.1, 9.2.1, 9.2.2 and 9.3 of the NAPRA Guidance Document for Pharmacy Compounding of Non-sterile Preparations.
It is preferable to have separate areas for compounding hazardous and non-hazardous non-sterile preparations, however, if this is impossible and the same area is used, compounding and/or cleaning personnel must, at minimum, be assured that the area and any reusable equipment has been meticulously deactivated, decontaminated and cleaned to prevent any risk of cross-contamination from the hazardous materials before other preparations are compounded.
Because of the difficulty of removing hazardous product contamination, the surfaces of ceilings, walls, floors, fixtures, shelving, counters and cabinets in the non-sterile compounding area should be smooth, impermeable, free from cracks and crevices, and made of non-shedding material. It is strongly recommended that equipment be dedicated for compounding each of hazardous and non-hazardous drugs. Alternatively, disposable equipment should be used, if possible, to reduce the chances of cross-contamination.
The Designated Manager/department head and/or non-sterile compounding supervisor must have policies and procedure in place for the deactivation, decontamination and cleaning required after compounding hazardous non-sterile preparations. As part of the pharmacy’s quality assurance program, personnel must be trained and their work routinely assessed to ensure compliance with procedures.
RISK ASSESSMENT AND MITIGATION
Refer to the Sections of the NAPRA Guidance Document for Pharmacy Compounding of Non-sterile Preparations referenced in the table below.
Ventilation (the “V” in HVAC) is an engineering control intended to remove or control contaminants released in indoor work environments by bringing in fresh air. Fans, while they circulate the air, are not suitable for ventilation as they would blow the contaminant around the work area without effectively controlling it. Opening a window or door might allow outdoor air in, however it is not controllable and risks bringing in other contaminants and disrupting the compounding environment.
The Canadian Centre for Occupational Health and Safety (CCOHS) Fact Sheet on Industrial Ventilation may be helpful for background information on this subject. Compounding personnel should know how the secondary ventilation (HVAC) system operates.
The external ventilation requirements differ between Levels A, B and C and are summarized below. Refer to the Guidance Document for comprehensive information.
| LEVEL | External Ventilation | GD section |
|---|---|---|
| A |
|
|
| B |
|
|
| C |
|
|
| All levels |
|
|
Refer to Sections 9.1, 9.1.1, 9.2.1, 9.2.2 and 9.3 of the NAPRA Guidance Document for Pharmacy Compounding of Non-sterile Preparations.
Compounding of hazardous non-sterile preparations should occur in a separate room specifically dedicated for this purpose.
The level of requirements needed (i.e., B or C) depends more on the risk(s) posed by the hazardous product than on the complexity of the preparations. Drugs listed in NIOSH† Group 1 (antineoplastic/cytotoxic) require handling in the greater precautions provided by Level C (e.g., a closed-off room under negative pressure, filtered air exhausted to the outside, etc.) to avoid contaminating the environment and to further protect personnel. Similarly, compounding with drugs categorized by WHMIS‡ as a health hazard because they are very irritating to the respiratory tract, skin and/or mucous membranes should also take place in a Level C room.
If it is not possible to have a dedicated room for hazardous compounding, at an absolute minimum there should be assurances that the area is meticulously cleaned before non-hazardous preparations are compounded. To prevent any risk of cross-contamination, the compounding area, equipment and accessories must be deactivated, decontaminated and cleaned as described in Section 9, immediately after compounding with the hazardous materials.
Because of the difficulty of removing hazardous product contamination, the surfaces of ceilings, walls, floors, fixtures, shelving, counters and cabinets in the non-sterile compounding area should be smooth, impermeable, free from cracks and crevices, and made of non-shedding material.
As part of the pharmacy’s quality assurance program, personnel must be trained to perform these tasks and their work routinely assessed to ensure compliance with policies and procedures.
†National Institute for Occupational Safety and Health
‡Workplace Hazardous Materials Information System
Refer to Sections 9.2.1, 9.2.2, 9.2.3 and 9.3 of the NAPRA Guidance Document for Pharmacy Compounding of Non-sterile Preparations.
It is strongly recommended that equipment (including personal protective equipment) be dedicated for compounding each of hazardous and non-hazardous drugs. Alternatively, disposable equipment should be used, if possible, to reduce the risk of cross-contamination.
If it is not possible to have a dedicated equipment for hazardous compounding, at an absolute minimum there should be assurances that it is meticulously deactivated, decontaminated and cleaned immediately after compounding with the hazardous materials, before being used for non-hazardous preparations.
For occasional non-sterile hazardous compounding, a C-PEC used for sterile hazardous compounding (e.g., Class II BSC or CACI) may be used, provided it is decontaminated, cleaned and disinfected before compounding the non-sterile preparation and again before resuming sterile compounding in that C-PEC due to the higher risk posed to patients.
Refer to Section 4 of the NAPRA Guidance Document for Pharmacy Compounding of Non-sterile Preparations.
The NAPRA Non-Sterile Compounding Standards do not assign specific drugs, ingredients or formulations to each Level. Compounding – like other aspects of pharmacy practice – is highly varied and dynamic.
Examples of how a risk assessment may be conducted to determine the Level of requirements needed for some compounded preparations have been provided by other regulatory bodies in Canada, however, the individual factors in your practice setting may result in a different risk assessment for a similar formulation because:
Refer to Sections 4.3 and 8.3 of the NAPRA Guidance Document for Pharmacy Compounding of Non-sterile Preparations.
The National Institute for Occupational Safety and Health (NIOSH) is a recognized occupational health and safety agency, and part of the Centers for Disease Control and Prevention (CDC) in the U.S.
The NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings places hazardous drugs into one of 3 groups based on specific criteria. A drug/active pharmaceutical ingredient (API) not listed on any NIOSH list did not meet their specific criteria for a hazardous drug It is important to read the NIOSH document in its entirety, and not simply refer to the list of drugs in each group (table). The actual risk to personnel depends on how the drug is handled and what risk mitigation measures are in place.
In Canada, the Hazardous Products Act (HPA) and its regulations establish hazard classifications, cautionary labelling requirements, and mandate the provision of Safety Data Sheets (SDS). SDS are part of an organization’s Workplace Hazardous Materials Information System (WHMIS) program as required by federal and provincial occupational health and safety legislation.
WHMIS includes products used in various workplaces — a far wider group of chemicals than NIOSH — that are categorized as either physical or health hazards (See Schedule 2 of the HPA). It also identifies products that can be very irritating to the respiratory tract, skin or mucous membranes which is important for determining the Level of requirements.
Although both WHMIS and NIOSH provide information on various toxicities, the NAPRA Non-Sterile Compounding Standards require both references to be consulted in the risk assessment process, as described in Section 4 of the Guidance Document and illustrated in the Decision Algorithm. Risk assessments for compounded preparations should be available to all compounding personnel.
Refer to Section 4.3, 6.3.4, 8, 8.1, 8.2, 8.3 and Glossary of the NAPRA Guidance Document for Pharmacy Compounding of Non-sterile Preparations.
The health hazards (defined under the Hazardous Products Act) of active pharmaceutical ingredients (API) are identified on the Safety Data Sheet (SDS) in Section 2 – Hazards Identification. Health hazard classes can be identified by a pictogram (see below) which also appear on the API’s label.
SDS provide information about a product’s risks and include recommended preventive measures to protect personnel, such as engineering controls and personnel protective equipment (Section 8). This is helpful in identifying products that are volatile, aromatic, sensitizing, or very irritating to the respiratory tract, skin or mucous membranes, as part of the risk assessment and determining the Level of requirements needed. The information must be interpreted and applied in the context the pharmacy’s compounding practice, taking into account the potential exposure of personnel and patients to the product (e.g., the physical and characteristics and chemical properties of the API, the frequency and duration of manipulation and potential for contact, etc.)
SDS are available from the supplier or through the Canadian Centre for Occupational Health and Safety (CCOHS) and are updated every 3 years They should be readily accessible and kept together in a location known to all non-sterile compounding personnel.
Manufactured drugs approved by Health Canada (i.e., those with a DIN) are exempt from the HPA and therefore do not have SDS. However, when used in a preparation, the SDS for the active ingredient(s) can be consulted, and the drug’s Product Monograph includes information on Storage, Stability and Disposal and Special Handling Instructions to consider.
Refer to Section 4.1, Section 9 of the NAPRA Guidance Document for Pharmacy Compounding of Non-sterile Preparations.
The NAPRA Non-Sterile Compounding Standards does not assign a specific numerical value to define “small quantity” or “occasional”. Rather, this is only one of many factors involved in assessing the overall degree of risk to preparation and to personnel to determine the appropriate Level of Requirements for a preparation that contains a hazardous product.
What constitutes an “occasional small quantity” for a preparation or ingredient depends on the amount handled and frequency it is used, however these cannot be considered in isolation. The cumulative risk of exposure over time must be considered, even if the preparations are compounded on different days. The level of requirements must be sufficient for the pharmacy’s compounding practice as a whole, to minimize contamination of compounded products and to provide adequate protection for compounding personnel, other staff and patients entering the premises.
When determining that an amount is ‘small’ or ‘large’, or a frequency is ‘occasional’ or ‘routine’, the rationale must be documented on the risk assessment. Compounding supervisors should be prepared to defend their decision in this regard.
Refer to Section 9, 9.1.1, 9.2.1, 9.2.3 and 9.6 of the NAPRA Guidance Document for Pharmacy Compounding of Non-sterile Preparations and the Pharmacy Connection Article — A Closer Look at Personal Protective Equipment (Summer 2019).
The NIOSH website explains that a hierarchy of controls is “a means of determining how to implement feasible and effective control solutions” to minimize the risk of exposure to occupational hazards. Compounding supervisors should review the descriptions of each level of control. The diagram below (from the November 4th OCP webinar) provides examples of what the various controls might be in the context of pharmacy compounding.
It is the responsibility of the compounding supervisor and manager to evaluate and choose the appropriate ‘controls’ depending on the type of risk posed by a hazardous product. Key points to consider in your decision making are:
Pharmacy professionals are expected to perform a risk assessment of each preparation they compound (or intend to) considering the applicable factors outlined in the guidance document and consulting additional references as necessary.
If there is uncertainty regarding the risk level to assign, defer to the higher standard in the interest of safety. The rationale to defend the pharmacy’s decision must be documented in the risk assessment along with supporting references. Procedures for mitigating risk must be documented on the Master Formulation Record and reviewed at least every 12 months.
Each prescription and patient situation must be assessed individually. In the event if it is necessary to compound a particular preparation requiring processes that are not currently in place within the pharmacy, the documentation should specify the potential risks of doing so, the extra steps that must be taken to mitigate the risks and references confirming that these steps actually will minimize risks to the quality of the product and safety of personnel.
Adapted from: https://www.cdc.gov/niosh/topics/hierarchy/default.html
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