How do I determine if a product is listed as a health hazard under the Hazardous Products Act? How do I use the product’s safety data sheet to determine the hazards identified with that product?

Schedule 2 of the Hazardous Products Act (HPA) lists the health hazard classes, not individual products. The health hazard(s) for an active pharmaceutical ingredient (API) are identified on its safety data sheet under Section 2 – Hazards Identification.

The health hazard classes can be identified by a pictogram (see an example below), which also appears on the API’s label.

Safety data sheets provide information about a product’s risks and include recommended preventive measures to protect staff, such as engineering controls and personal 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 in the safety data sheet must be interpreted and applied in the context of the pharmacy’s compounding practice. Compounding supervisors must consider the potential exposure of both staff and patients to the product (e.g., the physical and characteristics and chemical properties of the API, the frequency and duration of manipulation, and the potential for contact).

Note: Safety data sheets are available from the API supplier or through the Canadian Centre for Occupational Health and Safety and are updated every three years. They should be readily accessible and retrievable, and kept in a location known to all pharmacy personnel.

Manufactured drugs approved by Health Canada (i.e., those with a drug identification number [DIN]) are exempt from the HPA and therefore do not have safety data sheets. If a Health Canada–approved drug is used in a preparation, the safety data sheet for the API(s) in that drug should be consulted. The drug’s product monograph should also be considered, as it includes information on storage, stability and disposal and special handling instructions

If a compound is made up of more than one API or drug, then all of the available safety data sheets and product monographs (if applicable) must be consulted to complete your risk assessment.

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. Note that where the guidance document uses the language of “should,” it may be acceptable to meet the required standard using other technologies, techniques, materials and procedures than those suggested only if they have been proven to be equivalent or superior to those described in the guidance document.