manufacturing

Question 1

Who can compound without an establishment license?

Answer 1

• NOT required by a pharmacist, practitioner, or a person compounding under supervision of a practitioner, pursuant to a prescription
• NOT required by a Public Hospital or Public Health Institution when preparing medications for their own patients, or for another hospital/health institution

Question 2

What are the risk levels?

Answer 2

Risk Levels:
Level A: Simple to moderate compounds - separate space designated for compounding
Level B: Complex compounds or small qty of ingredients or preps that require ventilation and compounded occasionally
Level C: Hazardous drugs in NIOSH Group 1. Hazardous materials by WHMIS which represent a health hazard (irritating to respiratory tract, skin or mucous membrane). NIOSH group 2 or 3 for which large quantities of API are used

Question 3

Hazardous drugs are further divided into:

Answer 3

-Group 1:Antineoplastic drugs- These drugs may also pose a reproductive risk for susceptible populations (aka: TABLE 1)
-Group 2: Non-antineoplastic drugs that meet one or more of the NIOSH criteria for a hazardous drug. Note that some of these drugs may also pose a reproductive risk for susceptible populations(aka: TABLE 2)
-Group 3: Drugs that primarily pose a reproductive risk to men and women who are actively trying to conceive and women who are pregnant or breast feeding, because some of these drugs may be present in breast milk(aka TABLE 3).