According to figures provided by Industry Canada, the operating revenues of Pharmacies and drugs stores in Canada reached $ 27.2 billion in 2008, up from $ 24.8 billion in 2007. This was an increase of 9.6%. Since 1999, operating revenues have increased 5.3% per year on average. The operating revenues of the country’s pharmacies and drug stores is largely driven by sales with commissions, manufacturing sales, labor revenues and revenues from rental and leasing contributing the remaining. Canada drugs include both prescription and non prescription medicines, biologically derived products such as vaccines, serums and blood derived products, tissues and organs, disinfectants and radiopharmaceuticals The manufacturing and compounding of all Canada drugs in dosage form is to be done in compliance with the requirements of the Food and Drugs Act and associated regulations.
Canada Drugs: Manufacturing and Compounding
All manufactured Canada drugs can be sold in Canada only after receiving the necessary approvals from Health Canada. Each drug should have a Drug Identification Number (DIN) and a Notice of Compliance (NOC). Some products such as radiopharmaceuticals will not have a DIN. In addition, all fabricators, packagers, distributors, importers, testers and wholesalers need to get an Establishment License besides meeting the Good Manufacturing Practices (GMP) norms and other Food and Drug regulations.
However, in cases where a healthcare professional recommends customization of a medicine or drug to meet the special needs of a patient, compounding is recommended.
Compounding is a way of preparing custom drugs by combining the necessary ingredients. This activity is undertaken to meet the special needs of patients like his/her allergy to some preservatives, requirement of a different strength or flavor of the medicine to suit the patient. Compounding of drugs is also undertaken to reduce the side effects associated with the normal form of a medicine. For patients who have problems in swallowing a pill, a liquid form may be created.
According to the Canada Laws, compounding of drugs is a licensed or authorized act that falls within the scope of the practice of the professions such as pharmacy and medicine/dentistry/veterinary medicine or other healthcare professionals. The responsibility for risks arising from compounding activities is assumed by licensed healthcare professionals in the treatment and servicing of their patients.
Policy for Compounding of Canada Drugs
Canadian laws state that Compounding of Canada drugs must be a legitimate part of the practice of regulated healthcare professionals and should not be used as a means to bypass the federal drug review and approval system. Also all drug compounding and manufacturing activities are to be regulated and fall under the federal or the provincial/territorial jurisdiction. The authorities must take a decision on whether an activity is compounding or manufacturing on a case to case basis. Certain factors need to be considered in case of compounding of drugs in Canada:Compounding should be undertaken only if a patient-healthcare relationship exists.Appropriate risk management processes should be in place to manage the risks associated with the compounded product in line with the standards set by the regulatory bodies.A pharmacy may prepare drugs in limited quantities, in anticipation of a prescription.Compounding should be done only if there is a therapeutic need or lack of product availability and not solely for economic reasons for the healthcare professionals.The compounded product should not be a duplicate of an approved drug product.Compounding of Canada drugs should not be undertaken for sale to third parties who will in turn sell or deliver them to patients outside of their defined patient-healthcare professional relationship.Pharmacists who do not provide specific compounding services may contract this activity to a compounding pharmacist.The compounded product should be produced from an authorized drug or active pharmaceutical ingredients used in an authorized drug.Compounding of sterile products is only permitted in hospitals or other place where the necessary environment for making sterile products is in place.Compounded Canada drugs must comply with the provisions of the Food & Drugs Act.
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