Health Canada Notice

02-102647-645

Advisory

March 7, 2002

To: Registrars of Pharmacy; Ms. Barbara Wells, NAPRA; Ms. Bonnie Salsman, CSHP

It has come to our attention that certain manufacturers are attempting to sell non-compliant drug products to pharmacists for compounding and dispensing purposes.  Whether they be solid oral dosage forms or powders for reconstitution, drug products sold in Canada must comply with the Food and Drugs Act and Regulations, including those provisions requiring Drug Identification Nubmers and Good Manufacturing Practices.  Sale of non-compliant products would be a violation of the Act.

The Canadian Society of Hospital Pharmacists (CSHP) and the National Association of Pharmacy Regulatory Authorities (NAPRA), in collaboration with the Health Products and Food Branch of Health Canada, developed a policy document, implemented in July 2000, to differentiate which products may or may not be legitimately sold to pharmacists for compounding and dispensing purposes.  It can be found on our web site at : http://www.hc-sc.gc.ca/hpb-dgps/therapeut and can be accessed in the ISSUED section of the POLICIES page.

It has also come to our attention that drug products in final dosage form without a valid Notice of Compliance are also being sold to pharmacists.  The sale of these non-compliant products would also be in violation of the Food and Drugs Act. 

Pharmacists who are in doubt as to the compliance status of drug products may contact the nearest Operational Centre of the Health Products and Food Branch Inspectorate (coordinates attched).

Thank you for your cooperation in ensuring that drug products sold in Canada are safe, effective and of high quality.

Yours sincerely,
Diane Gorman
Assistant Deputy Minister 

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