ARCHIVED - Labelling of Professional Sample of Drugs
From the Drugs Directorate
February 11, 1994
This policy is to clarify the labelling requirements for professional samples of drugs.
Samples of drugs given to physicians, veterinary surgeons, dentists and pharmacists and intended for subsequent distribution to the consulting patient (or animal) must be labelled with all directions required for safe and effective use, as required for regular package sizes of prescription and nonprescription drugs. It is understood that the labelling detail required for a nonprescription drug may be greater than that required for a prescription drug.
"Labelling" or "label" includes any legend, word or mark attached to, included in, belonging to or accompanying any drug and is commonly understood to mean all packaging and product inserts.
"Adequate directions for use" means all information necessary for the proper and recommended use of the drug, including cautionary and warning statements.
A "sample" is considered to be a package of a drug provided free of charge.
Subsection C.01.048(1) of the Food and Drug Regulations permits the distribution of samples only when labelled in accordance with the Regulations.
There has been an incorrect perception that the labelling requirements for a sample are less stringent than those required for other package sizes of prescription or nonprescription drugs. The lack of a clear guideline has created inconsistency in labelling.
Dann M. Michols
National Pharmaceutical Strategy
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