This article was updated on July 11, 2024 to provide clarity about labelling requirements.
Licensed pharmacies that dispense compounded preparations are reminded that advertising and labelling of compounded preparations must not include claims about the preparations.
Labelling and advertising for compounded preparations must not be false, misleading, or deceptive and must not encourage the misuse or inappropriate use of drugs or otherwise have the potential to compromise patient safety.[1] For example, packaging, labels, and advertisements must not mislead a consumer to believe that a compounded preparation is a commercially manufactured product.
ACP’s guidance and standards provide further information about proper labelling for compounds, including, but not limited to, the name of the drugs or ingredients used in the compounded preparation, strength, inclusion of pharmacy identification, and beyond use date. Refer to the Guidance document for pharmacy compounding of non-sterile preparations, the Model Standards for Pharmacy Compounding of Non-Hazardous and Hazardous Sterile Preparations, and Standards 7.5 and 21.3 of the Standards of Practice for Pharmacists and Pharmacy Technicians for more information about labelling requirements.
Licensees must ensure there are policies and procedures in place for labelling and packaging compounded preparations to ensure their pharmacy is meeting the requirements of applicable legislation and standards.
[1] As per section 9(1) of the Food and Drugs Act and section 24(1) of the Pharmacy and Drug Regulation.
