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AgVetLink: Number 51, August 2005

Sale or use of old product

The ACVM Group has had a number of enquiries about the legal status of old product.

Some products, like most veterinary medicines, have specific expiry dates. Other products, like most plant compounds and vertebrate toxic agents, have a ‘best used by’ date.  In either case, the simple answer is that neither sale nor use of old product is a breach of the conditions of registration or the ACVM Act, but this answer needs some explanation.

Product stability

The ACVM Group assesses trade name products for registration on the basis of the chemistry and manufacturing information provided, including the stability of the product over time. The risks are assessed for the product before it deteriorates. Over time products can change in composition or concentration.

The ACVM Group imposes a limited time in which a person can use the product with confidence. This limited time is based on the stability data provided when the product was registered. Consequently, the assessments may not be relevant after that time.

Use of old product

While it is not illegal to use old product, nothing should be assumed about the efficacy, safety or prudent withholding period for product that has not been used before the expiry of that period. In effect, the ACVM Group assessment of the product may not be relevant any longer and it should not be used to support use beyond that time.

Prudent action would be to either not use the product or to check with the registrant to see if it would still be appropriate to use it. Registrants are usually helpful in this regard but sometimes they may be reluctant to give advice because it may create liabilities for themselves that they are not prepared to accept. 

The ACVM Group would advise that, if product has not been used before the expiry date or the ‘best used by’ date, then the product should not be used.

If it is inappropriate to use the product, then it should be disposed of carefully and in a way that is consistent with obligations under other legislation such as the Hazardous Substances and New Organisms and Resource Management Acts and local authority requirements. It should not be kept if it should not be used.

Sale of product after the expiry date or use by period

Sale of old product is not a breach under the ACVM Act. However, the ACVM assessment may not be relevant and the seller would be offering for sale a product that has no supporting information or assurances in regard to safety, potential residues or effectiveness. While this is not an offence under the ACVM Act, it may be one under the Fair Trading Act, especially if anything goes wrong.

Use or sale after registration is cancelled or expired

It is illegal to use or sell product after the product’s registration has expired or has been cancelled. Such products are unregistered. Registrants are advised that they must not supply any more product from their stores.

As for product that is already in the marketplace or has already been purchased, the ACVM Group provides a 12-month grace period in which that product may be sold and used to clear stock-in-trade. After that time further sale or use would be illegal.