Change in the classification of certain glucosamine containing products

Change in the classification of certain glucosamine containing products

November 6, 2018

Glucosamine containing products (GCPs), marketed as food supplements, with dosage levels of base glucosamine at 1178mg/day or higher can no longer be sold or supplied by pharmacy teams as they are now considered unauthorised medicines. It is important to note that under Regulation 47 of the Human Medicines Regulations 2012 it is an offence to sell or supply an unauthorised medicinal product (unless an exception applies). GCPs with a daily dose of base glucosamine at, or exceeding 1178mg/day are now regarded as medicines. In practice, this mainly affects food supplements which are marketed with daily dosage levels of 1500mg glucosamine sulphate or glucosamine hydrochloride1. GCPs that already have a valid marketing authorisation (for example, Dolenio) remain unaffected.

The reclassification follows a 2016 Court of Appeal Judgement, after which the Medicines and Healthcare products Regulatory Agency (MHRA) conducted a review to understand how and why glucosamine is used by consumers. The review found that GCPs are mainly used for medicinal purposes to treat symptoms of osteoarthritis of the knee and for general joint health. The evidence of pharmacological effect was then used to determine the dosage levels of base glucosamine (1178mg/day) at which GCPs cannot be sold without a valid marketing authorisation.

Information for Pharmacy Teams

MHRA have advised that affected GCPs should be removed from counter and dispensary shelves to avoid the inadvertent sale or supply of unauthorised medicinal products. Any prescriptions received for GCPs with a daily dose of base glucosamine at 1178mg which cannot be met by a licenced product should be referred back to the prescriber.

GCPs that can no longer be dispensed or sold over-the-counter as food supplements:

  • GCPs with a daily dose of base glucosamine at 1178mg/day or higher

GCPs that can legally be dispensed or sold over-the-counter as food supplements:

  • GCPs with a daily dose of base glucosamine less than 1178mg

 

If you require further information on this change, please contact borderline_medicine@mhra.gov.uk

For the MHRA news story go to the MHRA website here

 

1 1500mg glucosamine sulphate or glucosamine hydrochloride contain base glucosamine levels of 1178mg and 1246mg respectively.

Glucosamine sulphate is available in two salt forms; a sodium chloride and potassium chloride salt form. This means that, in practice, more than 1500mg of either salt form is added to achieve 1500mg of glucosamine sulphate and, therefore, a base glucosamine level of 1178mg.

In licensed medicines 1884.60mg of the sodium salt is added to achieve 1500mg/day of glucosamine sulphate, providing 1178mg of base glucosamine.

Glucosamine sulphate [2NaCl] contains 79.6% glucosamine sulphate and 62.5% base glucosamine.
Glucosamine sulphate [2KCl] contains 75.4% glucosamine sulphate and 59.2% base glucosamine.

 



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