Regulator warns pharmacists to ensure patient safety when selling unregulated products

In a letter to pharmacy technicians and owners, the General Pharmaceutical Council has warned that non-medicinal and unlicensed products being supplied by pharmacies “have potentially caused serious harm”.
Headshot of Roz Gittins

Pharmacies selling unlicensed, unregulated products must ensure these items are safe for patients and the public by seeking assurances from the product supplier and/or completing their own due diligence, according to Roz Gittins, chief pharmacy officer at the General Pharmaceutical Council (GPhC).

In a letter sent to pharmacy technicians and owners on 9 April 2025, Gittins said that the GPhC had “received concerns relating to non-medicinal, unregulated, unlicensed products, including ‘Lemon Bottle’ and other products used for non-surgical cosmetic procedures, being supplied by community pharmacies, or being administered by pharmacists via injection in other settings”.

Gittins added that the concerns suggested “these products have potentially caused serious harm”.

Unlicensed, unregulated products are not licensed by the Medicines and Healthcare Products Regulatory Agency (MHRA), so they are not required to meet MHRA standards.

Therefore, the letter said: ”There are concerns that such products do not disclose the full ingredients or sufficient information about their contents, and there is limited or no clinical safety data available.”

As well as conducting due diligence, Gittins also advised pharmacy superintendents and owners to check that their indemnity arrangements cover the provision of the items.

They should also consider the risks of administering the product, particularly by injection, the letter said, adding that pharmacy superintendents and owners must also ensure that the packaging or promotional material does not make any medicinal claims, and staff must not make any such claims, either.

If their pharmacy chooses to offer complementary therapies, Gittins said pharmacists must ensure that staff have the knowledge, skills and training to do so, as well as appropriate indemnity cover.

Commenting on the advice, Wing Tang, head of professional standards at the Royal Pharmaceutical Society (RPS), said: “We are deeply concerned by the reports of non-medicinal, unregulated, unlicensed products being administered by pharmacists via injections, leading to serious harm in some cases. 

“The RPS does not support this use and notes the GPhC has warned the profession about the risks.

“Patient safety must remain priority across all healthcare settings, and pharmacy professionals must ensure they are adhering to the standards for pharmacy professionals at all times.”

Last updated
Citation
The Pharmaceutical Journal, PJ, April 2025, Vol 314, No 7996;314(7996)::DOI:10.1211/PJ.2025.1.353613

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