Treatments and age limits question

Is filler-dissolving medicine prescription-only?

The answer

Hyalase: prescription-only

Yes, for Hyalase. Hyalase, a hyaluronidase medicine, is listed as a prescription-only medicine. Dissolving cosmetic filler isn't one of its listed licensed uses, so using it that way is "off-label". The MHRA says prescribers can use medicines off-label, with extra responsibilities. The Department of Health describes hyaluronidase as a prescription medication that practitioners need timely access to, for responding to complications.

Where you live matters

Hyalase

UK

Prescription-only medicine

Its listed uses are to enhance permeation of subcutaneous or intramuscular injections, local anaesthetics and subcutaneous infusions, and to promote resorption of excess fluids and blood in the tissues.

Off-label use

MHRA guidance

Allowed, with extra responsibilities

The prescriber must be satisfied the use would better serve the patient than a licensed alternative, be satisfied there is a sufficient evidence base or experience of using the medicine, take responsibility for prescribing and overseeing the patient's care, keep records, and give the patient enough information about the proposed treatment.

Who may inject it

Medicines law, UK-wide

Administration restricted

Hyalase is a prescription-only medicine. Under the general rule in medicines law, it may only be injected by an "appropriate practitioner" (such as a doctor, a dentist, or an independent-prescribing nurse or pharmacist) acting within their legal powers, or by someone acting in accordance with that practitioner's directions. The regulations also contain some exemptions. Meeting this rule doesn't by itself mean someone is competent, insured or otherwise allowed to provide the treatment. Other professional and healthcare rules may apply.

Under-18s (England)

Botulinum Toxin and Cosmetic Fillers (Children) Act 2021

Offence, with defences

Injecting filler for a cosmetic purpose into anyone under 18 in England is an offence, subject to statutory defences. These cover registered doctors, some regulated health professionals acting on a doctor's directions, and anyone who took reasonable steps to check age and reasonably believed the person was 18 or over.

Fillers themselves

Classification can depend on the product

Proposed changes in England

The ASA doesn't treat dermal fillers as prescription-only medicines. In England, the draft regulations would restrict permanent (non-resorbable) face fillers to named healthcare professionals, and treat filler injected outside the face as cosmetic surgery, for doctors only. These are proposals.

What the law says

A person may not parenterally administer (otherwise than to himself or herself) a prescription only medicine unless the person isβ€” (a) an appropriate practitioner other than an approved country health professional; or (b) acting in accordance with the directions of such an appropriate practitioner.

Human Medicines Regulations 2012, regulation 214(2)

It is an offence for a person to administer, in England, to another person (β€œA”)β€” (a) botulinum toxin, or (b) a subcutaneous, submucous or intradermal injection of a filler for a cosmetic purpose, where A is under the age of 18.

Botulinum Toxin and Cosmetic Fillers (Children) Act 2021, section 1(1)

What this doesn't tell you

Whether a particular practitioner is trained or insured to treat filler complications. This page also isn't medical advice.

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Sources