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Even if reclassified, it will not be FDA-approved it will simply be eligible for legal compounding with a prescription

New physical activity guidelines issued by UK Chief Medical Officers

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Bethesda: American Society of Hospital Systems Pharmacists, 2012:22362239

Consequently, neither NICE nor the Scottish Medicines Consortium (SMC) has issued guidance on its use, and it is not currently available through NHS prescribing pathways

The labdane class of chemicals is so-called because the original compound was isolated from labdanum which is a sticky resin obtained from Cistus ladanifer and Cistus creticus (commonly known as rockrose)