Schedule F Revisions Published

The long-awaited Schedule F revisions have been published in Canada Gazette II. Amendments to the Food and Drug Regulations have been made to 10 naturally sourced medicinal ingredients. Details are listed below.

The following 4 ingredients have been removed from Schedule F, allowing them to have nonprescription status:

• Apiol, oil of
• Deanol, and its salts and derivatives
• Theobromine and its salts
• Centella asiatica extract and active principles thereof

The entries for the following 3 ingredients: dopamine, gold and uracil, have been revised to the following providing exemptions to allow nonprescription status:

• Dopamine and its salts, when sold for administration by injection
• Gold and its salts and derivatives, when sold for administration by injection
• Uracil and its salts, when sold for the treatment of cancer

The entries for the following 3 ingredients: dimethyl sulfoxide, levocarnitine (L-carnitine)and L-tryptophan, have been revised to the following providing exemptions to allow nonprescription status:

• Dimethyl sulfoxide, for veterinary use or when sold for the treatment of interstitial cystitis or scleroderma in humans
• Levocarnitine (L-carnitine) and its salts and derivatives, when sold for the treatment of primary or secondary levocarnitine deficiency
• L-Tryptophan, when sold:

(a) for human use in oral dosage form at a concentration of more than 220 mg per dosage unit or per daily dose, as a single ingredient or in combination with other ingredients; or
(b) for human or veterinary use as a single ingredient intended for any route of administration other than oral.

Canada Gazette II Links:
http://www.gazette.gc.ca/rp-pr/p2/2011/2011-12-07/html/sor-dors273-eng.html
http://www.gazette.gc.ca/rp-pr/p2/2011/2011-12-07/html/sor-dors274-eng.html
http://www.gazette.gc.ca/rp-pr/p2/2011/2011-12-07/html/sor-dors275-eng.html

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