Dicentra Special Alert – Update

March 31, 2011 By


The NHPD has confirmed that the 11 Schedule F Ingredient Regulatory Amendments previously expected this spring have been deferred to the fall of 2011 due to the current election. One exception to this may be the proposed amendment for Lovastatin, which may be released this week, but to date it has not been published in Canada Gazette.

The 11 substances which were recently assessed are listed below.

Health Canada is proposing that the following 4 substances be removed from Schedule F:

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

Health Canada is proposing that the Schedule F listings for the following 7 substances be modified such that the substances are permitted for sale without a prescription at certain doses or for certain indications:

  • Dimethyl sulfoxide
  • Dopamine and its salts
  • Gold and its salts
  • Levocarnitine and its salts and derivatives
  • Lovastatin
  • L-Tryptophan, when sold as a single ingredient
  • Uracil and its salts

Lovastatin: Moving forward with its own regulatory package. Health Canada is reviewing comments received until further to the Notice of Intent and undertaking further internal analysis.

We can be reached at 1-866-647-3279 or at dicentra.com