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ontario regulation 372/03

made under the

Ontario drug benefit act

Made: August 6, 2003
Filed: September 4, 2003
Printed in The Ontario Gazette: September 20, 2003

Amending O. Reg. 201/96


1. (1) Clause 9 (2) (b) of Ontario Regulation 201/96 is amended by adding “subject to subsection (3),” at the beginning.

(2) Section 9 of the Regulation is amended by adding the following subsection:

(3) An extemporaneous preparation described in clause (2) (b) is not designated as a pharmaceutical product if,

(a) it contains one or more of the following:

(i) alprostadil,

(ii) amphotericin B lipid complex,

(iii) ancestim,

(iv) azithromycin,

(v) baclofen,

(vi) calcitriol,

(vii) cefotaxime,

(viii) cephalothin,

(ix) clodronate,

(x) daclizumab,

(xi) danaparoid,

(xii) darbepoietin,

(xiii) deferoxamine,

(xiv) desmopressin,

(xv) dolasetron,

(xvi) epoetin alfa,

(xvii) epoprostenol,

(xviii) estradiol dienanthate/estradiol benzoate/testosterone enanthate benzilic acid hydrazone,

(xix) etanercept,

(xx) filgrastim,

(xxi) fludarabine,

(xxii) fondaparinux,

(xxiii) glatiramer acetate,

(xxiv) hepatitis A vaccine,

(xxv) hepatitis B vaccine,

(xxvi) infliximab,

(xxvii) interferon alfa-2b/ribavirin,

(xxviii) interferon beta 1-a,

(xxix) interferon beta 1-b,

(xxx) iron dextran,

(xxxi) ketorolac,

(xxxii) levofloxacin,

(xxxiii) mycophenolate mofetil,

(xxxiv) nandrolone decanoate,

(xxxv) octreotide,

(xxxvi) peginterferon alfa 2-b,

(xxxvii) somatrem,

(xxxviii) somatropin,

(xxxix) sumatriptan,

(xl) verteporfin, or

(xli) zoledronic acid;

(b) it contains one or more products listed in Parts III and XII of the Formulary, but the patient for whom the extemporaneous preparation is prescribed does not meet the criteria set out in the Formulary for the use of the component product or products; or

(c) it contains a product for which Health Canada provides a Notice of Compliance to the product’s manufacturer on or after September 4, 2003.