Notice - Prescription Drug List (PDL): Hydrocortisone

December 24, 2014
Our file number: 14-115588-419

The purpose of this Notice of Amendment is to announce the revised listing for hydrocortisone on the Prescription Drug List (PDL). As stated in the Notice of Intent to Amend, posted June 25, 2014, the revision will allow hydrocortisone to be marketed as a nonprescription product when sold as a single medicinal ingredient that provides no more than 1.0% or less hydrocortisone in preparations for topical use on the skin. Only the Human part of the PDL has been revised.

The wording of the revised listing is:

Drugs containing any of the following:

• Adrenocortical hormones or their salts or derivatives

Including (but not limited to):

• hydrocortisone, hydrocortisone acetate, hydrocortisone valerate, hydrocortisone sodium succinate and clobetasone butyrate

Qualifier:

• Except:

• (a) hydrocortisone or hydrocortisone acetate, when sold as a single medicinal ingredient in a concentration that provides 1.0% or less hydrocortisone in preparations for topical use on the skin; or,
• (b) hydrocortisone or hydrocortisone acetate, when sold in combination with any other non prescription medicinal ingredient that provides 1.0% or less hydrocortisone in preparations for topical use on the skin; or,
• (c) clobetasone butyrate when sold in a concentration of 0.05% in cream preparations for topical use on the skin.

Effective Date: December 25, 2014

Should you have any questions on this update to the Prescription Drug List, please contact:

• Prescription Drug Status Committee
  Health Canada
  Holland Cross, Tower B, 2^nd Floor
  1600 Scott Street
  Address Locator 3102C3
  Ottawa, Ontario
  K1A 0K9
• Email: drug_prescription_status-statut_d'ordonnance_des_drogues@hc-sc.gc.ca
  Phone: 613-957-1058
  Fax: 613-941-5035