Notice: Prescription Drug List (PDL): Naproxen

June 4, 2014
Our file number: 14-105860-242

The purpose of this Notice of Consultation is to provide an opportunity to comment on the proposal to revise the listing for Naproxen on the Prescription Drug List (PDL). Only the human part of the PDL is proposed to be revised. The proposed wording of the new listing is:

• Drugs containing any of the following:
  • Naproxen or its salts
  • Naproxène ou ses sels
• Including (but not limited to)
• Qualifier
  • except when sold for oral use with a daily dose equivalent to 400 milligram (mg) naproxen base
• Effective Date
  • to be determined

Rationale:

The current listing on the PDL for naproxen reads as follows: "Naproxen and its salts, except when sold for oral use with a daily dosage of 440 mg". This qualifier only allows a naproxen salt form to be nonprescription. It is proposed that the current listing be revised to permit flexibility in using different salts, either individually or in combination with the naproxen base. There are no safety or effectiveness concerns in allowing this flexibility.

In conclusion, none of the prescription criteria outlined in section C.01.040.3 of the Food and Drug Regulations apply to Naproxen when sold for oral use with a daily dose equivalent to 400 mg naproxen base.

Additional information on how Health Canada determines prescription status (or nonprescription status) is available in the Guidance Document: Determining Prescription Status for Human and Veterinary Drugs.

Please send your comments to:

Health Canada
Prescription Drug Status Committee
Address Locator 3102C3
Holland Cross, Tower B
1600 Scott Street
Ottawa, Ontario
K1A 0K9

Telephone: 613-957-1058
Facsimile: 613-941-5035
E-mail: drug_prescription_status-statut_d'ordonnance_des_drogues@hc-sc.gc.caa

If all comments not in favour of this change can be addressed, a Notice of Intent to Amend will be posted on the Health Canada website. This Notice will address these comments and inform stakeholders of Health Canada's intention to revise the PDL. The actual revision to the PDL would be made six months from the date of the Notice of Intent to Amend and communicated to stakeholders through a Notice of Amendment.