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Notice Board

National Drug Scheduling Advisory Committee (NDSAC) Meeting scheduled

The next meeting of the National Drug Scheduling Advisory Committee (NDSAC) is scheduled for Monday, June 9, 2008.  The primary purpose of the meeting is to consider a request for Unscheduled status for naproxen sodium 220 mg for oral administration, pending final amendment of Part I of Schedule F to the Food and Drugs Regulations to remove naproxen and its salts when sold for oral use with a daily dose of 440 mg.

 

Individuals, companies or organizations seeking Interested Party status (see http://www.napra.org/docs/0/92/116/119.asp) for this matter are invited to contact NAPRA as soon as possible.  All requests for Interested Party standing must be submitted in writing to Barbara Wells, NDSAC Secretary via e-mail at wells@magma.ca or fax at 613-233-0343 no later than Friday, April 25, 2008.   

 

For more information, please contact Barbara Wells, at 613-233-0348.

 

NDSAC Initial Recommendations for: levonorgestrel, benzoyl peroxide, and famotidine (April 6-7, 2008)

A meeting of the National Drug Scheduling Advisory Committee (NDSAC) was held on April 6-7, 2008 with the following Initial Recommendations made:

 

  • Levonorgestrel (when sold in concentrations of 1.5 mg per oral dosage unit, packaged and labelled for emergency contraception, in package sizes containing no more than 1.5 mg of levonorgestrel) - Schedule III, pursuant to removal from federal Schedule F.
  • Levonorgestrel (when sold in concentrations of 0.75 mg per oral dosage unit to be taken as a single dose of 1.5 mg, packaged and labelled for emergency contraception, in package sizes containing no more than 1.5 mg of levonorgestrel) - Schedule III (from Schedule II).
  • Levonorgestrel when sold in concentrations of 0.75 mg per oral dosage unit (except when labelled to be taken as a single dose of 1.5 mg and in package sizes containing no more than 1.5 mg levonorgestrel, packaged and labelled for emergency contraception) – retain in Schedule II.
  • Benzoyl peroxide (preparations of 5% or less, as a single ingredient) - Unscheduled (from Schedule III)
  • Famotidine and its salts (when sold in concentrations of 20 mg or less per oral dosage unit and indicated for the treatment of heartburn, in package sizes containing more than 600 mg of famotidine)  - Schedule III (from current Schedule II)

 

Any objections to these Initial Recommendations must be received by the NAPRA office by May 14, 2008.  Questions or comments should be directed to the interim Executive Director of NAPRA, Jim Dunsdon, at (613) 569-9658 ext. 224 or jdunsdon@napra.ca.  

 

National Drug Scheduling Advisory Committee (NDSAC) Recruitment Notice - Deadline for nominations extended until May 2, 2008 (click here)  (March 27, 2008)

 

National Drug Scheduling Advisory Committee Meeting - March 9 - 10, 2008 (updated March 26, 2008)

NOTICE: The meeting of the National Drug Scheduling Advisory Committee planned for March 9-10 was cancelled due to weather conditions affecting travel.  The new meeting date is April 6-7, 2008.

 

 

NDSAC Review of Ranitidine and its salts  (March 7, 2008)

 

The initial recommendation made by National Drug Scheduling Advisory Committee (NDSAC) on January 25, 2008 for the Schedule III placement of Ranitidine and its salts, when sold in concentrations of 150 mg or less per oral dosage unit and indicated for the treatment of heartburn, in package sizes containing more than 4,500 mg of ranitidine was finalized by NAPRA’s Executive Committee on March 7, 2008.  The National Drug Schedules will be revised accordingly.

 

NDSAC Initial Recommendations on Ranitidine 150 mg (in package sizes containing more than 4,500 mg of ranitidine) (January 29, 2008)

A teleconference meeting of the National Drug Scheduling Advisory Committee (NDSAC) was held on January 25, 2008 to consider additional information requested by the Committee from the sponsor in regards to their request in December 2007 to move ranitidine 150mg (in package sizes containing more than 4,500 mg) from Schedule II to Schedule III.

The following Initial Recommendation was made:

  • Ranitidine and its salts, when sold in concentrations of 150 mg or less per oral dosage unit and indicated for the treatment of heartburn, in package sizes containing more than 4,500 mg of ranitidine -  Schedule III (from Schedule II)

Any objections to these Initial Recommendations must be received by the NAPRA office by February 29, 2008.  Questions or comments should be directed to the Executive Director of NAPRA, Karen Wolfe, at (613) 569-9658 ext. 225 or kwolfe@napra.ca .

 

National Drug Scheduling Advisory Committee Meeting - March 9 - 10, 2008 (posted January 10, 2008)

 

The next meeting of the National Drug Scheduling Advisory Committee (NDSAC) is scheduled for March 9th and 10th, 2008.  The primary purpose of the meeting is to consider the following matters:

 

·          Request for a change in scheduling of benzoyl peroxide, in concentrations of 5% or less when sold as a single ingredient – from Schedule III to Unscheduled.

 

·          Request for a change in scheduling of famotidine and its salts. (when sold in concentrations of 20 mg or less per oral dosage unit and indicated for the treatment of heartburn, in package sizes containing more than 600 mg of famotidine) from Schedule II to Schedule III.

 

Individuals, companies or organizations seeking Interested Party status (see http://www.napra.org/docs/0/92/116/119.asp) for either of these agenda item are invited to contact NAPRA as soon as possible.  All requests for Interested Party standing must be submitted in writing to Karen Wolfe, NAPRA Executive Director at the NAPRA office in Ottawa or via e-mail at ndsac@napra.ca by January 24, 2008.

 

For more information, please contact Karen Wolfe, at 613-569-9658 ext. 225.

 

 

NDSAC Review of Ranitidine and its salts, December 2007

 

The National Drug Scheduling Advisory Committee (NDSAC) met on  December 2nd, 2007  to consider the following matter:

  • Ranitidine and its salts, when sold in concentrations of 150 mg or less per oral dosage unit and indicated for the treatment of heartburn, in package sizes containing more than 4,500 mg of ranitidine -  from Schedule II to Schedule III

The Committee requested additional information from the sponsor prior to finalizing a decision.  The Committee is reserving their initial recommendation until such time as they are in receipt of and can consider additional information.

 

 

NDSAC Final Recommendations on Ibuprofen 400mg

 

The initial recommendations made by National Drug Scheduling Advisory Committee (NDSAC) on September 16 and 17, 2007 for the scheduling of:

  • Ibuprofen and its salts in strengths not to exceed 400 mg per oral dosage unit - Unscheduled (from Schedule III)

Were finalized effective November 2, 2007.  Final approval of the initial recommendation was made by NAPRA'S Executive Committee, in consideration of comments received during the 30 day review period.  The National Drug Schedules will be revised accordingly.

 

 

 

NDSAC Welcomes Two New Members

 

NDSAC recently appointed two new members Kim Abbass and Dr. Peter Zed replacing Dr. Anita Carrie and Phil Hudson.

Ms. Abbass is a health professional with many years of experience in both the private and the public sector.  A graduate of Dalhousie University’s College of Pharmacy,  her career has taken her from managing a pharmacy to inaugurating and teaching the Pharmacy Assistant program for the Cape Breton Business College, to Cardiovascular Resource Division Specialist for a leading research-based pharmaceutical company   She is currently a pharmacist with the Sobey’s Pharmacy Group and a Chief Examiner with the Pharmacy Examining Board of Canada.

 

Dr. Zed is a respected, award-winning practicing Doctor of Pharmacy.  He is currently the Clinical Coordinator - Emergency Medicine at the Queen Elizabeth II Health Sciences Centre in Halifax, and an Associate Professor at both the College of Pharmacy and at the Department of Emergency Medicine at Dalhousie University.  An accomplished clinician, teacher, and researcher, with many publications and awards to his credit who has served on many committees, he is licensed in Nova Scotia and holds a Pharmacy Examining Board of Canada certificate.

 

We welcome these two new members and thank Dr. Carrie and Mr. Hudson for their dedicated service to NDSAC.

 

 

Request for Comments:  Revised Scheduling Factors (October 10, 2007)

 

In 2002, NDSAC members began a process to edit the current drug scheduling factors with the objective of clarifying their intent. Since that time, NDSAC has continued to refine the scheduling factors on an ongoing basis. The factors have been tested following each scheduling recommendation made over the past year to ensure the proposed changes both preserve and clarify the intent of the factors for the Committee’s deliberations. The Committee has been satisfied with the results of the pilot, and is circulating the draft factors externally for review and comment (please click here). The existing factors are available on the NAPRA website at http://www.napra.ca/docs/0/92/112/154/140.asp#factI.

 

Your written comments are greatly appreciated, and can be sent directly to Karen Wolfe, Executive Director at kwolfe@napra.ca by Monday December 10th, 2007. Comments will be circulated at the March 2008 NDSAC meeting, and final changes to the scheduling factors will be considered by the NAPRA Board of Directors at their April 2008 meeting.

 

 

 

National Drug Scheduling Advisory Committee Meeting – December 2-3, 2007 (October 5, 2007)

 

The next meeting of the National Drug Scheduling Advisory Committee (NDSAC) is scheduled for December 2nd and 3rd, 2007.  The primary purpose of the meeting is to consider the following matters:

  • Ranitidine and its salts, when sold in concentrations of 150 mg or less per oral dosage unit and indicated for the treatment of heartburn, in package sizes containing more than 4,500 mg of ranitidine -  from Schedule II to Schedule III

Individuals, companies or organizations seeking Interested Party status (see http://www.napra.org/docs/0/92/116/119.asp) for either of these agenda item are invited to contact NAPRA as soon as possible.  All requests for Interested Party standing must be submitted in writing to Karen Wolfe, NAPRA Executive Director at the NAPRA office in Ottawa or via e-mail at ndsac@napra.ca by October 18, 2007.

 

For more information, please contact Karen Wolfe, at 613-569-9658 ext. 225.

 

 

 

NDSAC Initial Recommendation on Ibuprofen 400 mg (September 21, 2007)

 

A meeting of the National Drug Scheduling Advisory Committee (NDSAC) was held on September 16 and 17, 2007 with the following Initial Recommendation made:

·          Ibuprofen and its salts in strengths not to exceed 400 mg per oral dosage unit - Unscheduled (from Schedule III)

 

Any objections to this Initial Recommendation must be received by the NAPRA office by October 21, 2007.  Questions or comments should be directed to the Executive Director of NAPRA, Karen Wolfe, at (613) 569-9658 ext. 225 or kwolfe@napra.ca. 

 

 NDSAC Initial Recommendations on Levonorgestrel 0.75 mg and Levonorgestrel 1.5 mg - deferred

A decision regarding the scheduling of levonorgestrel 0.75 mg and levonorgestrel 1.5 mg is deferred until the March 2008 meeting of NDSAC.

 

 

NDSAC Final Recommendations on topical diclofenac in concentrations of not more than 1% diclofenac and 50% Isopropyl myristate (July 19, 2007)

 

The initial recommendations made by National Drug Scheduling Advisory Committee (NDSAC) on June 10 and 11, 2007 for the scheduling of:

·          Diclofenac diethylamine in preparations for topical use on the skin in concentrations of not more than the equivalent of 1% diclofenac – Schedule III

 

(Note:  Schedule III status is pending final amendment of Part I of Schedule F to the federal Food and Drugs Regulations to remove diclofenac and its salts for topical use on the skin in concentrations of not more than the equivalent of 1% diclofenac.  This change may not occur until late 2007 or early 2008.  This scheduling decision will only apply to the diclofenac diethylamine salt.)

 

 ·          50% Isopropyl myristate for use in the treatment of head lice – Schedule III

were finalized effective July 19, 2007.  Final approval of the initial recommendations were made by NAPRA’s Executive Committee, in consideration of comments received during the 30 day review period.  The change to the National Drug Schedules (NDS) for the isopropyl myristate is effective immediately while the change to the NDS for diclofenac diethylamine is pending Health Canada’s regulatory amendment for this drug.

 

 

 

NDSAC Recruitment Notice (click here)  (July 4, 2007)

 

 

NDSAC Recruitment Notice (click here)  (June 22, 2007)

 

 

Request for Comments:  Revised Scheduling Factors

 

On May 1st, 2007 revised scheduling factors were circulated to stakeholders for review and feedback to be supplied to NAPRA by June 1st, 2007.

 

Due to the important nature of this consultation, and the need for a comprehensive guidance document to assist stakeholders in this process, this consultation has been suspended for the time being.  It is anticipated this consultation will commence again in earnest in the fall of 2007.

 

Thank you to those stakeholders that have provided feedback to date.  We look forward to your participation in the future.

 

 

Scheduling Status Finalized for Fexofenadine and Loperamide (April 11, 2007)

 

The initial recommendations made by the National Drug Scheduling Advisory Committee (NDSAC) on March 8, 2007 to revise the scheduling of:

 

·          fexofenadine HCl (in products marketed for adult use – 12 years and older) - moved to Unscheduled status

 

·          fexofenadine HCl (in products marketed for paediatric use – under 12 years of age) - retained in Schedule III

 

·          loperamide and its salts in products marketed for adult use – 12 years and older - Unscheduled

 

·          loperamide and its salts in products marketed for paediatric use – under 12 years of age – Schedule II

 

were finalized effective April 11, 2007. Final approval of the initial recommendations were made by NAPRA’s Executive Committee, in consideration of comments received during the 30 day review period. The National Drug Schedules will be revised accordingly.

 

 

Final Decision on Schedule Status of Diphenhydramine (March 8, 2007) 

 

At the request of NAPRA’s Executive Committee, the National Drug Scheduling Advisory Committee (NDSAC) conducted a reassessment of its December 2006 Initial Recommendation in regard to Diphenhydramine.  The sponsor had submitted a revised request, for consideration of:

 

single entity 25 mg oral diphenhydramine and its salts for the treatment of allergies in adults and children over 12 years of age

 

This reassessment took place at the March 4, 2007 meeting of NDSAC. Upon further review and application of the scheduling factors, the Committee affirmed its recommendation that the current National Drug Schedule listing remain unchanged as:

 

Diphenhydramine and its salts and preparations (except for parenteral or topical use) – Schedule III

 

On March 7, 2007 NAPRA’s Executive Committee approved this recommendation from NDSAC.  For more information, please contact Karen Wolfe, Interim Executive Director of NAPRA, at 613-569-9658 ext. 225 or kwolfe@napra.ca.

 

 

 

Scheduling Status Finalized for Ranitidine 150 mg and Famotidine 20 mg (January 10, 2007)

 

The Initial Recommendations made by the National Drug Scheduling Advisory Committee (NDSAC) on December 3-4, 2006:

 

·          Ranitidine and its salts, when sold in concentrations of 150 mg or less per oral dosage unit and indicated for the treatment of heartburn, in package sizes containing no more than 4,500 mg of ranitidine -  Unscheduled*

 

·          Ranitidine and its salts, when sold in concentrations of 150 mg or less per oral dosage unit and indicated for the treatment of heartburn, in package sizes containing more than 4,500 mg of ranitidine -  Schedule II*

 

* Subject to federal deregulation as described in Health Canada’s Notice of Intent - Project No. 1510 - proposal to amend Part I of Schedule F to the Food and Drug Regulations to revise the listing for ranitidine and its salts to “Ranitidine and its salts, except when sold in concentrations of 150 mg or less per oral dosage unit and indicated for the treatment of heartburn”.

·         Famotidine and its salts, when sold in preparations for oral use containing 20 mg or less of famotidine per dosage unit and indicated for the treatment of heartburn, in package sizes containing no more than 600 mg of famotidine -  Unscheduled+

 

·          Famotidine and its salts, when sold in preparations for oral use containing 20 mg or less of famotidine per dosage unit and indicated for the treatment of heartburn, in package sizes containing more than 600 mg of famotidine -  Schedule II+

 

+Subject to federal deregulation as described in Health Canada’s Notice of Intent – Project No. 1496 - proposal to amend Part I of Schedule F to the Food and Drug Regulations to revise the listing for famotidine and its salts to “Famotidine and its salts, except when sold in preparations for oral use containing 20 mg or less of famotidine per dosage unit and indicated for the treatment of heartburn”.

 

were finalized effective upon federal deregulation from Schedule F. Final approval of the Initial Recommendations was made by NAPRA's Executive Committee on January 10, 2007 in consideration of comments received during the 30 day period of review.

 

 

 

Changes in NDSAC’s Membership (October 5, 2006)

 

The National Association of Pharmacy Regulatory Authorities (NAPRA) would like to express its appreciation to Dr. Jeff Taylor on the conclusion of his term of service to NDSAC. In the six years that Dr. Taylor was affiliated with NDSAC, he served as a member, Vice-Chair and Chair of the Committee. We gratefully acknowledge Dr. Taylor's contributions to both the Committee and NAPRA.

 

NAPRA is very pleased to welcome Drs. Nancy MacDonald and Anita Carrie to NDSAC for three-year appointments. Dr. MacDonald worked in community and hospital pharmacy practice, undergraduate and clinical teaching, and as Director of a regional Drug Information Centre before beginning a career of more than 20 years with a major manufacturer of nonprescription drugs in Canada. During the latter, Dr. MacDonald was a frequent participant and representative of the industry in the development of provincial and federal regulatory policies pertaining to nonprescription drugs in Canada. Although officially retired from that role in 2003, she continues to work as an independent consultant accepting periodic assignments which match her healthcare interests and experience.

 

Dr. Carrie is an Assistant Professor with the Faculty of Pharmacy and Pharmaceutical Sciences at the University of Alberta (Edmonton), and a Fellow of the Institute of Health Economics. She has 16 years of practice experience in both community and hospital settings and currently teaches in the area of drug information, evidence-based medicine, and pharmacoepidemiology. Her research interests include access and quality-of-care issues related to pharmaceutical use at the population level. Dr. Carrie’s term commences in December 2006.

 

To see a list of all NDSAC Members and Observers, please click here.

 

 

Scheduling Status Changes Approved for Polymyxin B (ophth), Gramicidin (ophth), Bacitracin (ophth) and Lidocaine (otic) (August 9, 2006)

 

The Initial Recommendations made by the National Drug Scheduling Advisory Committee (NDSAC) on June 11-12, 2006 to revise the scheduling of:

 

·          Polymyxin B and its salts and derivatives (for ophthalmic use) – Schedule III

 

 

·          Gramicidin and its salts and derivatives (for ophthalmic use) - Schedule III

 

 

·          Bacitracin and its salts and derivatives (for ophthalmic use) – Schedule III

 

 

·          Lidocaine and its salts (for otic use) – Schedule III

 

 

were finalized effective August 9, 2006. Final approval of the Initial Recommendations was made by NAPRA's Executive Committee, in consideration of comments received during the 30 day period of review. The National Drug Schedules will be amended accordingly.

 

Scheduling Status Changes Approved for Nicotine Lozenge and Diphenhydramine Topical Preparations (May 24, 2006)

The Initial Recommendations made by the National Drug Scheduling Advisory Committee (NDSAC) on March 26-27, 2006 to revise the scheduling of:

 

 

·          Nicotine and its salts (when sold in a form to be administered orally as a lozenge containing 4 mg or less of nicotine per lozenge) - Unscheduled

 

(Note:  Unscheduled status is pending final amendment of Part I of Schedule F to the Food and Drug Regulations to remove nicotine from Schedule F, when administered by an oral lozenge containing 4 mg or less of nicotine per lozenge – Project #1370)