A teleconference meeting of the National Drug Scheduling Advisory Committee was held on Friday, August 30, 2002, for the express purpose of finalizing their review of the previous recommendation that DM in solid dosage forms be retained in Schedule III.
Participants
Committee members: Dr. Marilyn Caughlin (Chairman), Dawn Frail, Larry Lynd, Dr. Colleen Metge, and Dr. Jeff Taylor
Dr. Mark Armstrong was not included in this teleconference call as he had not participated in the June 1-2 2002 meeting when the original scheduling decision for DM was made.
Similarly, Phil Hudson and Joan Sayer did not participate in the previous August 12 teleconference meeting when the Committee initiated their review of the DM recommendation, so were not included in this meeting.
Consultant: Denis Belanger, Drug Information Specialist, Ottawa Valley Regional Drug Information
Service
The Chairman called the meeting to order at 9:45 am and asked for approval of the minutes of the previous meeting.
Dawn Frail, seconded by Dr. Jeff Taylor, moved that the minutes of the August 12, 2002 meeting be approved as circulated. Motion carried.
Dr. Caughlin then reminded Committee members about the purpose of the meeting, and reiterated the three decisions made at the previous meeting, as follows:
1. dextromethorphan in both liquid and solid dosage forms in package sizes containing more than 300 mg should remain in Schedule III, as originally recommended,
2. the original decision to allow for liquid dosage forms in package sizes containing up to and including 300 mg of dextromethorphan to be assigned Unscheduled status was confirmed
3. further information would be requested from McNeil before completing the review of the decision regarding solid dosage forms of dextromethorphan, and the specific review should be conducted as expeditiously as possible
Ms. Wells reported that she had sent a communication to McNeil inviting them to submit any further information but that none was forthcoming.
The Committee re-reviewed the material submitted by McNeil Consumer Healthcare, alleging that solid oral dosage forms of dextromethorphan presented no more or less a potential for abuse than liquid. After considering the McNeil submission, there was agreement that McNeil had made a compelling case to grant the same scheduling status to all oral dosage forms.
After considerable discussion:
Dawn Frail, seconded by Dr. Jeff Taylor, moved that dextromethorphan in all oral dosage forms in package sizes containing no more than 300 mg be assigned Unscheduled status. Motion carried.
Mrs. Wells indicated that this recommendation, resulting from the re-assessment, would be reported to the Executive Committee and that on approval, it would be effective immediately.
The Chairman then thanked Committee members for their diligence throughout this re-assessment. The meeting was adjourned at 10:15 am.