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CPSC RIN: 3041-AD18 Publication ID: 2012 
Title: ●Products Containing Imidazolines Equivalent to 0.08 Milligrams or More 
Abstract: Pursuant to the Poison Prevention Packaging Act of 1970, the Commission is considering a proposed rule that would require child-resistant ("CR") packaging for any over-the-counter or prescription product containing the equivalent of 0.08 milligrams or more of an imidazoline, a class of drugs that includes tetrahydrozoline, naphazoline, oxymetazoline, and xylometazoline, in a single package. Products containing imidazolines can cause serious adverse reactions, such as central nervous system ("CNS") depression, decreased heart rate, and depressed ventilation in children treated with these drugs or who accidentally ingest them. CPSC staff submitted a briefing package on the proposed rule for Commission consideration on January 11, 2012. The Commission found preliminarily that availability of 0.08 milligrams or more of an imidazoline in a single package, by reason of its packaging, is such that special packaging is required to protect children under 5-years-old from serious personal injury or illness due to handling, using, or ingesting such a substance. On January 18, 2012, the Commission voted unanimously to publish the proposed rule in the Federal Register. The proposed rule published on January 25, 2012, and the comment period ended on April 9, 2012. Staff is preparing for Commission consideration a briefing package on a final rule. 
Agency: Consumer Product Safety Commission(CPSC)  Priority: Substantive, Nonsignificant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations.
Legal Authority: Not Yet Determined 
Legal Deadline:  None
Timetable:
Action Date FR Cite
Staff Sent Briefing Package to Commission  01/11/2012   
Commission Decision  01/18/2012   
NPRM  01/25/2012  77 FR 3646 
NPRM Comment Period End  04/09/2012   
Commission Decision  12/00/2012   
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Undetermined 
Federalism: Undetermined 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Cheryl Osterhout
Project Manager
Consumer Product Safety Commission
Directorate for Health Sciences, 5 Research Place,
Rockville, MD 20850
Phone:301 987-2572
Email: costerhout@cpsc.gov

 
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