| | 10/29/2012 | http://www.cpsc.gov/Global/PDF/Statues/pppa.pdf
(100%)
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Summary:
Poison Prevention Packaging Act (PPPA)
| | | | | | | | 07/23/2012 | http://www.cpsc.gov/PageFiles/107555/01-pppa.pdf
(100%)
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Summary:
PPPA
| | | | | | | | 06/26/2012 | http://www.cpsc.gov/PageFiles/81191/pppa.pdf
(100%)
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Summary:
Products Containing Methacrylic Acid
| | | | | | | | 10/14/2008 | http://www.cpsc.gov/PageFiles/111246/pppa.pdf
(88%)
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Summary:
Poison Prevention Packaging Act, As Amended
| | | | | | | | 08/06/2012 | PPPA Petitions for Exemption
(84%)
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Summary:
PPPA Petitions for Exemption (pdf)
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Extract:
Poison Prevention Packaging Act PPPA Petitions for Exemption March 16, 2005 Suzanne Barone, Ph.D. Project Manager for Poison Prevention The views expressed in this presentation are those of the CPSC staff, have not been reviewed or approved by, and may not necessarily reflect the views of, the Commission. Examples of Exempted Products Powdered unflavored aspirin Effervescent aspirin Sublingual nitroglycerin Oral contraceptives Hormone replacement therapy Powdered iron preparations Effervescent acetaminophen Hydrocarboncontaining products where the liquid cannot flow freely. | | | | 08/06/2012 | PPPA Petitions for Exemption
(84%)
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Summary:
PPPA Petitions for Exemption (pdf)
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Extract:
Poison Prevention Packaging Act PPPA Petitions for Exemption March 16, 2005 Suzanne Barone, Ph.D. Project Manager for Poison Prevention The views expressed in this presentation are those of the CPSC staff, have not been reviewed or approved by, and may not necessarily reflect the views of, the Commission. Examples of Exempted Products Powdered unflavored aspirin Effervescent aspirin Sublingual nitroglycerin Oral contraceptives Hormone replacement therapy Powdered iron preparations Effervescent acetaminophen Hydrocarboncontaining products where the liquid cannot flow freely. | | | | 11/13/2012 | http://www.cpsc.gov/PageFiles/131787/imidazfinal.pdf
(82%)
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Summary:
Final Rule: PPPA Rule Requiring Child-Resistant Packaging for Imidazolines - November 8, 2012
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Extract:
A copy of the NPR is online at: http://www.cpsc.gov/businfo/frnotices/fr12/imidazolines.pdf. The Commission received five comments with none opposing the proposed rule. Several commenters requested more time to package their products in CR packaging. Two comments requested a stay of enforcement 12 months beyond the proposed 1-year effective date of a final rule. Another commenter requested that a metered nasal spray with a crimped-on cap be exempted from PPPA child testing because the commenter believes it is inherently child resistant. Staff addresses these and other comments in the briefing package. |
Extract:
pdf (Tab B) THIS DOCUMENT HAS NOT BEEN REVIEWED OR ACCEPTED BY THE COMMISSION. CLEARED FOR PUBLIC RELEASE UNDER CPSA 6(b)(1) 14 III. Effective Date The PPPA provides that no regulation shall take effect sooner than 180 days or later than 1 year from the date such regulation is issued, unless the Commission determines that an earlier effective date is in the public interest. For imidazolines, staff recommends an effective date of 1 year after the issuance of a final rule, with the opportunity for manufacturers to qualify for a conditional 1 year stay of enforcement due to the current lack of appropriate CR packages on the market and the need for manufacturers to design and develop new CR packages.
Extract:
Section 7 of the PPPA provides that, generally, when a special packaging standard issued under the PPPA is in effect, "no State or political subdivision thereof shall have any authority either to establish or continue in effect, with DRAFT 11/13/12 25 respect to such household substance, any standard for special packaging (and any exemption therefrom and requirement related thereto) which is not identical to the [PPPA] standard." 15 U.S.C. 1476(a). A state or local standard may be excepted from this preemptive effect if: (1) the state or local standard provides a higher degree of protection from the risk of injury or illness than the PPPA standard;
Extract:
Kameros, Attorney, OGC SUBJECT: Final Rule: PPPA Rule Requiring Child-Resistant Packaging for Imidazolines Ballot Vote Due: _________________ Staff prepared a briefing package recommending that the Commission issue the attached draft final rule pursuant to the Poison Prevention Packaging Act of 1970 (PPPA). The rule would require child-resistant (CR) packaging for any over-the-counter drug product containing the equivalent of 0.08 milligrams or more of an imidazoline (tetrahydrozoline, naphazoline, oxymetazoline, and xylometazoline) in a single package. | | | | 01/18/2012 | http://www.cpsc.gov/PageFiles/93525/imidazolines.pdf
(79%)
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Summary:
RCA - Notice of Proposed Rulemaking: PPPA Rule Requiring Child-Resistant Packaging for Imidazolines
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Extract:
Adler ITEM: Notice ofProposed Rulemaking: PPPA Rule Requiring Child-Resistant Packaging for Imidazolines (Briefing package dated January 11,2012) DECISION: The Commission voted unanimously (4-0) to approve publication of the draft proposed rule in the Federal Register. Pursuant to the Poison Prevention Packaging Act of 1970 ("PPPA"), the proposed rule would require child-resistant packaging for any over-the-counter or prescription drug product containing the equivalent of0.08 milligrams or more of an imidazoline (tetrahydrozonline, naphazoline, oxymetazoline and xylometazoline) in a single package. |
Extract:
PPPA Rule Requiring Child-Resistant Packaging for Imidazolines, Tab D, "Economic Analysis," at page 67. 3 CPSIA $ 233 (2008). analysis will never be needed or welcome in a PPP A rulemaking, but that it shall never be required. To me, the addition ofthis language to the PPPA is perfectly logical given the extensive fmdings that must be made in order for the Commission to move forward on any PPP A rulemaking. Specifically, prior to the CPSC establishing any standards for the "special packaging" ofany household substance, the Commission must find that: (1) the degree or nature of the hazard to children in the availability ofsuch substance, by reason of its packaging, is such that special packaging is required to protect children from serious personal injury or serious illness
Extract:
as a matter of law under the Regulatory Flexibility Act (RF A), review proposed rules for their potential economic impact on small entities, including small businesses.6 To me, this coupled with the findings required by the PPPA, satisfies our obligations to assess the impact ofour actions in the market. Unless some good reason is shown for further economic analysis, I find it difficult to justify expending scarce Commission resources to reach conclusions that are apparent without such analysis. While I look forward to comments on this proposed rule, I urge caution regarding the use ofour limited resources in this marmer in future rulemaking proceedings. 4 PPPA, 15 U.S.C. $ 1472 (3)(a)(1) (emphasis added).
Extract:
ADLER REGARDING THE NOTICE OF PROPOSED RULEMAKING REQUIRING CHILD-RESISTANT PACKAGING FOR IMIDAZOLINES January 19, 2012 The Poison Prevention Packaging Act of 1970 (PPPA), 15 U.S.C. 1471 et seq., has been one ofthe great successes in the history ofthe Consumer Product Safety Commission (CPSC) evidenced by the 84% decrease in pediatric poisoning fatalities since 1972.1 Accordingly, I was pleased to recently vote to approve a Notice of Proposed Rulemaking that would require child-resistant packaging on products containing Imidazolines equivalent to 0.08 milligrams or more. In my opinion, the data provided by CPSC staff provides a solid basis for a preliminary fmding that such packaging is technically feasible, practical, and appropriate. | | | | 11/20/2012 | http://www.cpsc.gov/PageFiles/133435/imidazolinefinal.pdf
(78%)
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Summary:
Final Rule: PPPA Rule Requiring Child-Resistant Packaging for Imidazolines
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Extract:
Adler ITEM: Final Rule: PPPA Rule Requiring Child-Resistant Packaging for Imidazolines (Briefing package dated November 8, 2012, OS No. 4734) DECISION: The Commission voted unanimously (3-0) to approve publication of the final rule as drafted in the Federal Register. Pursuant to the Poison Prevention Packaging Act of 1970 ("PPPA"), the final rule requires child-resistant packaging for any over-the-counter or prescription drug 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. | | | | 07/13/2012 | Poison Prevention Packaging Act
(78%)
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Summary:
Disclaimer Poison Prevention Packaging Act The Purpose of the PPPA Enacted in 1970, the PPPA (available in PDF and Text), requires a number of household substances to be packaged in child-resistant packaging. The packaging required by the PPPA | | | |
Extract:
Documents Relating to the PPPA Drugs dispensed for household use in clinical trials (pdf) The PPPA is available above in text and PDF format. PDF (Portable Document Format) requires use of Adobe Acrobat Reader.The PDF version of the PPPA has a clickable hyperlinked table of contents. To activate this feature, open the document in Acrobat Reader, click on the Navigation Pane icon, next to the printer icon. If the table of contents does not appear, click on the "Bookmarks." tab. The statutory citations in red are clickable hyperlinks to the statutory text.All five statutes are available in a single book, with an index, from the Office of the Secretary, Consumer Product Safety Commission, Washington, D. |
Extract:
The Purpose of the PPPA Enacted in 1970, the PPPA (available in PDF and Text), requires a number of household substances to be packaged in child-resistant packaging. The packaging required by the PPPA must be designed or constructed to be significantly difficult for children under five years of age to open within a reasonable time, and not difficult for normal adults to use properly. For the sake of the elderly and handicapped who might have difficulty opening such containers, the Act provides that a regulated product available for purchase on store shelves may be packaged in one non-complying size provided it carries a warning that it is not recommended for use in households with children, and provided that the product is also supplied in complying popular size packages.
Extract:
However, the CPSC regulates the child-resistant packaging for certain drugs as required by the Poison Prevention Packaging Act (PPPA). If any drug, for children or adults, is required by a CPSC regulation to be in child-resistant packaging, the importer or the domestic party that packages the children's drug must issue a certificate of conformity with the special packaging requirements of the PPPA. Does a dosing cup or similar device that accompanies a children's drug need a certificate of compliance? No. A dosing cup or similar device that accompanies a children's drug is not a "children's product" under the new CPSIA because it is not a consumer product.
Extract:
However, a dosing dropper that can be used in lieu of a cap as a closure mechanism on a children's drug would be subject to the PPPA's special packaging requirements and require certification. Who must certify that a substance required to be in special packaging is properly packaged? The importer or the domestic party that packages a PPPA regulated substance in special packaging must issue the general conformity certificate. The child resistance and senior friendly testing data (also known as protocol data) obtained in accordance with the procedures described under 16 C.F.R. 1700.20 may be used by the importer or domestic packager to support its certification. | | |
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