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The proper application/usage, scope, and cause for revisions of the <661> suite of chapters is not clear nor intuitive which is a concern given the potential impact.

Sep 28, 2018


In general, CHPA supports FDA's intent to harmonize the requirements for Rx and OTC products and make them consistent with long-standing Agency policy.

Mar 22, 2016


CHPA is generally supportive of the revision proposal to update and clarify the Chapter. We would however request that the implementation be delayed for 24 months.

Jul 30, 2015


The proposed rule will require child-resistant packaging for OTC and prescription products containing the equivalent of 0.08 milligrams or more of an imidazoline.

Apr 9, 2012


In order to ensure the continued safe reporting of adverse events associated with our member's products and prevent consumer confusion, we strongly believe OTC and dietary supplement product incident reports should not be included in the CPSC safety incident database.

Jul 20, 2010


CHPA and its member companies have an interest and expertise in dosage delivery devices and support FDA's efforts to develop guidance for industry on this important topic.

Feb 2, 2010


The undersigned trade associations are writing to request that the Commission exercise enforcement discretion with respect to the new general conformity certification requirement imposed by the Consumer Product Safety Improvement Act of 2008 (CSPIA).

Oct 29, 2008


CHPA welcomes the opportunity to comment on the proposed rule change on labeling requirements for OTC human drugs.

Mar 23, 2007


CHPA seeks clarification concerning FDA’s interpretation of the recordkeeping requirement as applied to packaging manufacturers and distributors.

Jul 7, 2003

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