Rather than legislate additional state-level extended producer responsibility mandates aimed at packaging, lawmakers should support manufacturers already innovating sustainability solutions within the FDA's extensive regulatory framework that balances both environmental considerations and patient safety needs.
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.
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.
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.
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).
Under a voluntary program which began in November 2007, manufacturers of OTC oral pediatric cough and cold medicines should take the following steps in the labeling, packaging, and promotion of these medicines.
The objective of this guideline is to define the minimum stability data package to support the commercial distribution of OTC monograph drug products in the United States per climatic zone.
