Packaging

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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

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.

Having individual states impose distinct labeling rules would create confusion around critical health details printed on packaging.

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.

Child-resistant packaging is used to reduce the risk of poisoning in children via the ingestion of potentially hazardous items including certain prescription and OTC medications, pesticides, and household chemicals.

The advertising of nonprescription, over-the-counter medicines helps acquaint the public with these products and must be truthful, not misleading, and must meet high standards reflecting the nature of the product advertised.

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.

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