The current Federal Poison Prevention Packaging Act provides no exemption for unit dose or patient med paks. Unit dose packages are acceptable container systems for prescription drug delivery in certain applications. Unit dose packages are intended to be administered to the patient by a third party, preferably a licensed professional nurse. Collection of moisture within the package following exposure to heat or sudden changes in temperature is unacceptable. This policy statement is prepared and circulated to protect the public health relevant to prescription drug packaging systems, their contents, labeling and use.
Compliance is based on official compendium standards.