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Answer :
Final answer:
The labeling requirements under the Tamper Evident Packaging Act include patient labeling, container labeling, and structured product labeling. These requirements ensure that patients have access to important information and help prevent tampering or misuse of products.
Explanation:
The labeling requirements under the Tamper Evident Packaging Act include several components:
- Patient Labeling: This includes medication guides for patients, which provide information about known serious side effects and directions for use.
- Container Label: The container or carton labels for biologicals must contain the product name, manufacturer's name, contact information, lot number, expiration date, recommended dose, and may include additional information such as storage conditions and preservatives.
- Structured Product Label (SPL): SPLs are publicly posted online and allow consumers to access accurate and up-to-date information about a product.
These labeling requirements ensure that patients have access to important information about the medicine they are using and help prevent tampering or misuse of products.
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