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IACP and National Pharmacy Associations Protest eLabeling Requirements

Tuesday, May 19, 2015   (0 Comments)
Posted by: Dagmar Anderson
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The International Academy of Compounding Pharmacists (IACP), in collaboration with the Academy of Managed Care Pharmacy (AMCP), National Alliance of State Pharmacy Associations (NASPA), National Association of Chain Drug Stores (NACDS), and the National Community Pharmacists Association (NCPA), submitted formal comments on May 18, 2015, on a proposed Food and Drug Administration (FDA) plan to require pharmacists to take on the cost and responsibility of providing package inserts and patient package inserts.


This is part of a FDA's Proposed Rule to Require the Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products [Docket No. FDA–2007–N–0363] This information is currently distributed in paper form on or within the package from which the product is dispensed. In the proposed rule, the FDA makes it clear that pharmacies will incur net costs due to initial capital costs to access the information, increased search time when accessing the information and the printing cost when a request is received for the information in printed form. The FDA estimates the annualized costs range from $47 million to $89 million and are a shift from manufacturers to pharmacies.


Please click here to read the submitted joint letter.

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