Drug Classification
Abuse Deterrent and Tamper Resistant Formulations
Policy 1802
04/23/2018 Introduced | AMCP encourages the U.S. Food and Drug Administration (FDA) to use its expertise to establish standards for the definition of “abuse-deterrent” and “tamper resistant.” The Agency should also require that manufacturers of those products undertake reasonable post-marketing surveillance studies that will help assess the impact of the products on both the abuse of the specific product, as well as overall rates of abuse. Because opioids may vary in their clinical effectiveness and abuse potential, AMCP supports expanding the ability of health plans to clinically manage these products. Therefore, AMCP does not support mandating the use of “abuse deterrent” and “tamper resistant products.” AMCP maintains that such products are not clinically necessary for all patients. |
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