Drug Classification

Prescription to Over the Counter "Rx-to-OTC"  Switches
 

Policy 0108

03/01/2001 Introduced
02/01/2006 Revised
02/01/2011 Revised
10/29/2019 Revised

AMCP supports the Food and Drug Administration’s regulatory process that allows the marketing of over-the-counter (OTC) drug products which were previously available by prescription only.  In the process of determining whether a drug product should be classified as prescription only or available as OTC, AMCP encourages that: (1) a range of stakeholders such as health care providers and managed care organizations be included in the evaluation process; (2) procedures to initiate petitions to switch drugs from one status to another be available to stakeholders; and (3) stakeholders take an active role in the FDA's scientific and clinical evaluation of drugs potentially eligible for OTC status. 

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.