Authors: Ruth A. Carter

Publication Year: 2015

Last Updated: 2017-03-30

Journal: U.S. Department of Justice, Drug Enforcement Administration

Keywords: IHS, Indian Health Services, FDA, Food and Drug Administration, DEA, Drug Enforcement Administration, Electronic Prescriptions, Controlled Substances

Abstract:

This is in response to your letter dated April 27, 2015, to the Drug Enforcement Administration (DEA). On behalf ofindian Health Service (IHS), and pursuant to Title 21, C_ode of Federal Regulations, Section 1307.03 (21 C.F.R. § 1307.03) you requested an exception to the conditions of 21 C.F .R. Part 1311, Subpart C. Specifically, you requô€€¨sted an exception to 21 C.F .R. § § 1311.115, 1311.120(b )(9), (b )(13), (b )(23), (b )(25), 1311.150, l 311.215(b ), and 1311.300 because IHS anticipates completion of software development, testing, certification, and release to bring IRS' s Resource and Patient Management System Electronic Health Record (RPMS/EHR) into conformity with the Interim Final Rule (IFR) titled, Electronic Prescriptions for Controlled Substances by December 2018. This IRF became effective June 1, 2010.

Pursuant to 21 C.F.R. § 1307.03, the Administrator of the DEA may grant an exception to the application of the regulations contained in chapter II of Title 21 of the Code of Federal Regulations; however, the Administrator may not grant any exceptions to the requirements of the Controlled Substances Act. This authority is delegated to the Deputy Assistant Administrator, Office of Diversion Control.

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