IHS Request to FDA for Exception to the Requirements of the Controlled Substances Act Due to Utilization of an Electronic Prescription Application
Authors: Ruth A. Carter
Publication Year: 2015
Last Updated: 2017-03-30 15:05:49
Journal: U.S. Department.of Justice, Drug Enforcement Administration
Keywords: IHS, FDA, Electronic Prescriptions for Controlled Substances
Short Abstract:
This is inresponse 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.
Abstract:
This is inresponse 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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