Pharmacy List Of Controlled Drugs
The Federal Comprehensive Drug Abuse Prevention and Control Act of 1970, more commonly known as the Controlled Substances Act, became effective on May 1, 1971., This federal law contains 3 different titles. Title I deals with the establishment of rehabilitation programs for drug abusers, Title II addresses the registration and distribution of controlled substances, and Title III discusses issues related to the importation and exportation of controlled substances. The main segment of interest to pharmacists is Title II.
This RxLegal column is the first of a 4-part series that provides an overview of key components of this important federal law. The goal of the Controlled Substances Act is to improve the manufacturing, importation and exportation, distribution, and dispensing of controlled substances. To achieve this goal, manufacturers, distributors, and dispensers of controlled substances must be registered with the Drug Enforcement Administration (DEA), the agency charged with enforcement of the Act on the federal level.
Registration of these entities with the DEA results in the formation of a “closed system” for controlled substances distribution. This closed system allows for controlled substances to be traced from initial manufacture to final dispensing to the patient. Controlled substances are generally defined as medications that are considered easily abusable. Under the Controlled Substances Act, these medications are categorized into 5 schedules.
Definitions of each schedule with corresponding examples of medications are presented in. Schedule I medications have the highest abuse potential, while medications in Schedule V have a low abuse potential.
In addition to the schedules, the Controlled Substances Act contains information on scheduled listed chemical products or SLCPs. These listed chemicals are products that contain ephedrine, pseudoephedrine, or phenylpropanolamine that may be marketed or distributed legally in the United States as nonprescription drugs. Of note, some states have passed laws allowing for the medical or recreational use of marijuana. These state laws do not alter the fact that marijuana remains a Schedule I medication under federal law.
In addition, medications may be removed or added to a schedule or be switched from one schedule to another. The US Attorney General has the authority to add, remove, or switch. The Attorney General generally works with the Secretary of the Department of Health and Human Services to determine a medication’s schedule. Every pharmacy that dispenses controlled substances is required to register with the DEA. Prior to obtaining a DEA registration, a pharmacy must have a state license for operation. A DEA pharmacy registration is obtained by completing the Application for New Registration (ie, DEA Form-224). Instructions for completing the form are found on the US Department of Justice DEA Office of Diversion Control Web site.
Commonly Used Controlled Substances List
Pharmacies can also apply electronically for a new or renewed registration. Once approved, a pharmacy must renew registration every 3 years. Some drug products such as pseudoephedrine, phenylpropanolamine, and ephedrine-containing medications are classified as SLCPs as described previously. These chemicals may be used inappropriately to compound illegal substances such as methamphetamine (ie, crystal).
If a pharmacy were to engage in the wholesale distribution of these chemicals, a DEA chemical registration would be required in addition to the registration for handling controlled substances. This is rarely the case, because most pharmacies are retail distributors of these chemicals (ie, regulated sellers) and not wholesale distributors. A regulated seller legally sells the aforementioned chemicals only for personal use either directly to walk-in customers or via other face-to-face transactions. Once granted, a DEA registration may be suspended or revoked by the US Attorney General. Reasons for suspending or revoking a registration include the following:.
Being excluded from Medicare or Medicaid programs The Attorney General may also deny registration or renewal. In so doing, he or she determines whether issuing the registration or renewal would be inconsistent with the public interest. This decision is made by weighing factors such as state licensing board or professional disciplinary authority recommendations, compliance with laws regarding controlled substances, and a prior conviction record related to any aspect of controlled substances (ie, manufacture, distribution, or dispensing). The second article in this series will focus on requirements for controlled substances prescriptions.
List of Controlled Substances (December 2018) This document is a general reference and not a comprehensive list. This list describes the basic or parent chemical and does not describe the salts, isomers and salts of isomers, esters, ethers and derivatives which may also be controlled substances. Scheduling Actions Controlled Substances List I and II Regulated Chemicals Exempted Lists Exempt Anabolic Steroid Products (February 6, 2015) Exempt Chemical Preparations (November 7, 2017) For Application Dates Through December 31, 2016 Exempted Prescription Products (October 24, 2018) Lists of Controlled Substances Disclaimer of the Controlled Substances Act ( et seq.) (CSA) lists substances which were controlled in 1970 when the CSA was enacted. Since then many substances have been added, removed, or transferred from one schedule to another.
The current list of controlled substances can be found in of the most recent issue of and the final rules which were published in the Federal Register subsequent to the issuance of the CFR. These lists describe the basic or parent chemical and do not describe the salts, isomers, salts of isomers, esters, ethers, and derivatives which may be controlled substances. These are not comprehensive lists so please note that a substance need not be listed as a controlled substance to be treated as a scheduled substance for criminal prosecution. The 'Other Names' column, provides some examples of alternate names for certain compounds, and in some instances provides examples of 'positional isomers'. If outside parties want to ensure that a compound is not considered a scheduled substance or listed chemical, they should write the DEA, Drug and Chemical Evaluation Section (DRE), Diversion Control Division, 8701 Morrissette Drive, Springfield, Virginia 22152, for an official determination. A substance (not included on these lists) may also be regulated as a controlled substance analogue. A controlled substance analogue is a substance which is intended for human consumption, is structurally substantially similar to a schedule I or schedule II substance, is pharmacologically substantially similar to a schedule I or schedule II substance, or is represented as being similar to a schedule I or schedule II substance and is not an approved medication in the United States.
Controlled Drugs
See (32)(A) for the definition of a controlled substance analogue and for the schedule.