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What Does DEA Compliance Training Entail?

DEA registrants and their employees have to understand the regulations and requirements set forth by the DEA. Training will equip them to handle controlled substances safely and in a compliant manner. Any clinic, hospital, pharmacy or other healthcare facility that handles controlled substances requires DEA compliance training for sure. While this is not mandatory by law, on a practical front it ensures that all the staff members are well aware of applicable regulations and can work to ensure complete compliance at all times. DEA compliance service providers offer a suite of services that include training packages as well. There are various programs like general compliance training, drug diversion training, safeguarding controlled substances, how to conduct mock DEA audits and more. These could be online or offline.   While every training program will vary in terms of the content base, the topics that are usually covered are: Overview of DEA regulations: The program will first ac...
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How can you store controlled substances following DEA regulations?

Storage is a very important part of DEA controlled substance regulations. The security requirement for control substance drugs demands very safe cabinets. Steel cabinets are usually the best for storing control substance drugs according to the DEA control substance regulations . The storage cupboard must be either bolted, cemented to the floor or the wall which prevents the removal of the cabinet from its storage place. The cabinet should be strong enough to counter any kind of outside breakage or forced entry. Vaults are also chosen by many for storing DEA controlled substance drugs under the DEA controlled substance regulations. The vault must be reinforced by 8 inches of concrete or any sustainable material. The vault should be reinforced to the wall, floor and ceiling securely. The door and frame must prevent forced entry. The vault should be equipped with an alarm system, and it must signal if a forced entry is detected. The alarm system should be connected to the local state pol...

Recordkeeping Requirements for Controlled Substances

All DEA registrants are subject to a host of regulations which include maintaining a clear and complete record of the inventory of controlled substances. The form and period is also prescribed by the Act. The Drug Enforcement Administration (DEA) maintains a strict vigil over the manufacturing, prescribing, administering, dispensing and usage of the controlled substance drugs in tune with the stipulations of the Controlled Substances Act. The prescribed protocols for controlled substances require clear recordkeeping in the stipulated manner. This is applicable to veterinary controlled substances too with specific inventories and records in the form of a veterinary controlled drug log . Moreover, the inventory requirements also extend to the samples of controlled substances provided to healthcare practitioners by the pharmaceutical companies. That’s not all either. Records of controlled substances listed in Schedule I and II have to be maintained separately from all other records of co...

Mere Lock and Key Will Not Suffice for Controlled Substances

 All entities that are registered to handle controlled substances have to abide by a set of strict security requirements to ensure that they are not mishandled or misused in any manner whatsoever. The Controlled Substances Act requires that all DEA registered healthcare providers and other organizations – be it DEA veterinary or others – should institute effective controls and procedures to safeguard against theft and diversion of controlled substances. The standards for the mandated physical security controls and operating procedures are clearly laid out in the Code of Federal Regulations. There are slight variations in the requirements for practitioners and non-practitioners with certain distinctions in what is expected in case of manufacturing and compounding areas, narcotic treatment programs, freight forwarding facilities, etc. The security prerequisites are more stringent for Schedule I and II drugs. For instance, these must be stored in a safe or steel cabinet that is equiv...

A DEA Form for Every Eventuality

The DEA prescribes a set of forms to regulate everything from the registration and license renewal to the ordering of certain drugs, transfer, theft, loss and even surrendering of unused drugs. There are certain drugs that serve a crucial medical purpose, yet, their use is fraught with risks. Unchecked or excessive usage by patients can lead to dependence and even grow into a full-blown depression. Then, there is always the threat of the drugs being misappropriated or stolen, thus leading to misuse and abuse. Such drugs have been termed as controlled substances and are governed by the Controlled Substances Act in our country. The Drug Enforcement Administration (DEA) has been identified as the federal enforcement agency which takes it task pretty seriously. There are specific DEA forms for controlled substances for various aspects of handling the controlled substances with an eye on checking drug diversion, drug trafficking and other related crimes.   Let us take a look at some of...

Changes Regarding DEA Application Regulations

Those applying for DEA registration and existing registrants have to keep abreast of the changes in the regulations to ensure that they do not run afoul even unintentionally on any occasion. The U.S. law clearly mandates that every physician, nurse, veterinarian or pharmacist that prescribes, administers or dispenses controlled substances should have a controlled substance license registration issued by the federal Drug Enforcement Administration (DEA). Any person can apply for the DEA license using the DEA Form 224. Manufacturers, distributors, researchers, importers and exporters should use DEA Form 225. Complete instructions accompany the forms. These forms are available on the DEA website and could also be obtained by contacting the DEA field office or headquarters. However, since May last year, the DEA regulations have been amended to require all applications for both DEA new registration and renewal to be submitted online only. Indeed, from 11th May, 2022, the DEA has stopped ac...

Can Your DEA License be Revoked?

Getting a DEA license is not the end of the road for those dealing with controlled substances. Not only does the license have to be renewed periodically, but it can also be suspended or revoked in the future. The Drug Enforcement Administration (DEA) is responsible for preventing misuse and abuse of controlled substances. Towards this end, it cracks down heavily on both pharmacies and physicians that are guilty of aiding drug diversion in any form. And the age-old weapon in its arsenal is – revocation of license! Indeed, when it comes to controlled substance drugs , all those who are involved in prescribing, dispensing, administering or otherwise handling them must mandatorily get themselves registered with the DEA under the Controlled Substances Act. The registrants get a DEA number which allows them to deal with the controlled substances. Needless to say, prescribing, dispensing or administering controlled substances without a DEA license is illegal and can lead to harsh consequences...