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Are You Truly Complying with Controlled Substance Regulations?

The CSA strives to create a closed system for the handling of controlled substances to prevent potential misuse or diversion. Expert assistance can help handlers stay on the right side of the law.

The United States deems certain drugs, chemicals and chemicals used to make drugs as classified based on the acceptable medical use and potential for abuse or dependency. The Controlled Substances Act (CSA) establishes a legal framework to regulate the scheduled drugs that have been designated for control.
 

A comprehensive system of regulatory requirements is in place to protect the public from the dangers of these substances while ensuring that patients have access to them for legitimate medical purposes. These controlled substance regulations apply to all persons and organizations (except the end user) that handle that substance. The Drug Enforcement Administration (DEA) is the federal agency primarily responsible for implementing and enforcing the provisions like:

Registration: It is mandatory for entities that work with controlled substances – like manufacturers, distributors, hospitals, pharmacies and medical practitioners– to register with the DEA and get it renewed on a regular basis. This ensures that every controlled substance is accounted for and under the control of an authorized handler until it reaches the patient or is destroyed.

Recordkeeping: Every registrant is required to maintain records of each controlled substance they manufacture, transport, sell, administer or deliver. Some of them can only be distributed pursuant to a written order; copies of the order form must be transmitted to the DEA with records preserved for two years and made available for government review upon request. They also have to initiate a system to detect suspicious orders and report them to the DEA.

Security: All registrants have to establish effective security measures to prevent and diversion of controlled substances. The controls and procedures include physical security requirements, limiting access to specifically authorized employees, etc.

In addition to this, the DEA is authorized to conduct announced or unannounced inspections of the said establishments to check whether the required security protocols and other requirements are being followed or not. In case of any noncompliance, the DEA can take actions like issuing warning letters, suspending or revoking the registration or imposing fines. Serious violation scan lead to criminal proceedings and imprisonment as well.

While most registrants exercise due diligence to comply with the varied regulatory requirements, an inherent risk of gaps in the process of handling, administering or dispensing the controlled substances looms large. Trouble can arise anytime, that too from the most unexpected avenues, leading to both financial and reputational losses that can cause irreparable damage to the business.

In sum, ensuring full compliance with the regulations governing CSA controlled substances is a tall order indeed. Expert assistance becomes essential to ensure that a manufacturer, distributor or seller does not inadvertently end up running afoul with the law. Fortunately, there are special service providers that offer a full suite of compliance protection and fraud detection services from assessing the imminent risks to providing remedial solutions.
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