DEA 21 CFR 1301.74b Requirements for Controlled Substances
Suspicious Order Management and Monitoring Software is the tool that can save one from fines and loss of license from the DEA enforcement. A common problem with distribution center and suppliers is they do not have sufficient software to track and monitor suspicious orders. Therefore they are subject to hefty fines as we recently saw in the Walgreens case with an $80 million fine. Below is how the DEA and CSA systems tend to work in licensing, revocation of license and fines.
The Drug Enforcement Administration (DEA) is a centralized body of the United States authorized to combat drug smuggling and its use within the country and also empowered to handle investigations of US drug cases abroad. DEA is a subsidiary of the US Department of Justice and shares parallel jurisdiction with the FBI and ICE and is responsible for enforcing the Controlled Substances Act (CSA).
The CSA has established a structure giving distinct regulations and guidelines. The government uses these DEA Regulations Controlled Substances guidelines to determine the use of controlled substances. The CSA reference for this is DEA 21 CFR 1301.74b Requirements for Controlled Substances. This Act regulates the usage of controlled substances and allows them to be used in the fields of medicine, scientific research and in some industries also. It gives definite guidelines as to which usage is legitimate and which is not.
For manufacturing, selling or using any controlled substance, a person needs to register with the DEA. A detailed record of the usage of such substances needs to be maintained and the same needs to be submitted to the department. The registrants also have to ensure these substances are stored carefully as per the guidelines provided by the DEA.
The DEA drug schedule list is comprised of five schedules – Schedule I to V. The CSA has allocated various drugs and chemicals which have been labeled as controlled substances to each of these schedules depending on the usages of these substances. The substances that have no medical use and selling them is prohibited even with a prescription are included in Schedule I. These chemicals however, can be prescribed by a DEA licensed medical practitioner. If the medical practitioner misuses this power given to him, the CSA authorizes the Administrator or head of DEA to revoke or cancel his membership.
The other four schedules include substances having medicinal value. These substances are manufactured, sold and used as per the guidelines provided by the CSA. The substances are listed in an order starting with the most addictive and dangerous to the ones having the least effect.
The CSA has also listed forty chemicals that have restricted access and some substances which are equivalent to those mentioned in schedule I and II and having no medical use but are not controlled.
The CSA has also set guidelines for the penalties to be levied for illegitimate manufacture, distribution or use of the controlled substances. This also holds good for the people who have been registered under the DEA but have misused the powers given to them.