Skip to main content

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 controlled substances. In a similar vein, records of Schedule III, IV and V substances must be maintained separately from the regular business records of the DEA-registered healthcare practitioner.



What does it entail?


Recordkeeping is nothing but maintaining a complete and accurate record of the controlled substances on hand along with the date that the inventory was conducted. It can be handwritten, typewritten or in printed form; what is important is that it should be readily retrievable for inspection or audit purposes from the ordinary business records of the DEA-registered practitioners.

An initial inventory has to be taken at the start of business or when the healthcare practitioner obtains the DEA license to prescribe, administer or dispense the controlled substances. This has to be followed by an inventory of all controlled substances on hand at least once in every two years. Moreover, all records related to controlled substances have to be maintained for a minimum period of two years from the date of the last transaction.

In practice, it is advisable to conduct the inventory at more frequent intervals to avoid any chance of discrepancy, loss, theft, etc. This ensures internal accountability and can bring any inconsistency to light immediately as two years is quite a long time to keep track of what might have gone wrong and when. Any diversion or loss can be tracked and reported quickly.

While the DEA does not mandate any specific format for the logbook or recordkeeping, it should include the names and descriptions of the controlled substances, number of dosage units and commercial containers – be it tablets, bottles, etc. It should also indicate the date the controlled substance was received, name of supplier, amount received and authorized person handling the substances. It should be signed or initialled with the authorized person’s name.

How to do it?


Neither does the recordkeeping sound easy nor is it simple to practice. And given all that is riding on maintaining full and proper DEA compliance, it is always better to engage the services of a DEA compliance professional – like Titan Group (https://titangroupdea.com/). They will train, guide and handhold the team to ensure that the recordkeeping and other protocols are in order at all times!

Comments

Popular posts from this blog

What are Controlled Drugs?

Medications that can be abused or cause dependance are classified as controlled drugs. They are subject to strict government regulations at every level with an eye on preventing misuse and abuse. Medical science invented drugs to provide relief from various ailments and enable us to stay healthy. These medications are of different types and work on the human body in myriad ways. While the benefits are wide-ranging, some of them are also known to have a potential of physical or psychological dependance. This can cause addiction, leading to abuse or other kinds of misuse. Considering the risks involved in such drugs, governments across the world take measures to regulate their use even while ensuring access to the patients. Control Measures in USA The United States enacted the Controlled Substances Act (CSA) - as part of the Comprehensive Drug Abuse Prevention and Control Act, 1970 – to control and regulate controlled substance drugs . Accordingly, the Drug Enforcement Administration (DE...

Training Begets DEA Compliance in a Big Way!

Every DEA registrant and their team needs to fully understand the DEA requirements. However, the regulations are complex and wide-ranging. Training is the perfect solution for maintaining full compliance! Every physician, dentist, veterinarian, pharmacy and hospital that prescribes, administers or dispenses controlled substances in the USA is required to get registered with the Drug Enforcement Administration (DEA). These registrants are subject to a host of regulations that are designed to curtail the misuse, abuse and diversion of the controlled substances as they can lead to addiction and other health risks. The regulations cover everything from the ordering and prescribing of the scheduled drugs to the security, inventory, recordkeeping and reporting. The DEA maintains constant oversight with inspections and audits on a regular basis. Any hint of non-compliance can invite an investigation, and the consequences can be detrimental. Therefore, staying in compliance is crucial and DEA ...

Registration and Renewal with the DEA

The DEA has a specific procedure for applying for registration and obtaining a DEA license and number. This also has to be renewed at regular intervals. We delve into the details of the requisite procedures. The Drug Enforcement Administration (DEA) is charged with the responsibility of regulating all aspects of handling the controlled substances. Accordingly, any physician, dentist, veterinarian, scientific investigator, pharmacy, hospital or other person who will distribute, dispense, administer, conduct research, or use in teaching or chemical analysis any controlled substance has to first register with the DEA. In other words, any person or entity that handles controlled substances must be registered with the DEA.   Following are the steps for obtaining a regular or veterinary DEA license : Download the requisite DEA Form 224 or 225 from https://www.deadiversion.usdoj.gov/drugreg/index.html From May 11th, 2022, the DEA requires all applications for registration and renewal to ...