A DEA inspection can happen at regular, set intervals or can happen unannounced. A drug or narcotics company has to take proper steps to ensure that it is smooth.
The Drug Enforcement Agency (DEA) is a federal agency that has oversight of the vast responsibility of monitoring the supply and distribution of all drugs in the entire country. This means that every medical practitioner who prescribes drugs, as well as anyone involved in the manufacture, supply or sale of drugs, has to be registered with the DEA.
Inspections form one of the most important mechanisms in which the DEA carries out its work. These DEA inspections are carried out through Diversion Investigators. The DEA has been steadily increasing the frequency and reach of its inspections. These inspections cover those involved directly or indirectly with the manufacture, distribution, retailing, import and export of drugs and narcotic substances.
Preparing for a DEA inspection
Since a DEA inspector can come unannounced; there are some steps any of those who are subject to a DEA inspection can take to get prepared for a DEA inspection.
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- The first premise to successfully undergoing a DEA inspection is to understand the scope of the investigation. This requires a little knowledge of the existing rules.
- Since the DEA inspectors audit facilities, they start by talking to a responsible person. So, organizations need to designate a person for this. This person will be the one who will guide the DEA inspectors in the facility and interact with them during the inspection.
- The organization should keep regularly updated records, reports and audits in place to show the DEA inspectors whenever they arrive at the facility. These should ideally be kept in one location to avoid confusion or difficulty of access at the time of a DEA inspection.
- These should have full details of the substances they receive, process and remit out of their facility. This will not only make the auditor's work easy; it will also clear them of any potential suspicion.
- Ensure that drugs and narcotic substances that enter and leave the facility are compliant with DEA requirement. Having a checklist and conducting mock DEA inspections are a good practice to ensure these.
- Securing and documenting of controlled substances that are due for destruction or return is very important
- The designated person in the organization can ask for the investigators' credentials and proof of identity. They can also ask them if this is a cyclical (routine) or standalone DEA inspection.
- Any comments, suggestions, observations, criticisms, or recommendations the investigators make during the DEA inspection should be made note of immediately
- The designated employee can ask the DEA inspectors questions relating to any aspect of the inspection. Conversely, they should also answer questions posed to them. If the employee doesn't know, it is a good idea to say so instead of groping for an answer.
- It is a good practice to make a photocopy of all records the investigators access and raise questions about
- The designated employee should take a DEA receipt, called the "DEA Form 12" when the DEA inspectors take a drug or an original record from the premises. This form lists all these items.
- When any records or part of the inventories being inspected are found missing, this should be immediately made note of.