By EAS Senior Consultant Karen Famiglietti
Everyone has read recent newspaper and internet stories about the rise in heroin abuse and its relationship with pharmaceutical opiates that were originally prescribed for legitimate medical reasons. Unfortunately, this problem has been around since the Civil War when morphine was given to soldiers for horrific injuries, and the soldiers became dependent on that narcotic. Any controlled substance—narcotics, depressants, or stimulants—has the potential for abuse.
It is the responsibility of the U.S. Food and Drug Administration (FDA) to protect the public health by assuring the safety, efficacy and security of human and veterinary drugs, but the U.S. Drug Enforcement Administration (DEA) is responsible for a subgroup of drugs—controlled substances. A controlled substance differs from a regular prescription drug in that controlled substances have the potential for physiological and/or psychological abuse and have been designated as controlled under U.S. law or international treaty.
The DEA is responsible for preventing the diversion of controlled substances and listed chemicals (used to manufacture illicit drugs) from their legitimate medical use to illicit drug trafficking. To prevent the diversion of legitimate controlled substances and listed chemicals, DEA registers and issues individual registration numbers to all businesses that import, export, manufacture or distribute controlled substances; all medical professionals licensed to dispense, administer or prescribe controlled substances; and all pharmacies authorized to fill prescriptions.
When a business or individual is issued a DEA registration, that business or individual is responsible for keeping all controlled substances under their control from being used for illegal purposes. This is accomplished by requiring each DEA registrant to keep certain records and maintain specific security measures to manage their controlled substances. The records allow the registrant to know the kinds and amounts of controlled substances under their supervision at any time. There are different security requirements for specific controlled substances, depending on their potential for abuse.
When DEA investigators conduct a regulatory investigation of a business establishment, their primary purpose is to assure that no controlled substances are being diverted illegally. The investigations are required under federal law and are usually unannounced. The investigators will take an inventory of controlled substances on hand and review records. The investigators will usually audit individual controlled substances using records and documents provided by the business.
During the DEA regulatory investigation, the DEA investigators will attempt to account for every dosage unit of controlled substance at the location during a three-month to one-year period. The investigators accomplish this by reviewing all controlled substance records including records of receipt, sales or dispensing, destruction, theft or loss, and any other record relating to controlled substances.
The investigation will also include a review and testing of the security measures for all controlled substance storage locations at the business. This includes providing the names and personal information of employees having access to controlled substances. The registrant must check the background of all employees with access to controlled substances to ensure they have not been convicted of a drug related felony or used controlled substances illegally.
Depending on the results of the regulatory investigation, the investigators may use the visit to educate the registrant. If deficiencies are found, DEA may issue a Letter of Admonition requiring a written response describing the actions to correct any deficiencies. If more serious deficiencies are noted, the registrant may be subject to a formal administrative hearing or federal civil or criminal charges.
A regulatory investigation is one of the tools DEA uses to ensure that controlled substances are used for legitimate reasons.