NATIONALLY RECOGNIZED FEDERAL LAWYERS
Last Updated on: 26th August 2023, 03:14 pm
Controlled Substances and DEA Regulations
Controlled substances are classified into five schedules according to their potential for abuse, medical usefulness, and safety. Pharmacies must obtain a license from the DEA in order to dispense controlled substances, which are also subject to other regulations. In addition, pharmacies and pharmacists must comply with state laws, which often mirror the federal regulations.
The DEA typically audits pharmacies to ensure compliance with the Controlled Substances Act and the DEA’s own regulations. Audits are also typically initiated when there are concerns about a specific pharmacy or pharmacist. These audits are meant to review a pharmacy’s compliance with the applicable regulations. They typically involve a review of the pharmacy’s license, recordkeeping, and security procedures. The DEA will also look at the manner in which controlled substances are controlled, stored, and dispensed. If the DEA finds that a pharmacy is in compliance, the audit will be closed. If the audit reveals that a pharmacy has committed an infraction, the DEA may initiate disciplinary proceedings to impose a civil fine or revoke the pharmacy’s license.
In addition to audits, the DEA regularly conducts investigations of pharmacies and pharmacists based on reports of suspicious activity or illegal dispensing of controlled substances. These investigations typically involve interviews with the pharmacy’s employees, customers, and other pharmacies in the area. The DEA will also look at the pharmacy’s recordkeeping procedures and the manner in which it controls and stores controlled substances. If the DEA finds that a pharmacy or pharmacist has committed an infraction, it may initiate disciplinary proceedings to impose a civil fine or revoke the pharmacy’s license.
The DEA also has the authority to inspect pharmacies without notice. These inspections are typically conducted when the DEA has reason to believe that a pharmacy is not in compliance with the Controlled Substances Act or the DEA’s own regulations. These inspections typically involve a review of the pharmacy’s license, recordkeeping, and security procedures. The DEA will also look at the manner in which controlled substances are controlled, stored, and dispensed. If the DEA finds that a pharmacy is not in compliance, it may initiate disciplinary proceedings to impose a civil fine or revoke the pharmacy’s license.
Audit vs Inspection
An audit is a limited review of a pharmacy’s records to determine compliance with the Controlled Substances Act. An inspection is a more thorough review of records and can include interviews with employees, observations of pharmacy operations, and physical searches.
Consequences of Failing an Audit or Inspection
If the DEA finds that a pharmacy has violated the Controlled Substances Act, it may take disciplinary action against the pharmacy’s registration. Disciplinary actions can include revocation or suspension of registration, civil monetary penalties, and exclusion from participation in Medicare and Medicaid.
If you are contacted by the DEA for an audit or inspection, you should consult with an attorney before consenting to the investigation. An attorney can help you understand your rights and make sure that you do not inadvertently provide information that could be used against you in an enforcement action.
The attorneys at Spodek Law Group have a long history of representing physicians and other health care providers in audits and investigations by the DEA. Our attorneys are experienced in handling civil and criminal investigations by the DEA, as well as other federal and state agencies. We will work with you to ensure that your rights are protected during an audit or investigation.
DEA Investigations and State Laws
In addition to a review of the pharmacy’s compliance with the Controlled Substances Act, a DEA investigation will also focus on the compliance of the pharmacy with state laws and regulations. A pharmacy’s failure to comply with state laws and regulations may result in civil or criminal penalties, as well as disciplinary action by state boards of pharmacy.
The scope of a DEA investigation will be determined by the facts and circumstances surrounding the alleged violations.
However, a typical DEA investigation will include:
- A review of the pharmacy’s compliance with federal and state laws and regulations
- Interviews with employees, customers, and others
- A review of financial records
- Inspection of the physical premises
Penalties for Violations
If the DEA finds that a provider has violated the CSA, it may impose civil or criminal penalties. Civil penalties can include fines of up to $25,000 per violation and suspension or revocation of a provider’s registration to process, distribute, or dispense controlled substances. Criminal penalties can include fines of up to $1 million per violation and imprisonment for up to 20 years.
The DEA may also impose administrative sanctions against providers who violate the CSA. These sanctions can include imposing conditions on a provider’s registration, restricting the types of controlled substances that a provider is allowed to process, distribute, or dispense, and requiring providers to report inventory levels and transactions involving controlled substances.
The DEA has published guidance on how it enforces the CSA. This guidance includes information on how the DEA investigates violations of the CSA and what types of penalties it can impose for these violations.