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DEA Authority Over Prescribing and Pharmacy Dispensing
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The Drug Enforcement Administration (DEA) is the federal agency responsible for enforcing the controlled substances laws and regulations in the United States. The DEA’s authority over prescribing and dispensing controlled substances comes from the Controlled Substances Act (CSA) which was passed by Congress in 1970[6]. The CSA established five schedules of controlled substances based on their potential for abuse and dependence. It also requires all individuals and companies that manufacture, distribute, dispense, import, export, or conduct research with controlled substances to register with the DEA.
DEA Registration
Any healthcare provider who wants to prescribe, administer, or dispense controlled substances must first obtain a DEA registration number. This applies to physicians, nurse practitioners, physician assistants, pharmacists, hospitals, clinics, retail pharmacies, distributors, and manufacturers. The specific registration required depends on the activities the registrant will engage in. For example, a retail pharmacy needs a pharmacy registration while a physician needs a practitioner registration.
Registration acts as a control measure, allowing the DEA to track and monitor controlled substances from their origin through the distribution system to the end user. All registrants must follow DEA regulations for ordering, recordkeeping, inventory, security, and disposal of controlled substances. Registrations must be renewed every 1-3 years depending on the type[4].
Only DEA-registered practitioners are permitted to prescribe controlled substances. This includes physicians, nurse practitioners, physician assistants, optometrists, dentists, and veterinarians. They must comply with all federal and state laws governing the practice of their profession in order to prescribe controlled substances.
Practitioners can only prescribe controlled substances for legitimate medical purposes within the usual course of professional practice. They are required to complete a full medical evaluation and document the medical necessity in the patient’s chart before prescribing. Practitioners must also discuss the risks and benefits of controlled substance treatment with patients.
There are additional regulations around prescribing Schedule II controlled substances like oxycodone or amphetamines. These medications have the highest potential for abuse and dependence. Schedule II prescriptions cannot be refilled – the patient must obtain a new written prescription from the practitioner each time. Prescriptions also cannot be phoned into the pharmacy except for certain emergency situations.
Only DEA-registered pharmacies with state pharmacy licenses can dispense controlled substances to patients. The pharmacist must verify that the prescription is valid and issued by a DEA-registered practitioner for a legitimate medical purpose. They must also ensure the dosage, directions, and quantity are appropriate and that there are no significant drug interactions or contraindications.
Pharmacists are required to properly label the prescription container and record specific information about the dispensing in a written or electronic log. This includes the patient name, controlled substance and strength dispensed, quantity, practitioner name, and date. Dispensing records must be maintained for at least 2 years and made available for inspection if requested by the DEA.
Recordkeeping & Reporting
In addition to dispensing records, all DEA registrants must also maintain complete and accurate inventories and records of receipt and distribution for all controlled substances. This allows the DEA to track controlled substances through the supply chain.
Registrants must also report thefts or significant losses of controlled substances to the DEA within one business day of discovery. Pharmacies may have additional reporting requirements under state laws, like reporting Schedule II prescriptions filled to a state prescription drug monitoring program (PDMP).
Audits & Inspections
The DEA periodically conducts regulatory audits and inspections of DEA registrants to ensure compliance with the CSA and DEA regulations. This includes on-site inspections of manufacturing facilities, distributors, pharmacies, clinics, and practitioner offices. The DEA also has the authority to inspect all records related to controlled substances.
If violations are found, the DEA can issue fines or administrative penalties depending on the severity. In cases of serious or repeated noncompliance, the DEA may opt to revoke a registrant’s DEA registration which prevents them from handling controlled substances.
Recent Changes
The COVID-19 public health emergency prompted several temporary changes around DEA-registered telemedicine and telehealth services. Practitioners have been allowed to issue prescriptions for controlled substances without an in-person medical evaluation, which expanded patient access to care[5]. The DEA recently proposed making this telemedicine flexibility permanent under certain conditions once the public health emergency ends[5].
States have also implemented new laws and programs to improve controlled substance monitoring and help prevent misuse, abuse, and overdose deaths. For example, most states now require pharmacists to check the state PDMP before dispensing controlled substances to patients.
Conclusion
In summary, the DEA has extensive authority to regulate the prescribing and dispensing of controlled substances through the CSA registration system. Only authorized, licensed practitioners can prescribe controlled substances for legitimate medical purposes, and only licensed pharmacies can dispense them. All registrants must comply with laws, regulations, recordkeeping, reporting, security, and audits. Recent changes are aimed at expanding appropriate patient access while preventing misuse and diversion.
References
[1] California State Board of Pharmacy Laws and Regulations
[2] California Pharmacy Law Book
[3] DEA Pharmacist’s Manual