Search Results for agency_names:"Drug Enforcement Administration"

The Drug Enforcement Administration (DEA) is proposing a new rule to require that all applications and renewals for DEA registration be submitted online. This change will eliminate the current option to submit paper forms, making the process more efficient and cost-effective. The proposal is expected to save money for both the DEA and applicants by reducing errors and the need for corrections, while nearly all current applicants already use the internet for submissions. The rule change also aligns with federal efforts to streamline and modernize regulatory processes.

The Drug Enforcement Administration (DEA) has proposed a new rule to allow healthcare practitioners to prescribe controlled substances via telemedicine, without needing an in-person exam, through a Special Registration framework. This framework permits three types of special registrations: Telemedicine Prescribing Registration for Schedule III-V drugs, Advanced Telemedicine Prescribing Registration for Schedule II-V drugs for certain specialists, and Telemedicine Platform Registration for online platforms to dispense these drugs. These changes, which aim to expand patient access while safeguarding against drug abuse, also require practitioners to perform additional prescription checks and comply with detailed reporting and recordkeeping. Public comments on this proposal are welcome before final implementation.

The Drug Enforcement Administration proposes to make seven fentanyl-related substances permanently controlled under Schedule I of the Controlled Substances Act. These substances, identified as dangerous opioids, are currently regulated under a temporary order due to their potential for abuse and health hazards. If this proposal is finalized, it would enforce permanent restrictions and legal penalties on the handling of these substances, which include para-chlorofentanyl and ortho-chlorofentanyl. The public is encouraged to submit comments on this rule by January 29, 2025.

The final rule from the Department of Justice and the Department of Health and Human Services allows Veterans Affairs (VA) practitioners to prescribe controlled substances to VA patients via telemedicine without needing an in-person medical evaluation by the prescribing practitioner. This is permissible if another VA practitioner has conducted an in-person evaluation. This change provides greater access to care for veterans, especially those in rural or underserved areas, while still implementing safeguards against the misuse of controlled substances. The rule includes requirements for reviewing the patient's electronic health record and state prescription drug monitoring program data before prescribing.

The Drug Enforcement Administration (DEA) temporarily placed a substance called brorphine in Schedule I of the Controlled Substances Act due to its high potential for abuse, lack of accepted medical use, and potential danger to public safety. This action means strict regulatory controls are now in place regarding the manufacturing, distribution, and possession of brorphine. The DEA found brorphine on the illicit market in several countries and associated it with several fatalities in the U.S. Brorphine is a synthetic opioid with effects similar to fentanyl, which poses significant health risks and has been linked to the ongoing opioid epidemic. This temporary scheduling will last for two years and can be extended for an additional year.

In January 2025, the Drug Enforcement Administration and the Department of Health and Human Services published new rules about expanding telemedicine practices. These rules were supposed to take effect on February 18, 2025, but have been delayed to March 21, 2025. This delay aligns with a Presidential order for a "Regulatory Freeze Pending Review," allowing more time for feedback on the rules. The rules allow certain medical professionals to prescribe medications via telemedicine, even without an initial in-person visit, under specific conditions. Public comments about this delay are encouraged, focusing on potential policy, legal, and factual issues.

The Drug Enforcement Administration (DEA) is proposing to place the substance 4-chloromethcathinone (4-CMC) in schedule I of the Controlled Substances Act. This move aims to impose strict regulations similar to other highly controlled drugs, as 4-CMC is known to have a high potential for abuse and no accepted medical use in the U.S. The decision also helps the United States comply with international agreements on psychotropic substances. Public comments on this proposal are accepted until January 29, 2025.

The Drug Enforcement Administration (DEA) has revoked the DEA registration of Xubex Community Pharmacy in Casselberry, Florida. This decision was made because the pharmacy dispensed controlled substances, specifically Schedule II drugs like oxycodone and hydromorphone, without prescriptions. The DEA considered these actions a threat to public health and safety, demonstrating that the pharmacy cannot be trusted to comply with legal requirements. Furthermore, the pharmacy did not request a hearing to dispute these conclusions, leading to the default revocation of its registration.

The Drug Enforcement Administration (DEA) and the Department of Health and Human Services (HHS) have finalized a rule expanding the ability for practitioners to prescribe certain controlled substances for opioid use disorder (OUD) treatment through telemedicine, including audio-only calls. Under these new rules, practitioners can prescribe a six-month supply of these medications after reviewing the patient's prescription drug monitoring program data, with the possibility of extending prescriptions through telemedicine or after a face-to-face evaluation. Additional safeguards include identity verification by pharmacists before filling prescriptions to prevent misuse. The rule aims to continue the telemedicine flexibilities introduced during the COVID-19 pandemic while addressing the opioid crisis and concerns about substance misuse.

The Drug Enforcement Administration (DEA) and the Department of Health and Human Services (HHS) have decided to delay the start date for two rules about using telemedicine to prescribe certain medications to December 31, 2025. These rules include the "Expansion of Buprenorphine Treatment via Telemedicine Encounter," which allows practitioners to prescribe medications for opioid use disorder, and "Continuity of Care via Telemedicine for Veterans Affairs Patients," which permits Veterans Affairs practitioners to prescribe controlled substances via telemedicine under specific conditions. The delay grants additional time to address any questions or issues and follows public feedback, with some comments favoring an immediate start and others requesting a postponement.