On December 29, 2022, President Biden signed the Consolidated Appropriations Act of 2023. Section 1264 amended Section 309A(a)(5) of the Controlled Substances Act. Section 309A(a)(5) provided that controlled substances could only be administered to a patient within 14 days of the pharmacy delivering the medication to a practitioner. The amendment changes the number of days from 14 to 45 days. Buprenorphine is a Schedule III controlled substance and one of the three FDA-approved treatments for opioid use disorder. Injectable buprenorphine is a long-acting medication administered by a health care practitioner to deliver a steady dose over time, which could help increase treatment adherence and reduce the risk of diversion. However, the 14-day limit served as a significant barrier to care with injectable buprenorphine for many with OUD, as it did not take into consideration the coordination required for prescription processing, insurance coverage and payment, delivery and receipt, and appointment scheduling and attendance. If a patient was unable to pick up the medication within the given time frame, the medication would have had to be disposed of, which not only would put the patient at risk but also would waste valuable health care resources.
Aimed Alliance supports the expansion of the 14-day limit. A 45-day limit will provide practitioners, patients, pharmacies, and insurers the necessary time to coordinate the administration of injectable buprenorphine and avoid the waste associated with mandatory product disposal.
Last Updated on March 28, 2023 by Aimed Alliance
