💊DEA Adjusts Production Quota for Lisdexamfetamine and d-Amphetamine
Adjustment to the Aggregate Production Quota for Lisdexamfetamine and d-Amphetamine (for Conversion) for 2025 Pursuant to 21 U.S.C. 826(h)
Summary
The Drug Enforcement Administration (DEA) is adjusting the 2025 aggregate production quota for the schedule II controlled substances lisdexamfetamine and d-amphetamine (for conversion). In making this determination, DEA has considered the factors set forth in 21 CFR 1303.13(b) in accordance with 21 U.S.C. 826(a) and is expediting publication of this determination to comply with the timeframes specified in 21 U.S.C. 826(h)(1).
Agencies
- Justice Department
- Drug Enforcement Administration
Business Impact
$$$ - High
This regulation affects manufacturers of controlled substances by adjusting the Aggregate Production Quota (APQ) for lisdexamfetamine and d-amphetamine in response to a domestic shortage. The increase in quotas is essential for meeting both domestic and global demand, impacting production capacity and business operations for those in the pharmaceutical sector.