DEA Seeks Public Input on Next Year's Controlled-Drug Production Limits
Published Date: 11/10/2026
Notice
Summary
The DEA is setting limits on how much of certain controlled drugs and chemicals can be made in 2027. This affects drug makers and anyone involved in producing or handling these substances. They’re asking for public comments by December 10, 2026, before finalizing the amounts, which helps keep drug supply safe and balanced.
Analyzed Economic Effects
6 provisions identified: 4 benefits, 2 costs, 0 mixed.
2027 Production Limits Set for Controlled Substances
The DEA is proposing the 2027 aggregate production quotas (APQs) for Schedule I and II controlled substances and assessments of annual needs (AANs) for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. These APQs/AANs set specific gram-based limits on how much of each listed drug or chemical may be manufactured or imported for use in the United States in 2027.
Proposed Lower Quotas for Several Opioids
DEA proposes reduced 2027 APQs for several schedule II opioids — including fentanyl, hydrocodone (for sale), hydromorphone, oxycodone (for sale), and oxymorphone (for sale) — based on FDA's prediction that medical usage of schedule II opioids will decline an average of 9.68 percent from 2026 to 2027. The notice also proposes lower APQs for acetyl fentanyl and heroin compared to their 2026 proposed revised APQs, and states DEA believes these decreases will not affect manufacturers' ability to meet estimated medical, research, export, or reserve needs.
Higher Quotas for ADHD Stimulant Medicines
DEA proposes higher 2027 APQs for certain Schedule II stimulants used to treat ADHD — including d-amphetamine (for sale), d,l-amphetamine, lisdexamfetamine, and methylphenidate — to address projected increases in medical use and reported shortages. FDA predicted a 3.93 percent average increase in schedule II stimulant medical usage for 2027, FDA estimated a 3.90 percent individual increase for d-amphetamine and d,l-amphetamine, and DEA's IQVIA-based projection estimated a 6.98 percent increase for those amphetamine products.
Pentobarbital Increase to Build API Reserve
DEA is proposing a higher 2027 APQ for pentobarbital than the 2026 established APQ to support Executive Order 14336 (Ensuring American Pharmaceutical Supply Chain Resilience) and to allow for a reserve stockpile of the active pharmaceutical ingredient for essential medications at the request of the Administration for Strategic Preparedness and Response (ASPR).
DEA's Diversion Estimates Will Reduce Quotas
In compliance with 21 U.S.C. 826(i), DEA calculated national diversion estimates for five covered controlled substances and will consider these when setting 2027 APQs. The combined diversion estimates listed are: fentanyl 208 grams, hydrocodone 135,849 grams, hydromorphone 1,177 grams, oxycodone 407,717 grams, and oxymorphone 97 grams.
More Quota for MDMA and Ibogaine Research
DEA proposes higher 2027 APQs for the Schedule I substances MDMA and ibogaine to support increased research and clinical trials related to potential treatments for conditions including post-traumatic stress disorder (PTSD) and depression. DEA links this increase to Executive Orders: E.O. 14379 (Addressing Addiction Through the Great American Recovery Initiative, Jan. 29, 2026) and E.O. 14401 (Accelerating Medical Treatments for Serious Mental Illness, Apr. 18, 2026).
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