The Drug Enforcement Administration has raised aggregate production quotas (APQ) for the active ingredients in Adderall, Ritalin and Concerta, as the nationwide shortage of ADHD medications enters its third year. The agency denied that current medical demand exceeds what its APQ will allow manufacturers to produce, stating that the increases are necessary to support the development of new products.
Effective October 2, the DEA increased the 2025 APQ for d-amphetamine, the primary active ingredient in Adderall, from 21.2 million grams to 26.5 million grams. It also increased the APQ for methylphenidate, better known by brand names Ritalin and Concerta, as it has done once before since the shortage began to affect those medications in late 2022.
“DEA has determined that although [both] APQs are adequate to address both the domestic and foreign medical demand, they are insufficient to accommodate an unexpected rise of quota requests for product development activities,” the agency stated in its October 2 notice. “The proposed increases are to support manufacturers’ product development activities toward obtaining FDA approval.”
Amphetamine is a central nervous system (CNS) stimulant, a category that includes many other commonly used substances like methamphetamine, cocaine, caffeine and nicotine. Its chemical structure is made up of two isomers, d-amphetamine and l-amphetamine, which are mirror images—like a left hand and a right hand. Adderall contains both, but d-amphetamine, short for “dextroamphetamine,” is the more potent of the two. That’s why generic versions of Adderall are often labeled “dextroamphetamine-amphetamine mixed salts,” or some variation along those lines.
This is the first time the DEA has ever adjusted the APQ for sales of Adderall and its generic versions. The d-amphetamine cap of 21.2 million hasn’t budged since 2021, the year the agency began assigning APQ by specific isomer rather than a larger lump sum to just “amphetamine.”
In 2021, the APQ for methylphenidate was 57.4 million grams. The DEA then slashed it to 41.8 million grams, then during the shortage raised it to 53.3 million grams. The October 2 adjustment brings the APQ to 58.3 million grams.
In September the DEA also increased APQ for lisdexamfetamine, the active ingredient in Vyvanse, from 32.7 million grams to 39.9 million grams. Vyvanse is a similar-but-different CNS stimulant approved for treatment of ADHD, as well as for binge-eating disorder. The agency had previously increased its APQ in September 2024. Both of those changes were technically accompanied by increases in APQ for d-amphetamine, but only for use as part of the synthesis process for lisdexamfetamine products—not for sale as an ingredient in Adderall or its generics.
Slide from DEA presentation on its online portal for APQ applicants
Vyvanse went generic in 2023, but this has yet to make much of an impact on the shortage. Generics have gotten off to a rocky start, with issues ranging from the DEA’s failure to assign APQ allotments to numerous reports of inconsistent potency. There are currently two ongoing recalls for lisdexamfetamine products.
All medications designated Schedule I or II under the Controlled Substances Act are assigned APQ, and that sum total is then divvied up between the various DEA-licensed manufacturers that have applied for quota allotments. But APQ are often gravely out of sync with actual demand—they’re set about two years in advance, in a somewhat arbitrary fashion, and are nontransferrable regardless of whether a company has been assigned more or less than it intends to use. Demand itself also tends to be underestimated because those estimates derive in large part from sales data, which of course reflect sales capped by APQ in the first place. The DEA also controls the quantities of medications that can be stocked by individual pharmacies.
Medical demand increased during COVID-19 pandemic-era telemedicine prescribing, but the DEA maintains that “diversion” risk outweighs the benefits of increasing the supply. At publication time at least six companies that manufacture methylphenidate and at least five that manufacture amphetamine salts are reporting shortages of one or more of their formulations.
The agency has blamed overseas manufacturing issues, or pharma companies failing to max out their quotas. But oral formulations are typically pretty straightforward to produce, and not the kinds of medications that get caught up in extended delays at a manufacturing plant. The DEA is avoiding acknowledging that its APQ are the root of the problem, or that barring access to pharmaceutical stimulants increases demand for the methamphetamine-based counterfeit Adderall tablets it keeps warning everyone to avoid.
Top image via International Trade Administration. Inset graphic (cropped) via Drug Enforcement Administration.
