Why It Matters

The Drug Enforcement Administration placed centanafadine, the newly FDA-approved ADHD drug sold as Simtriyo, in Schedule III of the Controlled Substances Act (CSA), effective Oct. 30, subjecting manufacturers, distributors, prescribers, and pharmacies to federal registration, security, recordkeeping, and prescription requirements. ​

Centanafadine had never been scheduled or legally marketed before this action, making it the first scheduling action for the substance. The DEA issued an immediately effective interim final rule without prior notice and comment under the Improving Regulatory Transparency for New Medical Therapies Act (Pub. L. 114-89), a 2015 amendment to 21 U.S.C. 811(j) intended to expedite scheduling of newly approved drugs so they can be marketed without undue delay following FDA approval.

The Big Picture

The Food and Drug Administration (FDA) approved Simtriyo on July 24 for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients ages 6 and older weighing at least 20 kilograms. The Department of Health and Human Services (HHS) delivered its Schedule III recommendation to DEA on July 18, six days before FDA approved the new drug application.

DEA conducted its own eight-factor review and concluded that centanafadine meets the Schedule III criteria: abuse potential lower than substances in Schedules I and II, currently accepted medical use in the United States, and abuse that may lead to moderate or low physical dependence or high psychological dependence.

The rule gives no estimate of the number of manufacturers, distributors, prescribers, or pharmacies affected. The Office of Management and Budget determined that the rule is a significant regulatory action but is not economically significant under Executive Order 12866.

What Changes for the Supply Chain

Any person who manufactures, distributes, reverse distributes, dispenses, imports, exports, engages in research, conducts instructional activities or chemical analysis with, or possesses centanafadine must obtain the applicable DEA registration unless otherwise exempt under the CSA. Patients who possess centanafadine under a lawful prescription are not subject to registration, security, or inventory requirements.

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The rule's requirements for registered handlers include:

  • Registration: Required under 21 U.S.C. 822, 823, 957, and 958 and applicable DEA regulations before handling the substance, unless an exemption applies.
  • Security: Storage must comply with Schedule III-V security standards under 21 CFR §§ 1301.71-1301.77.
  • Inventory: An initial inventory when a registrant first begins handling controlled substances and a biennial inventory thereafter.
  • Records and prescriptions: Records, reports and prescriptions must comply with applicable DEA regulations, including 21 CFR Parts 1304, 1306, 1311, 1312 and 1317.
  • Disposal: Anyone unwilling or unable to obtain the required DEA registration must surrender or transfer centanafadine in accordance with applicable controlled-substance disposal and transfer requirements.

Manufacturing or distribution may occur only for legitimate purposes consistent with the drug's labeling or for research activities authorized under the Federal Food, Drug, and Cosmetic Act and the CSA. Any activity not authorized by, or in violation of, the CSA may subject the person to administrative, civil or criminal sanctions.

The Law Now and After

Before this rule, 21 C.F.R. § 1308.13 listed chlorphentermine (DEA code 1645) as paragraph (b)(3) under Schedule III stimulants, followed by clortermine (1647) as paragraph (b)(4) and phendimetrazine (1615) as paragraph (b)(5). The rule inserts centanafadine (DEA code 1641) as the new paragraph (b)(3) and redesignates those three substances as paragraphs (b)(4) through (b)(6).

The Schedule III registration, security, inventory, recordkeeping, and prescription controls that now apply to centanafadine are standing CSA and DEA regulatory requirements already in force for other Schedule III substances. This rule applies them to centanafadine for the first time.

The Fight Over the Rule

The interim final rule does not summarize a prior public comment cycle or objections received before its publication. The Federal Register's public comment portal lists a submission on the rulemaking, but the available record does not establish broader organized opposition or support.

Interested parties may submit comments or request a hearing addressing whether centanafadine meets the statutory criteria for placement in Schedule III. The expedited scheduling statute permits DEA to make the interim rule effective before completing the public comment and hearing process.

The Bottom Line

Comments and hearing requests are due Nov. 30. Electronic comments must be submitted by 11:59 p.m. Eastern time, while mailed comments must be postmarked by that date. DEA must receive hearing requests by Nov. 30. After the required proceedings conclude, DEA must issue a final rule.

Comments may be submitted electronically at regulations.gov, referencing Docket No. DEA-1743, or mailed to Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, VA 22152. Address hearing requests to the DEA Administrator at the same street address.

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