DEA Notice of Application: Purisys, LLC Seeks Bulk Manufacturer Registration for Controlled Substances
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
The U.S. Drug Enforcement Administration (DEA) published a notice on April 3, 2026, announcing that Purisys, LLC, located at 1550 Olympic Drive, Athens, Georgia 30601-1602, applied on February 4, 2026, for registration as a bulk manufacturer of numerous controlled substances under 21 CFR 1301.33(a). The application covers 25 Schedule I substances, including cathinone (1235), lysergic acid diethylamide (7315), heroin (9200), and fentanyl-related substances (9850), plus 35 Schedule II substances such as amphetamine (1100), fentanyl (9801), oxycodone (9143), and morphine (9300). Purisys plans to produce these substances exclusively for creating active pharmaceutical ingredients (APIs), analytical reference standards, clinical trial materials, and starting materials for compounds sold to customers. No other activities, like distribution or research beyond these purposes, are authorized if approved. Registered bulk manufacturers and applicants have until June 2, 2026, to submit electronic comments or objections via https://www.regulations.gov, or request a hearing. Comments receive a tracking number upon submission, but are not immediately public.
AI-generated summary. May contain errors. Refer to official sources for legal decisions.
Key Changes
- Purisys LLC applied for bulk manufacturer registration on February 4, 2026
- Covers 25 Schedule I substances (e.g., heroin 9200, LSD 7315) and 35 Schedule II (e.g., fentanyl 9801, oxycodone 9143)
- Production limited to APIs, reference standards, clinical trials, and starting materials for customer compounds
+ 3 more changes with Pro
Obligations
What this law requires
Maintain registration documentation at the registered location: 1550 Olympic Drive, Athens, Georgia 30601-1602
Submit electronic comments or objections to the Purisys, LLC bulk manufacturer registration application via https://www.regulations.gov on or before June 2, 2026
File written request for hearing on the Purisys, LLC application via https://www.regulations.gov on or before June 2, 2026
Limit bulk manufacturing activities to production of active pharmaceutical ingredients (APIs), analytical reference standards, clinical trial materials, and starting materials for compounds sold to customers only
Prohibit distribution, research, or any activities beyond the explicitly authorized purposes of API production, analytical standards, clinical trials, and starting materials